Raw JSON 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": {
"moreInfoModule": {
"pointOfContact": {
"email": "langerj@nrgoncology.org",
"phone": "412-339-5300",
"title": "Director, Department of Regulatory Affairs",
"organization": "NRG Oncology"
},
"certainAgreement": {
"restrictionType": "LTE60",
"piSponsorEmployee": false,
"restrictiveAgreement": true
}
},
"adverseEventsModule": {
"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.",
"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": [
{
"id": "EG000",
"title": "Standard WBI",
"description": "standard WBI",
"otherNumAtRisk": 998,
"deathsNumAtRisk": 1005,
"otherNumAffected": 292,
"seriousNumAtRisk": 998,
"deathsNumAffected": 11,
"seriousNumAffected": 3
},
{
"id": "EG001",
"title": "WBI, Trastuzumab",
"description": "WBI, trastuzumab",
"otherNumAtRisk": 990,
"deathsNumAtRisk": 993,
"otherNumAffected": 254,
"seriousNumAtRisk": 990,
"deathsNumAffected": 10,
"seriousNumAffected": 9
}
],
"otherEvents": [
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 998,
"numAffected": 80
},
{
"groupId": "EG001",
"numAtRisk": 990,
"numAffected": 77
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Dermatitis radiation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 998,
"numAffected": 261
},
{
"groupId": "EG001",
"numAtRisk": 990,
"numAffected": 208
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
}
],
"seriousEvents": [
{
"term": "Atrial flutter",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 998,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 990,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Cardiac troponin I increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 998,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 990,
"numAffected": 0
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Cholecystitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 998,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 990,
"numAffected": 1
}
],
"organSystem": "Hepatobiliary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Dehydration",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 998,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 990,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Hyperglycemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 998,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 990,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Hypotension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 998,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 990,
"numAffected": 1
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Injury, poisoning and procedural complications - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 998,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 990,
"numAffected": 1
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Myocardial infarction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 998,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 990,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 998,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 990,
"numAffected": 1
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Thromboembolic event",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 998,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 990,
"numAffected": 1
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Urinary tract infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 998,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 990,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Vertigo",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 998,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 990,
"numAffected": 1
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Leukemia secondary to oncology chemotherapy",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 998,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 990,
"numAffected": 0
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Treatment related secondary malignancy",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 998,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 990,
"numAffected": 1
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Lung infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 998,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 990,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
}
],
"frequencyThreshold": "5"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence, or Ipsilateral DCIS-Free Survival",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1005",
"groupId": "OG000"
},
{
"value": "993",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Standard WBI)",
"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": "OG001",
"title": "Arm II (WBI, Trastuzumab)",
"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>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "95.1",
"groupId": "OG000",
"lowerLimit": "93.8",
"upperLimit": "96.5"
},
{
"value": "96.1",
"groupId": "OG001",
"lowerLimit": "94.9",
"upperLimit": "97.3"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"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%.",
"unitOfMeasure": "percentage of patients event free",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED"
},
{
"type": "SECONDARY",
"title": "Invasive or DCIS Disease-free Survival",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1005",
"groupId": "OG000"
},
{
"value": "993",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Standard WBI)",
"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": "OG001",
"title": "Arm II (WBI, Trastuzumab)",
"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>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "88.4",
"groupId": "OG000",
"lowerLimit": "86.3",
"upperLimit": "90.4"
},
{
"value": "90.6",
"groupId": "OG001",
"lowerLimit": "88.8",
"upperLimit": "92.5"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"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",
"unitOfMeasure": "percentage of patients event free",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED"
},
{
"type": "SECONDARY",
"title": "Invasive or DCIS Recurrence-free Interval",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1005",
"groupId": "OG000"
},
{
"value": "993",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Standard WBI)",
"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": "OG001",
"title": "Arm II (WBI, Trastuzumab)",
"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>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "94.4",
"groupId": "OG000",
"lowerLimit": "92.9",
"upperLimit": "95.8"
},
{
"value": "95.8",
"groupId": "OG001",
"lowerLimit": "94.5",
"upperLimit": "97.1"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"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%.",
"unitOfMeasure": "percentage of patients event free",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED"
},
{
"type": "SECONDARY",
"title": "Invasive Regional or Distant-Free Recurrence",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1005",
"groupId": "OG000"
},
{
"value": "993",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Standard WBI)",
"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": "OG001",
"title": "Arm II (WBI, Trastuzumab)",
"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>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "99.9",
"groupId": "OG000",
"lowerLimit": "99.7",
"upperLimit": "100.0"
},
{
"value": "99.9",
"groupId": "OG001",
"lowerLimit": "99.7",
"upperLimit": "100.0"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"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>",
"unitOfMeasure": "percentage of patients event free",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED"
},
{
"type": "SECONDARY",
"title": "Contralateral Breast Cancer (Invasive or DCIS) - Free Survival",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1005",
"groupId": "OG000"
},
{
"value": "993",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Standard WBI)",
"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": "OG001",
"title": "Arm II (WBI, Trastuzumab)",
"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>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "97.9",
"groupId": "OG000",
"lowerLimit": "97.0",
"upperLimit": "98.8"
},
{
"value": "98.4",
"groupId": "OG001",
"lowerLimit": "97.6",
"upperLimit": "99.2"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"description": "<p>Percentage of patients free of Contralateral Breast Cancer (Invasive or DCIS) as estimated by</p><p>(1- cumulative incidence) x 100%.</p>",
"unitOfMeasure": "percentage of patients event free",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED"
},
{
"type": "SECONDARY",
"title": "Overall Survival",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1005",
"groupId": "OG000"
},
{
"value": "993",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Standard WBI)",
"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": "OG001",
"title": "Arm II (WBI, Trastuzumab)",
"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>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "98.9",
"groupId": "OG000",
"lowerLimit": "98.2",
"upperLimit": "99.5"
},
{
"value": "99.0",
"groupId": "OG001",
"lowerLimit": "98.3",
"upperLimit": "99.6"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"description": "Percentage of patients surviving as estimated by a Kaplan-Meier",
"unitOfMeasure": "percentage of patients surviving",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED"
},
{
"type": "SECONDARY",
"title": "Incidence of Post-treatment Amenorrhea in Women Who Were Premenopausal at the Time of Study Entry Premenopausal at the Time of Study Entry",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "126",
"groupId": "OG000"
},
{
"value": "121",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Standard WBI)",
"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": "OG001",
"title": "Arm II (WBI, Trastuzumab)",
"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>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "63",
"groupId": "OG000"
},
{
"value": "72",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "18 months",
"description": "Proportion of patients who were pre-menopausal at randomization and who self-reported as not having menstrual periods afterwards",
"unitOfMeasure": "percentage of participants",
"reportingStatus": "POSTED",
"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."
