evt_NCT05549505_v9_v10_5dd2fd74cbee

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/measureCategoriesReviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/description",
    "/resultsSection/adverseEventsModule/timeFrame",
    "/resultsSection/adverseEventsModule/description",
    "/annotationSection"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT05549505_v9_v10_5dd2fd74cbee. ClinicalTrials.gov NCT05549505, versions 9-10. 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 9 to version 10 for NCT05549505.",
    "The JSON Patch for this comparison has hash 098370f38adbb892660901329a3b4a4524bf708773debab65bef32ebac5830e1.",
    "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 post_recruitment.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/description, /resultsSection/adverseEventsModule/timeFrame, /resultsSection/adverseEventsModule/description, /annotationSection.",
    "An outcome path changed between versions 9 and 10 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": [
      "outcome_edit_cooccurs_with_results_posting"
    ],
    "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/primaryOutcomes/0/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/description"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT05549505_v9_v10_5dd2fd74cbee",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2025-08"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2025-08-12"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2025-08-29"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
      "value": "2025-08-12"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
      "value": {
        "date": "2025-08-29",
        "type": "ACTUAL"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "value": "Tumor biopsy Ki-67 expression (% of tumor cells that are positive for Ki-67) at baseline and Cycle 1 Day 15 (C1D15) was collected.\nKi-67 expression was assessed by immunohistochemical staining in a central laboratory.\nThe log-transformed Ki-67 after approximately 2 weeks of treatment as a percentage of the baseline value, ie, the ratio between the Ki-67 measurements obtained from C1D15 visit and baseline was modelled using a generalized linear model (GLM) with both stratification factors (ie, baseline Ki-67 score and the tumor size) and treatment as co-variates.\nThe treatment effects were back transformed into geometric means and their Confidence Intervals.\nThe percent change, in other words, relative reduction, of Ki-67 after 2 weeks of treatment is reported as the complement of the ratio between the Ki-67 measurement from C1D15 and baseline, that is 100% × (1 - geometric mean ratio between Ki-67 at C1D15 and Ki-67 at baseline)."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
      "value": "<p>Local pathological assessment of the tissue from surgical resection (performed after approximately 5.5 months of treatment), at minimum, included pathologic stage (ypT and ypN stage) as described in the Laboratory Manual.\nParticipants were analysed based on the current American Joint Committee on Cancer (AJCC) staging system as follows:</p><ul><li>Pathologic Tumor - post-neoadjuvant therapy pathologic tumor categorization (ypT): (ypTx, ypT0, ypTis, ypT1mi, ypT1a, ypT1b, ypT1c, ypT2, ypT3, ypT4a, ypT4b, ypT4c).</li><li>Pathological Lymph Nodes - post-neoadjuvant therapy pathologic node categorization (ypN): (ypNX, ypN0, ypN0(i+), ypN0(mol+), ypN1, ypN1mi, ypN1a, ypN1b, ypN1c, ypN2, ypN2a, ypN2b, ypN3, ypN3a, ypN3b, ypN3c).</li><li>ypT0 &#x2F; ypN0 indicates no evidence of disease and the progressive grades indicate increasing size of tumor and increasing area of lymph node involvement respectively and ypTx&#x2F;ypNX indicates non-measurable disease.</li></ul>"
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
      "value": "<p>Modified Pre-operative Endocrine Prognostic Index (mPEPI) score is an investigational prognostic tool used to predict the risk of breast cancer recurrence.\nIt will be derived from factors assigned a numerical score following Neoadjuvant endocrine treatment (NET).\nThe factors include pathologic tumor size, and lymph node status and Ki67 expression in the surgical specimen.\nTotal mPEPI score (mPEPI_T) per participant is the sum of mPEPI score of each factor.</p><p>mPEPI score of 0 indicates Pathological tumor size T1-T2, no lymph nodes and Ki67 level of 0%-2.7%, 1 indicates: Ki67 level &gt;2.7%-7.3%, 2 indicates Ki67 level &gt;19.7%-53.1% and 3 indicates: tumor sizeT3-T4, presence of lymph nodes and Ki67 level &gt;53.1%.</p>"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description",
