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Evidence Record

evt_NCT00490139_v190_v191_96e341a53167

NCT00490139 · ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

View field-level diff Canonical JSON Supersession index ClinicalTrials.gov
Superseded Evidence Record

This page preserves the immutable v0.1.2 record. Its current successor is evt_NCT00490139_v190_v191_3123eaf8ae6b.

Severity is deterministic, reproducible, uncalibrated triage metadata, not validated review priority or proven wrongdoing. This page states what the registry evidence supports and what it does not support.
Triage severity
Triage: Low
Category
Results Reconciliation
Versions
v190 to v191
Timing
Late Recruitment

Claims Supported

  • TrialDiff compared ClinicalTrials.gov record version 190 to version 191 for NCT00490139.
  • The JSON Patch for this comparison has hash fa3c641377f8e3ae6ebb703ca52b4eeede4c9fb7ab047d7b18bebaf50fa12dd8.
  • The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.
  • The deterministic triage label was low; before timing adjustment it was low.
  • The triage label is uncalibrated metadata, not a validated review-priority finding.
  • The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting, secondary_outcome_removed_after_primary_completion.
  • The timing context for the from-version record was late_recruitment.
  • The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /protocolSection/outcomesModule/secondaryOutcomes/4/measure, /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/5, /protocolSection/outcomesModule/secondaryOutcomes/5, /protocolSection/outcomesModule/secondaryOutcomes/5, /hasResults, /resultsSection.
  • An outcome path changed between versions 190 and 191 in a patch that also carried a hasResults or resultsSection co-occurrence signal.
  • The JSON Patch removed a whole secondary outcome item after primary completion between versions 190 and 191; when a TO-version outcome list is available, reindex-only removals are excluded.

Claims Not Supported

  • That the amendment was scientifically unjustified.
  • That the change constitutes misconduct or wrongdoing.
  • That sponsor intent can be inferred from this registry change.
  • That the change caused or altered the trial's results.
  • That the change was or was not disclosed in a manuscript.
  • That TrialDiff determines regulatory compliance or non-compliance.
  • That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.
  • That event-class membership is a validated global review-priority ranking.

Neutral Review Question

What source document explains this registry amendment, and does it change interpretation of the trial record?

Citation

TrialDiff Evidence Record evt_NCT00490139_v190_v191_96e341a53167. ClinicalTrials.gov NCT00490139, versions 190-191. Evidence version 1.

Event Classes

outcome_edit_cooccurs_with_results_postingsecondary_outcome_removed_after_primary_completion

Changed Paths

/protocolSection/statusModule/statusVerifiedDate
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/statusModule/resultsFirstSubmitQcDate
/protocolSection/statusModule/resultsFirstPostDateStruct
/protocolSection/outcomesModule/primaryOutcomes/0/measure
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
/protocolSection/outcomesModule/primaryOutcomes/0/description
/protocolSection/outcomesModule/secondaryOutcomes/0/measure
/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/0/description
/protocolSection/outcomesModule/secondaryOutcomes/1/measure
/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/1/description
/protocolSection/outcomesModule/secondaryOutcomes/2/measure
/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/2/description
/protocolSection/outcomesModule/secondaryOutcomes/3/measure
/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/3/description
/protocolSection/outcomesModule/secondaryOutcomes/4/measure
/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/4/description
/protocolSection/outcomesModule/secondaryOutcomes/5
/protocolSection/outcomesModule/secondaryOutcomes/5
/protocolSection/outcomesModule/secondaryOutcomes/5
/hasResults
/resultsSection

View the field-level diff for before/after values on each changed path.

Deterministic Rules

No deterministic rules recorded.

Provenance

Package generation
v0.1.2
Succeeded by
evt_NCT00490139_v190_v191_3123eaf8ae6b
Patch hash
fa3c641377f8e3ae6ebb703ca52b4eeede4c9fb7ab047d7b18bebaf50fa12dd8
Canonical hash
623f7e83eb6830c5a047e5f2ca63c143ba91f1727ca1f61de30cbac323e21b25
Rule set hash
318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86
From snapshot
3fc603bb2a616bd872535930bc88ac3c2ef35cf79b7cb2c936a283dc39498544
To snapshot
a939a6f051c270517e3e2c7c0f1f37f642dedfa9e5b0084b3f06eed7a9c22de8
Patch source
ctgov_internal_history
Generated at
2026-07-31T00:42:12.000Z
Source URL
Registry payload