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Arm I (Standard WBI)",
"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": "FG001",
"title": "Arm II (WBI, Trastuzumab)",
"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>"
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "1008"
},
{
"groupId": "FG001",
"numSubjects": "1006"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "1005"
},
{
"groupId": "FG001",
"numSubjects": "993"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "3"
},
{
"groupId": "FG001",
"numSubjects": "13"
}
]
}
],
"dropWithdraws": [
{
"type": "No follow up data mapped to Other.",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "3"
},
{
"groupId": "FG001",
"numSubjects": "13"
}
]
}
]
}
]
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1008",
"groupId": "BG000"
},
{
"value": "1006",
"groupId": "BG001"
},
{
"value": "2014",
"groupId": "BG002"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Standard WBI",
"description": "Standard WBI (Radiation Therapy)"
},
{
"id": "BG001",
"title": "WBI, Trastuzumab",
"description": "WBI, trastuzumab (Radiation Therapy + Trastuzumab x 2 doses.\nDose 1: 8 mg/kg IV Dose 2: 6 mg/kg IV-given 3 weeks after dose 1"
},
{
"id": "BG002",
"title": "Total",
"description": "Total of all reporting groups"
}
],
"measures": [
{
"title": "Age, Continuous",
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "56",
"spread": "9.3",
"groupId": "BG000"
},
{
"value": "56",
"spread": "8.7",
"groupId": "BG001"
},
{
"value": "56",
"spread": "9.0",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "MEAN",
"unitOfMeasure": "years",
"dispersionType": "STANDARD_DEVIATION"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "1008",
"groupId": "BG000"
},
{
"value": "1006",
"groupId": "BG001"
},
{
"value": "2014",
"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 (NIH/OMB)",
"classes": [
{
"categories": [
{
"title": "American Indian or Alaska Native",
"measurements": [
{
"value": "5",
"groupId": "BG000"
},
{
"value": "5",
"groupId": "BG001"
},
{
"value": "10",
"groupId": "BG002"
}
]
},
{
"title": "Asian",
"measurements": [
{
"value": "33",
"groupId": "BG000"
},
{
"value": "43",
"groupId": "BG001"
},
{
"value": "76",
"groupId": "BG002"
}
]
},
{
"title": "Native Hawaiian or Other Pacific Islander",
"measurements": [
{
"value": "4",
"groupId": "BG000"
},
{
"value": "4",
"groupId": "BG001"
},
{
"value": "8",
"groupId": "BG002"
}
]
},
{
"title": "Black or African American",
"measurements": [
{
"value": "59",
"groupId": "BG000"
},
{
"value": "58",
"groupId": "BG001"
},
{
"value": "117",
"groupId": "BG002"
}
]
},
{
"title": "White",
"measurements": [
{
"value": "893",
"groupId": "BG000"
},
{
"value": "885",
"groupId": "BG001"
},
{
"value": "1778",
"groupId": "BG002"
}
]
},
{
"title": "More than one race",
"measurements": [
{
"value": "4",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "5",
"groupId": "BG002"
}
]
},
{
"title": "Unknown or Not Reported",
"measurements": [
{
"value": "10",
"groupId": "BG000"
},
{
"value": "10",
"groupId": "BG001"
},
{
"value": "20",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race/Ethnicity, Customized",
"classes": [
{
"title": "Latino",
"categories": [
{
"measurements": [
{
"value": "45",
"groupId": "BG000"
},
{
"value": "47",
"groupId": "BG001"
},
{
"value": "92",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Non-Latino",
"categories": [
{
"measurements": [
{
"value": "925",
"groupId": "BG000"
},
{
"value": "920",
"groupId": "BG001"
},
{
"value": "1845",
"groupId": "BG002"
}
]
}
]
},
{
"title": "Unknown",
"categories": [
{
"measurements": [
{
"value": "38",
"groupId": "BG000"
},
{
"value": "39",
"groupId": "BG001"
},
{
"value": "77",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
}
]
}
}
}
]