Evidence Record
evt_NCT03393845_v16_v17_6b4c956d1259
NCT03393845 · Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients
Severity is deterministic, reproducible, uncalibrated triage metadata, not validated review priority or proven wrongdoing. This page states what the registry evidence supports and what it does not support.
Triage severity
Triage: Low Category
Timeline Actual Date Correction
Versions
v16 to v17
Timing
Late Recruitment
Claims Supported
- TrialDiff compared ClinicalTrials.gov record version 16 to version 17 for NCT03393845.
- The JSON Patch for this comparison has hash fb6df65c96a15b731fdbd097118f285406cb657523e95590210a301de93bc68b.
- The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.
- The deterministic triage label was low; before timing adjustment it was low.
- The triage label is uncalibrated metadata, not a validated review-priority finding.
- The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting.
- The timing context for the from-version record was late_recruitment.
- The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/primaryCompletionDateStruct/date, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame, /hasResults, /resultsSection, /annotationSection, /documentSection.
- The timeline value moved by 546 days.
- An outcome path changed between versions 16 and 17 in a patch that also carried a hasResults or resultsSection co-occurrence signal.
Claims Not Supported
- That the amendment was scientifically unjustified.
- That the change constitutes misconduct or wrongdoing.
- That sponsor intent can be inferred from this registry change.
- That the change caused or altered the trial's results.
- That the change was or was not disclosed in a manuscript.
- That TrialDiff determines regulatory compliance or non-compliance.
- That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.
- That event-class membership is a validated global review-priority ranking.
Neutral Review Question
What source document explains this registry amendment, and does it change interpretation of the trial record?
Citation
TrialDiff Evidence Record evt_NCT03393845_v16_v17_6b4c956d1259. ClinicalTrials.gov NCT03393845, versions 16-17. Evidence version 1.
Event Classes
outcome_edit_cooccurs_with_results_posting Changed Paths
/protocolSection/statusModule/statusVerifiedDate
/protocolSection/statusModule/primaryCompletionDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/statusModule/resultsFirstSubmitQcDate
/protocolSection/statusModule/resultsFirstPostDateStruct
/protocolSection/outcomesModule/primaryOutcomes/0/description
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/0/measure
/protocolSection/outcomesModule/secondaryOutcomes/0/description
/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/1/measure
/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/2/measure
/protocolSection/outcomesModule/secondaryOutcomes/2/description
/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame
/hasResults
/resultsSection
/annotationSection
/documentSection
View the field-level diff for before/after values on each changed path.
Deterministic Rules
No deterministic rules recorded.
Provenance
- Package generation
v0.1.3(active)- Supersedes
- evt_NCT03393845_v16_v17_db50797ae371
- Patch hash
fb6df65c96a15b731fdbd097118f285406cb657523e95590210a301de93bc68b- Canonical hash
8859315c381ef46a351f32609f6f773a6606a2be24d37dcb19bfd7952e5aad89- Rule set hash
fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621- From snapshot
2a0332d6f7225119daea29fe5130c9394a827bba3ade71b777a72ba22cbcba98- To snapshot
Unavailable- Patch source
- ctgov_internal_history
- Generated at
- 2026-08-03T06:46:43.000Z
- Source URL
- Registry payload
Canonical JSON Preview
Stored payload{
"changed_paths": [
"/protocolSection/statusModule/statusVerifiedDate",
"/protocolSection/statusModule/primaryCompletionDateStruct/date",
"/protocolSection/statusModule/lastUpdateSubmitDate",
"/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"/protocolSection/statusModule/resultsFirstSubmitDate",
"/protocolSection/statusModule/resultsFirstSubmitQcDate",
"/protocolSection/statusModule/resultsFirstPostDateStruct",
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"/hasResults",
"/resultsSection",
"/annotationSection",
"/documentSection"
],
"citation_text": "TrialDiff Evidence Record evt_NCT03393845_v16_v17_6b4c956d1259. ClinicalTrials.gov NCT03393845, versions 16-17. Evidence version 1.",
"claims_not_supported": [
"That the amendment was scientifically unjustified.",
"That the change constitutes misconduct or wrongdoing.",
"That sponsor intent can be inferred from this registry change.",
"That the change caused or altered the trial's results.",
"That the change was or was not disclosed in a manuscript.",
"That TrialDiff determines regulatory compliance or non-compliance.",
"That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.",
"That event-class membership is a validated global review-priority ranking."