Canonical JSON Preview

Stored payload 
{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/resultsFirstSubmitDate",
    "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/5",
    "/protocolSection/outcomesModule/secondaryOutcomes/5",
    "/protocolSection/outcomesModule/secondaryOutcomes/5",
    "/hasResults",
    "/resultsSection"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT00490139_v190_v191_96e341a53167. ClinicalTrials.gov NCT00490139, versions 190-191. Evidence version 1.",
  "claims_not_supported": [
    "That the amendment was scientifically unjustified.",
    "That the change constitutes misconduct or wrongdoing.",
    "That sponsor intent can be inferred from this registry change.",
    "That the change caused or altered the trial's results.",
    "That the change was or was not disclosed in a manuscript.",
    "That TrialDiff determines regulatory compliance or non-compliance.",
    "That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.",
    "That event-class membership is a validated global review-priority ranking."
  ],
  "claims_supported": [
    "TrialDiff compared ClinicalTrials.gov record version 190 to version 191 for NCT00490139.",
    "The JSON Patch for this comparison has hash fa3c641377f8e3ae6ebb703ca52b4eeede4c9fb7ab047d7b18bebaf50fa12dd8.",
    "The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.",
    "The deterministic triage label was low; before timing adjustment it was low.",
    "The triage label is uncalibrated metadata, not a validated review-priority finding.",
    "The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting, secondary_outcome_removed_after_primary_completion.",
    "The timing context for the from-version record was late_recruitment.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /protocolSection/outcomesModule/secondaryOutcomes/4/measure, /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/5, /protocolSection/outcomesModule/secondaryOutcomes/5, /protocolSection/outcomesModule/secondaryOutcomes/5, /hasResults, /resultsSection.",
    "An outcome path changed between versions 190 and 191 in a patch that also carried a hasResults or resultsSection co-occurrence signal.",
    "The JSON Patch removed a whole secondary outcome item after primary completion between versions 190 and 191; when a TO-version outcome list is available, reindex-only removals are excluded."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "results_reconciliation"
    ],
    "category": "results_reconciliation",
    "deterministic_rules": [],
    "event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting",
      "secondary_outcome_removed_after_primary_completion"
    ],
    "rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
    "severity": "low",
    "severity_pre_timing": "low",
    "timing_context": "late_recruitment",
    "triage_label": "low",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/primaryOutcomes/0/description",
          "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
          "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/5"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT00490139_v190_v191_96e341a53167",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2014-07"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2014-07-30"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2014-08-18"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitDate",
      "value": "2014-07-30"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
      "value": "2014-07-30"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
      "value": {
        "date": "2014-08-18",
        "type": "ESTIMATED"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "value": "Disease-free Survival (DFS)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "value": "From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "value": "Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer (SPC), or death from any cause.\nDFS was estimated using the Kaplan Meier method.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who had disease free survival for the indicated years."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
      "value": "Overall Survival (OS)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
      "value": "From randomization until death due to any cause (median follow-up of 4.5 years)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
      "value": "Overall survival is defined as the time from randomization until death due to any cause.\nOverall survival was calculated in years as (date of death minus the date of randomization +1) divided by 365.25.\nThe percentile data values presented here indicate the percentage (99, 98, 97, 96, 95 and 90 percent) of participants who survived for the indicated years."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
      "value": "Time to Recurrence"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
      "value": "From randomization until the date of the first occurrence of a disease recurrence (median follow-up of 4.5 years)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
      "value": "Time to recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a disease recurrence (local, regional or distant).\nThe percentile data values presented here indicate the percentage (95, 90, 85, and 80 percent) of participants who did not have disease recurrence for the indicated years."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
      "value": "Time to Distant Recurrence"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
      "value": "From randomization until the date of the first occurrence of distant recurrence (median follow-up of 4.5 years)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
      "value": "Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of distant recurrence (including central nervous system recurrence).\nThe percentile data values presented here indicate the percentage (95, 90, 85 and 80 percent) of participants who did not have distant recurrence for the indicated years."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
      "value": "Time to Central Nervous System Recurrence"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
      "value": "From randomization until the first central nervous system recurrence (median follow-up of 4.5 years)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
      "value": "Time to central nervous system recurrence is defined as the time from randomization until the first central nervous system recurrence.\nBoth brain metastasis and meningitis carcinomatosa were considered.The percentile data values presented here indicate that 95 percent of participants did not have central nervous system recurrence for the indicated years."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
      "value": "DFS Ignoring Non-breast Second Primary Malignancies"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
      "value": "From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
      "value": "Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer, or death from any cause.\nDFS was estimated using the Kaplan Meier method.\nThe non-breast second primary malignancies were not considered events.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who did not have DFS ignoring non-breast second primary malignancies for the indicated years."
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5"
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5"
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5"
    },
    {
      "op": "replace",
      "path": "/hasResults",
      "value": true
    },
    {
      "op": "add",
      "path": "/resultsSection",
      "value": {
        "adverseEventsModule": {
          "description": "SAEs and non-serious AEs are reported for the Safety Population, comprised of all randomized participants who were administered at least one dose of investigational targeted treatment, as recorded on the "administration of study drug" Case Report Form pages, but excluding any post-event treatments and not considering compliance.",
          "eventGroups": [
            {
              "description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
              "id": "EG000",
              "otherNumAffected": 1928,
              "otherNumAtRisk": 2061,
              "seriousNumAffected": 430,
              "seriousNumAtRisk": 2061,
              "title": "Lapatinib plusTrastuzumab"
            },
            {
              "description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
              "id": "EG001",
              "otherNumAffected": 1861,
              "otherNumAtRisk": 2076,
              "seriousNumAffected": 352,
              "seriousNumAtRisk": 2076,
              "title": "Trastuzumab Followed by Lapatinib"
            },
            {
              "description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
              "id": "EG002",
              "otherNumAffected": 1887,
              "otherNumAtRisk": 2057,
              "seriousNumAffected": 431,
              "seriousNumAtRisk": 2057,
              "title": "Lapatinib"
            },
            {
              "description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
              "id": "EG003",
              "otherNumAffected": 1652,
              "otherNumAtRisk": 2076,
              "seriousNumAffected": 292,
              "seriousNumAtRisk": 2076,
              "title": "Trastuzumab"
            }
          ],
          "frequencyThreshold": "5",
          "otherEvents": [
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1514,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1038,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1278,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 401,
                  "numAtRisk": 2076
                }
              ],
              "term": "Diarrhoea"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 394,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 393,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 381,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 286,
                  "numAtRisk": 2076
                }
              ],
              "term": "Nausea"
            },
            {
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                  "groupId": "EG003",
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              "term": "Abdominal Pain"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                {
                  "groupId": "EG002",
                  "numAffected": 0,
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                {
                  "groupId": "EG003",
                  "numAffected": 3,
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              ],
              "term": "Atrial Fibrillation"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
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                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 4,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 2,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 6,
                  "numAtRisk": 2076
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              ],
              "term": "Dyspnoea"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 2,
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
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                {
                  "groupId": "EG003",
                  "numAffected": 2,
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              ],
              "term": "Fatigue"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 4,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Rash"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
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                {
                  "groupId": "EG003",
                  "numAffected": 5,
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              ],
              "term": "Colon Cancer"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 2,
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              ],
              "term": "Pulmonary Embolism"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 3,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 5,
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              ],
              "term": "Sepsis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Immune system disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
                  "numAffected": 1,
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                {
                  "groupId": "EG003",
                  "numAffected": 4,
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              ],
              "term": "Hypersensitivity"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
                  "numAffected": 6,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 3,
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              ],
              "term": "Mastitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Blood and lymphatic system disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
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                {
                  "groupId": "EG003",
                  "numAffected": 7,
                  "numAtRisk": 2076
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              ],
              "term": "Thrombocytopenia"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 4,
                  "numAtRisk": 2076
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              ],
              "term": "Breast Cancer"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 4,
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              ],
              "term": "Intraductal Proliferative Breast Lesion"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
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                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Malignant Melanoma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 5,
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              ],
              "term": "Pneumonitis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
                  "numAffected": 5,
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              ],
              "term": "Syncope"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
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                {
                  "groupId": "EG003",
                  "numAffected": 3,
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              ],
              "term": "Gastric Cancer"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Gastroenteritis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Hepatobiliary disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 3,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
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                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Hepatotoxicity"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
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                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Chest Pain"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Psychiatric disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "groupId": "EG003",
                  "numAffected": 3,
                  "numAtRisk": 2076
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              ],
              "term": "Depression"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
                  "numAffected": 4,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Hyperphosphatasaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 3,
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              ],
              "term": "Myocardial Infarction"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Hepatobiliary disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 3,
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              ],
              "term": "Cholecystitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Gamma-Glutamyltransferase Increased"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Hepatobiliary disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 4,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Hepatic Function Abnormal"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
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                },
                {
                  "groupId": "EG002",
                  "numAffected": 2,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 3,
                  "numAtRisk": 2076
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              ],
              "term": "Hypotension"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Reproductive system and breast disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 3,
                  "numAtRisk": 2076
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              ],
              "term": "Ovarian Cyst"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 2,
                  "numAtRisk": 2076
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              ],
              "term": "Thrombosis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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              "stats": [
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 5,
                  "numAtRisk": 2076
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              ],
              "term": "Acute Myeloid Leukaemia"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Asthenia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Colitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 2,
                  "numAtRisk": 2076
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              ],
              "term": "Gastritis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Lower Respiratory Tract Infection"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
