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NCT01033032

Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic Breast Cancer

Version 15 to 16 · SCRI Development Innovations, LLC

Patch inspector

Version 15 to 16

30 operations 6 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
arms_or_interventions_changeenrollment_count_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_actualized_earlier",
    "category": "timeline_actualized_earlier",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2013-07",
    "old_value": "2014-11",
    "delta_days": 488,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_actualized_earlier",
    "category": "timeline_actualized_earlier",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2014-10",
    "old_value": "2014-12",
    "delta_days": 61,
    "date_struct": "completionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  },
  {
    "paths": [
      "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "/protocolSection/outcomesModule/primaryOutcomes/1",
      "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
      "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
      "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
      "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
      "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
      "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
      "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
      "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
      "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame"
    ],
    "signal": "results_reconciliation_outcome_suppression",
    "category": "results_reconciliation",
    "severity": "low"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:59:43+00
Raw hash
2d0ed30100f62f25c1c347acdad62c2fab7026df324b350f7b7bfac165966d14
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 4 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/measure
Triage: Critical
Primary Outcome Change Operation 16
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Phase I: Evaluate the maximum tolerated dose (MTD) and tolerability of amrubicin monotherapy in HER2-negative metastatic breast cancer
After
Progression-free Survival (PFS)
replace /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 17
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
18 months
After
every 6 weeks until progressive disease
add /protocolSection/outcomesModule/primaryOutcomes/0/description
Triage: Critical
Primary Outcome Change Operation 18
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
After
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 study.
Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
remove /protocolSection/outcomesModule/primaryOutcomes/1
Triage: Critical
Primary Outcome Change Operation 19
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
{
  "measure": "Phase II: Assess progression-free survival (PFS) of patients with HER2-negative metastatic breast cancer treated with single-agent amrubicin as second- or third-line therapy. (Phase II will use the amrubicin dose determined in Phase I).",
  "timeFrame": "18 months"
}
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 4 ops
replace /protocolSection/designModule/enrollmentInfo/count
Triage: High
Enrollment Change Operation 12
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
77
After
78
replace /protocolSection/armsInterventionsModule/armGroups/0/label
Triage: High
Arm Intervention Change Operation 13
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Amrubicin
After
Amrubicin Phase I/II
replace /protocolSection/armsInterventionsModule/interventions/0/description
Triage: High
Arm Intervention Change Operation 14
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
<p>Phase I: dose escalating portion with the starting dose of amrubicin at 90mg&#x2F;m2 IV q21 days.
Dose escalations are as follows: DL2 - 100mg&#x2F;m2, DL3 - 110mg&#x2F;m2, and DL4 - 120mg&#x2F;m2.
All cycles are q21 days</p><p>Phase II: Amrubicin will be administered at the maximum tolerated dose established in Phase I by IV every 21 days</p>
After
<p>Phase I: dose escalating portion with the starting dose of amrubicin at 90mg&#x2F;m2 IV q21 days.
Dose escalations are as follows:</p><p>DL2 - 100mg&#x2F;m2; DL3 - 110mg&#x2F;m2; and DL4 - 120mg&#x2F;m2.
All cycles are q21 days</p><p>Phase II: Amrubicin will be administered at the maximum tolerated dose established in Phase I by IV every 21 days</p>
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 15
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Amrubicin
After
Amrubicin Phase I&#x2F;II
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 9 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/0/measure
Triage: High
Secondary Outcome Change Operation 20
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Determine toxicity (including cardiotoxicity) of amrubicin when given as second- or third-line treatment for HER2-negative metastatic breast cancer.
After
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
replace /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
Triage: High
Secondary Outcome Change Operation 21
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
18 months
After
every 6 weeks until treatment discontinuation, expected average 18 months
add /protocolSection/outcomesModule/secondaryOutcomes/0/description
Triage: High
Secondary Outcome Change Operation 22
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs)
replace /protocolSection/outcomesModule/secondaryOutcomes/1/measure
Triage: High
Secondary Outcome Change Operation 23
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Determine overall survival (OS) of patients with HER2-negative metastatic breast cancer who receive amrubicin as second- or third-line metastatic breast cancer treatment.
