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NCT01818063

Carboplatin and Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IIB-IIIC Breast Cancer

Version 14 to 15 · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Patch inspector

Version 14 to 15

14 operations 5 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

None recorded.

Value signals
[
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_earlier_adjustment",
    "category": "timeline_minor_adjustment",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2018-04",
    "old_value": "2019-01",
    "delta_days": 275,
    "date_struct": "completionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  },
  {
    "paths": [
      "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
      "/protocolSection/outcomesModule/secondaryOutcomes/1/measure"
    ],
    "signal": "results_reconciliation_outcome_suppression",
    "category": "results_reconciliation",
    "severity": "low"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:14:21+00
Raw hash
997aceb9617118bbd9a4d64750d16df2e2cef981e3c4e6b968166ac8443a6c1f
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 2 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/measure
Triage: Critical
Primary Outcome Change Operation 8
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Pathologic complete response (PCR)
After
Count of Participants That Achieve Pathologic Complete Response (PCR)
replace /protocolSection/outcomesModule/primaryOutcomes/0/description
Triage: Critical
Primary Outcome Change Operation 9
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
PCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H&E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes.
The posterior distribution of the odds ratio will be used to assess whether carboplatin and/or carboplatin +veliparib in combination with paclitaxel has a higher PCR compared to each other and simulations will be used to compare to paclitaxel alone.
A 95% credible region will be calculated for the odds ratio comparing the two combination treatments, the odds ratio comparing each treatment to paclitaxel alone, the PCR for each treatment regimen, for the difference in the PCR between each combination regimen, and the difference of each combination regimen to paclitaxel alone.
After
PCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H&E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes.
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 2 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/0/measure
Triage: High
Secondary Outcome Change Operation 10
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Overall clinical response
After
Overall Clinical Response
replace /protocolSection/outcomesModule/secondaryOutcomes/1/measure
Triage: High
Secondary Outcome Change Operation 11
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Relapse free survival
After
Relapse Free Survival
Timeline Start, primary completion, and completion date movement. Triage: Medium 1 ops
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 2
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2019-01
After
2018-04
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
2017-11
After
2017-12
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2017-11-13
After
2017-12-14
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 4
Before
2017-11-17
After
2018-01-16
add /protocolSection/statusModule/resultsFirstSubmitDate
Triage: Uncategorized
Uncategorized Operation 5
After
2017-12-14
add /protocolSection/statusModule/resultsFirstSubmitQcDate
Triage: Uncategorized
Uncategorized Operation 6
After
2017-12-14
add /protocolSection/statusModule/resultsFirstPostDateStruct
Triage: Uncategorized
Uncategorized Operation 7
After
{
  "date": "2018-01-16",
  "type": "ACTUAL"
}
replace /hasResults
Triage: Uncategorized
Uncategorized Operation 13
Before
false
After
true
add /resultsSection
Triage: Uncategorized
Uncategorized Operation 14
After
{
  "moreInfoModule": {
    "pointOfContact": {
      "email": "edith.mitchell@jefferson.edu",
      "phone": "215-955-8874",
      "title": "Dr. Edith Mitchell",
      "organization": "Sidney Kimmel Cancer Center at Thomas Jefferson University"
    },
    "certainAgreement": {
      "piSponsorEmployee": true
    }
  },
  "adverseEventsModule": {
    "eventGroups": [
      {
        "id": "EG000",
        "title": "Arm 1 (Paclitaxel, Carboplatin)",
        "description": "<p>Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p>",
        "otherNumAtRisk": 5,
        "deathsNumAtRisk": 5,
        "otherNumAffected": 3,
        "seriousNumAtRisk": 5,
        "deathsNumAffected": 0,
        "seriousNumAffected": 1
      },
      {
        "id": "EG001",
        "title": "Arm 2 (Veliparib, Paclitaxel, Carboplatin)",
        "description": "<p>Patients receive veliparib PO BID on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p><p>Veliparib: Given PO</p>",
        "otherNumAtRisk": 4,
        "deathsNumAtRisk": 4,
        "otherNumAffected": 1,
        "seriousNumAtRisk": 4,
        "deathsNumAffected": 0,
        "seriousNumAffected": 0
      }
    ],
    "otherEvents": [
      {
        "term": "Alopecia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Alkaline phosphatase Increased",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 7,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "ALT Increase",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Anemia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Anxiety",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Psychiatric disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Bone Pain",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 7,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Burn",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 7,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Constipation",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Cough",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Dehydration",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Diarrhea",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Diverticulitis",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Dizziness",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Dyspnea",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Fall",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Fatigue",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Flu like symptoms",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 3,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 2,
            "numAffected": 1
