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NCT03094169

AVID100 in Advanced Epithelial Carcinomas

Version 11 to 12 · Formation Biologics

Patch inspector

Version 11 to 12

1,188 operations 5 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
adverse_event_group_changeother_adverse_event_additionother_adverse_event_modificationother_adverse_event_removalserious_adverse_event_additionserious_adverse_event_modification
Value signals
[
  {
    "paths": [
      "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
      "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "/protocolSection/outcomesModule/primaryOutcomes/1/description",
      "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
      "/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit/resetReasons/0",
      "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame"
    ],
    "signal": "results_reconciliation_outcome_suppression",
    "category": "results_reconciliation",
    "severity": "low"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:58:20+00
Raw hash
2be3f12c653b18830807f0f1dff1d4ef52f595257e62ec808eb56f1ee686f163
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 8 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/measure
Triage: Critical
Primary Outcome Change Operation 4
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Phase 1a: Determine Safety and Tolerability of AVID100
After
Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1
replace /protocolSection/outcomesModule/primaryOutcomes/0/description
Triage: Critical
Primary Outcome Change Operation 5
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
After
<p>Any of the following toxicities, if judged to be associated with study, were considered a DLT:</p><ol><li>Evidence of pulmonary fibrosis</li><li><p>G3 non-hematologic toxicity regardless of duration with the exceptions of:</p><ul><li>G3 nausea, vomiting, diarrhea, or fatigue lasting &lt; 2 days</li><li>G3 asymptomatic electrolyte abnormalities lasting &lt; 3 days not considered clinically relevant</li></ul></li><li>AST and&#x2F;or ALT elevation &gt; 3 x ULN with total bilirubin &gt; 2 x ULN without initial findings of cholestasis, that cannot be explained by other factors</li><li><p>Any G4 non-hematologic toxicity with the exception of:</p><p>• G4 asymptomatic electrolyte abnormalities lasting &lt; 7 days not considered clinically significant</p></li><li><p>Neutropenia that is:</p><ul><li>&gt; G3 and associated with fever</li><li>G4 and sustained (ANC &lt; 500 per mm3, duration &gt; 5 days)</li></ul></li><li><p>Thrombocytopenia that is:</p><ul><li>G3 with clinically significant hemorrhage or requirement for transfusion</li><li>G4 (platelets &lt; 25,000 per mm3)</li></ul></li><li>Inability to complete Cycle 1 at the assigned dose</li></ol>
replace /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 6
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Overall study timeframe
After
Cycle 1 during Dose Escalation (ie the first 3 weeks of dosing)
remove /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit
Triage: Critical
Primary Outcome Change Operation 7
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
{
  "resetReasons": [
    "There does not appear to be sufficient information to understand the Time Frame."
  ]
}
replace /protocolSection/outcomesModule/primaryOutcomes/1/measure
Triage: Critical
Primary Outcome Change Operation 8
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Phase 2a: Evaluation of the Preliminary Antineoplastic Effects of AVID100
After
Phase 2a: Number of Participants With Best Overall Response by RECIST 1.1
replace /protocolSection/outcomesModule/primaryOutcomes/1/description
Triage: Critical
Primary Outcome Change Operation 9
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Number of participants with objective response or stable disease
After
Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening and every 2 cycles during study treatment.
replace /protocolSection/outcomesModule/primaryOutcomes/1/timeFrame
Triage: Critical
Primary Outcome Change Operation 10
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Overall Study
After
Imaging for Disease status (tumour measurements) occurred after every even cycle and at EOT visit
remove /protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit/resetReasons/0
Triage: Critical
Primary Outcome Change Operation 11
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
The measure does not appear to include sufficient information to understand how outcomes are measured and reported.
Adverse events and safety Posted serious or other adverse event data. Triage: High 956 ops
replace /resultsSection/adverseEventsModule/timeFrame
Triage: Uncategorized
Uncategorized Operation 231
Before
Overall Study
After
Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved.
replace /resultsSection/adverseEventsModule/eventGroups/0/title
Triage: High
Adverse Event Group Change Operation 232
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
Dose Escalation
After
AVID100 20 mg&#x2F;m^2
replace /resultsSection/adverseEventsModule/eventGroups/0/description
Triage: High
Adverse Event Group Change Operation 233
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
<p>Minimum of 1 to 3 patients per dose cohort; approximately 4 dose cohorts to be evaluated to establish the Maximum tolerated dose.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>
After
Phase 1 Cohort 1: Participants were administered 20 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
replace /resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected
Triage: High
Adverse Event Group Change Operation 234
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/eventGroups/0/deathsNumAtRisk
Triage: High
Adverse Event Group Change Operation 235
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/eventGroups/0/seriousNumAffected
Triage: High
Adverse Event Group Change Operation 236
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
8
After
0
replace /resultsSection/adverseEventsModule/eventGroups/0/seriousNumAtRisk
Triage: High
Adverse Event Group Change Operation 237
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/eventGroups/0/otherNumAffected
Triage: High
Adverse Event Group Change Operation 238
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
23
After
1
replace /resultsSection/adverseEventsModule/eventGroups/0/otherNumAtRisk
Triage: High
Adverse Event Group Change Operation 239
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/eventGroups/1/title
Triage: High
Adverse Event Group Change Operation 240
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
Phase 2a Triple Negative Breast Cancer
After
AVID100 40 mg&#x2F;m^2
replace /resultsSection/adverseEventsModule/eventGroups/1/description
Triage: High
Adverse Event Group Change Operation 241
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
<p>Addition of up to 15 patients in each of 2 subpopulations of patients with triple negative breast cancer (30 total).
One group of 15 patients will have 3+ EGFR over-expression.
The second group will have 2+ EGFR over-expression.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>
After
Phase 1 Cohort 1: Participants were administered 40 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
replace /resultsSection/adverseEventsModule/eventGroups/1/deathsNumAffected
Triage: High
Adverse Event Group Change Operation 242
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/eventGroups/1/deathsNumAtRisk
Triage: High
Adverse Event Group Change Operation 243
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/eventGroups/1/seriousNumAffected
Triage: High
Adverse Event Group Change Operation 244
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/eventGroups/1/seriousNumAtRisk
Triage: High
Adverse Event Group Change Operation 245
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/eventGroups/1/otherNumAffected
Triage: High
Adverse Event Group Change Operation 246
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/eventGroups/1/otherNumAtRisk
Triage: High
Adverse Event Group Change Operation 247
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/eventGroups/2/title
Triage: High
Adverse Event Group Change Operation 248
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
Phase 2a Head and Neck Carcinoma
After
AVID100 80 mg&#x2F;m^2
replace /resultsSection/adverseEventsModule/eventGroups/2/description
Triage: High
Adverse Event Group Change Operation 249
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
<p>Addition of 15 patients with squamous head and neck carcinoma.
Patients will have 3+ EGFR over-expression.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>
After
Phase 1 Cohort 1: Participants were administered 80 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
replace /resultsSection/adverseEventsModule/eventGroups/2/deathsNumAtRisk
Triage: High
Adverse Event Group Change Operation 250
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/eventGroups/2/seriousNumAffected
Triage: High
Adverse Event Group Change Operation 251
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
9
After
1
replace /resultsSection/adverseEventsModule/eventGroups/2/seriousNumAtRisk
Triage: High
Adverse Event Group Change Operation 252
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/eventGroups/2/otherNumAffected
Triage: High
Adverse Event Group Change Operation 253
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/eventGroups/2/otherNumAtRisk
Triage: High
Adverse Event Group Change Operation 254
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/eventGroups/3/title
Triage: High
Adverse Event Group Change Operation 255
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
Phase 2a Non-Small Cell Lung Carcinoma
After
AVID100 120 mg&#x2F;m^2
replace /resultsSection/adverseEventsModule/eventGroups/3/description
Triage: High
Adverse Event Group Change Operation 256
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
<p>Addition of 15 patients with squamous histology non-small cell lung carcinoma.
Patients will have 3+ EGFR over-expression</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>
After
Phase 1 Cohort 1: Participants were administered 120 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
replace /resultsSection/adverseEventsModule/eventGroups/3/seriousNumAffected
Triage: High
Adverse Event Group Change Operation 257
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
1
After
2
add /resultsSection/adverseEventsModule/eventGroups/4
Triage: High
Adverse Event Group Change Operation 258
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
After
{
  "id": "EG004",
  "title": "AVID100 180 mg&#x2F;m^2",
  "description": "Phase 1 Cohort 1: Participants were administered 180 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.",
  "otherNumAtRisk": 3,
  "deathsNumAtRisk": 3,
  "otherNumAffected": 3,
  "seriousNumAtRisk": 3,
  "deathsNumAffected": 0,
  "seriousNumAffected": 1
}
add /resultsSection/adverseEventsModule/eventGroups/5
Triage: High
Adverse Event Group Change Operation 259
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
After
{
  "id": "EG005",
  "title": "AVID100 220 mg&#x2F;m^2",
  "description": "Phase 1 Cohort 1: Participants were administered 220 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.",
  "otherNumAtRisk": 6,
  "deathsNumAtRisk": 6,
  "otherNumAffected": 6,
  "seriousNumAtRisk": 6,
  "deathsNumAffected": 0,
  "seriousNumAffected": 3
}
add /resultsSection/adverseEventsModule/eventGroups/6
Triage: High
Adverse Event Group Change Operation 260
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
After
{
  "id": "EG006",
  "title": "AVID100 270 mg&#x2F;m^2",
  "description": "Phase 1 Cohort 1: Participants were administered 270 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.",
  "otherNumAtRisk": 7,
  "deathsNumAtRisk": 7,
  "otherNumAffected": 7,
  "seriousNumAtRisk": 7,
  "deathsNumAffected": 1,
  "seriousNumAffected": 2
}
add /resultsSection/adverseEventsModule/eventGroups/7
Triage: High
Adverse Event Group Change Operation 261
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
After
{
  "id": "EG007",
  "title": "Phase 2a Expansion: AVID100 220 mg&#x2F;m^2",
  "description": "Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg&#x2F;m^2 administered every 3 weeks IV, for at least 1 cycle.\nExtended treatment was permitted for participants tolerating and benefiting from treatment.",
  "otherNumAtRisk": 25,
  "deathsNumAtRisk": 25,
  "otherNumAffected": 25,
  "seriousNumAtRisk": 25,
  "deathsNumAffected": 3,
  "seriousNumAffected": 13
}
replace /resultsSection/adverseEventsModule/seriousEvents/0/stats/0/numEvents
Triage: High
Serious Adverse Event Modification Operation 262
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/0/stats/0/numAffected
Triage: High
Serious Adverse Event Modification Operation 263
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/0/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 264
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/0/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 265
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/0/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 266
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/0/stats/4
Triage: High
Serious Adverse Event Addition Operation 267
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/0/stats/5
Triage: High
Serious Adverse Event Addition Operation 268
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/seriousEvents/0/stats/6
Triage: High
Serious Adverse Event Addition Operation 269
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/0/stats/7
Triage: High
Serious Adverse Event Addition Operation 270
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/seriousEvents/1/stats/0/numEvents
Triage: High
Serious Adverse Event Modification Operation 271
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/1/stats/0/numAffected
Triage: High
Serious Adverse Event Modification Operation 272
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/1/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 273
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/1/stats/1/numEvents
Triage: High
Serious Adverse Event Modification Operation 274
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/1/stats/1/numAffected
Triage: High
Serious Adverse Event Modification Operation 275
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/1/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 276
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/1/stats/2/numEvents
Triage: High
Serious Adverse Event Modification Operation 277
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/1/stats/2/numAffected
Triage: High
Serious Adverse Event Modification Operation 278
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/1/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 279
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/1/stats/4
Triage: High
Serious Adverse Event Addition Operation 280
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/1/stats/5
Triage: High
Serious Adverse Event Addition Operation 281
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/1/stats/6
Triage: High
Serious Adverse Event Addition Operation 282
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/seriousEvents/1/stats/7
Triage: High
Serious Adverse Event Addition Operation 283
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 2,
  "numAffected": 2
}
replace /resultsSection/adverseEventsModule/seriousEvents/2/stats/0/numEvents
Triage: High
Serious Adverse Event Modification Operation 284
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/2/stats/0/numAffected
Triage: High
Serious Adverse Event Modification Operation 285
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/2/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 286
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/2/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 287
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/2/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 288
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/2/stats/4
Triage: High
Serious Adverse Event Addition Operation 289
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/2/stats/5
Triage: High
Serious Adverse Event Addition Operation 290
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/seriousEvents/2/stats/6
Triage: High
Serious Adverse Event Addition Operation 291
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/2/stats/7
Triage: High
Serious Adverse Event Addition Operation 292
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/seriousEvents/3/stats/0/numEvents
Triage: High
Serious Adverse Event Modification Operation 293
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/3/stats/0/numAffected
Triage: High
Serious Adverse Event Modification Operation 294
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/3/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 295
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/3/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 296
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/3/stats/2/numEvents
Triage: High
Serious Adverse Event Modification Operation 297
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/3/stats/2/numAffected
Triage: High
Serious Adverse Event Modification Operation 298
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/3/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 299
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/3/stats/4
Triage: High
Serious Adverse Event Addition Operation 300
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/3/stats/5
Triage: High
Serious Adverse Event Addition Operation 301
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/3/stats/6
Triage: High
Serious Adverse Event Addition Operation 302
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/seriousEvents/3/stats/7
Triage: High
Serious Adverse Event Addition Operation 303
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/seriousEvents/4/stats/0/numEvents
Triage: High
Serious Adverse Event Modification Operation 304
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/4/stats/0/numAffected
Triage: High
Serious Adverse Event Modification Operation 305
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/4/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 306
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/4/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 307
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/4/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 308
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/4/stats/4
Triage: High
Serious Adverse Event Addition Operation 309
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/4/stats/5
Triage: High
Serious Adverse Event Addition Operation 310
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/4/stats/6
Triage: High
Serious Adverse Event Addition Operation 311
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/seriousEvents/4/stats/7
Triage: High
Serious Adverse Event Addition Operation 312
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/seriousEvents/5/stats/0/numEvents
Triage: High
Serious Adverse Event Modification Operation 313
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/5/stats/0/numAffected
Triage: High
Serious Adverse Event Modification Operation 314
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/5/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 315
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/5/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 316
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/5/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 317
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/5/stats/4
Triage: High
Serious Adverse Event Addition Operation 318
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/5/stats/5
Triage: High
Serious Adverse Event Addition Operation 319
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/5/stats/6
Triage: High
Serious Adverse Event Addition Operation 320
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/seriousEvents/5/stats/7
Triage: High
Serious Adverse Event Addition Operation 321
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/seriousEvents/6/stats/0/numEvents
Triage: High
Serious Adverse Event Modification Operation 322
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/6/stats/0/numAffected
Triage: High
Serious Adverse Event Modification Operation 323
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/6/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 324
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/6/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 325
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/6/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 326
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/seriousEvents/6/stats/3/numEvents
Triage: High
Serious Adverse Event Modification Operation 327
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/6/stats/3/numAffected
Triage: High
Serious Adverse Event Modification Operation 328
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
0
After
1
add /resultsSection/adverseEventsModule/seriousEvents/6/stats/4
Triage: High
Serious Adverse Event Addition Operation 329
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/6/stats/5
Triage: High
Serious Adverse Event Addition Operation 330
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/6/stats/6
Triage: High
Serious Adverse Event Addition Operation 331
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/6/stats/7
Triage: High
Serious Adverse Event Addition Operation 332
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/seriousEvents/7/stats/0/numEvents
Triage: High
Serious Adverse Event Modification Operation 333
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/7/stats/0/numAffected
Triage: High
Serious Adverse Event Modification Operation 334
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/7/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 335
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/7/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 336
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/7/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 337
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/seriousEvents/7/stats/3/numEvents
Triage: High
Serious Adverse Event Modification Operation 338
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/7/stats/3/numAffected
Triage: High
Serious Adverse Event Modification Operation 339
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
0
After
1
add /resultsSection/adverseEventsModule/seriousEvents/7/stats/4
Triage: High
Serious Adverse Event Addition Operation 340
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/7/stats/5
Triage: High
Serious Adverse Event Addition Operation 341
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/7/stats/6
Triage: High
Serious Adverse Event Addition Operation 342
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/7/stats/7
Triage: High
Serious Adverse Event Addition Operation 343
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/seriousEvents/8/stats/0/numEvents
Triage: High
Serious Adverse Event Modification Operation 344
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/8/stats/0/numAffected
Triage: High
Serious Adverse Event Modification Operation 345
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/8/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 346
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/8/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 347
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/8/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 348
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/8/stats/4
Triage: High
Serious Adverse Event Addition Operation 349
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/8/stats/5
Triage: High
Serious Adverse Event Addition Operation 350
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/8/stats/6
Triage: High
Serious Adverse Event Addition Operation 351
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/8/stats/7
Triage: High
Serious Adverse Event Addition Operation 352
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/seriousEvents/9/term
Triage: High
Serious Adverse Event Modification Operation 353
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
Dysphagia
After
Dysphasia
replace /resultsSection/adverseEventsModule/seriousEvents/9/stats/0/numEvents
Triage: High
Serious Adverse Event Modification Operation 354
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/9/stats/0/numAffected
Triage: High
Serious Adverse Event Modification Operation 355
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/9/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 356
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/9/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 357
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/9/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 358
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/9/stats/4
Triage: High
Serious Adverse Event Addition Operation 359
