evt_NCT03515798_v6_v7_debc9302fbac

{
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    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/groups",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/denoms",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/measureCategoriesReviewUnit",
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    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/13",
    "/resultsSection/adverseEventsModule/timeFrame",
    "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date",
    "/reviewUnit"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT03515798_v6_v7_debc9302fbac. ClinicalTrials.gov NCT03515798, versions 6-7. 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 6 to version 7 for NCT03515798.",
    "The JSON Patch for this comparison has hash 3b8ac6cb69a604f3bd69649d68d4f1777c68c9280aca25a98881388e80dc48ce.",
    "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/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit, /resultsSection/participantFlowModule/preAssignmentDetails, /resultsSection/participantFlowModule/recruitmentDetails, /resultsSection/baselineCharacteristicsModule/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/anticipatedPostingDate, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/denomUnitsSelected, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/denoms, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/type, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/paramType, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/unitOfMeasure, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/0/value, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/measureCategoriesReviewUnit/resetReasons/0, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/anticipatedPostingDate, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/anticipatedPostingDate, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denomUnitsSelected, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denomUnitsSelected, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denomUnitsSelected, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denomUnitsSelected, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denomUnitsSelected, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/denomUnitsSelected, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/groups, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/denoms, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/8/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/8/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/8/denomUnitsSelected, /resultsSection/outcomeMeasuresModule/outcomeMeasures/8/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/8/groups, /resultsSection/outcomeMeasuresModule/outcomeMeasures/8/denoms, /resultsSection/outcomeMeasuresModule/outcomeMeasures/8/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/9/type, /resultsSection/outcomeMeasuresModule/outcomeMeasures/9/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/9/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/9/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/9/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/9/denomUnitsSelected, /resultsSection/outcomeMeasuresModule/outcomeMeasures/9/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/9/groups, /resultsSection/outcomeMeasuresModule/outcomeMeasures/9/denoms, /resultsSection/outcomeMeasuresModule/outcomeMeasures/9/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/10, /resultsSection/outcomeMeasuresModule/outcomeMeasures/13, /resultsSection/adverseEventsModule/timeFrame, /annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date, /reviewUnit.",
    "An outcome path changed between versions 6 and 7 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "results_reconciliation"
    ],
    "category": "results_reconciliation",
    "deterministic_rules": [],
    "event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
    "event_classes": [
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    ],
    "rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
    "severity": "low",
    "severity_pre_timing": "low",
    "timing_context": "late_recruitment",
    "triage_label": "low",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
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        "category": "results_reconciliation",
        "paths": [
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          "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
          "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
          "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT03515798_v6_v7_debc9302fbac",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2025-11-17"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2025-12-02"
    },
    {
      "op": "add",
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      "value": "2025-11-17"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
      "value": {
        "date": "2025-12-02",
        "type": "ACTUAL"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "value": "Central Evaluation of Pathological Complete Response (pCR)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "value": "No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "value": "after mastectomy and axillary lymph node dissection, if applicable"
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit"
    },
    {
      "op": "add",
      "path": "/resultsSection/participantFlowModule/preAssignmentDetails",
      "value": "<p>Primary endpoint number 1 : DLT analysis.</p><p>DLT analysis (one of the two primary endpoints) was conducted only on the 6 first patients of Arm A (Pembrolizumab Arm, 6 first patients out of the 33 included in Arm A. Zero patient out of the 19 patients included in Arm B were included in DLT analysis.)</p>"
    },
    {
      "op": "add",
      "path": "/resultsSection/participantFlowModule/recruitmentDetails",
      "value": "33 patients were assigned to Arm A. 19 patients were assigned to Arm B."
    },
    {
      "op": "replace",
      "path": "/resultsSection/baselineCharacteristicsModule/populationDescription",
      "value": "The DLT analysis was limited to the 6 first patients of Arm A (the 6 first patients out of the 33 included in Arm A. Zero patient out of the 19 patients included in Arm B were included in DLT analysis)."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/title",
      "value": "Central Evaluation of Pathological Complete Response (pCR)"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description",
      "value": "No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reportingStatus",
      "value": "POSTED"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/anticipatedPostingDate"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
      "value": "after mastectomy and axillary lymph node dissection, if applicable"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/denomUnitsSelected"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/populationDescription",
      "value": "No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups",
      "value": [
        {
          "description": "EC Paclitaxel + Pembrolizumab Injection",
          "id": "OG000",
          "title": "Pembrolizumab"
        },
        {
          "description": "EC Paclitaxel alone",
          "id": "OG001",
          "title": "Standard Neoadjuvant Chemotherapy"
        }
      ]
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/denoms",
      "value": [
        {
          "counts": [
            {
              "groupId": "OG000",
              "value": "0"
            },
            {
              "groupId": "OG001",
              "value": "0"
            }
          ],
          "units": "Participants"
        }
      ]
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/measureCategoriesReviewUnit",
      "value": {
        "resetReasons": [
          "Results information appears incomplete."