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                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Neuropathy Peripheral"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Decreased Appetite"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Deep Vein Thrombosis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
                  "numAffected": 0,
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                {
                  "groupId": "EG003",
                  "numAffected": 4,
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              ],
              "term": "Haemorrhoids"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
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                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              "term": "Headache"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 2,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Herpes Zoster"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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              "stats": [
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                {
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              "term": "Ovarian Cancer"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "stats": [
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
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              "term": "Papillary Thyroid Cancer"
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              "stats": [
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
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              "term": "Thyroid Cancer"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Immune system disorders",
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                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              "term": "Anaphylactic Reaction"
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              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 2,
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              "term": "Bronchitis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Convulsion"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Endometrial Cancer"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              "term": "Hypertension"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              "term": "Infection"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
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                  "groupId": "EG003",
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              "term": "Interstitial Lung Disease"
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
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                  "groupId": "EG003",
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              "term": "Lung Adenocarcinoma"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
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                  "groupId": "EG003",
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              "term": "Mucosal Inflammation"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Radiation Skin Injury"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Rectal Cancer"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Seroma"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Skin Infection"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Ear and labyrinth disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Vertigo"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Wound Infection"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
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                  "groupId": "EG003",
                  "numAffected": 1,
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              "term": "Adenocarcinoma Of Colon"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
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                  "groupId": "EG003",
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              "term": "Arthralgia"
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            {
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Back Pain"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
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                  "groupId": "EG003",
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
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                  "groupId": "EG003",
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              "term": "Breast Calcifications"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "numAtRisk": 2057
                },
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                  "groupId": "EG003",
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              ],
              "term": "Breast Cellulitis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "numAtRisk": 2057
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                  "groupId": "EG003",
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              "term": "Cardiac Failure"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
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                  "groupId": "EG003",
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                  "numAtRisk": 2076
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              ],
              "term": "Chills"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Hypocalcaemia"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 2,
                  "numAtRisk": 2076
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              ],
              "term": "Invasive Ductal Breast Carcinoma"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Myocardial Ischaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
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                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Radiation Fibrosis - Lung"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Radiation Pneumonitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Renal and urinary disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                  "groupId": "EG001",
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                },
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                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Renal Failure"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 2,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Subcutaneous Abscess"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 2,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Thrombosis In Device"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Acute Coronary Syndrome"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
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                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Acute Lymphocytic Leukaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 2,
                  "numAtRisk": 2076
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              ],
              "term": "Ankle Fracture"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Arrhythmia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Hepatobiliary disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Biliary Colic"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Blood Creatinine Increased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Cardiac Arrest"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Hepatobiliary disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Cholelithiasis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
                  "numAffected": 2,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Constipation"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Dermatitis Acneiform"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 3,
                  "numAtRisk": 2076
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              ],
              "term": "Diabetes Mellitus"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Dizziness"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Immune system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Drug Hypersensitivity"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Hepatobiliary disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Drug-Induced Liver Injury"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                },
                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Gastrointestinal Haemorrhage"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Humerus Fracture"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
                  "numAffected": 1,
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Hyperglycaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Hypomagnesaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
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                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Ileus"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Intestinal Obstruction"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Hepatobiliary disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 2,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Jaundice"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 3,
                  "numAtRisk": 2076
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              ],
              "term": "Lung Disorder"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Lung Infiltration"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Lung Neoplasm Malignant"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Oedema Peripheral"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Pancreatitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Pericarditis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
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                {
                  "groupId": "EG002",
                  "numAffected": 2,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Respiratory Tract Infection"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 2,
                  "numAtRisk": 2076
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              ],
              "term": "Sinusitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 2,
                  "numAtRisk": 2076
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              ],
              "term": "Small Cell Lung Cancer"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Psychiatric disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Suicide Attempt"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Supraventricular Tachycardia"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 2,
                  "numAtRisk": 2076
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              ],
              "term": "Upper Limb Fracture"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Uterine Leiomyoma"
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            {
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              "organSystem": "Reproductive system and breast disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Uterine Polyp"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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              "term": "Abdominal Pain Upper"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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              "term": "Abdominal Wall Abscess"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG001",
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              "term": "Acne"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                {
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              "term": "Acute Promyelocytic Leukaemia"
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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              "term": "Adenocarcinoma Gastric"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Adverse Drug Reaction"
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              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Anal Abscess"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Angina Pectoris"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Angina Unstable"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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              "term": "Angioedema"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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              "term": "Bacteraemia"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
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                  "groupId": "EG002",
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              "term": "Bronchiectasis"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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              "term": "Cerebrovascular Accident"
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Chronic Lymphocytic Leukaemia"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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              "term": "Coronary Artery Disease"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG002",
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              "term": "Costochondritis"
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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              "term": "Cystitis"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Death"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Device Dislocation"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Device Related Sepsis"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Diverticulitis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Duodenal Ulcer"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
                  "numAffected": 0,
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              "term": "Eastern Cooperative Oncology Group Performance Status Worsened"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Electrocardiogram Qt Prolonged"
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            {
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Endometrial Adenocarcinoma"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Reproductive system and breast disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG001",
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                  "groupId": "EG003",
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              "term": "Endometrial Hyperplasia"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG003",
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              "term": "Enteritis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Enterocolitis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Erythema"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              ],
              "term": "Fat Necrosis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Gastroenteritis Viral"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Gastrointestinal Obstruction"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              ],
              "term": "Gastrointestinal Toxicity"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
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              "stats": [
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "numAtRisk": 2057
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                  "groupId": "EG003",
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              "term": "General Physical Health Deterioration"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
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                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Hepatitis C"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "Hip Fracture"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Hypertensive Crisis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Hypovolaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Impaired Healing"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Influenza"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Jugular Vein Thrombosis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Leukaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Lipase"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Liver Function Test Abnormal"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Lobar Pneumonia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Localised Infection"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Lung Infection"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Lymph Gland Infection"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Psychiatric disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Major Depression"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Malaise"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Metastases To Central Nervous System"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Myalgia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Myelodysplastic Syndrome"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Nail Disorder"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Renal and urinary disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
                  "numAffected": 2,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Nephrolithiasis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Non-Hodgkin's Lymphoma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Oesophagitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
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                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Osteomyelitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 2,
                  "numAtRisk": 2076
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              ],