      "value": "Tumor biopsy Ki-67 expression (% of tumor cells that are positive for Ki-67) at baseline and Cycle 1 Day 15 (C1D15) was collected.\nKi-67 expression was assessed by immunohistochemical staining in a central laboratory.\nThe log-transformed Ki-67 after approximately 2 weeks of treatment as a percentage of the baseline value, ie, the ratio between the Ki-67 measurements obtained from C1D15 visit and baseline was modelled using a generalized linear model (GLM) with both stratification factors (ie, baseline Ki-67 score and the tumor size) and treatment as co-variates.\nThe treatment effects were back transformed into geometric means and their Confidence Intervals.\nThe percent change, in other words, relative reduction, of Ki-67 after 2 weeks of treatment is reported as the complement of the ratio between the Ki-67 measurement from C1D15 and baseline, that is 100% × (1 - geometric mean ratio between Ki-67 at C1D15 and Ki-67 at baseline)."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/measureCategoriesReviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description",
      "value": "<p>Local pathological assessment of the tissue from surgical resection (performed after approximately 5.5 months of treatment), at minimum, included pathologic stage (ypT and ypN stage) as described in the Laboratory Manual.\nParticipants were analysed based on the current American Joint Committee on Cancer (AJCC) staging system as follows:</p><ul><li>Pathologic Tumor - post-neoadjuvant therapy pathologic tumor categorization (ypT): (ypTx, ypT0, ypTis, ypT1mi, ypT1a, ypT1b, ypT1c, ypT2, ypT3, ypT4a, ypT4b, ypT4c).</li><li>Pathological Lymph Nodes - post-neoadjuvant therapy pathologic node categorization (ypN): (ypNX, ypN0, ypN0(i+), ypN0(mol+), ypN1, ypN1mi, ypN1a, ypN1b, ypN1c, ypN2, ypN2a, ypN2b, ypN3, ypN3a, ypN3b, ypN3c).</li><li>ypT0 &#x2F; ypN0 indicates no evidence of disease and the progressive grades indicate increasing size of tumor and increasing area of lymph node involvement respectively and ypTx&#x2F;ypNX indicates non-measurable disease.</li></ul>"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/description",
      "value": "<p>Modified Pre-operative Endocrine Prognostic Index (mPEPI) score is an investigational prognostic tool used to predict the risk of breast cancer recurrence.\nIt will be derived from factors assigned a numerical score following Neoadjuvant endocrine treatment (NET).\nThe factors include pathologic tumor size, and lymph node status and Ki67 expression in the surgical specimen.\nTotal mPEPI score (mPEPI_T) per participant is the sum of mPEPI score of each factor.</p><p>mPEPI score of 0 indicates Pathological tumor size T1-T2, no lymph nodes and Ki67 level of 0%-2.7%, 1 indicates: Ki67 level &gt;2.7%-7.3%, 2 indicates Ki67 level &gt;19.7%-53.1% and 3 indicates: tumor sizeT3-T4, presence of lymph nodes and Ki67 level &gt;53.1%.</p>"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/timeFrame",
      "value": "Adverse Events: From first study drug administration up to approximately 6.5 months. All-cause mortality: From randomization up to approximately 6.5 months."
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/description",
      "value": "Adverse events were collected for the Safety Analysis Set consisting of all enrolled participants who received at least 1 dose of study intervention.\nFor All-Cause Mortality, events were collected from the Full Analysis Set, which included all the enrolled participants who were randomized."
    },
    {
      "op": "remove",
      "path": "/annotationSection"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "946531f46c65ff4a2af47e4632618a073871ecbd6c491b638223f6472c1ad733",
    "materiality_event_hash": "d416cde94cae8e882100d7e0a0f18312a1fcb1ca16298641cd6d0fa021356c4f",
    "patch_hash": "098370f38adbb892660901329a3b4a4524bf708773debab65bef32ebac5830e1",
    "patch_raw_hash": "149835ac8d8943939533cdc95225d79b51dc3d414cac7db6595585c2572d7205",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT05549505/history/9?patchToVersion=10",
    "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/NCT05549505",
    "nct_id": "NCT05549505"
  },
  "versions": {
    "from_version": 9,
    "submitted_date": "2025-08-12",
    "to_version": 10
  }
}