],
"claims_supported": [
"TrialDiff compared ClinicalTrials.gov record version 16 to version 17 for NCT03393845.",
"The JSON Patch for this comparison has hash fb6df65c96a15b731fdbd097118f285406cb657523e95590210a301de93bc68b.",
"The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
"The deterministic triage label was low; before timing adjustment it was low.",
"The triage label is uncalibrated metadata, not a validated review-priority finding.",
"The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting.",
"The timing context for the from-version record was late_recruitment.",
"The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/primaryCompletionDateStruct/date, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame, /hasResults, /resultsSection, /annotationSection, /documentSection.",
"The timeline value moved by 546 days.",
"An outcome path changed between versions 16 and 17 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
],
"classification": {
"calibration_status": "uncalibrated",
"categories": [
"timeline_actual_date_correction",
"results_reconciliation"
],
"category": "timeline_actual_date_correction",
"deterministic_rules": [],
"event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
"event_classes": [
"outcome_edit_cooccurs_with_results_posting"
],
"rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
"severity": "low",
"severity_pre_timing": "low",
"timing_context": "late_recruitment",
"triage_label": "low",
"triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
"value_signals": [
{
"category": "timeline_actual_date_correction",
"date_struct": "primaryCompletionDateStruct",
"delta_days": 546,
"direction": "later",
"new_precision": "day",
"new_type": "ACTUAL",
"new_value": "2025-01-31",
"old_precision": "day",
"old_type": "ACTUAL",
"old_value": "2023-08-04",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"severity": "low",
"signal": "timeline_actual_date_correction"
},
{
"category": "results_reconciliation",
"paths": [
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame"
],
"severity": "low",
"signal": "results_reconciliation_outcome_suppression"
}
]
},
"event_id": "evt_NCT03393845_v16_v17_6b4c956d1259",
"evidence_version": 1,
"patch": [
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2026-04"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"value": "2025-01-31"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2026-04-06"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2026-04-24"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2026-04-06"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2026-04-06"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2026-04-24",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "<p>Clinical benefit ratio (CBR) is defined as the percentage of patients that achieve CR, PR, or stable disease for a minimum of four months.\nPatients will be evaluated for response by RECIST 1.1 and irRECIST.</p><p>Complete Response (CR)(RECIST1.1):\nAll target lesions disappear.\nAny pathological lymph nodes must have a reduction in short axis to <10 mm.</p><p>Partial Response (PR)(RECIST1.1):\nAt least a 30 % decrease in the sum of the longest diameters (LD) of target lesions, using the baseline sum as reference.</p><p>Stable Disease (SD)(RECIST1.1):\nNeither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking the smallest sum of diameters since treatment started as a reference irCR(irRECIST):Complete Resolution of non-nodal lesions and <10 mm short-axis for lymph nodes irPR(irRECIST): ≥30% decrease in tumor burden irSD(irRECIST): Does not meet criteria for irCR/irPR/irPD</p>"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "From C1D1 up to a maximum of 31 months or until death"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Safety Profile of Pembrolizumab Plus Fulvestrant"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "The toxicity profile will report all grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v4"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "From C1D1 up to a maximum of 18 months or until death"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Progression Free Survival (PFS)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "From C1D1 up to a maximum of 33 months or until death"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Durable Response Rate (DRR)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "<p>Durable response rate is defined as the number of months that a stable disease, partial or complete response per RECIST 1.1 is observed.</p><p>Complete Response (CR): All target lesions disappear.\nAny pathological lymph nodes must have a reduction in short axis to <10 mm.</p><p>Partial Response (PR): At least a 30 % decrease in the sum of the longest diameters (LD) of target lesions, using the baseline sum as reference.</p><p>Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking the smallest sum of diameters since treatment started as a reference</p>"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"value": "From C1D1 until death or up to a maximum of 31 months"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "From C1D1 up to a maximum of 44 months until death"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"adverseEventsModule": {