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/seriousEvents/9/stats/5
Triage: High
Serious Adverse Event Addition Operation 360
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/9/stats/6
Triage: High
Serious Adverse Event Addition Operation 361
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/9/stats/7
Triage: High
Serious Adverse Event Addition Operation 362
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/seriousEvents/10/stats/0/numEvents
Triage: High
Serious Adverse Event Modification Operation 363
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/10/stats/0/numAffected
Triage: High
Serious Adverse Event Modification Operation 364
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/10/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 365
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/10/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 366
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/10/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 367
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/10/stats/4
Triage: High
Serious Adverse Event Addition Operation 368
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/10/stats/5
Triage: High
Serious Adverse Event Addition Operation 369
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/seriousEvents/10/stats/6
Triage: High
Serious Adverse Event Addition Operation 370
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/10/stats/7
Triage: High
Serious Adverse Event Addition Operation 371
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/seriousEvents/11/stats/0/numEvents
Triage: High
Serious Adverse Event Modification Operation 372
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/11/stats/0/numAffected
Triage: High
Serious Adverse Event Modification Operation 373
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/11/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 374
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/11/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 375
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/11/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 376
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/11/stats/4
Triage: High
Serious Adverse Event Addition Operation 377
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/11/stats/5
Triage: High
Serious Adverse Event Addition Operation 378
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/seriousEvents/11/stats/6
Triage: High
Serious Adverse Event Addition Operation 379
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/11/stats/7
Triage: High
Serious Adverse Event Addition Operation 380
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/seriousEvents/12/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 381
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/12/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 382
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/12/stats/2/numEvents
Triage: High
Serious Adverse Event Modification Operation 383
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/12/stats/2/numAffected
Triage: High
Serious Adverse Event Modification Operation 384
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/12/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 385
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/12/stats/4
Triage: High
Serious Adverse Event Addition Operation 386
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/12/stats/5
Triage: High
Serious Adverse Event Addition Operation 387
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/12/stats/6
Triage: High
Serious Adverse Event Addition Operation 388
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/12/stats/7
Triage: High
Serious Adverse Event Addition Operation 389
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/seriousEvents/13/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 390
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/13/stats/1/numEvents
Triage: High
Serious Adverse Event Modification Operation 391
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/13/stats/1/numAffected
Triage: High
Serious Adverse Event Modification Operation 392
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/13/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 393
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/13/stats/2/numEvents
Triage: High
Serious Adverse Event Modification Operation 394
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/13/stats/2/numAffected
Triage: High
Serious Adverse Event Modification Operation 395
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/13/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 396
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/13/stats/4
Triage: High
Serious Adverse Event Addition Operation 397
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/13/stats/5
Triage: High
Serious Adverse Event Addition Operation 398
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/13/stats/6
Triage: High
Serious Adverse Event Addition Operation 399
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/13/stats/7
Triage: High
Serious Adverse Event Addition Operation 400
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 3,
  "numAffected": 3
}
replace /resultsSection/adverseEventsModule/seriousEvents/14/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 401
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/14/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 402
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/14/stats/2/numEvents
Triage: High
Serious Adverse Event Modification Operation 403
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/14/stats/2/numAffected
Triage: High
Serious Adverse Event Modification Operation 404
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/14/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 405
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/14/stats/4
Triage: High
Serious Adverse Event Addition Operation 406
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/14/stats/5
Triage: High
Serious Adverse Event Addition Operation 407
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/14/stats/6
Triage: High
Serious Adverse Event Addition Operation 408
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/14/stats/7
Triage: High
Serious Adverse Event Addition Operation 409
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/seriousEvents/15/sourceVocabulary
Triage: High
Serious Adverse Event Modification Operation 410
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
MedDRA 22.0
After
MedDRA 23.0
replace /resultsSection/adverseEventsModule/seriousEvents/15/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 411
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/15/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 412
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/15/stats/2/numEvents
Triage: High
Serious Adverse Event Modification Operation 413
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/15/stats/2/numAffected
Triage: High
Serious Adverse Event Modification Operation 414
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/15/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 415
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/15/stats/4
Triage: High
Serious Adverse Event Addition Operation 416
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/15/stats/5
Triage: High
Serious Adverse Event Addition Operation 417
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/15/stats/6
Triage: High
Serious Adverse Event Addition Operation 418
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/15/stats/7
Triage: High
Serious Adverse Event Addition Operation 419
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/seriousEvents/16/sourceVocabulary
Triage: High
Serious Adverse Event Modification Operation 420
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
MedDRA 22.0
After
MedDRA 23.0
replace /resultsSection/adverseEventsModule/seriousEvents/16/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 421
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/16/stats/1/numEvents
Triage: High
Serious Adverse Event Modification Operation 422
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/16/stats/1/numAffected
Triage: High
Serious Adverse Event Modification Operation 423
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/16/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 424
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/16/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 425
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/16/stats/4
Triage: High
Serious Adverse Event Addition Operation 426
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/16/stats/5
Triage: High
Serious Adverse Event Addition Operation 427
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/16/stats/6
Triage: High
Serious Adverse Event Addition Operation 428
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/16/stats/7
Triage: High
Serious Adverse Event Addition Operation 429
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/seriousEvents/17/sourceVocabulary
Triage: High
Serious Adverse Event Modification Operation 430
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
MedDRA 22.0
After
MedDRA 23.0
replace /resultsSection/adverseEventsModule/seriousEvents/17/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 431
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/17/stats/1/numEvents
Triage: High
Serious Adverse Event Modification Operation 432
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/17/stats/1/numAffected
Triage: High
Serious Adverse Event Modification Operation 433
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/17/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 434
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/17/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 435
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/17/stats/4
Triage: High
Serious Adverse Event Addition Operation 436
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/17/stats/5
Triage: High
Serious Adverse Event Addition Operation 437
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/17/stats/6
Triage: High
Serious Adverse Event Addition Operation 438
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/17/stats/7
Triage: High
Serious Adverse Event Addition Operation 439
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/seriousEvents/18/sourceVocabulary
Triage: High
Serious Adverse Event Modification Operation 440
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
MedDRA 22.0
After
MedDRA 23.0
replace /resultsSection/adverseEventsModule/seriousEvents/18/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 441
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/18/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 442
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/18/stats/2/numEvents
Triage: High
Serious Adverse Event Modification Operation 443
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/18/stats/2/numAffected
Triage: High
Serious Adverse Event Modification Operation 444
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/18/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 445
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/18/stats/4
Triage: High
Serious Adverse Event Addition Operation 446
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/18/stats/5
Triage: High
Serious Adverse Event Addition Operation 447
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/18/stats/6
Triage: High
Serious Adverse Event Addition Operation 448
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/18/stats/7
Triage: High
Serious Adverse Event Addition Operation 449
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/seriousEvents/19/sourceVocabulary
Triage: High
Serious Adverse Event Modification Operation 450
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
MedDRA 22.0
After
MedDRA 23.0
replace /resultsSection/adverseEventsModule/seriousEvents/19/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 451
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/19/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 452
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/19/stats/2/numEvents
Triage: High
Serious Adverse Event Modification Operation 453
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/19/stats/2/numAffected
Triage: High
Serious Adverse Event Modification Operation 454
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/19/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 455
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/19/stats/4
Triage: High
Serious Adverse Event Addition Operation 456
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/19/stats/5
Triage: High
Serious Adverse Event Addition Operation 457
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/19/stats/6
Triage: High
Serious Adverse Event Addition Operation 458
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/19/stats/7
Triage: High
Serious Adverse Event Addition Operation 459
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/seriousEvents/20/sourceVocabulary
Triage: High
Serious Adverse Event Modification Operation 460
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
MedDRA 22.0
After
MedDRA 23.0
replace /resultsSection/adverseEventsModule/seriousEvents/20/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 461
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/20/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 462
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/20/stats/2/numEvents
Triage: High
Serious Adverse Event Modification Operation 463
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/20/stats/2/numAffected
Triage: High
Serious Adverse Event Modification Operation 464
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/20/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 465
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/20/stats/4
Triage: High
Serious Adverse Event Addition Operation 466
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/20/stats/5
Triage: High
Serious Adverse Event Addition Operation 467
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/20/stats/6
Triage: High
Serious Adverse Event Addition Operation 468
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/20/stats/7
Triage: High
Serious Adverse Event Addition Operation 469
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/seriousEvents/21/sourceVocabulary
Triage: High
Serious Adverse Event Modification Operation 470
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
MedDRA 22.0
After
MedDRA 23.0
replace /resultsSection/adverseEventsModule/seriousEvents/21/stats/0/numEvents
Triage: High
Serious Adverse Event Modification Operation 471
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/21/stats/0/numAffected
Triage: High
Serious Adverse Event Modification Operation 472
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/21/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 473
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/21/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 474
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/21/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 475
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/21/stats/4
Triage: High
Serious Adverse Event Addition Operation 476
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/21/stats/5
Triage: High
Serious Adverse Event Addition Operation 477
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/21/stats/6
Triage: High
Serious Adverse Event Addition Operation 478
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/21/stats/7
Triage: High
Serious Adverse Event Addition Operation 479
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/seriousEvents/22/sourceVocabulary
Triage: High
Serious Adverse Event Modification Operation 480
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
MedDRA 22.0
After
MedDRA 23.0
replace /resultsSection/adverseEventsModule/seriousEvents/22/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 481
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/22/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 482
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/22/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 483
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/seriousEvents/22/stats/3/numEvents
Triage: High
Serious Adverse Event Modification Operation 484
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/22/stats/3/numAffected
Triage: High
Serious Adverse Event Modification Operation 485
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
add /resultsSection/adverseEventsModule/seriousEvents/22/stats/4
Triage: High
Serious Adverse Event Addition Operation 486
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/22/stats/5
Triage: High
Serious Adverse Event Addition Operation 487
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/22/stats/6
Triage: High
Serious Adverse Event Addition Operation 488
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/22/stats/7
Triage: High
Serious Adverse Event Addition Operation 489
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/seriousEvents/23/sourceVocabulary
Triage: High
Serious Adverse Event Modification Operation 490
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
MedDRA 22.0
After
MedDRA 23.0
replace /resultsSection/adverseEventsModule/seriousEvents/23/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 491
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/23/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 492
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/23/stats/2/numEvents
Triage: High
Serious Adverse Event Modification Operation 493
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/23/stats/2/numAffected
Triage: High
Serious Adverse Event Modification Operation 494
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/23/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 495
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/23/stats/4
Triage: High
Serious Adverse Event Addition Operation 496
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/23/stats/5
Triage: High
Serious Adverse Event Addition Operation 497
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/23/stats/6
Triage: High
Serious Adverse Event Addition Operation 498
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/23/stats/7
Triage: High
Serious Adverse Event Addition Operation 499
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/seriousEvents/24/sourceVocabulary
Triage: High
Serious Adverse Event Modification Operation 500
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
MedDRA 22.0
After
MedDRA 23.0
replace /resultsSection/adverseEventsModule/seriousEvents/24/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 501
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/24/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 502
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/24/stats/2/numEvents
Triage: High
Serious Adverse Event Modification Operation 503
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/24/stats/2/numAffected
Triage: High
Serious Adverse Event Modification Operation 504
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/24/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 505
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/24/stats/4
Triage: High
Serious Adverse Event Addition Operation 506
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/24/stats/5
Triage: High
Serious Adverse Event Addition Operation 507
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/24/stats/6
Triage: High
Serious Adverse Event Addition Operation 508
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/24/stats/7
Triage: High
Serious Adverse Event Addition Operation 509
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/seriousEvents/25/sourceVocabulary
Triage: High
Serious Adverse Event Modification Operation 510
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
MedDRA 22.0
After
MedDRA 23.0
replace /resultsSection/adverseEventsModule/seriousEvents/25/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 511
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/25/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 512
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/25/stats/2/numEvents
Triage: High
Serious Adverse Event Modification Operation 513
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/25/stats/2/numAffected
Triage: High
Serious Adverse Event Modification Operation 514
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/25/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 515
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/25/stats/4
Triage: High
Serious Adverse Event Addition Operation 516
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/25/stats/5
Triage: High
Serious Adverse Event Addition Operation 517
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/25/stats/6
Triage: High
Serious Adverse Event Addition Operation 518
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/25/stats/7
Triage: High
Serious Adverse Event Addition Operation 519
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/seriousEvents/26/sourceVocabulary
Triage: High
Serious Adverse Event Modification Operation 520
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
MedDRA 22.0
After
MedDRA 23.0
replace /resultsSection/adverseEventsModule/seriousEvents/26/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 521
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/26/stats/1/numEvents
Triage: High
Serious Adverse Event Modification Operation 522
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/26/stats/1/numAffected
Triage: High
Serious Adverse Event Modification Operation 523
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/26/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 524
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/26/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 525
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/26/stats/4
Triage: High
Serious Adverse Event Addition Operation 526
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/26/stats/5
Triage: High
Serious Adverse Event Addition Operation 527
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/26/stats/6
Triage: High
Serious Adverse Event Addition Operation 528
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/26/stats/7
Triage: High
Serious Adverse Event Addition Operation 529
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/seriousEvents/27/sourceVocabulary
Triage: High
Serious Adverse Event Modification Operation 530
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
MedDRA 22.0
After
MedDRA 23.0
replace /resultsSection/adverseEventsModule/seriousEvents/27/stats/0/numEvents
Triage: High
Serious Adverse Event Modification Operation 531
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/27/stats/0/numAffected
Triage: High
Serious Adverse Event Modification Operation 532
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/seriousEvents/27/stats/0/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 533
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/27/stats/1/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 534
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/seriousEvents/27/stats/2/numAtRisk
Triage: High
Serious Adverse Event Modification Operation 535
Matched rules
  • serious_adverse_event_modification Modification of reported serious adverse event data after results posting is high review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/seriousEvents/27/stats/4
Triage: High
Serious Adverse Event Addition Operation 536
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/27/stats/5
Triage: High
Serious Adverse Event Addition Operation 537
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/27/stats/6
Triage: High
Serious Adverse Event Addition Operation 538
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/seriousEvents/27/stats/7
Triage: High
Serious Adverse Event Addition Operation 539
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/seriousEvents/28
Triage: High
Serious Adverse Event Addition Operation 540
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "term": "Urinary tract obstruction",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 1,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 1,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numEvents": 1,
      "numAffected": 1
    },
    {
      "groupId": "EG004",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 6,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG006",
      "numAtRisk": 7,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG007",
      "numAtRisk": 25,
      "numEvents": 0,
      "numAffected": 0
    }
  ],
  "organSystem": "Renal and urinary disorders",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 22.0"
}
add /resultsSection/adverseEventsModule/seriousEvents/29
Triage: High
Serious Adverse Event Addition Operation 541
Matched rules
  • serious_adverse_event_addition Addition of reported serious adverse event data after results posting is high review priority.