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Head Injury",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 3,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Injury, poisoning and procedural complications",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Hot flashes",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Hyperglycemia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Hypoglycemia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Infection UTI",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Infections and infestations",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Insomnia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 2,
            "numAffected": 1
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Laryngeal Inflammation",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Mucositis",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 2,
            "numAffected": 1
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Nausea",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 2,
            "numAffected": 1
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Neuropathy",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Night Sweats",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Pain",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Paresthesia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Platelet Count decreased",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Psychiatric Disorders, mood",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Psychiatric disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Rash Acneiform",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Rash Maculopapular",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Runny nose",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Scalp pain",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Sciatica",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Scratch",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Urinary Urgency",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Renal and urinary disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Voice alteration",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Vomiting",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      }
    ],
    "seriousEvents": [
      {
        "term": "Viral Meningitis",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 4,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Infections and infestations",
        "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
      }
    ],
    "frequencyThreshold": "5"
  },
  "outcomeMeasuresModule": {
    "outcomeMeasures": [
      {
        "type": "PRIMARY",
        "title": "Count of Participants That Achieve Pathologic Complete Response (PCR)",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "5",
                "groupId": "OG000"
              },
              {
                "value": "4",
                "groupId": "OG001"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Arm 1 (Paclitaxel, Carboplatin)",
            "description": "<p>Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p>"
          },
          {
            "id": "OG001",
            "title": "Arm 2 (Veliparib, Paclitaxel, Carboplatin)",
            "description": "<p>Patients receive veliparib PO BID on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p><p>Veliparib: Given PO</p>"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "3",
                    "groupId": "OG000"
                  },
                  {
                    "value": "3",
                    "groupId": "OG001"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "timeFrame": "At the time of surgery",
        "description": "PCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H&amp;E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes.",
        "unitOfMeasure": "Participants",
        "reportingStatus": "POSTED"
      },
      {
        "type": "SECONDARY",
        "title": "Overall Clinical Response",
        "timeFrame": "Up to 3 years",
        "description": "The proportion of subjects with each category of overall clinical response will be summarized by presence of baseline measureable disease (i.e., complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], unable to evaluate [UE], neurogenerative disease [ND]).\nBeta will be used as priors for combination regimens in calculating the posterior distribution of the PCR for each respective treatment group.\nAmong subjects with measurable disease, a 95% credible region will be calculated for the odds ratio for each treatment combination relative to each other.",
        "reportingStatus": "NOT_POSTED",
        "denomUnitsSelected": "Participants",
        "anticipatedPostingDate": "2019-04"
      },
      {
        "type": "SECONDARY",
        "title": "Relapse Free Survival",
        "timeFrame": "Up to 3 years",
        "description": "Analyzed using Kaplan-Meier methods, stratified by study group, and the log rank test will be completed.",
        "reportingStatus": "NOT_POSTED",
        "denomUnitsSelected": "Participants",
        "anticipatedPostingDate": "2019-04"
      }
    ]
  },
  "participantFlowModule": {
    "groups": [
      {
        "id": "FG000",
        "title": "Arm 1 (Paclitaxel, Carboplatin)",
        "description": "<p>Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p>"
      },
      {
        "id": "FG001",
        "title": "Arm 2 (Veliparib, Paclitaxel, Carboplatin)",
        "description": "<p>Patients receive veliparib PO BID on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p><p>Veliparib: Given PO</p>"
      }
    ],
    "periods": [
      {
        "title": "Overall Study",
        "milestones": [
          {
            "type": "STARTED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "5"
              },
              {
                "groupId": "FG001",
                "numSubjects": "4"
              }
            ]
          },
          {
            "type": "COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "5"
              },
              {
                "groupId": "FG001",
                "numSubjects": "4"
              }
            ]
          },
          {
            "type": "NOT COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "0"
              },
              {
                "groupId": "FG001",
                "numSubjects": "0"
              }
            ]
          }
        ]
      }
    ]
  },
  "baselineCharacteristicsModule": {
    "denoms": [
      {
        "units": "Participants",
        "counts": [
          {
            "value": "5",
            "groupId": "BG000"
          },
          {
            "value": "4",
            "groupId": "BG001"
          },
          {
            "value": "9",
            "groupId": "BG002"
