evt_NCT00099437_v22_v23_2fe77a937f58

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/completionDateStruct/date",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/6",
    "/protocolSection/eligibilityModule/stdAges/0",
    "/protocolSection/eligibilityModule/minimumAge",
    "/protocolSection/contactsLocationsModule/locations/0",
    "/protocolSection/contactsLocationsModule/locations/0",
    "/protocolSection/contactsLocationsModule/locations/2",
    "/protocolSection/contactsLocationsModule/locations/8",
    "/protocolSection/contactsLocationsModule/locations/11/state",
    "/protocolSection/contactsLocationsModule/locations/12/city",
    "/protocolSection/contactsLocationsModule/locations/12/state",
    "/protocolSection/contactsLocationsModule/locations/13/city",
    "/protocolSection/contactsLocationsModule/locations/13/state",
    "/protocolSection/contactsLocationsModule/locations/14/state",
    "/protocolSection/contactsLocationsModule/locations/15/state",
    "/protocolSection/contactsLocationsModule/locations/16/state",
    "/protocolSection/contactsLocationsModule/locations/17/state",
    "/protocolSection/contactsLocationsModule/locations/18/state",
    "/protocolSection/contactsLocationsModule/locations/19/state",
    "/protocolSection/contactsLocationsModule/locations/20/city",
    "/protocolSection/contactsLocationsModule/locations/20/state",
    "/protocolSection/contactsLocationsModule/locations/20/geoPoint/lat",
    "/protocolSection/contactsLocationsModule/locations/20/geoPoint/lon",
    "/protocolSection/contactsLocationsModule/locations/21/city",
    "/protocolSection/contactsLocationsModule/locations/21/state",
    "/protocolSection/contactsLocationsModule/locations/21/geoPoint/lat",
    "/protocolSection/contactsLocationsModule/locations/21/geoPoint/lon",
    "/protocolSection/contactsLocationsModule/locations/22/city",
    "/protocolSection/contactsLocationsModule/locations/22/state",
    "/protocolSection/contactsLocationsModule/locations/22/geoPoint/lat",
    "/protocolSection/contactsLocationsModule/locations/22/geoPoint/lon",
    "/protocolSection/contactsLocationsModule/locations/23/city",
    "/protocolSection/contactsLocationsModule/locations/23/state",
    "/protocolSection/contactsLocationsModule/locations/23/country",
    "/protocolSection/contactsLocationsModule/locations/23/geoPoint/lat",
    "/protocolSection/contactsLocationsModule/locations/23/geoPoint/lon",
    "/protocolSection/contactsLocationsModule/locations/24/city",
    "/protocolSection/contactsLocationsModule/locations/24/country",
    "/protocolSection/contactsLocationsModule/locations/24/geoPoint/lat",
    "/protocolSection/contactsLocationsModule/locations/24/geoPoint/lon",
    "/protocolSection/contactsLocationsModule/locations/25/city",
    "/protocolSection/contactsLocationsModule/locations/25/country",
    "/protocolSection/contactsLocationsModule/locations/25/geoPoint/lat",
    "/protocolSection/contactsLocationsModule/locations/25/geoPoint/lon",
    "/protocolSection/contactsLocationsModule/locations/26",
    "/protocolSection/contactsLocationsModule/locations/26",
    "/protocolSection/contactsLocationsModule/locations/26",
    "/protocolSection/contactsLocationsModule/locations/31/city",
    "/protocolSection/contactsLocationsModule/locations/31/country",
    "/protocolSection/contactsLocationsModule/locations/31/geoPoint",
    "/protocolSection/contactsLocationsModule/locations/32",
    "/protocolSection/contactsLocationsModule/locations/33/state",
    "/protocolSection/contactsLocationsModule/locations/34/city",
    "/protocolSection/contactsLocationsModule/locations/34/state",
    "/protocolSection/contactsLocationsModule/locations/34/geoPoint/lat",
    "/protocolSection/contactsLocationsModule/locations/34/geoPoint/lon",
    "/protocolSection/contactsLocationsModule/locations/35/city",
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    "/protocolSection/contactsLocationsModule/locations/36/city",
    "/protocolSection/contactsLocationsModule/locations/36/state",
    "/protocolSection/contactsLocationsModule/locations/36/geoPoint",
    "/protocolSection/contactsLocationsModule/locations/37/state",
    "/protocolSection/contactsLocationsModule/locations/38",
    "/protocolSection/contactsLocationsModule/locations/38",
    "/protocolSection/contactsLocationsModule/locations/38",
    "/protocolSection/contactsLocationsModule/locations/38",
    "/protocolSection/contactsLocationsModule/locations/38",
    "/protocolSection/contactsLocationsModule/locations/39/city",
    "/protocolSection/contactsLocationsModule/locations/39/state",
    "/protocolSection/contactsLocationsModule/locations/39/country",
    "/protocolSection/contactsLocationsModule/locations/39/geoPoint/lat",
    "/protocolSection/contactsLocationsModule/locations/39/geoPoint/lon",
    "/protocolSection/contactsLocationsModule/locations/40/city",
    "/protocolSection/contactsLocationsModule/locations/40/state",
    "/protocolSection/contactsLocationsModule/locations/40/geoPoint/lat",
    "/protocolSection/contactsLocationsModule/locations/40/geoPoint/lon",
    "/protocolSection/contactsLocationsModule/locations/41/city",
    "/protocolSection/contactsLocationsModule/locations/41/state",
    "/protocolSection/contactsLocationsModule/locations/41/geoPoint/lat",
    "/protocolSection/contactsLocationsModule/locations/41/geoPoint/lon",
    "/protocolSection/contactsLocationsModule/locations/42/city",
    "/protocolSection/contactsLocationsModule/locations/42/state",
    "/protocolSection/contactsLocationsModule/locations/42/geoPoint/lat",
    "/protocolSection/contactsLocationsModule/locations/42/geoPoint/lon",
    "/protocolSection/contactsLocationsModule/locations/43/state",
    "/protocolSection/contactsLocationsModule/locations/44/state",
    "/protocolSection/contactsLocationsModule/locations/45/state",
