evt_NCT00769379_v1590_v1591_26d91261795d

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/resultsFirstSubmitDate",
    "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
    "/annotationSection",
    "/hasResults",
    "/resultsSection"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT00769379_v1590_v1591_26d91261795d. ClinicalTrials.gov NCT00769379, versions 1590-1591. 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 1590 to version 1591 for NCT00769379.",
    "The JSON Patch for this comparison has hash 87072e77c81bf3b0dc28cb59ecfaa103818fd11a2b7c94b1c35ef8a9e2d5f6c2.",
    "The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.",
    "The deterministic triage label was low; before timing adjustment it was low.",
    "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.",
    "The timing context for the from-version record was late_recruitment.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4/measure, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/5/measure, /protocolSection/outcomesModule/secondaryOutcomes/5/description, /annotationSection, /hasResults, /resultsSection.",
    "An outcome path changed between versions 1590 and 1591 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "results_reconciliation"
    ],
    "category": "results_reconciliation",
    "deterministic_rules": [],
    "event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting"
    ],
    "rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
    "severity": "low",
    "severity_pre_timing": "low",
    "timing_context": "late_recruitment",
    "triage_label": "low",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/primaryOutcomes/0/description",
          "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
          "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/5/measure"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT00769379_v1590_v1591_26d91261795d",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2022-01"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2022-01-31"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2022-02-23"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitDate",
      "value": "2021-03-23"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
      "value": "2022-01-31"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
      "value": {
        "date": "2022-02-23",
        "type": "ACTUAL"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "value": "Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence, or Ipsilateral DCIS-Free Survival"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "value": "Patients who are free from Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence or Ipsilateral DCIS as estimated by (1- cumulative incidence) x 100%."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "value": "5 years"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
      "value": "Invasive or DCIS Disease-free Survival"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
      "value": "Events for analysis of IDFS-DCIS include: local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer (other than squamous and basal cell carcinoma of the skin, melanoma in situ, and carcinoma in situ of the colon and cervix), or death from any cause prior to recurrence or second primary cancer.\nInvasive breast cancer, ipsilateral recurrence, and contralateral breast cancer will be compared across treatment arms using cumulative incidence functions.\nPercentage of patients by a Kaplan-Meier analysis who are free of invasive or DCIS disease"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
      "value": "5 years"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
      "value": "Invasive or DCIS Recurrence-free Interval"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
      "value": "Cox proportional hazards models will be used to evaluate the effect of treatment on time to event.\nThe distributions of time to event will be estimated by the Kaplan-Meier method for each treatment group and will be compared between treatments by simple and stratified log-rank tests.\nCompared across treatment arms using cumulative incidence functions.Percentage of patients who are invasive or DCIS recurrence free estimated by (1-cumulative incidence) x 100%."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
      "value": "5 years"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
      "value": "Invasive Regional or Distant-Free Recurrence"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
      "value": "<p>Percentage of patients who are free of invasive regional or distant recurrence as estimated by</p><p>(1 - cumulative incidence) x 100%.</p>"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
      "value": "5 years"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
      "value": "Contralateral Breast Cancer (Invasive or DCIS) - Free Survival"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
      "value": "<p>Percentage of patients free of Contralateral Breast Cancer (Invasive or DCIS) as estimated by</p><p>(1- cumulative incidence) x 100%.</p>"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
      "value": "5 years"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
      "value": "Overall Survival"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
      "value": "Percentage of patients surviving as estimated by a Kaplan-Meier"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
      "value": "5 years"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
      "value": "Incidence of Post-treatment Amenorrhea in Women Who Were Premenopausal at the Time of Study Entry Premenopausal at the Time of Study Entry"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
      "value": "Proportion of patients who were pre-menopausal at randomization and who self-reported as not having menstrual periods afterwards"
    },
    {
      "op": "remove",
      "path": "/annotationSection"
    },
    {
      "op": "replace",
      "path": "/hasResults",
      "value": true
    },
    {
      "op": "add",
      "path": "/resultsSection",
      "value": {
        "adverseEventsModule": {
          "description": "All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization.\nAdverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.",
          "eventGroups": [
            {
              "deathsNumAffected": 11,
              "deathsNumAtRisk": 1005,
              "description": "standard WBI",
              "id": "EG000",
              "otherNumAffected": 292,
              "otherNumAtRisk": 998,
              "seriousNumAffected": 3,
              "seriousNumAtRisk": 998,
              "title": "Standard WBI"
            },
            {
              "deathsNumAffected": 10,
              "deathsNumAtRisk": 993,
              "description": "WBI, trastuzumab",
              "id": "EG001",
              "otherNumAffected": 254,
              "otherNumAtRisk": 990,
              "seriousNumAffected": 9,
              "seriousNumAtRisk": 990,
              "title": "WBI, Trastuzumab"
            }
          ],
