{"description":"The safety population included all participants who received at least one dose of study medication and at least one safety assessment performed at baseline. Participants were assigned to treatment groups according to treatment actually received.","eventGroups":[{"description":"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m\\^2 on Day 1 of Cycle 1 followed by 100 mg/m\\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.\n\nAdjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.","id":"EG000","otherNumAffected":107,"otherNumAtRisk":107,"seriousNumAffected":21,"seriousNumAtRisk":107,"title":"Trastuzumab+Docetaxel"},{"description":"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\\^2 on Day 1 of Cycle 1 followed by 100 mg/m\\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.\n\nAdjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.","id":"EG001","otherNumAffected":105,"otherNumAtRisk":107,"seriousNumAffected":22,"seriousNumAtRisk":107,"title":"Trastuzumab+Pertuzumab+Docetaxel"},{"description":"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.\n\nAdjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m\\^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m\\^2 for three cycles (Cycles 6-8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17.","id":"EG002","otherNumAffected":101,"otherNumAtRisk":108,"seriousNumAffected":19,"seriousNumAtRisk":108,"title":"Trastuzumab+Pertuzumab"},{"description":"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\\^2 on Day 1 of Cycle 1 followed by 100 mg/m\\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.\n\nAdjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21.","id":"EG003","otherNumAffected":94,"otherNumAtRisk":94,"seriousNumAffected":21,"seriousNumAtRisk":94,"title":"Pertuzumab+Docetaxel"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":70,"numAtRisk":107},{"groupId":"EG001","numAffected":71,"numAtRisk":107},{"groupId":"EG002","numAffected":52,"numAtRisk":108},{"groupId":"EG003","numAffected":61,"numAtRisk":94}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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(17.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":107},{"groupId":"EG001","numAffected":14,"numAtRisk":107},{"groupId":"EG002","numAffected":9,"numAtRisk":108},{"groupId":"EG003","numAffected":6,"numAtRisk":94}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":107},{"groupId":"EG001","numAffected":11,"numAtRisk":107},{"groupId":"EG002","numAffected":8,"numAtRisk":108},{"groupId":"EG003","numAffected":10,"numAtRisk":94}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":107},{"groupId":"EG001","numAffected":8,"numAtRisk":107},{"groupId":"EG002","numAffected":8,"numAtRisk":108},{"groupId":"EG003","numAffected":4,"numAtRisk":94}],"term":"Haemorrhoids"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":107},{"groupId":"EG001","numAffected":6,"numAtRisk":107},{"groupId":"EG002","numAffected":6,"numAtRisk":108},{"groupId":"EG003","numAffected":5,"numAtRisk":94}],"term":"Dyspepsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":107},{"groupId":"EG001","numAffected":1,"numAtRisk":107},{"groupId":"EG002","numAffected":2,"numAtRisk":108},{"groupId":"EG003","numAffected":5,"numAtRisk":94}],"term":"Abdominal distension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":75,"numAtRisk":107},{"groupId":"EG001","numAffected":73,"numAtRisk":107},{"groupId":"EG002","numAffected":59,"numAtRisk":108},{"groupId":"EG003","numAffected":65,"numAtRisk":94}],"term":"Alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":107},{"groupId":"EG001","numAffected":30,"numAtRisk":107},{"groupId":"EG002","numAffected":22,"numAtRisk":108},{"groupId":"EG003","numAffected":30,"numAtRisk":94}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":107},{"groupId":"EG001","numAffected":13,"numAtRisk":107},{"groupId":"EG002","numAffected":16,"numAtRisk":108},{"groupId":"EG003","numAffected":13,"numAtRisk":94}],"term":"Nail disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":107},{"groupId":"EG001","numAffected":5,"numAtRisk":107},{"groupId":"EG002","numAffected":10,"numAtRisk":108},{"groupId":"EG003","numAffected":8,"numAtRisk":94}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":107},{"groupId":"EG001","numAffected":6,"numAtRisk":107},{"groupId":"EG002","numAffected":7,"numAtRisk":108},{"groupId":"EG003","numAffected":11,"numAtRisk":94}],"term":"Erythema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":107},{"groupId":"EG001","numAffected":7,"numAtRisk":107},{"groupId":"EG002","numAffected":2,"numAtRisk":108},{"groupId":"EG003","numAffected":6,"numAtRisk":94}],"term":"Skin