              "term": "Otitis Media"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Palpitations"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Pancreatitis Acute"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Photosensitivity Reaction"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Platelet Count Decreased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Pleural Effusion"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 2,
                  "numAtRisk": 2076
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              ],
              "term": "Pleuritic Pain"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                },
                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Polyneuropathy"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Pruritus"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Pyelonephritis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Quadriparesis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Eye disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 2,
                  "numAtRisk": 2076
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              ],
              "term": "Retinal Detachment"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
                  "numAffected": 2,
                  "numAtRisk": 2076
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Rib Fracture"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Stomatitis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Tibia Fracture"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
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                {
                  "groupId": "EG003",
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              "term": "Transitional Cell Carcinoma"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Upper Respiratory Tract Infection"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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              "term": "Urticaria"
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Uterine Cancer"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Venous Thrombosis Limb"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Ventricular Tachycardia"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Viral Infection"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Wound Complication"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Wrist Fracture"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Abdominal Distension"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
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                  "groupId": "EG001",
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                  "groupId": "EG003",
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              "term": "Abdominal Mass"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Abdominal Pain Lower"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Psychiatric disorders",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Abnormal Behaviour"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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              "term": "Abortion Induced"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Abortion Spontaneous"
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Abscess"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Acral Lentiginous Melanoma"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Acute Hepatitis B"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Acute Leukaemia"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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              "term": "Acute Myocardial Infarction"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Acute Respiratory Distress Syndrome"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Acute Sinusitis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Adenomyosis"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Agranulocytosis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Alanine Aminotransferase Increased"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Alcohol Withdrawal Syndrome"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Amnesia"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Amoebic Dysentery"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Amylase"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Amyotrophic Lateral Sclerosis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
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                  "groupId": "EG003",
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              ],
              "term": "Anal Fissure"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Anal Fistula"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Anal Haemorrhage"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Anal Infection"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Immune system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Anaphylactoid Reaction"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Anaplastic Meningioma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Angiodermatitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Aortic Valve Sclerosis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Atelectasis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Atrial Tachycardia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Atrial Thrombosis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Atrioventricular Block Complete"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Atypical Pneumonia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Hepatobiliary disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Autoimmune Hepatitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Endocrine disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Autoimmune Thyroiditis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "B-Cell Lymphoma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Bacterial Infection"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Benign Breast Neoplasm"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Benign Ovarian Tumour"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Hepatobiliary disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              ],
              "term": "Bile Duct Stenosis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Bladder Neoplasm"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              ],
              "term": "Bladder Transitional Cell Carcinoma"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Blood Alkaline Phosphatase Increased"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Blood Bilirubin Increased"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
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                {
                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              ],
              "term": "Blood Creatinine"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Blood Magnesium Decreased"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Blood Potassium Decreased"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Blood Urea Increased"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Blood Urine Present"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Bone Pain"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Borderline Ovarian Tumour"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Brain Hypoxia"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Breast Cancer In Situ"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Reproductive system and breast disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Breast Disorder"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Reproductive system and breast disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Breast Fibrosis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Reproductive system and breast disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Breast Haematoma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Reproductive system and breast disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Breast Inflammation"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Reproductive system and breast disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Breast Necrosis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Reproductive system and breast disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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              "term": "Breast Swelling"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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              "stats": [
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              "term": "Bronchioloalveolar Carcinoma"
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            {
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              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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              "term": "Bronchitis Viral"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
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              "term": "Bronchospasm"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "term": "Calculus Urinary"
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                {
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              "term": "Candida Infection"
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              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
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              "term": "Carbon Monoxide Poisoning"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Cardiac Ventricular Thrombosis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Cardio-Respiratory Arrest"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
              "stats": [
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Cardiomyopathy"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Catheter Site Cellulitis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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              "term": "Cerebellar Ataxia"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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              "stats": [
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                {
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Cervix Carcinoma"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
              "stats": [
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Cervix Carcinoma Stage 0"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Chest Wall Abscess"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG001",
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              "term": "Chlamydial Infection"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG003",
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              "term": "Cholecystitis Acute"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Chronic Fatigue Syndrome"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Chronic Myeloid Leukaemia"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Circulatory Collapse"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Clostridium Difficile Colitis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Clostridium Difficile Infection"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Colon Cancer Metastatic"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Colon Neoplasm"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Colorectal Cancer"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              ],
              "term": "Completed Suicide"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Concussion"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Conjunctivitis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Contusion"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Cough"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Device Expulsion"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Diarrhoea Infectious"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Eye disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Diplopia"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Dyspepsia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Dysphagia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Dysphonia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Dyspnoea Exertional"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Ejection Fraction Decreased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Electrocardiogram Abnormal"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Electrocardiogram St Segment Depression"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Electrocardiogram T Wave Inversion"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Embolism Venous"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Blood and lymphatic system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Eosinophilia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Epilepsy"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Epiploic Appendagitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                },
                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Epistaxis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Exfoliative Rash"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Fallopian Tube Cancer"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Feeling Cold"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Fibula Fracture"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Flushing"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Pregnancy, puerperium and perinatal conditions",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Foetal Death"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Follicular Thyroid Cancer"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Foot Fracture"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Foreign Body"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Fracture"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Fractured Coccyx"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Gallbladder Neoplasm"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Hepatobiliary disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Gallbladder Obstruction"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Gamma-Glutamyltransferase"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
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                  "groupId": "EG003",
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              ],
              "term": "Gastric Cancer Stage I"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
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                  "groupId": "EG003",
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              ],
              "term": "Gastric Haemorrhage"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Gastric Infection"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Gastric Ulcer"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Gastritis Erosive"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Gastrointestinal Carcinoma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Gastrointestinal Infection"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Gastrointestinal Perforation"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
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                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Gastrointestinal Stromal Tumour"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Gastrointestinal Ulcer"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Congenital, familial and genetic disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Gilbert's Syndrome"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Endocrine disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Goitre"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Granuloma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Haemangioma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Haemoptysis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Hepatobiliary disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Hepatic Cirrhosis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Hepatobiliary disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
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                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "Hepatic Failure"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Hepatobiliary disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Hepatic Lesion"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Hepatitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                },
                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Hepatitis B"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Hepatitis Viral"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Hepatocellular Carcinoma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Hypercholesterolaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Hypernatraemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Endocrine disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Hyperparathyroidism"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Hypersensitivity Vasculitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Hypertrophic Scar"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Hyperuricaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Hyponatraemia"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Hypophagia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Hypophosphataemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Endocrine disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Hypothyroidism"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Hypotonia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Hypoxia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Implant Site Cellulitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Infected Cyst"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Infected Lymphocele"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Infectious Colitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Infective Exacerbation Of Chronic Obstructive Airways Disease"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Inflammation"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Infusion Related Reaction"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Psychiatric disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Insomnia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "International Normalised Ratio"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Intervertebral Discitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Intestinal Adenocarcinoma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "Intestinal Haemorrhage"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