          "frequencyThreshold": "5",
          "otherEvents": [
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "CTCAE v4.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 80,
                  "numAtRisk": 998
                },
                {
                  "groupId": "EG001",
                  "numAffected": 77,
                  "numAtRisk": 990
                }
              ],
              "term": "Fatigue"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "CTCAE v4.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 261,
                  "numAtRisk": 998
                },
                {
                  "groupId": "EG001",
                  "numAffected": 208,
                  "numAtRisk": 990
                }
              ],
              "term": "Dermatitis radiation"
            }
          ],
          "seriousEvents": [
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "CTCAE v4.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 998
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 990
                }
              ],
              "term": "Atrial flutter"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "CTCAE v4.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 998
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 990
                }
              ],
              "term": "Cardiac troponin I increased"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Hepatobiliary disorders",
              "sourceVocabulary": "CTCAE v4.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 998
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 990
                }
              ],
              "term": "Cholecystitis"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "CTCAE v4.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 998
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 990
                }
              ],
              "term": "Dehydration"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "CTCAE v4.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 998
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 990
                }
              ],
              "term": "Hyperglycemia"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "CTCAE v4.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 998
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 990
                }
              ],
              "term": "Hypotension"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "CTCAE v4.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 998
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 990
                }
              ],
              "term": "Injury, poisoning and procedural complications - Other, specify"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "CTCAE v4.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 998
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 990
                }
              ],
              "term": "Myocardial infarction"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "CTCAE v4.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 998
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 990
                }
              ],
              "term": "Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "CTCAE v4.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 998
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 990
                }
              ],
              "term": "Thromboembolic event"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "CTCAE v4.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 998
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 990
                }
              ],
              "term": "Urinary tract infection"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Ear and labyrinth disorders",
              "sourceVocabulary": "CTCAE v4.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 998
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 990
                }
              ],
              "term": "Vertigo"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "CTCAE v4.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 998
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 990
                }
              ],
              "term": "Leukemia secondary to oncology chemotherapy"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
              "sourceVocabulary": "CTCAE v4.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 998
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 990
                }
              ],
              "term": "Treatment related secondary malignancy"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "CTCAE v4.0",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 998
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 990
                }
              ],
              "term": "Lung infection"
            }
          ],
          "timeFrame": "All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose."
        },
        "baselineCharacteristicsModule": {
          "denoms": [
            {
              "counts": [
                {
                  "groupId": "BG000",
                  "value": "1008"
                },
                {
                  "groupId": "BG001",
                  "value": "1006"
                },
                {
                  "groupId": "BG002",
                  "value": "2014"
                }
              ],
              "units": "Participants"
            }
          ],
          "groups": [
            {
              "description": "Standard WBI (Radiation Therapy)",
              "id": "BG000",
              "title": "Standard WBI"
            },
            {
              "description": "WBI, trastuzumab (Radiation Therapy + Trastuzumab x 2 doses.\nDose 1: 8 mg&#x2F;kg IV Dose 2: 6 mg&#x2F;kg IV-given 3 weeks after dose 1",
              "id": "BG001",
              "title": "WBI, Trastuzumab"
            },
            {
              "description": "Total of all reporting groups",
              "id": "BG002",
              "title": "Total"
            }
          ],
          "measures": [
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "spread": "9.3",
                          "value": "56"
                        },
                        {
                          "groupId": "BG001",
                          "spread": "8.7",
                          "value": "56"
                        },
                        {
                          "groupId": "BG002",
                          "spread": "9.0",
                          "value": "56"
                        }
                      ]
                    }
                  ]
                }
              ],
              "dispersionType": "STANDARD_DEVIATION",
              "paramType": "MEAN",
              "title": "Age, Continuous",
              "unitOfMeasure": "years"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "1008"
                        },
                        {
                          "groupId": "BG001",
                          "value": "1006"
