{"description":"Safety population included all participants who were randomized and received study drug.","eventGroups":[{"description":"5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.","id":"EG000","otherNumAffected":72,"otherNumAtRisk":72,"seriousNumAffected":23,"seriousNumAtRisk":72,"title":"T+P Concomitant Anthracycline-based Chemotherapy"},{"description":"FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.","id":"EG001","otherNumAffected":73,"otherNumAtRisk":75,"seriousNumAffected":18,"seriousNumAtRisk":75,"title":"T+P Sequential Anthracycline-based Chemotherapy"},{"description":"Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.","id":"EG002","otherNumAffected":76,"otherNumAtRisk":76,"seriousNumAffected":31,"seriousNumAtRisk":76,"title":"T+P Concomitant Non-Anthracycline Chemotherapy"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":72},{"groupId":"EG001","numAffected":44,"numAtRisk":75},{"groupId":"EG002","numAffected":55,"numAtRisk":76}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":72},{"groupId":"EG001","numAffected":41,"numAtRisk":75},{"groupId":"EG002","numAffected":34,"numAtRisk":76}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":72},{"groupId":"EG001","numAffected":27,"numAtRisk":75},{"groupId":"EG002","numAffected":30,"numAtRisk":76}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":72},{"groupId":"EG001","numAffected":9,"numAtRisk":75},{"groupId":"EG002","numAffected":17,"numAtRisk":76}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":72},{"groupId":"EG001","numAffected":18,"numAtRisk":75},{"groupId":"EG002","numAffected":13,"numAtRisk":76}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":72},{"groupId":"EG001","numAffected":13,"numAtRisk":75},{"groupId":"EG002","numAffected":9,"numAtRisk":76}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":72},{"groupId":"EG001","numAffected":6,"numAtRisk":75},{"groupId":"EG002","numAffected":5,"numAtRisk":76}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":72},{"groupId":"EG001","numAffected":7,"numAtRisk":75},{"groupId":"EG002","numAffected":6,"numAtRisk":76}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":72},{"groupId":"EG001","numAffected":2,"numAtRisk":75},{"groupId":"EG002","numAffected":8,"numAtRisk":76}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":4,"numAtRisk":76}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":2,"numAtRisk":75},{"groupId":"EG002","numAffected":4,"numAtRisk":76}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":4,"numAtRisk":75},{"groupId":"EG002","numAffected":2,"numAtRisk":76}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":72},{"groupId":"EG001","numAffected":39,"numAtRisk":75},{"groupId":"EG002","numAffected":42,"numAtRisk":76}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":72},{"groupId":"EG001","numAffected":8,"numAtRisk":75},{"groupId":"EG002","numAffected":20,"numAtRisk":76}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":72},{"groupId":"EG001","numAffected":8,"numAtRisk":75},{"groupId":"EG002","numAffected":10,"numAtRisk":76}],"term":"Nail disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":72},{"groupId":"EG001","numAffected":5,"numAtRisk":75},{"groupId":"EG002","numAffected":11,"numAtRisk":76}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":72},{"groupId":"EG001","numAffected":7,"numAtRisk":75},{"groupId":"EG002","numAffected":8,"numAtRisk":76}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":72},{"groupId":"EG001","numAffected":9,"numAtRisk":75},{"groupId":"EG002","numAffected":6,"numAtRisk":76}],"term":"Palmar -plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":72},{"groupId":"EG001","numAffected":7,"numAtRisk":75},{"groupId":"EG002","numAffected":4,"numAtRisk":76}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":5,"numAtRisk":75},{"groupId":"EG002","numAffected":3,"numAtRisk":76}],"term":"Skin reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":5,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":5,"numAtRisk":76}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":5,"numAtRisk":76}],"term":"Night sweats"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":4,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Skin hyperpigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":4,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Skin exfoliation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":72},{"groupId":"EG001","numAffected":28,"numAtRisk":75},{"groupId":"EG002","numAffected":33,"numAtRisk":76}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":72},{"groupId":"EG001","numAffected":15,"numAtRisk":75},{"groupId":"EG002","numAffected":12,"numAtRisk":76}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":72},{"groupId":"EG001","numAffected":9,"numAtRisk":75},{"groupId":"EG002","numAffected":15,"numAtRisk":76}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":72},{"groupId":"EG001","numAffected":14,"numAtRisk":75},{"groupId":"EG002","numAffected":10,"numAtRisk":76}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":72},{"groupId":"EG001","numAffected":5,"numAtRisk":75},{"groupId":"EG002","numAffected":9,"numAtRisk":76}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":72},{"groupId":"EG001","numAffected":7,"numAtRisk":75},{"groupId":"EG002","numAffected":4,"numAtRisk":76}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":7,"numAtRisk":76}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":4,"numAtRisk":75},{"groupId":"EG002","numAffected":5,"numAtRisk":76}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":5,"numAtRisk":75},{"groupId":"EG002","numAffected":2,"numAtRisk":76}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":3,"numAtRisk":75},{"groupId":"EG002","numAffected":5,"numAtRisk":76}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":2,"numAtRisk":75},{"groupId":"EG002","numAffected":5,"numAtRisk":76}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":5,"numAtRisk":76}],"term":"Axillary pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":72},{"groupId":"EG001","numAffected":33,"numAtRisk":75},{"groupId":"EG002","numAffected":37,"numAtRisk":76}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":72},{"groupId":"EG001","numAffected":8,"numAtRisk":75},{"groupId":"EG002","numAffected":29,"numAtRisk":76}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":72},{"groupId":"EG001","numAffected":12,"numAtRisk":75},{"groupId":"EG002","numAffected":13,"numAtRisk":76}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":23,"numAtRisk":76}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":72},{"groupId":"EG001","numAffected":3,"numAtRisk":75},{"groupId":"EG002","numAffected":2,"numAtRisk":76}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":72},{"groupId":"EG001","numAffected":18,"numAtRisk":75},{"groupId":"EG002","numAffected":11,"numAtRisk":76}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":72},{"groupId":"EG001","numAffected":16,"numAtRisk":75},{"groupId":"EG002","numAffected":8,"numAtRisk":76}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":72},{"groupId":"EG001","numAffected":9,"numAtRisk":75},{"groupId":"EG002","numAffected":7,"numAtRisk":76}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":72},{"groupId":"EG001","numAffected":8,"numAtRisk":75},{"groupId":"EG002","numAffected":5,"numAtRisk":76}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":72},{"groupId":"EG001","numAffected":7,"numAtRisk":75},{"groupId":"EG002","numAffected":7,"numAtRisk":76}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":72},{"groupId":"EG001","numAffected":4,"numAtRisk":75},{"groupId":"EG002","numAffected":6,"numAtRisk":76}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":72},{"groupId":"EG001","numAffected":3,"numAtRisk":75},{"groupId":"EG002","numAffected":5,"numAtRisk":76}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":72},{"groupId":"EG001","numAffected":4,"numAtRisk":75},{"groupId":"EG002","numAffected":2,"numAtRisk":76}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":72},{"groupId":"EG001","numAffected":15,"numAtRisk":75},{"groupId":"EG002","numAffected":16,"numAtRisk":76}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":72},{"groupId":"EG001","numAffected":10,"numAtRisk":75},{"groupId":"EG002","numAffected":16,"numAtRisk":76}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":72},{"groupId":"EG001","numAffected":9,"numAtRisk":75},{"groupId":"EG002","numAffected":15,"numAtRisk":76}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":72},{"groupId":"EG001","numAffected":4,"numAtRisk":75},{"groupId":"EG002","numAffected":8,"numAtRisk":76}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":72},{"groupId":"EG001","numAffected":8,"numAtRisk":75},{"groupId":"EG002","numAffected":5,"numAtRisk":76}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":72},{"groupId":"EG001","numAffected":4,"numAtRisk":75},{"groupId":"EG002","numAffected":9,"numAtRisk":76}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":4,"numAtRisk":76}],"term":"Polyneuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":72},{"groupId":"EG001","numAffected":8,"numAtRisk":75},{"groupId":"EG002","numAffected":10,"numAtRisk":76}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":72},{"groupId":"EG001","numAffected":10,"numAtRisk":75},{"groupId":"EG002","numAffected":11,"numAtRisk":76}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":72},{"groupId":"EG001","numAffected":8,"numAtRisk":75},{"groupId":"EG002","numAffected":10,"numAtRisk":76}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":72},{"groupId":"EG001","numAffected":6,"numAtRisk":75},{"groupId":"EG002","numAffected":9,"numAtRisk":76}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":72},{"groupId":"EG001","numAffected":5,"numAtRisk":75},{"groupId":"EG002","numAffected":7,"numAtRisk":76}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":72},{"groupId":"EG001","numAffected":9,"numAtRisk":75},{"groupId":"EG002","numAffected":9,"numAtRisk":76}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":72},{"groupId":"EG001","numAffected":10,"numAtRisk":75},{"groupId":"EG002","numAffected":3,"numAtRisk":76}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":72},{"groupId":"EG001","numAffected":7,"numAtRisk":75},{"groupId":"EG002","numAffected":7,"numAtRisk":76}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":4,"numAtRisk":76}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":4,"numAtRisk":75},{"groupId":"EG002","numAffected":6,"numAtRisk":76}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":72},{"groupId":"EG001","numAffected":13,"numAtRisk":75},{"groupId":"EG002","numAffected":17,"numAtRisk":76}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":72},{"groupId":"EG001","numAffected":3,"numAtRisk":75},{"groupId":"EG002","numAffected":4,"numAtRisk":76}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":4,"numAtRisk":75},{"groupId":"EG002","numAffected":4,"numAtRisk":76}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":72},{"groupId":"EG001","numAffected":9,"numAtRisk":75},{"groupId":"EG002","numAffected":10,"numAtRisk":76}],"term":"Hot