evt_NCT00530868_v26_v27_4101d5b7cdee

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  "citation_text": "TrialDiff Evidence Record evt_NCT00530868_v26_v27_4101d5b7cdee. ClinicalTrials.gov NCT00530868, versions 26-27. 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."
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  "claims_supported": [
    "TrialDiff compared ClinicalTrials.gov record version 26 to version 27 for NCT00530868.",
    "The JSON Patch for this comparison has hash 9e43a1b41805234e81c7a41dbe49cdf4ae3d650e8a0a2bbcda1d9259bcb2161b.",
    "The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.",
    "The deterministic triage label was high; before timing adjustment it was high.",
    "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.",
    "A registry field under an arm or intervention module changed between ClinicalTrials.gov versions 26 and 27.",
    "The timing context for the from-version record was post_recruitment.",
    "The deterministic rules that fired were: arms_or_interventions_change.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/primaryCompletionDateStruct/date, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName, /protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorTitle, /protocolSection/armsInterventionsModule/armGroups/0/description, /protocolSection/armsInterventionsModule/armGroups/1/description, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/contactsLocationsModule/overallOfficials/0/name, /protocolSection/referencesModule, /annotationSection, /hasResults, /resultsSection, /documentSection.",
    "The timeline value moved by 480 days.",
    "The timeline value moved by 510 days.",
    "An outcome path changed between versions 26 and 27 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
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    "severity": "high",
    "severity_pre_timing": "high",
    "timing_context": "post_recruitment",
    "triage_label": "high",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
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        "date_struct": "primaryCompletionDateStruct",
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        "direction": "later",
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        "new_type": "ACTUAL",
        "new_value": "2022-03-01",
        "old_precision": "day",
        "old_type": "ACTUAL",
        "old_value": "2020-11-06",
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        "severity": "low",
        "signal": "timeline_actual_date_correction"
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        "new_value": "2022-03-31",
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        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
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    ]
  },
  "event_id": "evt_NCT00530868_v26_v27_4101d5b7cdee",
  "evidence_version": 1,
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      "value": "Professor, Med-Hematology & Oncology"
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      "value": "50 evaluable patients received the combination therapy of 2.5 gm daily oral Letrozole and Avastin 15 mg/kg IV every 3 weeks for 24 weeks."
    },
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      "value": "Pathological complete response is defined as the absence of residual invasive tumor in the breast or axillary lymph nodes or if only residual ductal carcinoma in-situ was seen on review of the surgical specimen."
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              "seriousNumAtRisk": 50,
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              "notes": "proteinuria 4%",
              "organSystem": "Renal and urinary disorders",
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              "term": "Proteinuria"
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                      "title": "&gt;=65 years"
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              "title": "Age, Categorical",
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          "populationDescription": "Postmenopausal women with newly diagnosed stage 2 or 3 estrogen and&#x2F;or progesterone receptor-positive, HER2-negative breast cancer were randomly assigned (2:1) between letrozole 2.5 mg PO daily plus bevacizumab 15 mg&#x2F; kg IV every 3 weeks (Let&#x2F;Bev) and letrozole 2.5 mg PO daily (Let) for 24 weeks prior to definitive surgery."
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            "email": "Lnabell@uabmc.edu",
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            "title": "Lisle Nabell"
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              "description": "Pathological complete response is defined as the absence of residual invasive tumor in the breast or axillary lymph nodes or if only residual ductal carcinoma in-situ was seen on review of the surgical specimen.",
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                  "description": "Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg&#x2F;kg IV every 3 weeks",
                  "id": "OG000",
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              "populationDescription": "Patients with postmenopausal hormone receptor positive breast cancer T2-4,N0-2 and M0 were randomized 2:1 to receive letrozole 2.5 mg PO daily and bevacizumab 15 mg&#x2F;kg IV for 24 weeks or daily treatment with letrozole 2.5 mg PO alone (control arm).\nThe duration of each cycle was 3 weeks for a total of 24 weeks.\nThe pCR was defined as the absence of any residual invasive cancer in the resected breast specimen and lymph nodes.\nData below is representative of the raw data.",
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              "title": "The Percentage of Participants With Pathologic Complete Response",
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                {
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                  "id": "OG000",
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  "review_question": "What source document explains this registry amendment, and does it change interpretation of the trial record?",
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