evt_NCT01033032_v16_v17_dbdea2664453

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    "/resultsSection/adverseEventsModule/otherEvents/40",
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  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT01033032_v16_v17_dbdea2664453. ClinicalTrials.gov NCT01033032, versions 16-17. 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 16 to version 17 for NCT01033032.",
    "The JSON Patch for this comparison has hash 6c54a6303748bd55d2053d00c4865512fa8bf333994cd15e9470b39c073d7775.",
    "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 field under an arm or intervention module changed between ClinicalTrials.gov versions 16 and 17.",
    "The timing context for the from-version record was post_recruitment.",
    "The deterministic rules that fired were: adverse_event_group_change, arms_or_interventions_change, other_adverse_event_addition, other_adverse_event_modification, serious_adverse_event_addition, serious_adverse_event_modification.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/lastUpdatePostDateStruct/type, /protocolSection/sponsorCollaboratorsModule/collaborators/0/name, /protocolSection/armsInterventionsModule/interventions/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, 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    "An outcome path changed between versions 16 and 17 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
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      "serious_adverse_event_addition",
      "serious_adverse_event_modification",
      "adverse_event_group_change",
      "other_adverse_event_addition",
      "other_adverse_event_modification",
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    "category": "arm_intervention_change",
    "deterministic_rules": [
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      "arms_or_interventions_change",
      "other_adverse_event_addition",
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    "event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
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    "rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
    "severity": "high",
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    "timing_context": "post_recruitment",
    "triage_label": "high",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
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          "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
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          "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
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  "event_id": "evt_NCT01033032_v16_v17_dbdea2664453",
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      "op": "replace",
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    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
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    },
    {
      "op": "replace",
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    {
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    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/description",
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    },
    {
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    {
      "op": "replace",
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    },
    {
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    {
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    {
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      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
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      "op": "replace",
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    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
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    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
      "value": "The number of patients with observed complete response [CR] or partial response [PR].\nPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.\nThis outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II.\nThe phase I and phase II results are not separated as the timing of enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure."
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      }
    },
    {
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    },
    {
      "op": "remove",
      "path": "/resultsSection/baselineCharacteristicsModule/populationDescription"
    },
    {
      "op": "replace",
      "path": "/resultsSection/baselineCharacteristicsModule/groups/0/title",
      "value": "Phase I - Dose Level 1"
    },
    {
      "op": "replace",
      "path": "/resultsSection/baselineCharacteristicsModule/groups/0/description",
      "value": "Amrubicin -90 mg&#x2F;m^2 by intravenous(IV) every 21days"
    },
    {
      "op": "add",
      "path": "/resultsSection/baselineCharacteristicsModule/groups/1",
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        "description": "Amrubicin -120 mg&#x2F;m^2 every 21 days",
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      }
    },
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    },
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        "description": "Total of all reporting groups",
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      "path": "/resultsSection/baselineCharacteristicsModule/measures/0/paramType",
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    {
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      "path": "/resultsSection/baselineCharacteristicsModule/measures/0/dispersionType"
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    {
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        "groupId": "BG004",
        "value": "0"
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    },
    {
      "op": "add",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/1/classes/0/categories/1/measurements/5",
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        "groupId": "BG005",
        "value": "0"
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/2/title",
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    },
    {
      "op": "replace",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/2/paramType",
      "value": "COUNT_OF_PARTICIPANTS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/2/unitOfMeasure",
      "value": "Participants"
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    {
      "op": "remove",
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    {
      "op": "replace",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/0/measurements/0/value",
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        "groupId": "BG004",
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        "value": "4"
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    {
      "op": "add",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/0/title",
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    },
    {
      "op": "add",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/1",
      "value": {
        "measurements": [
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            "groupId": "BG000",
            "value": "1"
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          {
            "groupId": "BG001",
            "value": "1"
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          {
            "groupId": "BG002",
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            "value": "5"
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          {
