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NCT02137252

Naltrexone RCT for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer

Version 6 to 7 · Dana-Farber Cancer Institute

Patch inspector

Version 6 to 7

26 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
arms_or_interventions_changeterminal_status_changewhy_stopped_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_actual_date_correction",
    "category": "timeline_actual_date_correction",
    "new_type": "ACTUAL",
    "old_type": "ACTUAL",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2015-08-01",
    "old_value": "2017-11",
    "delta_days": 823,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_actual_date_correction",
    "category": "timeline_actual_date_correction",
    "new_type": "ACTUAL",
    "old_type": "ACTUAL",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2015-08-01",
    "old_value": "2017-11",
    "delta_days": 823,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  },
  {
    "paths": [
      "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame"
    ],
    "signal": "results_reconciliation_outcome_suppression",
    "category": "results_reconciliation",
    "severity": "low"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:14:28+00
Raw hash
3984b48ea0b83390a19183b851b23a23a1ee5bc88812a2e2422bb1e46d72d4ff
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 3 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/measure
Triage: Critical
Primary Outcome Change Operation 18
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Change in FACIT-fatigue subscale score from randomization to end of study
After
Change in FACIT-fatigue Subscale Score From Randomization to End of Study
replace /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 19
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
baseline, week 5
After
Evaluated at baseline, weekly monitoring visits from start of radiation therapy and meets fatigue eligibility threshold
add /protocolSection/outcomesModule/primaryOutcomes/0/description
Triage: Critical
Primary Outcome Change Operation 20
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
After
Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-fatigue subscale): This 13-item self-report scale measuring fatigue and functional impairment as a result of fatigue has been validated in cancer patients (Cella et al.
Cancer 2002;94:528-38) The scale is reverse-scored and the range is 0 (maximum fatigue) - 52 (minimum fatigue).
According to ICD10 criteria, a score <= 34 indicates significant cancer related fatigue.
A change of 10 points has been shown to constitute a clinically meaningful difference on this subscale.
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 7 ops
replace /protocolSection/armsInterventionsModule/armGroups/0/description
Triage: High
Arm Intervention Change Operation 11
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
The treatment schedule includes a daily dose of double-blinded naltrexone vs. placebo for 5 weeks.
Treatment will be initiated at 25 mg/day (or equivalent placebo) during the first week to improve tolerability.
The dose will be escalated to 50 mg/day (or equivalent placebo) after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.
After
The treatment schedule includes a daily dose of naltrexone for 5 weeks.
Treatment will be initiated at 25 mg/day during the first week to improve tolerability.
The dose will be escalated to 50 mg/day after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.
replace /protocolSection/armsInterventionsModule/armGroups/1/label
Triage: High
Arm Intervention Change Operation 12
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Monitoring Phase
After
Sugar Pill
replace /protocolSection/armsInterventionsModule/armGroups/1/type
Triage: High
Arm Intervention Change Operation 13
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
NO_INTERVENTION
After
PLACEBO_COMPARATOR
replace /protocolSection/armsInterventionsModule/armGroups/1/description
Triage: High
Arm Intervention Change Operation 14
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Brief self-report questionnaire (Functional Assessment of Chronic Illness Therapy-Fatigue Subscale; FACIT-F)
After
The treatment schedule includes a daily dose of equivalent placebo for 5 weeks.
Treatment will be initiated at 25 mg/day during the first week to improve tolerability.
The dose will be escalated to 50 mg/day after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.
add /protocolSection/armsInterventionsModule/armGroups/1/interventionNames
Triage: High
Arm Intervention Change Operation 15
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
[
  "Drug: Sugar Pill"
]
remove /protocolSection/armsInterventionsModule/armGroups/2
Triage: High
Arm Intervention Change Operation 16
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
{
  "type": "PLACEBO_COMPARATOR",
  "label": "Sugar Pill",
  "description": "daily dose placebo for 5 week treatment period",
  "interventionNames": [
    "Drug: Sugar Pill"
  ]
}
replace /protocolSection/armsInterventionsModule/interventions/0/otherNames/0
Triage: High
Arm Intervention Change Operation 17
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
•ReVia®
After
ReVia®
Status and stopping reason Recruitment status, termination, suspension, withdrawal, or why-stopped text. Triage: High 2 ops
replace /protocolSection/statusModule/overallStatus
Triage: High
Status Termination Operation 2
Matched rules
  • terminal_status_change Status changed to terminated, suspended, or withdrawn; whyStopped content determines whether critical review is warranted.
