NCT00490139
Version 190 to 191 · Novartis Pharmaceuticals
Patch inspector
Manual review pending.
None recorded.
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"signal": "results_reconciliation_outcome_suppression",
"category": "results_reconciliation",
"severity": "low"
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] 33713bcbdbfbcff2e0fe686deb9b652b909447219ca6134d35a6c307dca0be4e/protocolSection/outcomesModule/primaryOutcomes/0/measure primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Disease-free survival
Disease-free Survival (DFS)
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Approximately 6-10 years
From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)
/protocolSection/outcomesModule/primaryOutcomes/0/description primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer (SPC), or death from any cause. DFS was estimated using the Kaplan Meier method.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who had disease free survival for the indicated years.
/protocolSection/outcomesModule/secondaryOutcomes/0/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Overall survival
Overall Survival (OS)
/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Approximately 6-10 years
From randomization until death due to any cause (median follow-up of 4.5 years)
/protocolSection/outcomesModule/secondaryOutcomes/0/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Overall survival is defined as the time from randomization until death due to any cause. Overall survival was calculated in years as (date of death minus the date of randomization +1) divided by 365.25. The percentile data values presented here indicate the percentage (99, 98, 97, 96, 95 and 90 percent) of participants who survived for the indicated years.
/protocolSection/outcomesModule/secondaryOutcomes/1/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Time to recurrence
Time to Recurrence
/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Approximately 6-10 years
From randomization until the date of the first occurrence of a disease recurrence (median follow-up of 4.5 years)
/protocolSection/outcomesModule/secondaryOutcomes/1/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Time to recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a disease recurrence (local, regional or distant). The percentile data values presented here indicate the percentage (95, 90, 85, and 80 percent) of participants who did not have disease recurrence for the indicated years.
/protocolSection/outcomesModule/secondaryOutcomes/2/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Time to distant recurrence
Time to Distant Recurrence
/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Approximately 6-10 years
From randomization until the date of the first occurrence of distant recurrence (median follow-up of 4.5 years)
/protocolSection/outcomesModule/secondaryOutcomes/2/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of distant recurrence (including central nervous system recurrence). The percentile data values presented here indicate the percentage (95, 90, 85 and 80 percent) of participants who did not have distant recurrence for the indicated years.
/protocolSection/outcomesModule/secondaryOutcomes/3/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Incidence of brain metastases as first site of breast cancer recurrence
Time to Central Nervous System Recurrence
/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Approximately 6-10 years
From randomization until the first central nervous system recurrence (median follow-up of 4.5 years)
/protocolSection/outcomesModule/secondaryOutcomes/3/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Time to central nervous system recurrence is defined as the time from randomization until the first central nervous system recurrence. Both brain metastasis and meningitis carcinomatosa were considered.The percentile data values presented here indicate that 95 percent of participants did not have central nervous system recurrence for the indicated years.
/protocolSection/outcomesModule/secondaryOutcomes/4/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Safety and Tolerability
DFS Ignoring Non-breast Second Primary Malignancies
/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Approximately 6-10 years
From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)
/protocolSection/outcomesModule/secondaryOutcomes/4/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer, or death from any cause. DFS was estimated using the Kaplan Meier method. The non-breast second primary malignancies were not considered events.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who did not have DFS ignoring non-breast second primary malignancies for the indicated years.
/protocolSection/outcomesModule/secondaryOutcomes/5 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Conduct analyses separately for cohorts defined by the presence or absence of cMyc gene amplification",
"timeFrame": "Approximately 6-10 years"
} /protocolSection/outcomesModule/secondaryOutcomes/5 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Conduct analyses separately for cohorts defined by the expression levels of PTEN",
"timeFrame": "Approximately 6-10 years"
} /protocolSection/outcomesModule/secondaryOutcomes/5 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Conduct analyses separately for cohorts defined by the presence or absence of p95HER2 domain",
"timeFrame": "Approximately 6-10 years"
} /protocolSection/statusModule/statusVerifiedDate 2014-06
2014-07
/protocolSection/statusModule/lastUpdateSubmitDate 2014-07-03
2014-07-30
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2014-07-08
2014-08-18
/protocolSection/statusModule/resultsFirstSubmitDate 2014-07-30
/protocolSection/statusModule/resultsFirstSubmitQcDate 2014-07-30
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"date": "2014-08-18",
"type": "ESTIMATED"
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true
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"pointOfContact": {
"phone": "866-435-7343",
"title": "GSK Response Center",
"organization": "GlaxoSmithKline"
},
"certainAgreement": {
"otherDetails": "GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing.\nGSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.",
"restrictionType": "OTHER",
"piSponsorEmployee": false,
"restrictiveAgreement": true
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},
"adverseEventsModule": {
"timeFrame": "Serious adverse events (SAEs) and non-serious AEs were collected from randomization until 10 years post-study entry.",
"description": "SAEs and non-serious AEs are reported for the Safety Population, comprised of all randomized participants who were administered at least one dose of investigational targeted treatment, as recorded on the "administration of study drug" Case Report Form pages, but excluding any post-event treatments and not considering compliance.",
"eventGroups": [
{
"id": "EG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
"otherNumAtRisk": 2061,
"otherNumAffected": 1928,
"seriousNumAtRisk": 2061,
"seriousNumAffected": 430
},
{
"id": "EG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
"otherNumAtRisk": 2076,
"otherNumAffected": 1861,
"seriousNumAtRisk": 2076,
"seriousNumAffected": 352
},
{
"id": "EG002",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
"otherNumAtRisk": 2057,
"otherNumAffected": 1887,
"seriousNumAtRisk": 2057,
"seriousNumAffected": 431
},
{
"id": "EG003",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
"otherNumAtRisk": 2076,
"otherNumAffected": 1652,
"seriousNumAtRisk": 2076,
"seriousNumAffected": 292
}
],
"otherEvents": [
{
"term": "Diarrhoea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 1514
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 1038
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 1278
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 401
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 394
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 393
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 381
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 286
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Vomiting",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 251
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 181
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 215
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 151
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Stomatitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 203
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 141
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 161
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 98
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 120
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 183
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 133
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 156
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Dyspepsia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 175
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 140
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 156
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 116
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Abdominal Pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 146
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 108
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 149
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 79
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Abdominal Pain Upper",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 137
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 111
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 110
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 77
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Rash",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 757
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 673
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 753
