{"eventGroups":[{"description":"Pemetrexed 500 mg/m\\^2 administered by IV infusion followed by cisplatin 75 mg/m\\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.","id":"EG000","otherNumAffected":65,"otherNumAtRisk":66,"seriousNumAffected":45,"seriousNumAtRisk":66,"title":"Pemetrexed Cisplatin Cetuximab"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":66,"numEvents":30}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":66,"numEvents":36}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":66,"numEvents":35}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":66,"numEvents":19}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":66,"numEvents":7}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":66,"numEvents":5}],"term":"Lacrimation increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":66,"numEvents":6}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":66,"numEvents":7}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":66,"numEvents":29}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":66,"numEvents":28}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":66,"numEvents":11}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":66,"numEvents":13}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":66,"numEvents":33}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":66,"numEvents":24}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":66,"numEvents":26}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":66,"numEvents":25}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":66,"numEvents":4}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":66,"numEvents":45}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":66,"numEvents":35}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":66,"numEvents":9}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":66,"numEvents":5}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":66,"numEvents":12}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":66,"numEvents":6}],"term":"Folliculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":66,"numEvents":5}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":66,"numEvents":4}],"term":"Creatinine renal clearance decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":66,"numEvents":10}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":66,"numEvents":6}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":66,"numEvents":31}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":66,"numEvents":4}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":66,"numEvents":10}],"term":"Fluid retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":66,"numEvents":5}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":66,"numEvents":26}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":66,"numEvents":24}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":66,"numEvents":8}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":66,"numEvents":4}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":66,"numEvents":5}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":66,"numEvents":18}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":66,"numEvents":8}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":66,"numEvents":6}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":66,"numEvents":4}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":66,"numEvents":6}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":66,"numEvents":7}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":66,"numEvents":6}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":66,"numEvents":5}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":66,"numEvents":12}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":66,"numEvents":9}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":66,"numEvents":6}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":66,"numEvents":11}],"term":"Acne"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":66,"numEvents":12}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":66,"numEvents":6}],"term":"Dermatitis acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":66,"numEvents":17}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":66,"numEvents":10}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":66,"numEvents":5}],"term":"Nail disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":66,"numEvents":5}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":66,"numEvents":37}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":66,"numEvents":12}],"term":"Skin fissures"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":66,"numEvents":4}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":66,"numEvents":8}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":66,"numEvents":7}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":66,"numEvents":3}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":66,"numEvents":6}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":66,"numEvents":5}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Cardio-respiratory arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Fanconi syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":66,"numEvents":5}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":66,"numEvents":2}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Large intestine perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Subileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":66,"numEvents":3}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":66,"numEvents":2}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":66,"numEvents":2}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":66,"numEvents":2}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Implant site haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Medical device complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Medical device pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":66,"numEvents":2}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Performance status decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":66,"numEvents":4}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Anaphylactic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Catheter site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Endocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Oesophageal candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":66,"numEvents":7}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Postoperative wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Pseudomonal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":66,"numEvents":4}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":66,"numEvents":2}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Septic embolus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Staphylococcal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Staphylococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Subcutaneous abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":66,"numEvents":2}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Post procedural haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":66,"numEvents":2}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":66,"numEvents":4}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":66,"numEvents":2}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":66,"numEvents":2}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Tumour embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Tumour haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Asterixis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Cerebral ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":66,"numEvents":3}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Transient ischaemic attack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":66,"numEvents":3}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":66,"numEvents":2}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":66,"numEvents":2}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Respiratory distress"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":66,"numEvents":3}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66,"numEvents":1}],"term":"Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":66,"numEvents":5}],"term":"Hypotension"}]}