Before
COMPLETED
After
TERMINATED
add /protocolSection/statusModule/whyStopped
Triage: High
Status Termination Operation 7
Matched rules
  • why_stopped_change Why-stopped changes explain discontinuation and need review.
After
no enough patients
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 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
2017-11
After
2015-08-01
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2017-11
After
2015-08-01
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 12 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2019-05
After
2021-11
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 5
Before
2019-05-31
After
2021-11-12
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 6
Before
2019-06-04
After
2021-11-16
add /protocolSection/statusModule/resultsFirstSubmitDate
Triage: Uncategorized
Uncategorized Operation 8
After
2021-10-01
add /protocolSection/statusModule/resultsFirstSubmitQcDate
Triage: Uncategorized
Uncategorized Operation 9
After
2021-11-12
add /protocolSection/statusModule/resultsFirstPostDateStruct
Triage: Uncategorized
Uncategorized Operation 10
After
{
  "date": "2021-11-16",
  "type": "ACTUAL"
}
remove /protocolSection/outcomesModule/otherOutcomes
Triage: Uncategorized
Uncategorized Operation 21
Before
[
  {
    "measure": "Changes in sleep continuity (sleep efficiency, total sleep time, sleep latency) from randomization to end of study",
    "timeFrame": "baseline, week 5",
    "description": "Pittsburgh Sleep Quality Index, Insomnia Severity Index"
  },
  {
    "measure": "Changes in quality of life measures from randomization to end of study",
    "timeFrame": "baseline, week 5",
    "description": "Functional Assessment of Cancer Therapy-Breast Subscale Functional Assessment of Cancer Therapy-Endocrine Symptoms Subscale"
  },
  {
    "measure": "Change in depression from randomization to end of study",
    "timeFrame": "baseline, week 5",
    "description": "Patient Health Questionnaire-9"
  },
  {
    "measure": "Change in anxiety from randomization to end of study",
    "timeFrame": "baseline, week 5",
    "description": "Generalized Anxiety Disorder-7"
  }
]
add /protocolSection/ipdSharingStatementModule
Triage: Uncategorized
Uncategorized Operation 22
After
{
  "ipdSharing": "NO"
}
remove /annotationSection
Triage: Uncategorized
Uncategorized Operation 23
Before
{
  "annotationModule": {
    "unpostedAnnotation": {
      "unpostedEvents": [
        {
          "date": "2021-10-01",
          "type": "RELEASE"
        },
        {
          "date": "2021-10-29",
          "type": "RESET"
        }
      ],
      "unpostedResponsibleParty": "Fremonta Meyer, MD, Principal Investigator, Dana-Farber Cancer Institute"
    }
  }
}
replace /hasResults
Triage: Uncategorized
Uncategorized Operation 24
Before
false
After
true
add /resultsSection
Triage: Uncategorized
Uncategorized Operation 25
After
{
  "moreInfoModule": {
    "pointOfContact": {
      "email": "flmeyer@partners.org",
      "title": "Fremonta Meyer, MD",
      "organization": "Dana-Farber Cancer Institute/Brigham and Women's Hospital"
    },
    "certainAgreement": {
      "piSponsorEmployee": true
    }
  },
  "adverseEventsModule": {
    "timeFrame": "Participants in the monitoring phase of the study will be followed for a maximum of 10 weeks, ending 4 weeks after cessation of radiotherapy or until they consent (if eligible) to participate in the intervention phase of the study, followed until the end of the study and beyond, until resolution or stabilization of the adverse event has occurred.",
    "description": "Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher.\nAll remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events.\nMaximum grade toxicity by type was then calculated within SAE and OAE datasets.\nNo further data is available to specify classification of other beyond the general term.",
    "eventGroups": [
      {
        "id": "EG000",
        "title": "Naltrexone",
        "description": "The dose will be escalated to 50 mg/day (or equivalent placebo) after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.",
        "otherNumAtRisk": 2,