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 221
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Nail Disorder",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 359
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 280
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 295
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 221
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Pruritus",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 287
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 249
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 313
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 124
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Dry Skin",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 262
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 245
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 280
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 86
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Alopecia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 109
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 136
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 110
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 151
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Palmar-Plantar Erythrodysaesthesia Syndrome",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 181
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 106
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 126
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 47
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Erythema",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 122
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 104
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 92
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 87
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Acne",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 134
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 138
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 112
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 20
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Skin Fissures",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 145
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 98
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 124
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 7
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Dermatitis Acneiform",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 116
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 96
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 124
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 19
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 511
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 517
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 443
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 438
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Asthenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 202
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 178
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 175
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 171
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Pyrexia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 227
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 188
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 131
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 171
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Mucosal Inflammation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 227
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 149
},
{
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{
"value": "2091",
"groupId": "OG001"
},
{
"value": "2100",
"groupId": "OG002"
},
{
"value": "2097",
"groupId": "OG003"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG002",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG003",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
}
],
"classes": [
{
"title": "95th Percentile",
"categories": [
{
"measurements": [
{
"value": "1.9",
"groupId": "OG000"
},
{
"value": "1.3",
"groupId": "OG001"
},
{
"value": "1.0",
"groupId": "OG002"
},
{
"value": "1.5",
"groupId": "OG003"
}
]
}
]
},
{
"title": "90th Percentile",
"categories": [
{
"measurements": [
{
"value": "3.2",
"groupId": "OG000"
},
{
"value": "2.8",
"groupId": "OG001"
},
{
"value": "1.8",
"groupId": "OG002"
},
{
"value": "2.6",
"groupId": "OG003"
}
]
}
]
},
{
"title": "85th Percentile",
"categories": [
{
"measurements": [
{
"value": "5.1",
"groupId": "OG000"
},
{
"value": "4.8",
"groupId": "OG001"
},
{
"value": "2.8",
"groupId": "OG002"
},
{
"value": "4.2",
"groupId": "OG003"
}
]
}
]
},
{
"title": "80th Percentile",
"categories": [
{
"measurements": [
{
"value": "6.1",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "4.9",
"groupId": "OG002"
},
{
"value": "5.6",
"groupId": "OG003"
}
]
}
]
},
{
"title": "75th Percentile",
"categories": [
{
"measurements": [
{
"value": "6.1",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "5.5",
"groupId": "OG002"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG003"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.048",
"groupIds": [
"OG000",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "97.5",
"paramValue": "0.84",
"ciLowerLimit": "0.70",
"ciUpperLimit": "1.02",
"estimateComment": "The estimate of the treatment hazard ratio (lap plus tras versus tras) is based on the Cox's proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and auxillary lymph node status.",
"statisticalMethod": "Stratified log-rank test",
"nonInferiorityType": "SUPERIORITY_OR_OTHER",
"statisticalComment": "Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.",
"testedNonInferiority": false
},
{
"pValue": "0.610",
"groupIds": [
"OG001",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "97.5",
"paramValue": "0.96",
"ciLowerLimit": "0.80",
"ciUpperLimit": "1.15",
"estimateComment": "The estimate of the treatment hazard ratio (tras followed by lap versus tras) is based on the Cox's proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and auxillary lymph node status.",
"statisticalMethod": "Stratified log-rank test",
"nonInferiorityType": "SUPERIORITY_OR_OTHER",
"statisticalComment": "Stratification is by chemotherapy timing, hormone receptor status, and axillary lymph node status.",
"testedNonInferiority": false
},
{
"pValue": "<0.0005",
"groupIds": [
"OG002",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "97.5",
"paramValue": "1.34",
"ciLowerLimit": "1.13",
"ciUpperLimit": "1.60",
"estimateComment": "The estimate of the treatment hazard ratio (lap versus tras) is based on the Cox's proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and auxillary lymph node status.",
"statisticalMethod": "Stratified log-rank test",
"nonInferiorityType": "SUPERIORITY_OR_OTHER",
"statisticalComment": "Stratification is by chemotherapy timing, hormone receptor status, and axillary lymph node status.",
"testedNonInferiority": false
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)",
"description": "Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer (SPC), or death from any cause.\nDFS was estimated using the Kaplan Meier method.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who had disease free survival for the indicated years.",
"unitOfMeasure": "years",
"reportingStatus": "POSTED",
"populationDescription": "Intent-to-Treat (ITT) Population: all randomized par., except for those who withdrew their consent to use any of their data prior to receiving any study medication.\nPar. with no recurrence of the initial disease or SPC, or who did not die, were lost to follow-up, or were withdrawn from the study were censored at the date of last clinical contact."
},
{
"type": "SECONDARY",
"title": "Overall Survival (OS)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2093",
"groupId": "OG000"
},
{
"value": "2091",
"groupId": "OG001"
},
{
"value": "2097",
"groupId": "OG002"
},
{
"value": "0",
"groupId": "OG003"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG002",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG003",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
}
],
"classes": [
{
"title": "99th Percentile",
"categories": [
{
"measurements": [
{
"value": "1.7",
"groupId": "OG000"
},
{
"value": "1.2",
"groupId": "OG001"
},
{
"value": "1.7",
"groupId": "OG002"
}
]
}
]
},
{
"title": "98th Percentile",
"categories": [
{
"measurements": [
{
"value": "2.2",
"groupId": "OG000"
},
{
"value": "1.6",
"groupId": "OG001"
},
{
"value": "2.1",
"groupId": "OG002"
}
]
}
]
},
{
"title": "97th Percentile",
"categories": [
{
"measurements": [
{
"value": "2.8",
"groupId": "OG000"
},
{
"value": "2.2",
"groupId": "OG001"
},
{
"value": "2.6",
"groupId": "OG002"
}
]
}
]
},
{
"title": "96th Percentile",
"categories": [
{
"measurements": [
{
"value": "3.4",
"groupId": "OG000"
},
{
"value": "2.9",
"groupId": "OG001"
},
{
"value": "3.0",
"groupId": "OG002"
}
]
}
]
},
{
"title": "95th Percentile",
"categories": [
{
"measurements": [
{
"value": "3.9",
"groupId": "OG000"
},
{
"value": "3.7",
"groupId": "OG001"
},
{
"value": "3.6",
"groupId": "OG002"
}
]
}
]
},
{
"title": "90th Percentile",
"categories": [
{
"measurements": [
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "5.9",
"groupId": "OG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization until death due to any cause (median follow-up of 4.5 years)",
"description": "Overall survival is defined as the time from randomization until death due to any cause.\nOverall survival was calculated in years as (date of death minus the date of randomization +1) divided by 365.25.\nThe percentile data values presented here indicate the percentage (99, 98, 97, 96, 95 and 90 percent) of participants who survived for the indicated years.",
"unitOfMeasure": "years",
"reportingStatus": "POSTED",
"populationDescription": "ITT Population.\nParticipants who did not die were censored at the date of last survival contact."