                }
              ],
              "term": "Intracardiac Thrombus"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Intracranial Aneurysm"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Intraductal Papilloma Of Breast"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Invasive Lobular Breast Carcinoma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Blood and lymphatic system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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                }
              ],
              "term": "Iron Deficiency Anaemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Ischaemic Cardiomyopathy"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
                }
              ],
              "term": "Large Intestine Perforation"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "Laryngeal Oedema"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Laryngitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                },
                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Leiomyoma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
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                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Leiomyosarcoma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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                }
              ],
              "term": "Lentigo Maligna"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Ligament Disorder"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
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                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Ligament Sprain"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Lipogranuloma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Lipoma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Local Swelling"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Lower Limb Fracture"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Lumbar Spinal Stenosis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Lung Consolidation"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Lymph Node Abscess"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Lymphangitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                },
                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Malaria"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Malignant Melanoma In Situ"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Malignant Neoplasm Of Unknown Primary Site"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Melanocytic Naevus"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Meningioma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Meningioma Benign"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Meningitis Viral"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Psychiatric disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
                }
              ],
              "term": "Mental Disorder"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Metabolic Acidosis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Metastases To Meninges"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Reproductive system and breast disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Metrorrhagia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Migraine"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Motor Neurone Disease"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
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                {
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                {
                  "groupId": "EG003",
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              ],
              "term": "Multiple Injuries"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
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                {
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                {
                  "groupId": "EG003",
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              ],
              "term": "Musculoskeletal Chest Pain"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Musculoskeletal Pain"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Myocarditis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
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              ],
              "term": "Myositis"
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            {
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              "organSystem": "Infections and infestations",
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                },
                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Nail Infection"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Nasopharyngitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Necrosis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Renal and urinary disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Nephritic Syndrome"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                },
                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Neuroborreliosis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Neuroendocrine Tumour"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Neutropenic Sepsis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Nodular Melanoma"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Non-Cardiac Chest Pain"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Oedema"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG003",
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              "term": "Oesophageal Candidiasis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                {
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              "term": "Oesophageal Infection"
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            {
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              ],
              "term": "Oropharyngeal Cancer"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              ],
              "term": "Orthostatic Hypotension"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Osteoarthritis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Osteoporosis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Ovarian Abscess"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Ovarian Adenoma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Reproductive system and breast disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Ovarian Cyst Ruptured"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Ovarian Germ Cell Teratoma Benign"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
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              "term": "Ovarian Neoplasm"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Palmar-Plantar Erythrodysaesthesia Syndrome"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Pancreatic Carcinoma"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Blood and lymphatic system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Pancytopenia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Parathyroid Tumour Benign"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Paronychia"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Pelvic Fracture"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Reproductive system and breast disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Pelvic Pain"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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              "term": "Pericardial Effusion"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Eye disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              ],
              "term": "Periorbital Oedema"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Peripheral Motor Neuropathy"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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              "term": "Peripheral Sensory Neuropathy"
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            {
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              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG003",
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              "term": "Peritonitis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                {
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                  "groupId": "EG002",
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              "term": "Pharyngitis"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                {
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              "term": "Plasma Cell Myeloma"
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Pleurisy"
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              "organSystem": "Infections and infestations",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Pneumocystis Jirovecii Infection"
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              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Pneumonia Aspiration"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
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              ],
              "term": "Pneumonia Cytomegaloviral"
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            {
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              ],
              "term": "Pneumothorax"
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            {
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              ],
              "term": "Post Procedural Pneumonia"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Reproductive system and breast disorders",
              "sourceVocabulary": "MedDRA",
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              "term": "Postmenopausal Haemorrhage"
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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              "term": "Progressive Multifocal Leukoencephalopathy"
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            {
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              ],
              "term": "Pulmonary Granuloma"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG003",
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              "term": "Pulmonary Mass"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Pulmonary Oedema"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Pulmonary Thrombosis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Pyelonephritis Acute"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Radius Fracture"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Rash Maculo-Papular"
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            {
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Rectal Adenocarcinoma"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG003",
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              "term": "Rectosigmoid Cancer"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
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                  "groupId": "EG003",
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              "term": "Reflux Gastritis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG003",
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              ],
              "term": "Renal Cancer"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG003",
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              "term": "Renal Colic"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Renal Failure Acute"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "term": "Respiratory Failure"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG000",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG003",
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              "term": "Rheumatoid Vasculitis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Road Traffic Accident"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Immune system disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Sarcoidosis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              ],
              "term": "Schizophrenia"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Scleroderma"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Second Primary Malignancy"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
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                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Serotonin Syndrome"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Sialoadenitis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Skin Necrosis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              "term": "Skin Swelling"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
                  "numAffected": 1,
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              "term": "Skin Ulcer"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Small Intestinal Obstruction"
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              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              "term": "Small Intestine Adenocarcinoma"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Soft Tissue Infection"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              "term": "Somnolence"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
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                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Spinal Compression Fracture"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Spinal Fracture"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Spondylolisthesis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Squamous Cell Carcinoma Of Skin"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "stats": [
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              "term": "Squamous Cell Carcinoma Of The Vulva"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              "term": "Staphylococcal Bacteraemia"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Staphylococcal Infection"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Sternal Fracture"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              "term": "Streptococcal Infection"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              "term": "Streptococcal Sepsis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Subarachnoid Haemorrhage"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "groupId": "EG003",
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              "term": "Subclavian Vein Thrombosis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Subdural Haemorrhage"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Sudden Death"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Superficial Spreading Melanoma Stage Unspecified"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "numAtRisk": 2057
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                {
                  "groupId": "EG003",
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              ],
              "term": "Superinfection"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
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              ],
              "term": "Synovial Cyst"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA",
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                  "groupId": "EG002",
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                {
                  "groupId": "EG003",
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              "term": "Synovitis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA",
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                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Thermal Burn"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Thrombophlebitis Superficial"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Ear and labyrinth disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
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                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Tinnitus"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
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              ],
              "term": "Tooth Infection"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
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                {
                  "groupId": "EG001",
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                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
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              ],
              "term": "Toxic Epidermal Necrolysis"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Congenital, familial and genetic disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                },
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                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
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              ],
              "term": "Trisomy 21"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
