evt_NCT02137252_v6_v7_3e5b9e9e79b4

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/overallStatus",
    "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "/protocolSection/statusModule/completionDateStruct/date",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/whyStopped",
    "/protocolSection/statusModule/resultsFirstSubmitDate",
    "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "/protocolSection/armsInterventionsModule/armGroups/0/description",
    "/protocolSection/armsInterventionsModule/armGroups/1/label",
    "/protocolSection/armsInterventionsModule/armGroups/1/type",
    "/protocolSection/armsInterventionsModule/armGroups/1/description",
    "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames",
    "/protocolSection/armsInterventionsModule/armGroups/2",
    "/protocolSection/armsInterventionsModule/interventions/0/otherNames/0",
    "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "/protocolSection/outcomesModule/otherOutcomes",
    "/protocolSection/ipdSharingStatementModule",
    "/annotationSection",
    "/hasResults",
    "/resultsSection",
    "/documentSection"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT02137252_v6_v7_3e5b9e9e79b4. ClinicalTrials.gov NCT02137252, versions 6-7. Evidence version 1.",
  "claims_not_supported": [
    "That the amendment was scientifically unjustified.",
    "That the change constitutes misconduct or wrongdoing.",
    "That sponsor intent can be inferred from this registry change.",
    "That the change caused or altered the trial's results.",
    "That the change was or was not disclosed in a manuscript.",
    "That TrialDiff determines regulatory compliance or non-compliance.",
    "That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.",
    "That event-class membership is a validated global review-priority ranking."
  ],
  "claims_supported": [
    "TrialDiff compared ClinicalTrials.gov record version 6 to version 7 for NCT02137252.",
    "The JSON Patch for this comparison has hash 0fc4acbaa587335c07d2b23d9a608c7b8572f20f87d2871d5d46530697e2f907.",
    "The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
    "The deterministic triage label was high; before timing adjustment it was high.",
    "The triage label is uncalibrated metadata, not a validated review-priority finding.",
    "The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting.",
    "A registry field under an arm or intervention module changed between ClinicalTrials.gov versions 6 and 7.",
    "The timing context for the from-version record was post_recruitment.",
    "The deterministic rules that fired were: arms_or_interventions_change, terminal_status_change, why_stopped_change.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/overallStatus, /protocolSection/statusModule/primaryCompletionDateStruct/date, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/whyStopped, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/armsInterventionsModule/armGroups/0/description, /protocolSection/armsInterventionsModule/armGroups/1/label, /protocolSection/armsInterventionsModule/armGroups/1/type, /protocolSection/armsInterventionsModule/armGroups/1/description, /protocolSection/armsInterventionsModule/armGroups/1/interventionNames, /protocolSection/armsInterventionsModule/armGroups/2, /protocolSection/armsInterventionsModule/interventions/0/otherNames/0, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/otherOutcomes, /protocolSection/ipdSharingStatementModule, /annotationSection, /hasResults, /resultsSection, /documentSection.",
    "The timeline value moved by 823 days.",
    "An outcome path changed between versions 6 and 7 in a patch that also carried a hasResults or resultsSection co-occurrence signal.",
    "The changed paths include the ClinicalTrials.gov whyStopped field, a stopped-trial explanation field relevant to 42 CFR 11.64 when applicable."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "arm_intervention_change",
      "status_termination",
      "timeline_actual_date_correction",
      "results_reconciliation"
    ],
    "category": "arm_intervention_change",
    "deterministic_rules": [
      "arms_or_interventions_change",
      "terminal_status_change",
      "why_stopped_change"
    ],
    "event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting"
    ],
    "rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
    "severity": "high",
    "severity_pre_timing": "high",
    "timing_context": "post_recruitment",
    "triage_label": "high",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "timeline_actual_date_correction",
        "date_struct": "primaryCompletionDateStruct",
        "delta_days": 823,
        "direction": "earlier",
        "new_precision": "day",
        "new_type": "ACTUAL",
        "new_value": "2015-08-01",
        "old_precision": "month",
        "old_type": "ACTUAL",
        "old_value": "2017-11",
        "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
        "severity": "low",
        "signal": "timeline_actual_date_correction"
      },
      {
        "category": "timeline_actual_date_correction",
        "date_struct": "completionDateStruct",
        "delta_days": 823,
        "direction": "earlier",
        "new_precision": "day",
        "new_type": "ACTUAL",
        "new_value": "2015-08-01",
        "old_precision": "month",
        "old_type": "ACTUAL",
        "old_value": "2017-11",
        "path": "/protocolSection/statusModule/completionDateStruct/date",
        "severity": "low",
        "signal": "timeline_actual_date_correction"
      },
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/primaryOutcomes/0/description",
          "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
          "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT02137252_v6_v7_3e5b9e9e79b4",
  "evidence_version": 1,
  "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",
      "value": "2015-08-01"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/completionDateStruct/date",
      "value": "2015-08-01"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2021-11-12"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2021-11-16"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/whyStopped",
      "value": "no enough patients"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitDate",
      "value": "2021-10-01"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
      "value": "2021-11-12"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
      "value": {
        "date": "2021-11-16",
        "type": "ACTUAL"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
      "value": "The treatment schedule includes a daily dose of naltrexone for 5 weeks.\nTreatment will be initiated at 25 mg/day during the first week to improve tolerability.\nThe 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."