        ]
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/type",
      "value": "SECONDARY"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/title",
      "value": "Occurrence of Serious Adverse Events and Adverse Events Starting Grade 2 or Grade 1 (run-in Period)"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description",
      "value": "according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V5.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription",
      "value": "No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/paramType"
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    {
      "op": "remove",
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    },
    {
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      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/0/value",
      "value": "0"
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      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/measureCategoriesReviewUnit/resetReasons/0",
      "value": "Results information appears incomplete."
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    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/anticipatedPostingDate",
      "value": "2027-08"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/title",
      "value": "Local Evaluation of Pathological Complete Response Rate"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description",
      "value": "defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of NAST (i.e., ypT0&#x2F;is, ypN0 in the current AJCC staging system)"
    },
    {
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      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reportingStatus",
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      "op": "remove",
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    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame",
      "value": "Following completion of neoadjuvant systemic treatment, an average of 24 weeks"
    },
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      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denomUnitsSelected"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription",
      "value": "No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups",
      "value": [
        {
          "description": "EC Paclitaxel + Pembrolizumab Injection",
          "id": "OG000",
          "title": "Pembrolizumab"
        },
        {
          "description": "EC Paclitaxel alone",
          "id": "OG001",
          "title": "Standard Neoadjuvant Chemotherapy"
        }
      ]
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms",
      "value": [
        {
          "counts": [
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              "groupId": "OG000",
              "value": "0"
            },
            {
              "groupId": "OG001",
              "value": "0"
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          ],
          "units": "Participants"
        }
      ]
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/measureCategoriesReviewUnit",
      "value": {
        "resetReasons": [
          "Results information appears incomplete."
        ]
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/title",
      "value": "Invasive Disease-free Survival (IDFS)"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/description",
      "value": "time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reportingStatus",
      "value": "POSTED"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
      "value": "3 years"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denomUnitsSelected"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/populationDescription",
      "value": "No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups",
      "value": [
        {
          "description": "<p>EC Paclitaxel + Pembrolizumab Injection</p><p>Pembrolizumab Injection: Patients will receive intravenously 1 dose of Pembrolizumab every 3 weeks</p><p>neoadjuvant EC-paclitaxel chemotherapy: The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel</p>",
          "id": "OG000",
          "title": "Pembrolizumab"
        },
        {
          "description": "<p>EC Paclitaxel alone</p><p>neoadjuvant EC-paclitaxel chemotherapy: The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel</p>",
          "id": "OG001",
          "title": "Standard Neoadjuvant Chemotherapy"
        }
      ]
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms",
      "value": [
        {
          "counts": [
            {
              "groupId": "OG000",
              "value": "0"
            },
            {
              "groupId": "OG001",
              "value": "0"
            }
          ],
          "units": "Participants"
        }
      ]
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/measureCategoriesReviewUnit",
      "value": {
        "resetReasons": [
          "Results information appears incomplete."
        ]
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reportingStatus",
      "value": "POSTED"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame",
      "value": "5 years"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denomUnitsSelected"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/populationDescription",
      "value": "No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups",
      "value": [
        {
          "description": "<p>EC Paclitaxel + Pembrolizumab Injection</p><p>Pembrolizumab Injection: Patients will receive intravenously 1 dose of Pembrolizumab every 3 weeks</p><p>neoadjuvant EC-paclitaxel chemotherapy: The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel</p>",
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          "title": "Pembrolizumab"
        },
        {
          "description": "<p>EC Paclitaxel alone</p><p>neoadjuvant EC-paclitaxel chemotherapy: The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel</p>",
          "id": "OG001",
          "title": "Standard Neoadjuvant Chemotherapy"
        }
      ]
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms",
      "value": [
        {
          "counts": [
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              "groupId": "OG000",
              "value": "0"
            },
            {
              "groupId": "OG001",
              "value": "0"
            }
          ],
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        }
      ]
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/measureCategoriesReviewUnit",
      "value": {
        "resetReasons": [
          "Results information appears incomplete."
