Evidence Record
evt_NCT01471106_v28_v29_62caa2915a70
NCT01471106 · Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer
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 Actualized Earlier
Versions
v28 to v29
Timing
Late Recruitment
Claims Supported
- TrialDiff compared ClinicalTrials.gov record version 28 to version 29 for NCT01471106.
- The JSON Patch for this comparison has hash 8120d0e5423e6640083785aaf433cd22c2f08dc9f6d810f5a789e93ac59249dc.
- 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/overallStatus, /protocolSection/statusModule/primaryCompletionDateStruct/date, /protocolSection/statusModule/primaryCompletionDateStruct/type, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/completionDateStruct/type, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes, /hasResults, /resultsSection, /documentSection.
- The timeline value moved by 366 days.
- The timeline value moved by 246 days.
- An outcome path changed between versions 28 and 29 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_NCT01471106_v28_v29_62caa2915a70. ClinicalTrials.gov NCT01471106, versions 28-29. Evidence version 1.
Event Classes
outcome_edit_cooccurs_with_results_posting Changed Paths
/protocolSection/statusModule/statusVerifiedDate
/protocolSection/statusModule/overallStatus
/protocolSection/statusModule/primaryCompletionDateStruct/date
/protocolSection/statusModule/primaryCompletionDateStruct/type
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/completionDateStruct/type
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/statusModule/resultsFirstSubmitQcDate
/protocolSection/statusModule/resultsFirstPostDateStruct
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes
/hasResults
/resultsSection
/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_NCT01471106_v28_v29_f223d3c1ad6f
- Patch hash
8120d0e5423e6640083785aaf433cd22c2f08dc9f6d810f5a789e93ac59249dc- Canonical hash
5236b99b2896db2fec7befd27b2fb9db1806125a2cafe693f8016c70b4e9c8ce- Rule set hash
fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621- From snapshot
e3006ca109379d08bd5b5eedacd7a110593a7aaace5a83d571dfdc78a02f86b5- 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/overallStatus",
"/protocolSection/statusModule/primaryCompletionDateStruct/date",
"/protocolSection/statusModule/primaryCompletionDateStruct/type",
"/protocolSection/statusModule/completionDateStruct/date",
"/protocolSection/statusModule/completionDateStruct/type",
"/protocolSection/statusModule/lastUpdateSubmitDate",
"/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"/protocolSection/statusModule/resultsFirstSubmitDate",
"/protocolSection/statusModule/resultsFirstSubmitQcDate",
"/protocolSection/statusModule/resultsFirstPostDateStruct",
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes",
"/hasResults",
"/resultsSection",
"/documentSection"
],
"citation_text": "TrialDiff Evidence Record evt_NCT01471106_v28_v29_62caa2915a70. ClinicalTrials.gov NCT01471106, versions 28-29. 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 28 to version 29 for NCT01471106.",
"The JSON Patch for this comparison has hash 8120d0e5423e6640083785aaf433cd22c2f08dc9f6d810f5a789e93ac59249dc.",
"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/overallStatus, /protocolSection/statusModule/primaryCompletionDateStruct/date, /protocolSection/statusModule/primaryCompletionDateStruct/type, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/completionDateStruct/type, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes, /hasResults, /resultsSection, /documentSection.",
"The timeline value moved by 366 days.",
"The timeline value moved by 246 days.",
"An outcome path changed between versions 28 and 29 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
],
"classification": {
"calibration_status": "uncalibrated",
"categories": [
"timeline_actualized_earlier",
"results_reconciliation"
],
"category": "timeline_actualized_earlier",
"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_actualized_earlier",
"date_struct": "primaryCompletionDateStruct",
"delta_days": 366,
"direction": "earlier",
"new_precision": "day",
"new_type": "ACTUAL",
"new_value": "2024-01-31",
"old_precision": "day",
"old_type": "ESTIMATED",
"old_value": "2025-01-31",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"severity": "low",
"signal": "timeline_actualized_earlier"
},
{
"category": "timeline_actualized_earlier",
"date_struct": "completionDateStruct",
"delta_days": 246,
"direction": "earlier",
"new_precision": "day",
"new_type": "ACTUAL",
"new_value": "2024-05-30",
"old_precision": "day",
"old_type": "ESTIMATED",
"old_value": "2025-01-31",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"severity": "low",
"signal": "timeline_actualized_earlier"
},
{
"category": "results_reconciliation",
"paths": [
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame"
],
"severity": "low",
"signal": "results_reconciliation_outcome_suppression"
}
]
},
"event_id": "evt_NCT01471106_v28_v29_62caa2915a70",
"evidence_version": 1,
"patch": [
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2024-06"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/overallStatus",
"value": "COMPLETED"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"value": "2024-01-31"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"value": "2024-05-30"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2024-06-13"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2024-07-10"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2024-06-13"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2024-06-13"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2024-07-10",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "up to 3 months"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes",
"value": [
{
"description": "Evaluation of serum utilizing ELISA kits for IGFBP1",