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                  "groupId": "EG000",
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                  "groupId": "EG001",
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                },
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                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Tuberculosis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
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                {
                  "groupId": "EG001",
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                  "groupId": "EG002",
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                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
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              ],
              "term": "Tuberculous Pleurisy"
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            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
                }
              ],
              "term": "Upper Gastrointestinal Haemorrhage"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "Upper Respiratory Tract Infection Bacterial"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "Urethral Cancer"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Renal and urinary disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "Urethral Obstruction"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Renal and urinary disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "Urinary Bladder Haemorrhage"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "Urosepsis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Reproductive system and breast disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "Vaginal Haemorrhage"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "Vascular Insufficiency"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "Ventricular Arrhythmia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "Ventricular Extrasystoles"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Ear and labyrinth disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 1,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "Vertigo Positional"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "Viith Nerve Paralysis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "Volvulus"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "Weight Decreased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 0,
                  "numAtRisk": 2076
                }
              ],
              "term": "White Blood Cell Count Decreased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
                }
              ],
              "term": "Wound Infection Bacterial"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "MedDRA",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 2061
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 2076
                },
                {
                  "groupId": "EG002",
                  "numAffected": 0,
                  "numAtRisk": 2057
                },
                {
                  "groupId": "EG003",
                  "numAffected": 1,
                  "numAtRisk": 2076
                }
              ],
              "term": "Wound Infection Staphylococcal"
            }
          ],
          "timeFrame": "Serious adverse events (SAEs) and non-serious AEs were collected from randomization until 10 years post-study entry."
        },
        "baselineCharacteristicsModule": {
          "denoms": [
            {
              "counts": [
                {
                  "groupId": "BG000",
                  "value": "2093"
                },
                {
                  "groupId": "BG001",
                  "value": "2091"
                },
                {
                  "groupId": "BG002",
                  "value": "2100"
                },
                {
                  "groupId": "BG003",
                  "value": "2097"
                },
                {
                  "groupId": "BG004",
                  "value": "8381"
                }
              ],
              "units": "Participants"
            }
          ],
          "groups": [
            {
              "description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
              "id": "BG000",
              "title": "Lapatinib plusTrastuzumab"
            },
            {
              "description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
              "id": "BG001",
              "title": "Trastuzumab Followed by Lapatinib"
            },
            {
              "description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
              "id": "BG002",
              "title": "Lapatinib"
            },
            {
              "description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
              "id": "BG003",
              "title": "Trastuzumab"
            },
            {
              "description": "Total of all reporting groups",
              "id": "BG004",
              "title": "Total"
            }
          ],
          "measures": [
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "spread": "10.23",
                          "value": "50.9"
                        },
                        {
                          "groupId": "BG001",
                          "spread": "10.32",
                          "value": "50.8"
                        },
                        {
                          "groupId": "BG002",
                          "spread": "10.18",
                          "value": "51.2"
                        },
                        {
                          "groupId": "BG003",
                          "spread": "10.25",
                          "value": "51.0"
                        },
                        {
                          "groupId": "BG004",
                          "spread": "10.24",
                          "value": "51.0"
                        }
                      ]
                    }
                  ]
                }
              ],
              "dispersionType": "STANDARD_DEVIATION",
              "paramType": "MEAN",
              "title": "Age, Continuous",
              "unitOfMeasure": "years"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "2091"
                        },
                        {
                          "groupId": "BG001",
                          "value": "2086"
                        },
                        {
                          "groupId": "BG002",
                          "value": "2098"
                        },
                        {
                          "groupId": "BG003",
                          "value": "2097"
                        },
                        {
                          "groupId": "BG004",
                          "value": "8372"
                        }
                      ],
                      "title": "Female"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "2"
                        },
                        {
                          "groupId": "BG001",
                          "value": "5"
                        },
                        {
                          "groupId": "BG002",
                          "value": "2"
                        },
                        {
                          "groupId": "BG003",
                          "value": "0"
                        },
                        {
                          "groupId": "BG004",
                          "value": "9"
                        }
                      ],
                      "title": "Male"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Sex: Female, Male",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "48"
                        },
                        {
                          "groupId": "BG001",
                          "value": "45"
                        },
                        {
                          "groupId": "BG002",
                          "value": "47"
                        },
                        {
                          "groupId": "BG003",
                          "value": "47"
                        },
                        {
                          "groupId": "BG004",
                          "value": "187"
                        }
                      ]
                    }
                  ],
                  "title": "American Indian or Alaska Native"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "107"
                        },
                        {
                          "groupId": "BG001",
                          "value": "103"
                        },
                        {
                          "groupId": "BG002",
                          "value": "110"
                        },
                        {
                          "groupId": "BG003",
                          "value": "109"
                        },
                        {
                          "groupId": "BG004",
                          "value": "429"
                        }
                      ]
                    }
                  ],
                  "title": "Asian: Central/South"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "311"
                        },
                        {
                          "groupId": "BG001",
                          "value": "312"
                        },
                        {
                          "groupId": "BG002",
                          "value": "299"
                        },
                        {
                          "groupId": "BG003",
                          "value": "314"
                        },
                        {
                          "groupId": "BG004",
                          "value": "1236"
                        }
                      ]
                    }
                  ],
                  "title": "Asian: East"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "33"
                        },
                        {
                          "groupId": "BG001",
                          "value": "36"
                        },
                        {
                          "groupId": "BG002",
                          "value": "33"
                        },
                        {
                          "groupId": "BG003",
                          "value": "43"
                        },
                        {
                          "groupId": "BG004",
                          "value": "145"
                        }
                      ]
                    }
                  ],
                  "title": "Asian: Japanese"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "95"
                        },
                        {
                          "groupId": "BG001",
                          "value": "92"
                        },
                        {
                          "groupId": "BG002",
                          "value": "107"
                        },
                        {
                          "groupId": "BG003",
                          "value": "89"
                        },
                        {
                          "groupId": "BG004",
                          "value": "383"
                        }
                      ]
                    }
                  ],
                  "title": "Asian: South East"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "38"
                        },
                        {
                          "groupId": "BG001",
                          "value": "30"
                        },
                        {
                          "groupId": "BG002",
                          "value": "43"
                        },
                        {
                          "groupId": "BG003",
                          "value": "25"
                        },
                        {
                          "groupId": "BG004",
                          "value": "136"
                        }
                      ]
                    }
                  ],
                  "title": "Black or African American"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "2"
                        },
                        {
                          "groupId": "BG001",
                          "value": "4"
                        },
                        {
                          "groupId": "BG002",
                          "value": "4"
                        },
                        {
                          "groupId": "BG003",
                          "value": "5"
                        },
                        {
                          "groupId": "BG004",
                          "value": "15"
                        }
                      ]
                    }
                  ],
                  "title": "Native Hawaiian (NH) or Other Pacific"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "53"
                        },
                        {
                          "groupId": "BG001",
                          "value": "52"
                        },
                        {
                          "groupId": "BG002",
                          "value": "62"
                        },
                        {
                          "groupId": "BG003",
                          "value": "69"
                        },
                        {
                          "groupId": "BG004",
                          "value": "236"
                        }
                      ]
                    }
                  ],
                  "title": "White: Arabic"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "1392"
                        },
                        {
                          "groupId": "BG001",
                          "value": "1402"
                        },
                        {
                          "groupId": "BG002",
                          "value": "1372"
                        },
                        {
                          "groupId": "BG003",
                          "value": "1382"
                        },
                        {
                          "groupId": "BG004",
                          "value": "5548"
                        }
                      ]
                    }
                  ],
                  "title": "White: Caucasian"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "5"
                        },
                        {
                          "groupId": "BG001",
                          "value": "7"
                        },
                        {
                          "groupId": "BG002",
                          "value": "10"
                        },
                        {
                          "groupId": "BG003",
                          "value": "3"
                        },
                        {
                          "groupId": "BG004",
                          "value": "25"
                        }
                      ]
                    }
                  ],
                  "title": "Mixed Race/Ancestry"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "2"
                        },
                        {
                          "groupId": "BG001",
                          "value": "1"
                        },
                        {
                          "groupId": "BG002",
                          "value": "1"
                        },
                        {
                          "groupId": "BG003",
                          "value": "3"
                        },
                        {
                          "groupId": "BG004",
                          "value": "7"
                        }
                      ]
                    }
                  ],
                  "title": "Hispanic"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "1"
                        },
                        {
                          "groupId": "BG001",
                          "value": "1"
                        },
                        {
                          "groupId": "BG002",
                          "value": "3"
                        },
                        {
                          "groupId": "BG003",
                          "value": "0"
                        },
                        {
                          "groupId": "BG004",
                          "value": "5"
                        }
                      ]
                    }
                  ],
                  "title": "Mestizo"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        },
                        {
                          "groupId": "BG003",
                          "value": "1"
                        },
                        {
                          "groupId": "BG004",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "Mauritius Islander"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "1"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "1"
                        },
                        {
                          "groupId": "BG003",
                          "value": "0"
                        },
                        {
                          "groupId": "BG004",
                          "value": "2"
                        }
                      ]
                    }
                  ],
                  "title": "Coloured"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "1"
                        },
                        {
                          "groupId": "BG003",
                          "value": "0"
                        },
                        {
                          "groupId": "BG004",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "NH and White (Arabic/North African Heritage [HER])"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "1"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        },
                        {