Flush"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":72},{"groupId":"EG001","numAffected":2,"numAtRisk":75},{"groupId":"EG002","numAffected":5,"numAtRisk":76}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":5,"numAtRisk":75},{"groupId":"EG002","numAffected":4,"numAtRisk":76}],"term":"Lymphoedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":72},{"groupId":"EG001","numAffected":4,"numAtRisk":75},{"groupId":"EG002","numAffected":7,"numAtRisk":76}],"term":"Haemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":72},{"groupId":"EG001","numAffected":3,"numAtRisk":75},{"groupId":"EG002","numAffected":8,"numAtRisk":76}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":72},{"groupId":"EG001","numAffected":3,"numAtRisk":75},{"groupId":"EG002","numAffected":5,"numAtRisk":76}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":72},{"groupId":"EG001","numAffected":4,"numAtRisk":75},{"groupId":"EG002","numAffected":5,"numAtRisk":76}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":72},{"groupId":"EG001","numAffected":8,"numAtRisk":75},{"groupId":"EG002","numAffected":16,"numAtRisk":76}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":72},{"groupId":"EG001","numAffected":14,"numAtRisk":75},{"groupId":"EG002","numAffected":7,"numAtRisk":76}],"term":"Radiation skin injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":72},{"groupId":"EG001","numAffected":4,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Seroma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":72},{"groupId":"EG001","numAffected":4,"numAtRisk":75},{"groupId":"EG002","numAffected":6,"numAtRisk":76}],"term":"Lacrimation increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":72},{"groupId":"EG001","numAffected":2,"numAtRisk":75},{"groupId":"EG002","numAffected":4,"numAtRisk":76}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":4,"numAtRisk":76}],"term":"Eyelid oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":72},{"groupId":"EG001","numAffected":8,"numAtRisk":75},{"groupId":"EG002","numAffected":7,"numAtRisk":76}],"term":"Left ventricular dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":4,"numAtRisk":76}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":3,"numAtRisk":75},{"groupId":"EG002","numAffected":6,"numAtRisk":76}],"term":"Breast pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":4,"numAtRisk":76}],"term":"Vulvovaginal dryness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":72},{"groupId":"EG001","numAffected":2,"numAtRisk":75},{"groupId":"EG002","numAffected":7,"numAtRisk":76}],"term":"Drug hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":7,"numAtRisk":76}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":72},{"groupId":"EG001","numAffected":4,"numAtRisk":75},{"groupId":"EG002","numAffected":2,"numAtRisk":76}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":72},{"groupId":"EG001","numAffected":3,"numAtRisk":75},{"groupId":"EG002","numAffected":3,"numAtRisk":76}],"term":"Chest discomfort"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":72},{"groupId":"EG001","numAffected":4,"numAtRisk":75},{"groupId":"EG002","numAffected":11,"numAtRisk":76}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":3,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":2,"numAtRisk":76}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":2,"numAtRisk":76}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":2,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Neutropenic infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Anal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Catheter site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Clostridium difficile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Device related sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Lung Abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Neutropenic sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Pseudomembranous colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":3,"numAtRisk":75},{"groupId":"EG002","numAffected":4,"numAtRisk":76}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":2,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":3,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Left ventricular dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Cardiovascular disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Conduction disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Electrolyte imbalance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":2,"numAtRisk":76}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":2,"numAtRisk":76}],"term":"Drug hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Anaphylactic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Breast mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Breast necrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Ovarian cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Vaginal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Post procedural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Seroma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":1,"numAtRisk":76}],"term":"Epilepsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":72},{"groupId":"EG001","numAffected":0,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Metastatic neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (18.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":72},{"groupId":"EG001","numAffected":1,"numAtRisk":75},{"groupId":"EG002","numAffected":0,"numAtRisk":76}],"term":"Panic attack"}],"timeFrame":"Up to approximately 5 years"}