},
{
"type": "SECONDARY",
"title": "Time to Recurrence",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2093",
"groupId": "OG000"
},
{
"value": "2091",
"groupId": "OG001"
},
{
"value": "2097",
"groupId": "OG002"
},
{
"value": "0",
"groupId": "OG003"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG002",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG003",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
}
],
"classes": [
{
"title": "95th Percentile",
"categories": [
{
"measurements": [
{
"value": "2.2",
"groupId": "OG000"
},
{
"value": "1.5",
"groupId": "OG001"
},
{
"value": "1.7",
"groupId": "OG002"
}
]
}
]
},
{
"title": "90th Percentile",
"categories": [
{
"measurements": [
{
"value": "4.5",
"groupId": "OG000"
},
{
"value": "3.7",
"groupId": "OG001"
},
{
"value": "3.2",
"groupId": "OG002"
}
]
}
]
},
{
"title": "85th Percentile",
"categories": [
{
"measurements": [
{
"value": "6.1",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG002"
}
]
}
]
},
{
"title": "80th Percentile",
"categories": [
{
"measurements": [
{
"value": "6.1",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization until the date of the first occurrence of a disease recurrence (median follow-up of 4.5 years)",
"description": "Time to recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a disease recurrence (local, regional or distant).\nThe percentile data values presented here indicate the percentage (95, 90, 85, and 80 percent) of participants who did not have disease recurrence for the indicated years.",
"unitOfMeasure": "years",
"reportingStatus": "POSTED",
"populationDescription": "ITT Population.\nParticipants who did not have a recurrence of the initial disease were censored at the date of the last recorded physical or radiological examination.\nDeath was treated as a competing risk."
},
{
"type": "SECONDARY",
"title": "Time to Distant Recurrence",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2093",
"groupId": "OG000"
},
{
"value": "2091",
"groupId": "OG001"
},
{
"value": "2097",
"groupId": "OG002"
},
{
"value": "0",
"groupId": "OG003"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG002",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG003",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
}
],
"classes": [
{
"title": "95th Percentile",
"categories": [
{
"measurements": [
{
"value": "2.4",
"groupId": "OG000"
},
{
"value": "1.8",
"groupId": "OG001"
},
{
"value": "1.9",
"groupId": "OG002"
}
]
}
]
},
{
"title": "90th Percentile",
"categories": [
{
"measurements": [
{
"value": "5.5",
"groupId": "OG000"
},
{
"value": "4.2",
"groupId": "OG001"
},
{
"value": "4.1",
"groupId": "OG002"
}
]
}
]
},
{
"title": "85th Percentile",
"categories": [
{
"measurements": [
{
"value": "6.1",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG002"
}
]
}
]
},
{
"title": "80th Percentile",
"categories": [
{
"measurements": [
{
"value": "6.1",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization until the date of the first occurrence of distant recurrence (median follow-up of 4.5 years)",
"description": "Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of distant recurrence (including central nervous system recurrence).\nThe percentile data values presented here indicate the percentage (95, 90, 85 and 80 percent) of participants who did not have distant recurrence for the indicated years.",
"unitOfMeasure": "years",
"reportingStatus": "POSTED",
"populationDescription": "ITT Population.\nParticipants who did not have a distant recurrence of the initial disease were censored at the date of the last recorded physical or radiological examination.\nDeath was treated as a competing risk."
},
{
"type": "SECONDARY",
"title": "Time to Central Nervous System Recurrence",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2093",
"groupId": "OG000"
},
{
"value": "2091",
"groupId": "OG001"
},
{
"value": "2097",
"groupId": "OG002"
},
{
"value": "0",
"groupId": "OG003"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG002",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG003",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "5.8",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization until the first central nervous system recurrence (median follow-up of 4.5 years)",
"description": "Time to central nervous system recurrence is defined as the time from randomization until the first central nervous system recurrence.\nBoth brain metastasis and meningitis carcinomatosa were considered.The percentile data values presented here indicate that 95 percent of participants did not have central nervous system recurrence for the indicated years.",
"unitOfMeasure": "years",
"reportingStatus": "POSTED",
"populationDescription": "ITT Population.\nParticipants who did not have a central nervous system recurrence were censored at the date of the last recorded physical or radiological examination.\nDeath was treated as a competing risk."
},
{
"type": "SECONDARY",
"title": "DFS Ignoring Non-breast Second Primary Malignancies",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1155",
"groupId": "OG000"
},
{
"value": "1143",
"groupId": "OG001"
},
{
"value": "1147",
"groupId": "OG002"
},
{
"value": "0",
"groupId": "OG003"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG002",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG003",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
}
],
"classes": [
{
"title": "95th Percentile",
"categories": [
{
"measurements": [
{
"value": "1.9",
"groupId": "OG000"
},
{
"value": "1.2",
"groupId": "OG001"
},
{
"value": "1.4",
"groupId": "OG002"
}
]
}
]
},
{
"title": "90th Percentile",
"categories": [
{
"measurements": [
{
"value": "3.0",
"groupId": "OG000"
},
{
"value": "2.3",
"groupId": "OG001"
},
{
"value": "2.3",
"groupId": "OG002"
}
]
}
]
},
{
"title": "85th Percentile",
"categories": [
{
"measurements": [
{
"value": "5.6",
"groupId": "OG000"
},
{
"value": "4.7",
"groupId": "OG001"
},
{
"value": "3.5",
"groupId": "OG002"
}
]
}
]
},
{
"title": "80th Percentile",
"categories": [
{
"measurements": [
{
"value": "6.1",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG002"
}
]
}
]
},
{
"title": "75th Percentile",
"categories": [
{
"measurements": [
{
"value": "6.1",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)",
"description": "Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer, or death from any cause.\nDFS was estimated using the Kaplan Meier method.\nThe non-breast second primary malignancies were not considered events.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who did not have DFS ignoring non-breast second primary malignancies for the indicated years.",
"unitOfMeasure": "years",
"reportingStatus": "POSTED",
"populationDescription": "ITT Population.\nParticipants who did not have a recurrence of the initial disease, or did not die, were lost to follow-up, or were withdrawn from the study were censored at the date of last clinical contact.\nNon-breast second primary cancers were ignored."
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "FG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "FG002",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "FG003",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "2093"
},
{
"groupId": "FG001",
"numSubjects": "2091"
},
{
"groupId": "FG002",
"numSubjects": "2100"
},
{
"groupId": "FG003",
"numSubjects": "2097"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "1785"
},
{
"groupId": "FG001",
"numSubjects": "1816"
},
{
"groupId": "FG002",
"numSubjects": "1666"
},
{
"groupId": "FG003",
"numSubjects": "1790"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "308"
},
{
"groupId": "FG001",
"numSubjects": "275"
},
{
"groupId": "FG002",
"numSubjects": "434"
},
{
"groupId": "FG003",
"numSubjects": "307"
}
]
}
],
"dropWithdraws": [
{
"type": "Death",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "106"
},
{
"groupId": "FG001",
"numSubjects": "119"
},
{
"groupId": "FG002",
"numSubjects": "168"
},
{
"groupId": "FG003",
"numSubjects": "135"
}
]
},
{
"type": "Lost to Follow-up",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "56"
},
{
"groupId": "FG001",
"numSubjects": "46"
},
{
"groupId": "FG002",
"numSubjects": "58"
},
{
"groupId": "FG003",
"numSubjects": "56"
}
]
},
{
"type": "Participant Withdrew Consent",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "146"
},
{
"groupId": "FG001",
"numSubjects": "110"
},
{
"groupId": "FG002",
"numSubjects": "208"
},
{
"groupId": "FG003",
"numSubjects": "116"
}
]
}
]
}
],
"preAssignmentDetails": "Treatments administered differed per timing/type of adjuvant chemotherapy.\nDesign (D) 1: (neo) adjuvant anthracycline-based chemotherapy (AABC) prior to targeted therapy (TT); Design 2: TT concurrently with paclitaxel or docetaxel, after completion of a (neo) AABC; Design 2B: TT concurrently with chemotherapy with docetaxel and carboplatin."
