Evidence Record
evt_NCT01147016_v18_v19_b05049cb557e
NCT01147016 · Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or III Breast Cancer Undergoing Surgery
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: High Category
Status Termination
Versions
v18 to v19
Timing
Late Recruitment
Claims Supported
- TrialDiff compared ClinicalTrials.gov record version 18 to version 19 for NCT01147016.
- The JSON Patch for this comparison has hash 0b069cf9f3969fbcd776537be319c59270cbde482972a162c52805709b9bed98.
- The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.
- The deterministic triage label was high; before timing adjustment it was high.
- 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.
- A registry field under the status or stopped-trial explanation module changed between ClinicalTrials.gov versions 18 and 19.
- The timing context for the from-version record was late_recruitment.
- The deterministic rules that fired were: terminal_status_change, why_stopped_change.
- The changed JSON Pointer paths were: /protocolSection/identificationModule/orgStudyIdInfo/id, /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/overallStatus, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/completionDateStruct/type, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/whyStopped, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName, /protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorTitle, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/1, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /annotationSection, /hasResults, /resultsSection, /documentSection.
- The timeline value moved by 493 days.
- An outcome path changed between versions 18 and 19 in a patch that also carried a hasResults or resultsSection co-occurrence signal.
- The changed paths include the ClinicalTrials.gov whyStopped field, a stopped-trial explanation field relevant to 42 CFR 11.64 when applicable.
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 TrialDiff determines whether the stopped-trial explanation satisfies 42 CFR 11.64.
- 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
Does the public registry record give a specific explanation for the stopped or terminal status?
Citation
TrialDiff Evidence Record evt_NCT01147016_v18_v19_b05049cb557e. ClinicalTrials.gov NCT01147016, versions 18-19. Evidence version 1.
Event Classes
outcome_edit_cooccurs_with_results_posting Changed Paths
/protocolSection/identificationModule/orgStudyIdInfo/id
/protocolSection/statusModule/statusVerifiedDate
/protocolSection/statusModule/overallStatus
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/completionDateStruct/type
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/whyStopped
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/statusModule/resultsFirstSubmitQcDate
/protocolSection/statusModule/resultsFirstPostDateStruct
/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName
/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorTitle
/protocolSection/outcomesModule/primaryOutcomes/0/measure
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
/protocolSection/outcomesModule/primaryOutcomes/0/description
/protocolSection/outcomesModule/primaryOutcomes/1
/protocolSection/outcomesModule/secondaryOutcomes/0/measure
/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/0/description
/annotationSection
/hasResults
/resultsSection
/documentSection
View the field-level diff for before/after values on each changed path.
Deterministic Rules
terminal_status_changewhy_stopped_change Provenance
- Package generation
v0.1.3(active)- Supersedes
- evt_NCT01147016_v18_v19_bcc484a7cf80
- Patch hash
0b069cf9f3969fbcd776537be319c59270cbde482972a162c52805709b9bed98- Canonical hash
5b925727bd747e7cff8bb9fd13d4e2d370457cd7c2f4413fdb091798424ddc57- Rule set hash
fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621- From snapshot
b0137277adcbac77968ab195a485563d983c6ae71845fadc728bcd189ddef176- 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/identificationModule/orgStudyIdInfo/id",
"/protocolSection/statusModule/statusVerifiedDate",
"/protocolSection/statusModule/overallStatus",
"/protocolSection/statusModule/completionDateStruct/date",
"/protocolSection/statusModule/completionDateStruct/type",
"/protocolSection/statusModule/lastUpdateSubmitDate",
"/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"/protocolSection/statusModule/whyStopped",
"/protocolSection/statusModule/resultsFirstSubmitDate",
"/protocolSection/statusModule/resultsFirstSubmitQcDate",
"/protocolSection/statusModule/resultsFirstPostDateStruct",
"/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName",
"/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorTitle",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/primaryOutcomes/1",
"/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"/annotationSection",
"/hasResults",
"/resultsSection",
"/documentSection"
],
"citation_text": "TrialDiff Evidence Record evt_NCT01147016_v18_v19_b05049cb557e. ClinicalTrials.gov NCT01147016, versions 18-19. 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 TrialDiff determines whether the stopped-trial explanation satisfies 42 CFR 11.64.",
"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 18 to version 19 for NCT01147016.",
"The JSON Patch for this comparison has hash 0b069cf9f3969fbcd776537be319c59270cbde482972a162c52805709b9bed98.",
"The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
"The deterministic triage label was high; before timing adjustment it was high.",
"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.",
"A registry field under the status or stopped-trial explanation module changed between ClinicalTrials.gov versions 18 and 19.",
"The timing context for the from-version record was late_recruitment.",
"The deterministic rules that fired were: terminal_status_change, why_stopped_change.",
"The changed JSON Pointer paths were: /protocolSection/identificationModule/orgStudyIdInfo/id, /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/overallStatus, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/completionDateStruct/type, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/whyStopped, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName, /protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorTitle, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/1, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /annotationSection, /hasResults, /resultsSection, /documentSection.",
"The timeline value moved by 493 days.",
"An outcome path changed between versions 18 and 19 in a patch that also carried a hasResults or resultsSection co-occurrence signal.",
"The changed paths include the ClinicalTrials.gov whyStopped field, a stopped-trial explanation field relevant to 42 CFR 11.64 when applicable."
