Evidence Record
evt_NCT02297412_v12_v13_bcd02fb6245f
NCT02297412 · Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel
Superseded Evidence Record
This page preserves the immutable v0.1.2 record. Its current successor is evt_NCT02297412_v12_v13_643967d0530f.
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
v12 to v13
Timing
Post Recruitment
Claims Supported
- TrialDiff compared ClinicalTrials.gov record version 12 to version 13 for NCT02297412.
- The JSON Patch for this comparison has hash e65659fad6c6f7ccc8e87a4115076aadda4faf09d15b81bc1a8511a838cadbbc.
- The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.
- 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 post_recruitment.
- The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/primaryCompletionDateStruct/date, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/1/measure, /protocolSection/outcomesModule/primaryOutcomes/1/description, /protocolSection/outcomesModule/primaryOutcomes/2/measure, /protocolSection/outcomesModule/primaryOutcomes/2/description, /protocolSection/outcomesModule/primaryOutcomes/2/timeFrame, /annotationSection, /hasResults, /resultsSection.
- The timeline value moved by 269 days.
- The timeline value moved by 37 days.
- An outcome path changed between versions 12 and 13 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_NCT02297412_v12_v13_bcd02fb6245f. ClinicalTrials.gov NCT02297412, versions 12-13. Evidence version 1.
Event Classes
outcome_edit_cooccurs_with_results_posting Changed Paths
/protocolSection/statusModule/statusVerifiedDate
/protocolSection/statusModule/primaryCompletionDateStruct/date
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/statusModule/resultsFirstSubmitQcDate
/protocolSection/statusModule/resultsFirstPostDateStruct
/protocolSection/outcomesModule/primaryOutcomes/0/measure
/protocolSection/outcomesModule/primaryOutcomes/0/description
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
/protocolSection/outcomesModule/primaryOutcomes/1/measure
/protocolSection/outcomesModule/primaryOutcomes/1/description
/protocolSection/outcomesModule/primaryOutcomes/2/measure
/protocolSection/outcomesModule/primaryOutcomes/2/description
/protocolSection/outcomesModule/primaryOutcomes/2/timeFrame
/annotationSection
/hasResults
/resultsSection
View the field-level diff for before/after values on each changed path.
Deterministic Rules
No deterministic rules recorded.
Provenance
- Package generation
v0.1.2- Succeeded by
- evt_NCT02297412_v12_v13_643967d0530f
- Patch hash
e65659fad6c6f7ccc8e87a4115076aadda4faf09d15b81bc1a8511a838cadbbc- Canonical hash
9102398da3d98bd2fe230d237787de8ecfa83393b5607d17f0c83a35d9d39fea- Rule set hash
318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86- From snapshot
fbef6005c163fd4b9b06c538a647462c9dddd1870f606d60c64dcd6d6654e19d- To snapshot
e22c8547b42fbcb2d78d7e3366dc201fcadf1a19e2a76c4a22cd9dbc578a6b68- Patch source
- ctgov_internal_history
- Generated at
- 2026-07-31T00:42:12.000Z
- Source URL
- Registry payload
Canonical JSON Preview
Stored payload{
"changed_paths": [
"/protocolSection/statusModule/statusVerifiedDate",
"/protocolSection/statusModule/primaryCompletionDateStruct/date",
"/protocolSection/statusModule/completionDateStruct/date",
"/protocolSection/statusModule/lastUpdateSubmitDate",
"/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"/protocolSection/statusModule/resultsFirstSubmitDate",
"/protocolSection/statusModule/resultsFirstSubmitQcDate",
"/protocolSection/statusModule/resultsFirstPostDateStruct",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/primaryOutcomes/1/measure",
"/protocolSection/outcomesModule/primaryOutcomes/1/description",
"/protocolSection/outcomesModule/primaryOutcomes/2/measure",
"/protocolSection/outcomesModule/primaryOutcomes/2/description",
"/protocolSection/outcomesModule/primaryOutcomes/2/timeFrame",
"/annotationSection",
"/hasResults",
"/resultsSection"
],
"citation_text": "TrialDiff Evidence Record evt_NCT02297412_v12_v13_bcd02fb6245f. ClinicalTrials.gov NCT02297412, versions 12-13. 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 12 to version 13 for NCT02297412.",
"The JSON Patch for this comparison has hash e65659fad6c6f7ccc8e87a4115076aadda4faf09d15b81bc1a8511a838cadbbc.",
"The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.",
"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 post_recruitment.",
"The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/primaryCompletionDateStruct/date, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/1/measure, /protocolSection/outcomesModule/primaryOutcomes/1/description, /protocolSection/outcomesModule/primaryOutcomes/2/measure, /protocolSection/outcomesModule/primaryOutcomes/2/description, /protocolSection/outcomesModule/primaryOutcomes/2/timeFrame, /annotationSection, /hasResults, /resultsSection.",
"The timeline value moved by 269 days.",
"The timeline value moved by 37 days.",
"An outcome path changed between versions 12 and 13 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": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
"event_classes": [
"outcome_edit_cooccurs_with_results_posting"
],
"rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
"severity": "low",
"severity_pre_timing": "low",
"timing_context": "post_recruitment",
"triage_label": "low",
"triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
"value_signals": [
{
"category": "timeline_actual_date_correction",