"description": "Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4.\nEvents were assessed at every visit at an interval of 21 days.",
"eventGroups": [
{
"deathsNumAffected": 25,
"deathsNumAtRisk": 47,
"description": "<p>Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 21 days.\nSites should make every effort to target infusion timing to be as close to 30 minutes as possible.\nHowever, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).</p><p>Fulvestrant 500 mg will be administered as two 5mL IM injections (one in each buttock).\nThe standard dosing is as follows: Loading doses will be given on Cycle 1 Day 1 and 15.\nThereafter, dosing will be every 4 weeks.</p>",
"id": "EG000",
"otherNumAffected": 46,
"otherNumAtRisk": 47,
"seriousNumAffected": 12,
"seriousNumAtRisk": 47,
"title": "Pembrolizumab, 200 mg + Fulvestrant, 500mg"
}
],
"frequencyThreshold": "0",
"otherEvents": [
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "ABDOMINAL INFECTION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 9,
"numAtRisk": 47,
"numEvents": 15
}
],
"term": "ABDOMINAL PAIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Renal and urinary disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "ACUTE KIDNEY INJURY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "AGITATION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 16,
"numAtRisk": 47,
"numEvents": 21
}
],
"term": "ALANINE AMINOTRANSFERASE INCREASED"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 17,
"numAtRisk": 47,
"numEvents": 35
}
],
"term": "ALKALINE PHOSPHATASE INCREASED"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Immune system disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "ALLERGIC REACTION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 47,
"numEvents": 4
}
],
"term": "ALLERGIC RHINITIS"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 47,
"numEvents": 3
}
],
"term": "ALOPECIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 21,
"numAtRisk": 47,
"numEvents": 54
}
],
"term": "ANEMIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 47,
"numEvents": 6
}
],
"term": "ANOREXIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 47,
"numEvents": 4
}
],
"term": "ANXIETY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 47,
"numEvents": 6
}
],
"term": "ARTHRALGIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "ARTHRITIS"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 22,
"numAtRisk": 47,
"numEvents": 36
}
],
"term": "ASPARTATE AMINOTRANSFERASE INCREASED"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 47,
"numEvents": 6
}
],
"term": "BACK PAIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "BLOATING"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 47,
"numEvents": 6
}
],
"term": "BLOOD BILIRUBIN INCREASED"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "BLURRED VISION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "BONE INFECTION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 47,
"numEvents": 5
}
],
"term": "BONE PAIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Reproductive system and breast disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 47,
"numEvents": 3
}
],
"term": "BREAST PAIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "BRONCHOSPASM"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Injury, poisoning and procedural complications",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 47,
"numEvents": 4
}
],
"term": "BRUISING"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "BULLOUS DERMATITIS"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "CARDIAC TROPONIN I INCREASED"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "CHEST WALL PAIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "CHILLS"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "CONFUSION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 12,
"numAtRisk": 47,
"numEvents": 13
}
],
"term": "CONSTIPATION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 47,
"numEvents": 9
}
],
"term": "COUGH"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 47,
"numEvents": 7
}
],
"term": "CREATININE INCREASED"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "DEHYDRATION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "DEPRESSION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 14,
"numAtRisk": 47,
"numEvents": 25
}
],
"term": "DIARRHEA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 47,
"numEvents": 4
}
],
"term": "DIZZINESS"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 47,
"numEvents": 3
}
],
"term": "DRY SKIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "DYSGEUSIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 3
}
],
"term": "DYSPEPSIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 47,
"numEvents": 3
}
],
"term": "DYSPHAGIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 10,
"numAtRisk": 47,
"numEvents": 16
}
],
"term": "DYSPNEA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Ear and labyrinth disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Ear and labyrinth disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "EAR PAIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 47,
"numEvents": 4
}
],
"term": "EDEMA LIMBS"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "ERYTHEMA MULTIFORME"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "EYE DISORDERS - OTHER, SPECIFY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 5
