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NCT01471106

Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer

Version 28 to 29 · M.D. Anderson Cancer Center

Patch inspector

Version 28 to 29

16 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/primaryCompletionDateStruct/date",
    "signal": "timeline_actualized_earlier",
    "category": "timeline_actualized_earlier",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2024-01-31",
    "old_value": "2025-01-31",
    "delta_days": 366,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_actualized_earlier",
    "category": "timeline_actualized_earlier",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2024-05-30",
    "old_value": "2025-01-31",
    "delta_days": 246,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "paths": [
      "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame"
    ],
    "signal": "results_reconciliation_outcome_suppression",
    "category": "results_reconciliation",
    "severity": "low"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:11:17+00
Raw hash
c17adaf86785582f7c84317257ebc98d8da0e25050d98a1df914f416c3295bdf
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 1 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 12
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
3 months
After
up to 3 months
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 1 ops
add /protocolSection/outcomesModule/secondaryOutcomes
Triage: High
Secondary Outcome Change Operation 13
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
[
  {
    "measure": "To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway",
    "timeFrame": "up to 3 months",
    "description": "Evaluation of serum utilizing ELISA kits for IGFBP1"
  },
  {
    "measure": "To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway",
    "timeFrame": "up to 3 months",
    "description": "Evaluation of serum utilizing ELISA kits for IGF1"
  },
  {
    "measure": "To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway",
    "timeFrame": "up to 3 months",
    "description": "Evaluation of serum utilizing ELISA kits for IGFBP3"
  }
]
Timeline Start, primary completion, and completion date movement. Triage: Medium 4 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2025-01-31
After
2024-01-31
replace /protocolSection/statusModule/primaryCompletionDateStruct/type
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2025-01-31
After
2024-05-30
replace /protocolSection/statusModule/completionDateStruct/type
Triage: Medium
Timeline Shift Operation 6
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 9 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2023-12
After
2024-06
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 7
Before
2023-12-13
After
2024-06-13
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 8
Before
2023-12-14
After
2024-07-10
add /protocolSection/statusModule/resultsFirstSubmitDate
Triage: Uncategorized
Uncategorized Operation 9
After
2024-06-13
add /protocolSection/statusModule/resultsFirstSubmitQcDate
Triage: Uncategorized
Uncategorized Operation 10
After
2024-06-13
add /protocolSection/statusModule/resultsFirstPostDateStruct
Triage: Uncategorized
Uncategorized Operation 11
After
{
  "date": "2024-07-10",
  "type": "ACTUAL"
}
replace /hasResults
Triage: Uncategorized
Uncategorized Operation 14
Before
false
After
true
add /resultsSection
Triage: Uncategorized
Uncategorized Operation 15
After
{
  "moreInfoModule": {
    "pointOfContact": {
      "email": "barun@mdanderson.org",
      "phone": "(713) 792-2817",
      "title": "Dr. Arun K. Banu",
      "organization": "M D Anderson Cancer Center"
    },
    "certainAgreement": {
      "piSponsorEmployee": true
    }
  },
  "adverseEventsModule": {
    "timeFrame": "Up to 3 months",
    "eventGroups": [
      {
        "id": "EG000",
        "title": "Group 1: Dasatinib 40 mg",
        "description": "<p>Dasatinib 40 mg by mouth once a day for 3 months (+&#x2F;- 7 days), At the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>",
        "otherNumAtRisk": 12,
        "deathsNumAtRisk": 12,
        "otherNumAffected": 11,
        "seriousNumAtRisk": 12,
        "deathsNumAffected": 0,
        "seriousNumAffected": 0
      },
      {
        "id": "EG001",
        "title": "Group 2: Dasatinib 80 mg",
        "description": "<p>Dasatinib 80 mg by mouth once a day for 3 months (+&#x2F;- 7 days).\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>",
        "otherNumAtRisk": 6,
        "deathsNumAtRisk": 6,
        "otherNumAffected": 5,
        "seriousNumAtRisk": 6,
        "deathsNumAffected": 0,
        "seriousNumAffected": 0
      },
      {
        "id": "EG002",
        "title": "Group 3: No Dasatinib",
        "description": "No treatment control group.\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.",
        "otherNumAtRisk": 6,
        "deathsNumAtRisk": 6,
        "otherNumAffected": 0,
        "seriousNumAtRisk": 6,
        "deathsNumAffected": 0,
        "seriousNumAffected": 0
      }
    ],
    "otherEvents": [
      {
        "term": "Alopecia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Arthralgia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Musculoskeletal and connective tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Aspartate aminotransferase increased",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Investigations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Back pain",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Musculoskeletal and connective tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Cough",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Diarrhea",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Dizziness",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Dysgeusia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Fatigue",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 5,