"date_struct": "primaryCompletionDateStruct",
"delta_days": 269,
"direction": "later",
"new_precision": "day",
"new_type": "ACTUAL",
"new_value": "2016-07-08",
"old_precision": "day",
"old_type": "ACTUAL",
"old_value": "2015-10-13",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"severity": "low",
"signal": "timeline_actual_date_correction"
},
{
"category": "timeline_actual_date_correction",
"date_struct": "completionDateStruct",
"delta_days": 37,
"direction": "later",
"new_precision": "day",
"new_type": "ACTUAL",
"new_value": "2016-07-08",
"old_precision": "month",
"old_type": "ACTUAL",
"old_value": "2016-06",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"severity": "low",
"signal": "timeline_actual_date_correction"
},
{
"category": "results_reconciliation",
"paths": [
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/primaryOutcomes/1/description",
"/protocolSection/outcomesModule/primaryOutcomes/1/measure",
"/protocolSection/outcomesModule/primaryOutcomes/2/description",
"/protocolSection/outcomesModule/primaryOutcomes/2/measure",
"/protocolSection/outcomesModule/primaryOutcomes/2/timeFrame"
],
"severity": "low",
"signal": "results_reconciliation_outcome_suppression"
}
]
},
"event_id": "evt_NCT02297412_v12_v13_bcd02fb6245f",
"evidence_version": 1,
"patch": [
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2018-10"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"value": "2016-07-08"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"value": "2016-07-08"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2018-10-08"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2018-11-07"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2018-08-17"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2018-10-08"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2018-11-07",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Area Under the Curve (AUC) Per Assessment (aAUCpa) of Average Pain (Item 3 on the Daily Post-Paclitaxel Questionnaire)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Average Area Under the Curve (AUC) per assessment (aAUCpa) of average pain (item 3 on the Daily Post-Paclitaxel Questionnaire; "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.")\nover 12 weeks.\nScores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL).\nThe aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "Up to 12 weeks"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
"value": "Area Under the Curve (AUC) of EORTC CIPN20 Sensory Neuropathy Subscale"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/description",
"value": "Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neurophathy Module (EORTC QLQ-CIPN20) Sensory Neuropathy Subscale.\nThe EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL).\nThe aAUCpa for the subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment.\nFor example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period.\nThen these AUCs for all available assessment time-periods up to week-12 are averaged to yield the aAUCpa per patient per subcale."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/2/measure",
"value": "Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/2/description",
"value": "Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire); "Over the past week, did you experience fatigue?") over 12 weeks.\nScores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL).\nThe aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/2/timeFrame",
"value": "Baseline to up to 12 weeks"
},
{
"op": "remove",
"path": "/annotationSection"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"adverseEventsModule": {
"description": "The descriptions & grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.\nEach CTCAE term in the current version is a unique representation of a specific event used for medical documentation & scientific analysis & is a single MedDRA Lowest Level Term (LLT).",
"eventGroups": [
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 22,
"description": "Patients receive minocycline hydrochloride PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.",
"id": "EG000",
"otherNumAffected": 8,
"otherNumAtRisk": 22,
"seriousNumAffected": 3,
"seriousNumAtRisk": 22,
"title": "Arm I (Minocycline Hydrochloride)"
},
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 23,
"description": "Patients receive a placebo PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.",
"id": "EG001",
"otherNumAffected": 9,
"otherNumAtRisk": 23,
"seriousNumAffected": 1,
"seriousNumAtRisk": 23,
"title": "Arm II (Placebo)"
}
],
"frequencyThreshold": "0",
"otherEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 22,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 23,
"numEvents": 1
}
],
"term": "Abdominal pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 22,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 23,
"numEvents": 1
}
],
"term": "Diarrhea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 22,
"numEvents": 3
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 23,
"numEvents": 2
}
],
"term": "Fatigue"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 22,
"numEvents": 3
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 23,
"numEvents": 1
}
],
"term": "Lymphocyte count decreased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 22,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 23,
"numEvents": 1
}
],