After
Overall Survival (OS)
replace /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
Triage: High
Secondary Outcome Change Operation 24
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
18 months
After
every 6 weeks until treatment discontinuation, expected average of 18 months
add /protocolSection/outcomesModule/secondaryOutcomes/1/description
Triage: High
Secondary Outcome Change Operation 25
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
Measured from Day 1 of study drug administration to date of death due to any cause.
replace /protocolSection/outcomesModule/secondaryOutcomes/2/measure
Triage: High
Secondary Outcome Change Operation 26
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Determine response rate (RR) of patients with HER2-negative metastatic breast cancer who receive amrubicin as second- or third-line metastatic breast cancer treatment
After
Overall Response Rate (ORR)
replace /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame
Triage: High
Secondary Outcome Change Operation 27
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
18 months
After
every 6 weeks until treatment discontinuation, expected average 18 months
add /protocolSection/outcomesModule/secondaryOutcomes/2/description
Triage: High
Secondary Outcome Change Operation 28
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
The number of patients with observed complete response [CR] or partial response [PR].
Per 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
Timeline Start, primary completion, and completion date movement. Triage: Medium 4 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2014-11
After
2013-07
replace /protocolSection/statusModule/primaryCompletionDateStruct/type
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2014-12
After
2014-10
replace /protocolSection/statusModule/completionDateStruct/type
Triage: Medium
Timeline Shift Operation 6
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 8 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2014-07
After
2014-12
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 7
Before
2014-07-17
After
2014-12-22
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 8
Before
2014-07-18
After
2015-01-06
add /protocolSection/statusModule/resultsFirstSubmitDate
Triage: Uncategorized
Uncategorized Operation 9
After
2014-11-21
add /protocolSection/statusModule/resultsFirstSubmitQcDate
Triage: Uncategorized
Uncategorized Operation 10
After
2014-12-22
add /protocolSection/statusModule/resultsFirstPostDateStruct
Triage: Uncategorized
Uncategorized Operation 11
After
{
  "date": "2015-01-06",
  "type": "ESTIMATED"
}
replace /hasResults
Triage: Uncategorized
Uncategorized Operation 29
Before
false
After
true
add /resultsSection
Triage: Uncategorized
Uncategorized Operation 30
After
{
  "moreInfoModule": {
    "pointOfContact": {
      "email": "asksarah@scresearch.net",
      "phone": "1-877-691-7274",
      "title": "John D. Hainsworth, MD",
      "organization": "Sarah Cannon Research Institute"
    },
    "certainAgreement": {
      "otherDetails": "The sponsor can review&#x2F;embargo results communications prior to public release for a period that is &gt;60 days but ≤180 days from the date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and&#x2F;or delay the proposed publication to enable the sponsor to seek patent protection for inventions.\nThe PI may not publish results until 18 mos.\nafter the trial has been completed at all sites.",
      "restrictionType": "OTHER",
      "piSponsorEmployee": false,
      "restrictiveAgreement": true
    }
  },
  "adverseEventsModule": {
    "description": "Adverse Event analysis includes only patients treated at the MTD (Dose Level 3)",
    "eventGroups": [
      {
        "id": "EG000",
        "title": "Dose Level 3",
        "description": "Includes patients treated at the MTD (Dose Level 3)",
        "otherNumAtRisk": 66,
        "otherNumAffected": 65,
        "seriousNumAtRisk": 66,
        "seriousNumAffected": 5
      }
    ],
    "otherEvents": [
      {
        "term": "ABDOMINAL PAIN",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 9,
            "numAffected": 4
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "ALKALINE PHOSPHATASE INCREASED",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 17,
            "numAffected": 6
          }
        ],
        "organSystem": "Investigations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "ALLERGIC RHINITIS",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 39,
            "numAffected": 8
          }
        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "ALOPECIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 126,
            "numAffected": 32
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "ANEMIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 130,
            "numAffected": 27
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "ANOREXIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 40,
            "numAffected": 21
          }
        ],
        "organSystem": "Metabolism and nutrition disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "ANXIETY",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 7,
            "numAffected": 4
          }
        ],
        "organSystem": "Psychiatric disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "ARTHRALGIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 39,
            "numAffected": 14
          }
        ],
        "organSystem": "Musculoskeletal and connective tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "ASPARTATE AMINOTRANSFERASE INCREASED",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 12,
            "numAffected": 6
          }
        ],
        "organSystem": "Investigations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "BACK PAIN",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 16,
            "numAffected": 8
          }
        ],
        "organSystem": "Musculoskeletal and connective tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "BONE PAIN",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 49,
            "numAffected": 15
          }
        ],
        "organSystem": "Musculoskeletal and connective tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "CHEST PAIN",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 13,
            "numAffected": 6
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "CONSTIPATION",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 48,
            "numAffected": 18
