evt_NCT04482309_v28_v29_770c03aa2804

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/completionDateStruct/date",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/descriptionModule/briefSummary",
    "/protocolSection/conditionsModule/conditions/0",
    "/protocolSection/conditionsModule/conditions/1",
    "/protocolSection/designModule/designInfo/interventionModelDescription",
    "/protocolSection/armsInterventionsModule/armGroups/0/label",
    "/protocolSection/armsInterventionsModule/armGroups/0/description",
    "/protocolSection/armsInterventionsModule/armGroups/1/label",
    "/protocolSection/armsInterventionsModule/armGroups/1/description",
    "/protocolSection/armsInterventionsModule/armGroups/2/label",
    "/protocolSection/armsInterventionsModule/armGroups/2/description",
    "/protocolSection/armsInterventionsModule/armGroups/3/label",
    "/protocolSection/armsInterventionsModule/armGroups/3/description",
    "/protocolSection/armsInterventionsModule/armGroups/4/label",
    "/protocolSection/armsInterventionsModule/armGroups/4/description",
    "/protocolSection/armsInterventionsModule/armGroups/5/label",
    "/protocolSection/armsInterventionsModule/armGroups/5/description",
    "/protocolSection/armsInterventionsModule/armGroups/6/label",
    "/protocolSection/armsInterventionsModule/armGroups/6/description",
    "/protocolSection/armsInterventionsModule/armGroups/7",
    "/protocolSection/armsInterventionsModule/armGroups/8",
    "/protocolSection/armsInterventionsModule/armGroups/9",
    "/protocolSection/armsInterventionsModule/armGroups/10",
    "/protocolSection/armsInterventionsModule/armGroups/11",
    "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
    "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1",
    "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/2",
    "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/3",
    "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/4",
    "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/5",
    "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/6",
    "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/7",
    "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/8",
    "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/9",
    "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/10",
    "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/11",
    "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame",
    "/protocolSection/eligibilityModule/eligibilityCriteria",
    "/protocolSection/contactsLocationsModule/locations/6",
    "/protocolSection/contactsLocationsModule/locations/8",
    "/protocolSection/contactsLocationsModule/locations/11/zip",
    "/protocolSection/contactsLocationsModule/locations/23/zip",
    "/protocolSection/contactsLocationsModule/locations/32",
    "/protocolSection/contactsLocationsModule/locations/38/zip",
    "/protocolSection/contactsLocationsModule/locations/52",
    "/protocolSection/contactsLocationsModule/locations/54"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT04482309_v28_v29_770c03aa2804. ClinicalTrials.gov NCT04482309, versions 28-29. 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 the outcome change was inconsistent with the protocol or statistical analysis plan.",
    "That event-class membership is a validated global review-priority ranking."
  ],
  "claims_supported": [
    "TrialDiff compared ClinicalTrials.gov record version 28 to version 29 for NCT04482309.",
    "The JSON Patch for this comparison has hash 3852ef07707a680efab8253d133a94228788744176921b23cfa8acda86dae8a4.",
    "The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
    "The deterministic triage label was critical; before timing adjustment it was critical.",
    "The triage label is uncalibrated metadata, not a validated review-priority finding.",
    "The patch satisfied these deterministic event-class predicates: primary_endpoint_changed_after_primary_completion_without_results_reconciliation.",
    "A registry field under the primary outcome module changed between ClinicalTrials.gov versions 28 and 29.",
    "The timing context for the from-version record was late_recruitment.",
    "The deterministic rules that fired were: arms_or_interventions_change, design_info_change, eligibility_criteria_change, primary_outcome_any_change, secondary_outcome_any_change.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/descriptionModule/briefSummary, /protocolSection/conditionsModule/conditions/0, /protocolSection/conditionsModule/conditions/1, /protocolSection/designModule/designInfo/interventionModelDescription, /protocolSection/armsInterventionsModule/armGroups/0/label, /protocolSection/armsInterventionsModule/armGroups/0/description, /protocolSection/armsInterventionsModule/armGroups/1/label, /protocolSection/armsInterventionsModule/armGroups/1/description, /protocolSection/armsInterventionsModule/armGroups/2/label, /protocolSection/armsInterventionsModule/armGroups/2/description, /protocolSection/armsInterventionsModule/armGroups/3/label, /protocolSection/armsInterventionsModule/armGroups/3/description, /protocolSection/armsInterventionsModule/armGroups/4/label, /protocolSection/armsInterventionsModule/armGroups/4/description, /protocolSection/armsInterventionsModule/armGroups/5/label, /protocolSection/armsInterventionsModule/armGroups/5/description, /protocolSection/armsInterventionsModule/armGroups/6/label, /protocolSection/armsInterventionsModule/armGroups/6/description, /protocolSection/armsInterventionsModule/armGroups/7, /protocolSection/armsInterventionsModule/armGroups/8, /protocolSection/armsInterventionsModule/armGroups/9, /protocolSection/armsInterventionsModule/armGroups/10, /protocolSection/armsInterventionsModule/armGroups/11, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/2, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/3, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/4, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/5, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/6, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/7, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/8, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/9, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/10, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/11, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame, /protocolSection/eligibilityModule/eligibilityCriteria, /protocolSection/contactsLocationsModule/locations/6, /protocolSection/contactsLocationsModule/locations/8, /protocolSection/contactsLocationsModule/locations/11/zip, /protocolSection/contactsLocationsModule/locations/23/zip, /protocolSection/contactsLocationsModule/locations/32, /protocolSection/contactsLocationsModule/locations/38/zip, /protocolSection/contactsLocationsModule/locations/52, /protocolSection/contactsLocationsModule/locations/54.",
    "The timeline value moved by 121 days.",
    "A primary outcome definition field changed after primary completion between versions 28 and 29, without a results-posting co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "primary_outcome_change",
      "design_change",
      "arm_intervention_change",
      "secondary_outcome_change",
      "eligibility_change",
      "timeline_significant_shift"
    ],
    "category": "primary_outcome_change",
    "deterministic_rules": [
      "arms_or_interventions_change",
      "design_info_change",
      "eligibility_criteria_change",
      "primary_outcome_any_change",
      "secondary_outcome_any_change"
    ],
    "event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
    "event_classes": [
      "primary_endpoint_changed_after_primary_completion_without_results_reconciliation"
    ],
    "rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
    "severity": "critical",
    "severity_pre_timing": "critical",
    "timing_context": "late_recruitment",
    "triage_label": "critical",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "timeline_significant_shift",
        "date_struct": "completionDateStruct",
        "delta_days": 121,
        "direction": "later",
        "new_precision": "day",
        "new_type": "ESTIMATED",
        "new_value": "2027-07-30",
        "old_precision": "day",
        "old_type": "ESTIMATED",
        "old_value": "2027-03-31",
        "path": "/protocolSection/statusModule/completionDateStruct/date",
        "severity": "medium",
        "signal": "timeline_significant_shift"
      }
    ]
  },
  "event_id": "evt_NCT04482309_v28_v29_770c03aa2804",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2024-01"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/completionDateStruct/date",
      "value": "2027-07-30"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2024-02-05"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2024-02-06"
    },
    {
      "op": "replace",
      "path": "/protocolSection/descriptionModule/briefSummary",
      "value": "<p>This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.</p><p>This study will consist of Part 1 which includes 7 cohorts of: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors; and Part 2 which includes 5 cohorts A to E of: A) any tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer), B) any tumor type that is HER2 IHC 2+&#x2F;ISH+ (excluding breast, gastric cancer, and colorectal cancer), C) HER2 IHC 2+ or 1+ endometrial cancer, D) HER2 IHC 2+ or 1+ ovarian cancer, and E) HER2 IHC 2+ or 1+ cervical cancer.</p><p>Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.</p>"
    },
    {
      "op": "replace",
      "path": "/protocolSection/conditionsModule/conditions/0",
      "value": "Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer"
    },
    {
      "op": "add",
      "path": "/protocolSection/conditionsModule/conditions/1",
      "value": "Part 2: HER2 Expressing&#x2F;Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer"
    },
    {
      "op": "replace",
      "path": "/protocolSection/designModule/designInfo/interventionModelDescription",
      "value": "This study will consist of Part 1 which includes 7 cohorts of: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors; and Part 2 which includes 5 cohorts A to E of: A) any tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer), B) any tumor type that is HER2 IHC 2+&#x2F;ISH+ (excluding breast, gastric cancer, and colorectal cancer), C) HER2 IHC 2+ or 1+ endometrial cancer, D) HER2 IHC 2+ or 1+ ovarian cancer, and E) HER2 IHC 2+ or 1+ cervical cancer."
