Evidence Record
evt_NCT01033032_v15_v16_38e70a2599f4
NCT01033032 · Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic 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: High Category
Arm Intervention Change
Versions
v15 to v16
Timing
Late Recruitment
Claims Supported
- TrialDiff compared ClinicalTrials.gov record version 15 to version 16 for NCT01033032.
- The JSON Patch for this comparison has hash 7a52508c0f97e1d1afc6b352338ba03066d5c4a6f80ed8b970f152b2e43e94e7.
- 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 an arm or intervention module changed between ClinicalTrials.gov versions 15 and 16.
- The timing context for the from-version record was late_recruitment.
- The deterministic rules that fired were: arms_or_interventions_change, enrollment_count_change.
- 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/designModule/enrollmentInfo/count, /protocolSection/armsInterventionsModule/armGroups/0/label, /protocolSection/armsInterventionsModule/interventions/0/description, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0, /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, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /hasResults, /resultsSection.
- The timeline value moved by 488 days.
- The timeline value moved by 61 days.
- An outcome path changed between versions 15 and 16 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_NCT01033032_v15_v16_38e70a2599f4. ClinicalTrials.gov NCT01033032, versions 15-16. 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/designModule/enrollmentInfo/count
/protocolSection/armsInterventionsModule/armGroups/0/label
/protocolSection/armsInterventionsModule/interventions/0/description
/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0
/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
/protocolSection/outcomesModule/secondaryOutcomes/1/measure
/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/1/description
/protocolSection/outcomesModule/secondaryOutcomes/2/measure
/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/2/description
/hasResults
/resultsSection
View the field-level diff for before/after values on each changed path.
Deterministic Rules
arms_or_interventions_changeenrollment_count_change Provenance
- Package generation
v0.1.3(active)- Supersedes
- evt_NCT01033032_v15_v16_cdceaf3d4739
- Patch hash
7a52508c0f97e1d1afc6b352338ba03066d5c4a6f80ed8b970f152b2e43e94e7- Canonical hash
8727d6b47fdfd58d08574feb16cfe44fb51f6f27ab9722a4a4c63a238993c5eb- Rule set hash
fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621- From snapshot
0da0b40fa45f6df08f3445388012d2b0bb6e995c2ba54ec3d616b871d7963820- To snapshot
2db5056d5f46593b700c6baa87ad42253de5367779ca992e85b753ab5d53e5d7- 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/designModule/enrollmentInfo/count",
"/protocolSection/armsInterventionsModule/armGroups/0/label",
"/protocolSection/armsInterventionsModule/interventions/0/description",
"/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
"/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",
"/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"/hasResults",
"/resultsSection"
],
"citation_text": "TrialDiff Evidence Record evt_NCT01033032_v15_v16_38e70a2599f4. ClinicalTrials.gov NCT01033032, versions 15-16. 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 15 to version 16 for NCT01033032.",
"The JSON Patch for this comparison has hash 7a52508c0f97e1d1afc6b352338ba03066d5c4a6f80ed8b970f152b2e43e94e7.",
"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 an arm or intervention module changed between ClinicalTrials.gov versions 15 and 16.",
"The timing context for the from-version record was late_recruitment.",
"The deterministic rules that fired were: arms_or_interventions_change, enrollment_count_change.",
"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/designModule/enrollmentInfo/count, /protocolSection/armsInterventionsModule/armGroups/0/label, /protocolSection/armsInterventionsModule/interventions/0/description, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0, /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, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /hasResults, /resultsSection.",
"The timeline value moved by 488 days.",
"The timeline value moved by 61 days.",
"An outcome path changed between versions 15 and 16 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
],
"classification": {
"calibration_status": "uncalibrated",
"categories": [
"arm_intervention_change",
"enrollment_change",
"timeline_actualized_earlier",
"results_reconciliation"
],
"category": "arm_intervention_change",
"deterministic_rules": [
"arms_or_interventions_change",
"enrollment_count_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": "primaryCompletionDateStruct",
"delta_days": 488,
"direction": "earlier",
"new_precision": "month",
"new_type": "ACTUAL",
"new_value": "2013-07",
"old_precision": "month",
"old_type": "ESTIMATED",
"old_value": "2014-11",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"severity": "low",
"signal": "timeline_actualized_earlier"
