evt_NCT01818063_v17_v18_960235c25f8b

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/overallStatus",
    "/protocolSection/statusModule/completionDateStruct/date",
    "/protocolSection/statusModule/completionDateStruct/type",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reportingStatus",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/anticipatedPostingDate",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denomUnitsSelected",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/paramType",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/unitOfMeasure",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reportingStatus",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/anticipatedPostingDate",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denomUnitsSelected",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT01818063_v17_v18_960235c25f8b. ClinicalTrials.gov NCT01818063, versions 17-18. 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 17 to version 18 for NCT01818063.",
    "The JSON Patch for this comparison has hash 9f33259e10bab354ac0de6619ac9cae402b3851181d0c3f98bb4c3914c0cf58e.",
    "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 late_recruitment.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/overallStatus, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/completionDateStruct/type, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/anticipatedPostingDate, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denomUnitsSelected, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/paramType, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/unitOfMeasure, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/anticipatedPostingDate, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denomUnitsSelected, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms.",
    "The timeline value moved by 141 days.",
    "An outcome path changed between versions 17 and 18 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "timeline_actualized_earlier",
      "results_reconciliation"
    ],
    "category": "timeline_actualized_earlier",
    "deterministic_rules": [],
    "event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting"
    ],
    "rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
    "severity": "low",
    "severity_pre_timing": "low",
    "timing_context": "late_recruitment",
    "triage_label": "low",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "timeline_actualized_earlier",
        "date_struct": "completionDateStruct",
        "delta_days": 141,
        "direction": "earlier",
        "new_precision": "day",
        "new_type": "ACTUAL",
        "new_value": "2018-12-10",
        "old_precision": "day",
        "old_type": "ESTIMATED",
        "old_value": "2019-04-30",
        "path": "/protocolSection/statusModule/completionDateStruct/date",
        "severity": "low",
        "signal": "timeline_actualized_earlier"
      },
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/secondaryOutcomes/0/description"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT01818063_v17_v18_960235c25f8b",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2019-10"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/overallStatus",
      "value": "COMPLETED"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/completionDateStruct/date",
      "value": "2018-12-10"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/completionDateStruct/type",
      "value": "ACTUAL"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2019-10-07"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2019-10-28"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
      "value": "<p>The count and percentage of subjects with each category of overall clinical response will be summarized by presence of baseline measureable disease (i.e., complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], unable to evaluate [UE], neurogenerative disease [ND]).\nEvaluated per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) as assessed b MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.</p><p>Beta will be used as priors for combination regimens in calculating the posterior distribution of the pathologic complete response [pCR] for each respective treatment group.\nAmong subjects with measurable disease, a 95% credible region will be calculated for the odds ratio for each treatment combination relative to each other.</p>"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description",
      "value": "<p>The count and percentage of subjects with each category of overall clinical response will be summarized by presence of baseline measureable disease (i.e., complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], unable to evaluate [UE], neurogenerative disease [ND]).\nEvaluated per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) as assessed b MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.</p><p>Beta will be used as priors for combination regimens in calculating the posterior distribution of the pathologic complete response [pCR] for each respective treatment group.\nAmong subjects with measurable disease, a 95% credible region will be calculated for the odds ratio for each treatment combination relative to each other.</p>"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reportingStatus",
      "value": "POSTED"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/anticipatedPostingDate"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denomUnitsSelected"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/paramType",
      "value": "COUNT_OF_PARTICIPANTS"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/unitOfMeasure",
      "value": "Participants"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups",
      "value": [
        {
          "description": "<p>Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p>",
          "id": "OG000",
          "title": "Arm 1 (Paclitaxel, Carboplatin)"
        },
        {
          "description": "<p>Patients receive veliparib PO BID on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p><p>Veliparib: Given PO</p>",
          "id": "OG001",
          "title": "Arm 2 (Veliparib, Paclitaxel, Carboplatin)"
        }
      ]
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms",
      "value": [
        {
          "counts": [
            {
              "groupId": "OG000",
              "value": "5"
            },
            {
              "groupId": "OG001",
              "value": "4"
            }
          ],
          "units": "Participants"
        }
      ]
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes",
      "value": [
        {
          "categories": [
            {
              "measurements": [
                {
                  "groupId": "OG000",
                  "value": "1"
                },
                {
                  "groupId": "OG001",
                  "value": "1"
                }
              ],
              "title": "Progressive Disease"
            },
            {
              "measurements": [
                {
                  "groupId": "OG000",
                  "value": "2"
                },
                {
                  "groupId": "OG001",
                  "value": "1"
                }
              ],
              "title": "Partial Response"
            },
            {
              "measurements": [
                {
                  "groupId": "OG000",
                  "value": "2"
                },
                {
                  "groupId": "OG001",
                  "value": "2"
                }
              ],
              "title": "Pathological Complete Response"
            }
          ]
        }
      ]
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reportingStatus",
      "value": "POSTED"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/anticipatedPostingDate"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denomUnitsSelected"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription",
      "value": "Sincere efforts have been made to gather and report the data, however, no data is available for this outcome measure."
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups",
      "value": [
        {
          "description": "<p>Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p>",
          "id": "OG000",
          "title": "Arm 1 (Paclitaxel, Carboplatin)"
        },
        {
          "description": "<p>Patients receive veliparib PO BID on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p><p>Veliparib: Given PO</p>",
          "id": "OG001",
          "title": "Arm 2 (Veliparib, Paclitaxel, Carboplatin)"
        }
      ]
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms",
      "value": [
        {
          "counts": [
            {
              "groupId": "OG000",
              "value": "0"
            },
            {
              "groupId": "OG001",
              "value": "0"
            }
          ],
          "units": "Participants"
        }
      ]
    }
  ],
  "provenance": {
    "from_snapshot_hash": "2703396162a61900538160a3df5b8276027ec631719c575fee4a98ee60174aa1",
    "materiality_event_hash": "1fdd20ef7050961d6def5d6fe2aeabcda0d4ce930c092eb68c9ec39c1f8b71c0",
    "patch_hash": "9f33259e10bab354ac0de6619ac9cae402b3851181d0c3f98bb4c3914c0cf58e",
    "patch_raw_hash": "c925a77d17281c3eab268b28441974da9aa18ed49e047d486d8247ac159b2ae9",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT01818063/history/17?patchToVersion=18",
    "to_snapshot_hash": "7900f3068dfdcd7d26b4ba0bc45f9095365fc43e164a6f3af05e0bb6dc6e9340"
  },
  "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/NCT01818063",
    "nct_id": "NCT01818063"
  },
  "versions": {
    "from_version": 17,
    "submitted_date": "2019-10-07",
    "to_version": 18
  }
}