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
      "value": "Part 1 Cohort 1"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
      "value": "Biliary tract cancer"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/1/label",
      "value": "Part 1 Cohort 2"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
      "value": "Bladder cancer"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/2/label",
      "value": "Part 1 Cohort 3"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/2/description",
      "value": "Cervical cancer"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/3/label",
      "value": "Part 1 Cohort 4"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/3/description",
      "value": "Endometrial cancer"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/4/label",
      "value": "Part 1 Cohort 5"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/4/description",
      "value": "Ovarian cancer"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/5/label",
      "value": "Part 1 Cohort 6"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/5/description",
      "value": "Pancreatic cancer"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/6/label",
      "value": "Part 1 Cohort 7"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/6/description",
      "value": "Rare tumors"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/armGroups/7",
      "value": {
        "description": "Any tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer)",
        "interventionNames": [
          "Drug: Trastuzumab deruxtecan"
        ],
        "label": "Part 2 Cohort A",
        "type": "EXPERIMENTAL"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/armGroups/8",
      "value": {
        "description": "Any tumor type that is HER2 IHC 2+&#x2F;ISH+ (excluding breast, gastric cancer, and colorectal cancer)",
        "interventionNames": [
          "Drug: Trastuzumab deruxtecan"
        ],
        "label": "Part 2 Cohort B",
        "type": "EXPERIMENTAL"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/armGroups/9",
      "value": {
        "description": "HER2 IHC 2+ or 1+ endometrial cancer",
        "interventionNames": [
          "Drug: Trastuzumab deruxtecan"
        ],
        "label": "Part 2 Cohort C",
        "type": "EXPERIMENTAL"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/armGroups/10",
      "value": {
        "description": "HER2 IHC 2+ or 1+ ovarian cancer",
        "interventionNames": [
          "Drug: Trastuzumab deruxtecan"
        ],
        "label": "Part 2 Cohort D",
        "type": "EXPERIMENTAL"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/armGroups/11",
      "value": {
        "description": "HER2 IHC 2+ or 1+ cervical cancer",
        "interventionNames": [
          "Drug: Trastuzumab deruxtecan"
        ],
        "label": "Part 2 Cohort E",
        "type": "EXPERIMENTAL"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
      "value": "Part 1 Cohort 1"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1",
      "value": "Part 1 Cohort 2"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/2",
      "value": "Part 1 Cohort 3"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/3",
      "value": "Part 1 Cohort 4"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/4",
      "value": "Part 1 Cohort 5"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/5",
      "value": "Part 1 Cohort 6"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/6",
      "value": "Part 1 Cohort 7"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/7",
      "value": "Part 2 Cohort A"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/8",
      "value": "Part 2 Cohort B"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/9",
      "value": "Part 2 Cohort C"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/10",
      "value": "Part 2 Cohort D"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/11",
      "value": "Part 2 Cohort E"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "value": "An average of approximately 6 months"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
      "value": "An average of approximately 6 months"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
      "value": "An average of approximately 6 months"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
      "value": "An average of approximately 6 months"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
      "value": "An average of approximately 14 months"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
      "value": "An average of approximately 8 months"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame",
      "value": "An average of approximately 8 months"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame",
      "value": "An average of approximately 6 months"
    },
    {
      "op": "replace",
      "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