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "COUGH",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 26,
            "numAffected": 9
          }
        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "DECREASED BREATH SOUNDS",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 13,
            "numAffected": 4
          }
        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "DEHYDRATION",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 5,
            "numAffected": 5
          }
        ],
        "organSystem": "Metabolism and nutrition disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "DEPRESSION",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 13,
            "numAffected": 4
          }
        ],
        "organSystem": "Psychiatric disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "DIARRHEA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 24,
            "numAffected": 9
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "DIZZINESS",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 13,
            "numAffected": 12
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "DYSGEUSIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 9,
            "numAffected": 4
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "DYSPEPSIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 5,
            "numAffected": 5
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "DYSPNEA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 49,
            "numAffected": 10
          }
        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "EDEMA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 19,
            "numAffected": 7
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "FATIGUE",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 203,
            "numAffected": 47
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "FEBRILE NEUTROPENIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 4,
            "numAffected": 4
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "HEADACHE",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 16,
            "numAffected": 9
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "HYPERGLYCEMIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 15,
            "numAffected": 8
          }
        ],
        "organSystem": "Metabolism and nutrition disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "HYPOKALEMIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 7,
            "numAffected": 4
          }
        ],
        "organSystem": "Metabolism and nutrition disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "INSOMNIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 9,
            "numAffected": 5
          }
        ],
        "organSystem": "Psychiatric disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "LEUKOPENIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 83,
            "numAffected": 34
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "MUCOSITIS",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 11,
            "numAffected": 9
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "MYALGIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 41,
            "numAffected": 8
          }
        ],
        "organSystem": "Musculoskeletal and connective tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "NAUSEA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 82,
            "numAffected": 25
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "NEUROPATHY",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 58,
            "numAffected": 11
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "NEUTROPENIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 87,
            "numAffected": 36
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "RASH",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 17,
            "numAffected": 7
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "THROMBOCYTOPENIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 49,
            "numAffected": 19
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "UPPER RESPIRATORY INFECTION",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 5,
            "numAffected": 5
          }
        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "VOMITING",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 26,
            "numAffected": 15
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "WEIGHT LOSS",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 11,
            "numAffected": 6
          }
        ],
        "organSystem": "Investigations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      }
    ],
    "seriousEvents": [
      {
        "term": "ALOPECIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "CHEST PAIN",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "DEHYDRATION",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Metabolism and nutrition disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "FEBRILE NEUTROPENIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "LYMPH NODE PAIN",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "PLEURAL EFFUSION",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      },
      {
        "term": "PNEUMONITIS",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 66,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE v 4.0"
      }
    ],
    "frequencyThreshold": "5"
  },
  "outcomeMeasuresModule": {
    "outcomeMeasures": [
      {
        "type": "PRIMARY",
        "title": "Progression-free Survival (PFS)",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "66",
                "groupId": "OG000"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Amrubicin",
            "description": "Systemic therapy with amrubicin"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "4.0",
                    "groupId": "OG000",
                    "lowerLimit": "2.5",
                    "upperLimit": "5.8"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEDIAN",
        "timeFrame": "every 6 weeks until progressive disease",
        "description": "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 study.\nProgression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions",
        "unitOfMeasure": "months",
        "dispersionType": "95% Confidence Interval",
        "reportingStatus": "POSTED",
        "populationDescription": "Includes patients treated at the MTD (Dose Level 3)"
      },
      {
        "type": "SECONDARY",