},
{
"category": "timeline_actualized_earlier",
"date_struct": "completionDateStruct",
"delta_days": 61,
"direction": "earlier",
"new_precision": "month",
"new_type": "ACTUAL",
"new_value": "2014-10",
"old_precision": "month",
"old_type": "ESTIMATED",
"old_value": "2014-12",
"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",
"/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame"
],
"severity": "low",
"signal": "results_reconciliation_outcome_suppression"
}
]
},
"event_id": "evt_NCT01033032_v15_v16_38e70a2599f4",
"evidence_version": 1,
"patch": [
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2014-12"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/overallStatus",
"value": "COMPLETED"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"value": "2013-07"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"value": "2014-10"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2014-12-22"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2015-01-06"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2014-11-21"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2014-12-22"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2015-01-06",
"type": "ESTIMATED"
}
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/count",
"value": 78
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
"value": "Amrubicin Phase I/II"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/description",
"value": "<p>Phase I: dose escalating portion with the starting dose of amrubicin at 90mg/m2 IV q21 days.\nDose escalations are as follows:</p><p>DL2 - 100mg/m2; DL3 - 110mg/m2; and DL4 - 120mg/m2.\nAll cycles are q21 days</p><p>Phase II: Amrubicin will be administered at the maximum tolerated dose established in Phase I by IV every 21 days</p>"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
"value": "Amrubicin Phase I/II"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Progression-free Survival (PFS)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "every 6 weeks until progressive disease"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study.\nProgression is defined in RECIST v1.1 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 lesions"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Number of Patients With Adverse Events as a Measure of Safety and Tolerability"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "every 6 weeks until treatment discontinuation, expected average 18 months"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Overall Survival (OS)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "every 6 weeks until treatment discontinuation, expected average of 18 months"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"value": "Measured from Day 1 of study drug administration to date of death due to any cause."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Overall Response Rate (ORR)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"value": "every 6 weeks until treatment discontinuation, expected average 18 months"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "The number of patients with observed complete response [CR] or partial response [PR].\nPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"adverseEventsModule": {
"description": "Adverse Event analysis includes only patients treated at the MTD (Dose Level 3)",
"eventGroups": [
{
"description": "Includes patients treated at the MTD (Dose Level 3)",
"id": "EG000",
"otherNumAffected": 65,
"otherNumAtRisk": 66,
"seriousNumAffected": 5,
"seriousNumAtRisk": 66,
"title": "Dose Level 3"
}
],
"frequencyThreshold": "5",
"otherEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 66,
"numEvents": 9
}
],
"term": "ABDOMINAL PAIN"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 66,
"numEvents": 17
}
],
"term": "ALKALINE PHOSPHATASE INCREASED"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 8,
"numAtRisk": 66,
"numEvents": 39
}
],
"term": "ALLERGIC RHINITIS"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 32,
"numAtRisk": 66,
"numEvents": 126
}
],
"term": "ALOPECIA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 27,
"numAtRisk": 66,
"numEvents": 130
}
],
"term": "ANEMIA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 21,
"numAtRisk": 66,
"numEvents": 40
}
],
"term": "ANOREXIA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 66,
"numEvents": 7
}
],
"term": "ANXIETY"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 14,
"numAtRisk": 66,
"numEvents": 39
}
],
"term": "ARTHRALGIA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 66,
"numEvents": 12
}
],
"term": "ASPARTATE AMINOTRANSFERASE INCREASED"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 8,
"numAtRisk": 66,
"numEvents": 16
}
],
"term": "BACK PAIN"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 15,
"numAtRisk": 66,
"numEvents": 49
}
],
"term": "BONE PAIN"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 66,
"numEvents": 13
}
],
"term": "CHEST PAIN"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 18,
"numAtRisk": 66,
"numEvents": 48
}
],