],
"classification": {
"calibration_status": "uncalibrated",
"categories": [
"status_termination",
"timeline_actualized_earlier",
"results_reconciliation"
],
"category": "status_termination",
"deterministic_rules": [
"terminal_status_change",
"why_stopped_change"
],
"event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
"event_classes": [
"outcome_edit_cooccurs_with_results_posting"
],
"rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
"severity": "high",
"severity_pre_timing": "high",
"timing_context": "late_recruitment",
"triage_label": "high",
"triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
"value_signals": [
{
"category": "timeline_actualized_earlier",
"date_struct": "completionDateStruct",
"delta_days": 493,
"direction": "earlier",
"new_precision": "day",
"new_type": "ACTUAL",
"new_value": "2017-07-26",
"old_precision": "month",
"old_type": "ESTIMATED",
"old_value": "2018-12",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"severity": "low",
"signal": "timeline_actualized_earlier"
},
{
"category": "results_reconciliation",
"paths": [
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/primaryOutcomes/1",
"/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame"
],
"severity": "low",
"signal": "results_reconciliation_outcome_suppression"
}
]
},
"event_id": "evt_NCT01147016_v18_v19_b05049cb557e",
"evidence_version": 1,
"patch": [
{
"op": "replace",
"path": "/protocolSection/identificationModule/orgStudyIdInfo/id",
"value": "2010-056(b)"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2023-04"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/overallStatus",
"value": "TERMINATED"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"value": "2017-07-26"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2023-04-05"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2023-04-27"
},
{
"op": "add",
"path": "/protocolSection/statusModule/whyStopped",
"value": "Primary co-investigator leaving the institution & funding transfer."
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2020-12-21"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2023-04-05"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2023-04-27",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName",
"value": "Abhinav Deol"
},
{
"op": "replace",
"path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorTitle",
"value": "Investigator"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Progression-free Survival"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years.."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Overall Deaths"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "From date of randomization until date of death from any cause or end of study, whichever came first, assessed up to 7 years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "Total number of deaths"
},
{
"op": "remove",
"path": "/annotationSection"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"adverseEventsModule": {
"eventGroups": [
{
"deathsNumAffected": 1,
"deathsNumAtRisk": 8,
"description": "All 8 participants enrolled",
"id": "EG000",
"otherNumAffected": 8,
"otherNumAtRisk": 8,
"seriousNumAffected": 0,
"seriousNumAtRisk": 8,
"title": "Treated"
}
],
"frequencyThreshold": "0",
"otherEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 2",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1,
"numEvents": 1
}
],
"term": "Hypertension"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "grade 1 1 grade 2 5 grade 31",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 7,
"numAtRisk": 8,
"numEvents": 7
}
],
"term": "chills/rigors"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 5 Grade 2 1",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 7,
"numAtRisk": 8,
"numEvents": 7
}
],
"term": "Nausea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 3 Grade 2 1",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 8,
"numEvents": 4
}
],
"term": "Vomiting"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 4 Grade 2 3",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 7,
"numAtRisk": 8,
"numEvents": 7
}
],
"term": "fatigue"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 3",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 8,
"numEvents": 3
}
],
"term": "Rash"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 1 Grade 2 1",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 8,
"numEvents": 2
}
],
"term": "edema"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 1 Grade 2 1 Grade 3 1",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 8,
"numEvents": 3
}
],
"term": "neuroppathy"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 2 5",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 8,
"numEvents": 5
}
],
"term": "hypotension"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "grade 1 4 Grade 2 2",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 8,
"numEvents": 6
}
],
"term": "fever"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 1",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 8,
"numEvents": 1
}
],
"term": "hyponatremia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 2",
"organSystem": "Endocrine disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 8,
"numEvents": 2
}
],
"term": "hypoglycemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 1 Grade 2 1 Grade 3 1 Grade 4 1",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 8,
"numEvents": 4
}
],
"term": "neutropenia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "grade 1 1",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 8,
"numEvents": 1
}
],
"term": "AST elevation"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 1",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 8,
"numEvents": 1
}
],
"term": "ALT elevation"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 4 Grade 2 1",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 8,
"numEvents": 5
}
],
"term": "Anemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 2 1",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 8,
"numEvents": 1
}
],
"term": "Afibrillation"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 1",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 8,
"numEvents": 1
}
],
"term": "Diarrhea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 2 Grade 2 1",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 8,
"numEvents": 3
}
],
"term": "Infection"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 3 Grade 2 2",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 8,
"numEvents": 5
}
],
"term": "Low platelets"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 1 Grade 2 1",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 8,
"numEvents": 2
}
],
"term": "hypoalbuminemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 1 Grade 2 1",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 8,
"numEvents": 2
}
],
"term": "Alkaline Phosphatase"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 2 Grade 2 1",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 8,
"numEvents": 2
}
],
"term": "Hypercalcemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 3 1",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 1,
"numEvents": 1
}
],
"term": "Hypocalcemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"notes": "Grade 1 1",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE (3.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 8,
"numEvents": 1
}
],
"term": "hypokalemia"
}
],
"timeFrame": "Up to 7 years."
},
"baselineCharacteristicsModule": {
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "8"
}
],
"units": "Participants"
}
],
"groups": [
{
"description": "Single group study",
"id": "BG000",
"title": "Treated"
}
],
"measures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"lowerLimit": "39",
"upperLimit": "52",
"value": "44.5"
}
]
}
]
}
],
"dispersionType": "INTER_QUARTILE_RANGE",
"paramType": "MEDIAN",
"title": "Age, Continuous",
"unitOfMeasure": "years"
},
{
"classes": [
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