After
{
  "term": "Elevated AST",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 1,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 1,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG004",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG005",
      "numAtRisk": 6,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG006",
      "numAtRisk": 7,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG007",
      "numAtRisk": 25,
      "numEvents": 2,
      "numAffected": 2
    }
  ],
  "organSystem": "Investigations",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 23.0"
}
replace /resultsSection/adverseEventsModule/otherEvents/0/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 542
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
11
After
1
replace /resultsSection/adverseEventsModule/otherEvents/0/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 543
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
11
After
1
replace /resultsSection/adverseEventsModule/otherEvents/0/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 544
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/0/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 545
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/0/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 546
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/0/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 547
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/0/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 548
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
0
replace /resultsSection/adverseEventsModule/otherEvents/0/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 549
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
0
replace /resultsSection/adverseEventsModule/otherEvents/0/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 550
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/0/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 551
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
2
replace /resultsSection/adverseEventsModule/otherEvents/0/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 552
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
add /resultsSection/adverseEventsModule/otherEvents/0/stats/4
Triage: Medium
Other Adverse Event Addition Operation 553
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 3,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/0/stats/5
Triage: Medium
Other Adverse Event Addition Operation 554
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 2,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/0/stats/6
Triage: Medium
Other Adverse Event Addition Operation 555
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 4,
  "numAffected": 4
}
add /resultsSection/adverseEventsModule/otherEvents/0/stats/7
Triage: Medium
Other Adverse Event Addition Operation 556
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 8,
  "numAffected": 8
}
replace /resultsSection/adverseEventsModule/otherEvents/1/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 557
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/1/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 558
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/1/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 559
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/1/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 560
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/1/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 561
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/1/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 562
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/1/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 563
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
add /resultsSection/adverseEventsModule/otherEvents/1/stats/4
Triage: Medium
Other Adverse Event Addition Operation 564
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/1/stats/5
Triage: Medium
Other Adverse Event Addition Operation 565
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/1/stats/6
Triage: Medium
Other Adverse Event Addition Operation 566
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/1/stats/7
Triage: Medium
Other Adverse Event Addition Operation 567
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/2/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 568
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/2/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 569
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/2/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 570
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/2/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 571
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/2/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 572
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/2/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 573
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/2/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 574
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/2/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 575
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/2/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 576
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/2/stats/4
Triage: Medium
Other Adverse Event Addition Operation 577
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/2/stats/5
Triage: Medium
Other Adverse Event Addition Operation 578
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/2/stats/6
Triage: Medium
Other Adverse Event Addition Operation 579
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/2/stats/7
Triage: Medium
Other Adverse Event Addition Operation 580
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 6,
  "numAffected": 6
}
replace /resultsSection/adverseEventsModule/otherEvents/3/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 581
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/3/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 582
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/3/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 583
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/3/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 584
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/3/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 585
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/3/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 586
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/3/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 587
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/3/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 588
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/3/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 589
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
add /resultsSection/adverseEventsModule/otherEvents/3/stats/4
Triage: Medium
Other Adverse Event Addition Operation 590
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/3/stats/5
Triage: Medium
Other Adverse Event Addition Operation 591
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/3/stats/6
Triage: Medium
Other Adverse Event Addition Operation 592
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/3/stats/7
Triage: Medium
Other Adverse Event Addition Operation 593
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/otherEvents/4/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 594
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/4/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 595
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/4/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 596
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/4/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 597
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/4/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 598
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/4/stats/4
Triage: Medium
Other Adverse Event Addition Operation 599
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/4/stats/5
Triage: Medium
Other Adverse Event Addition Operation 600
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/4/stats/6
Triage: Medium
Other Adverse Event Addition Operation 601
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 2,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/4/stats/7
Triage: Medium
Other Adverse Event Addition Operation 602
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/5/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 603
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/5/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 604
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/5/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 605
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/5/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 606
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/5/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 607
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/5/stats/4
Triage: Medium
Other Adverse Event Addition Operation 608
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/5/stats/5
Triage: Medium
Other Adverse Event Addition Operation 609
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 3,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/5/stats/6
Triage: Medium
Other Adverse Event Addition Operation 610
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/5/stats/7
Triage: Medium
Other Adverse Event Addition Operation 611
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/6/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 612
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/6/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 613
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/6/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 614
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/6/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 615
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/6/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 616
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/6/stats/4
Triage: Medium
Other Adverse Event Addition Operation 617
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/6/stats/5
Triage: Medium
Other Adverse Event Addition Operation 618
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/6/stats/6
Triage: Medium
Other Adverse Event Addition Operation 619
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 2,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/6/stats/7
Triage: Medium
Other Adverse Event Addition Operation 620
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/7/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 621
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/7/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 622
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/7/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 623
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/7/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 624
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/7/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 625
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/7/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 626
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/7/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 627
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/7/stats/4
Triage: Medium
Other Adverse Event Addition Operation 628
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/7/stats/5
Triage: Medium
Other Adverse Event Addition Operation 629
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/7/stats/6
Triage: Medium
Other Adverse Event Addition Operation 630
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/7/stats/7
Triage: Medium
Other Adverse Event Addition Operation 631
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/otherEvents/8/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 632
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/8/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 633
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/8/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 634
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/8/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 635
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/8/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 636
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/8/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 637
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/8/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 638
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/8/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 639
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/8/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 640
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/8/stats/4
Triage: Medium
Other Adverse Event Addition Operation 641
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/8/stats/5
Triage: Medium
Other Adverse Event Addition Operation 642
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/8/stats/6
Triage: Medium
Other Adverse Event Addition Operation 643
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/8/stats/7
Triage: Medium
Other Adverse Event Addition Operation 644
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/otherEvents/9/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 645
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/9/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 646
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/9/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 647
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/9/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 648
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/9/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 649
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/9/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 650
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/9/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 651
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/9/stats/4
Triage: Medium
Other Adverse Event Addition Operation 652
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/9/stats/5
Triage: Medium
Other Adverse Event Addition Operation 653
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/9/stats/6
Triage: Medium
Other Adverse Event Addition Operation 654
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/9/stats/7
Triage: Medium
Other Adverse Event Addition Operation 655
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 2,
  "numAffected": 2
}
replace /resultsSection/adverseEventsModule/otherEvents/10/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 656
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/10/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 657
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/10/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 658
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/10/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 659
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/10/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 660
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/10/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 661
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/10/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 662
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/10/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 663
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/10/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 664
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/10/stats/4
Triage: Medium
Other Adverse Event Addition Operation 665
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/10/stats/5
Triage: Medium
Other Adverse Event Addition Operation 666
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 2,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/10/stats/6
Triage: Medium
Other Adverse Event Addition Operation 667
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/10/stats/7
Triage: Medium
Other Adverse Event Addition Operation 668
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 2,
  "numAffected": 2
}
replace /resultsSection/adverseEventsModule/otherEvents/11/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 669
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/11/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 670
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/11/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 671
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/11/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 672
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/11/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 673
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/11/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 674
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/11/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 675
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/11/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 676
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/11/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 677
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/11/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 678
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
1
add /resultsSection/adverseEventsModule/otherEvents/11/stats/4
Triage: Medium
Other Adverse Event Addition Operation 679
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/11/stats/5
Triage: Medium
Other Adverse Event Addition Operation 680
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/11/stats/6
Triage: Medium
Other Adverse Event Addition Operation 681
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/11/stats/7
Triage: Medium
Other Adverse Event Addition Operation 682
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 4,
  "numAffected": 4
}
replace /resultsSection/adverseEventsModule/otherEvents/12/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 683
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/12/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 684
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/12/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 685
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/12/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 686
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/12/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 687
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/12/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 688
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/12/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 689
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
1
replace /resultsSection/adverseEventsModule/otherEvents/12/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 690
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
1
replace /resultsSection/adverseEventsModule/otherEvents/12/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 691
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/12/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 692
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/12/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 693
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
add /resultsSection/adverseEventsModule/otherEvents/12/stats/4
Triage: Medium
Other Adverse Event Addition Operation 694
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/12/stats/5
Triage: Medium
Other Adverse Event Addition Operation 695
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/12/stats/6
Triage: Medium
Other Adverse Event Addition Operation 696
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/12/stats/7
Triage: Medium
Other Adverse Event Addition Operation 697
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 5,
  "numAffected": 5
}
replace /resultsSection/adverseEventsModule/otherEvents/13/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 698
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/13/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 699
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/13/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 700
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/13/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 701
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/13/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 702
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/13/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 703
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/13/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 704
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/13/stats/4
Triage: Medium
Other Adverse Event Addition Operation 705
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/13/stats/5
Triage: Medium
Other Adverse Event Addition Operation 706
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/13/stats/6
Triage: Medium
Other Adverse Event Addition Operation 707
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/13/stats/7
Triage: Medium
Other Adverse Event Addition Operation 708
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 6,
  "numAffected": 4
}
replace /resultsSection/adverseEventsModule/otherEvents/14/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 709
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/14/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 710
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/14/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 711
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/14/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 712
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/14/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 713
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/14/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 714
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/14/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 715
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
add /resultsSection/adverseEventsModule/otherEvents/14/stats/4
Triage: Medium
Other Adverse Event Addition Operation 716
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 2,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/14/stats/5
Triage: Medium
Other Adverse Event Addition Operation 717
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/14/stats/6
Triage: Medium
Other Adverse Event Addition Operation 718
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/14/stats/7
Triage: Medium
Other Adverse Event Addition Operation 719
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/15/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 720
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/15/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 721
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/15/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 722
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/15/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 723
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/15/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 724
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/15/stats/4
Triage: Medium
Other Adverse Event Addition Operation 725
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 3,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/15/stats/5
Triage: Medium
Other Adverse Event Addition Operation 726
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 2,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/15/stats/6
Triage: Medium
Other Adverse Event Addition Operation 727
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/15/stats/7
Triage: Medium
Other Adverse Event Addition Operation 728
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/otherEvents/16/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 729
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/16/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 730
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/16/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 731
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/16/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 732
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/16/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 733
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/16/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 734
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/16/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 735
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/16/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 736
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/16/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 737
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/16/stats/4
Triage: Medium
Other Adverse Event Addition Operation 738
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/16/stats/5
Triage: Medium
Other Adverse Event Addition Operation 739
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/16/stats/6
Triage: Medium
Other Adverse Event Addition Operation 740
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 2,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/16/stats/7
Triage: Medium
Other Adverse Event Addition Operation 741
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 2,
  "numAffected": 2
}
replace /resultsSection/adverseEventsModule/otherEvents/17/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 742
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/17/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 743
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/17/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 744
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/17/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 745
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
1
replace /resultsSection/adverseEventsModule/otherEvents/17/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 746
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
1
replace /resultsSection/adverseEventsModule/otherEvents/17/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 747
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/17/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 748
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/17/stats/4
Triage: Medium
Other Adverse Event Addition Operation 749
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/17/stats/5
Triage: Medium
Other Adverse Event Addition Operation 750
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/17/stats/6
Triage: Medium
Other Adverse Event Addition Operation 751
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/17/stats/7
Triage: Medium
Other Adverse Event Addition Operation 752
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 3,
  "numAffected": 3
}
replace /resultsSection/adverseEventsModule/otherEvents/18/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 753
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/18/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 754
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/18/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 755
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/18/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 756
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/18/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 757
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/18/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 758
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/18/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 759
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/18/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 760
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/18/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 761
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
add /resultsSection/adverseEventsModule/otherEvents/18/stats/4
Triage: Medium
Other Adverse Event Addition Operation 762
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/18/stats/5
Triage: Medium
Other Adverse Event Addition Operation 763
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/18/stats/6
Triage: Medium
Other Adverse Event Addition Operation 764
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 2,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/18/stats/7
Triage: Medium
Other Adverse Event Addition Operation 765
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 2,
  "numAffected": 2
}
replace /resultsSection/adverseEventsModule/otherEvents/19/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 766
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/19/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 767
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/19/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 768
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/19/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 769
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/19/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 770
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/19/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 771
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/19/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 772
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/19/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 773
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/19/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 774
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/19/stats/4
Triage: Medium
Other Adverse Event Addition Operation 775
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 5,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/19/stats/5
Triage: Medium
Other Adverse Event Addition Operation 776