                          "groupId": "BG003",
                          "value": "0"
                        },
                        {
                          "groupId": "BG004",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "European Heritage and South American"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "1"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        },
                        {
                          "groupId": "BG003",
                          "value": "0"
                        },
                        {
                          "groupId": "BG004",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "South American, African HER and European HER"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "1"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        },
                        {
                          "groupId": "BG003",
                          "value": "0"
                        },
                        {
                          "groupId": "BG004",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "Afrikaans-South Africa"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        },
                        {
                          "groupId": "BG003",
                          "value": "1"
                        },
                        {
                          "groupId": "BG004",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "White South African"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "1"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "2"
                        },
                        {
                          "groupId": "BG003",
                          "value": "0"
                        },
                        {
                          "groupId": "BG004",
                          "value": "3"
                        }
                      ]
                    }
                  ],
                  "title": "White South American"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "1"
                        },
                        {
                          "groupId": "BG003",
                          "value": "0"
                        },
                        {
                          "groupId": "BG004",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "Southeast and Northeast of South America"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "1"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        },
                        {
                          "groupId": "BG003",
                          "value": "0"
                        },
                        {
                          "groupId": "BG004",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "Mulatto"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "1"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        },
                        {
                          "groupId": "BG003",
                          "value": "0"
                        },
                        {
                          "groupId": "BG004",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "South American Latin American and European HER"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "1"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        },
                        {
                          "groupId": "BG003",
                          "value": "0"
                        },
                        {
                          "groupId": "BG004",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "Black from South America"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "1"
                        },
                        {
                          "groupId": "BG003",
                          "value": "0"
                        },
                        {
                          "groupId": "BG004",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "Northeast of South America and European HER"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        },
                        {
                          "groupId": "BG003",
                          "value": "1"
                        },
                        {
                          "groupId": "BG004",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "Asian (East), NH or Other Pacific Islander"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        },
                        {
                          "groupId": "BG003",
                          "value": "1"
                        },
                        {
                          "groupId": "BG004",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "Peruvian"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        },
                        {
                          "groupId": "BG003",
                          "value": "1"
                        },
                        {
                          "groupId": "BG004",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "Mexican"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "1"
                        },
                        {
                          "groupId": "BG003",
                          "value": "0"
                        },
                        {
                          "groupId": "BG004",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "American Indian or Alaska Native and White"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "1"
                        },
                        {
                          "groupId": "BG003",
                          "value": "0"
                        },
                        {
                          "groupId": "BG004",
                          "value": "1"
                        }
                      ]
                    }
                  ],
                  "title": "Caucasian and Guamanian (Chamorro)"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "1"
                        },
                        {
                          "groupId": "BG001",
                          "value": "3"
                        },
                        {
                          "groupId": "BG002",
                          "value": "1"
                        },
                        {
                          "groupId": "BG003",
                          "value": "3"
                        },
                        {
                          "groupId": "BG004",
                          "value": "8"
                        }
                      ]
                    }
                  ],
                  "title": "Unknown/Missing"
                }
              ],
              "paramType": "NUMBER",
              "title": "Race/Ethnicity, Customized",
              "unitOfMeasure": "participants"
            }
          ]
        },
        "moreInfoModule": {
          "certainAgreement": {
            "otherDetails": "GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing.\nGSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.",
            "piSponsorEmployee": false,
            "restrictionType": "OTHER",
            "restrictiveAgreement": true
          },
          "pointOfContact": {
            "organization": "GlaxoSmithKline",
            "phone": "866-435-7343",
            "title": "GSK Response Center"
          }
        },
        "outcomeMeasuresModule": {
          "outcomeMeasures": [
            {
              "analyses": [
                {
                  "ciLowerLimit": "0.70",
                  "ciNumSides": "TWO_SIDED",
                  "ciPctValue": "97.5",
                  "ciUpperLimit": "1.02",
                  "estimateComment": "The estimate of the treatment hazard ratio (lap plus tras versus tras) is based on the Cox's proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and auxillary lymph node status.",
                  "groupIds": [
                    "OG000",
                    "OG003"
                  ],
                  "nonInferiorityType": "SUPERIORITY_OR_OTHER",
                  "pValue": "0.048",
                  "paramType": "Hazard Ratio (HR)",
                  "paramValue": "0.84",
                  "statisticalComment": "Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.",
                  "statisticalMethod": "Stratified log-rank test",
                  "testedNonInferiority": false
                },
                {
                  "ciLowerLimit": "0.80",
                  "ciNumSides": "TWO_SIDED",
                  "ciPctValue": "97.5",
                  "ciUpperLimit": "1.15",
                  "estimateComment": "The estimate of the treatment hazard ratio (tras followed by lap versus tras) is based on the Cox's proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and auxillary lymph node status.",
                  "groupIds": [
                    "OG001",
                    "OG003"
                  ],
                  "nonInferiorityType": "SUPERIORITY_OR_OTHER",
                  "pValue": "0.610",
                  "paramType": "Hazard Ratio (HR)",
                  "paramValue": "0.96",
                  "statisticalComment": "Stratification is by chemotherapy timing, hormone receptor status, and axillary lymph node status.",
                  "statisticalMethod": "Stratified log-rank test",
                  "testedNonInferiority": false
                },
                {
                  "ciLowerLimit": "1.13",
                  "ciNumSides": "TWO_SIDED",
                  "ciPctValue": "97.5",
                  "ciUpperLimit": "1.60",
                  "estimateComment": "The estimate of the treatment hazard ratio (lap versus tras) is based on the Cox's proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and auxillary lymph node status.",
                  "groupIds": [
                    "OG002",
                    "OG003"
                  ],
                  "nonInferiorityType": "SUPERIORITY_OR_OTHER",
                  "pValue": "<0.0005",
                  "paramType": "Hazard Ratio (HR)",
                  "paramValue": "1.34",
                  "statisticalComment": "Stratification is by chemotherapy timing, hormone receptor status, and axillary lymph node status.",
                  "statisticalMethod": "Stratified log-rank test",
                  "testedNonInferiority": false
                }
              ],
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.3"
                        },
                        {
                          "groupId": "OG002",
                          "value": "1.0"
                        },
                        {
                          "groupId": "OG003",
                          "value": "1.5"
                        }
                      ]
                    }
                  ],
                  "title": "95th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "3.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.8"
                        },
                        {
                          "groupId": "OG002",
                          "value": "1.8"
                        },
                        {
                          "groupId": "OG003",
                          "value": "2.6"
                        }
                      ]
                    }
                  ],
                  "title": "90th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "5.1"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4.8"
                        },
                        {
                          "groupId": "OG002",
                          "value": "2.8"
                        },
                        {
                          "groupId": "OG003",
                          "value": "4.2"
                        }
                      ]
                    }
                  ],
                  "title": "85th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.1"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG001",
                          "value": "NA"
                        },
                        {
                          "groupId": "OG002",
                          "value": "4.9"
                        },
                        {
                          "groupId": "OG003",
                          "value": "5.6"
                        }
                      ]
                    }
                  ],
                  "title": "80th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.1"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG001",
                          "value": "NA"
                        },
                        {
                          "groupId": "OG002",
                          "value": "5.5"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG003",
                          "value": "NA"
                        }
                      ]
                    }
                  ],
                  "title": "75th Percentile"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "2093"
                    },
                    {
                      "groupId": "OG001",
                      "value": "2091"
                    },
                    {
                      "groupId": "OG002",
                      "value": "2100"
                    },
                    {
                      "groupId": "OG003",
                      "value": "2097"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer (SPC), or death from any cause.\nDFS was estimated using the Kaplan Meier method.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who had disease free survival for the indicated years.",
              "groups": [
                {
                  "description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG000",
                  "title": "Lapatinib plusTrastuzumab"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG001",
                  "title": "Trastuzumab Followed by Lapatinib"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG002",
                  "title": "Lapatinib"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG003",
                  "title": "Trastuzumab"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "Intent-to-Treat (ITT) Population: all randomized par., except for those who withdrew their consent to use any of their data prior to receiving any study medication.\nPar. with no recurrence of the initial disease or SPC, or who did not die, were lost to follow-up, or were withdrawn from the study were censored at the date of last clinical contact.",
              "reportingStatus": "POSTED",
              "timeFrame": "From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)",
              "title": "Disease-free Survival (DFS)",
              "type": "PRIMARY",
              "unitOfMeasure": "years"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.7"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.2"
                        },
                        {
                          "groupId": "OG002",
                          "value": "1.7"
                        }
                      ]
                    }
                  ],
                  "title": "99th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.6"
                        },
                        {
                          "groupId": "OG002",
                          "value": "2.1"
                        }
                      ]
                    }
                  ],
                  "title": "98th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.8"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.2"
                        },
                        {
                          "groupId": "OG002",
                          "value": "2.6"
                        }
                      ]
                    }
                  ],
                  "title": "97th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "3.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.9"
                        },
                        {
                          "groupId": "OG002",
                          "value": "3.0"
                        }
                      ]
                    }
                  ],
                  "title": "96th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "3.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3.7"
                        },
                        {
                          "groupId": "OG002",
                          "value": "3.6"
                        }
                      ]
                    }
                  ],
                  "title": "95th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG000",
                          "value": "NA"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG001",
                          "value": "NA"
                        },
                        {
                          "groupId": "OG002",
                          "value": "5.9"
                        }
                      ]
                    }
                  ],
                  "title": "90th Percentile"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "2093"
                    },
                    {
                      "groupId": "OG001",
                      "value": "2091"
                    },
                    {
                      "groupId": "OG002",
                      "value": "2097"
                    },
                    {
                      "groupId": "OG003",
                      "value": "0"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Overall survival is defined as the time from randomization until death due to any cause.\nOverall survival was calculated in years as (date of death minus the date of randomization +1) divided by 365.25.\nThe percentile data values presented here indicate the percentage (99, 98, 97, 96, 95 and 90 percent) of participants who survived for the indicated years.",
              "groups": [
                {
                  "description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG000",
                  "title": "Lapatinib plusTrastuzumab"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG001",