            "numAffected": 5
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Fever",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Fracture",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Injury, poisoning and procedural complications",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Gastritis",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Gastrointestinal disorders - (Other), specify",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 3,
            "numAffected": 3
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Headache",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 5,
            "numAffected": 5
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Hot flashes",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Vascular disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Infections and infestations - (Other), specify",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Infections and infestations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Musculoskeletal and connective tissue disorder - Specify (Other)",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Musculoskeletal and connective tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Nausea",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Pain",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Pain in extremity",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Musculoskeletal and connective tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Peripheral sensory neuropathy",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Pruritus",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 3,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Rash acneiform",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Rash maculo-papular",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "Renal and urinary disorders - (Other), specify",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 12,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 6,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 6,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Renal and urinary disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      }
    ],
    "frequencyThreshold": "0"
  },
  "outcomeMeasuresModule": {
    "outcomeMeasures": [
      {
        "type": "PRIMARY",
        "title": "Change in Ki-67 in Breast Tissue of High-Risk Women",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "0",
                "groupId": "OG000"
              },
              {
                "value": "0",
                "groupId": "OG001"
              },
              {
                "value": "0",
                "groupId": "OG002"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Group 1: Dasatinib 40 mg",
            "description": "<p>Dasatinib 40 mg by mouth once a day for 3 months (+&#x2F;- 7 days), At the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>"
          },
          {
            "id": "OG001",
            "title": "Group 2: Dasatinib 80 mg",
            "description": "<p>Dasatinib 80 mg by mouth once a day for 3 months (+&#x2F;- 7 days).\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>"
          },
          {
            "id": "OG002",
            "title": "Group 3: No Dasatinib",
            "description": "No treatment control group.\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses."
          }
        ],
        "timeFrame": "up to 3 months",
        "description": "Change in Ki-67 measured in baseline and month 3 using contralateral breast Fine Needle Aspiration (FNA) samples.\nSamples evaluated by immunohistochemistry (IHC).\nBaseline and follow up Ki-67 values presented in percentage (%) of cell positive, change reflects difference in percentage.\nKi-67 is measured as a continuous variable and a one-way ANOVA followed by Dunnett&#x27;s multiple comparison test comparing the change of Ki-67 of each of the three treated groups with control.",
        "reportingStatus": "POSTED",
        "populationDescription": "FNA yield for matched pre-and-post treatment FNA samples was technically insufficient for Ki-67 immunohistochemitry analysis"
      },
      {
        "type": "SECONDARY",
        "title": "To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "12",
                "groupId": "OG000"
              },
              {
                "value": "6",
                "groupId": "OG001"
              },
              {
                "value": "6",
                "groupId": "OG002"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Group 1: Dasatinib 40 mg",
            "description": "<p>Dasatinib 40 mg by mouth once a day for 3 months (+&#x2F;- 7 days), At the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>"
          },
          {
            "id": "OG001",
            "title": "Group 2: Dasatinib 80 mg",
            "description": "<p>Dasatinib 80 mg by mouth once a day for 3 months (+&#x2F;- 7 days).\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>"
          },
          {
            "id": "OG002",
            "title": "Group 3: No Dasatinib",
            "description": "No treatment control group.\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses."