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/19/stats/6
Triage: Medium
Other Adverse Event Addition Operation 777
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/19/stats/7
Triage: Medium
Other Adverse Event Addition Operation 778
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 12,
  "numAffected": 5
}
add /resultsSection/adverseEventsModule/otherEvents/19/notes
Triage: Medium
Other Adverse Event Addition Operation 779
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
MedDRA 23.0 used for Phase 2
replace /resultsSection/adverseEventsModule/otherEvents/20/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 780
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
5
After
0
replace /resultsSection/adverseEventsModule/otherEvents/20/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 781
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
5
After
0
replace /resultsSection/adverseEventsModule/otherEvents/20/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 782
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/20/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 783
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/20/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 784
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/20/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 785
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/20/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 786
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/20/stats/4
Triage: Medium
Other Adverse Event Addition Operation 787
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/20/stats/5
Triage: Medium
Other Adverse Event Addition Operation 788
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/20/stats/6
Triage: Medium
Other Adverse Event Addition Operation 789
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 3,
  "numAffected": 3
}
add /resultsSection/adverseEventsModule/otherEvents/20/stats/7
Triage: Medium
Other Adverse Event Addition Operation 790
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/21/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 791
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
5
After
0
replace /resultsSection/adverseEventsModule/otherEvents/21/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 792
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
5
After
0
replace /resultsSection/adverseEventsModule/otherEvents/21/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 793
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/21/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 794
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/21/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 795
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/21/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 796
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/21/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 797
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
5
After
1
replace /resultsSection/adverseEventsModule/otherEvents/21/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 798
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
5
After
1
replace /resultsSection/adverseEventsModule/otherEvents/21/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 799
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/21/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 800
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/21/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 801
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
add /resultsSection/adverseEventsModule/otherEvents/21/stats/4
Triage: Medium
Other Adverse Event Addition Operation 802
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/21/stats/5
Triage: Medium
Other Adverse Event Addition Operation 803
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 4,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/21/stats/6
Triage: Medium
Other Adverse Event Addition Operation 804
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 3,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/21/stats/7
Triage: Medium
Other Adverse Event Addition Operation 805
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 13,
  "numAffected": 6
}
add /resultsSection/adverseEventsModule/otherEvents/21/notes
Triage: Medium
Other Adverse Event Addition Operation 806
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
MedDRA 23.0 for Phase 2
replace /resultsSection/adverseEventsModule/otherEvents/22/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 807
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/22/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 808
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/22/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 809
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/22/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 810
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/22/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 811
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
2
replace /resultsSection/adverseEventsModule/otherEvents/22/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 812
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
2
replace /resultsSection/adverseEventsModule/otherEvents/22/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 813
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/22/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 814
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
2
replace /resultsSection/adverseEventsModule/otherEvents/22/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 815
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
2
add /resultsSection/adverseEventsModule/otherEvents/22/stats/4
Triage: Medium
Other Adverse Event Addition Operation 816
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/22/stats/5
Triage: Medium
Other Adverse Event Addition Operation 817
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/22/stats/6
Triage: Medium
Other Adverse Event Addition Operation 818
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/22/stats/7
Triage: Medium
Other Adverse Event Addition Operation 819
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/otherEvents/23/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 820
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
5
After
0
replace /resultsSection/adverseEventsModule/otherEvents/23/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 821
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
5
After
0
replace /resultsSection/adverseEventsModule/otherEvents/23/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 822
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/23/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 823
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/23/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 824
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/23/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 825
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/23/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 826
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/23/stats/4
Triage: Medium
Other Adverse Event Addition Operation 827
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/23/stats/5
Triage: Medium
Other Adverse Event Addition Operation 828
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/23/stats/6
Triage: Medium
Other Adverse Event Addition Operation 829
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/23/stats/7
Triage: Medium
Other Adverse Event Addition Operation 830
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 4,
  "numAffected": 4
}
replace /resultsSection/adverseEventsModule/otherEvents/24/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 831
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
5
After
0
replace /resultsSection/adverseEventsModule/otherEvents/24/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 832
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
5
After
0
replace /resultsSection/adverseEventsModule/otherEvents/24/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 833
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/24/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 834
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/24/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 835
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/24/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 836
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/24/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 837
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/24/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 838
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/24/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 839
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
add /resultsSection/adverseEventsModule/otherEvents/24/stats/4
Triage: Medium
Other Adverse Event Addition Operation 840
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/24/stats/5
Triage: Medium
Other Adverse Event Addition Operation 841
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 2,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/24/stats/6
Triage: Medium
Other Adverse Event Addition Operation 842
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/24/stats/7
Triage: Medium
Other Adverse Event Addition Operation 843
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/25/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 844
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
7
After
0
replace /resultsSection/adverseEventsModule/otherEvents/25/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 845
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
7
After
0
replace /resultsSection/adverseEventsModule/otherEvents/25/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 846
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/25/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 847
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
1
replace /resultsSection/adverseEventsModule/otherEvents/25/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 848
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
1
replace /resultsSection/adverseEventsModule/otherEvents/25/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 849
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/25/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 850
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
3
replace /resultsSection/adverseEventsModule/otherEvents/25/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 851
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/25/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 852
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/25/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 853
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/25/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 854
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
add /resultsSection/adverseEventsModule/otherEvents/25/stats/4
Triage: Medium
Other Adverse Event Addition Operation 855
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 2,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/25/stats/5
Triage: Medium
Other Adverse Event Addition Operation 856
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/25/stats/6
Triage: Medium
Other Adverse Event Addition Operation 857
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 2,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/25/stats/7
Triage: Medium
Other Adverse Event Addition Operation 858
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 2,
  "numAffected": 2
}
replace /resultsSection/adverseEventsModule/otherEvents/26/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 859
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
7
After
0
replace /resultsSection/adverseEventsModule/otherEvents/26/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 860
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
7
After
0
replace /resultsSection/adverseEventsModule/otherEvents/26/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 861
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/26/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 862
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/26/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 863
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/26/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 864
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/26/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 865
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
1
replace /resultsSection/adverseEventsModule/otherEvents/26/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 866
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
1
replace /resultsSection/adverseEventsModule/otherEvents/26/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 867
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/26/stats/4
Triage: Medium
Other Adverse Event Addition Operation 868
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/26/stats/5
Triage: Medium
Other Adverse Event Addition Operation 869
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/26/stats/6
Triage: Medium
Other Adverse Event Addition Operation 870
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/26/stats/7
Triage: Medium
Other Adverse Event Addition Operation 871
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 7,
  "numAffected": 6
}
add /resultsSection/adverseEventsModule/otherEvents/26/notes
Triage: Medium
Other Adverse Event Addition Operation 872
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
MedDRA 23.0 used for Phase 2
replace /resultsSection/adverseEventsModule/otherEvents/27/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 873
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
9
After
0
replace /resultsSection/adverseEventsModule/otherEvents/27/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 874
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
9
After
0
replace /resultsSection/adverseEventsModule/otherEvents/27/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 875
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/27/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 876
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/27/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 877
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/27/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 878
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/27/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 879
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
1
replace /resultsSection/adverseEventsModule/otherEvents/27/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 880
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
1
replace /resultsSection/adverseEventsModule/otherEvents/27/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 881
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/27/stats/4
Triage: Medium
Other Adverse Event Addition Operation 882
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/27/stats/5
Triage: Medium
Other Adverse Event Addition Operation 883
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/27/stats/6
Triage: Medium
Other Adverse Event Addition Operation 884
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 4,
  "numAffected": 4
}
add /resultsSection/adverseEventsModule/otherEvents/27/stats/7
Triage: Medium
Other Adverse Event Addition Operation 885
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 16,
  "numAffected": 12
}
add /resultsSection/adverseEventsModule/otherEvents/27/notes
Triage: Medium
Other Adverse Event Addition Operation 886
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
MedDRA 23.0 for Phase 2
replace /resultsSection/adverseEventsModule/otherEvents/28/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 887
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
1
replace /resultsSection/adverseEventsModule/otherEvents/28/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 888
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
10
After
1
replace /resultsSection/adverseEventsModule/otherEvents/28/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 889
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/28/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 890
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/28/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 891
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/28/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 892
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/28/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 893
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/28/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 894
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/28/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 895
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
add /resultsSection/adverseEventsModule/otherEvents/28/stats/4
Triage: Medium
Other Adverse Event Addition Operation 896
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 2,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/28/stats/5
Triage: Medium
Other Adverse Event Addition Operation 897
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 4,
  "numAffected": 4
}
add /resultsSection/adverseEventsModule/otherEvents/28/stats/6
Triage: Medium
Other Adverse Event Addition Operation 898
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 3,
  "numAffected": 3
}
add /resultsSection/adverseEventsModule/otherEvents/28/stats/7
Triage: Medium
Other Adverse Event Addition Operation 899
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 3,
  "numAffected": 3
}
replace /resultsSection/adverseEventsModule/otherEvents/29/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 900
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/29/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 901
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/29/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 902
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/29/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 903
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/29/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 904
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/29/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 905
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/29/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 906
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
add /resultsSection/adverseEventsModule/otherEvents/29/stats/4
Triage: Medium
Other Adverse Event Addition Operation 907
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/29/stats/5
Triage: Medium
Other Adverse Event Addition Operation 908
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/29/stats/6
Triage: Medium
Other Adverse Event Addition Operation 909
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/29/stats/7
Triage: Medium
Other Adverse Event Addition Operation 910
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 4,
  "numAffected": 3
}
replace /resultsSection/adverseEventsModule/otherEvents/30/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 911
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/30/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 912
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/30/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 913
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/30/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 914
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/30/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 915
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/30/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 916
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/30/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 917
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
add /resultsSection/adverseEventsModule/otherEvents/30/stats/4
Triage: Medium
Other Adverse Event Addition Operation 918
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/30/stats/5
Triage: Medium
Other Adverse Event Addition Operation 919
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/30/stats/6
Triage: Medium
Other Adverse Event Addition Operation 920
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/30/stats/7
Triage: Medium
Other Adverse Event Addition Operation 921
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 3,
  "numAffected": 3
}
replace /resultsSection/adverseEventsModule/otherEvents/31/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 922
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/31/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 923
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/31/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 924
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/31/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 925
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
3
After
0
replace /resultsSection/adverseEventsModule/otherEvents/31/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 926
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/31/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 927
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/31/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 928
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
add /resultsSection/adverseEventsModule/otherEvents/31/stats/4
Triage: Medium
Other Adverse Event Addition Operation 929
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/31/stats/5
Triage: Medium
Other Adverse Event Addition Operation 930
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 3,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/31/stats/6
Triage: Medium
Other Adverse Event Addition Operation 931
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/31/stats/7
Triage: Medium
Other Adverse Event Addition Operation 932
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 4,
  "numAffected": 4
}
replace /resultsSection/adverseEventsModule/otherEvents/32/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 933
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/32/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 934
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/32/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 935
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/32/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 936
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/32/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 937
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/32/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 938
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
4
After
0
replace /resultsSection/adverseEventsModule/otherEvents/32/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 939
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/32/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 940
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/32/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 941
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
add /resultsSection/adverseEventsModule/otherEvents/32/stats/4
Triage: Medium
Other Adverse Event Addition Operation 942
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/32/stats/5
Triage: Medium
Other Adverse Event Addition Operation 943
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/32/stats/6
Triage: Medium
Other Adverse Event Addition Operation 944
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/32/stats/7
Triage: Medium
Other Adverse Event Addition Operation 945
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 6,
  "numAffected": 6
}
replace /resultsSection/adverseEventsModule/otherEvents/33/term
Triage: Medium
Other Adverse Event Modification Operation 946
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Dry Skin
After
Lacrimation Increased
replace /resultsSection/adverseEventsModule/otherEvents/33/organSystem
Triage: Medium
Other Adverse Event Modification Operation 947
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Skin and subcutaneous tissue disorders
After
Eye disorders
replace /resultsSection/adverseEventsModule/otherEvents/33/sourceVocabulary
Triage: Medium
Other Adverse Event Modification Operation 948
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
MedDRA 22.0
After
MedDRA 23.0
replace /resultsSection/adverseEventsModule/otherEvents/33/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 949
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/33/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 950
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/33/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 951
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/33/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 952
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/33/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 953
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/33/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 954
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/33/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 955
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/33/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 956
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/33/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 957
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
add /resultsSection/adverseEventsModule/otherEvents/33/stats/4
Triage: Medium
Other Adverse Event Addition Operation 958
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/33/stats/5
Triage: Medium
Other Adverse Event Addition Operation 959
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 2,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/33/stats/6
Triage: Medium
Other Adverse Event Addition Operation 960
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/33/stats/7
Triage: Medium
Other Adverse Event Addition Operation 961
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 7,
  "numAffected": 5
}
replace /resultsSection/adverseEventsModule/otherEvents/34/term
Triage: Medium
Other Adverse Event Modification Operation 962
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Lacrimation Increased
After
Alanine Aminotransferase Increased
replace /resultsSection/adverseEventsModule/otherEvents/34/organSystem
Triage: Medium
Other Adverse Event Modification Operation 963
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Eye disorders
After
Investigations
replace /resultsSection/adverseEventsModule/otherEvents/34/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 964
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/34/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 965
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/34/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 966
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/34/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 967
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/34/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 968
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/34/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 969
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/34/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 970
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/34/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 971
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/34/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 972
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
add /resultsSection/adverseEventsModule/otherEvents/34/stats/4
Triage: Medium
Other Adverse Event Addition Operation 973
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/34/stats/5
Triage: Medium
Other Adverse Event Addition Operation 974
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/34/stats/6
Triage: Medium
Other Adverse Event Addition Operation 975
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/34/stats/7
Triage: Medium
Other Adverse Event Addition Operation 976
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 6,
  "numAffected": 2
}
replace /resultsSection/adverseEventsModule/otherEvents/35/term
Triage: Medium
Other Adverse Event Modification Operation 977
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Alanine Aminotransferase Increased
After
Back Pain
replace /resultsSection/adverseEventsModule/otherEvents/35/organSystem
Triage: Medium
Other Adverse Event Modification Operation 978
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Investigations
After
Musculoskeletal and connective tissue disorders
replace /resultsSection/adverseEventsModule/otherEvents/35/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 979
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/35/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 980
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/35/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 981
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/35/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 982
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/35/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 983
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/35/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 984
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/35/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 985
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/35/stats/4
Triage: Medium
Other Adverse Event Addition Operation 986
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/35/stats/5
Triage: Medium
Other Adverse Event Addition Operation 987
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/35/stats/6
Triage: Medium
Other Adverse Event Addition Operation 988
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/35/stats/7
Triage: Medium
Other Adverse Event Addition Operation 989
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 2,
  "numAffected": 2
}
replace /resultsSection/adverseEventsModule/otherEvents/36/term
Triage: Medium