}
],
"term": "FACIAL PAIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Injury, poisoning and procedural complications",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "FALL"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 20,
"numAtRisk": 47,
"numEvents": 25
}
],
"term": "FATIGUE"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "FEVER"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "FLANK PAIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 3
}
],
"term": "FLU LIKE SYMPTOMS"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Injury, poisoning and procedural complications",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "FRACTURE"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "GASTROESOPHAGEAL REFLUX DISEASE"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "GASTROINTESTINAL PAIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "GENERALIZED MUSCLE WEAKNESS"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 47,
"numEvents": 6
}
],
"term": "HEADACHE"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "HEMORRHOIDS"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Injury, poisoning and procedural complications",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "HIP FRACTURE"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 47,
"numEvents": 6
}
],
"term": "HOT FLASHES"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 47,
"numEvents": 4
}
],
"term": "HYPERCALCEMIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 19,
"numAtRisk": 47,
"numEvents": 34
}
],
"term": "HYPERGLYCEMIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "HYPERHIDROSIS"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "HYPERKALEMIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "HYPERNATREMIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 10,
"numAtRisk": 47,
"numEvents": 16
}
],
"term": "HYPERTENSION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Endocrine disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 47,
"numEvents": 7
}
],
"term": "HYPERTHYROIDISM"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "HYPERURICEMIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 9,
"numAtRisk": 47,
"numEvents": 14
}
],
"term": "HYPOALBUMINEMIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 47,
"numEvents": 15
}
],
"term": "HYPOCALCEMIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 7,
"numAtRisk": 47,
"numEvents": 9
}
],
"term": "HYPOKALEMIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "HYPOMAGNESEMIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 8,
"numAtRisk": 47,
"numEvents": 15
}
],
"term": "HYPONATREMIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 47,
"numEvents": 4
}
],
"term": "HYPOPHOSPHATEMIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Endocrine disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 9,
"numAtRisk": 47,
"numEvents": 11
}
],
"term": "HYPOTHYROIDISM"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "HYPOXIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 47,
"numEvents": 3
}
],
"term": "INFECTIONS AND INFESTATIONS - OTHER, SPECIFY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 47,
"numEvents": 4
}
],
"term": "INJECTION SITE REACTION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "INSOMNIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "JOINT EFFUSION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "JOINT RANGE OF MOTION DECREASED"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 12,
"numAtRisk": 47,
"numEvents": 20
}
],
"term": "LYMPHOCYTE COUNT DECREASED"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "MEMORY IMPAIRMENT"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Ear and labyrinth disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "MIDDLE EAR INFLAMMATION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "MUCOSAL INFECTION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "MUCOSITIS ORAL"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 47,
"numEvents": 4
}
],
"term": "MUSCLE WEAKNESS LOWER LIMB"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 3
}
],
"term": "MYALGIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "NASAL CONGESTION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 13,
"numAtRisk": 47,
"numEvents": 21
}
],
"term": "NAUSEA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 47,
"numEvents": 5
}
],
"term": "NECK PAIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 47,
"numEvents": 6
}
],
"term": "NEUTROPHIL COUNT DECREASED"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "NON-CARDIAC CHEST PAIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 47,
"numEvents": 3
}
],
"term": "ORAL PAIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "OSTEONECROSIS OF JAW"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "OTITIS MEDIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 12,
"numAtRisk": 47,
"numEvents": 15
}
],
"term": "PAIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 10,
"numAtRisk": 47,
"numEvents": 14
}
],
"term": "PAIN IN EXTREMITY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "PALPITATIONS"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 47,
"numEvents": 4
}
],