          }
        ],
        "classes": [
          {
            "title": "Pre-treatment",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "6683",
                    "spread": "4086.6",
                    "groupId": "OG000"
                  },
                  {
                    "value": "2320.9",
                    "spread": "797.1",
                    "groupId": "OG001"
                  },
                  {
                    "value": "6524",
                    "spread": "3900.3",
                    "groupId": "OG002"
                  }
                ]
              }
            ]
          },
          {
            "title": "Post-treatment",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "8508.5",
                    "spread": "7992.3",
                    "groupId": "OG000"
                  },
                  {
                    "value": "4270.6",
                    "spread": "4405.3",
                    "groupId": "OG001"
                  },
                  {
                    "value": "7270.1",
                    "spread": "4715.4",
                    "groupId": "OG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEAN",
        "timeFrame": "up to 3 months",
        "description": "Evaluation of serum utilizing ELISA kits for IGFBP1",
        "unitOfMeasure": "pg&#x2F;ml",
        "dispersionType": "Standard Deviation",
        "reportingStatus": "POSTED"
      },
      {
        "type": "SECONDARY",
        "title": "To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "12",
                "groupId": "OG000"
              },
              {
                "value": "6",
                "groupId": "OG001"
              },
              {
                "value": "6",
                "groupId": "OG002"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Group 1: Dasatinib 40 mg",
            "description": "<p>Dasatinib 40 mg by mouth once a day for 3 months (+&#x2F;- 7 days), At the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>"
          },
          {
            "id": "OG001",
            "title": "Group 2: Dasatinib 80 mg",
            "description": "<p>Dasatinib 80 mg by mouth once a day for 3 months (+&#x2F;- 7 days).\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>"
          },
          {
            "id": "OG002",
            "title": "Group 3: No Dasatinib",
            "description": "No treatment control group.\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses."
          }
        ],
        "classes": [
          {
            "title": "Pre-treatment",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "71.8",
                    "spread": "35.6",
                    "groupId": "OG000"
                  },
                  {
                    "value": "79.8",
                    "spread": "22.3",
                    "groupId": "OG001"
                  },
                  {
                    "value": "95.2",
                    "spread": "25.7",
                    "groupId": "OG002"
                  }
                ]
              }
            ]
          },
          {
            "title": "Post-treatment",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "70.3",
                    "spread": "41",
                    "groupId": "OG000"
                  },
                  {
                    "value": "68.2",
                    "spread": "24.4",
                    "groupId": "OG001"
                  },
                  {
                    "value": "95.3",
                    "spread": "27.7",
                    "groupId": "OG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEAN",
        "timeFrame": "up to 3 months",
        "description": "Evaluation of serum utilizing ELISA kits for IGF1",
        "unitOfMeasure": "ng&#x2F;ml",
        "dispersionType": "Standard Deviation",
        "reportingStatus": "POSTED"
      },
      {
        "type": "SECONDARY",
        "title": "To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "12",
                "groupId": "OG000"
              },
              {
                "value": "6",
                "groupId": "OG001"
              },
              {
                "value": "6",
                "groupId": "OG002"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Group 1: Dasatinib 40 mg",
            "description": "<p>Dasatinib 40 mg by mouth once a day for 3 months (+&#x2F;- 7 days), At the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>"
          },
          {
            "id": "OG001",
            "title": "Group 2: Dasatinib 80 mg",
            "description": "<p>Dasatinib 80 mg by mouth once a day for 3 months (+&#x2F;- 7 days).\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>"
          },
          {
            "id": "OG002",
            "title": "Group 3: No Dasatinib",
            "description": "No treatment control group.\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses."