                        },
                        {
                          "groupId": "BG002",
                          "value": "2014"
                        }
                      ],
                      "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": "5"
                        },
                        {
                          "groupId": "BG001",
                          "value": "5"
                        },
                        {
                          "groupId": "BG002",
                          "value": "10"
                        }
                      ],
                      "title": "American Indian or Alaska Native"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "33"
                        },
                        {
                          "groupId": "BG001",
                          "value": "43"
                        },
                        {
                          "groupId": "BG002",
                          "value": "76"
                        }
                      ],
                      "title": "Asian"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "4"
                        },
                        {
                          "groupId": "BG001",
                          "value": "4"
                        },
                        {
                          "groupId": "BG002",
                          "value": "8"
                        }
                      ],
                      "title": "Native Hawaiian or Other Pacific Islander"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "59"
                        },
                        {
                          "groupId": "BG001",
                          "value": "58"
                        },
                        {
                          "groupId": "BG002",
                          "value": "117"
                        }
                      ],
                      "title": "Black or African American"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "893"
                        },
                        {
                          "groupId": "BG001",
                          "value": "885"
                        },
                        {
                          "groupId": "BG002",
                          "value": "1778"
                        }
                      ],
                      "title": "White"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "4"
                        },
                        {
                          "groupId": "BG001",
                          "value": "1"
                        },
                        {
                          "groupId": "BG002",
                          "value": "5"
                        }
                      ],
                      "title": "More than one race"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "10"
                        },
                        {
                          "groupId": "BG001",
                          "value": "10"
                        },
                        {
                          "groupId": "BG002",
                          "value": "20"
                        }
                      ],
                      "title": "Unknown or Not Reported"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Race (NIH&#x2F;OMB)",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "45"
                        },
                        {
                          "groupId": "BG001",
                          "value": "47"
                        },
                        {
                          "groupId": "BG002",
                          "value": "92"
                        }
                      ]
                    }
                  ],
                  "title": "Latino"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "925"
                        },
                        {
                          "groupId": "BG001",
                          "value": "920"
                        },
                        {
                          "groupId": "BG002",
                          "value": "1845"
                        }
                      ]
                    }
                  ],
                  "title": "Non-Latino"
                },
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "38"
                        },
                        {
                          "groupId": "BG001",
                          "value": "39"
                        },
                        {
                          "groupId": "BG002",
                          "value": "77"
                        }
                      ]
                    }
                  ],
                  "title": "Unknown"
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Race&#x2F;Ethnicity, Customized",
              "unitOfMeasure": "Participants"
            }
          ]
        },
        "moreInfoModule": {
          "certainAgreement": {
            "piSponsorEmployee": false,
            "restrictionType": "LTE60",
            "restrictiveAgreement": true
          },
          "pointOfContact": {
            "email": "langerj@nrgoncology.org",
            "organization": "NRG Oncology",
            "phone": "412-339-5300",
            "title": "Director, Department of Regulatory Affairs"
          }
        },
        "outcomeMeasuresModule": {
          "outcomeMeasures": [
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "93.8",
                          "upperLimit": "96.5",
                          "value": "95.1"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "94.9",
                          "upperLimit": "97.3",
                          "value": "96.1"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "1005"
                    },
                    {
                      "groupId": "OG001",
                      "value": "993"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Patients who are free from Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence or Ipsilateral DCIS as estimated by (1- cumulative incidence) x 100%.",
              "dispersionType": "95% Confidence Interval",
              "groups": [
                {
                  "description": "<p>Patients undergo standard WBI over 5-6 weeks.</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Whole Breast Irradiation: Undergo standard whole breast irradiation</p>",
                  "id": "OG000",
                  "title": "Arm I (Standard WBI)"
                },
                {
                  "description": "<p>Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I.</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Trastuzumab: Given IV</p><p>Whole Breast Irradiation: Undergo standard whole breast irradiation</p>",
                  "id": "OG001",
                  "title": "Arm II (WBI, Trastuzumab)"
                }
              ],
              "paramType": "NUMBER",
              "reportingStatus": "POSTED",
              "timeFrame": "5 years",
