evt_NCT01275677_v978_v979_d043ad7899f8

{
  "changed_paths": [
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/outcomesModule/secondaryOutcomes/6",
    "/protocolSection/outcomesModule/secondaryOutcomes/6",
    "/protocolSection/outcomesModule/otherOutcomes",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/type",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/type",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/timeFrame"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT01275677_v978_v979_d043ad7899f8. ClinicalTrials.gov NCT01275677, versions 978-979. 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 978 to version 979 for NCT01275677.",
    "The JSON Patch for this comparison has hash eecb0138303d0b74a3f3aa820372285d22956baf0445c7f7eadf77f2a6a1e6c5.",
    "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, secondary_outcome_removed_after_primary_completion.",
    "The timing context for the from-version record was post_recruitment.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/outcomesModule/secondaryOutcomes/6, /protocolSection/outcomesModule/secondaryOutcomes/6, /protocolSection/outcomesModule/otherOutcomes, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/type, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/8/type, /resultsSection/outcomeMeasuresModule/outcomeMeasures/8/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/8/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/8/timeFrame.",
    "An outcome path changed between versions 978 and 979 in a patch that also carried a hasResults or resultsSection co-occurrence signal.",
    "The JSON Patch removed a whole secondary outcome item after primary completion between versions 978 and 979; when a TO-version outcome list is available, reindex-only removals are excluded."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "results_reconciliation"
    ],
    "category": "results_reconciliation",
    "deterministic_rules": [],
    "event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting",
      "secondary_outcome_removed_after_primary_completion"
    ],
    "rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
    "severity": "low",
    "severity_pre_timing": "low",
    "timing_context": "post_recruitment",
    "triage_label": "low",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/secondaryOutcomes/6"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT01275677_v978_v979_d043ad7899f8",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2025-06-25"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2025-07-14"
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/6"
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/6"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/otherOutcomes",
      "value": [
        {
          "description": "The polymorphism of the Fcgamma 158 receptor gene will be dichotomized as V/V (valine) vs. other genotypes and the polymorphism of the Fcgamma 131 receptor gene will be dichotomized as H/H (histidine) vs. other genotypes to evaluate an interaction between treatment group and Fcgamma polymorphism.\nThe Kaplan-Meier method105 will be used to estimate the distribution of the primary endpoints stratified by the dichotomized subgroups, and the log-rank test106 will be used to statistically compare the time-to-event distributions.",
          "measure": "Fcgamma Receptor Polymorphism",
          "timeFrame": "From baseline to up to 24 months"
        },
        {
          "description": "The interaction between treatment effect and HER2 mRNA level will be evaluated in the proportional hazards model, which would include an indicator for treatment group and the HER2 mRNA level as a continuous variable, and the corresponding interaction term.\nThe log-hazard ratio plot for the interaction term with 95% confidence intervals will be used to determine the cut-off of the HER2 mRNA level that would determine a subset of the patients who would benefit from the adjuvant trastuzumab therapy.",
          "measure": "Change in HER2 mRNA Level",
          "timeFrame": "From baseline to 24 months"
        }
      ]
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/type",
      "value": "OTHER_PRE_SPECIFIED"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/title",
      "value": "Fcgamma Receptor Polymorphism"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/description",
      "value": "The polymorphism of the Fcgamma 158 receptor gene will be dichotomized as V/V (valine) vs. other genotypes and the polymorphism of the Fcgamma 131 receptor gene will be dichotomized as H/H (histidine) vs. other genotypes to evaluate an interaction between treatment group and Fcgamma polymorphism.\nThe Kaplan-Meier method105 will be used to estimate the distribution of the primary endpoints stratified by the dichotomized subgroups, and the log-rank test106 will be used to statistically compare the time-to-event distributions."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/timeFrame",
      "value": "From baseline to up to 24 months"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/type",
      "value": "OTHER_PRE_SPECIFIED"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/title",
      "value": "Change in HER2 mRNA Level"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/description",
      "value": "The interaction between treatment effect and HER2 mRNA level will be evaluated in the proportional hazards model, which would include an indicator for treatment group and the HER2 mRNA level as a continuous variable, and the corresponding interaction term.\nThe log-hazard ratio plot for the interaction term with 95% confidence intervals will be used to determine the cut-off of the HER2 mRNA level that would determine a subset of the patients who would benefit from the adjuvant trastuzumab therapy."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/timeFrame",
      "value": "From baseline to 24 months"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "f2430ea04100f839891f8eb0acf5e36f6f2373c7496f6d405b0907589df64d32",
    "materiality_event_hash": "3a39bd28726355fd7aa45269c070084dedfd9075af112c83bcf3fb131b732a95",
    "patch_hash": "eecb0138303d0b74a3f3aa820372285d22956baf0445c7f7eadf77f2a6a1e6c5",
    "patch_raw_hash": "dfe502b251ced15519cf635cb784cbafa1238e85f8484054cfc2b661d029de5b",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT01275677/history/978?patchToVersion=979",
    "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/NCT01275677",
    "nct_id": "NCT01275677"
  },
  "versions": {
    "from_version": 978,
    "submitted_date": "2025-06-25",
    "to_version": 979
  }
}