          }
        ],
        "classes": [
          {
            "title": "pretreatment",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "2041",
                    "spread": "411.1",
                    "groupId": "OG000"
                  },
                  {
                    "value": "1999",
                    "spread": "136.7",
                    "groupId": "OG001"
                  },
                  {
                    "value": "2279.9",
                    "spread": "394.5",
                    "groupId": "OG002"
                  }
                ]
              }
            ]
          },
          {
            "title": "Post-treatment",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "2027.6",
                    "spread": "348.9",
                    "groupId": "OG000"
                  },
                  {
                    "value": "2048.4",
                    "spread": "220.7",
                    "groupId": "OG001"
                  },
                  {
                    "value": "2080.2",
                    "spread": "514.4",
                    "groupId": "OG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEAN",
        "timeFrame": "up to 3 months",
        "description": "Evaluation of serum utilizing ELISA kits for IGFBP3",
        "unitOfMeasure": "ng&#x2F;ml",
        "dispersionType": "Standard Deviation",
        "reportingStatus": "POSTED"
      }
    ]
  },
  "participantFlowModule": {
    "groups": [
      {
        "id": "FG000",
        "title": "Group 1: Dasatinib 40 mg",
        "description": "<p>Dasatinib 40 mg by mouth once a day for 3 months (+&#x2F;- 7 days), At the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>"
      },
      {
        "id": "FG001",
        "title": "Group 2: Dasatinib 80 mg",
        "description": "<p>Dasatinib 80 mg by mouth once a day for 3 months (+&#x2F;- 7 days).\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>"
      },
      {
        "id": "FG002",
        "title": "Group 3: No Dasatinib",
        "description": "No treatment control group.\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses."
      }
    ],
    "periods": [
      {
        "title": "Overall Study",
        "milestones": [
          {
            "type": "STARTED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "12"
              },
              {
                "groupId": "FG001",
                "numSubjects": "6"
              },
              {
                "groupId": "FG002",
                "numSubjects": "6"
              }
            ]
          },
          {
            "type": "COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "12"
              },
              {
                "groupId": "FG001",
                "numSubjects": "6"
              },
              {
                "groupId": "FG002",
                "numSubjects": "6"
              }
            ]
          },
          {
            "type": "NOT COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "0"
              },
              {
                "groupId": "FG001",
                "numSubjects": "0"
              },
              {
                "groupId": "FG002",
                "numSubjects": "0"
              }
            ]
          }
        ]
      }
    ],
    "recruitmentDetails": "26 patients were enrolled by 08&#x2F;13&#x2F;2018, of which were 24 randomized, 6 in No Treatment&#x2F;Control, 12 in Dasatinib 40 mg, and 6 in Dasatinib 80 mg."
  },
  "baselineCharacteristicsModule": {
    "denoms": [
      {
        "units": "Participants",
        "counts": [
          {
            "value": "12",
            "groupId": "BG000"
          },
          {
            "value": "6",
            "groupId": "BG001"
          },
          {
            "value": "6",
            "groupId": "BG002"
          },
          {
            "value": "24",
            "groupId": "BG003"
          }
        ]
      }
    ],
    "groups": [
      {
        "id": "BG000",
        "title": "Group 1: Dasatinib 40 mg",
        "description": "<p>Dasatinib 40 mg by mouth once a day for 3 months (+&#x2F;- 7 days), At the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>"
      },
      {
        "id": "BG001",
        "title": "Group 2: Dasatinib 80 mg",
        "description": "<p>Dasatinib 80 mg by mouth once a day for 3 months (+&#x2F;- 7 days).\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>"
      },
      {
        "id": "BG002",
        "title": "Group 3: No Dasatinib",
        "description": "No treatment control group.\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses."