        "title": "Number of Patients With Adverse Events as a Measure of Safety and Tolerability",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "66",
                "groupId": "OG000"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Amrubicin",
            "description": "Systemic therapy with amrubicin"
          }
        ],
        "classes": [
          {
            "title": "Neutropenia",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "19",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Febrile neutropenia",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "4",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Leukopenia",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "26",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Anemia",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "3",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Thrombocytopenia",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "4",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Dehydration",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "3",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Anorexia",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Bone pain",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Diarrhea",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Fatigue",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Nausea&#x2F;vomiting",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Pulmonary infiltrates",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Typhlitis",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Decreased ejection fraction",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "NUMBER",
        "timeFrame": "every 6 weeks until treatment discontinuation, expected average 18 months",
        "description": "Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs)",
        "unitOfMeasure": "participants",
        "reportingStatus": "POSTED",
        "populationDescription": "Includes patients treated at the MTD (Dose Level 3)"
      },
      {
        "type": "SECONDARY",
        "title": "Overall Survival (OS)",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "66",
                "groupId": "OG000"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Amrubicin",
            "description": "Systemic therapy with amrubicin"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "14.4",
                    "groupId": "OG000",
                    "lowerLimit": "10.1",
                    "upperLimit": "18.5"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEDIAN",
        "timeFrame": "every 6 weeks until treatment discontinuation, expected average of 18 months",
        "description": "Measured from Day 1 of study drug administration to date of death due to any cause.",
        "unitOfMeasure": "months",
        "dispersionType": "95% Confidence Interval",
        "reportingStatus": "POSTED",
        "populationDescription": "Includes patients treated at the MTD (Dose Level 3)"
      },
      {
        "type": "SECONDARY",
        "title": "Overall Response Rate (ORR)",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "66",
                "groupId": "OG000"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Amrubicin",
            "description": "Systemic therapy with amrubicin"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "12",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "NUMBER",
        "timeFrame": "every 6 weeks until treatment discontinuation, expected average 18 months",
        "description": "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",
        "unitOfMeasure": "participants",
        "reportingStatus": "POSTED",
        "populationDescription": "Includes patients treated at the MTD (Dose Level 3)"
      }
    ]
  },
  "participantFlowModule": {
    "groups": [
      {
        "id": "FG000",
        "title": "Dose Level 1",
        "description": "Amrubicin - 90 mg&#x2F;m^2 by intravenous (IV) every 21 days"
      },
      {
        "id": "FG001",
        "title": "Dose Level 2",
        "description": "Amrubicin - 100 mg&#x2F;m^2 IV every 21 days"
      },
      {
        "id": "FG002",
        "title": "Dose Level 3",
        "description": "Amrubicin - 110 mg&#x2F;m^2 IV every 21 days"
      },
      {
        "id": "FG003",
        "title": "Dose Level 4",
        "description": "Amrubicin - 120 mg&#x2F;m^2 every 21 days"
      }
    ],
    "periods": [
      {
        "title": "Phase I",
        "milestones": [
          {
            "type": "STARTED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "3"
              },
              {
                "groupId": "FG001",
                "numSubjects": "3"
              },
              {
                "groupId": "FG002",
                "numSubjects": "3"
              },
              {
                "groupId": "FG003",
                "numSubjects": "6"
              }
            ]
          },
          {
            "type": "COMPLETED",
            "achievements": [
              {
                "comment": "Patients were on-study until determination of the Maximum Tolerated Dose (MTD)",
                "groupId": "FG000",
                "numSubjects": "0"
              },
              {
                "comment": "Patients were on-study until determination of the Maximum Tolerated Dose (MTD)",
                "groupId": "FG001",
                "numSubjects": "0"
              },
              {
                "groupId": "FG002",
                "numSubjects": "3"
              },
              {
                "comment": "Patients were on-study until determination of the Maximum Tolerated Dose (MTD)",
                "groupId": "FG003",
                "numSubjects": "0"
              }
            ]
          },
          {
            "type": "NOT COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "3"
              },
              {
                "groupId": "FG001",
                "numSubjects": "3"
              },
              {
                "groupId": "FG002",
                "numSubjects": "0"
              },
              {
                "groupId": "FG003",
                "numSubjects": "6"
              }
            ]
          }
        ]
      },
      {
        "title": "Phase II",
        "milestones": [
          {
            "type": "STARTED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "0"
              },
              {
                "groupId": "FG001",
                "numSubjects": "0"
              },
              {