            "groupId": "BG004",
            "value": "53"
          },
          {
            "groupId": "BG005",
            "value": "63"
          }
        ],
        "title": "Not Hispanic or Latino"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/2/classes/0/categories/2",
      "value": {
        "measurements": [
          {
            "groupId": "BG000",
            "value": "2"
          },
          {
            "groupId": "BG001",
            "value": "2"
          },
          {
            "groupId": "BG002",
            "value": "0"
          },
          {
            "groupId": "BG003",
            "value": "0"
          },
          {
            "groupId": "BG004",
            "value": "7"
          },
          {
            "groupId": "BG005",
            "value": "11"
          }
        ],
        "title": "Unknown or Not Reported"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/3",
      "value": {
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "groupId": "BG000",
                    "value": "0"
                  },
                  {
                    "groupId": "BG001",
                    "value": "0"
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                  {
                    "groupId": "BG002",
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                  {
                    "groupId": "BG003",
                    "value": "0"
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                  {
                    "groupId": "BG004",
                    "value": "0"
                  },
                  {
                    "groupId": "BG005",
                    "value": "0"
                  }
                ],
                "title": "American Indian or Alaska Native"
              },
              {
                "measurements": [
                  {
                    "groupId": "BG000",
                    "value": "0"
                  },
                  {
                    "groupId": "BG001",
                    "value": "0"
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                  {
                    "groupId": "BG002",
                    "value": "0"
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                  {
                    "groupId": "BG003",
                    "value": "0"
                  },
                  {
                    "groupId": "BG004",
                    "value": "0"
                  },
                  {
                    "groupId": "BG005",
                    "value": "0"
                  }
                ],
                "title": "Asian"
              },
              {
                "measurements": [
                  {
                    "groupId": "BG000",
                    "value": "0"
                  },
                  {
                    "groupId": "BG001",
                    "value": "0"
                  },
                  {
                    "groupId": "BG002",
                    "value": "0"
                  },
                  {
                    "groupId": "BG003",
                    "value": "0"
                  },
                  {
                    "groupId": "BG004",
                    "value": "0"
                  },
                  {
                    "groupId": "BG005",
                    "value": "0"
                  }
                ],
                "title": "Native Hawaiian or Other Pacific Islander"
              },
              {
                "measurements": [
                  {
                    "groupId": "BG000",
                    "value": "1"
                  },
                  {
                    "groupId": "BG001",
                    "value": "0"
                  },
                  {
                    "groupId": "BG002",
                    "value": "0"
                  },
                  {
                    "groupId": "BG003",
                    "value": "0"
                  },
                  {
                    "groupId": "BG004",
                    "value": "7"
                  },
                  {
                    "groupId": "BG005",
                    "value": "8"
                  }
                ],
                "title": "Black or African American"
              },
              {
                "measurements": [
                  {
                    "groupId": "BG000",
                    "value": "2"
                  },
                  {
                    "groupId": "BG001",
                    "value": "3"
                  },
                  {
                    "groupId": "BG002",
                    "value": "3"
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                  {
                    "groupId": "BG003",
                    "value": "6"
                  },
                  {
                    "groupId": "BG004",
                    "value": "53"
                  },
                  {
                    "groupId": "BG005",
                    "value": "67"
                  }
                ],
                "title": "White"
              },
              {
                "measurements": [
                  {
                    "groupId": "BG000",
                    "value": "0"
                  },
                  {
                    "groupId": "BG001",
                    "value": "0"
                  },
                  {
                    "groupId": "BG002",
                    "value": "0"
                  },
                  {
                    "groupId": "BG003",
                    "value": "0"
                  },
                  {
                    "groupId": "BG004",
                    "value": "0"
                  },
                  {
                    "groupId": "BG005",
                    "value": "0"
                  }
                ],
                "title": "More than one race"
              },
              {
                "measurements": [
                  {
                    "groupId": "BG000",
                    "value": "0"
                  },
                  {
                    "groupId": "BG001",
                    "value": "0"
                  },
                  {
                    "groupId": "BG002",
                    "value": "0"
                  },
                  {
                    "groupId": "BG003",
                    "value": "0"
                  },
                  {
                    "groupId": "BG004",
                    "value": "3"
                  },
                  {
                    "groupId": "BG005",
                    "value": "3"
                  }
                ],
                "title": "Unknown or Not Reported"
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "title": "Race (NIH&#x2F;OMB)",
        "unitOfMeasure": "Participants"
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/title",
      "value": "Progression-Free Survival (PFS) of MTD&#x2F;Phase II Patients"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description",
      "value": "Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on the study.\nProgression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions.\nThis outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II.\nThe phase I and phase II results are not separated as the timing of enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/populationDescription",
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    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description",
      "value": "Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs)."
