Evidence Record
evt_NCT01224678_v109_v110_ff2c4175d5fe
NCT01224678 · Vitamin D and Breast Cancer Biomarkers in Female Patients
Severity is deterministic, reproducible, uncalibrated triage metadata, not validated review priority or proven wrongdoing. This page states what the registry evidence supports and what it does not support.
Triage severity
Triage: High Category
Arm Intervention Change
Versions
v109 to v110
Timing
Late Recruitment
Claims Supported
- TrialDiff compared ClinicalTrials.gov record version 109 to version 110 for NCT01224678.
- The JSON Patch for this comparison has hash f0c9463ce0560a439dbe869684749a7e66ac1469b702ccd8d8c5dee820823fc6.
- 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, secondary_outcome_removed_after_primary_completion.
- A registry field under an arm or intervention module changed between ClinicalTrials.gov versions 109 and 110.
- The timing context for the from-version record was late_recruitment.
- The deterministic rules that fired were: arms_or_interventions_change, enrollment_count_change, enrollment_type_change.
- The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/overallStatus, /protocolSection/statusModule/startDateStruct/type, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/lastUpdatePostDateStruct/type, /protocolSection/statusModule/completionDateStruct, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/designModule/enrollmentInfo/type, /protocolSection/armsInterventionsModule/armGroups/0/label, /protocolSection/armsInterventionsModule/armGroups/1/label, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0, /protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes, /annotationSection, /hasResults, /resultsSection.
- A timeline value changed and was classified by TrialDiff's timeline signal rules.
- The enrollment count changed by at least 20 percent.
- An outcome path changed between versions 109 and 110 in a patch that also carried a hasResults or resultsSection co-occurrence signal.
- The JSON Patch removed a whole secondary outcome item after primary completion between versions 109 and 110; when a TO-version outcome list is available, reindex-only removals are excluded.
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_NCT01224678_v109_v110_ff2c4175d5fe. ClinicalTrials.gov NCT01224678, versions 109-110. Evidence version 1.
Event Classes
outcome_edit_cooccurs_with_results_postingsecondary_outcome_removed_after_primary_completion Changed Paths
/protocolSection/statusModule/statusVerifiedDate
/protocolSection/statusModule/overallStatus
/protocolSection/statusModule/startDateStruct/type
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/type
/protocolSection/statusModule/completionDateStruct
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/statusModule/resultsFirstSubmitQcDate
/protocolSection/statusModule/resultsFirstPostDateStruct
/protocolSection/designModule/enrollmentInfo/count
/protocolSection/designModule/enrollmentInfo/type
/protocolSection/armsInterventionsModule/armGroups/0/label
/protocolSection/armsInterventionsModule/armGroups/1/label
/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0
/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0
/protocolSection/outcomesModule/primaryOutcomes/0/measure
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
/protocolSection/outcomesModule/primaryOutcomes/0/description
/protocolSection/outcomesModule/secondaryOutcomes
/annotationSection
/hasResults
/resultsSection
View the field-level diff for before/after values on each changed path.