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/1/label",
      "value": "Sugar Pill"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/1/type",
      "value": "PLACEBO_COMPARATOR"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
      "value": "The treatment schedule includes a daily dose of equivalent placebo for 5 weeks.\nTreatment will be initiated at 25 mg/day during the first week to improve tolerability.\nThe 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."
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames",
      "value": [
        "Drug: Sugar Pill"
      ]
    },
    {
      "op": "remove",
      "path": "/protocolSection/armsInterventionsModule/armGroups/2"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames/0",
      "value": "ReVia®"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "value": "Change in FACIT-fatigue Subscale Score From Randomization to End of Study"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "value": "Evaluated at baseline, weekly monitoring visits from start of radiation therapy and meets fatigue eligibility threshold"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "value": "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 <= 34 indicates significant cancer related fatigue.\nA change of 10 points has been shown to constitute a clinically meaningful difference on this subscale."
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/otherOutcomes"
    },
    {
      "op": "add",
      "path": "/protocolSection/ipdSharingStatementModule",
      "value": {
        "ipdSharing": "NO"
      }
    },
    {
      "op": "remove",
      "path": "/annotationSection"
    },
    {
      "op": "replace",
      "path": "/hasResults",
      "value": true
    },
    {
      "op": "add",
      "path": "/resultsSection",
      "value": {
        "adverseEventsModule": {
          "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": [
            {
              "deathsNumAffected": 0,
              "deathsNumAtRisk": 2,
              "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.",
              "id": "EG000",
              "otherNumAffected": 2,
              "otherNumAtRisk": 2,
              "seriousNumAffected": 0,
              "seriousNumAtRisk": 2,
              "title": "Naltrexone"
            },
            {
              "deathsNumAffected": 0,
              "deathsNumAtRisk": 1,
              "description": "daily dose placebo for 5 week treatment period",
              "id": "EG001",
              "otherNumAffected": 1,
              "otherNumAtRisk": 1,
              "seriousNumAffected": 0,
              "seriousNumAtRisk": 1,
              "title": "Sugar Pill"
            }
          ],
          "frequencyThreshold": "0",
          "otherEvents": [
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "CTCAE (4.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 2
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 1
                }
              ],
              "term": "Dermatitis radiation"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "CTCAE (4.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 2
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 1
                }
              ],
              "term": "fatigue"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "CTCAE (4.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 1
                }
              ],
              "term": "headache"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "CTCAE (4.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 1
                }
              ],
              "term": "nausea"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "CTCAE (4.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 1
                }
              ],
              "term": "dizziness"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "CTCAE (4.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 1
                }
              ],
              "term": "irritability"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "CTCAE (4.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 2
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 1
                }
              ],
              "term": "mental fogginess"
            }
          ],
          "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."