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    "/protocolSection/contactsLocationsModule/locations/52",
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    "/protocolSection/contactsLocationsModule/locations/57",
    "/protocolSection/contactsLocationsModule/locations/60",
    "/protocolSection/contactsLocationsModule/locations/62/city",
    "/protocolSection/contactsLocationsModule/locations/62/country",
    "/protocolSection/contactsLocationsModule/locations/62/geoPoint/lat",
    "/protocolSection/contactsLocationsModule/locations/62/geoPoint/lon",
    "/protocolSection/contactsLocationsModule/locations/63/state",
    "/protocolSection/contactsLocationsModule/locations/64/city",
    "/protocolSection/contactsLocationsModule/locations/64/state",
    "/protocolSection/contactsLocationsModule/locations/64/geoPoint/lat",
    "/protocolSection/contactsLocationsModule/locations/64/geoPoint/lon",
    "/protocolSection/contactsLocationsModule/locations/65/state",
    "/protocolSection/contactsLocationsModule/locations/65/geoPoint/lat",
    "/protocolSection/contactsLocationsModule/locations/65/geoPoint/lon",
    "/protocolSection/contactsLocationsModule/locations/66/city",
    "/protocolSection/contactsLocationsModule/locations/66/state",
    "/protocolSection/contactsLocationsModule/locations/66/geoPoint",
    "/protocolSection/contactsLocationsModule/locations/67",
    "/protocolSection/contactsLocationsModule/locations/67",
    "/protocolSection/contactsLocationsModule/locations/73",
    "/protocolSection/contactsLocationsModule/locations/74",
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    "/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/0/numSubjects",
    "/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/1/numSubjects",
    "/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/type",
    "/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/0/numSubjects",
    "/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/1/numSubjects",
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    "/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/0/numSubjects",
    "/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/1/numSubjects",
    "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/type",
    "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/0/numSubjects",
    "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/1/numSubjects",
    "/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/type",
    "/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/0/numSubjects",
    "/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/1/numSubjects",
    "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4",
    "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4",
    "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4",
    "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4",
    "/resultsSection/baselineCharacteristicsModule/measures/0/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/0/upperLimit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/0/comment",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/1/upperLimit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/1/comment",
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    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/comment",
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    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/comment",
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    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/0/comment",
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    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/comment",
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    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/upperLimit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/comment",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/upperLimit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/comment",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/reportingStatus",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/paramType",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/dispersionType",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/unitOfMeasure",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7",
    "/resultsSection/adverseEventsModule/description",
    "/resultsSection/adverseEventsModule/eventGroups/0/seriousNumAffected",
    "/resultsSection/adverseEventsModule/eventGroups/1/seriousNumAffected",
    "/resultsSection/adverseEventsModule/seriousEvents/0/stats/1/numAffected",
    "/resultsSection/adverseEventsModule/seriousEvents/5/stats/0/numAffected",
    "/resultsSection/adverseEventsModule/seriousEvents/20/stats/1/numAffected",
    "/resultsSection/adverseEventsModule/seriousEvents/26/stats/0/numAffected",
    "/resultsSection/adverseEventsModule/seriousEvents/31/stats/1/numAffected",
    "/resultsSection/adverseEventsModule/seriousEvents/61",
    "/resultsSection/adverseEventsModule/seriousEvents/62",
    "/resultsSection/adverseEventsModule/seriousEvents/63",
    "/resultsSection/adverseEventsModule/seriousEvents/64",
    "/resultsSection/adverseEventsModule/seriousEvents/65",
    "/resultsSection/adverseEventsModule/seriousEvents/66",
    "/resultsSection/adverseEventsModule/timeFrame"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT00099437_v22_v23_2fe77a937f58. ClinicalTrials.gov NCT00099437, versions 22-23. 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 22 to version 23 for NCT00099437.",
    "The JSON Patch for this comparison has hash f024c4431266fe5000b3bf7c84929367a32ba4f22bd7e219a301e56cbce4597a.",
    "The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
    "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 path under serious adverse event results was added between ClinicalTrials.gov versions 22 and 23.",