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2093",
"groupId": "BG000"
},
{
"value": "2091",
"groupId": "BG001"
},
{
"value": "2100",
"groupId": "BG002"
},
{
"value": "2097",
"groupId": "BG003"
},
{
"value": "8381",
"groupId": "BG004"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "BG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "BG002",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "BG003",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "BG004",
"title": "Total",
"description": "Total of all reporting groups"
}
],
"measures": [
{
"title": "Age, Continuous",
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "50.9",
"spread": "10.23",
"groupId": "BG000"
},
{
"value": "50.8",
"spread": "10.32",
"groupId": "BG001"
},
{
"value": "51.2",
"spread": "10.18",
"groupId": "BG002"
},
{
"value": "51.0",
"spread": "10.25",
"groupId": "BG003"
},
{
"value": "51.0",
"spread": "10.24",
"groupId": "BG004"
}
]
}
]
}
],
"paramType": "MEAN",
"unitOfMeasure": "years",
"dispersionType": "STANDARD_DEVIATION"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "2091",
"groupId": "BG000"
},
{
"value": "2086",
"groupId": "BG001"
},
{
"value": "2098",
"groupId": "BG002"
},
{
"value": "2097",
"groupId": "BG003"
},
{
"value": "8372",
"groupId": "BG004"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "2",
"groupId": "BG000"
},
{
"value": "5",
"groupId": "BG001"
},
{
"value": "2",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "9",
"groupId": "BG004"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race/Ethnicity, Customized",
"classes": [
{
"title": "American Indian or Alaska Native",
"categories": [
{
"measurements": [
{
"value": "48",
"groupId": "BG000"
},
{
"value": "45",
"groupId": "BG001"
},
{
"value": "47",
"groupId": "BG002"
},
{
"value": "47",
"groupId": "BG003"
},
{
"value": "187",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Asian: Central/South",
"categories": [
{
"measurements": [
{
"value": "107",
"groupId": "BG000"
},
{
"value": "103",
"groupId": "BG001"
},
{
"value": "110",
"groupId": "BG002"
},
{
"value": "109",
"groupId": "BG003"
},
{
"value": "429",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Asian: East",
"categories": [
{
"measurements": [
{
"value": "311",
"groupId": "BG000"
},
{
"value": "312",
"groupId": "BG001"
},
{
"value": "299",
"groupId": "BG002"
},
{
"value": "314",
"groupId": "BG003"
},
{
"value": "1236",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Asian: Japanese",
"categories": [
{
"measurements": [
{
"value": "33",
"groupId": "BG000"
},
{
"value": "36",
"groupId": "BG001"
},
{
"value": "33",
"groupId": "BG002"
},
{
"value": "43",
"groupId": "BG003"
},
{
"value": "145",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Asian: South East",
"categories": [
{
"measurements": [
{
"value": "95",
"groupId": "BG000"
},
{
"value": "92",
"groupId": "BG001"
},
{
"value": "107",
"groupId": "BG002"
},
{
"value": "89",
"groupId": "BG003"
},
{
"value": "383",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Black or African American",
"categories": [
{
"measurements": [
{
"value": "38",
"groupId": "BG000"
},
{
"value": "30",
"groupId": "BG001"
},
{
"value": "43",
"groupId": "BG002"
},
{
"value": "25",
"groupId": "BG003"
},
{
"value": "136",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Native Hawaiian (NH) or Other Pacific",
"categories": [
{
"measurements": [
{
"value": "2",
"groupId": "BG000"
},
{
"value": "4",
"groupId": "BG001"
},
{
"value": "4",
"groupId": "BG002"
},
{
"value": "5",
"groupId": "BG003"
},
{
"value": "15",
"groupId": "BG004"
}
]
}
]
},
{
"title": "White: Arabic",
"categories": [
{
"measurements": [
{
"value": "53",
"groupId": "BG000"
},
{
"value": "52",
"groupId": "BG001"
},
{
"value": "62",
"groupId": "BG002"
},
{
"value": "69",
"groupId": "BG003"
},
{
"value": "236",
"groupId": "BG004"
}
]
}
]
},
{
"title": "White: Caucasian",
"categories": [
{
"measurements": [
{
"value": "1392",
"groupId": "BG000"
},
{
"value": "1402",
"groupId": "BG001"
},
{
"value": "1372",
"groupId": "BG002"
},
{
"value": "1382",
"groupId": "BG003"
},
{
"value": "5548",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Mixed Race/Ancestry",
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "BG000"
},
{
"value": "7",
"groupId": "BG001"
},
{
"value": "10",
"groupId": "BG002"
},
{
"value": "3",
"groupId": "BG003"
},
{
"value": "25",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Hispanic",
"categories": [
{
"measurements": [
{
"value": "2",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
},
{
"value": "3",
"groupId": "BG003"
},
{
"value": "7",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Mestizo",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "3",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "5",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Mauritius Islander",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "1",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Coloured",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "2",
"groupId": "BG004"
}
]
}
]
},
{
"title": "NH and White (Arabic/North African Heritage [HER])",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "European Heritage and South American",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "South American, African HER and European HER",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Afrikaans-South Africa",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "White South African",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "1",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "White South American",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "2",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "3",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Southeast and Northeast of South America",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Mulatto",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "South American Latin American and European HER",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Black from South America",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Northeast of South America and European HER",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Asian (East), NH or Other Pacific Islander",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "1",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Peruvian",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "1",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Mexican",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "1",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "American Indian or Alaska Native and White",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Caucasian and Guamanian (Chamorro)",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Unknown/Missing",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "3",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
},
{
"value": "3",
"groupId": "BG003"
},
{
"value": "8",
"groupId": "BG004"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "participants"
}
]
}
} [
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2014-07"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2014-07-30"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2014-08-18"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2014-07-30"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2014-07-30"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2014-08-18",
"type": "ESTIMATED"
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Disease-free Survival (DFS)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer (SPC), or death from any cause.\nDFS was estimated using the Kaplan Meier method.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who had disease free survival for the indicated years."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Overall Survival (OS)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "From randomization until death due to any cause (median follow-up of 4.5 years)"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "Overall survival is defined as the time from randomization until death due to any cause.\nOverall survival was calculated in years as (date of death minus the date of randomization +1) divided by 365.25.\nThe percentile data values presented here indicate the percentage (99, 98, 97, 96, 95 and 90 percent) of participants who survived for the indicated years."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Time to Recurrence"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "From randomization until the date of the first occurrence of a disease recurrence (median follow-up of 4.5 years)"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"value": "Time to recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a disease recurrence (local, regional or distant).\nThe percentile data values presented here indicate the percentage (95, 90, 85, and 80 percent) of participants who did not have disease recurrence for the indicated years."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Time to Distant Recurrence"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"value": "From randomization until the date of the first occurrence of distant recurrence (median follow-up of 4.5 years)"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of distant recurrence (including central nervous system recurrence).\nThe percentile data values presented here indicate the percentage (95, 90, 85 and 80 percent) of participants who did not have distant recurrence for the indicated years."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "Time to Central Nervous System Recurrence"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "From randomization until the first central nervous system recurrence (median follow-up of 4.5 years)"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"value": "Time to central nervous system recurrence is defined as the time from randomization until the first central nervous system recurrence.\nBoth brain metastasis and meningitis carcinomatosa were considered.The percentile data values presented here indicate that 95 percent of participants did not have central nervous system recurrence for the indicated years."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"value": "DFS Ignoring Non-breast Second Primary Malignancies"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"value": "From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"value": "Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer, or death from any cause.\nDFS was estimated using the Kaplan Meier method.\nThe non-breast second primary malignancies were not considered events.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who did not have DFS ignoring non-breast second primary malignancies for the indicated years."