                "comment": "Includes patients treated at MTD during Phase I (3 patients); 63 additional patients enrolled",
                "groupId": "FG002",
                "numSubjects": "66"
              },
              {
                "groupId": "FG003",
                "numSubjects": "0"
              }
            ]
          },
          {
            "type": "COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "0"
              },
              {
                "groupId": "FG001",
                "numSubjects": "0"
              },
              {
                "comment": "Patients continued recieving treatment until disease progression or unacceptable toxicity",
                "groupId": "FG002",
                "numSubjects": "0"
              },
              {
                "groupId": "FG003",
                "numSubjects": "0"
              }
            ]
          },
          {
            "type": "NOT COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "0"
              },
              {
                "groupId": "FG001",
                "numSubjects": "0"
              },
              {
                "groupId": "FG002",
                "numSubjects": "66"
              },
              {
                "groupId": "FG003",
                "numSubjects": "0"
              }
            ]
          }
        ]
      }
    ],
    "recruitmentDetails": "Patients were recruited at multiple dose levels into the Dose Escalation (Phase I) portion of this study to determine the safest dose of this regime (MTD - Maximum Tolerated Dose).\nUpon determination of this dose, patients being treated at the MTD proceeded to the Dose Expansion (Phase II) portion of the study and additional patients were recruited"
  },
  "baselineCharacteristicsModule": {
    "denoms": [
      {
        "units": "Participants",
        "counts": [
          {
            "value": "78",
            "groupId": "BG000"
          }
        ]
      }
    ],
    "groups": [
      {
        "id": "BG000",
        "title": "All Patients",
        "description": "Includes all Phase I and Phase II patients treated at all dose levels (total enrollment = 78 patients)"
      }
    ],
    "measures": [
      {
        "title": "Age, Continuous",
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "58",
                    "groupId": "BG000",
                    "lowerLimit": "27",
                    "upperLimit": "86"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEDIAN",
        "unitOfMeasure": "Years",
        "dispersionType": "FULL_RANGE"
      },
      {
        "title": "Sex: Female, Male",
        "classes": [
          {
            "categories": [
              {
                "title": "Female",
                "measurements": [
                  {
                    "value": "78",
                    "groupId": "BG000"
                  }
                ]
              },
              {
                "title": "Male",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Region of Enrollment",
        "classes": [
          {
            "title": "United States",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "78",
                    "groupId": "BG000"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "NUMBER",
        "unitOfMeasure": "participants"
      }
    ],
    "populationDescription": "Includes Phase I and Phase II patients"
  }
}
Status and stopping reason Recruitment status, termination, suspension, withdrawal, or why-stopped text. Triage: Uncategorized 1 ops
replace /protocolSection/statusModule/overallStatus
Triage: Uncategorized
Uncategorized Operation 2
Before
ACTIVE_NOT_RECRUITING
After
COMPLETED
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2014-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "COMPLETED"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2013-07"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2014-10"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2014-12-22"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2015-01-06"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitDate",
    "value": "2014-11-21"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "value": "2014-12-22"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "value": {
      "date": "2015-01-06",
      "type": "ESTIMATED"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 78
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
    "value": "Amrubicin Phase I&#x2F;II"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/description",
    "value": "<p>Phase I: dose escalating portion with the starting dose of amrubicin at 90mg&#x2F;m2 IV q21 days.\nDose escalations are as follows:</p><p>DL2 - 100mg&#x2F;m2; DL3 - 110mg&#x2F;m2; and DL4 - 120mg&#x2F;m2.\nAll cycles are q21 days</p><p>Phase II: Amrubicin will be administered at the maximum tolerated dose established in Phase I by IV every 21 days</p>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
    "value": "Amrubicin Phase I&#x2F;II"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "value": "Progression-free Survival (PFS)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "every 6 weeks until progressive disease"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/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 study.\nProgression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/1"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "value": "Number of Patients With Adverse Events as a Measure of Safety and Tolerability"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "every 6 weeks until treatment discontinuation, expected average 18 months"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/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)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "value": "Overall Survival (OS)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "value": "every 6 weeks until treatment discontinuation, expected average of 18 months"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
    "value": "Measured from Day 1 of study drug administration to date of death due to any cause."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "value": "Overall Response Rate (ORR)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "value": "every 6 weeks until treatment discontinuation, expected average 18 months"
  },
  {
    "op": "add",
    "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"
  },
  {
    "op": "replace",
    "path": "/hasResults",
    "value": true
  },
  {
    "op": "add",
    "path": "/resultsSection",
    "value": {
      "moreInfoModule": {