Other Adverse Event Modification Operation 990
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Back Pain
After
Hyperuricaemia
replace /resultsSection/adverseEventsModule/otherEvents/36/organSystem
Triage: Medium
Other Adverse Event Modification Operation 991
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Musculoskeletal and connective tissue disorders
After
Investigations
replace /resultsSection/adverseEventsModule/otherEvents/36/sourceVocabulary
Triage: Medium
Other Adverse Event Modification Operation 992
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
MedDRA 22.0
After
MedDRA 23.0
replace /resultsSection/adverseEventsModule/otherEvents/36/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 993
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/36/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 994
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/36/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 995
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/36/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 996
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/36/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 997
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/36/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 998
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/36/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 999
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/36/stats/4
Triage: Medium
Other Adverse Event Addition Operation 1000
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 4,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/36/stats/5
Triage: Medium
Other Adverse Event Addition Operation 1001
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/36/stats/6
Triage: Medium
Other Adverse Event Addition Operation 1002
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/36/stats/7
Triage: Medium
Other Adverse Event Addition Operation 1003
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 2,
  "numAffected": 2
}
replace /resultsSection/adverseEventsModule/otherEvents/37/term
Triage: Medium
Other Adverse Event Modification Operation 1004
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Hyperuricaemia
After
Insomnia
replace /resultsSection/adverseEventsModule/otherEvents/37/organSystem
Triage: Medium
Other Adverse Event Modification Operation 1005
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Investigations
After
Psychiatric disorders
replace /resultsSection/adverseEventsModule/otherEvents/37/stats/0/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1006
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/37/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1007
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/37/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1008
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/37/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1009
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/37/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1010
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/37/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1011
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/37/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1012
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/37/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1013
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/37/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1014
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/37/stats/4
Triage: Medium
Other Adverse Event Addition Operation 1015
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/37/stats/5
Triage: Medium
Other Adverse Event Addition Operation 1016
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/37/stats/6
Triage: Medium
Other Adverse Event Addition Operation 1017
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/37/stats/7
Triage: Medium
Other Adverse Event Addition Operation 1018
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 2,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/37/notes
Triage: Medium
Other Adverse Event Addition Operation 1019
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
MedDRA 23.0 for Phase 2
replace /resultsSection/adverseEventsModule/otherEvents/38/term
Triage: Medium
Other Adverse Event Modification Operation 1020
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Insomnia
After
Dysphagia
replace /resultsSection/adverseEventsModule/otherEvents/38/organSystem
Triage: Medium
Other Adverse Event Modification Operation 1021
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Psychiatric disorders
After
General disorders
replace /resultsSection/adverseEventsModule/otherEvents/38/sourceVocabulary
Triage: Medium
Other Adverse Event Modification Operation 1022
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
MedDRA 22.0
After
MedDRA 23.0
replace /resultsSection/adverseEventsModule/otherEvents/38/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1023
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/38/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1024
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/38/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1025
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/38/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1026
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/38/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1027
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/38/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1028
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/38/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1029
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/38/stats/4
Triage: Medium
Other Adverse Event Addition Operation 1030
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/38/stats/5
Triage: Medium
Other Adverse Event Addition Operation 1031
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/38/stats/6
Triage: Medium
Other Adverse Event Addition Operation 1032
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/38/stats/7
Triage: Medium
Other Adverse Event Addition Operation 1033
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 2,
  "numAffected": 2
}
replace /resultsSection/adverseEventsModule/otherEvents/39/term
Triage: Medium
Other Adverse Event Modification Operation 1034
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Dysphagia
After
Hypomagnesaemia
replace /resultsSection/adverseEventsModule/otherEvents/39/organSystem
Triage: Medium
Other Adverse Event Modification Operation 1035
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
General disorders
After
Metabolism and nutrition disorders
replace /resultsSection/adverseEventsModule/otherEvents/39/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1036
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/39/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1037
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/39/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1038
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/39/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1039
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/39/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1040
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/39/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1041
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/39/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1042
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/39/stats/4
Triage: Medium
Other Adverse Event Addition Operation 1043
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/39/stats/5
Triage: Medium
Other Adverse Event Addition Operation 1044
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/39/stats/6
Triage: Medium
Other Adverse Event Addition Operation 1045
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/39/stats/7
Triage: Medium
Other Adverse Event Addition Operation 1046
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 3,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/39/notes
Triage: Medium
Other Adverse Event Addition Operation 1047
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
MedDRA 23.0 for Phase 2 event
replace /resultsSection/adverseEventsModule/otherEvents/40/term
Triage: Medium
Other Adverse Event Modification Operation 1048
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Hypomagnesaemia
After
Face Oedema
replace /resultsSection/adverseEventsModule/otherEvents/40/organSystem
Triage: Medium
Other Adverse Event Modification Operation 1049
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Metabolism and nutrition disorders
After
General disorders
replace /resultsSection/adverseEventsModule/otherEvents/40/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1050
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/40/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1051
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/40/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1052
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/40/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1053
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/40/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1054
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/40/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1055
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/40/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1056
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/40/stats/4
Triage: Medium
Other Adverse Event Addition Operation 1057
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/40/stats/5
Triage: Medium
Other Adverse Event Addition Operation 1058
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/40/stats/6
Triage: Medium
Other Adverse Event Addition Operation 1059
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/40/stats/7
Triage: Medium
Other Adverse Event Addition Operation 1060
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/40/notes
Triage: Medium
Other Adverse Event Addition Operation 1061
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
MedDRA 23.0 for Phase 2
replace /resultsSection/adverseEventsModule/otherEvents/41/term
Triage: Medium
Other Adverse Event Modification Operation 1062
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Muscular weakness
After
Gastrooesophageal reflux disease
replace /resultsSection/adverseEventsModule/otherEvents/41/organSystem
Triage: Medium
Other Adverse Event Modification Operation 1063
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Musculoskeletal and connective tissue disorders
After
Gastrointestinal disorders
replace /resultsSection/adverseEventsModule/otherEvents/41/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1064
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/41/stats/1/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1065
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/41/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1066
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
1
After
0
replace /resultsSection/adverseEventsModule/otherEvents/41/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1067
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/41/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1068
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/41/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1069
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/41/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1070
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/41/stats/4
Triage: Medium
Other Adverse Event Addition Operation 1071
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/41/stats/5
Triage: Medium
Other Adverse Event Addition Operation 1072
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 2,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/41/stats/6
Triage: Medium
Other Adverse Event Addition Operation 1073
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/41/stats/7
Triage: Medium
Other Adverse Event Addition Operation 1074
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/41/notes
Triage: Medium
Other Adverse Event Addition Operation 1075
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
MedDRA 23.0 for Phase 2
replace /resultsSection/adverseEventsModule/otherEvents/42/term
Triage: Medium
Other Adverse Event Modification Operation 1076
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Activated Partial Thromboplastin Time
After
Hyponatremia
replace /resultsSection/adverseEventsModule/otherEvents/42/organSystem
Triage: Medium
Other Adverse Event Modification Operation 1077
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Investigations
After
Metabolism and nutrition disorders
replace /resultsSection/adverseEventsModule/otherEvents/42/sourceVocabulary
Triage: Medium
Other Adverse Event Modification Operation 1078
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
MedDRA 22.0
After
MedDRA 23.0
replace /resultsSection/adverseEventsModule/otherEvents/42/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1079
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/42/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1080
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/42/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1081
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/42/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1082
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/42/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1083
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/42/stats/4
Triage: Medium
Other Adverse Event Addition Operation 1084
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/42/stats/5
Triage: Medium
Other Adverse Event Addition Operation 1085
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/42/stats/6
Triage: Medium
Other Adverse Event Addition Operation 1086
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 2,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/42/stats/7
Triage: Medium
Other Adverse Event Addition Operation 1087
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/43/term
Triage: Medium
Other Adverse Event Modification Operation 1088
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Erythema
After
Mucosal Inflammation
replace /resultsSection/adverseEventsModule/otherEvents/43/organSystem
Triage: Medium
Other Adverse Event Modification Operation 1089
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Skin and subcutaneous tissue disorders
After
General disorders
replace /resultsSection/adverseEventsModule/otherEvents/43/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1090
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/43/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1091
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/43/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1092
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/43/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1093
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/43/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1094
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/43/stats/4
Triage: Medium
Other Adverse Event Addition Operation 1095
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/43/stats/5
Triage: Medium
Other Adverse Event Addition Operation 1096
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/43/stats/6
Triage: Medium
Other Adverse Event Addition Operation 1097
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 2,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/43/stats/7
Triage: Medium
Other Adverse Event Addition Operation 1098
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/43/notes
Triage: Medium
Other Adverse Event Addition Operation 1099
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
MedDRA 23.0 for Phase 2
replace /resultsSection/adverseEventsModule/otherEvents/44/term
Triage: Medium
Other Adverse Event Modification Operation 1100
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Face Oedema
After
Rash
replace /resultsSection/adverseEventsModule/otherEvents/44/organSystem
Triage: Medium
Other Adverse Event Modification Operation 1101
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
General disorders
After
Skin and subcutaneous tissue disorders
replace /resultsSection/adverseEventsModule/otherEvents/44/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1102
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/44/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1103
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/44/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1104
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/44/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1105
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/44/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1106
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/44/stats/4
Triage: Medium
Other Adverse Event Addition Operation 1107
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/44/stats/5
Triage: Medium
Other Adverse Event Addition Operation 1108
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/44/stats/6
Triage: Medium
Other Adverse Event Addition Operation 1109
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/44/stats/7
Triage: Medium
Other Adverse Event Addition Operation 1110
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 2,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/44/notes
Triage: Medium
Other Adverse Event Addition Operation 1111
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
MedDRA 23.0 for Phase 2
replace /resultsSection/adverseEventsModule/otherEvents/45/term
Triage: Medium
Other Adverse Event Modification Operation 1112
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Fall
After
Pain
replace /resultsSection/adverseEventsModule/otherEvents/45/organSystem
Triage: Medium
Other Adverse Event Modification Operation 1113
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Injury, poisoning and procedural complications
After
General disorders
replace /resultsSection/adverseEventsModule/otherEvents/45/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1114
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/45/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1115
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/45/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1116
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/45/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1117
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/45/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1118
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/45/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1119
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/45/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1120
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
add /resultsSection/adverseEventsModule/otherEvents/45/stats/4
Triage: Medium
Other Adverse Event Addition Operation 1121
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/45/stats/5
Triage: Medium
Other Adverse Event Addition Operation 1122
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/45/stats/6
Triage: Medium
Other Adverse Event Addition Operation 1123
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/45/stats/7
Triage: Medium
Other Adverse Event Addition Operation 1124
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/45/notes
Triage: Medium
Other Adverse Event Addition Operation 1125
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
MedDRA 23.0 for Phase 2
replace /resultsSection/adverseEventsModule/otherEvents/46/term
Triage: Medium
Other Adverse Event Modification Operation 1126
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Gastrooesophageal reflux disease
After
Weight decreased
replace /resultsSection/adverseEventsModule/otherEvents/46/organSystem
Triage: Medium
Other Adverse Event Modification Operation 1127
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Gastrointestinal disorders
After
Investigations
replace /resultsSection/adverseEventsModule/otherEvents/46/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1128
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/46/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1129
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/46/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1130
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/46/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1131
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/46/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1132
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
replace /resultsSection/adverseEventsModule/otherEvents/46/stats/3/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1133
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
replace /resultsSection/adverseEventsModule/otherEvents/46/stats/3/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1134
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
0
After
1
add /resultsSection/adverseEventsModule/otherEvents/46/stats/4
Triage: Medium
Other Adverse Event Addition Operation 1135
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/46/stats/5
Triage: Medium
Other Adverse Event Addition Operation 1136
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/46/stats/6
Triage: Medium
Other Adverse Event Addition Operation 1137
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/46/stats/7
Triage: Medium
Other Adverse Event Addition Operation 1138
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/46/notes
Triage: Medium
Other Adverse Event Addition Operation 1139
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
MedDRA 23.0 for Phase 2
replace /resultsSection/adverseEventsModule/otherEvents/47/term
Triage: Medium
Other Adverse Event Modification Operation 1140
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Hypoacusis
After
Anaemia
replace /resultsSection/adverseEventsModule/otherEvents/47/organSystem
Triage: Medium
Other Adverse Event Modification Operation 1141
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Ear and labyrinth disorders
After
Blood and lymphatic system disorders
replace /resultsSection/adverseEventsModule/otherEvents/47/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1142
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/47/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1143
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/47/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1144
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/47/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1145
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
0
replace /resultsSection/adverseEventsModule/otherEvents/47/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1146
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/47/stats/4
Triage: Medium
Other Adverse Event Addition Operation 1147
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/47/stats/5
Triage: Medium
Other Adverse Event Addition Operation 1148
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/47/stats/6
Triage: Medium
Other Adverse Event Addition Operation 1149
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/47/stats/7
Triage: Medium
Other Adverse Event Addition Operation 1150
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 2,
  "numAffected": 1
}
replace /resultsSection/adverseEventsModule/otherEvents/48/term
Triage: Medium
Other Adverse Event Modification Operation 1151
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Hypoaesthesia
After
Alkaline Phosphatase Increase
replace /resultsSection/adverseEventsModule/otherEvents/48/organSystem
Triage: Medium
Other Adverse Event Modification Operation 1152
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Nervous system disorders
After
Investigations
replace /resultsSection/adverseEventsModule/otherEvents/48/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1153
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/48/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1154
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/48/stats/2/numEvents
Triage: Medium
Other Adverse Event Modification Operation 1155
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
1
replace /resultsSection/adverseEventsModule/otherEvents/48/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1156
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
1
replace /resultsSection/adverseEventsModule/otherEvents/48/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1157
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/48/stats/4
Triage: Medium
Other Adverse Event Addition Operation 1158
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/48/stats/5
Triage: Medium
Other Adverse Event Addition Operation 1159
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 2,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/48/stats/6
Triage: Medium
Other Adverse Event Addition Operation 1160
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 1,
  "numAffected": 1
}
add /resultsSection/adverseEventsModule/otherEvents/48/stats/7
Triage: Medium
Other Adverse Event Addition Operation 1161
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
replace /resultsSection/adverseEventsModule/otherEvents/49/term
Triage: Medium
Other Adverse Event Modification Operation 1162
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Hyponatremia
After
Anorexia
replace /resultsSection/adverseEventsModule/otherEvents/49/organSystem
Triage: Medium
Other Adverse Event Modification Operation 1163
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
Metabolism and nutrition disorders
After
General disorders
replace /resultsSection/adverseEventsModule/otherEvents/49/stats/0/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1164
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
24
After
1
replace /resultsSection/adverseEventsModule/otherEvents/49/stats/1/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1165
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
6
After
1
replace /resultsSection/adverseEventsModule/otherEvents/49/stats/2/numAffected
Triage: Medium
Other Adverse Event Modification Operation 1166
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
2
After
1
replace /resultsSection/adverseEventsModule/otherEvents/49/stats/2/numAtRisk
Triage: Medium
Other Adverse Event Modification Operation 1167
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
15
After
3
add /resultsSection/adverseEventsModule/otherEvents/49/stats/4
Triage: Medium
Other Adverse Event Addition Operation 1168
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG004",
  "numAtRisk": 3,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/49/stats/5
Triage: Medium
Other Adverse Event Addition Operation 1169
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG005",
  "numAtRisk": 6,
  "numEvents": 0,
  "numAffected": 0
}
add /resultsSection/adverseEventsModule/otherEvents/49/stats/6
Triage: Medium
Other Adverse Event Addition Operation 1170
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG006",
  "numAtRisk": 7,
  "numEvents": 2,
  "numAffected": 2
}
add /resultsSection/adverseEventsModule/otherEvents/49/stats/7
Triage: Medium
Other Adverse Event Addition Operation 1171
Matched rules
  • other_adverse_event_addition Addition of other adverse event result data is medium review priority.
After
{
  "groupId": "EG007",
  "numAtRisk": 25,
  "numEvents": 0,
  "numAffected": 0
}
remove /resultsSection/adverseEventsModule/otherEvents/50
Triage: High
Other Adverse Event Removal Operation 1172
Matched rules
  • other_adverse_event_removal Removal of other adverse event result data is high review priority.
Before
{
  "term": "Mucosal Inflammation",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 24,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 6,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 15,
      "numEvents": 2,
      "numAffected": 2
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    }
  ],
  "organSystem": "General disorders",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 22.0"
}
remove /resultsSection/adverseEventsModule/otherEvents/50
Triage: High
Other Adverse Event Removal Operation 1173
Matched rules
  • other_adverse_event_removal Removal of other adverse event result data is high review priority.
Before
{
  "term": "Ocular Hyperaemia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 24,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 6,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 15,
      "numEvents": 2,
      "numAffected": 2
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    }
  ],
  "organSystem": "Eye disorders",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 22.0"
}
remove /resultsSection/adverseEventsModule/otherEvents/50
Triage: High
Other Adverse Event Removal Operation 1174
Matched rules
  • other_adverse_event_removal Removal of other adverse event result data is high review priority.
Before
{
  "term": "Odynophagia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 24,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 6,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 15,
      "numEvents": 2,
      "numAffected": 2
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    }
  ],
  "organSystem": "Gastrointestinal disorders",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 22.0"
}
remove /resultsSection/adverseEventsModule/otherEvents/50
Triage: High
Other Adverse Event Removal Operation 1175
Matched rules
  • other_adverse_event_removal Removal of other adverse event result data is high review priority.
Before
{
  "term": "Pneumonia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 24,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 6,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 15,
      "numEvents": 2,
      "numAffected": 2
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    }
  ],
  "organSystem": "Respiratory, thoracic and mediastinal disorders",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 22.0"
}
remove /resultsSection/adverseEventsModule/otherEvents/50
Triage: High
Other Adverse Event Removal Operation 1176
Matched rules
  • other_adverse_event_removal Removal of other adverse event result data is high review priority.