Deterministic Rules
arms_or_interventions_changeenrollment_count_changeenrollment_type_change Provenance
- Package generation
v0.1.3(active)- Supersedes
- evt_NCT01224678_v109_v110_c6b7700d37eb
- Patch hash
f0c9463ce0560a439dbe869684749a7e66ac1469b702ccd8d8c5dee820823fc6- Canonical hash
9aa1aad2e1606c07f80279067c062924b20e54dc8dd81a2a506c222cc0ffd776- Rule set hash
fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621- From snapshot
63a547030692070c5d6e067e3667cfe73d4fb462a80f349583f8f04a4e8c760b- To snapshot
54c296c6fe0136f216c90794255d7a66777101d6803b856aad3117485ba62cb7- 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/startDateStruct/type",
"/protocolSection/statusModule/lastUpdateSubmitDate",
"/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"/protocolSection/statusModule/lastUpdatePostDateStruct/type",
"/protocolSection/statusModule/completionDateStruct",
"/protocolSection/statusModule/resultsFirstSubmitDate",
"/protocolSection/statusModule/resultsFirstSubmitQcDate",
"/protocolSection/statusModule/resultsFirstPostDateStruct",
"/protocolSection/designModule/enrollmentInfo/count",
"/protocolSection/designModule/enrollmentInfo/type",
"/protocolSection/armsInterventionsModule/armGroups/0/label",
"/protocolSection/armsInterventionsModule/armGroups/1/label",
"/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
"/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/secondaryOutcomes",
"/annotationSection",
"/hasResults",
"/resultsSection"
],
"citation_text": "TrialDiff Evidence Record evt_NCT01224678_v109_v110_ff2c4175d5fe. ClinicalTrials.gov NCT01224678, versions 109-110. 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 109 to version 110 for NCT01224678.",
"The JSON Patch for this comparison has hash f0c9463ce0560a439dbe869684749a7e66ac1469b702ccd8d8c5dee820823fc6.",
"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, secondary_outcome_removed_after_primary_completion.",
"A registry field under an arm or intervention module changed between ClinicalTrials.gov versions 109 and 110.",
"The timing context for the from-version record was late_recruitment.",
"The deterministic rules that fired were: arms_or_interventions_change, enrollment_count_change, enrollment_type_change.",
"The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/overallStatus, /protocolSection/statusModule/startDateStruct/type, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/lastUpdatePostDateStruct/type, /protocolSection/statusModule/completionDateStruct, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/designModule/enrollmentInfo/type, /protocolSection/armsInterventionsModule/armGroups/0/label, /protocolSection/armsInterventionsModule/armGroups/1/label, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0, /protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes, /annotationSection, /hasResults, /resultsSection.",
"A timeline value changed and was classified by TrialDiff's timeline signal rules.",
"The enrollment count changed by at least 20 percent.",
"An outcome path changed between versions 109 and 110 in a patch that also carried a hasResults or resultsSection co-occurrence signal.",
"The JSON Patch removed a whole secondary outcome item after primary completion between versions 109 and 110; when a TO-version outcome list is available, reindex-only removals are excluded."
],
"classification": {
"calibration_status": "uncalibrated",
"categories": [
"arm_intervention_change",
"enrollment_change",
"timeline_shift",
"results_reconciliation"
],
"category": "arm_intervention_change",
"deterministic_rules": [
"arms_or_interventions_change",
"enrollment_count_change",
"enrollment_type_change"
],
"event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
"event_classes": [
"outcome_edit_cooccurs_with_results_posting",
"secondary_outcome_removed_after_primary_completion"
],
"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_shift",
"date_struct": "completionDateStruct",
"direction": "unknown",
"new_type": "ACTUAL",
"new_value": "2014-12",
"old_type": null,
"old_value": null,
"path": "/protocolSection/statusModule/completionDateStruct",
"reason": "date_unparsed_or_missing",
"severity": "medium",
"signal": "timeline_shift"
},
{
"category": "enrollment_change",
"new_value": 300,
"old_value": 250,
"path": "/protocolSection/designModule/enrollmentInfo/count",
"pct_change": 0.2,
"severity": "high",
"signal": "enrollment_count_change_ge_20pct"
},
{
"category": "results_reconciliation",
"paths": [
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame"
],
"severity": "low",
"signal": "results_reconciliation_outcome_suppression"
}
]
},
"event_id": "evt_NCT01224678_v109_v110_ff2c4175d5fe",
"evidence_version": 1,
"patch": [
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2018-06"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/overallStatus",
"value": "COMPLETED"
},
{
"op": "add",
"path": "/protocolSection/statusModule/startDateStruct/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2018-06-20"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2018-06-25"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/type",
"value": "ACTUAL"
},
{
"op": "add",
"path": "/protocolSection/statusModule/completionDateStruct",
"value": {
"date": "2014-12",
"type": "ACTUAL"
}
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2017-03-06"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2018-06-20"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2018-06-25",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/count",
"value": 300
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
"value": "Placebo"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/label",
"value": "Vitamin D"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
"value": "Vitamin D"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0",
"value": "Placebo"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "12 months"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women.\nThe percent change in breast density will be reported here."