          }
        ]
      }
    ],
    "groups": [
      {
        "id": "BG000",
        "title": "Arm 1 (Paclitaxel, Carboplatin)",
        "description": "<p>Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p>"
      },
      {
        "id": "BG001",
        "title": "Arm 2 (Veliparib, Paclitaxel, Carboplatin)",
        "description": "<p>Patients receive veliparib PO BID on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p><p>Veliparib: Given PO</p>"
      },
      {
        "id": "BG002",
        "title": "Total",
        "description": "Total of all reporting groups"
      }
    ],
    "measures": [
      {
        "title": "Age, Categorical",
        "classes": [
          {
            "categories": [
              {
                "title": "&lt;=18 years",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Between 18 and 65 years",
                "measurements": [
                  {
                    "value": "3",
                    "groupId": "BG000"
                  },
                  {
                    "value": "4",
                    "groupId": "BG001"
                  },
                  {
                    "value": "7",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "&gt;=65 years",
                "measurements": [
                  {
                    "value": "2",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "2",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Sex: Female, Male",
        "classes": [
          {
            "categories": [
              {
                "title": "Female",
                "measurements": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "4",
                    "groupId": "BG001"
                  },
                  {
                    "value": "9",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Male",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Ethnicity (NIH&#x2F;OMB)",
        "classes": [
          {
            "categories": [
              {
                "title": "Hispanic or Latino",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "1",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Not Hispanic or Latino",
                "measurements": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "3",
                    "groupId": "BG001"
                  },
                  {
                    "value": "8",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Unknown or Not Reported",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Race (NIH&#x2F;OMB)",
        "classes": [
          {
            "categories": [
              {
                "title": "American Indian or Alaska Native",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Asian",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Native Hawaiian or Other Pacific Islander",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Black or African American",
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "BG000"
                  },
                  {
                    "value": "2",
                    "groupId": "BG001"
                  },
                  {
                    "value": "3",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "White",
                "measurements": [
                  {
                    "value": "4",
                    "groupId": "BG000"
                  },
                  {
                    "value": "2",
                    "groupId": "BG001"
                  },
                  {
                    "value": "6",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "More than one race",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Unknown or Not Reported",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Region of Enrollment",
        "classes": [
          {
            "title": "United States",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "4",
                    "groupId": "BG001"
                  },
                  {
                    "value": "9",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "NUMBER",
        "unitOfMeasure": "participants"
      }
    ]
  }
}
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 1 ops
remove /protocolSection/referencesModule/seeAlsoLinks/0
Triage: Uncategorized
Uncategorized Operation 12
Before
{
  "url": "http:&#x2F;&#x2F;www.KimmelCancerCenter.org",
  "label": "Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center"
}
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2017-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2018-04"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2017-12-14"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2018-01-16"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitDate",
    "value": "2017-12-14"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "value": "2017-12-14"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "value": {
      "date": "2018-01-16",
      "type": "ACTUAL"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "value": "Count of Participants That Achieve Pathologic Complete Response (PCR)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "value": "PCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H&amp;E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "value": "Overall Clinical Response"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "value": "Relapse Free Survival"
  },
  {
    "op": "remove",
    "path": "/protocolSection/referencesModule/seeAlsoLinks/0"
  },
  {
    "op": "replace",
    "path": "/hasResults",
    "value": true
  },
  {
    "op": "add",
    "path": "/resultsSection",
    "value": {
      "moreInfoModule": {
        "pointOfContact": {
          "email": "edith.mitchell@jefferson.edu",
          "phone": "215-955-8874",
          "title": "Dr. Edith Mitchell",
          "organization": "Sidney Kimmel Cancer Center at Thomas Jefferson University"
        },
        "certainAgreement": {
          "piSponsorEmployee": true
        }
      },
      "adverseEventsModule": {
        "eventGroups": [
          {
            "id": "EG000",
            "title": "Arm 1 (Paclitaxel, Carboplatin)",
            "description": "<p>Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p>",
            "otherNumAtRisk": 5,
            "deathsNumAtRisk": 5,
            "otherNumAffected": 3,
            "seriousNumAtRisk": 5,
            "deathsNumAffected": 0,
            "seriousNumAffected": 1
          },
          {
            "id": "EG001",
            "title": "Arm 2 (Veliparib, Paclitaxel, Carboplatin)",
            "description": "<p>Patients receive veliparib PO BID on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p><p>Veliparib: Given PO</p>",
            "otherNumAtRisk": 4,
            "deathsNumAtRisk": 4,