Before
{
  "term": "Thrombocytopenia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 24,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 6,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 15,
      "numEvents": 2,
      "numAffected": 2
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    }
  ],
  "organSystem": "Investigations",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 22.0"
}
remove /resultsSection/adverseEventsModule/otherEvents/50
Triage: High
Other Adverse Event Removal Operation 1177
Matched rules
  • other_adverse_event_removal Removal of other adverse event result data is high review priority.
Before
{
  "term": "Tumour Haemorrhage",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 24,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 6,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 15,
      "numEvents": 2,
      "numAffected": 2
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    }
  ],
  "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 22.0"
}
remove /resultsSection/adverseEventsModule/otherEvents/50
Triage: High
Other Adverse Event Removal Operation 1178
Matched rules
  • other_adverse_event_removal Removal of other adverse event result data is high review priority.
Before
{
  "term": "Rash",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 24,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 6,
      "numEvents": 1,
      "numAffected": 1
    },
    {
      "groupId": "EG002",
      "numAtRisk": 15,
      "numEvents": 3,
      "numAffected": 3
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    }
  ],
  "organSystem": "Skin and subcutaneous tissue disorders",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 22.0"
}
remove /resultsSection/adverseEventsModule/otherEvents/50
Triage: High
Other Adverse Event Removal Operation 1179
Matched rules
  • other_adverse_event_removal Removal of other adverse event result data is high review priority.
Before
{
  "term": "Dry Mouth",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 24,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 6,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 15,
      "numEvents": 3,
      "numAffected": 3
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    }
  ],
  "organSystem": "Gastrointestinal disorders",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 22.0"
}
remove /resultsSection/adverseEventsModule/otherEvents/50
Triage: High
Other Adverse Event Removal Operation 1180
Matched rules
  • other_adverse_event_removal Removal of other adverse event result data is high review priority.
Before
{
  "term": "Pain",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 24,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 6,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 15,
      "numEvents": 3,
      "numAffected": 3
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    }
  ],
  "organSystem": "General disorders",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 22.0"
}
remove /resultsSection/adverseEventsModule/otherEvents/50
Triage: High
Other Adverse Event Removal Operation 1181
Matched rules
  • other_adverse_event_removal Removal of other adverse event result data is high review priority.
Before
{
  "term": "Weight decreased",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 24,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 6,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 15,
      "numEvents": 3,
      "numAffected": 3
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    }
  ],
  "organSystem": "Investigations",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 22.0"
}
remove /resultsSection/adverseEventsModule/otherEvents/50
Triage: High
Other Adverse Event Removal Operation 1182
Matched rules
  • other_adverse_event_removal Removal of other adverse event result data is high review priority.
Before
{
  "term": "White Blood Cell count decreased",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 24,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 6,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 15,
      "numEvents": 3,
      "numAffected": 3
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    }
  ],
  "organSystem": "Investigations",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 22.0"
}
remove /resultsSection/adverseEventsModule/otherEvents/50
Triage: High
Other Adverse Event Removal Operation 1183
Matched rules
  • other_adverse_event_removal Removal of other adverse event result data is high review priority.
Before
{
  "term": "Hypoalbuminaemia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 24,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 6,
      "numEvents": 1,
      "numAffected": 1
    },
    {
      "groupId": "EG002",
      "numAtRisk": 15,
      "numEvents": 4,
      "numAffected": 4
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    }
  ],
  "organSystem": "Metabolism and nutrition disorders",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 22.0"
}
remove /resultsSection/adverseEventsModule/otherEvents/50
Triage: High
Other Adverse Event Removal Operation 1184
Matched rules
  • other_adverse_event_removal Removal of other adverse event result data is high review priority.
Before
{
  "term": "Hyperglycaemia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 24,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 6,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG002",
      "numAtRisk": 15,
      "numEvents": 4,
      "numAffected": 4
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    }
  ],
  "organSystem": "Metabolism and nutrition disorders",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 22.0"
}
remove /resultsSection/adverseEventsModule/otherEvents/50
Triage: High
Other Adverse Event Removal Operation 1185
Matched rules
  • other_adverse_event_removal Removal of other adverse event result data is high review priority.
Before
{
  "term": "Anaemia",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 24,
      "numEvents": 0,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 6,
      "numEvents": 1,
      "numAffected": 1
    },
    {
      "groupId": "EG002",
      "numAtRisk": 15,
      "numEvents": 7,
      "numAffected": 7
    },
    {
      "groupId": "EG003",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    }
  ],
  "organSystem": "Blood and lymphatic system disorders",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 22.0"
}
remove /resultsSection/adverseEventsModule/armsReviewUnit
Triage: Uncategorized
Uncategorized Operation 1186
Before
{
  "resetReasons": [
    "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
  ]
}
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 1 ops
remove /protocolSection/outcomesModule/secondaryOutcomes
Triage: High
Secondary Outcome Change Operation 12
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
[
  {
    "measure": "PK Profile of Total Antibody",
    "timeFrame": "Not Completed",
    "description": "Characterization of the pharmacokinetic profile of total antibody"
  }
]
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 171 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2021-03
After
2022-03
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2021-09-10
After
2022-03-21
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2021-10-07
After
2022-04-14
replace /resultsSection/participantFlowModule/groups/0/title
Triage: Uncategorized
Uncategorized Operation 13
Before
Dose Escalation
After
AVID100 20 mg&#x2F;m^2
replace /resultsSection/participantFlowModule/groups/0/description
Triage: Uncategorized
Uncategorized Operation 14
Before
<p>Minimum of 1 to 3 patients per dose cohort; approximately 4 dose cohorts to be evaluated to establish the Maximum tolerated dose.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>
After
Phase 1 Cohort 1: Participants were administered 20 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
replace /resultsSection/participantFlowModule/groups/1/title
Triage: Uncategorized
Uncategorized Operation 15
Before
Phase 2a Triple Negative Breast Cancer
After
AVID100 40 mg&#x2F;m^2
replace /resultsSection/participantFlowModule/groups/1/description
Triage: Uncategorized
Uncategorized Operation 16
Before
<p>Addition of up to 30 patients in each of 2 subpopulations of patients with triple negative breast cancer (30 total).
One group of 15 patients will have 3+ EGFR over-expression.
The second group will have 2+ EGFR over-expression.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>
After
Phase 1 Cohort 2: Participants were administered 40 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
replace /resultsSection/participantFlowModule/groups/2/title
Triage: Uncategorized
Uncategorized Operation 17
Before
Phase 2a Head and Neck Carcinoma
After
AVID100 80 mg&#x2F;m^2
replace /resultsSection/participantFlowModule/groups/2/description
Triage: Uncategorized
Uncategorized Operation 18
Before
<p>Addition of 15 patients with squamous head and neck carcinoma.
Patients will have 3+ EGFR over-expression.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>
After
Phase 1 Cohort 3: Participants were administered 80 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
replace /resultsSection/participantFlowModule/groups/3/title
Triage: Uncategorized
Uncategorized Operation 19
Before
Phase 2a Non-Small Cell Lung Carcinoma
After
AVID100 120 mg&#x2F;m^2
replace /resultsSection/participantFlowModule/groups/3/description
Triage: Uncategorized
Uncategorized Operation 20
Before
<p>Addition of 15 patients with squamous histology non-small cell lung carcinoma.
Patients will have 3+ EGFR over-expression</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>
After
Phase 1 Cohort 4: Participants were administered 120 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
add /resultsSection/participantFlowModule/groups/4
Triage: Uncategorized
Uncategorized Operation 21
After
{
  "id": "FG004",
  "title": "AVID100 180 mg&#x2F;m^2",
  "description": "Phase 1 Cohort 5: Participants were administered 180 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
}
add /resultsSection/participantFlowModule/groups/5
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{
  "id": "FG005",
  "title": "AVID100 220 mg&#x2F;m^2",
  "description": "Phase 1 Cohort 6: Participants were administered 220 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
}
add /resultsSection/participantFlowModule/groups/6
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After
{
  "id": "FG006",
  "title": "AVID100 270 mg&#x2F;m^2",
  "description": "Phase 1 Cohort 7: Participants were administered 270 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
}
add /resultsSection/participantFlowModule/groups/7
Triage: Uncategorized
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After
{
  "id": "FG007",
  "title": "Phase 2a Expansion: AVID100 220 mg&#x2F;m^2",
  "description": "Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg&#x2F;m^2 administered every 3 weeks IV, for at least 1 cycle.\nExtended treatment was permitted for participants tolerating and benefiting from treatment."
}
replace /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/0/numSubjects
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1
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{
  "groupId": "FG004",
  "numSubjects": "3"
}
add /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/5
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{
  "groupId": "FG005",
  "numSubjects": "6"
}
add /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/6
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{
  "groupId": "FG006",
  "numSubjects": "7"
}
add /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/7
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{
  "groupId": "FG007",
  "numSubjects": "25"
}
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1
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Before
Only 6 participants were recruited.
Arm not completed.
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6
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1
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15
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3
remove /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/3/comment
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Before
Only 3 Participants were recruited.
Arm was not completed.
add /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/4
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After
{
  "groupId": "FG004",
  "numSubjects": "3"
}
add /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/5
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After
{
  "groupId": "FG005",
  "numSubjects": "6"
}
add /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/6
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{
  "groupId": "FG006",
  "numSubjects": "6"
}
add /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/7
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{
  "groupId": "FG007",
  "numSubjects": "0"
}
add /resultsSection/participantFlowModule/periods/0/milestones/2/achievements/4
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{
  "groupId": "FG004",
  "numSubjects": "0"
}
add /resultsSection/participantFlowModule/periods/0/milestones/2/achievements/5
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After
{
  "groupId": "FG005",
  "numSubjects": "0"
}
add /resultsSection/participantFlowModule/periods/0/milestones/2/achievements/6
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{
  "groupId": "FG006",
  "numSubjects": "1"
}
add /resultsSection/participantFlowModule/periods/0/milestones/2/achievements/7
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{
  "groupId": "FG007",
  "numSubjects": "25"
}
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[
  {
    "type": "Lack of Efficacy",
    "reasons": [
      {
        "groupId": "FG000",
        "numSubjects": "0"
      },
      {
        "groupId": "FG001",
        "numSubjects": "0"
      },
      {
        "groupId": "FG002",
        "numSubjects": "0"
      },
      {
        "groupId": "FG003",
        "numSubjects": "0"
      },
      {
        "groupId": "FG004",
        "numSubjects": "0"
      },
      {
        "groupId": "FG005",
        "numSubjects": "0"
      },
      {
        "groupId": "FG006",
        "numSubjects": "0"
      },
      {
        "groupId": "FG007",
        "numSubjects": "21"
      }
    ]
  },
  {
    "type": "Adverse Event",
    "reasons": [
      {
        "groupId": "FG000",
        "numSubjects": "0"
      },
      {
        "groupId": "FG001",
        "numSubjects": "0"
      },
      {
        "groupId": "FG002",
        "numSubjects": "0"
      },
      {
        "groupId": "FG003",
        "numSubjects": "0"
      },
      {
        "groupId": "FG004",
        "numSubjects": "0"
      },
      {
        "groupId": "FG005",
        "numSubjects": "0"
      },
      {
        "groupId": "FG006",
        "numSubjects": "0"
      },
      {
        "groupId": "FG007",
        "numSubjects": "2"
      }
    ]
  },
  {
    "type": "Withdrawal by Subject",
    "reasons": [
      {
        "groupId": "FG000",
        "numSubjects": "0"
      },
      {
        "groupId": "FG001",
        "numSubjects": "0"
      },
      {
        "groupId": "FG002",
        "numSubjects": "0"
      },
      {
        "groupId": "FG003",
        "numSubjects": "0"
      },
      {
        "groupId": "FG004",
        "numSubjects": "0"
      },
      {
        "groupId": "FG005",
        "numSubjects": "0"
      },
      {
        "groupId": "FG006",
        "numSubjects": "1"
      },
      {
        "groupId": "FG007",
        "numSubjects": "1"
      }
    ]
  },
  {
    "type": "Trial Termination",
    "reasons": [
      {
        "groupId": "FG000",
        "numSubjects": "0"
      },
      {
        "groupId": "FG001",
        "numSubjects": "0"
      },
      {
        "groupId": "FG002",
        "numSubjects": "0"
      },
      {
        "groupId": "FG003",
        "numSubjects": "0"
      },
      {
        "groupId": "FG004",
        "numSubjects": "0"
      },
      {
        "groupId": "FG005",
        "numSubjects": "0"
      },
      {
        "groupId": "FG006",
        "numSubjects": "0"
      },
      {
        "groupId": "FG007",
        "numSubjects": "1"
      }
    ]
  }
]
remove /resultsSection/participantFlowModule/reviewUnit
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Before
{
  "resetReasons": [
    "The participant flow appears to include insufficient information to understand the arms/groups to which participants were assigned, the intervention strategy used in each arm/group, or how participants progressed in the study."
  ]
}
replace /resultsSection/baselineCharacteristicsModule/groups/0/title
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Before
Dose Escalation
After
AVID100 20 mg&#x2F;m^2
replace /resultsSection/baselineCharacteristicsModule/groups/0/description
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Before
<p>Minimum of 1 to 3 patients per dose cohort; approximately 4 dose cohorts to be evaluated to establish the Maximum tolerated dose.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>
After
Phase 1 Cohort 1: Participants were administered 20 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
replace /resultsSection/baselineCharacteristicsModule/groups/1/title
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Before
Phase 2a Triple Negative Breast Cancer
After
AVID100 40 mg&#x2F;m^2
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Before
<p>Addition of up to 15 patients in each of 2 subpopulations of patients with triple negative breast cancer (30 total).
One group of 15 patients will have 3+ EGFR over-expression.
The second group will have 2+ EGFR over-expression.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>
After
Phase 1 Cohort 2: Participants were administered 40 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
replace /resultsSection/baselineCharacteristicsModule/groups/2/title
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Before
Phase 2a Head and Neck Carcinoma
After
AVID100 80 mg&#x2F;m^2 Cohort 3
replace /resultsSection/baselineCharacteristicsModule/groups/2/description
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Before
<p>Addition of 15 patients with squamous head and neck carcinoma.
Patients will have 3+ EGFR over-expression.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>
After
Phase 1 Cohort 3: Participants were administered 80 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
replace /resultsSection/baselineCharacteristicsModule/groups/3/title
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Before
Phase 2a Non-Small Cell Lung Carcinoma
After
AVID100 120 mg&#x2F;m^2
replace /resultsSection/baselineCharacteristicsModule/groups/3/description
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Before
<p>Addition of 15 patients with squamous histology non-small cell lung carcinoma.
Patients will have 3+ EGFR over-expression</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>
After
Phase 1 Cohort 4: Participants were administered 120 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
replace /resultsSection/baselineCharacteristicsModule/groups/4/title
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Before
Total
After
AVID100 180 mg&#x2F;m^2
replace /resultsSection/baselineCharacteristicsModule/groups/4/description
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Before
Total of all reporting groups
After
Phase 1 Cohort 5: Participants were administered 180 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
add /resultsSection/baselineCharacteristicsModule/groups/5
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After
{
  "id": "BG005",
  "title": "AVID100 220 mg&#x2F;m^2",
  "description": "Phase 1 Cohort 6: Participants were administered 220 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
}
add /resultsSection/baselineCharacteristicsModule/groups/6
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After
{
  "id": "BG006",
  "title": "AVID100 270 mg&#x2F;m^2",
  "description": "Phase 1 Cohort 7: Participants were administered 270 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
}
add /resultsSection/baselineCharacteristicsModule/groups/7
Triage: Uncategorized
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After
{
  "id": "BG007",
  "title": "Phase 2a Expansion: AVID100 220 mg&#x2F;m^2",
  "description": "Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg&#x2F;m^2 administered every 3 weeks IV, for at least 1 cycle.\nExtended treatment was permitted for participants tolerating and benefiting from treatment."
