evt_NCT01556243_v29_v30_3353a9777e16

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
    "/protocolSection/contactsLocationsModule/locations/43/city",
    "/protocolSection/contactsLocationsModule/locations/43/geoPoint",
    "/protocolSection/contactsLocationsModule/locations/172/city",
    "/protocolSection/contactsLocationsModule/locations/172/geoPoint",
    "/protocolSection/contactsLocationsModule/locations/237/city",
    "/protocolSection/contactsLocationsModule/locations/237/geoPoint/lat",
    "/protocolSection/contactsLocationsModule/locations/237/geoPoint/lon",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reportingStatus",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denomUnitsSelected",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/paramType",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/unitOfMeasure",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes",
    "/resultsSection/adverseEventsModule/otherEvents/6/organSystem",
    "/resultsSection/adverseEventsModule/otherEvents/7/organSystem",
    "/resultsSection/adverseEventsModule/otherEvents/8/organSystem",
    "/resultsSection/adverseEventsModule/otherEvents/9/organSystem",
    "/resultsSection/adverseEventsModule/otherEvents/10/organSystem"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT01556243_v29_v30_3353a9777e16. ClinicalTrials.gov NCT01556243, versions 29-30. 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 29 to version 30 for NCT01556243.",
    "The JSON Patch for this comparison has hash bb4795d06ea0982c23d9a3bf1448afea4439b1fec3a1e51df214f41448f39d30.",
    "The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.",
    "The deterministic triage label was medium; before timing adjustment it was medium.",
    "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 path under non-serious adverse event results changed between ClinicalTrials.gov versions 29 and 30.",
    "The timing context for the from-version record was post_recruitment.",
    "The deterministic rules that fired were: other_adverse_event_modification.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/contactsLocationsModule/locations/43/city, /protocolSection/contactsLocationsModule/locations/43/geoPoint, /protocolSection/contactsLocationsModule/locations/172/city, /protocolSection/contactsLocationsModule/locations/172/geoPoint, /protocolSection/contactsLocationsModule/locations/237/city, /protocolSection/contactsLocationsModule/locations/237/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/237/geoPoint/lon, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denomUnitsSelected, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/paramType, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/unitOfMeasure, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes, /resultsSection/adverseEventsModule/otherEvents/6/organSystem, /resultsSection/adverseEventsModule/otherEvents/7/organSystem, /resultsSection/adverseEventsModule/otherEvents/8/organSystem, /resultsSection/adverseEventsModule/otherEvents/9/organSystem, /resultsSection/adverseEventsModule/otherEvents/10/organSystem.",
    "An outcome path changed between versions 29 and 30 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "other_adverse_event_modification",
      "results_reconciliation"
    ],
    "category": "other_adverse_event_modification",
    "deterministic_rules": [
      "other_adverse_event_modification"
    ],
    "event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting"
    ],
    "rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
    "severity": "medium",
    "severity_pre_timing": "medium",
    "timing_context": "post_recruitment",
    "triage_label": "medium",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT01556243_v29_v30_3353a9777e16",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2026-05"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2026-05-19"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2026-06-12"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
      "value": "Severity of Adverse Effects"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
      "value": "17 monhts"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
      "value": "Severity of adverse effects of breast-conserving surgery and radiation as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be reported as the percentage of patients that experienced a grade 3 or higher adverse event."
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/43/city",
      "value": "Couer D'Alene"
    },
    {
      "op": "remove",
      "path": "/protocolSection/contactsLocationsModule/locations/43/geoPoint"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/172/city",
      "value": "Cape Giradeau"
    },
    {
      "op": "remove",
      "path": "/protocolSection/contactsLocationsModule/locations/172/geoPoint"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/237/city",
      "value": "East White Plains"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/237/geoPoint/lat",
      "value": 41.03899
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/237/geoPoint/lon",
      "value": -73.74763
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/title",
      "value": "Severity of Adverse Effects"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reportingStatus",
      "value": "POSTED"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame",
      "value": "17 monhts"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denomUnitsSelected"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description",
      "value": "Severity of adverse effects of breast-conserving surgery and radiation as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be reported as the percentage of patients that experienced a grade 3 or higher adverse event."
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/paramType",
      "value": "NUMBER"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/unitOfMeasure",
      "value": "percentage of patients"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups",
      "value": [
        {
          "description": "Patients undergo breast conserving surgery.\nPatients receive adjuvant chemotherapy at the physician's discretion.\nPatients receiving chemotherapy will start treatment within 12 weeks following surgery.\nPatients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy.\nPatients receive endocrine therapy at the physician's discretion.\nPatient observation will occur every 6 months until 5 years after the end of radiation therapy.",
          "id": "OG000",
          "title": "Breast Conservation Surgery and Radiation Therapy"
        }
      ]
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms",
      "value": [
        {
          "counts": [
            {
              "groupId": "OG000",
              "value": "270"
            }
          ],
          "units": "Participants"
        }
      ]
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes",
      "value": [
        {
          "categories": [
            {
              "measurements": [
                {
                  "groupId": "OG000",
                  "value": "4.8"
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/6/organSystem",
      "value": "General disorders and administration site conditions"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/7/organSystem",
      "value": "General disorders and administration site conditions"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/8/organSystem",
      "value": "General disorders and administration site conditions"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/9/organSystem",
      "value": "General disorders and administration site conditions"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/otherEvents/10/organSystem",
      "value": "General disorders and administration site conditions"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "6d36d1a617e03c4a0a05c407b4410c171c8868068b11b70bea2c26964a242f92",
    "materiality_event_hash": "2c15f76d9115079991f0cd1a0858611ec1a42ad322a479a3d398805c314b9bf3",
    "patch_hash": "bb4795d06ea0982c23d9a3bf1448afea4439b1fec3a1e51df214f41448f39d30",
    "patch_raw_hash": "9976e0c4e28b09a7e2c537db6b899377f365ef99d37d03a35ced074c8ecc4820",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT01556243/history/29?patchToVersion=30",
    "to_snapshot_hash": null
  },
  "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/NCT01556243",
    "nct_id": "NCT01556243"
  },
  "versions": {
    "from_version": 29,
    "submitted_date": "2026-05-19",
    "to_version": 30
  }
}