      },
      {
        "id": "BG003",
        "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"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  }
                ]
              },
              {
                "title": "Between 18 and 65 years",
                "measurements": [
                  {
                    "value": "11",
                    "groupId": "BG000"
                  },
                  {
                    "value": "6",
                    "groupId": "BG001"
                  },
                  {
                    "value": "6",
                    "groupId": "BG002"
                  },
                  {
                    "value": "23",
                    "groupId": "BG003"
                  }
                ]
              },
              {
                "title": "&gt;=65 years",
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "1",
                    "groupId": "BG003"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Age, Continuous",
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "62.4",
                    "groupId": "BG000",
                    "lowerLimit": "46.1",
                    "upperLimit": "74.4"
                  },
                  {
                    "value": "50.8",
                    "groupId": "BG001",
                    "lowerLimit": "30.7",
                    "upperLimit": "69.6"
                  },
                  {
                    "value": "54",
                    "groupId": "BG002",
                    "lowerLimit": "40.6",
                    "upperLimit": "63.2"
                  },
                  {
                    "value": "56.8",
                    "groupId": "BG003",
                    "lowerLimit": "30.7",
                    "upperLimit": "74.4"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEDIAN",
        "unitOfMeasure": "Years",
        "dispersionType": "FULL_RANGE"
      },
      {
        "title": "Sex: Female, Male",
        "classes": [
          {
            "categories": [
              {
                "title": "Female",
                "measurements": [
                  {
                    "value": "12",
                    "groupId": "BG000"
                  },
                  {
                    "value": "6",
                    "groupId": "BG001"
                  },
                  {
                    "value": "6",
                    "groupId": "BG002"
                  },
                  {
                    "value": "24",
                    "groupId": "BG003"
                  }
                ]
              },
              {
                "title": "Male",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Ethnicity (NIH&#x2F;OMB)",
        "classes": [
          {
            "categories": [
              {
                "title": "Hispanic or Latino",
                "measurements": [
                  {
                    "value": "3",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "4",
                    "groupId": "BG003"
                  }
                ]
              },
              {
                "title": "Not Hispanic or Latino",
                "measurements": [
                  {
                    "value": "9",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "6",
                    "groupId": "BG002"
                  },
                  {
                    "value": "20",
                    "groupId": "BG003"
                  }
                ]
              },
              {
                "title": "Unknown or Not Reported",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  }
                ]
              }
            ]
          }
        ],
        "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"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  }
                ]
              },
              {
                "title": "Asian",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "1",
                    "groupId": "BG003"
                  }
                ]
              },
              {
                "title": "Native Hawaiian or Other Pacific Islander",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  }
                ]
              },
              {
                "title": "Black or African American",
                "measurements": [
                  {
                    "value": "2",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "2",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  }
                ]
              },
              {
                "title": "White",
                "measurements": [
                  {
                    "value": "10",
                    "groupId": "BG000"
                  },
                  {
                    "value": "4",
                    "groupId": "BG001"
                  },
                  {
                    "value": "4",
                    "groupId": "BG002"
                  },
                  {
                    "value": "18",
                    "groupId": "BG003"
                  }
                ]
              },
              {
                "title": "More than one race",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  }
                ]
              },
              {
                "title": "Unknown or Not Reported",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Region of Enrollment",
        "classes": [
          {
            "title": "United States",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "12",
                    "groupId": "BG000"
                  },
                  {
                    "value": "6",
                    "groupId": "BG001"
                  },
                  {
                    "value": "6",
                    "groupId": "BG002"
                  },
                  {
                    "value": "24",
                    "groupId": "BG003"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "NUMBER",
        "unitOfMeasure": "participants"
      }
    ]
  }
}
add /documentSection
Triage: Uncategorized
Uncategorized Operation 16
After
{
  "largeDocumentModule": {
    "largeDocs": [
      {
        "date": "2017-06-13",
        "size": 1336838,
        "label": "Study Protocol and Statistical Analysis Plan",
        "hasIcf": false,
        "hasSap": true,
        "filename": "Prot_SAP_000.pdf",
        "typeAbbrev": "Prot_SAP",
        "uploadDate": "2024-06-12T16:24",
        "hasProtocol": true
      }
    ]
  }
}
Status and stopping reason Recruitment status, termination, suspension, withdrawal, or why-stopped text. Triage: Uncategorized 1 ops
replace /protocolSection/statusModule/overallStatus
Triage: Uncategorized
Uncategorized Operation 2
Before
ACTIVE_NOT_RECRUITING
After
COMPLETED
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2024-06"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "COMPLETED"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2024-01-31"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2024-05-30"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2024-06-13"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2024-07-10"
  },
