{"description":"After initiation of study drug, all AEs were reported until 28 days after the last dose of study drug. After this period, only drug-related serious AEs, heart failure, pregnancies, and malignancies were reported.","eventGroups":[{"deathsNumAffected":12,"deathsNumAtRisk":252,"description":"Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor \\[G-CSF\\] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.","id":"EG000","otherNumAffected":251,"otherNumAtRisk":252,"seriousNumAffected":52,"seriousNumAtRisk":252,"title":"Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy"},{"deathsNumAffected":14,"deathsNumAtRisk":248,"description":"Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.","id":"EG001","otherNumAffected":248,"otherNumAtRisk":248,"seriousNumAffected":49,"seriousNumAtRisk":248,"title":"Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":109,"numAtRisk":252,"numEvents":148},{"groupId":"EG001","numAffected":90,"numAtRisk":248,"numEvents":117}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":252,"numEvents":58},{"groupId":"EG001","numAffected":25,"numAtRisk":248,"numEvents":42}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":64,"numAtRisk":252,"numEvents":119},{"groupId":"EG001","numAffected":58,"numAtRisk":248,"numEvents":109}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":252,"numEvents":11},{"groupId":"EG001","numAffected":14,"numAtRisk":248,"numEvents":14}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":252,"numEvents":15},{"groupId":"EG001","numAffected":14,"numAtRisk":248,"numEvents":15}],"term":"Lacrimation increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":252,"numEvents":17},{"groupId":"EG001","numAffected":22,"numAtRisk":248,"numEvents":29}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":252,"numEvents":25},{"groupId":"EG001","numAffected":20,"numAtRisk":248,"numEvents":31}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":252,"numEvents":79},{"groupId":"EG001","numAffected":57,"numAtRisk":248,"numEvents":75}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":148,"numAtRisk":252,"numEvents":309},{"groupId":"EG001","numAffected":152,"numAtRisk":248,"numEvents":293}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":252,"numEvents":34},{"groupId":"EG001","numAffected":35,"numAtRisk":248,"numEvents":42}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":252,"numEvents":6},{"groupId":"EG001","numAffected":13,"numAtRisk":248,"numEvents":14}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":252,"numEvents":11},{"groupId":"EG001","numAffected":22,"numAtRisk":248,"numEvents":22}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":157,"numAtRisk":252,"numEvents":327},{"groupId":"EG001","numAffected":151,"numAtRisk":248,"numEvents":308}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":61,"numAtRisk":252,"numEvents":90},{"groupId":"EG001","numAffected":63,"numAtRisk":248,"numEvents":85}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":252,"numEvents":73},{"groupId":"EG001","numAffected":50,"numAtRisk":248,"numEvents":71}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":84,"numAtRisk":252,"numEvents":142},{"groupId":"EG001","numAffected":79,"numAtRisk":248,"numEvents":160}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":62,"numAtRisk":252,"numEvents":114},{"groupId":"EG001","numAffected":71,"numAtRisk":248,"numEvents":113}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":252,"numEvents":17},{"groupId":"EG001","numAffected":15,"numAtRisk":248,"numEvents":21}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":252,"numEvents":2},{"groupId":"EG001","numAffected":40,"numAtRisk":248,"numEvents":174}],"term":"Injection site reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":252,"numEvents":20},{"groupId":"EG001","numAffected":14,"numAtRisk":248,"numEvents":20}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":252,"numEvents":66},{"groupId":"EG001","numAffected":39,"numAtRisk":248,"numEvents":53}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":252,"numEvents":13},{"groupId":"EG001","numAffected":6,"numAtRisk":248,"numEvents":6}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":252,"numEvents":28},{"groupId":"EG001","numAffected":23,"numAtRisk":248,"numEvents":25}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":252,"numEvents":56},{"groupId":"EG001","numAffected":32,"numAtRisk":248,"numEvents":41}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":252,"numEvents":14},{"groupId":"EG001","numAffected":8,"numAtRisk":248,"numEvents":8}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":252,"numEvents":39},{"groupId":"EG001","numAffected":33,"numAtRisk":248,"numEvents":40}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":252,"numEvents":14},{"groupId":"EG001","numAffected":20,"numAtRisk":248,"numEvents":21}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":252,"numEvents":17},{"groupId":"EG001","numAffected":14,"numAtRisk":248,"numEvents":15}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":252,"numEvents":37},{"groupId":"EG001","numAffected":34,"numAtRisk":248,"numEvents":43}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":252,"numEvents":20},{"groupId":"EG001","numAffected":18,"numAtRisk":248,"numEvents":22}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":252,"numEvents":53},{"groupId":"EG001","numAffected":9,"numAtRisk":248,"numEvents":9}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":252,"numEvents":26},{"groupId":"EG001","numAffected":29,"numAtRisk":248,"numEvents":31}],"term":"Procedural pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":252,"numEvents":55},{"groupId":"EG001","numAffected":50,"numAtRisk":248,"numEvents":51}],"term":"Radiation skin injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":252,"numEvents":61},{"groupId":"EG001","numAffected":39,"numAtRisk":248,"numEvents":50}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":252,"numEvents":54},{"groupId":"EG001","numAffected":29,"numAtRisk":248,"numEvents":37}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":252,"numEvents":28},{"groupId":"EG001","numAffected":16,"numAtRisk":248,"numEvents":17}],"term":"Ejection fraction decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":252,"numEvents":141},{"groupId":"EG001","numAffected":40,"numAtRisk":248,"numEvents":97}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":252,"numEvents":16},{"groupId":"EG001","numAffected":26,"numAtRisk":248,"numEvents":27}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":252,"numEvents":108},{"groupId":"EG001","numAffected":19,"numAtRisk":248,"numEvents":58}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":252,"numEvents":70},{"groupId":"EG001","numAffected":43,"numAtRisk":248,"numEvents":50}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":252,"numEvents":24},{"groupId":"EG001","numAffected":16,"numAtRisk":248,"numEvents":17}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":82,"numAtRisk":252,"numEvents":106},{"groupId":"EG001","numAffected":71,"numAtRisk":248,"numEvents":91}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":252,"numEvents":20},{"groupId":"EG001","numAffected":25,"numAtRisk":248,"numEvents":32}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":252,"numEvents":19},{"groupId":"EG001","numAffected":20,"numAtRisk":248,"numEvents":24}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":252,"numEvents":20},{"groupId":"EG001","numAffected":21,"numAtRisk":248,"numEvents":23}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":252,"numEvents":18},{"groupId":"EG001","numAffected":8,"numAtRisk":248,"numEvents":9}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":252,"numEvents":63},{"groupId":"EG001","numAffected":67,"numAtRisk":248,"numEvents":80}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":252,"numEvents":30},{"groupId":"EG001","numAffected":22,"numAtRisk":248,"numEvents":26}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":252,"numEvents":39},{"groupId":"EG001","numAffected":34,"numAtRisk":248,"numEvents":39}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":252,"numEvents":45},{"groupId":"EG001","numAffected":43,"numAtRisk":248,"numEvents":53}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":68,"numAtRisk":252,"numEvents":84},{"groupId":"EG001","numAffected":45,"numAtRisk":248,"numEvents":72}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":252,"numEvents":53},{"groupId":"EG001","numAffected":33,"numAtRisk":248,"numEvents":38}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":252,"numEvents":26},{"groupId":"EG001","numAffected":25,"numAtRisk":248,"numEvents":30}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":252,"numEvents":44},{"groupId":"EG001","numAffected":42,"numAtRisk":248,"numEvents":45}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":252,"numEvents":8},{"groupId":"EG001","numAffected":15,"numAtRisk":248,"numEvents":17}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":252,"numEvents":45},{"groupId":"EG001","numAffected":44,"numAtRisk":248,"numEvents":50}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":252,"numEvents":13},{"groupId":"EG001","numAffected":15,"numAtRisk":248,"numEvents":17}],"term":"Breast pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":252,"numEvents":43},{"groupId":"EG001","numAffected":41,"numAtRisk":248,"numEvents":44}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":252,"numEvents":18},{"groupId":"EG001","numAffected":29,"numAtRisk":248,"numEvents":32}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":252,"numEvents":43},{"groupId":"EG001","numAffected":31,"numAtRisk":248,"numEvents":36}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":252,"numEvents":21},{"groupId":"EG001","numAffected":15,"numAtRisk":248,"numEvents":16}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":252,"numEvents":15},{"groupId":"EG001","numAffected":17,"numAtRisk":248,"numEvents":22}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":184,"numAtRisk":252,"numEvents":188},{"groupId":"EG001","numAffected":196,"numAtRisk":248,"numEvents":196}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":252,"numEvents":14},{"groupId":"EG001","numAffected":19,"numAtRisk":248,"numEvents":20}],"term":"Dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":252,"numEvents":39},{"groupId":"EG001","numAffected":38,"numAtRisk":248,"numEvents":43}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":252,"numEvents":14},{"groupId":"EG001","numAffected":22,"numAtRisk":248,"numEvents":26}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":252,"numEvents":17},{"groupId":"EG001","numAffected":23,"numAtRisk":248,"numEvents":23}],"term":"Nail