        "deathsNumAtRisk": 2,
        "otherNumAffected": 2,
        "seriousNumAtRisk": 2,
        "deathsNumAffected": 0,
        "seriousNumAffected": 0
      },
      {
        "id": "EG001",
        "title": "Sugar Pill",
        "description": "daily dose placebo for 5 week treatment period",
        "otherNumAtRisk": 1,
        "deathsNumAtRisk": 1,
        "otherNumAffected": 1,
        "seriousNumAtRisk": 1,
        "deathsNumAffected": 0,
        "seriousNumAffected": 0
      }
    ],
    "otherEvents": [
      {
        "term": "Dermatitis radiation",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Injury, poisoning and procedural complications",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "fatigue",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "headache",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 2,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 1,
            "numAffected": 0
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "nausea",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 2,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 1,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "dizziness",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 2,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "irritability",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 2,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      },
      {
        "term": "mental fogginess",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 2,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (4.0)"
      }
    ],
    "frequencyThreshold": "0"
  },
  "outcomeMeasuresModule": {
    "outcomeMeasures": [
      {
        "type": "PRIMARY",
        "title": "Change in FACIT-fatigue Subscale Score From Randomization to End of Study",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "0",
                "groupId": "OG000"
              },
              {
                "value": "0",
                "groupId": "OG001"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Naltrexone",
            "description": "<p>The treatment schedule includes a daily dose of naltrexone for 5 weeks.\nTreatment will be initiated at 25 mg&#x2F;day during the first week to improve tolerability.\nThe dose will be escalated to 50 mg&#x2F;day after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg&#x2F;day (or 25 mg&#x2F;day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.</p><p>Naltrexone</p>"
          },
          {
            "id": "OG001",
            "title": "Sugar Pill",
            "description": "<p>The treatment schedule includes a daily dose of equivalent placebo for 5 weeks.\nTreatment will be initiated at 25 mg&#x2F;day during the first week to improve tolerability.\nThe dose will be escalated to 50 mg&#x2F;day after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg&#x2F;day (or 25 mg&#x2F;day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.</p><p>Sugar Pill</p>"
          }
        ],
        "timeFrame": "Evaluated at baseline, weekly monitoring visits from start of radiation therapy and meets fatigue eligibility threshold",
        "description": "Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-fatigue subscale): This 13-item self-report scale measuring fatigue and functional impairment as a result of fatigue has been validated in cancer patients (Cella et al.\nCancer 2002;94:528-38) The scale is reverse-scored and the range is 0 (maximum fatigue) - 52 (minimum fatigue).\nAccording to ICD10 criteria, a score &lt;= 34 indicates significant cancer related fatigue.\nA change of 10 points has been shown to constitute a clinically meaningful difference on this subscale.",
        "reportingStatus": "POSTED",
        "populationDescription": "trial terminated early"
      }
    ]
  },
  "participantFlowModule": {
    "groups": [
      {
        "id": "FG000",
        "title": "Naltrexone",
        "description": "The dose will be escalated to 50 mg&#x2F;day (or equivalent placebo) after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg&#x2F;day (or 25 mg&#x2F;day if dose is not escalated) for 4 weeks to complete a 5-week treatment period."