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"moreInfoModule": {
"pointOfContact": {
"phone": "866-435-7343",
"title": "GSK Response Center",
"organization": "GlaxoSmithKline"
},
"certainAgreement": {
"otherDetails": "GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing.\nGSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.",
"restrictionType": "OTHER",
"piSponsorEmployee": false,
"restrictiveAgreement": true
}
},
"adverseEventsModule": {
"timeFrame": "Serious adverse events (SAEs) and non-serious AEs were collected from randomization until 10 years post-study entry.",
"description": "SAEs and non-serious AEs are reported for the Safety Population, comprised of all randomized participants who were administered at least one dose of investigational targeted treatment, as recorded on the "administration of study drug" Case Report Form pages, but excluding any post-event treatments and not considering compliance.",
"eventGroups": [
{
"id": "EG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
"otherNumAtRisk": 2061,
"otherNumAffected": 1928,
"seriousNumAtRisk": 2061,
"seriousNumAffected": 430
},
{
"id": "EG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
"otherNumAtRisk": 2076,
"otherNumAffected": 1861,
"seriousNumAtRisk": 2076,
"seriousNumAffected": 352
},
{
"id": "EG002",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
"otherNumAtRisk": 2057,
"otherNumAffected": 1887,
"seriousNumAtRisk": 2057,
"seriousNumAffected": 431
},
{
"id": "EG003",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.",
"otherNumAtRisk": 2076,
"otherNumAffected": 1652,
"seriousNumAtRisk": 2076,
"seriousNumAffected": 292
}
],
"otherEvents": [
{
"term": "Diarrhoea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 1514
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 1038
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 1278
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 401
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 394
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 393
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 381
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 286
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Vomiting",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 251
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 181
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 215
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 151
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Stomatitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 203
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 141
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 161
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 98
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 120
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 183
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 133
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 156
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Dyspepsia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 175
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 140
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 156
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 116
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Abdominal Pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 146
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 108
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 149
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 79
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Abdominal Pain Upper",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 137
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 111
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 110
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 77
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Rash",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 757
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 673
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 753
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 221
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Nail Disorder",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 359
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 280
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 295
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 221
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Pruritus",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 287
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 249
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 313
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 124
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Dry Skin",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 262
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 245
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 280
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 86
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Alopecia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 109
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 136
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 110
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 151
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Palmar-Plantar Erythrodysaesthesia Syndrome",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 181
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 106
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 126
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 47
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Erythema",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 122
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 104
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 92
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 87
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Acne",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 134
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 138
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 112
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 20
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Skin Fissures",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 145
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 98
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 124
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 7
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Dermatitis Acneiform",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 116
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 96
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 124
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 19
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 511
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 517
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 443
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 438
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Asthenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 202
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 178
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 175
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 171
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Pyrexia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 227
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 188
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 131
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 171
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Mucosal Inflammation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 227
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 149
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 164
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 114
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Oedema Peripheral",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 145
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 149
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 137
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 161
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Arthralgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 306
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 311
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 290
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 402
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Myalgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 213
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 215
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 174
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 253
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Pain In Extremity",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 135
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 125
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 99
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 175
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Back Pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 129
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 135
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 119
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 128
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Bone Pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 88
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 110
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 91
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 123
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Musculoskeletal Pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 79
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 97
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 70
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 110
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 193
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 240
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 161
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 262
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Neuropathy peripheral",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 179
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 182
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 174
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 178
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Peripheral Sensory Neuropathy",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 166
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 161
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 162
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 195
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Dysgeusia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 138
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 119
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 119
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 106
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Paraesthesia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 125
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 111
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 107
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 130
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Dizziness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 104
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 128
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 115
