{"description":"All enrolled participants who received at least one dose of study drug.","eventGroups":[{"description":"200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.","id":"EG000","otherNumAffected":132,"otherNumAtRisk":132,"seriousNumAffected":33,"seriousNumAtRisk":132,"title":"Abemaciclib"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":132,"numEvents":96}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":132,"numEvents":88}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":132,"numEvents":21}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":132,"numEvents":12}],"term":"Lacrimation increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":132,"numEvents":54}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":132,"numEvents":19}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":132,"numEvents":33}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":120,"numAtRisk":132,"numEvents":370}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":132,"numEvents":18}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":132,"numEvents":16}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":132,"numEvents":11}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":132,"numEvents":13}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":89,"numAtRisk":132,"numEvents":141}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":132,"numEvents":17}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":132,"numEvents":91}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":132,"numEvents":85}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":132,"numEvents":8}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":132,"numEvents":129}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":132,"numEvents":16}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":132,"numEvents":19}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":132,"numEvents":17}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":132,"numEvents":13}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":132,"numEvents":9}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":132,"numEvents":15}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":132,"numEvents":16}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":132,"numEvents":41}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":132,"numEvents":105}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":132,"numEvents":42}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":132,"numEvents":22}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":132,"numEvents":69}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":60,"numAtRisk":132,"numEvents":76}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":132,"numEvents":15}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":132,"numEvents":17}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":132,"numEvents":32}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":132,"numEvents":18}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":132,"numEvents":9}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":132,"numEvents":9}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":132,"numEvents":8}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":132,"numEvents":18}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":132,"numEvents":19}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":132,"numEvents":40}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":132,"numEvents":8}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":132,"numEvents":42}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":132,"numEvents":23}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":132,"numEvents":21}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":132,"numEvents":13}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":132,"numEvents":13}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":132,"numEvents":9}],"term":"Rash"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Haematotoxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":2}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132,"numEvents":2}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Large intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":132,"numEvents":3}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Pancreatic enzyme abnormality"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Varices oesophageal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":2}],"term":"Atypical pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132,"numEvents":5}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Gastroenteritis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":132,"numEvents":4}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Electrocardiogram abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Liver function test abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Renal function test abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":132,"numEvents":3}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Epilepsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132,"numEvents":2}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":132,"numEvents":2}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Arterial thrombosis"}],"timeFrame":"Up To 45.57 Months"}