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    "op": "add",
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  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "value": "2024-06-13"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "value": {
      "date": "2024-07-10",
      "type": "ACTUAL"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "up to 3 months"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes",
    "value": [
      {
        "measure": "To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway",
        "timeFrame": "up to 3 months",
        "description": "Evaluation of serum utilizing ELISA kits for IGFBP1"
      },
      {
        "measure": "To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway",
        "timeFrame": "up to 3 months",
        "description": "Evaluation of serum utilizing ELISA kits for IGF1"
      },
      {
        "measure": "To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway",
        "timeFrame": "up to 3 months",
        "description": "Evaluation of serum utilizing ELISA kits for IGFBP3"
      }
    ]
  },
  {
    "op": "replace",
    "path": "/hasResults",
    "value": true
  },
  {
    "op": "add",
    "path": "/resultsSection",
    "value": {
      "moreInfoModule": {
        "pointOfContact": {
          "email": "barun@mdanderson.org",
          "phone": "(713) 792-2817",
          "title": "Dr. Arun K. Banu",
          "organization": "M D Anderson Cancer Center"
        },
        "certainAgreement": {
          "piSponsorEmployee": true
        }
      },
      "adverseEventsModule": {
        "timeFrame": "Up to 3 months",
        "eventGroups": [
          {
            "id": "EG000",
            "title": "Group 1: Dasatinib 40 mg",
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            "otherNumAtRisk": 12,
            "deathsNumAtRisk": 12,
            "otherNumAffected": 11,
            "seriousNumAtRisk": 12,
            "deathsNumAffected": 0,
            "seriousNumAffected": 0
          },
          {
            "id": "EG001",
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            "otherNumAtRisk": 6,
            "deathsNumAtRisk": 6,
            "otherNumAffected": 5,
            "seriousNumAtRisk": 6,
            "deathsNumAffected": 0,
            "seriousNumAffected": 0
          },
          {
            "id": "EG002",
            "title": "Group 3: No Dasatinib",
            "description": "No treatment control group.\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.",
            "otherNumAtRisk": 6,
            "deathsNumAtRisk": 6,
            "otherNumAffected": 0,
            "seriousNumAtRisk": 6,
            "deathsNumAffected": 0,
            "seriousNumAffected": 0
          }
        ],
        "otherEvents": [
          {
            "term": "Alopecia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG002",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Arthralgia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG002",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Aspartate aminotransferase increased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              },
              {
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                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Back pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG002",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Cough",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG002",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Diarrhea",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 2,
                "numAffected": 2
              },
              {
                "groupId": "EG002",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Dizziness",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG002",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Dysgeusia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG002",
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                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Fatigue",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 5,
                "numAffected": 5
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 2,
                "numAffected": 2
              },
              {
                "groupId": "EG002",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Fever",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 1,
                "numAffected": 1
              },
              {
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                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Fracture",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
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                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG002",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Injury, poisoning and procedural complications",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Gastritis",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG002",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Gastrointestinal disorders - (Other), specify",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 3,
                "numAffected": 3
              },
              {
                "groupId": "EG001",
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                "numEvents": 0,
                "numAffected": 0
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              {
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                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Headache",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 5,
                "numAffected": 5
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 2,
                "numAffected": 2
              },
              {
                "groupId": "EG002",
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                "numAffected": 0
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            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Hot flashes",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG002",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Vascular disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Infections and infestations - (Other), specify",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 0,
                "numAffected": 0
              },
              {
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                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG002",
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                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Musculoskeletal and connective tissue disorder - Specify (Other)",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
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                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG002",
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                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Nausea",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 2,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
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                "numEvents": 2,