"term": "CONSTIPATION"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 9,
"numAtRisk": 66,
"numEvents": 26
}
],
"term": "COUGH"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 66,
"numEvents": 13
}
],
"term": "DECREASED BREATH SOUNDS"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 66,
"numEvents": 5
}
],
"term": "DEHYDRATION"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 66,
"numEvents": 13
}
],
"term": "DEPRESSION"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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{
"groupId": "EG000",
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"numAtRisk": 66,
"numEvents": 24
}
],
"term": "DIARRHEA"
},
{
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"numAtRisk": 66,
"numEvents": 13
}
],
"term": "DIZZINESS"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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"numEvents": 9
}
],
"term": "DYSGEUSIA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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"numEvents": 5
}
],
"term": "DYSPEPSIA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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"sourceVocabulary": "CTCAE v 4.0",
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"numAffected": 10,
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"numEvents": 49
}
],
"term": "DYSPNEA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
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"numEvents": 19
}
],
"term": "EDEMA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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"stats": [
{
"groupId": "EG000",
"numAffected": 47,
"numAtRisk": 66,
"numEvents": 203
}
],
"term": "FATIGUE"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
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],
"term": "FEBRILE NEUTROPENIA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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}
],
"term": "HEADACHE"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
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"stats": [
{
"groupId": "EG000",
"numAffected": 8,
"numAtRisk": 66,
"numEvents": 15
}
],
"term": "HYPERGLYCEMIA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 66,
"numEvents": 7
}
],
"term": "HYPOKALEMIA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
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"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 66,
"numEvents": 9
}
],
"term": "INSOMNIA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
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{
"groupId": "EG000",
"numAffected": 34,
"numAtRisk": 66,
"numEvents": 83
}
],
"term": "LEUKOPENIA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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"sourceVocabulary": "CTCAE v 4.0",
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{
"groupId": "EG000",
"numAffected": 9,
"numAtRisk": 66,
"numEvents": 11
}
],
"term": "MUCOSITIS"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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{
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"numAtRisk": 66,
"numEvents": 41
}
],
"term": "MYALGIA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
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"stats": [
{
"groupId": "EG000",
"numAffected": 25,
"numAtRisk": 66,
"numEvents": 82
}
],
"term": "NAUSEA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 11,
"numAtRisk": 66,
"numEvents": 58
}
],
"term": "NEUROPATHY"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 36,
"numAtRisk": 66,
"numEvents": 87
}
],
"term": "NEUTROPENIA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 7,
"numAtRisk": 66,
"numEvents": 17
}
],
"term": "RASH"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 19,
"numAtRisk": 66,
"numEvents": 49
}
],
"term": "THROMBOCYTOPENIA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 66,
"numEvents": 5
}
],
"term": "UPPER RESPIRATORY INFECTION"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 15,
"numAtRisk": 66,
"numEvents": 26
}
],
"term": "VOMITING"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 66,
"numEvents": 11
}
],
"term": "WEIGHT LOSS"
}
],
"seriousEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 66,
"numEvents": 1
}
],
"term": "ALOPECIA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 66,
"numEvents": 1
}
],
"term": "CHEST PAIN"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 66,
"numEvents": 1
}
],
"term": "DEHYDRATION"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 66,
"numEvents": 1
}
],
"term": "FEBRILE NEUTROPENIA"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 66,
"numEvents": 1
}
],
"term": "LYMPH NODE PAIN"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 66,
"numEvents": 1
}
],
"term": "PLEURAL EFFUSION"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE v 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 66,
"numEvents": 1
}
],
"term": "PNEUMONITIS"
}
]
},
"baselineCharacteristicsModule": {