        },
        "baselineCharacteristicsModule": {
          "denoms": [
            {
              "counts": [
                {
                  "groupId": "BG000",
                  "value": "2"
                },
                {
                  "groupId": "BG001",
                  "value": "1"
                },
                {
                  "groupId": "BG002",
                  "value": "3"
                }
              ],
              "units": "Participants"
            }
          ],
          "groups": [
            {
              "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.",
              "id": "BG000",
              "title": "Naltrexone"
            },
            {
              "description": "daily dose placebo for 5 week treatment period",
              "id": "BG001",
              "title": "Placebo: Sugar Pill"
            },
            {
              "description": "Total of all reporting groups",
              "id": "BG002",
              "title": "Total"
            }
          ],
          "measures": [
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "lowerLimit": "42",
                          "upperLimit": "56",
                          "value": "49"
                        },
                        {
                          "groupId": "BG001",
                          "lowerLimit": "59",
                          "upperLimit": "59",
                          "value": "59"
                        },
                        {
                          "groupId": "BG002",
                          "lowerLimit": "41",
                          "upperLimit": "59",
                          "value": "52.3"
                        }
                      ]
                    }
                  ]
                }
              ],
              "dispersionType": "FULL_RANGE",
              "paramType": "MEAN",
              "title": "Age, Continuous",
              "unitOfMeasure": "Years"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "2"
                        },
                        {
                          "groupId": "BG001",
                          "value": "1"
                        },
                        {
                          "groupId": "BG002",
                          "value": "3"
                        }
                      ],
                      "title": "Female"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        }
                      ],
                      "title": "Male"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Sex: Female, Male",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "2"
                        },
                        {
                          "groupId": "BG001",
                          "value": "1"
                        },
                        {
                          "groupId": "BG002",
                          "value": "3"
                        }
                      ]
                    }
                  ],
                  "title": "White"
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Race/Ethnicity, Customized",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "2"
                        },
                        {
                          "groupId": "BG001",
                          "value": "1"
                        },
                        {
                          "groupId": "BG002",
                          "value": "3"
                        }
                      ]
                    }
                  ],
                  "title": "United States"
                }
              ],
              "paramType": "NUMBER",
              "title": "Region of Enrollment",
              "unitOfMeasure": "participants"
            }
          ]
        },
        "moreInfoModule": {
          "certainAgreement": {
            "piSponsorEmployee": true
          },
          "pointOfContact": {
            "email": "flmeyer@partners.org",
            "organization": "Dana-Farber Cancer Institute/Brigham and Women's Hospital",
            "title": "Fremonta Meyer, MD"
          }
        },
        "outcomeMeasuresModule": {
          "outcomeMeasures": [
            {
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "0"
                    },
                    {
                      "groupId": "OG001",
                      "value": "0"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "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 <= 34 indicates significant cancer related fatigue.\nA change of 10 points has been shown to constitute a clinically meaningful difference on this subscale.",
              "groups": [
                {
                  "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": "OG000",
                  "title": "Naltrexone"
                },
                {
                  "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>",
                  "id": "OG001",
                  "title": "Sugar Pill"
                }
              ],
              "populationDescription": "trial terminated early",
              "reportingStatus": "POSTED",
              "timeFrame": "Evaluated at baseline, weekly monitoring visits from start of radiation therapy and meets fatigue eligibility threshold",
              "title": "Change in FACIT-fatigue Subscale Score From Randomization to End of Study",
              "type": "PRIMARY"
            }
          ]
        },
        "participantFlowModule": {
          "groups": [
            {
              "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": "FG000",
              "title": "Naltrexone"
            },
            {
              "description": "daily dose placebo for 5 week treatment period",
              "id": "FG001",
              "title": "Sugar Pill"
            }
          ],
          "periods": [
            {
              "dropWithdraws": [
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "2"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "1"
                    }
                  ],
                  "type": "trial terminated early"
                }
              ],
              "milestones": [
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "2"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "1"
                    }
                  ],
                  "comment": "Represents intervention phase",
                  "type": "STARTED"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "COMPLETED"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "2"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "1"
                    }
                  ],
                  "type": "NOT COMPLETED"
                }
              ],
              "title": "Overall Study"
            }
          ],
          "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."
        }
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  "review_question": "What source document explains this registry amendment, and does it change interpretation of the trial record?",
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