        "pointOfContact": {
          "email": "asksarah@scresearch.net",
          "phone": "1-877-691-7274",
          "title": "John D. Hainsworth, MD",
          "organization": "Sarah Cannon Research Institute"
        },
        "certainAgreement": {
          "otherDetails": "The sponsor can review&#x2F;embargo results communications prior to public release for a period that is &gt;60 days but ≤180 days from the date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and&#x2F;or delay the proposed publication to enable the sponsor to seek patent protection for inventions.\nThe PI may not publish results until 18 mos.\nafter the trial has been completed at all sites.",
          "restrictionType": "OTHER",
          "piSponsorEmployee": false,
          "restrictiveAgreement": true
        }
      },
      "adverseEventsModule": {
        "description": "Adverse Event analysis includes only patients treated at the MTD (Dose Level 3)",
        "eventGroups": [
          {
            "id": "EG000",
            "title": "Dose Level 3",
            "description": "Includes patients treated at the MTD (Dose Level 3)",
            "otherNumAtRisk": 66,
            "otherNumAffected": 65,
            "seriousNumAtRisk": 66,
            "seriousNumAffected": 5
          }
        ],
        "otherEvents": [
          {
            "term": "ABDOMINAL PAIN",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 9,
                "numAffected": 4
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "ALKALINE PHOSPHATASE INCREASED",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 17,
                "numAffected": 6
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "ALLERGIC RHINITIS",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 39,
                "numAffected": 8
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "ALOPECIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 126,
                "numAffected": 32
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "ANEMIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 130,
                "numAffected": 27
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "ANOREXIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 40,
                "numAffected": 21
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "ANXIETY",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 7,
                "numAffected": 4
              }
            ],
            "organSystem": "Psychiatric disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "ARTHRALGIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 39,
                "numAffected": 14
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "ASPARTATE AMINOTRANSFERASE INCREASED",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 12,
                "numAffected": 6
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "BACK PAIN",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 16,
                "numAffected": 8
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "BONE PAIN",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 49,
                "numAffected": 15
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "CHEST PAIN",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 13,
                "numAffected": 6
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "CONSTIPATION",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 48,
                "numAffected": 18
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "COUGH",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 26,
                "numAffected": 9
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "DECREASED BREATH SOUNDS",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 13,
                "numAffected": 4
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "DEHYDRATION",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 5,
                "numAffected": 5
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "DEPRESSION",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 13,
                "numAffected": 4
              }
            ],
            "organSystem": "Psychiatric disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "DIARRHEA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 24,
                "numAffected": 9
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "DIZZINESS",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 13,
                "numAffected": 12
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "DYSGEUSIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 9,
                "numAffected": 4
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "DYSPEPSIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 5,
                "numAffected": 5
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "DYSPNEA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 49,
                "numAffected": 10
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "EDEMA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 19,
                "numAffected": 7
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "FATIGUE",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 203,
                "numAffected": 47
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "FEBRILE NEUTROPENIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 4,
                "numAffected": 4
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "HEADACHE",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 16,
                "numAffected": 9
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "HYPERGLYCEMIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 15,
                "numAffected": 8
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "HYPOKALEMIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 7,
                "numAffected": 4
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "INSOMNIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 9,
                "numAffected": 5
              }
            ],
            "organSystem": "Psychiatric disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "LEUKOPENIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 83,
                "numAffected": 34
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "MUCOSITIS",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 11,
                "numAffected": 9
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "MYALGIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 41,
                "numAffected": 8