"term": "Neutrophil count decreased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 22,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 23,
"numEvents": 1
}
],
"term": "Hyponatremia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 22,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 23,
"numEvents": 2
}
],
"term": "Arthralgia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 22,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 23,
"numEvents": 0
}
],
"term": "Back pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 22,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 23,
"numEvents": 10
}
],
"term": "Myalgia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 22,
"numEvents": 3
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 23,
"numEvents": 0
}
],
"term": "Dizziness"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 22,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 23,
"numEvents": 1
}
],
"term": "Headache"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 22,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 23,
"numEvents": 3
}
],
"term": "Peripheral sensory neuropathy"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 22,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 23,
"numEvents": 1
}
],
"term": "Pruritus"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 22,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 23,
"numEvents": 1
}
],
"term": "Rash acneiform"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 22,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 23,
"numEvents": 7
}
],
"term": "Rash maculo-papular"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 22,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 23,
"numEvents": 1
}
],
"term": "Hypertension"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 22,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 23,
"numEvents": 0
}
],
"term": "Thromboembolic event"
}
],
"seriousEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 22,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 23,
"numEvents": 0
}
],
"term": "Lung infection"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 22,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 23,
"numEvents": 0
}
],
"term": "Lymphocyte count decreased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 22,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 23,
"numEvents": 1
}
],
"term": "Rash maculo-papular"
}
],
"timeFrame": "Up to 12 weeks"
},
"baselineCharacteristicsModule": {
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "22"
},
{
"groupId": "BG001",
"value": "23"
},
{
"groupId": "BG002",
"value": "45"
}
],
"units": "Participants"
}
],
"groups": [
{
"description": "Patients receive minocycline hydrochloride PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.",
"id": "BG000",
"title": "Arm I (Minocycline Hydrochloride)"
},
{
"description": "Patients receive a placebo PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.",
"id": "BG001",
"title": "Arm II (Placebo)"
},
{
"description": "Total of all reporting groups",
"id": "BG002",
"title": "Total"
}
],
"measures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"spread": "10.1",
"value": "54.8"
},
{
"groupId": "BG001",
"spread": "11.8",
"value": "55.0"
},
{
"groupId": "BG002",
"spread": "10.9",
"value": "54.9"
}
]
}
]
}
],
"dispersionType": "STANDARD_DEVIATION",
"paramType": "MEAN",
"title": "Age, Continuous",
"unitOfMeasure": "years"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "22"
},
{
"groupId": "BG001",
"value": "23"
},
{
"groupId": "BG002",
"value": "45"
}
],
"title": "Female"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
}
],
"title": "Male"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Sex: Female, Male",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "22"
},
{
"groupId": "BG001",
"value": "23"
},
{
"groupId": "BG002",
"value": "45"
}
]
}
],
"title": "United States"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Region of Enrollment",
"unitOfMeasure": "Participants"
}
]
},
"moreInfoModule": {
"certainAgreement": {
"piSponsorEmployee": false,
"restrictiveAgreement": false
},
"pointOfContact": {
"email": "cloprinzi@mayo.edu",
"organization": "Mayo Clinic",
"phone": "507/284-6026",
"title": "Charles L. Loprinzi, M.D."
}
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"analyses": [
{
"groupIds": [
"OG000",
"OG001"
],
"nonInferiorityType": "SUPERIORITY_OR_OTHER",
"pValue": "0.0186",
"statisticalMethod": "Wilcoxon (Mann-Whitney)"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "54.4",
"upperLimit": "100.0",
"value": "96.0"
},
{
"groupId": "OG001",
"lowerLimit": "46.5",
"upperLimit": "99.7",
"value": "84.3"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "20"
},
{
"groupId": "OG001",
"value": "20"
}
],
"units": "Participants"
}
],
"description": "Average Area Under the Curve (AUC) per assessment (aAUCpa) of average pain (item 3 on the Daily Post-Paclitaxel Questionnaire; "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.")\nover 12 weeks.\nScores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL).\nThe aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment.",
"dispersionType": "Full Range",
"groups": [
{
"description": "Patients receive minocycline hydrochloride PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.",
"id": "OG000",
"title": "Arm I (Minocycline Hydrochloride)"
},
{