                "numAffected": 2
              },
              {
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                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              },
              {
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                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Pain in extremity",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG002",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Peripheral sensory neuropathy",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
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                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG002",
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                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Pruritus",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 3,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG002",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Rash acneiform",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG002",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Rash maculo-papular",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG002",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          },
          {
            "term": "Renal and urinary disorders - (Other), specify",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 12,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 6,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG002",
                "numAtRisk": 6,
                "numEvents": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Renal and urinary disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (4.0)"
          }
        ],
        "frequencyThreshold": "0"
      },
      "outcomeMeasuresModule": {
        "outcomeMeasures": [
          {
            "type": "PRIMARY",
            "title": "Change in Ki-67 in Breast Tissue of High-Risk Women",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "0",
                    "groupId": "OG000"
                  },
                  {
                    "value": "0",
                    "groupId": "OG001"
                  },
                  {
                    "value": "0",
                    "groupId": "OG002"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Group 1: Dasatinib 40 mg",
                "description": "<p>Dasatinib 40 mg by mouth once a day for 3 months (+&#x2F;- 7 days), At the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>"
              },
              {
                "id": "OG001",
                "title": "Group 2: Dasatinib 80 mg",
                "description": "<p>Dasatinib 80 mg by mouth once a day for 3 months (+&#x2F;- 7 days).\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>"
              },
              {
                "id": "OG002",
                "title": "Group 3: No Dasatinib",
                "description": "No treatment control group.\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses."
              }
            ],
            "timeFrame": "up to 3 months",
            "description": "Change in Ki-67 measured in baseline and month 3 using contralateral breast Fine Needle Aspiration (FNA) samples.\nSamples evaluated by immunohistochemistry (IHC).\nBaseline and follow up Ki-67 values presented in percentage (%) of cell positive, change reflects difference in percentage.\nKi-67 is measured as a continuous variable and a one-way ANOVA followed by Dunnett&#x27;s multiple comparison test comparing the change of Ki-67 of each of the three treated groups with control.",
            "reportingStatus": "POSTED",
            "populationDescription": "FNA yield for matched pre-and-post treatment FNA samples was technically insufficient for Ki-67 immunohistochemitry analysis"
          },
          {
            "type": "SECONDARY",
            "title": "To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "12",
                    "groupId": "OG000"
                  },
                  {
                    "value": "6",
                    "groupId": "OG001"
                  },
                  {
                    "value": "6",
                    "groupId": "OG002"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Group 1: Dasatinib 40 mg",
                "description": "<p>Dasatinib 40 mg by mouth once a day for 3 months (+&#x2F;- 7 days), At the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>"
              },
              {
                "id": "OG001",
                "title": "Group 2: Dasatinib 80 mg",
                "description": "<p>Dasatinib 80 mg by mouth once a day for 3 months (+&#x2F;- 7 days).\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses.</p><p>Dasatinib: Group 1: 40 mg by mouth once a day.</p><p>Dasatinib Group 2: 80 mg by mouth once a day.</p>"
              },
              {
                "id": "OG002",
                "title": "Group 3: No Dasatinib",
                "description": "No treatment control group.\nAt the end of the 3 months (+&#x2F;- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses."
              }
            ],
            "classes": [
              {
                "title": "Pre-treatment",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "6683",
                        "spread": "4086.6",
                        "groupId": "OG000"
                      },
                      {
                        "value": "2320.9",
                        "spread": "797.1",
                        "groupId": "OG001"
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                        "value": "6524",
                        "spread": "3900.3",
                        "groupId": "OG002"
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                    ]
                  }
                ]
              },
              {
                "title": "Post-treatment",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "8508.5",
                        "spread": "7992.3",
                        "groupId": "OG000"
                      },
                      {
                        "value": "4270.6",
                        "spread": "4405.3",
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            "timeFrame": "up to 3 months",
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          },
          {
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            "title": "To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway",
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                        "spread": "35.6",
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                    ]
                  }
                ]
              },
              {
                "title": "Post-treatment",
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                        "spread": "41",
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                      {
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                ]
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              {
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