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "78"
}
],
"units": "Participants"
}
],
"groups": [
{
"description": "Includes all Phase I and Phase II patients treated at all dose levels (total enrollment = 78 patients)",
"id": "BG000",
"title": "All Patients"
}
],
"measures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
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"upperLimit": "86",
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}
]
}
]
}
],
"dispersionType": "FULL_RANGE",
"paramType": "MEDIAN",
"title": "Age, Continuous",
"unitOfMeasure": "Years"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "78"
}
],
"title": "Female"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
}
],
"title": "Male"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Sex: Female, Male",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
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}
]
}
],
"title": "United States"
}
],
"paramType": "NUMBER",
"title": "Region of Enrollment",
"unitOfMeasure": "participants"
}
],
"populationDescription": "Includes Phase I and Phase II patients"
},
"moreInfoModule": {
"certainAgreement": {
"otherDetails": "The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from the date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions.\nThe PI may not publish results until 18 mos.\nafter the trial has been completed at all sites.",
"piSponsorEmployee": false,
"restrictionType": "OTHER",
"restrictiveAgreement": true
},
"pointOfContact": {
"email": "asksarah@scresearch.net",
"organization": "Sarah Cannon Research Institute",
"phone": "1-877-691-7274",
"title": "John D. Hainsworth, MD"
}
},
"outcomeMeasuresModule": {
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{
"classes": [
{
"categories": [
{
"measurements": [
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"groupId": "OG000",
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}
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}
],
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"counts": [
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],
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],
"description": "Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study.\nProgression is defined in RECIST v1.1 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 lesions",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "Systemic therapy with amrubicin",
"id": "OG000",
"title": "Amrubicin"
}
],
"paramType": "MEDIAN",
"populationDescription": "Includes patients treated at the MTD (Dose Level 3)",
"reportingStatus": "POSTED",
"timeFrame": "every 6 weeks until progressive disease",
"title": "Progression-free Survival (PFS)",
"type": "PRIMARY",
"unitOfMeasure": "months"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "19"
}
]
}
],
"title": "Neutropenia"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "4"
}
]
}
],
"title": "Febrile neutropenia"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "26"
}
]
}
],
"title": "Leukopenia"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
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}
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}
],
"title": "Anemia"
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{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
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}
]
}
],
"title": "Thrombocytopenia"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
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}
]
}
],
"title": "Dehydration"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1"
}
]
}
],
"title": "Anorexia"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1"
}
]
}
],
"title": "Bone pain"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
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}
]
}
],
"title": "Diarrhea"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1"
}
]
}
],
"title": "Fatigue"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
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}
]
}
],
"title": "Nausea/vomiting"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1"
}
]
}
],
"title": "Pulmonary infiltrates"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1"
}
]
}
],
"title": "Typhlitis"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1"
}
]
}
],
"title": "Decreased ejection fraction"
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "66"
}
],
"units": "Participants"
}
],
"description": "Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs)",
"groups": [
{
"description": "Systemic therapy with amrubicin",
"id": "OG000",
"title": "Amrubicin"
}
],
"paramType": "NUMBER",
"populationDescription": "Includes patients treated at the MTD (Dose Level 3)",
"reportingStatus": "POSTED",
"timeFrame": "every 6 weeks until treatment discontinuation, expected average 18 months",
"title": "Number of Patients With Adverse Events as a Measure of Safety and Tolerability",
"type": "SECONDARY",
"unitOfMeasure": "participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "10.1",
"upperLimit": "18.5",