"measure": "To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway",
"timeFrame": "up to 3 months"
},
{
"description": "Evaluation of serum utilizing ELISA kits for IGF1",
"measure": "To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway",
"timeFrame": "up to 3 months"
},
{
"description": "Evaluation of serum utilizing ELISA kits for IGFBP3",
"measure": "To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway",
"timeFrame": "up to 3 months"
}
]
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"adverseEventsModule": {
"eventGroups": [
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 12,
"description": "<p>Dasatinib 40 mg by mouth once a day for 3 months (+/- 7 days), At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>",
"id": "EG000",
"otherNumAffected": 11,
"otherNumAtRisk": 12,
"seriousNumAffected": 0,
"seriousNumAtRisk": 12,
"title": "Group 1: Dasatinib 40 mg"
},
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 6,
"description": "<p>Dasatinib 80 mg by mouth once a day for 3 months (+/- 7 days).\nAt the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>",
"id": "EG001",
"otherNumAffected": 5,
"otherNumAtRisk": 6,
"seriousNumAffected": 0,
"seriousNumAtRisk": 6,
"title": "Group 2: Dasatinib 80 mg"
},
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 6,
"description": "No treatment control group.\nAt the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.",
"id": "EG002",
"otherNumAffected": 0,
"otherNumAtRisk": 6,
"seriousNumAffected": 0,
"seriousNumAtRisk": 6,
"title": "Group 3: No Dasatinib"
}
],
"frequencyThreshold": "0",
"otherEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 12,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 6,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Alopecia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 12,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Arthralgia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 12,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Aspartate aminotransferase increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 12,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 6,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Back pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 12,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 6,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Cough"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 12,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 6,
"numEvents": 2
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Diarrhea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 12,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 6,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Dizziness"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 12,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Dysgeusia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 12,
"numEvents": 5
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 6,
"numEvents": 2
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Fatigue"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 12,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 6,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Fever"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Injury, poisoning and procedural complications",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 12,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Fracture"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 12,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 6,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Gastritis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 12,
"numEvents": 3
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Gastrointestinal disorders - (Other), specify"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 12,
"numEvents": 5
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 6,
"numEvents": 2
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Headache"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 12,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Hot flashes"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 12,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 6,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Infections and infestations - (Other), specify"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 12,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Musculoskeletal and connective tissue disorder - Specify (Other)"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 12,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 6,
"numEvents": 2
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Nausea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 12,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 6,
"numEvents": 0
}
],
"term": "Pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 12,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 6,
"numEvents": 1
},
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},
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],
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"title": "To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway",
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],
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"title": "To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway",
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]
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"uploadDate": "2024-06-12T16:24"
}
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],
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},
"review_question": "What source document explains this registry amendment, and does it change interpretation of the trial record?",
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}