"term": "PARESTHESIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Reproductive system and breast disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "PELVIC PAIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 47,
"numEvents": 4
}
],
"term": "PERIPHERAL SENSORY NEUROPATHY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "PLATELET COUNT DECREASED"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "PLEURAL EFFUSION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "PNEUMONITIS"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 47,
"numEvents": 4
}
],
"term": "POSTNASAL DRIP"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "PRODUCTIVE COUGH"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 8,
"numAtRisk": 47,
"numEvents": 10
}
],
"term": "PRURITUS"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 11,
"numAtRisk": 47,
"numEvents": 13
}
],
"term": "RASH MACULO-PAPULAR"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Renal and urinary disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "RENAL AND URINARY DISORDERS - OTHER, SPECIFY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "SINUS TACHYCARDIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "SINUSITIS"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 9,
"numAtRisk": 47,
"numEvents": 11
}
],
"term": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "SKIN INFECTION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 47,
"numEvents": 7
}
],
"term": "SORE THROAT"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Surgical and medical procedures",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "THROMBOEMBOLIC EVENT"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "TOOTH INFECTION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "TOOTHACHE"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 3
}
],
"term": "TUMOR PAIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "UPPER RESPIRATORY INFECTION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Renal and urinary disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "URINARY FREQUENCY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 47,
"numEvents": 7
}
],
"term": "URINARY TRACT INFECTION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Renal and urinary disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "URINARY TRACT OBSTRUCTION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Renal and urinary disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "URINARY TRACT PAIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Renal and urinary disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "URINARY URGENCY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "URTICARIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "VAGINAL INFECTION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "VENTRICULAR TACHYCARDIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "VOICE ALTERATION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 47,
"numEvents": 10
}
],
"term": "VOMITING"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "WEIGHT GAIN"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 47,
"numEvents": 6
}
],
"term": "WEIGHT LOSS"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 11,
"numAtRisk": 47,
"numEvents": 19
}
],
"term": "WHITE BLOOD CELL DECREASED"
}
],
"reviewUnit": {
"resetReasons": [
"The Time Frame appears inconsistent with information provided here or in other parts of the record."
]
},
"seriousEvents": [
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Renal and urinary disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "ACUTE KIDNEY INJURY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "ALANINE AMINOTRANSFERASE INCREASED"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "ASCITES"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "ASPARTATE AMINOTRANSFERASE INCREASED"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "ATRIAL FIBRILLATION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "COLITIS"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "CONSTIPATION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "DYSPHAGIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "DYSPNEA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Injury, poisoning and procedural complications",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "FALL"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Injury, poisoning and procedural complications",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "FRACTURE"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "HYPERCALCEMIA"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "INFECTIONS AND INFESTATIONS - OTHER, SPECIFY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 47,
"numEvents": 4
}
],
"term": "PLEURAL EFFUSION"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 1
}
],
"term": "SEPSIS"
},
{
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAEv5",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 47,
"numEvents": 2
}
],
"term": "URINARY TRACT INFECTION"
}
],
"timeFrame": "Adverse Events have been recorded from the time of consent until 30 days after treatment discontinuation of study drugs or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 10 months"
},
"baselineCharacteristicsModule": {