                  "title": "Trastuzumab Followed by Lapatinib"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG002",
                  "title": "Trastuzumab"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG003",
                  "title": "Lapatinib"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "ITT Population.\nParticipants who did not die were censored at the date of last survival contact.",
              "reportingStatus": "POSTED",
              "timeFrame": "From randomization until death due to any cause (median follow-up of 4.5 years)",
              "title": "Overall Survival (OS)",
              "type": "SECONDARY",
              "unitOfMeasure": "years"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.2"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.5"
                        },
                        {
                          "groupId": "OG002",
                          "value": "1.7"
                        }
                      ]
                    }
                  ],
                  "title": "95th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "4.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3.7"
                        },
                        {
                          "groupId": "OG002",
                          "value": "3.2"
                        }
                      ]
                    }
                  ],
                  "title": "90th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.1"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG001",
                          "value": "NA"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG002",
                          "value": "NA"
                        }
                      ]
                    }
                  ],
                  "title": "85th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.1"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG001",
                          "value": "NA"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG002",
                          "value": "NA"
                        }
                      ]
                    }
                  ],
                  "title": "80th Percentile"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "2093"
                    },
                    {
                      "groupId": "OG001",
                      "value": "2091"
                    },
                    {
                      "groupId": "OG002",
                      "value": "2097"
                    },
                    {
                      "groupId": "OG003",
                      "value": "0"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Time to recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a disease recurrence (local, regional or distant).\nThe percentile data values presented here indicate the percentage (95, 90, 85, and 80 percent) of participants who did not have disease recurrence for the indicated years.",
              "groups": [
                {
                  "description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG000",
                  "title": "Lapatinib plusTrastuzumab"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG001",
                  "title": "Trastuzumab Followed by Lapatinib"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG002",
                  "title": "Trastuzumab"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG003",
                  "title": "Lapatinib"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "ITT Population.\nParticipants who did not have a recurrence of the initial disease were censored at the date of the last recorded physical or radiological examination.\nDeath was treated as a competing risk.",
              "reportingStatus": "POSTED",
              "timeFrame": "From randomization until the date of the first occurrence of a disease recurrence (median follow-up of 4.5 years)",
              "title": "Time to Recurrence",
              "type": "SECONDARY",
              "unitOfMeasure": "years"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2.4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.8"
                        },
                        {
                          "groupId": "OG002",
                          "value": "1.9"
                        }
                      ]
                    }
                  ],
                  "title": "95th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "5.5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4.2"
                        },
                        {
                          "groupId": "OG002",
                          "value": "4.1"
                        }
                      ]
                    }
                  ],
                  "title": "90th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.1"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG001",
                          "value": "NA"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG002",
                          "value": "NA"
                        }
                      ]
                    }
                  ],
                  "title": "85th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.1"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG001",
                          "value": "NA"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG002",
                          "value": "NA"
                        }
                      ]
                    }
                  ],
                  "title": "80th Percentile"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "2093"
                    },
                    {
                      "groupId": "OG001",
                      "value": "2091"
                    },
                    {
                      "groupId": "OG002",
                      "value": "2097"
                    },
                    {
                      "groupId": "OG003",
                      "value": "0"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of distant recurrence (including central nervous system recurrence).\nThe percentile data values presented here indicate the percentage (95, 90, 85 and 80 percent) of participants who did not have distant recurrence for the indicated years.",
              "groups": [
                {
                  "description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG000",
                  "title": "Lapatinib plusTrastuzumab"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG001",
                  "title": "Trastuzumab Followed by Lapatinib"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG002",
                  "title": "Trastuzumab"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG003",
                  "title": "Lapatinib"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "ITT Population.\nParticipants who did not have a distant recurrence of the initial disease were censored at the date of the last recorded physical or radiological examination.\nDeath was treated as a competing risk.",
              "reportingStatus": "POSTED",
              "timeFrame": "From randomization until the date of the first occurrence of distant recurrence (median follow-up of 4.5 years)",
              "title": "Time to Distant Recurrence",
              "type": "SECONDARY",
              "unitOfMeasure": "years"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "5.8"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG001",
                          "value": "NA"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG002",
                          "value": "NA"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "2093"
                    },
                    {
                      "groupId": "OG001",
                      "value": "2091"
                    },
                    {
                      "groupId": "OG002",
                      "value": "2097"
                    },
                    {
                      "groupId": "OG003",
                      "value": "0"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Time to central nervous system recurrence is defined as the time from randomization until the first central nervous system recurrence.\nBoth brain metastasis and meningitis carcinomatosa were considered.The percentile data values presented here indicate that 95 percent of participants did not have central nervous system recurrence for the indicated years.",
              "groups": [
                {
                  "description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG000",
                  "title": "Lapatinib plusTrastuzumab"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG001",
                  "title": "Trastuzumab Followed by Lapatinib"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG002",
                  "title": "Trastuzumab"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG003",
                  "title": "Lapatinib"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "ITT Population.\nParticipants who did not have a central nervous system recurrence were censored at the date of the last recorded physical or radiological examination.\nDeath was treated as a competing risk.",
              "reportingStatus": "POSTED",
              "timeFrame": "From randomization until the first central nervous system recurrence (median follow-up of 4.5 years)",
              "title": "Time to Central Nervous System Recurrence",
              "type": "SECONDARY",
              "unitOfMeasure": "years"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "1.9"
                        },
                        {
                          "groupId": "OG001",
                          "value": "1.2"
                        },
                        {
                          "groupId": "OG002",
                          "value": "1.4"
                        }
                      ]
                    }
                  ],
                  "title": "95th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "3.0"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2.3"
                        },
                        {
                          "groupId": "OG002",
                          "value": "2.3"
                        }
                      ]
                    }
                  ],
                  "title": "90th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "5.6"
                        },
                        {
                          "groupId": "OG001",
                          "value": "4.7"
                        },
                        {
                          "groupId": "OG002",
                          "value": "3.5"
                        }
                      ]
                    }
                  ],
                  "title": "85th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.1"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG001",
                          "value": "NA"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG002",
                          "value": "NA"
                        }
                      ]
                    }
                  ],
                  "title": "80th Percentile"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "6.1"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG001",
                          "value": "NA"
                        },
                        {
                          "comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
                          "groupId": "OG002",
                          "value": "NA"
                        }
                      ]
                    }
                  ],
                  "title": "75th Percentile"
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "1155"
                    },
                    {
                      "groupId": "OG001",
                      "value": "1143"
                    },
                    {
                      "groupId": "OG002",
                      "value": "1147"
                    },
                    {
                      "groupId": "OG003",
                      "value": "0"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer, or death from any cause.\nDFS was estimated using the Kaplan Meier method.\nThe non-breast second primary malignancies were not considered events.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who did not have DFS ignoring non-breast second primary malignancies for the indicated years.",
              "groups": [
                {
                  "description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG000",
                  "title": "Lapatinib plusTrastuzumab"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG001",
                  "title": "Trastuzumab Followed by Lapatinib"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG002",
                  "title": "Trastuzumab"
                },
                {
                  "description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
                  "id": "OG003",
                  "title": "Lapatinib"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "ITT Population.\nParticipants who did not have a recurrence of the initial disease, or did not die, were lost to follow-up, or were withdrawn from the study were censored at the date of last clinical contact.\nNon-breast second primary cancers were ignored.",
              "reportingStatus": "POSTED",
              "timeFrame": "From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)",
              "title": "DFS Ignoring Non-breast Second Primary Malignancies",
              "type": "SECONDARY",
              "unitOfMeasure": "years"
            }
          ]
        },
        "participantFlowModule": {
          "groups": [
            {
              "description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
              "id": "FG000",
              "title": "Lapatinib plusTrastuzumab"
            },
            {
              "description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
              "id": "FG001",
              "title": "Trastuzumab Followed by Lapatinib"
            },
            {
              "description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
              "id": "FG002",
              "title": "Lapatinib"
            },
            {
              "description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
              "id": "FG003",
              "title": "Trastuzumab"
            }
          ],
          "periods": [
            {
              "dropWithdraws": [
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "106"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "119"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "168"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "135"
                    }
                  ],
                  "type": "Death"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "56"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "46"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "58"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "56"
                    }
                  ],
                  "type": "Lost to Follow-up"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "146"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "110"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "208"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "116"
                    }
                  ],
                  "type": "Participant Withdrew Consent"
                }
              ],
              "milestones": [
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "2093"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "2091"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "2100"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "2097"
                    }
                  ],
                  "type": "STARTED"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "1785"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "1816"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "1666"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "1790"
                    }
                  ],
                  "type": "COMPLETED"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "308"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "275"
                    },
                    {
                      "groupId": "FG002",
                      "numSubjects": "434"
                    },
                    {
                      "groupId": "FG003",
                      "numSubjects": "307"
                    }
                  ],
                  "type": "NOT COMPLETED"
                }
              ],
              "title": "Overall Study"
            }
          ],
          "preAssignmentDetails": "Treatments administered differed per timing/type of adjuvant chemotherapy.\nDesign (D) 1: (neo) adjuvant anthracycline-based chemotherapy (AABC) prior to targeted therapy (TT); Design 2: TT concurrently with paclitaxel or docetaxel, after completion of a (neo) AABC; Design 2B: TT concurrently with chemotherapy with docetaxel and carboplatin."
        }
      }
    }
  ],
  "provenance": {
    "from_snapshot_hash": "3fc603bb2a616bd872535930bc88ac3c2ef35cf79b7cb2c936a283dc39498544",
    "materiality_event_hash": "4fd1f4d910e80ed76f8b4a7b454dda988543b0760249dec48971ce5bf42633d4",
    "patch_hash": "fa3c641377f8e3ae6ebb703ca52b4eeede4c9fb7ab047d7b18bebaf50fa12dd8",
    "patch_raw_hash": "33713bcbdbfbcff2e0fe686deb9b652b909447219ca6134d35a6c307dca0be4e",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT00490139/history/190?patchToVersion=191",
    "to_snapshot_hash": "a939a6f051c270517e3e2c7c0f1f37f642dedfa9e5b0084b3f06eed7a9c22de8"
  },
  "review_question": "What source document explains this registry amendment, and does it change interpretation of the trial record?",
  "schema": "trialdiff.evidence_record",
  "trial": {
    "clinicaltrials_gov_url": "https://clinicaltrials.gov/study/NCT00490139",
    "nct_id": "NCT00490139"
  },
  "versions": {
    "from_version": 190,
    "submitted_date": "2014-07-30",
    "to_version": 191
  }
}