hyperpigmentation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":107},{"groupId":"EG001","numAffected":6,"numAtRisk":107},{"groupId":"EG002","numAffected":4,"numAtRisk":108},{"groupId":"EG003","numAffected":7,"numAtRisk":94}],"term":"Urticaria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":107},{"groupId":"EG001","numAffected":7,"numAtRisk":107},{"groupId":"EG002","numAffected":2,"numAtRisk":108},{"groupId":"EG003","numAffected":4,"numAtRisk":94}],"term":"Acne"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":107},{"groupId":"EG001","numAffected":2,"numAtRisk":107},{"groupId":"EG002","numAffected":3,"numAtRisk":108},{"groupId":"EG003","numAffected":2,"numAtRisk":94}],"term":"Dry skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":107},{"groupId":"EG001","numAffected":35,"numAtRisk":107},{"groupId":"EG002","numAffected":34,"numAtRisk":108},{"groupId":"EG003","numAffected":37,"numAtRisk":94}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":107},{"groupId":"EG001","numAffected":33,"numAtRisk":107},{"groupId":"EG002","numAffected":18,"numAtRisk":108},{"groupId":"EG003","numAffected":28,"numAtRisk":94}],"term":"Mucosal inflammation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":107},{"groupId":"EG001","numAffected":29,"numAtRisk":107},{"groupId":"EG002","numAffected":19,"numAtRisk":108},{"groupId":"EG003","numAffected":23,"numAtRisk":94}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":107},{"groupId":"EG001","numAffected":25,"numAtRisk":107},{"groupId":"EG002","numAffected":21,"numAtRisk":108},{"groupId":"EG003","numAffected":14,"numAtRisk":94}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":107},{"groupId":"EG001","numAffected":7,"numAtRisk":107},{"groupId":"EG002","numAffected":18,"numAtRisk":108},{"groupId":"EG003","numAffected":9,"numAtRisk":94}],"term":"Oedema peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":107},{"groupId":"EG001","numAffected":4,"numAtRisk":107},{"groupId":"EG002","numAffected":10,"numAtRisk":108},{"groupId":"EG003","numAffected":2,"numAtRisk":94}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":107},{"groupId":"EG001","numAffected":2,"numAtRisk":107},{"groupId":"EG002","numAffected":4,"numAtRisk":108},{"groupId":"EG003","numAffected":6,"numAtRisk":94}],"term":"Chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":107},{"groupId":"EG001","numAffected":3,"numAtRisk":107},{"groupId":"EG002","numAffected":3,"numAtRisk":108},{"groupId":"EG003","numAffected":7,"numAtRisk":94}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":107},{"groupId":"EG001","numAffected":0,"numAtRisk":107},{"groupId":"EG002","numAffected":6,"numAtRisk":108},{"groupId":"EG003","numAffected":4,"numAtRisk":94}],"term":"Oedema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":80,"numAtRisk":107},{"groupId":"EG001","numAffected":64,"numAtRisk":107},{"groupId":"EG002","numAffected":46,"numAtRisk":108},{"groupId":"EG003","numAffected":67,"numAtRisk":94}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":107},{"groupId":"EG001","numAffected":13,"numAtRisk":107},{"groupId":"EG002","numAffected":13,"numAtRisk":108},{"groupId":"EG003","numAffected":15,"numAtRisk":94}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":107},{"groupId":"EG001","numAffected":6,"numAtRisk":107},{"groupId":"EG002","numAffected":11,"numAtRisk":108},{"groupId":"EG003","numAffected":12,"numAtRisk":94}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":107},{"groupId":"EG001","numAffected":25,"numAtRisk":107},{"groupId":"EG002","numAffected":29,"numAtRisk":108},{"groupId":"EG003","numAffected":22,"numAtRisk":94}],"term":"Myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":107},{"groupId":"EG001","numAffected":18,"numAtRisk":107},{"groupId":"EG002","numAffected":13,"numAtRisk":108},{"groupId":"EG003","numAffected":19,"numAtRisk":94}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":107},{"groupId":"EG001","numAffected":13,"numAtRisk":107},{"groupId":"EG002","numAffected":5,"numAtRisk":108},{"groupId":"EG003","numAffected":11,"numAtRisk":94}],"term":"Musculoskeletal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":107},{"groupId":"EG001","numAffected":11,"numAtRisk":107},{"groupId":"EG002","numAffected":7,"numAtRisk":108},{"groupId":"EG003","numAffected":8,"numAtRisk":94}],"term":"Bone pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":107},{"groupId":"EG001","numAffected":7,"numAtRisk":107},{"groupId":"EG002","numAffected":8,"numAtRisk":108},{"groupId":"EG003","numAffected":11,"numAtRisk":94}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":107},{"groupId":"EG001","numAffected":7,"numAtRisk":107},{"groupId":"EG002","numAffected":7,"numAtRisk":108},{"groupId":"EG003","numAffected":6,"numAtRisk":94}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (17.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":107},{"groupId":"EG001","numAffected":14,"numAtRisk":107},{"groupId":"EG002","numAffected":25,"numAtRisk":108},{"groupId":"EG003","numAffected":22,"numAtRisk":94}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 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