            "otherNumAffected": 1,
            "seriousNumAtRisk": 4,
            "deathsNumAffected": 0,
            "seriousNumAffected": 0
          }
        ],
        "otherEvents": [
          {
            "term": "Alopecia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 2,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Alkaline phosphatase Increased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 7,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "ALT Increase",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Anemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 2,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Anxiety",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Psychiatric disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Bone Pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 7,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Burn",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 7,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Constipation",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Cough",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 2,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Dehydration",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 2,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Diarrhea",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 2,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Diverticulitis",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Dizziness",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Dyspnea",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Fall",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 2,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Fatigue",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Flu like symptoms",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 3,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 2,
                "numAffected": 1
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Head Injury",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 3,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Injury, poisoning and procedural complications",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Hot flashes",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Hyperglycemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 2,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Hypoglycemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 2,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Infection UTI",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Insomnia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 2,
                "numAffected": 1
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Laryngeal Inflammation",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Mucositis",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 2,
                "numAffected": 1
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Nausea",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 2,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 2,
                "numAffected": 1
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Neuropathy",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Night Sweats",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Paresthesia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Platelet Count decreased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Psychiatric Disorders, mood",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Psychiatric disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Rash Acneiform",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Rash Maculopapular",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Runny nose",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Scalp pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Sciatica",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Scratch",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Urinary Urgency",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Renal and urinary disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Voice alteration",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Vomiting",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          }
        ],
        "seriousEvents": [
          {
            "term": "Viral Meningitis",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 4,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
          }
        ],
        "frequencyThreshold": "5"
      },
      "outcomeMeasuresModule": {
        "outcomeMeasures": [
          {
            "type": "PRIMARY",
            "title": "Count of Participants That Achieve Pathologic Complete Response (PCR)",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "OG000"
                  },
                  {
                    "value": "4",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Arm 1 (Paclitaxel, Carboplatin)",
                "description": "<p>Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p>"
              },
              {
                "id": "OG001",
                "title": "Arm 2 (Veliparib, Paclitaxel, Carboplatin)",
                "description": "<p>Patients receive veliparib PO BID on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p><p>Veliparib: Given PO</p>"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "3",
                        "groupId": "OG000"
                      },
                      {
                        "value": "3",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "timeFrame": "At the time of surgery",
            "description": "PCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H&amp;E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes.",
            "unitOfMeasure": "Participants",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Overall Clinical Response",
            "timeFrame": "Up to 3 years",
            "description": "The proportion of subjects with each category of overall clinical response will be summarized by presence of baseline measureable disease (i.e., complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], unable to evaluate [UE], neurogenerative disease [ND]).\nBeta will be used as priors for combination regimens in calculating the posterior distribution of the PCR for each respective treatment group.\nAmong subjects with measurable disease, a 95% credible region will be calculated for the odds ratio for each treatment combination relative to each other.",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants",
            "anticipatedPostingDate": "2019-04"
          },
          {
            "type": "SECONDARY",