"value": "14.4"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
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}
],
"units": "Participants"
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],
"description": "Measured from Day 1 of study drug administration to date of death due to any cause.",
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"groups": [
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],
"paramType": "MEDIAN",
"populationDescription": "Includes patients treated at the MTD (Dose Level 3)",
"reportingStatus": "POSTED",
"timeFrame": "every 6 weeks until treatment discontinuation, expected average of 18 months",
"title": "Overall Survival (OS)",
"type": "SECONDARY",
"unitOfMeasure": "months"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "12"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "66"
}
],
"units": "Participants"
}
],
"description": "The number of patients with observed complete response [CR] or partial response [PR].\nPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR",
"groups": [
{
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"id": "OG000",
"title": "Amrubicin"
}
],
"paramType": "NUMBER",
"populationDescription": "Includes patients treated at the MTD (Dose Level 3)",
"reportingStatus": "POSTED",
"timeFrame": "every 6 weeks until treatment discontinuation, expected average 18 months",
"title": "Overall Response Rate (ORR)",
"type": "SECONDARY",
"unitOfMeasure": "participants"
}
]
},
"participantFlowModule": {
"groups": [
{
"description": "Amrubicin - 90 mg/m^2 by intravenous (IV) every 21 days",
"id": "FG000",
"title": "Dose Level 1"
},
{
"description": "Amrubicin - 100 mg/m^2 IV every 21 days",
"id": "FG001",
"title": "Dose Level 2"
},
{
"description": "Amrubicin - 110 mg/m^2 IV every 21 days",
"id": "FG002",
"title": "Dose Level 3"
},
{
"description": "Amrubicin - 120 mg/m^2 every 21 days",
"id": "FG003",
"title": "Dose Level 4"
}
],
"periods": [
{
"milestones": [
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "3"
},
{
"groupId": "FG001",
"numSubjects": "3"
},
{
"groupId": "FG002",
"numSubjects": "3"
},
{
"groupId": "FG003",
"numSubjects": "6"
}
],
"type": "STARTED"
},
{
"achievements": [
{
"comment": "Patients were on-study until determination of the Maximum Tolerated Dose (MTD)",
"groupId": "FG000",
"numSubjects": "0"
},
{
"comment": "Patients were on-study until determination of the Maximum Tolerated Dose (MTD)",
"groupId": "FG001",
"numSubjects": "0"
},
{
"groupId": "FG002",
"numSubjects": "3"
},
{
"comment": "Patients were on-study until determination of the Maximum Tolerated Dose (MTD)",
"groupId": "FG003",
"numSubjects": "0"
}
],
"type": "COMPLETED"
},
{
"achievements": [
{
"groupId": "FG000",
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},
{
"groupId": "FG001",
"numSubjects": "3"
},
{
"groupId": "FG002",
"numSubjects": "0"
},
{
"groupId": "FG003",
"numSubjects": "6"
}
],
"type": "NOT COMPLETED"
}
],
"title": "Phase I"
},
{
"milestones": [
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "0"
},
{
"comment": "Includes patients treated at MTD during Phase I (3 patients); 63 additional patients enrolled",
"groupId": "FG002",
"numSubjects": "66"
},
{
"groupId": "FG003",
"numSubjects": "0"
}
],
"type": "STARTED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "0"
},
{
"comment": "Patients continued recieving treatment until disease progression or unacceptable toxicity",
"groupId": "FG002",
"numSubjects": "0"
},
{
"groupId": "FG003",
"numSubjects": "0"
}
],
"type": "COMPLETED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
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},
{
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"numSubjects": "66"
},
{
"groupId": "FG003",
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}
],
"type": "NOT COMPLETED"
}
],
"title": "Phase II"
}
],
"recruitmentDetails": "Patients were recruited at multiple dose levels into the Dose Escalation (Phase I) portion of this study to determine the safest dose of this regime (MTD - Maximum Tolerated Dose).\nUpon determination of this dose, patients being treated at the MTD proceeded to the Dose Expansion (Phase II) portion of the study and additional patients were recruited"
}
}
}
],
"provenance": {
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"patch_hash": "7a52508c0f97e1d1afc6b352338ba03066d5c4a6f80ed8b970f152b2e43e94e7",
"patch_raw_hash": "2d0ed30100f62f25c1c347acdad62c2fab7026df324b350f7b7bfac165966d14",
"patch_source": "ctgov_internal_history",
"patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT01033032/history/15?patchToVersion=16",
"to_snapshot_hash": "2db5056d5f46593b700c6baa87ad42253de5367779ca992e85b753ab5d53e5d7"
},
"review_question": "What source document explains this registry amendment, and does it change interpretation of the trial record?",
"schema": "trialdiff.evidence_record",
"trial": {
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"nct_id": "NCT01033032"
},
"versions": {
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"submitted_date": "2014-12-22",
"to_version": 16
}
}