      "value": "<p>Inclusion Criteria:</p><ul><li>Locally advanced, unresectable, or metastatic disease based on most recent imaging.</li><li><p>Part 1:The respective cohorts for patient inclusion are:</p><ul><li>Cohort 1: Biliary tract cancer</li><li>Cohort 2: Bladder cancer</li><li>Cohort 3: Cervical cancer</li><li>Cohort 4: Endometrial cancer</li><li>Cohort 5: Epithelial ovarian cancer</li><li>Cohort 6: Pancreatic cancer</li><li>Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.</li></ul></li><li><p>Part 2:The respective cohorts for patient inclusion are:</p><ul><li>Cohort A: Metastatic or advanced solid tumors that are HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer).\nPatients with non-small cell lung cancer can be included.</li><li>Cohort B: Metastatic or advanced solid tumors that are HER2 IHC 2+&#x2F;ISH+ any tumor type (excluding breast, gastric cancer, and colorectal cancer).\nPatients with non-small cell lung cancer can be included.</li><li>Cohort C: Metastatic or advanced solid endometrial cancer that is HER2 IHC 2+ or 1+.</li><li>Cohort D: Metastatic or advanced ovarian cancer that is HER2 IHC 2+ or 1+.</li><li>Cohort E: Metastatic or advanced solid cervical cancer that is HER2 IHC 2+ or 1+.</li></ul></li><li>Progressed following prior treatment or who have no satisfactory alternative treatment option.</li><li>Prior HER2 targeting therapy is permitted.</li><li><p>HER2 expression scored using current ASCO&#x2F;CAP guidelines for scoring HER2 for gastric cancer.</p><ul><li>Part 1: IHC 3+ or IHC 2+ by local or central assessment</li><li>Part 2: IHC and ISH results by central assessment as pre-defined for each cohort</li></ul></li><li>Has measurable target disease assessed by the Investigator based on RECIST version 1.1.</li><li>Has protocol- defined adequate organ function including cardiac, renal and hepatic function.</li></ul><p>Exclusion Criteria:</p><ul><li>History of non-infectious pneumonitis&#x2F;ILD that required steroids, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening</li><li>Lung-specific intercurrent clinically significant severe illnesses</li><li>Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals</li><li>Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART</li><li>Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression.</li><li>Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer for Part 1.\nFor Part 2, patients with primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction will be excluded.</li><li>Medical conditions that may interfere with the subject&#x27;s participation in the study.</li></ul>"
    },
    {
      "op": "remove",
      "path": "/protocolSection/contactsLocationsModule/locations/6"
    },
    {
      "op": "add",
      "path": "/protocolSection/contactsLocationsModule/locations/8",
      "value": {
        "city": "New York",
        "country": "United States",
        "facility": "Research Site",
        "geoPoint": {
          "lat": 40.71427,
          "lon": -74.00597
        },
        "state": "New York",
        "zip": "10065"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/11/zip",
      "value": "98195"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/23/zip",
      "value": "77900"
    },
    {
      "op": "remove",
      "path": "/protocolSection/contactsLocationsModule/locations/32"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/38/zip",
      "value": "31-501"
    },
    {
      "op": "add",
      "path": "/protocolSection/contactsLocationsModule/locations/52",
      "value": {
        "city": "Seoul",
        "country": "South Korea",
        "facility": "Research Site",
        "geoPoint": {
          "lat": 37.566,
          "lon": 126.9784
        },
        "zip": "06351"
      }
    },
    {
      "op": "remove",
      "path": "/protocolSection/contactsLocationsModule/locations/54"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "355169ad435122cbc2eb034c570382b8b9ed23267a019c02d8d81def2be21cad",
    "materiality_event_hash": "040b895bb9fb3cd17178f34312a651a7dc720965e007bd80962722b85c463186",
    "patch_hash": "3852ef07707a680efab8253d133a94228788744176921b23cfa8acda86dae8a4",
    "patch_raw_hash": "61ac586543459074003a4f7d2b23725f09c723f9c890863b953ba57177d23995",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT04482309/history/28?patchToVersion=29",
    "to_snapshot_hash": "b7596e3664432fcdc9c667b9ff147f7e731f667897f2674da364431a77227fc8"
  },
  "review_question": "What did the primary outcome field say before and after the amendment, and is there a public protocol, statistical analysis plan, or manuscript explaining the change?",
  "schema": "trialdiff.evidence_record",
  "trial": {
    "clinicaltrials_gov_url": "https://clinicaltrials.gov/study/NCT04482309",
    "nct_id": "NCT04482309"
  },
  "versions": {
    "from_version": 28,
    "submitted_date": "2024-02-05",
    "to_version": 29
  }
}