              "title": "Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence, or Ipsilateral DCIS-Free Survival",
              "type": "PRIMARY",
              "unitOfMeasure": "percentage of patients event free"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "86.3",
                          "upperLimit": "90.4",
                          "value": "88.4"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "88.8",
                          "upperLimit": "92.5",
                          "value": "90.6"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "1005"
                    },
                    {
                      "groupId": "OG001",
                      "value": "993"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Events for analysis of IDFS-DCIS include: local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer (other than squamous and basal cell carcinoma of the skin, melanoma in situ, and carcinoma in situ of the colon and cervix), or death from any cause prior to recurrence or second primary cancer.\nInvasive breast cancer, ipsilateral recurrence, and contralateral breast cancer will be compared across treatment arms using cumulative incidence functions.\nPercentage of patients by a Kaplan-Meier analysis who are free of invasive or DCIS disease",
              "dispersionType": "95% Confidence Interval",
              "groups": [
                {
                  "description": "<p>Patients undergo standard WBI over 5-6 weeks.</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Whole Breast Irradiation: Undergo standard whole breast irradiation</p>",
                  "id": "OG000",
                  "title": "Arm I (Standard WBI)"
                },
                {
                  "description": "<p>Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I.</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Trastuzumab: Given IV</p><p>Whole Breast Irradiation: Undergo standard whole breast irradiation</p>",
                  "id": "OG001",
                  "title": "Arm II (WBI, Trastuzumab)"
                }
              ],
              "paramType": "NUMBER",
              "reportingStatus": "POSTED",
              "timeFrame": "5 years",
              "title": "Invasive or DCIS Disease-free Survival",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of patients event free"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "92.9",
                          "upperLimit": "95.8",
                          "value": "94.4"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "94.5",
                          "upperLimit": "97.1",
                          "value": "95.8"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "1005"
                    },
                    {
                      "groupId": "OG001",
                      "value": "993"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Cox proportional hazards models will be used to evaluate the effect of treatment on time to event.\nThe distributions of time to event will be estimated by the Kaplan-Meier method for each treatment group and will be compared between treatments by simple and stratified log-rank tests.\nCompared across treatment arms using cumulative incidence functions.Percentage of patients who are invasive or DCIS recurrence free estimated by (1-cumulative incidence) x 100%.",
              "dispersionType": "95% Confidence Interval",
              "groups": [
                {
                  "description": "<p>Patients undergo standard WBI over 5-6 weeks.</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Whole Breast Irradiation: Undergo standard whole breast irradiation</p>",
                  "id": "OG000",
                  "title": "Arm I (Standard WBI)"
                },
                {
                  "description": "<p>Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I.</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Trastuzumab: Given IV</p><p>Whole Breast Irradiation: Undergo standard whole breast irradiation</p>",
                  "id": "OG001",
                  "title": "Arm II (WBI, Trastuzumab)"
                }
              ],
              "paramType": "NUMBER",
              "reportingStatus": "POSTED",
              "timeFrame": "5 years",
              "title": "Invasive or DCIS Recurrence-free Interval",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of patients event free"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "99.7",
                          "upperLimit": "100.0",
                          "value": "99.9"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "99.7",
                          "upperLimit": "100.0",
                          "value": "99.9"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "1005"
                    },
                    {
                      "groupId": "OG001",
                      "value": "993"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "<p>Percentage of patients who are free of invasive regional or distant recurrence as estimated by</p><p>(1 - cumulative incidence) x 100%.</p>",
              "dispersionType": "95% Confidence Interval",
              "groups": [
                {
                  "description": "<p>Patients undergo standard WBI over 5-6 weeks.</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Whole Breast Irradiation: Undergo standard whole breast irradiation</p>",
                  "id": "OG000",
                  "title": "Arm I (Standard WBI)"
                },
                {
                  "description": "<p>Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I.</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Trastuzumab: Given IV</p><p>Whole Breast Irradiation: Undergo standard whole breast irradiation</p>",
                  "id": "OG001",
                  "title": "Arm II (WBI, Trastuzumab)"
                }
              ],
              "paramType": "NUMBER",
              "reportingStatus": "POSTED",
              "timeFrame": "5 years",
              "title": "Invasive Regional or Distant-Free Recurrence",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of patients event free"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "97.0",
                          "upperLimit": "98.8",
                          "value": "97.9"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "97.6",
                          "upperLimit": "99.2",
                          "value": "98.4"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "1005"
                    },
                    {
                      "groupId": "OG001",
                      "value": "993"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "<p>Percentage of patients free of Contralateral Breast Cancer (Invasive or DCIS) as estimated by</p><p>(1- cumulative incidence) x 100%.</p>",
              "dispersionType": "95% Confidence Interval",
              "groups": [
                {
                  "description": "<p>Patients undergo standard WBI over 5-6 weeks.</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Whole Breast Irradiation: Undergo standard whole breast irradiation</p>",