    "The timing context for the from-version record was late_recruitment.",
    "The deterministic rules that fired were: adverse_event_group_change, serious_adverse_event_addition, serious_adverse_event_modification.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/5/measure, /protocolSection/outcomesModule/secondaryOutcomes/5/description, /protocolSection/outcomesModule/secondaryOutcomes/6, /protocolSection/eligibilityModule/stdAges/0, /protocolSection/eligibilityModule/minimumAge, /protocolSection/contactsLocationsModule/locations/0, /protocolSection/contactsLocationsModule/locations/0, /protocolSection/contactsLocationsModule/locations/2, /protocolSection/contactsLocationsModule/locations/8, /protocolSection/contactsLocationsModule/locations/11/state, /protocolSection/contactsLocationsModule/locations/12/city, /protocolSection/contactsLocationsModule/locations/12/state, /protocolSection/contactsLocationsModule/locations/13/city, /protocolSection/contactsLocationsModule/locations/13/state, /protocolSection/contactsLocationsModule/locations/14/state, /protocolSection/contactsLocationsModule/locations/15/state, /protocolSection/contactsLocationsModule/locations/16/state, /protocolSection/contactsLocationsModule/locations/17/state, /protocolSection/contactsLocationsModule/locations/18/state, /protocolSection/contactsLocationsModule/locations/19/state, /protocolSection/contactsLocationsModule/locations/20/city, /protocolSection/contactsLocationsModule/locations/20/state, /protocolSection/contactsLocationsModule/locations/20/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/20/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/21/city, /protocolSection/contactsLocationsModule/locations/21/state, /protocolSection/contactsLocationsModule/locations/21/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/21/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/22/city, /protocolSection/contactsLocationsModule/locations/22/state, /protocolSection/contactsLocationsModule/locations/22/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/22/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/23/city, /protocolSection/contactsLocationsModule/locations/23/state, /protocolSection/contactsLocationsModule/locations/23/country, /protocolSection/contactsLocationsModule/locations/23/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/23/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/24/city, /protocolSection/contactsLocationsModule/locations/24/country, /protocolSection/contactsLocationsModule/locations/24/geoPoint/lat, /protocolSection/contactsLocationsModule/locations/24/geoPoint/lon, /protocolSection/contactsLocationsModule/locations/25/city, 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    "The timeline value moved by 487 days.",
    "An outcome path changed between versions 22 and 23 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
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          "url": "http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=589&filename=CSR-D6997C00002.pdf"
        }
      ]
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/0/comment",
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    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/0/numSubjects",
      "value": "8"
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    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/1/comment",
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      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/1/numSubjects",
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    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/0/numSubjects",
      "value": "366"
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    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/1/numSubjects",
      "value": "349"
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    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/type",
      "value": "Lost to Follow-up"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/0/numSubjects",
      "value": "30"
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    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/1/numSubjects",
      "value": "33"
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      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/type",
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      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/0/numSubjects",
      "value": "293"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/1/numSubjects",
      "value": "261"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/type",
      "value": "Withdrawal by Subject"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/0/numSubjects",
      "value": "6"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/2/reasons/1/numSubjects",
      "value": "10"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/type",
      "value": "Ongoing in FU but not on treatment"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/0/numSubjects",
      "value": "37"
    },
    {
      "op": "replace",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/3/reasons/1/numSubjects",
      "value": "45"
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    },
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      "op": "remove",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4"
    },
    {
      "op": "remove",
      "path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/4"
    },
    {
      "op": "replace",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/0/title",
      "value": "Age, Continuous"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
      "value": "RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/0/upperLimit",
      "value": "NA"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/0/comment",