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "NAUSEA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 82,
                "numAffected": 25
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "NEUROPATHY",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 58,
                "numAffected": 11
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "NEUTROPENIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 87,
                "numAffected": 36
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "RASH",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 17,
                "numAffected": 7
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "THROMBOCYTOPENIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 49,
                "numAffected": 19
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "UPPER RESPIRATORY INFECTION",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 5,
                "numAffected": 5
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "VOMITING",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 26,
                "numAffected": 15
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "WEIGHT LOSS",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 11,
                "numAffected": 6
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          }
        ],
        "seriousEvents": [
          {
            "term": "ALOPECIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "CHEST PAIN",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "DEHYDRATION",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "FEBRILE NEUTROPENIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "LYMPH NODE PAIN",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "PLEURAL EFFUSION",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          },
          {
            "term": "PNEUMONITIS",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 66,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE v 4.0"
          }
        ],
        "frequencyThreshold": "5"
      },
      "outcomeMeasuresModule": {
        "outcomeMeasures": [
          {
            "type": "PRIMARY",
            "title": "Progression-free Survival (PFS)",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "66",
                    "groupId": "OG000"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Amrubicin",
                "description": "Systemic therapy with amrubicin"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "4.0",
                        "groupId": "OG000",
                        "lowerLimit": "2.5",
                        "upperLimit": "5.8"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEDIAN",
            "timeFrame": "every 6 weeks until progressive disease",
            "description": "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 study.\nProgression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions",
            "unitOfMeasure": "months",
            "dispersionType": "95% Confidence Interval",
            "reportingStatus": "POSTED",
            "populationDescription": "Includes patients treated at the MTD (Dose Level 3)"
          },
          {
            "type": "SECONDARY",
            "title": "Number of Patients With Adverse Events as a Measure of Safety and Tolerability",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "66",
                    "groupId": "OG000"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Amrubicin",
                "description": "Systemic therapy with amrubicin"
              }
            ],
            "classes": [
              {
                "title": "Neutropenia",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "19",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Febrile neutropenia",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "4",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Leukopenia",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "26",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Anemia",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "3",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Thrombocytopenia",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "4",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Dehydration",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "3",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Anorexia",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Bone pain",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Diarrhea",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Fatigue",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Nausea&#x2F;vomiting",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Pulmonary infiltrates",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Typhlitis",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Decreased ejection fraction",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "NUMBER",
            "timeFrame": "every 6 weeks until treatment discontinuation, expected average 18 months",
            "description": "Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs)",
            "unitOfMeasure": "participants",
            "reportingStatus": "POSTED",
            "populationDescription": "Includes patients treated at the MTD (Dose Level 3)"
          },
          {
            "type": "SECONDARY",
            "title": "Overall Survival (OS)",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "66",
                    "groupId": "OG000"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Amrubicin",
                "description": "Systemic therapy with amrubicin"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "14.4",
                        "groupId": "OG000",
                        "lowerLimit": "10.1",
                        "upperLimit": "18.5"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEDIAN",
            "timeFrame": "every 6 weeks until treatment discontinuation, expected average of 18 months",
            "description": "Measured from Day 1 of study drug administration to date of death due to any cause.",
            "unitOfMeasure": "months",
            "dispersionType": "95% Confidence Interval",
            "reportingStatus": "POSTED",
            "populationDescription": "Includes patients treated at the MTD (Dose Level 3)"
          },
          {
            "type": "SECONDARY",
            "title": "Overall Response Rate (ORR)",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "66",
                    "groupId": "OG000"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Amrubicin",