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 118
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Epistaxis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 319
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 214
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 244
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 165
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Cough",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 218
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 202
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 152
},
{
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"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Thrombophlebitis Superficial",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 1
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Tinnitus",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Tooth Infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Toxic Epidermal Necrolysis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Trisomy 21",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Congenital, familial and genetic disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Tuberculosis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Tuberculous Pleurisy",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 1
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Upper Gastrointestinal Haemorrhage",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Upper Respiratory Tract Infection Bacterial",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Urethral Cancer",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Urethral Obstruction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 1
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Urinary Bladder Haemorrhage",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 1
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Urosepsis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 1
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Vaginal Haemorrhage",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 1
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Reproductive system and breast disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Vascular Insufficiency",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Ventricular Arrhythmia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 1
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Ventricular Extrasystoles",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Vertigo Positional",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 1
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Viith Nerve Paralysis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Volvulus",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Weight Decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "White Blood Cell Count Decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 0
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Wound Infection Bacterial",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
},
{
"term": "Wound Infection Staphylococcal",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2061,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 2076,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 2057,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 2076,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA"
}
],
"frequencyThreshold": "5"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Disease-free Survival (DFS)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2093",
"groupId": "OG000"
},
{
"value": "2091",
"groupId": "OG001"
},
{
"value": "2100",
"groupId": "OG002"
},
{
"value": "2097",
"groupId": "OG003"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG002",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG003",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
}
],
"classes": [
{
"title": "95th Percentile",
"categories": [
{
"measurements": [
{
"value": "1.9",
"groupId": "OG000"
},
{
"value": "1.3",
"groupId": "OG001"
},
{
"value": "1.0",
"groupId": "OG002"
},
{
"value": "1.5",
"groupId": "OG003"
}
]
}
]
},
{
"title": "90th Percentile",
"categories": [
{
"measurements": [
{
"value": "3.2",
"groupId": "OG000"
},
{
"value": "2.8",
"groupId": "OG001"
},
{
"value": "1.8",
"groupId": "OG002"
},
{
"value": "2.6",
"groupId": "OG003"
}
]
}
]
},
{
"title": "85th Percentile",
"categories": [
{
"measurements": [
{
"value": "5.1",
"groupId": "OG000"
},
{
"value": "4.8",
"groupId": "OG001"
},
{
"value": "2.8",
"groupId": "OG002"
},
{
"value": "4.2",
"groupId": "OG003"
}
]
}
]
},
{
"title": "80th Percentile",
"categories": [
{
"measurements": [
{
"value": "6.1",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "4.9",
"groupId": "OG002"
},
{
"value": "5.6",
"groupId": "OG003"
}
]
}
]
},
{
"title": "75th Percentile",
"categories": [
{
"measurements": [
{
"value": "6.1",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "5.5",
"groupId": "OG002"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG003"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.048",
"groupIds": [
"OG000",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "97.5",
"paramValue": "0.84",
"ciLowerLimit": "0.70",
"ciUpperLimit": "1.02",
"estimateComment": "The estimate of the treatment hazard ratio (lap plus tras versus tras) is based on the Cox's proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and auxillary lymph node status.",
"statisticalMethod": "Stratified log-rank test",
"nonInferiorityType": "SUPERIORITY_OR_OTHER",
"statisticalComment": "Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.",
"testedNonInferiority": false
},
{
"pValue": "0.610",
"groupIds": [
"OG001",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "97.5",
"paramValue": "0.96",
"ciLowerLimit": "0.80",
"ciUpperLimit": "1.15",
"estimateComment": "The estimate of the treatment hazard ratio (tras followed by lap versus tras) is based on the Cox's proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and auxillary lymph node status.",
"statisticalMethod": "Stratified log-rank test",
"nonInferiorityType": "SUPERIORITY_OR_OTHER",
"statisticalComment": "Stratification is by chemotherapy timing, hormone receptor status, and axillary lymph node status.",
"testedNonInferiority": false
},
{
"pValue": "<0.0005",
"groupIds": [
"OG002",
"OG003"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "97.5",
"paramValue": "1.34",
"ciLowerLimit": "1.13",
"ciUpperLimit": "1.60",
"estimateComment": "The estimate of the treatment hazard ratio (lap versus tras) is based on the Cox's proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and auxillary lymph node status.",
"statisticalMethod": "Stratified log-rank test",
"nonInferiorityType": "SUPERIORITY_OR_OTHER",
"statisticalComment": "Stratification is by chemotherapy timing, hormone receptor status, and axillary lymph node status.",
"testedNonInferiority": false
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)",
"description": "Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer (SPC), or death from any cause.\nDFS was estimated using the Kaplan Meier method.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who had disease free survival for the indicated years.",
"unitOfMeasure": "years",
"reportingStatus": "POSTED",
"populationDescription": "Intent-to-Treat (ITT) Population: all randomized par., except for those who withdrew their consent to use any of their data prior to receiving any study medication.\nPar. with no recurrence of the initial disease or SPC, or who did not die, were lost to follow-up, or were withdrawn from the study were censored at the date of last clinical contact."
},
{
"type": "SECONDARY",
"title": "Overall Survival (OS)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2093",
"groupId": "OG000"
},
{
"value": "2091",
"groupId": "OG001"
},
{
"value": "2097",
"groupId": "OG002"
},
{
"value": "0",
"groupId": "OG003"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG002",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG003",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
}
],
"classes": [
{
"title": "99th Percentile",
"categories": [
{
"measurements": [
{
"value": "1.7",
"groupId": "OG000"
},
{
"value": "1.2",
"groupId": "OG001"
},
{
"value": "1.7",
"groupId": "OG002"
}
]
}
]
},
{
"title": "98th Percentile",
"categories": [
{
"measurements": [
{
"value": "2.2",
"groupId": "OG000"
},
{
"value": "1.6",
"groupId": "OG001"
},
{
"value": "2.1",
"groupId": "OG002"
}
]
}
]
},
{
"title": "97th Percentile",
"categories": [
{
"measurements": [
{
"value": "2.8",
"groupId": "OG000"
},
{
"value": "2.2",
"groupId": "OG001"
},
{
"value": "2.6",
"groupId": "OG002"
}
]
}
]
},
{
"title": "96th Percentile",
"categories": [
{
"measurements": [
{
"value": "3.4",
"groupId": "OG000"
},
{
"value": "2.9",
"groupId": "OG001"
},
{
"value": "3.0",
"groupId": "OG002"
}
]
}
]
},
{
"title": "95th Percentile",
"categories": [
{
"measurements": [
{
"value": "3.9",
"groupId": "OG000"
},
{
"value": "3.7",
"groupId": "OG001"
},
{
"value": "3.6",
"groupId": "OG002"
}
]
}
]
},
{
"title": "90th Percentile",
"categories": [
{
"measurements": [
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "5.9",
"groupId": "OG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization until death due to any cause (median follow-up of 4.5 years)",
"description": "Overall survival is defined as the time from randomization until death due to any cause.\nOverall survival was calculated in years as (date of death minus the date of randomization +1) divided by 365.25.\nThe percentile data values presented here indicate the percentage (99, 98, 97, 96, 95 and 90 percent) of participants who survived for the indicated years.",
"unitOfMeasure": "years",
"reportingStatus": "POSTED",
"populationDescription": "ITT Population.\nParticipants who did not die were censored at the date of last survival contact."
},
{
"type": "SECONDARY",
"title": "Time to Recurrence",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2093",
"groupId": "OG000"
},
{
"value": "2091",
"groupId": "OG001"
},
{
"value": "2097",
"groupId": "OG002"
},
{
"value": "0",
"groupId": "OG003"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG002",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG003",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
}
],
"classes": [
{
"title": "95th Percentile",
"categories": [
{
"measurements": [
{
"value": "2.2",
"groupId": "OG000"
},
{
"value": "1.5",
"groupId": "OG001"
},
{
"value": "1.7",
"groupId": "OG002"
}
]
}
]
},
{
"title": "90th Percentile",
"categories": [
{
"measurements": [
{
"value": "4.5",
"groupId": "OG000"
},
{
"value": "3.7",
"groupId": "OG001"
},
{
"value": "3.2",
"groupId": "OG002"
}
]
}
]
},
{
"title": "85th Percentile",
"categories": [
{
"measurements": [
{
"value": "6.1",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG002"
}
]
}
]
},
{
"title": "80th Percentile",
"categories": [
{
"measurements": [
{
"value": "6.1",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization until the date of the first occurrence of a disease recurrence (median follow-up of 4.5 years)",
"description": "Time to recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a disease recurrence (local, regional or distant).\nThe percentile data values presented here indicate the percentage (95, 90, 85, and 80 percent) of participants who did not have disease recurrence for the indicated years.",
"unitOfMeasure": "years",
"reportingStatus": "POSTED",
"populationDescription": "ITT Population.\nParticipants who did not have a recurrence of the initial disease were censored at the date of the last recorded physical or radiological examination.\nDeath was treated as a competing risk."