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "47"
}
],
"units": "Participants"
}
],
"groups": [
{
"description": "<p>Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 21 days.\nSites should make every effort to target infusion timing to be as close to 30 minutes as possible.\nHowever, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).</p><p>Fulvestrant 500 mg will be administered as two 5mL IM injections (one in each buttock).\nThe standard dosing is as follows: Loading doses will be given on Cycle 1 Day 1 and 15.\nThereafter, dosing will be every 4 weeks.</p>",
"id": "BG000",
"title": "Pembrolizumab, 200 mg + Fulvestrant, 500mg"
}
],
"measures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
}
],
"title": "<=18 years"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "29"
}
],
"title": "Between 18 and 65 years"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "18"
}
],
"title": ">=65 years"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Age, Categorical",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "46"
}
],
"title": "Female"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
}
],
"title": "Male"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Sex: Female, Male",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "4"
}
],
"title": "Hispanic or Latino"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "43"
}
],
"title": "Not Hispanic or Latino"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
}
],
"title": "Unknown or Not Reported"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Ethnicity (NIH/OMB)",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
}
],
"title": "American Indian or Alaska Native"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
}
],
"title": "Asian"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
}
],
"title": "Native Hawaiian or Other Pacific Islander"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "5"
}
],
"title": "Black or African American"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "39"
}
],
"title": "White"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
}
],
"title": "More than one race"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "3"
}
],
"title": "Unknown or Not Reported"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Race (NIH/OMB)",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "32"
}
],
"title": "0"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "14"
}
],
"title": "1"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
}
],
"title": "Not collected"
}
]
}
],
"description": "<p>ECOG Performance Status :</p><p>Grade 0: Fully active; no limitations on daily activities.\nGrade 1: Restricted in physically strenuous activity but ambulatory and able to perform light work.</p><p>Grade 2: Ambulatory and capable of all self-care; unable to work; up >50% of waking hours.</p><p>Grade 3: Capable of limited self-care; confined to bed/chair >50% of waking hours.</p><p>Grade 4: Completely disabled; totally confined to bed/chair.\nGrade 5: Dead.</p>",
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "ECOG",
"unitOfMeasure": "Participants"
}
]
},
"moreInfoModule": {
"certainAgreement": {
"piSponsorEmployee": false,
"restrictiveAgreement": false
},
"pointOfContact": {
"email": "amajumdar@hoosiercancer.org",
"organization": "Hoosier Cancer Research Network",
"phone": "3179212050",
"title": "Clinical Data Analyst"
}
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "16"
}
]
}
],
"title": "RECIST 1.1"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0"
}
]
}
],
"title": "irRECIST"
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "44"
}
],
"units": "Participants"
}
],
"description": "<p>Clinical benefit ratio (CBR) is defined as the percentage of patients that achieve CR, PR, or stable disease for a minimum of four months.\nPatients will be evaluated for response by RECIST 1.1 and irRECIST.</p><p>Complete Response (CR)(RECIST1.1):\nAll target lesions disappear.\nAny pathological lymph nodes must have a reduction in short axis to <10 mm.</p><p>Partial Response (PR)(RECIST1.1):\nAt least a 30 % decrease in the sum of the longest diameters (LD) of target lesions, using the baseline sum as reference.</p><p>Stable Disease (SD)(RECIST1.1):\nNeither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking the smallest sum of diameters since treatment started as a reference irCR(irRECIST):Complete Resolution of non-nodal lesions and <10 mm short-axis for lymph nodes irPR(irRECIST): ≥30% decrease in tumor burden irSD(irRECIST): Does not meet criteria for irCR/irPR/irPD</p>",
"groups": [
{
"description": "<p>Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 21 days.\nSites should make every effort to target infusion timing to be as close to 30 minutes as possible.\nHowever, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).</p><p>Fulvestrant 500 mg will be administered as two 5mL IM injections (one in each buttock).\nThe standard dosing is as follows: Loading doses will be given on Cycle 1 Day 1 and 15.\nThereafter, dosing will be every 4 weeks.</p>",
"id": "OG000",
"title": "Pembrolizumab, 200 mg + Fulvestrant, 500mg"
}
],
"measureCategoriesReviewUnit": {
"resetReasons": [
"One or more numbers in the table appear to be nonmeaningful placeholders that do not reflect data collected during the study."