"description": "Patients receive a placebo PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.",
"id": "OG001",
"title": "Arm II (Placebo)"
}
],
"paramType": "MEDIAN",
"populationDescription": "Patients who completed the Daily Post-Paclitaxel Questionnaire item 3 over 12 weeks were included in this analysis.",
"reportingStatus": "POSTED",
"timeFrame": "Up to 12 weeks",
"title": "Area Under the Curve (AUC) Per Assessment (aAUCpa) of Average Pain (Item 3 on the Daily Post-Paclitaxel Questionnaire)",
"type": "PRIMARY",
"unitOfMeasure": "scores on a scale"
},
{
"analyses": [
{
"groupIds": [
"OG000",
"OG001"
],
"nonInferiorityType": "SUPERIORITY_OR_OTHER",
"pValue": "0.1146",
"statisticalMethod": "Wilcoxon (Mann-Whitney)"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "58.7",
"upperLimit": "100.0",
"value": "94.1"
},
{
"groupId": "OG001",
"lowerLimit": "68.7",
"upperLimit": "98.3",
"value": "89.4"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "21"
},
{
"groupId": "OG001",
"value": "20"
}
],
"units": "Participants"
}
],
"description": "Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neurophathy Module (EORTC QLQ-CIPN20) Sensory Neuropathy Subscale.\nThe EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL).\nThe aAUCpa for the subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment.\nFor example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period.\nThen these AUCs for all available assessment time-periods up to week-12 are averaged to yield the aAUCpa per patient per subcale.",
"dispersionType": "Full Range",
"groups": [
{
"description": "Patients receive minocycline hydrochloride PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.",
"id": "OG000",
"title": "Arm I (Minocycline Hydrochloride)"
},
{
"description": "Patients receive a placebo PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.",
"id": "OG001",
"title": "Arm II (Placebo)"
}
],
"paramType": "MEDIAN",
"populationDescription": "Patients who completed the EORTC Chemotherapy-Induced Peripheral Neurophathy Module Sensory Neuropathy Subscale items over 12 weeks were included in this analysis.",
"reportingStatus": "POSTED",
"timeFrame": "Up to course 12",
"title": "Area Under the Curve (AUC) of EORTC CIPN20 Sensory Neuropathy Subscale",
"type": "PRIMARY",
"unitOfMeasure": "scores on a scale"
},
{
"analyses": [
{
"groupIds": [
"OG000",
"OG001"
],
"nonInferiorityType": "SUPERIORITY_OR_OTHER",
"pValue": "0.0243",
"statisticalMethod": "Wilcoxon (Mann-Whitney)"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "30.8",
"upperLimit": "90.0",
"value": "76.7"
},
{
"groupId": "OG001",
"lowerLimit": "29.4",
"upperLimit": "86.4",
"value": "59.0"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "21"
},
{
"groupId": "OG001",
"value": "21"
}
],
"units": "Participants"
}
],
"description": "Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire); "Over the past week, did you experience fatigue?") over 12 weeks.\nScores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL).\nThe aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment.",
"dispersionType": "Full Range",
"groups": [
{
"description": "Patients receive minocycline hydrochloride PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.",
"id": "OG000",
"title": "Arm I (Minocycline Hydrochloride)"
},
{
"description": "Patients receive a placebo PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.",
"id": "OG001",
"title": "Arm II (Placebo)"
}
],
"paramType": "MEDIAN",
"populationDescription": "Patients who completed the Acute Pain Syndrome Summary Questionnaire over 12 weeks are included in this analysis.",
"reportingStatus": "POSTED",
"timeFrame": "Baseline to up to 12 weeks",
"title": "Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire)",
"type": "PRIMARY",
"unitOfMeasure": "scores on a scale"
}
]
},
"participantFlowModule": {
"groups": [
{
"description": "Patients receive minocycline hydrochloride PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.",
"id": "FG000",
"title": "Arm I (Minocycline Hydrochloride)"
},
{
"description": "Patients receive a placebo PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.",
"id": "FG001",
"title": "Arm II (Placebo)"
}
],
"periods": [
{
"dropWithdraws": [
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
],
"type": "Canceled"
}
],
"milestones": [
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "23"
},
{
"groupId": "FG001",
"numSubjects": "24"
}
],
"type": "STARTED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "22"
},
{
"groupId": "FG001",
"numSubjects": "23"
}
],
"type": "COMPLETED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
],
"type": "NOT COMPLETED"
}
],
"title": "Overall Study"
}
]
}
}
}
],
"provenance": {
"from_snapshot_hash": "fbef6005c163fd4b9b06c538a647462c9dddd1870f606d60c64dcd6d6654e19d",
"materiality_event_hash": "c688c35eb5ea649870299324365587fbf7bb7c861a3ef3a2812357c28b69b7f4",
"patch_hash": "e65659fad6c6f7ccc8e87a4115076aadda4faf09d15b81bc1a8511a838cadbbc",
"patch_raw_hash": "c38c4e8fc5485b9648a57257c544df72c4389316613c89563fe726282563a038",
"patch_source": "ctgov_internal_history",
"patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT02297412/history/12?patchToVersion=13",
"to_snapshot_hash": "e22c8547b42fbcb2d78d7e3366dc201fcadf1a19e2a76c4a22cd9dbc578a6b68"
},
"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/NCT02297412",
"nct_id": "NCT02297412"
},
"versions": {
"from_version": 12,
"submitted_date": "2018-10-08",
"to_version": 13
}
}