}
add /resultsSection/baselineCharacteristicsModule/groups/8
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After
{
  "id": "BG008",
  "title": "Total",
  "description": "Total of all reporting groups"
}
replace /resultsSection/baselineCharacteristicsModule/denoms/0/counts/0/value
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{
  "value": "6",
  "groupId": "BG005"
}
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{
  "value": "7",
  "groupId": "BG006"
}
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{
  "value": "25",
  "groupId": "BG007"
}
add /resultsSection/baselineCharacteristicsModule/denoms/0/counts/8
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{
  "value": "49",
  "groupId": "BG008"
}
add /resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/0/measurements/5
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{
  "value": "0",
  "groupId": "BG005"
}
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{
  "value": "0",
  "groupId": "BG006"
}
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{
  "value": "0",
  "groupId": "BG007"
}
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{
  "value": "0",
  "groupId": "BG008"
}
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9
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{
  "value": "4",
  "groupId": "BG005"
}
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{
  "value": "3",
  "groupId": "BG006"
}
add /resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/1/measurements/7
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{
  "value": "16",
  "groupId": "BG007"
}
add /resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/1/measurements/8
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{
  "value": "32",
  "groupId": "BG008"
}
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12
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0
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{
  "value": "2",
  "groupId": "BG005"
}
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{
  "value": "4",
  "groupId": "BG006"
}
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{
  "value": "9",
  "groupId": "BG007"
}
add /resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/2/measurements/8
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{
  "value": "17",
  "groupId": "BG008"
}
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add /resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/0/measurements/5
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{
  "value": "4",
  "groupId": "BG005"
}
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{
  "value": "5",
  "groupId": "BG006"
}
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{
  "value": "10",
  "groupId": "BG007"
}
add /resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/0/measurements/8
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{
  "value": "24",
  "groupId": "BG008"
}
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{
  "value": "2",
  "groupId": "BG005"
}
add /resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/1/measurements/6
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{
  "value": "2",
  "groupId": "BG006"
}
add /resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/1/measurements/7
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{
  "value": "15",
  "groupId": "BG007"
}
add /resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/1/measurements/8
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{
  "value": "25",
  "groupId": "BG008"
}
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1
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1
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add /resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/0/measurements/5
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{
  "value": "0",
  "groupId": "BG005"
}
add /resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/0/measurements/6
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{
  "value": "0",
  "groupId": "BG006"
}
add /resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/0/measurements/7
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{
  "value": "1",
  "groupId": "BG007"
}
add /resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/0/measurements/8
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{
  "value": "1",
  "groupId": "BG008"
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{
  "title": "Canada",
  "categories": [
    {
      "measurements": [
        {
          "value": "0",
          "groupId": "BG000"
        },
        {
          "value": "0",
          "groupId": "BG001"
        },
        {
          "value": "0",
          "groupId": "BG002"
        },
        {
          "value": "0",
          "groupId": "BG003"
        },
        {
          "value": "0",
          "groupId": "BG004"
        },
        {
          "value": "0",
          "groupId": "BG005"
        },
        {
          "value": "0",
          "groupId": "BG006"
        },
        {
          "value": "2",
          "groupId": "BG007"
        },
        {
          "value": "2",
          "groupId": "BG008"
        }
      ]
    }
  ]
}
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  ]
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2021-10-06
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2022-04-13
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{
  "resetReasons": [
    "This record has new issues that must be addressed."
  ]
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Results outcome measures Posted result outcome measures and result-level endpoint data. Triage: Uncategorized 52 ops
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Before
Phase 1a: Determine Safety and Tolerability of AVID100
After
Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1
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Before
Number of Participants With Abnormal Laboratory Values and&#x2F;or Adverse Events That Are Related to Treatment
After
<p>Any of the following toxicities, if judged to be associated with study, were considered a DLT:</p><ol><li>Evidence of pulmonary fibrosis</li><li><p>G3 non-hematologic toxicity regardless of duration with the exceptions of:</p><ul><li>G3 nausea, vomiting, diarrhea, or fatigue lasting &lt; 2 days</li><li>G3 asymptomatic electrolyte abnormalities lasting &lt; 3 days not considered clinically relevant</li></ul></li><li>AST and&#x2F;or ALT elevation &gt; 3 x ULN with total bilirubin &gt; 2 x ULN without initial findings of cholestasis, that cannot be explained by other factors</li><li><p>Any G4 non-hematologic toxicity with the exception of:</p><p>• G4 asymptomatic electrolyte abnormalities lasting &lt; 7 days not considered clinically significant</p></li><li><p>Neutropenia that is:</p><ul><li>&gt; G3 and associated with fever</li><li>G4 and sustained (ANC &lt; 500 per mm3, duration &gt; 5 days)</li></ul></li><li><p>Thrombocytopenia that is:</p><ul><li>G3 with clinically significant hemorrhage or requirement for transfusion</li><li>G4 (platelets &lt; 25,000 per mm3)</li></ul></li><li>Inability to complete Cycle 1 at the assigned dose</li></ol>
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24 participants were treated.
10 patients experienced 16 SAEs.
Of these, 14 events were determined to be unrelated to treatment.
21 patients experienced treatment emergent adverse events (TEAEs) with the most common being: rash (16 patients); nausea (10 patients); fatigue (7 patients); IRR, platelets decreased &amp; vomiting (5 patients); lipase increased (4 patients); diarrhea, dry skin, and headache (3 patients each); and allergic conjunctivitis, anorexia, and AST increased (2 patients each).
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Overall study timeframe
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Cycle 1 during Dose Escalation (ie the first 3 weeks of dosing)
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Dose Escalation
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Dose Escalation Phase 1-Cohort 1
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<p>Minimum of 1 to 3 patients per dose cohort; approximately 4 dose cohorts to be evaluated to establish the Maximum tolerated dose.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>
After
1 Patient treated at 20mg&#x2F;m2, AVID100 IV is administered once every 3 weeks
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Phase 2a Triple Negative Breast Cancer
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Dose Escalation Phase 1-Cohort 2
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<p>Addition of up to 30 patients in each of 2 subpopulations of patients with triple negative breast cancer (30 total).
One group of 15 patients will have 3+ EGFR over-expression.
The second group will have 2+ EGFR over-expression.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>
After
1 Patient treated at 40mg&#x2F;m2, AVID100 IV is administered IV once every 3 weeks
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Phase 2a Head and Neck Carcinoma
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Dose Escalation Phase 1-Cohort 3
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<p>Addition of 15 patients with squamous head and neck carcinoma.
Patients will have 3+ EGFR over-expression.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>
After
3 Patients treated at 80mg&#x2F;m2, AVID100 IV administered once every 3 weeks
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Phase 2a Non-Small Cell Lung Carcinoma
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Dose Escalation Phase 1-Cohort 4
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<p>Addition of 15 patients with squamous histology non-small cell lung carcinoma.
Patients will have 3+ EGFR over-expression</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>
After
3 Patients treated at 120mg&#x2F;m2, AVID100 IV is administered once every 3 weeks
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{
  "id": "OG004",
  "title": "Dose Escalation Phase 1-Cohort 5",
  "description": "3 Patients treated at 180mg&#x2F;m2, AVID100 IV is administered once every 3 weeks"
}
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{
  "id": "OG005",
  "title": "Dose Escalation Phase 1-Cohort 6",
  "description": "6 Patients treated at 220 mg&#x2F;m2, AVID100 IV is administered once every 3 weeks"
}
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{
  "id": "OG006",
  "title": "Dose Escalation Phase 1-Cohort 7",
  "description": "7 Patients treated at 270mg&#x2F;m2, AVID100 IV is administered once every 3 weeks"
}
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{
  "value": "3",
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  "value": "6",
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{
  "value": "7",
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  "value": "0",
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  "value": "0",
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{
  "value": "2",
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    "There does not appear to be sufficient information to understand the Time Frame."
  ]
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    "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
  ]
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Phase 2a: Evaluation of the Preliminary Antineoplastic Effects of AVID100
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Phase 2a: Number of Participants With Best Overall Response by RECIST 1.1
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Number of participants with objective response or stable disease
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Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening and every 2 cycles during study treatment.
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Before
A total of 25 patients have been enrolled (16 with HNSCC, 6 with TNBC and 3 with sqNSCLC); of the three cohorts only HNSCC fully recruited the first stage.
1 CR was observed in the HNSCC cohort.
The criteria for expansion of this cohort were not met.
No RECIST responses were observed in the other two cohorts.
AVID100 was well tolerated overall.
After
Patients who completed Cycle 2 (6 weeks) of treatment, received at least 2 planned doses during that period, and had a follow-up assessment of disease status were considered evaluable for assessment of antineoplastic activity.
Patients who were withdrawn from the study before completion of Cycle 2 because of progressive disease also were included in assessments of antineoplastic activity.
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame
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Before
Overall Study
After
Imaging for Disease status (tumour measurements) occurred after every even cycle and at EOT visit
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/0/title
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Before
Dose Escalation
After
Phase 2a Expansion: AVID100 220 mg&#x2F;m^2
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Before
<p>Minimum of 1 to 3 patients per dose cohort; approximately 4 dose cohorts to be evaluated to establish the Maximum tolerated dose.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>
After
Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg&#x2F;m^2 administered every 3 weeks IV, for at least 1 cycle.
Extended treatment was permitted for participants tolerating and benefiting from treatment.
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Before
{
  "id": "OG001",
  "title": "Phase 2a Triple Negative Breast Cancer",
  "description": "<p>Addition of up to 30 patients in each of 2 subpopulations of patients with triple negative breast cancer (30 total).\nOne group of 15 patients will have 3+ EGFR over-expression.\nThe second group will have 2+ EGFR over-expression.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>"
}
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Before
{
  "id": "OG002",
  "title": "Phase 2a Head and Neck Carcinoma",
  "description": "<p>Addition of 15 patients with squamous head and neck carcinoma.\nPatients will have 3+ EGFR over-expression.</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>"
}
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Before
{
  "id": "OG003",
  "title": "Phase 2a Non-Small Cell Lung Carcinoma",
  "description": "<p>Addition of 15 patients with squamous histology non-small cell lung carcinoma.\nPatients will have 3+ EGFR over-expression</p><p>AVID100 IV: AVID100 is administered once every 3 weeks</p>"
}
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Before
{
  "value": "6",
  "groupId": "OG001"
}
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Before
{
  "value": "15",
  "groupId": "OG002"
}
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Before
{
  "value": "3",
  "groupId": "OG003"
}
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Before
0
After
23
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Before
{
  "value": "0",
  "groupId": "OG001"
}
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Before
{
  "value": "1",
  "groupId": "OG002"
}
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Before
{
  "value": "0",
  "groupId": "OG003"
}
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After
Progressive Disease
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After
{
  "title": "Stable Disease",
  "measurements": [
    {
      "value": "0",
      "groupId": "OG000"
    }
  ]
}
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After
{
  "title": "Complete Response",
  "measurements": [
    {
      "value": "1",
      "groupId": "OG000"
    }
  ]
}
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Before
The measure does not appear to include sufficient information to understand how outcomes are measured and reported.
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Before
{
  "resetReasons": [
    "A free-text field appears to include results data or conclusions drawn from the data. All results data must be reported in a tabular format.",
    "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
  ]
}
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Before
{
  "type": "SECONDARY",
  "title": "PK Profile of Total Antibody",
  "timeFrame": "Not Completed",
  "description": "Characterization of the pharmacokinetic profile of total antibody",
  "reportingStatus": "NOT_POSTED",
  "denomUnitsSelected": "Participants"
}
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2022-03"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2022-03-21"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2022-04-14"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "value": "Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "value": "<p>Any of the following toxicities, if judged to be associated with study, were considered a DLT:</p><ol><li>Evidence of pulmonary fibrosis</li><li><p>G3 non-hematologic toxicity regardless of duration with the exceptions of:</p><ul><li>G3 nausea, vomiting, diarrhea, or fatigue lasting &lt; 2 days</li><li>G3 asymptomatic electrolyte abnormalities lasting &lt; 3 days not considered clinically relevant</li></ul></li><li>AST and&#x2F;or ALT elevation &gt; 3 x ULN with total bilirubin &gt; 2 x ULN without initial findings of cholestasis, that cannot be explained by other factors</li><li><p>Any G4 non-hematologic toxicity with the exception of:</p><p>• G4 asymptomatic electrolyte abnormalities lasting &lt; 7 days not considered clinically significant</p></li><li><p>Neutropenia that is:</p><ul><li>&gt; G3 and associated with fever</li><li>G4 and sustained (ANC &lt; 500 per mm3, duration &gt; 5 days)</li></ul></li><li><p>Thrombocytopenia that is:</p><ul><li>G3 with clinically significant hemorrhage or requirement for transfusion</li><li>G4 (platelets &lt; 25,000 per mm3)</li></ul></li><li>Inability to complete Cycle 1 at the assigned dose</li></ol>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "Cycle 1 during Dose Escalation (ie the first 3 weeks of dosing)"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
    "value": "Phase 2a: Number of Participants With Best Overall Response by RECIST 1.1"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/1/description",
    "value": "Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening and every 2 cycles during study treatment."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
    "value": "Imaging for Disease status (tumour measurements) occurred after every even cycle and at EOT visit"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit/resetReasons/0"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes"
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  {
    "op": "replace",
    "path": "/resultsSection/participantFlowModule/groups/0/title",
    "value": "AVID100 20 mg&#x2F;m^2"
  },
  {
    "op": "replace",
    "path": "/resultsSection/participantFlowModule/groups/0/description",
    "value": "Phase 1 Cohort 1: Participants were administered 20 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
  },
  {
    "op": "replace",
    "path": "/resultsSection/participantFlowModule/groups/1/title",
    "value": "AVID100 40 mg&#x2F;m^2"
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  {
    "op": "replace",
    "path": "/resultsSection/participantFlowModule/groups/1/description",
    "value": "Phase 1 Cohort 2: Participants were administered 40 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
  },
  {
    "op": "replace",
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  },
  {
    "op": "replace",
    "path": "/resultsSection/participantFlowModule/groups/2/description",
    "value": "Phase 1 Cohort 3: Participants were administered 80 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
  },
  {
    "op": "replace",
    "path": "/resultsSection/participantFlowModule/groups/3/title",
    "value": "AVID100 120 mg&#x2F;m^2"
  },
  {
    "op": "replace",
    "path": "/resultsSection/participantFlowModule/groups/3/description",
    "value": "Phase 1 Cohort 4: Participants were administered 120 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/groups/4",
    "value": {
      "id": "FG004",
      "title": "AVID100 180 mg&#x2F;m^2",
      "description": "Phase 1 Cohort 5: Participants were administered 180 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
    }
  },
  {
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    }
  },
  {
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      "id": "FG006",
      "title": "AVID100 270 mg&#x2F;m^2",
      "description": "Phase 1 Cohort 7: Participants were administered 270 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
    }
  },
  {
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      "id": "FG007",
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      "description": "Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg&#x2F;m^2 administered every 3 weeks IV, for at least 1 cycle.\nExtended treatment was permitted for participants tolerating and benefiting from treatment."