                  "id": "OG000",
                  "title": "Arm I (Standard WBI)"
                },
                {
                  "description": "<p>Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I.</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Trastuzumab: Given IV</p><p>Whole Breast Irradiation: Undergo standard whole breast irradiation</p>",
                  "id": "OG001",
                  "title": "Arm II (WBI, Trastuzumab)"
                }
              ],
              "paramType": "NUMBER",
              "reportingStatus": "POSTED",
              "timeFrame": "5 years",
              "title": "Contralateral Breast Cancer (Invasive or DCIS) - Free Survival",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of patients event free"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "98.2",
                          "upperLimit": "99.5",
                          "value": "98.9"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "98.3",
                          "upperLimit": "99.6",
                          "value": "99.0"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "1005"
                    },
                    {
                      "groupId": "OG001",
                      "value": "993"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Percentage of patients surviving as estimated by a Kaplan-Meier",
              "dispersionType": "95% Confidence Interval",
              "groups": [
                {
                  "description": "<p>Patients undergo standard WBI over 5-6 weeks.</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Whole Breast Irradiation: Undergo standard whole breast irradiation</p>",
                  "id": "OG000",
                  "title": "Arm I (Standard WBI)"
                },
                {
                  "description": "<p>Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I.</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Trastuzumab: Given IV</p><p>Whole Breast Irradiation: Undergo standard whole breast irradiation</p>",
                  "id": "OG001",
                  "title": "Arm II (WBI, Trastuzumab)"
                }
              ],
              "paramType": "NUMBER",
              "reportingStatus": "POSTED",
              "timeFrame": "5 years",
              "title": "Overall Survival",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of patients surviving"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "63"
                        },
                        {
                          "groupId": "OG001",
                          "value": "72"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "126"
                    },
                    {
                      "groupId": "OG001",
                      "value": "121"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Proportion of patients who were pre-menopausal at randomization and who self-reported as not having menstrual periods afterwards",
              "groups": [
                {
                  "description": "<p>Patients undergo standard WBI over 5-6 weeks.</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Whole Breast Irradiation: Undergo standard whole breast irradiation</p>",
                  "id": "OG000",
                  "title": "Arm I (Standard WBI)"
                },
                {
                  "description": "<p>Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I.</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Trastuzumab: Given IV</p><p>Whole Breast Irradiation: Undergo standard whole breast irradiation</p>",
                  "id": "OG001",
                  "title": "Arm II (WBI, Trastuzumab)"
                }
              ],
              "paramType": "NUMBER",
              "populationDescription": "All patients who reported being postmenopausal at randomization who later self-reported as yes or no to whether or not they had menstrual periods.",
              "reportingStatus": "POSTED",
              "timeFrame": "18 months",
              "title": "Incidence of Post-treatment Amenorrhea in Women Who Were Premenopausal at the Time of Study Entry Premenopausal at the Time of Study Entry",
              "type": "SECONDARY",
              "unitOfMeasure": "percentage of participants"
            }
          ]
        },
        "participantFlowModule": {
          "groups": [
            {
              "description": "<p>Patients undergo standard WBI over 5-6 weeks.</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Whole Breast Irradiation: Undergo standard whole breast irradiation</p>",
              "id": "FG000",
              "title": "Arm I (Standard WBI)"
            },
            {
              "description": "<p>Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I.</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Trastuzumab: Given IV</p><p>Whole Breast Irradiation: Undergo standard whole breast irradiation</p>",
              "id": "FG001",
              "title": "Arm II (WBI, Trastuzumab)"
            }
          ],
          "periods": [
            {
              "dropWithdraws": [
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "3"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "13"
                    }
                  ],
                  "type": "No follow up data mapped to Other."
                }
              ],
              "milestones": [
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "1008"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "1006"
                    }
                  ],
                  "type": "STARTED"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "1005"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "993"
                    }
                  ],
                  "type": "COMPLETED"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "3"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "13"
                    }
                  ],
                  "type": "NOT COMPLETED"
                }
              ],
              "title": "Overall Study"
            }
          ]
        }
      }
    }
  ],
  "provenance": {
    "from_snapshot_hash": "2fa261cc3db93cb4ca73fd48809c8a41e95411249aebbd977259a079683e2757",
    "materiality_event_hash": "89aab6984e5e6f70a5325ebf4ae6d86152ff5e12da07d383d0f86186a7d820ab",
    "patch_hash": "87072e77c81bf3b0dc28cb59ecfaa103818fd11a2b7c94b1c35ef8a9e2d5f6c2",
    "patch_raw_hash": "c87aa9fac7b2d88d04f1fa5a86722a6f597e23fedb187e3a3e623ad2bf46205b",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT00769379/history/1590?patchToVersion=1591",
    "to_snapshot_hash": "407e04abbc0ae395bdf6806aa33e78c649565a89f2395626b5f5182941671509"
  },
  "review_question": "What source document explains this registry amendment, and does it change interpretation of the trial record?",
  "schema": "trialdiff.evidence_record",
  "trial": {
    "clinicaltrials_gov_url": "https://clinicaltrials.gov/study/NCT00769379",
    "nct_id": "NCT00769379"
  },
  "versions": {
    "from_version": 1590,
    "submitted_date": "2022-01-31",
    "to_version": 1591
  }
}