{"description":"Adverse events are reported for the intent-to-treat (ITT) population which included all patients who received at least 1 dose of rituximab, regardless of infusion rate.","eventGroups":[{"description":"Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin \\[doxorubicin\\], Oncovin \\[vincristine\\], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m\\^2 administered by intravenous (IV) infusion on Day 1 of each cycle.","id":"EG000","otherNumAffected":421,"otherNumAtRisk":425,"seriousNumAffected":107,"seriousNumAtRisk":425,"title":"Rituximab 375 mg/m^2"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":135,"numAtRisk":425}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":100,"numAtRisk":425}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":425}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":425}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":202,"numAtRisk":425}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":69,"numAtRisk":425}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":142,"numAtRisk":425}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":99,"numAtRisk":425}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":425}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":425}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":425}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":425}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":227,"numAtRisk":425}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":425}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":425}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":425}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":425}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":425}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":425}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":425}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":425}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":425}],"term":"Candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":425}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":72,"numAtRisk":425}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":425}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":425}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":425}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":425}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":56,"numAtRisk":425}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":425}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":425}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":425}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":425}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":99,"numAtRisk":425}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":425}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":58,"numAtRisk":425}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":75,"numAtRisk":425}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":59,"numAtRisk":425}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":425}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":100,"numAtRisk":425}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":425}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":425}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":425}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":57,"numAtRisk":425}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":65,"numAtRisk":425}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":169,"numAtRisk":425}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":425}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":425}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":425}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":425}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":425}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":425}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":425}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":425}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":425}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":425}],"term":"Ventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":425}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":425}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Cardiomyopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":425}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":425}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":425}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":425}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":425}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Faecaloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Gastric perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Intestinal mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Small intestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Colonic obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Megacolon"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":425}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":425}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":425}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":425}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Ischaemic hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":425}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":425}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Device related sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Fungal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Neutropenic sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":425}],"term":"Staphylococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Staphylococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":425}],"term":"Pseudomonal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Mastitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Meningitis aseptic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Hepatitis B"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Streptococcal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Wound dehiscence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Accidental overdose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":425}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Failure to thrive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Malnutrition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Breast cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Lymphoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":425}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Cerebral ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Convulsion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Renal failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":425}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Respiratory distress"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":425}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":425}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":425}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Jugular vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Venous thrombosis limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":425}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Orthostatic hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (14.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":425}],"term":"Superior vena cava syndrome"}],"timeFrame":"Adverse events and serious adverse events were recorded from the start of study treatment until 30 days following the last administration of study treatment or at study discontinuation/early termination, whichever occurred earlier."}