{"description":"Safety Population: All randomized participants who received at least one dose of study treatment and the participants were analyzed based on the treatment they actually received (N=353 in Trastuzumab + Taxane arm, N=361 in Trastuzumab Emtansine, Pertuzumab-placebo arm, N=366 in Trastuzumab emtansine + pertuzumab arm).","eventGroups":[{"description":"Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.","id":"EG000","otherNumAffected":342,"otherNumAtRisk":353,"seriousNumAffected":81,"seriousNumAtRisk":353,"title":"Trastuzumab + Taxane"},{"description":"Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.","id":"EG001","otherNumAffected":352,"otherNumAtRisk":361,"seriousNumAffected":86,"seriousNumAtRisk":361,"title":"Trastuzumab Emtansine + Placebo"},{"description":"Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.","id":"EG002","otherNumAffected":352,"otherNumAtRisk":366,"seriousNumAffected":93,"seriousNumAtRisk":366,"title":"Trastuzumab Emtansine + Pertuzumab"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":131,"numAtRisk":353},{"groupId":"EG001","numAffected":174,"numAtRisk":361},{"groupId":"EG002","numAffected":192,"numAtRisk":366}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":173,"numAtRisk":353},{"groupId":"EG001","numAffected":92,"numAtRisk":361},{"groupId":"EG002","numAffected":178,"numAtRisk":366}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General 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(17.1)","stats":[{"groupId":"EG000","numAffected":59,"numAtRisk":353},{"groupId":"EG001","numAffected":96,"numAtRisk":361},{"groupId":"EG002","numAffected":118,"numAtRisk":366}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":212,"numAtRisk":353},{"groupId":"EG001","numAffected":26,"numAtRisk":361},{"groupId":"EG002","numAffected":33,"numAtRisk":366}],"term":"Alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":69,"numAtRisk":353},{"groupId":"EG001","numAffected":80,"numAtRisk":361},{"groupId":"EG002","numAffected":111,"numAtRisk":366}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":76,"numAtRisk":353},{"groupId":"EG001","numAffected":84,"numAtRisk":361},{"groupId":"EG002","numAffected":84,"numAtRisk":366}],"term":"Decreased appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":91,"numAtRisk":353},{"groupId":"EG001","numAffected":83,"numAtRisk":361},{"groupId":"EG002","numAffected":71,"numAtRisk":366}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":86,"numAtRisk":353},{"groupId":"EG001","numAffected":62,"numAtRisk":361},{"groupId":"EG002","numAffected":89,"numAtRisk":366}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":72,"numAtRisk":353},{"groupId":"EG001","numAffected":82,"numAtRisk":361},{"groupId":"EG002","numAffected":71,"numAtRisk":366}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":74,"numAtRisk":353},{"groupId":"EG001","numAffected":72,"numAtRisk":361},{"groupId":"EG002","numAffected":79,"numAtRisk":366}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":99,"numAtRisk":353},{"groupId":"EG001","numAffected":52,"numAtRisk":361},{"groupId":"EG002","numAffected":69,"numAtRisk":366}],"term":"Neuropathy peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 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(17.1)","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":353},{"groupId":"EG001","numAffected":50,"numAtRisk":361},{"groupId":"EG002","numAffected":66,"numAtRisk":366}],"term":"Upper respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":98,"numAtRisk":353},{"groupId":"EG001","numAffected":37,"numAtRisk":361},{"groupId":"EG002","numAffected":35,"numAtRisk":366}],"term":"Oedema peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":70,"numAtRisk":353},{"groupId":"EG001","numAffected":47,"numAtRisk":361},{"groupId":"EG002","numAffected":46,"numAtRisk":366}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":353},{"groupId":"EG001","numAffected":60,"numAtRisk":361},{"groupId":"EG002","numAffected":63,"numAtRisk":366}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":353},{"groupId":"EG001","numAffected":52,"numAtRisk":361},{"groupId":"EG002","numAffected":66,"numAtRisk":366}],"term":"Nasopharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":353},{"groupId":"EG001","numAffected":51,"numAtRisk":361},{"groupId":"EG002","numAffected":52,"numAtRisk":366}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":74,"numAtRisk":353},{"groupId":"EG001","numAffected":44,"numAtRisk":361},{"groupId":"EG002","numAffected":37,"numAtRisk":366}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":353},{"groupId":"EG001","numAffected":53,"numAtRisk":361},{"groupId":"EG002","numAffected":54,"numAtRisk":366}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":56,"numAtRisk":353},{"groupId":"EG001","numAffected":42,"numAtRisk":361},{"groupId":"EG002","numAffected":53,"numAtRisk":366}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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(19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":353},{"groupId":"EG001","numAffected":1,"numAtRisk":361},{"groupId":"EG002","numAffected":0,"numAtRisk":366}],"term":"Acute Pulmonary Oedema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":353},{"groupId":"EG001","numAffected":1,"numAtRisk":361},{"groupId":"EG002","numAffected":1,"numAtRisk":366}],"term":"Cutaneous Lupus Erythematosus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":353},{"groupId":"EG001","numAffected":0,"numAtRisk":361},{"groupId":"EG002","numAffected":1,"numAtRisk":366}],"term":"Aneurysm"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":353},{"groupId":"EG001","numAffected":0,"numAtRisk":361},{"groupId":"EG002","numAffected":1,"numAtRisk":366}],"term":"Hypovolaemic Shock"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":353},{"groupId":"EG001","numAffected":1,"numAtRisk":361},{"groupId":"EG002","numAffected":0,"numAtRisk":366}],"term":"Orthostatic Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":353},{"groupId":"EG001","numAffected":0,"numAtRisk":361},{"groupId":"EG002","numAffected":1,"numAtRisk":366}],"term":"Hepatic Haematoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Per investigator, this serious adverse event was, \"gamma nail implant broke (status after femur fracture).\"","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":353},{"groupId":"EG001","numAffected":0,"numAtRisk":361},{"groupId":"EG002","numAffected":1,"numAtRisk":366}],"term":"Uncoded serious adverse event"}],"timeFrame":"Up to 70 months from randomization until clinical cutoff of 16 September 2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)."}