        ]
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/title",
      "value": "Event Free Survival (EFS)"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description",
      "value": "time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral [invasive or non invasive]), or death from any cause)"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reportingStatus",
      "value": "POSTED"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame",
      "value": "3 years"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denomUnitsSelected"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/populationDescription",
      "value": "No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups",
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        {
          "description": "EC Paclitaxel + Pembrolizumab Injection",
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          "title": "Pembrolizumab"
        },
        {
          "description": "EC Paclitaxel alone",
          "id": "OG001",
          "title": "Standard Neoadjuvant Chemotherapy"
        }
      ]
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms",
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              "value": "0"
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              "groupId": "OG001",
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      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/reportingStatus",
      "value": "POSTED"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/timeFrame",
      "value": "5 years"
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    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denomUnitsSelected"
    },
    {
      "op": "add",
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      "value": "No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups",
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          "title": "Pembrolizumab"
        },
        {
          "description": "EC Paclitaxel alone",
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      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/title",
      "value": "Overall Survival (OS)"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/description",
      "value": "time from randomization to death from any cause"
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    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/reportingStatus",
      "value": "POSTED"
    },
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      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/timeFrame",
      "value": "3 years"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/denomUnitsSelected"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/populationDescription",
      "value": "No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/groups",
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          "title": "Pembrolizumab"
        },
        {
          "description": "EC Paclitaxel alone",
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      ]
    },
    {
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          "counts": [
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              "groupId": "OG000",
              "value": "0"
            },
            {
              "groupId": "OG001",
              "value": "0"
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    },
    {
      "op": "add",
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        "resetReasons": [
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      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/reportingStatus",
      "value": "POSTED"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/timeFrame",
      "value": "5 years"
    },
    {
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    },
    {
      "op": "add",
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      "value": "No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/groups",
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        {
          "description": "EC Paclitaxel alone",
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      ]
    },
    {
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          "counts": [
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              "value": "0"
            },
            {
              "groupId": "OG001",
              "value": "0"
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          ],
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        }
      ]
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/measureCategoriesReviewUnit",
      "value": {
        "resetReasons": [
          "Results information appears incomplete."
        ]
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/type",
      "value": "OTHER_PRE_SPECIFIED"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/title",
      "value": "Evaluation of PD-L1 Expression in Pre, Per and Post-treatment Tissue"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/description",
      "value": "by IHC and mass spectrometry-based proteomics; and in plasma samples using quantitative proteomics,"
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      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/reportingStatus",
      "value": "POSTED"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/timeFrame",
      "value": "Following completion of neoadjuvant systemic treatment, an average of 24 weeks"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/denomUnitsSelected"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/populationDescription",
      "value": "No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/groups",
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          "description": "EC Paclitaxel + Pembrolizumab Injection",
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          "title": "Pembrolizumab"
        },
        {
          "description": "EC Paclitaxel alone",
          "id": "OG001",
          "title": "Standard Neoadjuvant Chemotherapy"
        }
      ]
    },
    {
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        ],
        "description": "incidence of DLT during the 21 days following the first administration of pembrolizumab in combination with EC, will be assessed separately in the first 3 patients of each stratum (HR+ and HR-).\nDLTs will be defined according to CTCAE.",
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            "description": "<p>EC Paclitaxel + Pembrolizumab Injection</p><p>Pembrolizumab Injection: Patients will receive intravenously 1 dose of Pembrolizumab every 3 weeks</p><p>neoadjuvant EC-paclitaxel chemotherapy: The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel</p>",
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            "title": "Standard Neoadjuvant Chemotherapy"
          }
        ],
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          ]
        },
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        "reportingStatus": "POSTED",
        "timeFrame": "during 21 days following the first administration of pembrolizumab",
        "title": "Dose Limiting Toxicity (DLT) Rates",
        "type": "PRIMARY",
        "unitOfMeasure": "patients"
      }
    },
    {
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      "value": "through 30 days after the last dose of study treatment or before the initiation of radiotherapy, whichever comes first. All AEs that occured prior to the Safety Follow-Up Visit were recorded. Patients with an AE of Grade &gt; 1 were followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-cancer therapy (excluding the scheduled post-mastectomy treatments), whichever occured first."
    },
    {
      "op": "replace",
      "path": "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date",
      "value": "2025-12-01"
    },
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  "review_question": "What source document explains this registry amendment, and does it change interpretation of the trial record?",
  "schema": "trialdiff.evidence_record",
  "trial": {
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    "nct_id": "NCT03515798"
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  "versions": {
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    "submitted_date": "2025-11-17",
    "to_version": 7
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}