},
{
"type": "SECONDARY",
"title": "Time to Distant Recurrence",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2093",
"groupId": "OG000"
},
{
"value": "2091",
"groupId": "OG001"
},
{
"value": "2097",
"groupId": "OG002"
},
{
"value": "0",
"groupId": "OG003"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG002",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG003",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
}
],
"classes": [
{
"title": "95th Percentile",
"categories": [
{
"measurements": [
{
"value": "2.4",
"groupId": "OG000"
},
{
"value": "1.8",
"groupId": "OG001"
},
{
"value": "1.9",
"groupId": "OG002"
}
]
}
]
},
{
"title": "90th Percentile",
"categories": [
{
"measurements": [
{
"value": "5.5",
"groupId": "OG000"
},
{
"value": "4.2",
"groupId": "OG001"
},
{
"value": "4.1",
"groupId": "OG002"
}
]
}
]
},
{
"title": "85th Percentile",
"categories": [
{
"measurements": [
{
"value": "6.1",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG002"
}
]
}
]
},
{
"title": "80th Percentile",
"categories": [
{
"measurements": [
{
"value": "6.1",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization until the date of the first occurrence of distant recurrence (median follow-up of 4.5 years)",
"description": "Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of distant recurrence (including central nervous system recurrence).\nThe percentile data values presented here indicate the percentage (95, 90, 85 and 80 percent) of participants who did not have distant recurrence for the indicated years.",
"unitOfMeasure": "years",
"reportingStatus": "POSTED",
"populationDescription": "ITT Population.\nParticipants who did not have a distant recurrence of the initial disease were censored at the date of the last recorded physical or radiological examination.\nDeath was treated as a competing risk."
},
{
"type": "SECONDARY",
"title": "Time to Central Nervous System Recurrence",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2093",
"groupId": "OG000"
},
{
"value": "2091",
"groupId": "OG001"
},
{
"value": "2097",
"groupId": "OG002"
},
{
"value": "0",
"groupId": "OG003"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG002",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG003",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "5.8",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization until the first central nervous system recurrence (median follow-up of 4.5 years)",
"description": "Time to central nervous system recurrence is defined as the time from randomization until the first central nervous system recurrence.\nBoth brain metastasis and meningitis carcinomatosa were considered.The percentile data values presented here indicate that 95 percent of participants did not have central nervous system recurrence for the indicated years.",
"unitOfMeasure": "years",
"reportingStatus": "POSTED",
"populationDescription": "ITT Population.\nParticipants who did not have a central nervous system recurrence were censored at the date of the last recorded physical or radiological examination.\nDeath was treated as a competing risk."
},
{
"type": "SECONDARY",
"title": "DFS Ignoring Non-breast Second Primary Malignancies",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1155",
"groupId": "OG000"
},
{
"value": "1143",
"groupId": "OG001"
},
{
"value": "1147",
"groupId": "OG002"
},
{
"value": "0",
"groupId": "OG003"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG002",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "OG003",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
}
],
"classes": [
{
"title": "95th Percentile",
"categories": [
{
"measurements": [
{
"value": "1.9",
"groupId": "OG000"
},
{
"value": "1.2",
"groupId": "OG001"
},
{
"value": "1.4",
"groupId": "OG002"
}
]
}
]
},
{
"title": "90th Percentile",
"categories": [
{
"measurements": [
{
"value": "3.0",
"groupId": "OG000"
},
{
"value": "2.3",
"groupId": "OG001"
},
{
"value": "2.3",
"groupId": "OG002"
}
]
}
]
},
{
"title": "85th Percentile",
"categories": [
{
"measurements": [
{
"value": "5.6",
"groupId": "OG000"
},
{
"value": "4.7",
"groupId": "OG001"
},
{
"value": "3.5",
"groupId": "OG002"
}
]
}
]
},
{
"title": "80th Percentile",
"categories": [
{
"measurements": [
{
"value": "6.1",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG002"
}
]
}
]
},
{
"title": "75th Percentile",
"categories": [
{
"measurements": [
{
"value": "6.1",
"groupId": "OG000"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG001"
},
{
"value": "NA",
"comment": "There were not enough data (insufficient follow-up) to be able to compute this data point.",
"groupId": "OG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)",
"description": "Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer, or death from any cause.\nDFS was estimated using the Kaplan Meier method.\nThe non-breast second primary malignancies were not considered events.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who did not have DFS ignoring non-breast second primary malignancies for the indicated years.",
"unitOfMeasure": "years",
"reportingStatus": "POSTED",
"populationDescription": "ITT Population.\nParticipants who did not have a recurrence of the initial disease, or did not die, were lost to follow-up, or were withdrawn from the study were censored at the date of last clinical contact.\nNon-breast second primary cancers were ignored."
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "FG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "FG002",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "FG003",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "2093"
},
{
"groupId": "FG001",
"numSubjects": "2091"
},
{
"groupId": "FG002",
"numSubjects": "2100"
},
{
"groupId": "FG003",
"numSubjects": "2097"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "1785"
},
{
"groupId": "FG001",
"numSubjects": "1816"
},
{
"groupId": "FG002",
"numSubjects": "1666"
},
{
"groupId": "FG003",
"numSubjects": "1790"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "308"
},
{
"groupId": "FG001",
"numSubjects": "275"
},
{
"groupId": "FG002",
"numSubjects": "434"
},
{
"groupId": "FG003",
"numSubjects": "307"
}
]
}
],
"dropWithdraws": [
{
"type": "Death",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "106"
},
{
"groupId": "FG001",
"numSubjects": "119"
},
{
"groupId": "FG002",
"numSubjects": "168"
},
{
"groupId": "FG003",
"numSubjects": "135"
}
]
},
{
"type": "Lost to Follow-up",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "56"
},
{
"groupId": "FG001",
"numSubjects": "46"
},
{
"groupId": "FG002",
"numSubjects": "58"
},
{
"groupId": "FG003",
"numSubjects": "56"
}
]
},
{
"type": "Participant Withdrew Consent",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "146"
},
{
"groupId": "FG001",
"numSubjects": "110"
},
{
"groupId": "FG002",
"numSubjects": "208"
},
{
"groupId": "FG003",
"numSubjects": "116"
}
]
}
]
}
],
"preAssignmentDetails": "Treatments administered differed per timing/type of adjuvant chemotherapy.\nDesign (D) 1: (neo) adjuvant anthracycline-based chemotherapy (AABC) prior to targeted therapy (TT); Design 2: TT concurrently with paclitaxel or docetaxel, after completion of a (neo) AABC; Design 2B: TT concurrently with chemotherapy with docetaxel and carboplatin."