      },
      {
        "id": "FG001",
        "title": "Sugar Pill",
        "description": "daily dose placebo for 5 week treatment period"
      }
    ],
    "periods": [
      {
        "title": "Overall Study",
        "milestones": [
          {
            "type": "STARTED",
            "comment": "Represents intervention phase",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "2"
              },
              {
                "groupId": "FG001",
                "numSubjects": "1"
              }
            ]
          },
          {
            "type": "COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "0"
              },
              {
                "groupId": "FG001",
                "numSubjects": "0"
              }
            ]
          },
          {
            "type": "NOT COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "2"
              },
              {
                "groupId": "FG001",
                "numSubjects": "1"
              }
            ]
          }
        ],
        "dropWithdraws": [
          {
            "type": "trial terminated early",
            "reasons": [
              {
                "groupId": "FG000",
                "numSubjects": "2"
              },
              {
                "groupId": "FG001",
                "numSubjects": "1"
              }
            ]
          }
        ]
      }
    ],
    "preAssignmentDetails": "In the monitoring phase, eligibility for randomization was defined as FACIT-F subscale score &gt;=10 pre-radiation therapy and decrease in FACIT-F of 10 points."
  },
  "baselineCharacteristicsModule": {
    "denoms": [
      {
        "units": "Participants",
        "counts": [
          {
            "value": "2",
            "groupId": "BG000"
          },
          {
            "value": "1",
            "groupId": "BG001"
          },
          {
            "value": "3",
            "groupId": "BG002"
          }
        ]
      }
    ],
    "groups": [
      {
        "id": "BG000",
        "title": "Naltrexone",
        "description": "The dose will be escalated to 50 mg&#x2F;day (or equivalent placebo) after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg&#x2F;day (or 25 mg&#x2F;day if dose is not escalated) for 4 weeks to complete a 5-week treatment period."
      },
      {
        "id": "BG001",
        "title": "Placebo: Sugar Pill",
        "description": "daily dose placebo for 5 week treatment period"
      },
      {
        "id": "BG002",
        "title": "Total",
        "description": "Total of all reporting groups"
      }
    ],
    "measures": [
      {
        "title": "Age, Continuous",
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "49",
                    "groupId": "BG000",
                    "lowerLimit": "42",
                    "upperLimit": "56"
                  },
                  {
                    "value": "59",
                    "groupId": "BG001",
                    "lowerLimit": "59",
                    "upperLimit": "59"
                  },
                  {
                    "value": "52.3",
                    "groupId": "BG002",
                    "lowerLimit": "41",
                    "upperLimit": "59"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEAN",
        "unitOfMeasure": "Years",
        "dispersionType": "FULL_RANGE"
      },
      {
        "title": "Sex: Female, Male",
        "classes": [
          {
            "categories": [
              {
                "title": "Female",
                "measurements": [
                  {
                    "value": "2",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "3",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Male",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Race&#x2F;Ethnicity, Customized",
        "classes": [
          {
            "title": "White",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "2",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "3",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Region of Enrollment",
        "classes": [
          {
            "title": "United States",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "2",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "3",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "NUMBER",
        "unitOfMeasure": "participants"
      }
    ]
  }
}
add /documentSection
Triage: Uncategorized
Uncategorized Operation 26
After
{
  "largeDocumentModule": {
    "largeDocs": [
      {
        "date": "2016-03-30",
        "size": 4890065,
        "label": "Study Protocol and Statistical Analysis Plan",
        "hasIcf": false,
        "hasSap": true,
        "filename": "Prot_SAP_000.pdf",
        "typeAbbrev": "Prot_SAP",
        "uploadDate": "2020-11-04T16:42",
        "hasProtocol": true
      },
      {
        "date": "2016-03-30",
        "size": 4891365,
        "label": "Study Protocol and Statistical Analysis Plan",
        "hasIcf": false,
        "hasSap": true,
        "filename": "Prot_SAP_001.pdf",
        "typeAbbrev": "Prot_SAP",
        "uploadDate": "2020-11-04T16:46",
        "hasProtocol": true
      }
    ]
  }
}
Raw JSON Patch
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2021-11"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "TERMINATED"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
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            "organSystem": "Gastrointestinal disorders",
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