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes"
},
{
"op": "remove",
"path": "/annotationSection"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"adverseEventsModule": {
"eventGroups": [
{
"description": "Patients receive oral placebo once daily for 12 months.",
"id": "EG000",
"otherNumAffected": 1,
"otherNumAtRisk": 150,
"seriousNumAffected": 0,
"seriousNumAtRisk": 150,
"title": "Placebo"
},
{
"description": "Patients receive oral vitamin D (2000 IU) once daily for 12 months.",
"id": "EG001",
"otherNumAffected": 1,
"otherNumAtRisk": 150,
"seriousNumAffected": 0,
"seriousNumAtRisk": 150,
"title": "Vitamin D"
}
],
"frequencyThreshold": "0",
"otherEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Ear and labyrinth disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 150,
"numEvents": 0
}
],
"term": "Vertigo"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 150,
"numEvents": 0
}
],
"term": "Abdominal pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 150,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 1
}
],
"term": "Colitis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 150,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 1
}
],
"term": "Constipation"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 9
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 7
}
],
"term": "Diarrhea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 150,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 1
}
],
"term": "Gastroesophageal reflux disease"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 20
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 18
}
],
"term": "Nausea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 7
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 10
}
],
"term": "Vomiting"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 150,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 1
}
],
"term": "Pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 150,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 1
}
],
"term": "Appendicitis perforated"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 150,
"numEvents": 0
}
],
"term": "Infections and infestations - Other, specify"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 150,
"numEvents": 0
}
],
"term": "GGT increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 150,
"numEvents": 0
}
],
"term": "Hypercalcemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 150,
"numEvents": 0
}
],
"term": "Hyperglycemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 150,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 6
}
],
"term": "Back pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 150,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 1
}
],
"term": "Musculoskeletal and connective tissue disorder - Other, specify"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 150,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 1
}
],
"term": "Neck pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 150,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 1
}
],
"term": "Pain in extremity"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 1
}
],
"term": "Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 50
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 49
}
],
"term": "Headache"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "MedDRA 12",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 150,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 150,
"numEvents": 0
}
],
"term": "Intracranial hemorrhage"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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],
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{
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{
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{
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{
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],
"term": "Pelvic pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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{
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],
"term": "Dyspnea"
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{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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{
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],
"term": "Rash acneiform"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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"sourceVocabulary": "MedDRA 12",
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{
"groupId": "EG000",
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},
{
"groupId": "EG001",
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],
"term": "Hematoma"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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{
"groupId": "EG000",
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},
{
"groupId": "EG001",
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"numEvents": 0
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],
"term": "Hot flashes"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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"sourceVocabulary": "MedDRA 12",
"stats": [
{
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},
{
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}
],
"term": "Hypertension"
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},
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{
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{
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{
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],
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{
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{
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"id": "BG001",
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{
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}
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"measures": [
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{
"categories": [
{
"measurements": [
{
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"value": "44.3"
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{
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"value": "42.7"
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{
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]
}
]
}
],
"dispersionType": "FULL_RANGE",
"paramType": "MEDIAN",
"title": "Age, Continuous",
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},
{
"classes": [
{
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{
"measurements": [
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{
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{