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2093",
"groupId": "BG000"
},
{
"value": "2091",
"groupId": "BG001"
},
{
"value": "2100",
"groupId": "BG002"
},
{
"value": "2097",
"groupId": "BG003"
},
{
"value": "8381",
"groupId": "BG004"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Lapatinib plusTrastuzumab",
"description": "Participants (par.) received treatment per one of three designs.\nD1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks).\nD2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.)\nwith wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks.\nAfter completion of pac or doc, par.\nreceived OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks.\nD2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc.\nwith doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks.\nAfter completion of doc and carb, par.\nreceived tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks.\nPar. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "BG001",
"title": "Trastuzumab Followed by Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks.\nDesign 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "BG002",
"title": "Lapatinib",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: oral lap 1500 mg daily for 52 weeks.\nDesign 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks.\nDesign 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "BG003",
"title": "Trastuzumab",
"description": "Participants received treatment per one of the following three designs.\nDesign 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks.\nDesign 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks.\nAfter completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks.\nDesign 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks.\nAfter completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks.\nParticipants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated."
},
{
"id": "BG004",
"title": "Total",
"description": "Total of all reporting groups"
}
],
"measures": [
{
"title": "Age, Continuous",
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "50.9",
"spread": "10.23",
"groupId": "BG000"
},
{
"value": "50.8",
"spread": "10.32",
"groupId": "BG001"
},
{
"value": "51.2",
"spread": "10.18",
"groupId": "BG002"
},
{
"value": "51.0",
"spread": "10.25",
"groupId": "BG003"
},
{
"value": "51.0",
"spread": "10.24",
"groupId": "BG004"
}
]
}
]
}
],
"paramType": "MEAN",
"unitOfMeasure": "years",
"dispersionType": "STANDARD_DEVIATION"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "2091",
"groupId": "BG000"
},
{
"value": "2086",
"groupId": "BG001"
},
{
"value": "2098",
"groupId": "BG002"
},
{
"value": "2097",
"groupId": "BG003"
},
{
"value": "8372",
"groupId": "BG004"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "2",
"groupId": "BG000"
},
{
"value": "5",
"groupId": "BG001"
},
{
"value": "2",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "9",
"groupId": "BG004"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race/Ethnicity, Customized",
"classes": [
{
"title": "American Indian or Alaska Native",
"categories": [
{
"measurements": [
{
"value": "48",
"groupId": "BG000"
},
{
"value": "45",
"groupId": "BG001"
},
{
"value": "47",
"groupId": "BG002"
},
{
"value": "47",
"groupId": "BG003"
},
{
"value": "187",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Asian: Central/South",
"categories": [
{
"measurements": [
{
"value": "107",
"groupId": "BG000"
},
{
"value": "103",
"groupId": "BG001"
},
{
"value": "110",
"groupId": "BG002"
},
{
"value": "109",
"groupId": "BG003"
},
{
"value": "429",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Asian: East",
"categories": [
{
"measurements": [
{
"value": "311",
"groupId": "BG000"
},
{
"value": "312",
"groupId": "BG001"
},
{
"value": "299",
"groupId": "BG002"
},
{
"value": "314",
"groupId": "BG003"
},
{
"value": "1236",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Asian: Japanese",
"categories": [
{
"measurements": [
{
"value": "33",
"groupId": "BG000"
},
{
"value": "36",
"groupId": "BG001"
},
{
"value": "33",
"groupId": "BG002"
},
{
"value": "43",
"groupId": "BG003"
},
{
"value": "145",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Asian: South East",
"categories": [
{
"measurements": [
{
"value": "95",
"groupId": "BG000"
},
{
"value": "92",
"groupId": "BG001"
},
{
"value": "107",
"groupId": "BG002"
},
{
"value": "89",
"groupId": "BG003"
},
{
"value": "383",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Black or African American",
"categories": [
{
"measurements": [
{
"value": "38",
"groupId": "BG000"
},
{
"value": "30",
"groupId": "BG001"
},
{
"value": "43",
"groupId": "BG002"
},
{
"value": "25",
"groupId": "BG003"
},
{
"value": "136",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Native Hawaiian (NH) or Other Pacific",
"categories": [
{
"measurements": [
{
"value": "2",
"groupId": "BG000"
},
{
"value": "4",
"groupId": "BG001"
},
{
"value": "4",
"groupId": "BG002"
},
{
"value": "5",
"groupId": "BG003"
},
{
"value": "15",
"groupId": "BG004"
}
]
}
]
},
{
"title": "White: Arabic",
"categories": [
{
"measurements": [
{
"value": "53",
"groupId": "BG000"
},
{
"value": "52",
"groupId": "BG001"
},
{
"value": "62",
"groupId": "BG002"
},
{
"value": "69",
"groupId": "BG003"
},
{
"value": "236",
"groupId": "BG004"
}
]
}
]
},
{
"title": "White: Caucasian",
"categories": [
{
"measurements": [
{
"value": "1392",
"groupId": "BG000"
},
{
"value": "1402",
"groupId": "BG001"
},
{
"value": "1372",
"groupId": "BG002"
},
{
"value": "1382",
"groupId": "BG003"
},
{
"value": "5548",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Mixed Race/Ancestry",
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "BG000"
},
{
"value": "7",
"groupId": "BG001"
},
{
"value": "10",
"groupId": "BG002"
},
{
"value": "3",
"groupId": "BG003"
},
{
"value": "25",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Hispanic",
"categories": [
{
"measurements": [
{
"value": "2",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
},
{
"value": "3",
"groupId": "BG003"
},
{
"value": "7",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Mestizo",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "3",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "5",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Mauritius Islander",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "1",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Coloured",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "2",
"groupId": "BG004"
}
]
}
]
},
{
"title": "NH and White (Arabic/North African Heritage [HER])",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "European Heritage and South American",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "South American, African HER and European HER",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Afrikaans-South Africa",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "White South African",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "1",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "White South American",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "2",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "3",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Southeast and Northeast of South America",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Mulatto",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "South American Latin American and European HER",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Black from South America",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Northeast of South America and European HER",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Asian (East), NH or Other Pacific Islander",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "1",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Peruvian",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "1",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Mexican",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
},
{
"value": "1",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "American Indian or Alaska Native and White",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Caucasian and Guamanian (Chamorro)",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
},
{
"value": "0",
"groupId": "BG003"
},
{
"value": "1",
"groupId": "BG004"
}
]
}
]
},
{
"title": "Unknown/Missing",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "3",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
},
{
"value": "3",
"groupId": "BG003"
},
{
"value": "8",
"groupId": "BG004"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "participants"
}
]
}
}
}
]