discolouration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":252,"numEvents":17},{"groupId":"EG001","numAffected":16,"numAtRisk":248,"numEvents":18}],"term":"Nail disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":252,"numEvents":13},{"groupId":"EG001","numAffected":11,"numAtRisk":248,"numEvents":11}],"term":"Onycholysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":252,"numEvents":13},{"groupId":"EG001","numAffected":17,"numAtRisk":248,"numEvents":17}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":252,"numEvents":29},{"groupId":"EG001","numAffected":29,"numAtRisk":248,"numEvents":35}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":56,"numAtRisk":252,"numEvents":75},{"groupId":"EG001","numAffected":46,"numAtRisk":248,"numEvents":56}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":252,"numEvents":44},{"groupId":"EG001","numAffected":41,"numAtRisk":248,"numEvents":44}],"term":"Hot flush"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":252,"numEvents":19},{"groupId":"EG001","numAffected":12,"numAtRisk":248,"numEvents":13}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":252,"numEvents":11},{"groupId":"EG001","numAffected":9,"numAtRisk":248,"numEvents":9}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Immune thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":252,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":252,"numEvents":6},{"groupId":"EG001","numAffected":4,"numAtRisk":248,"numEvents":5}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Cardiomyopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Goitre"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Anal incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":252,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Gastritis haemorrhagic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Gastrointestinal toxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Lithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":252,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":248,"numEvents":2}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Anal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Escherichia bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Laryngopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":252,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Mastitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":248,"numEvents":4}],"term":"Neutropenic sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":252,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Postoperative abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":252,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Postoperative wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Pseudomonas infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Pyelonephritis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":252,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":248,"numEvents":2}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Flap necrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":252,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Post procedural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Post procedural haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Clostridium test positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":248,"numEvents":3}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Periostitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Angiosarcoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Clear cell renal cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Endometrial cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Gastric cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Gastric cancer stage I"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Pancreatic carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Thyroid cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Breast haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Breast inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Intermenstrual bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Uterine haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":248,"numEvents":2}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":248,"numEvents":2}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":252,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":248,"numEvents":1}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":252,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":248,"numEvents":0}],"term":"Iliac artery occlusion"}],"timeFrame":"Adverse events (AEs): From first dose of study treatment until 28 days after last dose of study treatment (up to 1 year, 6 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 4 years, 11 months)"}