]
},
"paramType": "COUNT_OF_PARTICIPANTS",
"populationDescription": "Out of 47 enrolled subjects, 44 subjects received the study treatment and were deemed evaluable for efficacy.\nClinical Benefit Ratio has not been analyzed per irRECIST, therefore the count is kept 0.",
"reportingStatus": "POSTED",
"timeFrame": "From C1D1 up to a maximum of 31 months or until death",
"title": "Clinical Benefit Ratio (CBR)",
"type": "PRIMARY",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "46"
}
]
}
],
"title": "Number of patients had at least one adverse event of any grade"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "23"
}
]
}
],
"title": "Number of patients had at least one grade 3 and greater adverse event"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "8"
}
]
}
],
"title": "Number of patients had at least one grade 3 or greater Pembrolizumab related adverse event"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "2"
}
]
}
],
"title": "Number of patients had at least one grade 3 or greater Fulvestrant related adverse event"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "12"
}
]
}
],
"title": "Number of patients having serious adverse event"
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "47"
}
],
"units": "Participants"
}
],
"description": "The toxicity profile will report all grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v4",
"groups": [
{
"description": "<p>Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 21 days.\nSites should make every effort to target infusion timing to be as close to 30 minutes as possible.\nHowever, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).</p><p>Fulvestrant 500 mg will be administered as two 5mL IM injections (one in each buttock).\nThe standard dosing is as follows: Loading doses will be given on Cycle 1 Day 1 and 15.\nThereafter, dosing will be every 4 weeks.</p>",
"id": "OG000",
"title": "Pembrolizumab, 200 mg + Fulvestrant, 500mg"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"reportingStatus": "POSTED",
"timeFrame": "From C1D1 up to a maximum of 18 months or until death",
"title": "Safety Profile of Pembrolizumab Plus Fulvestrant",
"type": "SECONDARY",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "0.2",
"upperLimit": "33.0",
"value": "2.3"
}
]
}
],
"title": "RECIST 1.1"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "0.2",
"upperLimit": "33.0",
"value": "4.1"
}
]
}
],
"title": "irRECIST"
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "47"
}
],
"units": "Participants"
}
],
"description": "Progression free survival is defined as the time from date of treatment start until the criteria for disease progression is met or death from any cause.\nPFS will be assessed by RECIST 1.1 and irRECIST",
"dispersionType": "Full Range",
"groups": [
{
"description": "<p>Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 21 days.\nSites should make every effort to target infusion timing to be as close to 30 minutes as possible.\nHowever, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).</p><p>Fulvestrant 500 mg will be administered as two 5mL IM injections (one in each buttock).\nThe standard dosing is as follows: Loading doses will be given on Cycle 1 Day 1 and 15.\nThereafter, dosing will be every 4 weeks.</p>",
"id": "OG000",
"title": "Pembrolizumab, 200 mg + Fulvestrant, 500mg"
}
],
"paramType": "MEDIAN",
"reportingStatus": "POSTED",
"timeFrame": "From C1D1 up to a maximum of 33 months or until death",
"title": "Progression Free Survival (PFS)",
"type": "SECONDARY",
"unitOfMeasure": "months"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "2.3",
"upperLimit": "30.3",
"value": "6.3"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "44"
}
],
"units": "Participants"
}
],
"description": "<p>Durable response rate is defined as the number of months that a stable disease, partial or complete response per RECIST 1.1 is observed.</p><p>Complete Response (CR): All target lesions disappear.\nAny pathological lymph nodes must have a reduction in short axis to <10 mm.</p><p>Partial Response (PR): At least a 30 % decrease in the sum of the longest diameters (LD) of target lesions, using the baseline sum as reference.</p><p>Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking the smallest sum of diameters since treatment started as a reference</p>",
"dispersionType": "Full Range",
"groups": [
{
"description": "<p>Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 21 days.\nSites should make every effort to target infusion timing to be as close to 30 minutes as possible.\nHowever, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).</p><p>Fulvestrant 500 mg will be administered as two 5mL IM injections (one in each buttock).\nThe standard dosing is as follows: Loading doses will be given on Cycle 1 Day 1 and 15.\nThereafter, dosing will be every 4 weeks.</p>",