    }
  },
  {
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    "path": "/resultsSection/participantFlowModule/periods/0/milestones/0/achievements/0/numSubjects",
    "value": "1"
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    "path": "/resultsSection/participantFlowModule/periods/0/milestones/0/achievements/1/numSubjects",
    "value": "1"
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    "path": "/resultsSection/participantFlowModule/periods/0/milestones/0/achievements/2/numSubjects",
    "value": "3"
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  },
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      "groupId": "FG005",
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      "groupId": "FG006",
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    "value": {
      "groupId": "FG007",
      "numSubjects": "25"
    }
  },
  {
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    "path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/0/numSubjects",
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    "path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/1/numSubjects",
    "value": "1"
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    "path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/2/numSubjects",
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  },
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    "value": {
      "groupId": "FG004",
      "numSubjects": "3"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/5",
    "value": {
      "groupId": "FG005",
      "numSubjects": "6"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/6",
    "value": {
      "groupId": "FG006",
      "numSubjects": "6"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/7",
    "value": {
      "groupId": "FG007",
      "numSubjects": "0"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/4",
    "value": {
      "groupId": "FG004",
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    }
  },
  {
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    "path": "/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/5",
    "value": {
      "groupId": "FG005",
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  },
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    "value": {
      "groupId": "FG006",
      "numSubjects": "1"
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  },
  {
    "op": "add",
    "path": "/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/7",
    "value": {
      "groupId": "FG007",
      "numSubjects": "25"
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  },
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    "op": "add",
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        "type": "Lack of Efficacy",
        "reasons": [
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            "groupId": "FG000",
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          {
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            "numSubjects": "0"
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          {
            "groupId": "FG002",
            "numSubjects": "0"
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          {
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            "numSubjects": "0"
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            "numSubjects": "0"
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            "numSubjects": "0"
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          {
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            "numSubjects": "0"
          },
          {
            "groupId": "FG007",
            "numSubjects": "21"
          }
        ]
      },
      {
        "type": "Adverse Event",
        "reasons": [
          {
            "groupId": "FG000",
            "numSubjects": "0"
          },
          {
            "groupId": "FG001",
            "numSubjects": "0"
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          {
            "groupId": "FG002",
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          {
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            "numSubjects": "0"
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          {
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            "numSubjects": "0"
          },
          {
            "groupId": "FG005",
            "numSubjects": "0"
          },
          {
            "groupId": "FG006",
            "numSubjects": "0"
          },
          {
            "groupId": "FG007",
            "numSubjects": "2"
          }
        ]
      },
      {
        "type": "Withdrawal by Subject",
        "reasons": [
          {
            "groupId": "FG000",
            "numSubjects": "0"
          },
          {
            "groupId": "FG001",
            "numSubjects": "0"
          },
          {
            "groupId": "FG002",
            "numSubjects": "0"
          },
          {
            "groupId": "FG003",
            "numSubjects": "0"
          },
          {
            "groupId": "FG004",
            "numSubjects": "0"
          },
          {
            "groupId": "FG005",
            "numSubjects": "0"
          },
          {
            "groupId": "FG006",
            "numSubjects": "1"
          },
          {
            "groupId": "FG007",
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          }
        ]
      },
      {
        "type": "Trial Termination",
        "reasons": [
          {
            "groupId": "FG000",
            "numSubjects": "0"
          },
          {
            "groupId": "FG001",
            "numSubjects": "0"
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          {
            "groupId": "FG002",
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          {
            "groupId": "FG003",
            "numSubjects": "0"
          },
          {
            "groupId": "FG004",
            "numSubjects": "0"
          },
          {
            "groupId": "FG005",
            "numSubjects": "0"
          },
          {
            "groupId": "FG006",
            "numSubjects": "0"
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          {
            "groupId": "FG007",
            "numSubjects": "1"
          }
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      }
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    "path": "/resultsSection/baselineCharacteristicsModule/groups/0/title",
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    "path": "/resultsSection/baselineCharacteristicsModule/groups/0/description",
    "value": "Phase 1 Cohort 1: Participants were administered 20 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
  },
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    "value": "Phase 1 Cohort 2: Participants were administered 40 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
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  },
  {
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    }
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              "groupId": "BG001"
            },
            {
              "value": "0",
              "groupId": "BG002"
            },
            {
              "value": "0",
              "groupId": "BG003"
            },
            {
              "value": "0",
              "groupId": "BG004"
            },
            {
              "value": "0",
              "groupId": "BG005"
            },
            {
              "value": "0",
              "groupId": "BG006"
            },
            {
              "value": "2",
              "groupId": "BG007"
            },
            {
              "value": "2",
              "groupId": "BG008"
            }
          ]
        }
      ]
    }
  },
  {
    "op": "remove",
    "path": "/resultsSection/baselineCharacteristicsModule/popReviewUnit"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/title",
    "value": "Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description",
    "value": "<p>Any of the following toxicities, if judged to be associated with study, were considered a DLT:</p><ol><li>Evidence of pulmonary fibrosis</li><li><p>G3 non-hematologic toxicity regardless of duration with the exceptions of:</p><ul><li>G3 nausea, vomiting, diarrhea, or fatigue lasting &lt; 2 days</li><li>G3 asymptomatic electrolyte abnormalities lasting &lt; 3 days not considered clinically relevant</li></ul></li><li>AST and&#x2F;or ALT elevation &gt; 3 x ULN with total bilirubin &gt; 2 x ULN without initial findings of cholestasis, that cannot be explained by other factors</li><li><p>Any G4 non-hematologic toxicity with the exception of:</p><p>• G4 asymptomatic electrolyte abnormalities lasting &lt; 7 days not considered clinically significant</p></li><li><p>Neutropenia that is:</p><ul><li>&gt; G3 and associated with fever</li><li>G4 and sustained (ANC &lt; 500 per mm3, duration &gt; 5 days)</li></ul></li><li><p>Thrombocytopenia that is:</p><ul><li>G3 with clinically significant hemorrhage or requirement for transfusion</li><li>G4 (platelets &lt; 25,000 per mm3)</li></ul></li><li>Inability to complete Cycle 1 at the assigned dose</li></ol>"
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/populationDescription"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
    "value": "Cycle 1 during Dose Escalation (ie the first 3 weeks of dosing)"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/0/title",
    "value": "Dose Escalation Phase 1-Cohort 1"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/0/description",
    "value": "1 Patient treated at 20mg&#x2F;m2, AVID100 IV is administered once every 3 weeks"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/1/title",
    "value": "Dose Escalation Phase 1-Cohort 2"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/1/description",
    "value": "1 Patient treated at 40mg&#x2F;m2, AVID100 IV is administered IV once every 3 weeks"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/2/title",
    "value": "Dose Escalation Phase 1-Cohort 3"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/2/description",
    "value": "3 Patients treated at 80mg&#x2F;m2, AVID100 IV administered once every 3 weeks"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/3/title",
    "value": "Dose Escalation Phase 1-Cohort 4"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/3/description",
    "value": "3 Patients treated at 120mg&#x2F;m2, AVID100 IV is administered once every 3 weeks"
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/4",
    "value": {
      "id": "OG004",
      "title": "Dose Escalation Phase 1-Cohort 5",
      "description": "3 Patients treated at 180mg&#x2F;m2, AVID100 IV is administered once every 3 weeks"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/5",
    "value": {
      "id": "OG005",
      "title": "Dose Escalation Phase 1-Cohort 6",
      "description": "6 Patients treated at 220 mg&#x2F;m2, AVID100 IV is administered once every 3 weeks"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/6",
    "value": {
      "id": "OG006",
      "title": "Dose Escalation Phase 1-Cohort 7",
      "description": "7 Patients treated at 270mg&#x2F;m2, AVID100 IV is administered once every 3 weeks"
    }
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/denoms/0/counts/0/value",
    "value": "1"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/denoms/0/counts/1/value",
    "value": "1"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/denoms/0/counts/2/value",
    "value": "3"
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/denoms/0/counts/4",
    "value": {
      "value": "3",
      "groupId": "OG004"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/denoms/0/counts/5",
    "value": {
      "value": "6",
      "groupId": "OG005"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/denoms/0/counts/6",
    "value": {
      "value": "7",
      "groupId": "OG006"
    }
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/0/value",
    "value": "0"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/1/value",
    "value": "0"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/2/value",
    "value": "0"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/3/value",
    "value": "0"
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/4",
    "value": {
      "value": "0",
      "groupId": "OG004"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/5",
    "value": {
      "value": "0",
      "groupId": "OG005"
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/6",
    "value": {
      "value": "2",
      "groupId": "OG006"
    }
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit"
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/measureCategoriesReviewUnit"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/title",
    "value": "Phase 2a: Number of Participants With Best Overall Response by RECIST 1.1"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description",
    "value": "Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening and every 2 cycles during study treatment."
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription",
    "value": "Patients who completed Cycle 2 (6 weeks) of treatment, received at least 2 planned doses during that period, and had a follow-up assessment of disease status were considered evaluable for assessment of antineoplastic activity.\nPatients who were withdrawn from the study before completion of Cycle 2 because of progressive disease also were included in assessments of antineoplastic activity."
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame",
    "value": "Imaging for Disease status (tumour measurements) occurred after every even cycle and at EOT visit"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/0/title",
    "value": "Phase 2a Expansion: AVID100 220 mg&#x2F;m^2"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/0/description",
    "value": "Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg&#x2F;m^2 administered every 3 weeks IV, for at least 1 cycle.\nExtended treatment was permitted for participants tolerating and benefiting from treatment."
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/1"
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/1"
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/1"
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/1"
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/1"
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/1"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/0/value",
    "value": "23"
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/1"
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/1"
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/1"
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/title",
    "value": "Progressive Disease"
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/1",
    "value": {
      "title": "Stable Disease",
      "measurements": [
        {
          "value": "0",
          "groupId": "OG000"
        }
      ]
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/2",
    "value": {
      "title": "Complete Response",
      "measurements": [
        {
          "value": "1",
          "groupId": "OG000"
        }
      ]
    }
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reviewUnit/resetReasons/0"
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/measureCategoriesReviewUnit"
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2"
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/timeFrame",
    "value": "Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved."
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/0/title",
    "value": "AVID100 20 mg&#x2F;m^2"
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/0/description",
    "value": "Phase 1 Cohort 1: Participants were administered 20 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected",
    "value": 0
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAtRisk",
    "value": 1
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/0/seriousNumAffected",
    "value": 0
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/0/seriousNumAtRisk",
    "value": 1
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/0/otherNumAffected",
    "value": 1
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/0/otherNumAtRisk",
    "value": 1
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/1/title",
    "value": "AVID100 40 mg&#x2F;m^2"
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/1/description",
    "value": "Phase 1 Cohort 1: Participants were administered 40 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/1/deathsNumAffected",
    "value": 0
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/1/deathsNumAtRisk",
    "value": 1
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/1/seriousNumAffected",
    "value": 0
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/1/seriousNumAtRisk",
    "value": 1
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/1/otherNumAffected",
    "value": 1
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/1/otherNumAtRisk",
    "value": 1
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/2/title",
    "value": "AVID100 80 mg&#x2F;m^2"
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/2/description",
    "value": "Phase 1 Cohort 1: Participants were administered 80 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/2/deathsNumAtRisk",
    "value": 3
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/2/seriousNumAffected",
    "value": 1
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/2/seriousNumAtRisk",
    "value": 3
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/2/otherNumAffected",
    "value": 3
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/2/otherNumAtRisk",
    "value": 3
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/3/title",
    "value": "AVID100 120 mg&#x2F;m^2"
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/3/description",
    "value": "Phase 1 Cohort 1: Participants were administered 120 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered."
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/3/seriousNumAffected",
    "value": 2
  },
  {
    "op": "add",
    "path": "/resultsSection/adverseEventsModule/eventGroups/4",
    "value": {
      "id": "EG004",
      "title": "AVID100 180 mg&#x2F;m^2",
      "description": "Phase 1 Cohort 1: Participants were administered 180 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.",
      "otherNumAtRisk": 3,
      "deathsNumAtRisk": 3,
      "otherNumAffected": 3,
      "seriousNumAtRisk": 3,
      "deathsNumAffected": 0,
      "seriousNumAffected": 1
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/adverseEventsModule/eventGroups/5",
    "value": {
      "id": "EG005",
      "title": "AVID100 220 mg&#x2F;m^2",
      "description": "Phase 1 Cohort 1: Participants were administered 220 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.",
      "otherNumAtRisk": 6,
      "deathsNumAtRisk": 6,
      "otherNumAffected": 6,
      "seriousNumAtRisk": 6,
      "deathsNumAffected": 0,
      "seriousNumAffected": 3
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/adverseEventsModule/eventGroups/6",
    "value": {
      "id": "EG006",
      "title": "AVID100 270 mg&#x2F;m^2",
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      "otherNumAtRisk": 7,
      "deathsNumAtRisk": 7,
      "otherNumAffected": 7,
      "seriousNumAtRisk": 7,
      "deathsNumAffected": 1,
      "seriousNumAffected": 2
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/adverseEventsModule/eventGroups/7",
    "value": {
      "id": "EG007",
      "title": "Phase 2a Expansion: AVID100 220 mg&#x2F;m^2",
      "description": "Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg&#x2F;m^2 administered every 3 weeks IV, for at least 1 cycle.\nExtended treatment was permitted for participants tolerating and benefiting from treatment.",
      "otherNumAtRisk": 25,
      "deathsNumAtRisk": 25,
      "otherNumAffected": 25,
      "seriousNumAtRisk": 25,
      "deathsNumAffected": 3,
      "seriousNumAffected": 13
    }
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/0/numEvents",
    "value": 0
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/0/numAffected",
    "value": 0
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/0/numAtRisk",
    "value": 1
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/1/numAtRisk",
    "value": 1
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/2/numAtRisk",
    "value": 3
  },
  {
    "op": "add",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/4",
    "value": {
      "groupId": "EG004",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/5",
    "value": {
      "groupId": "EG005",
      "numAtRisk": 6,
      "numEvents": 1,
      "numAffected": 1
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/6",
    "value": {
      "groupId": "EG006",
      "numAtRisk": 7,
      "numEvents": 0,
      "numAffected": 0
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/7",
    "value": {
      "groupId": "EG007",
      "numAtRisk": 25,
      "numEvents": 0,
      "numAffected": 0
    }
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/0/numEvents",
    "value": 0
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/0/numAffected",
    "value": 0
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/0/numAtRisk",
    "value": 1
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/1/numEvents",
    "value": 0
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/1/numAffected",
    "value": 0
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/1/numAtRisk",
    "value": 1
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/2/numEvents",
    "value": 0
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/2/numAffected",
    "value": 0
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/2/numAtRisk",
    "value": 3
  },
  {
    "op": "add",
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    "value": {
      "groupId": "EG004",
      "numAtRisk": 3,
      "numEvents": 0,
      "numAffected": 0
    }
  },
  {
    "op": "add",
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    "value": {
      "groupId": "EG005",
      "numAtRisk": 6,
      "numEvents": 0,
      "numAffected": 0
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/6",
    "value": {
      "groupId": "EG006",
      "numAtRisk": 7,
      "numEvents": 1,
      "numAffected": 1
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/7",
    "value": {
      "groupId": "EG007",
      "numAtRisk": 25,
      "numEvents": 2,
      "numAffected": 2
    }
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/0/numEvents",
    "value": 0
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]