                "description": "Systemic therapy with amrubicin"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "12",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "NUMBER",
            "timeFrame": "every 6 weeks until treatment discontinuation, expected average 18 months",
            "description": "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",
            "unitOfMeasure": "participants",
            "reportingStatus": "POSTED",
            "populationDescription": "Includes patients treated at the MTD (Dose Level 3)"
          }
        ]
      },
      "participantFlowModule": {
        "groups": [
          {
            "id": "FG000",
            "title": "Dose Level 1",
            "description": "Amrubicin - 90 mg&#x2F;m^2 by intravenous (IV) every 21 days"
          },
          {
            "id": "FG001",
            "title": "Dose Level 2",
            "description": "Amrubicin - 100 mg&#x2F;m^2 IV every 21 days"
          },
          {
            "id": "FG002",
            "title": "Dose Level 3",
            "description": "Amrubicin - 110 mg&#x2F;m^2 IV every 21 days"
          },
          {
            "id": "FG003",
            "title": "Dose Level 4",
            "description": "Amrubicin - 120 mg&#x2F;m^2 every 21 days"
          }
        ],
        "periods": [
          {
            "title": "Phase I",
            "milestones": [
              {
                "type": "STARTED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "3"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "3"
                  },
                  {
                    "groupId": "FG002",
                    "numSubjects": "3"
                  },
                  {
                    "groupId": "FG003",
                    "numSubjects": "6"
                  }
                ]
              },
              {
                "type": "COMPLETED",
                "achievements": [
                  {
                    "comment": "Patients were on-study until determination of the Maximum Tolerated Dose (MTD)",
                    "groupId": "FG000",
                    "numSubjects": "0"
                  },
                  {
                    "comment": "Patients were on-study until determination of the Maximum Tolerated Dose (MTD)",
                    "groupId": "FG001",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG002",
                    "numSubjects": "3"
                  },
                  {
                    "comment": "Patients were on-study until determination of the Maximum Tolerated Dose (MTD)",
                    "groupId": "FG003",
                    "numSubjects": "0"
                  }
                ]
              },
              {
                "type": "NOT COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "3"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "3"
                  },
                  {
                    "groupId": "FG002",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG003",
                    "numSubjects": "6"
                  }
                ]
              }
            ]
          },
          {
            "title": "Phase II",
            "milestones": [
              {
                "type": "STARTED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "0"
                  },
                  {
                    "comment": "Includes patients treated at MTD during Phase I (3 patients); 63 additional patients enrolled",
                    "groupId": "FG002",
                    "numSubjects": "66"
                  },
                  {
                    "groupId": "FG003",
                    "numSubjects": "0"
                  }
                ]
              },
              {
                "type": "COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "0"
                  },
                  {
                    "comment": "Patients continued recieving treatment until disease progression or unacceptable toxicity",
                    "groupId": "FG002",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG003",
                    "numSubjects": "0"
                  }
                ]
              },
              {
                "type": "NOT COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG002",
                    "numSubjects": "66"
                  },
                  {
                    "groupId": "FG003",
                    "numSubjects": "0"
                  }
                ]
              }
            ]
          }
        ],
        "recruitmentDetails": "Patients were recruited at multiple dose levels into the Dose Escalation (Phase I) portion of this study to determine the safest dose of this regime (MTD - Maximum Tolerated Dose).\nUpon determination of this dose, patients being treated at the MTD proceeded to the Dose Expansion (Phase II) portion of the study and additional patients were recruited"
      },
      "baselineCharacteristicsModule": {
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "78",
                "groupId": "BG000"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "BG000",
            "title": "All Patients",
            "description": "Includes all Phase I and Phase II patients treated at all dose levels (total enrollment = 78 patients)"
          }
        ],
        "measures": [
          {
            "title": "Age, Continuous",
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "58",
                        "groupId": "BG000",
                        "lowerLimit": "27",
                        "upperLimit": "86"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEDIAN",
            "unitOfMeasure": "Years",
            "dispersionType": "FULL_RANGE"
          },
          {
            "title": "Sex: Female, Male",
            "classes": [
              {
                "categories": [
                  {
                    "title": "Female",
                    "measurements": [
                      {
                        "value": "78",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "Male",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Region of Enrollment",
            "classes": [
              {
                "title": "United States",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "78",
                        "groupId": "BG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "NUMBER",
            "unitOfMeasure": "participants"
          }
        ],
        "populationDescription": "Includes Phase I and Phase II patients"
      }
    }
  }
]