"groupId": "BG002",
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}
],
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},
{
"measurements": [
{
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},
{
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},
{
"groupId": "BG002",
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],
"title": "Male"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
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"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
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"groupId": "BG000",
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},
{
"groupId": "BG001",
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},
{
"groupId": "BG002",
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}
],
"title": "Hispanic or Latino"
},
{
"measurements": [
{
"groupId": "BG000",
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},
{
"groupId": "BG001",
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},
{
"groupId": "BG002",
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}
],
"title": "Not Hispanic or Latino"
},
{
"measurements": [
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},
{
"groupId": "BG001",
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},
{
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}
],
"title": "Unknown or Not Reported"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
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},
{
"classes": [
{
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{
"measurements": [
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},
{
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{
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],
"title": "American Indian or Alaska Native"
},
{
"measurements": [
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},
{
"groupId": "BG001",
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{
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}
],
"title": "Asian"
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{
"measurements": [
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},
{
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},
{
"groupId": "BG002",
"value": "2"
}
],
"title": "Native Hawaiian or Other Pacific Islander"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "14"
},
{
"groupId": "BG001",
"value": "21"
},
{
"groupId": "BG002",
"value": "35"
}
],
"title": "Black or African American"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "124"
},
{
"groupId": "BG001",
"value": "114"
},
{
"groupId": "BG002",
"value": "238"
}
],
"title": "White"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
},
{
"groupId": "BG001",
"value": "4"
},
{
"groupId": "BG002",
"value": "5"
}
],
"title": "More than one race"
},
{
"measurements": [
{
"groupId": "BG000",
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},
{
"groupId": "BG001",
"value": "3"
},
{
"groupId": "BG002",
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}
],
"title": "Unknown or Not Reported"
}
]
}
],
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},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
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},
{
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},
{
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}
]
}
],
"title": "United States"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Region of Enrollment",
"unitOfMeasure": "Participants"
}
],
"populationDescription": "All patients were used for baseline analysis"
},
"moreInfoModule": {
"certainAgreement": {
"piSponsorEmployee": false,
"restrictionType": "LTE60",
"restrictiveAgreement": true
},
"pointOfContact": {
"email": "marie.wood@uvm.edu",
"organization": "University of Vermont",
"phone": "802-656-5452",
"title": "Marie E. Wood, M.D"
}
},
"outcomeMeasuresModule": {
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{
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{
"categories": [
{
"measurements": [
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"value": "-3.4"
},
{
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]
}
],
"denoms": [
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"value": "46"
},
{
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],
"units": "Participants"
}
],
"description": "To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women.\nThe percent change in breast density will be reported here.",
"dispersionType": "Standard Deviation",
"groups": [
{
"description": "Patients receive oral placebo once daily for 12 months.",
"id": "OG000",
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},
{
"description": "Patients receive oral vitamin D (2000 IU) once daily for 12 months.",
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],
"paramType": "MEAN",
"populationDescription": "86 of the 300 patients were analyzed for the primary endpoint",
"reportingStatus": "POSTED",
"timeFrame": "12 months",
"title": "Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms",
"type": "PRIMARY",
"unitOfMeasure": "percent change"
}
]
},
"participantFlowModule": {
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{
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"id": "FG000",
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},
{
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}
],
"periods": [
{
"milestones": [
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},
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],
"type": "STARTED"
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{
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},
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],
"type": "COMPLETED"
},
{
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},
{
"groupId": "FG001",
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}
],
"type": "NOT COMPLETED"
}
],
"title": "Overall Study"
}
]
}
}
}
],
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"materiality_event_hash": "8d9fd554e59763474cb69d7149bdb12b1fb7126b6f53c48d3c310db864ce5d9c",
"patch_hash": "f0c9463ce0560a439dbe869684749a7e66ac1469b702ccd8d8c5dee820823fc6",
"patch_raw_hash": "d6824a290b4655719b153b6d772b7ab7b75c6d381e60f244b5c0325e6293e99e",
"patch_source": "ctgov_internal_history",
"patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT01224678/history/109?patchToVersion=110",
"to_snapshot_hash": "54c296c6fe0136f216c90794255d7a66777101d6803b856aad3117485ba62cb7"
},
"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/NCT01224678",
"nct_id": "NCT01224678"
},
"versions": {
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"submitted_date": "2018-06-20",
"to_version": 110
}
}