"id": "OG000",
"title": "Pembrolizumab, 200 mg + Fulvestrant, 500mg"
}
],
"paramType": "MEDIAN",
"populationDescription": "Out of 47 enrolled subjects, 44 subjects received the study treatment and were deemed evaluable for efficacy.",
"reportingStatus": "POSTED",
"timeFrame": "From C1D1 until death or up to a maximum of 31 months",
"title": "Durable Response Rate (DRR)",
"type": "SECONDARY",
"unitOfMeasure": "months"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "1.68",
"upperLimit": "43.4",
"value": "27.86"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "47"
}
],
"units": "Participants"
}
],
"description": "Overall survival is defined as defined as the time from date of treatment start until death",
"dispersionType": "Full Range",
"groups": [
{
"description": "<p>Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 21 days.\nSites should make every effort to target infusion timing to be as close to 30 minutes as possible.\nHowever, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).</p><p>Fulvestrant 500 mg will be administered as two 5mL IM injections (one in each buttock).\nThe standard dosing is as follows: Loading doses will be given on Cycle 1 Day 1 and 15.\nThereafter, dosing will be every 4 weeks.</p>",
"id": "OG000",
"title": "Pembrolizumab, 200 mg + Fulvestrant, 500mg"
}
],
"paramType": "MEDIAN",
"reportingStatus": "POSTED",
"timeFrame": "From C1D1 up to a maximum of 44 months until death",
"title": "Overall Survival",
"type": "SECONDARY",
"unitOfMeasure": "months"
}
]
},
"participantFlowModule": {
"groups": [
{
"description": "<p>Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 21 days.\nSites should make every effort to target infusion timing to be as close to 30 minutes as possible.\nHowever, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).</p><p>Fulvestrant 500 mg will be administered as two 5mL IM injections (one in each buttock).\nThe standard dosing is as follows: Loading doses will be given on Cycle 1 Day 1 and 15.\nThereafter, dosing will be every 4 weeks.</p>",
"id": "FG000",
"title": "Pembrolizumab, 200 mg + Fulvestrant, 500mg"
}
],
"periods": [
{
"dropWithdraws": [
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "25"
}
],
"type": "Death"
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
}
],
"type": "Lost to Follow-up"
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "4"
}
],
"type": "Patient refused to follow up"
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
}
],
"type": "symptomatic deterioration"
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
}
],
"type": "Patient did not start study treatment. Removed Per Dr Tandra and will receive SOC Eribulin."
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
}
],
"type": "Patient stated that she wanted her consent withdrawn."
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "5"
}
],
"type": "Subjects are still on survival follow up."
}
],
"milestones": [
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "47"
}
],
"type": "STARTED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "9"
}
],
"type": "COMPLETED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "38"
}
],
"type": "NOT COMPLETED"
}
],
"title": "Overall Study"
}
]
}
}
},
{
"op": "add",
"path": "/annotationSection",
"value": {
"annotationModule": {
"unpostedAnnotation": {
"unpostedEvents": [
{
"date": "2026-04-23",
"type": "RESET"
}
],
"unpostedResponsibleParty": "Nancy Chan, MD, Sponsor Investigator, Big Ten Cancer Research Consortium"
}
}
}
},
{
"op": "add",
"path": "/documentSection",
"value": {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2022-08-11",
"filename": "Prot_SAP_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 1457021,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2026-03-27T11:26"
}
]
}
}
}
],
"provenance": {
"from_snapshot_hash": "2a0332d6f7225119daea29fe5130c9394a827bba3ade71b777a72ba22cbcba98",
"materiality_event_hash": "324f4b309d08173a841cc5ec1cc7de897880f527afaf30019aef9ddc40083a66",
"patch_hash": "fb6df65c96a15b731fdbd097118f285406cb657523e95590210a301de93bc68b",
"patch_raw_hash": "9e58e2c5d9cac06596be0d9676d252fafc77187f798d9f5c38c1bbae48470290",
"patch_source": "ctgov_internal_history",
"patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT03393845/history/16?patchToVersion=17",
"to_snapshot_hash": null
},
"review_question": "What source document explains this registry amendment, and does it change interpretation of the trial record?",
"schema": "trialdiff.evidence_record",
"trial": {
"clinicaltrials_gov_url": "https://clinicaltrials.gov/study/NCT03393845",
"nct_id": "NCT03393845"
},
"versions": {
"from_version": 16,
"submitted_date": "2026-04-06",
"to_version": 17
}
}