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    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/paramType",
      "value": "COUNT_OF_PARTICIPANTS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/unitOfMeasure",
      "value": "Participants"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame",
      "value": "every 6 weeks until treatment discontinuation, up to 43 months"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/0/title",
      "value": "Dose Level 1"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/0/description",
      "value": "Amrubicin -90 mg&#x2F;m^2 by intravenous(IV) every 21days"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/1",
      "value": {
        "description": "Amrubicin -100 mg&#x2F;m^2 IV every 21days",
        "id": "OG001",
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      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/2",
      "value": {
        "description": "Amrubicin -110 mg&#x2F;m^2 IV every 21days",
        "id": "OG002",
        "title": "Dose Level 3"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/3",
      "value": {
        "description": "Amrubicin -120 mg&#x2F;m^2 IV every 21 days",
        "id": "OG003",
        "title": "Dose Level 4"
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/0/value",
      "value": "3"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/1",
      "value": {
        "groupId": "OG001",
        "value": "3"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/2",
      "value": {
        "groupId": "OG002",
        "value": "66"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/3",
      "value": {
        "groupId": "OG003",
        "value": "6"
      }
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/title"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/0/value",
      "value": "3"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/1",
      "value": {
        "groupId": "OG001",
        "value": "3"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/2",
      "value": {
        "groupId": "OG002",
        "value": "65"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/3",
      "value": {
        "groupId": "OG003",
        "value": "6"
      }
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/1"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/title",
      "value": "Overall Survival (OS) of MTD&#x2F;Phase II Patients"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description",
      "value": "Measured from Day 1 of study drug administration to date of death due to any cause.\nThis outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II.\nThe phase I and phase II results are not separated as the timing of enrollment (early in phase 1 or later phase II) is not relevant to this outcome measure."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription",
      "value": "Patients who received the dose level 3 MTD dose&#x2F;Phase II dose (Amrubicin -110 mg&#x2F;m^2) are included in the analysis.\nThe 3, dose level 3 phase I pts and 63 phase II pts treated at this dose level are all combined to evaluate the efficacy of the MTD&#x2F;phase II dose.\nThe phase I and phase II results are not separated out as the timing of their enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure.\nThe other 12 phase I pts who were not treated at the MTD are excluded."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame",
      "value": "every 6 weeks until treatment discontinuation, up to 43 months"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/description",
      "value": "The number of patients with observed complete response [CR] or partial response [PR].\nPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.\nThis outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II.\nThe phase I and phase II results are not separated as the timing of enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/populationDescription",
      "value": "Patients who received the dose level 3 MTD dose&#x2F;Phase II dose (Amrubicin -110 mg&#x2F;m^2) are included in the analysis.\nThe 3, dose level 3 phase I pts and 63 phase II pts treated at this dose level are all combined to evaluate the efficacy of the MTD&#x2F;phase II dose.\nThe phase I and phase II results are not separated out as the timing of their enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure.\nThe other 12 phase I pts who were not treated at the MTD are excluded."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
      "value": "every 6 weeks until treatment discontinuation, up to 43 months"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/description",
      "value": "All patients who received at least one dose of protocol treatment were followed for safety.\nAdverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/0/title",
      "value": "Dose Level 1"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/0/description",
      "value": "Amrubicin - 90 mg&#x2F;m^2 by intravenous (IV) every 21 days"
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/0/seriousNumAffected",
      "value": 1
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/0/seriousNumAtRisk",
      "value": 3
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/0/otherNumAffected",
      "value": 3
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/0/otherNumAtRisk",
      "value": 3
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/eventGroups/1",
      "value": {
        "description": "Amrubicin - 100 mg&#x2F;m^2 by intravenous (IV) every 21 days",
        "id": "EG001",
        "otherNumAffected": 3,
        "otherNumAtRisk": 3,
        "seriousNumAffected": 0,
        "seriousNumAtRisk": 3,
        "title": "Dose Level 2"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/eventGroups/2",
      "value": {
        "description": "Amrubicin - 110 mg&#x2F;m^2 by intravenous (IV) every 21 days Includes patients treated at the MTD in Dose Level 3 phase 1 and in phase II",
        "id": "EG002",
        "otherNumAffected": 65,
        "otherNumAtRisk": 66,
        "seriousNumAffected": 5,
        "seriousNumAtRisk": 66,
        "title": "Dose Level 3 (MTD)&#x2F;Phase II"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/eventGroups/3",
      "value": {
        "description": "Amrubicin - 120 mg&#x2F;m^2 by intravenous (IV) every 21 days",
        "id": "EG003",
        "otherNumAffected": 6,
        "otherNumAtRisk": 6,
        "seriousNumAffected": 1,
        "seriousNumAtRisk": 6,
        "title": "Dose Level 4"
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/0/numAffected",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/0/numAtRisk",
      "value": 3
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/1",
      "value": {
        "groupId": "EG001",
        "numAffected": 0,
        "numAtRisk": 3,
        "numEvents": 0
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/2",
      "value": {
        "groupId": "EG002",
        "numAffected": 1,
        "numAtRisk": 66,
        "numEvents": 1
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/0/stats/3",
      "value": {
        "groupId": "EG003",
        "numAffected": 0,
        "numAtRisk": 6,
        "numEvents": 0
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/0/numAffected",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/0/numAtRisk",
      "value": 3
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/1",
      "value": {
        "groupId": "EG001",
        "numAffected": 0,
        "numAtRisk": 3,
        "numEvents": 0
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/1/stats/2",
      "value": {
        "groupId": "EG002",
        "numAffected": 1,
        "numAtRisk": 66,
        "numEvents": 1
      }
    },
    {
      "op": "add",
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      "value": {
        "groupId": "EG003",
        "numAffected": 0,
        "numAtRisk": 6,
        "numEvents": 0
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/0/numEvents",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/0/numAffected",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/seriousEvents/2/stats/0/numAtRisk",
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    },
    {
      "op": "add",
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      "value": {
        "groupId": "EG001",
        "numAffected": 0,
        "numAtRisk": 3,
        "numEvents": 0
      }
    },
    {
      "op": "add",
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