evt_NCT00490139_v191_v192_25aaa1f7b706

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/conditionsModule/keywords/0",
    "/protocolSection/conditionsModule/keywords/0",
    "/protocolSection/conditionsModule/keywords/2",
    "/protocolSection/conditionsModule/keywords/3",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
    "/protocolSection/contactsLocationsModule/locations/1281/zip",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reportingStatus",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/0/ciNumSides",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/1/ciNumSides",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/2/ciNumSides",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reportingStatus",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/2/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/3/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reportingStatus",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/2/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/3/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/populationDescription",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reportingStatus",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/2/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/3/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/populationDescription",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reportingStatus",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/2/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/3/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reportingStatus",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/2/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/3/description"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT00490139_v191_v192_25aaa1f7b706. ClinicalTrials.gov NCT00490139, versions 191-192. 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 191 to version 192 for NCT00490139.",
    "The JSON Patch for this comparison has hash 9dc2af42013fb09f3620b16ae988bc23d250bc2e3c92dbee28a87ed7b93e04db.",
    "The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
    "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/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/conditionsModule/keywords/0, /protocolSection/conditionsModule/keywords/0, /protocolSection/conditionsModule/keywords/2, /protocolSection/conditionsModule/keywords/3, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/contactsLocationsModule/locations/1281/zip, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/0/ciNumSides, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/1/ciNumSides, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/2/ciNumSides, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/2/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/3/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/2/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/3/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/2/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/3/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/2/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/3/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reportingStatus, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/2/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/3/description.",
    "An outcome path changed between versions 191 and 192 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": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting"
    ],
    "rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
    "severity": "low",
    "severity_pre_timing": "low",
    "timing_context": "late_recruitment",
    "triage_label": "low",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/description"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT00490139_v191_v192_25aaa1f7b706",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2014-09"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2014-09-29"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2014-10-01"
    },
    {
      "op": "remove",
      "path": "/protocolSection/conditionsModule/keywords/0"
    },
    {
      "op": "remove",
      "path": "/protocolSection/conditionsModule/keywords/0"
    },
    {
      "op": "add",
      "path": "/protocolSection/conditionsModule/keywords/2",
      "value": "Early stage breast cancer"
    },
    {
      "op": "add",
      "path": "/protocolSection/conditionsModule/keywords/3",
      "value": "HER2/neu gene amplified"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
      "value": "Time to recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a disease recurrence (local, regional or distant).\nThe percentile data values presented here indicate the percentage (95, 90, 85, and 80 percent) of participants who did not have disease recurrence for the indicated years.\nIDMC=Independent Data Monitoring Committee."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
      "value": "Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer, or death from any cause.\nDFS was estimated using the Kaplan Meier method.\nThe non-breast second primary malignancies were not considered events.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who did not have DFS ignoring non-breast second primary malignancies for the indicated years.\nZero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility at the time of the first interim analysis (lapatinib participants were then offered trastuzumab)."
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/1281/zip",
      "value": "440-380"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reportingStatus"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/0/ciNumSides"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/1/ciNumSides"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/2/ciNumSides"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription",
      "value": "ITT Population.\nParticipants who did not die were censored at the date of last survival contact.\nZero participants were analyzed in the lapatinib arm, as the Independent Data Monitoring Committee discontinued the lapatinib-alone arm due to futility at the time of the first interim analysis (lapatinib participants were then offered trastuzumab)."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reportingStatus"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/2/description",
      "value": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/3/description",
      "value": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description",
      "value": "Time to recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a disease recurrence (local, regional or distant).\nThe percentile data values presented here indicate the percentage (95, 90, 85, and 80 percent) of participants who did not have disease recurrence for the indicated years.\nIDMC=Independent Data Monitoring Committee."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription",
      "value": "ITT Population.\nParticipants who did not have a recurrence of the initial disease were censored at the date of the last recorded physical or radiological examination.\nDeath was treated as a competing risk.\nZero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility at the interim analysis."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reportingStatus"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/2/description",
      "value": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/3/description",
      "value": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/populationDescription",
      "value": "ITT Population.\nParticipants who did not have a distant recurrence of the initial disease were censored at the date of the last recorded physical or radiological examination.\nDeath was treated as a competing risk.\nZero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reportingStatus"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/2/description",
      "value": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/3/description",
      "value": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/populationDescription",
      "value": "ITT Population.\nParticipants who did not have a central nervous system recurrence were censored at the date of the last recorded physical or radiological examination.\nDeath was treated as a competing risk.\nZero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility at the interim analysis."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reportingStatus"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/2/description",
      "value": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/3/description",
      "value": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description",
      "value": "Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer, or death from any cause.\nDFS was estimated using the Kaplan Meier method.\nThe non-breast second primary malignancies were not considered events.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who did not have DFS ignoring non-breast second primary malignancies for the indicated years.\nZero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility at the time of the first interim analysis (lapatinib participants were then offered trastuzumab)."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reportingStatus"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/2/description",
      "value": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/3/description",
      "value": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
    }
  ],
  "provenance": {
    "from_snapshot_hash": "a939a6f051c270517e3e2c7c0f1f37f642dedfa9e5b0084b3f06eed7a9c22de8",
    "materiality_event_hash": "ced15dd7fe23fcafab778274e986c162f8a6d8d2c864d7cf4fdc9a72820d270b",
    "patch_hash": "9dc2af42013fb09f3620b16ae988bc23d250bc2e3c92dbee28a87ed7b93e04db",
    "patch_raw_hash": "1e358479da5b01d6ca4915ec1b2e4475284179722b4a23546b5c53ca0b38f547",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT00490139/history/191?patchToVersion=192",
    "to_snapshot_hash": "ed5cc894f48cb1832aed69eea335d1c9911fb247d7b63992eb9e4d7942dbfe60"
  },
  "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/NCT00490139",
    "nct_id": "NCT00490139"
  },
  "versions": {
    "from_version": 191,
    "submitted_date": "2014-09-29",
    "to_version": 192
  }
}