            "title": "Relapse Free Survival",
            "timeFrame": "Up to 3 years",
            "description": "Analyzed using Kaplan-Meier methods, stratified by study group, and the log rank test will be completed.",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants",
            "anticipatedPostingDate": "2019-04"
          }
        ]
      },
      "participantFlowModule": {
        "groups": [
          {
            "id": "FG000",
            "title": "Arm 1 (Paclitaxel, Carboplatin)",
            "description": "<p>Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p>"
          },
          {
            "id": "FG001",
            "title": "Arm 2 (Veliparib, Paclitaxel, Carboplatin)",
            "description": "<p>Patients receive veliparib PO BID on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p><p>Veliparib: Given PO</p>"
          }
        ],
        "periods": [
          {
            "title": "Overall Study",
            "milestones": [
              {
                "type": "STARTED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "5"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "4"
                  }
                ]
              },
              {
                "type": "COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "5"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "4"
                  }
                ]
              },
              {
                "type": "NOT COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "0"
                  }
                ]
              }
            ]
          }
        ]
      },
      "baselineCharacteristicsModule": {
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "5",
                "groupId": "BG000"
              },
              {
                "value": "4",
                "groupId": "BG001"
              },
              {
                "value": "9",
                "groupId": "BG002"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "BG000",
            "title": "Arm 1 (Paclitaxel, Carboplatin)",
            "description": "<p>Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p>"
          },
          {
            "id": "BG001",
            "title": "Arm 2 (Veliparib, Paclitaxel, Carboplatin)",
            "description": "<p>Patients receive veliparib PO BID on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>Paclitaxel: Given IV</p><p>Carboplatin: Given IV</p><p>Doxorubicin: Given IV</p><p>Cyclophosphamide: Given IV</p><p>Veliparib: Given PO</p>"
          },
          {
            "id": "BG002",
            "title": "Total",
            "description": "Total of all reporting groups"
          }
        ],
        "measures": [
          {
            "title": "Age, Categorical",
            "classes": [
              {
                "categories": [
                  {
                    "title": "&lt;=18 years",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "Between 18 and 65 years",
                    "measurements": [
                      {
                        "value": "3",
                        "groupId": "BG000"
                      },
                      {
                        "value": "4",
                        "groupId": "BG001"
                      },
                      {
                        "value": "7",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "&gt;=65 years",
                    "measurements": [
                      {
                        "value": "2",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "2",
                        "groupId": "BG002"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Sex: Female, Male",
            "classes": [
              {
                "categories": [
                  {
                    "title": "Female",
                    "measurements": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "4",
                        "groupId": "BG001"
                      },
                      {
                        "value": "9",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "Male",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Ethnicity (NIH&#x2F;OMB)",
            "classes": [
              {
                "categories": [
                  {
                    "title": "Hispanic or Latino",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "1",
                        "groupId": "BG001"
                      },
                      {
                        "value": "1",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "Not Hispanic or Latino",
                    "measurements": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "3",
                        "groupId": "BG001"
                      },
                      {
                        "value": "8",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "Unknown or Not Reported",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Race (NIH&#x2F;OMB)",
            "classes": [
              {
                "categories": [
                  {
                    "title": "American Indian or Alaska Native",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "Asian",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "Native Hawaiian or Other Pacific Islander",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "Black or African American",
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "BG000"
                      },
                      {
                        "value": "2",
                        "groupId": "BG001"
                      },
                      {
                        "value": "3",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "White",
                    "measurements": [
                      {
                        "value": "4",
                        "groupId": "BG000"
                      },
                      {
                        "value": "2",
                        "groupId": "BG001"
                      },
                      {
                        "value": "6",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "More than one race",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "Unknown or Not Reported",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Region of Enrollment",
            "classes": [
              {
                "title": "United States",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "4",
                        "groupId": "BG001"
                      },
                      {
                        "value": "9",
                        "groupId": "BG002"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "NUMBER",
            "unitOfMeasure": "participants"
          }
        ]
      }
    }
  }
]