      "value": "Not Applicable - not all participants had an event at time of analysis, max time censored"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/1/upperLimit",
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      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/classes/0/categories/0/measurements/1/comment",
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    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/upperLimit",
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      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/comment",
      "value": "Not Applicable - not all participants had an event at time of analysis, max time censored"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/upperLimit",
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      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/1/comment",
      "value": "Not Applicable - not all participants had an event at time of analysis, max time censored"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/0/upperLimit",
      "value": "NA"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/0/comment",
      "value": "Not Applicable - not all participants had an event at time of analysis, max time censored"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/upperLimit",
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      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes/0/categories/0/measurements/1/comment",
      "value": "Not Applicable - not all participants had an event at time of analysis, max time censored"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description",
      "value": "Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/upperLimit",
      "value": "NA"
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    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/0/comment",
      "value": "Not Applicable - not all participants had an event at time of analysis, max time censored"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/upperLimit",
      "value": "NA"
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    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes/0/categories/0/measurements/1/comment",
      "value": "Not Applicable - not all participants had an event at time of analysis, max time censored"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/title",
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              "value": "35"
            },
            {
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              "value": "34"
            }
          ],
          "units": "Participants"
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                  "spread": "9.89",
                  "value": "-5.9"
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                  "spread": "13.72",
                  "value": "-7.5"
                }
              ]
            }
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    },
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                    "upperLimit": "NA",
                    "value": "22.3"
                  },
                  {
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        "type": "SECONDARY",
        "unitOfMeasure": "months"
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/description",
      "value": "1 participant was randomised to fulvestrant 500 mg but did not receive any treatment.\nAEs have been collected up to primary data cut off.\nSAEs have been collected up to follow-up phase data cut-off."
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/0/seriousNumAffected",
      "value": 27
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/1/seriousNumAffected",
      "value": 35
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            "numAtRisk": 374
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            "numAffected": 1,
            "numAtRisk": 361
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        ],
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    {
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            "numAtRisk": 374
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            "numAtRisk": 361
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        ],
        "term": "FALL"
      }
    },
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            "numAtRisk": 374
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            "numAtRisk": 361
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        ],
        "term": "BONE PAIN"
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            "numAtRisk": 374
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            "numAtRisk": 361
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      "value": "SAE- From baseline up to October 31st 2011; AE- From baseline up to 28th February 2009"
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    "materiality_event_hash": "710d14ee440e10110753e9585f508d16bec10bd835468835fbb5de0378937d99",
    "patch_hash": "f024c4431266fe5000b3bf7c84929367a32ba4f22bd7e219a301e56cbce4597a",
    "patch_raw_hash": "3acc98e2d127f63efaf7cce50f8f324649047e0341d30655bb7776609b827585",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT00099437/history/22?patchToVersion=23",
    "to_snapshot_hash": "902ef113a49f109f23523f53da382e62713d27ec9831e1dbbb9b59544ccb04cf"
  },
  "review_question": "What source document explains the added serious adverse event results record?",
  "schema": "trialdiff.evidence_record",
  "trial": {
    "clinicaltrials_gov_url": "https://clinicaltrials.gov/study/NCT00099437",
    "nct_id": "NCT00099437"
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  "versions": {
    "from_version": 22,
    "submitted_date": "2014-08-29",
    "to_version": 23
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}