{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":82,"description":"The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months.\n\nAspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.","id":"EG000","otherNumAffected":79,"otherNumAtRisk":82,"seriousNumAffected":14,"seriousNumAtRisk":82,"title":"PEGASYS"},{"deathsNumAffected":1,"deathsNumAtRisk":86,"description":"Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment.\n\nAspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.","id":"EG001","otherNumAffected":76,"otherNumAtRisk":86,"seriousNumAffected":4,"seriousNumAtRisk":86,"title":"Hydroxyurea"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Abdominal Distenstion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Abdominal hernias and other abdominal wall conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Administration site reactions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Administration site reactions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Alanine aminotransferace increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Allergic conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":82},{"groupId":"EG001","numAffected":10,"numAtRisk":86}],"term":"Anaemias nonhaemolytic and marrow depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Anxeity disorders and symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":82},{"groupId":"EG001","numAffected":4,"numAtRisk":86}],"term":"Appetite and general nutrition disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Arteriosclerosis, stenosis, vascular insufficiency and necrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":82},{"groupId":"EG001","numAffected":4,"numAtRisk":86}],"term":"Aural disorders NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Back pain due to retroperitoneal fibrosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":82},{"groupId":"EG001","numAffected":4,"numAtRisk":86}],"term":"Bacterial infectious disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Benign neoplasms gastrointestinal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Bladder and bladder neck disorders (excl calculi)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Blood Bilirubin Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Blurred vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":82},{"groupId":"EG001","numAffected":5,"numAtRisk":86}],"term":"Body temperature conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Bone and joint injuries"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":82},{"groupId":"EG001","numAffected":4,"numAtRisk":86}],"term":"Bone disorders (excl congenital and fractures)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Bone, calcium, magnesium and phosphorus metabolism disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Cardiac Signs and Symptoms NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":3,"numAtRisk":86}],"term":"Cardiac and vascular investigations (excl enzyme tests)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":3,"numAtRisk":86}],"term":"Cardiac arrhythmias"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":82},{"groupId":"EG001","numAffected":6,"numAtRisk":86}],"term":"Cardiac disorder signs and symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Central nervous system vascular disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Gastrointestinal nonspecific symptoms and therapeutic procedures (SMQ) Cardiomyopathy","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Coagulopathies and bleeding diatheses (excl thrombocytopenic)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Cognitive and attention disorders and disturbances"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Coronary artery disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Cranial nerve disorders (excl neoplasms)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Cutaneous neoplasms benign"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":82},{"groupId":"EG001","numAffected":3,"numAtRisk":86}],"term":"Decreased and nonspecific blood pressure disorders and shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":82},{"groupId":"EG001","numAffected":5,"numAtRisk":86}],"term":"Dental and gingival conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Depressed mood disorders and disturbances"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Dermatitis and eczema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Dermatology/skin, other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Gastrointestinal motility and defaecation conditions","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Diarrhoea (excl infective)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Diverticular disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Taste and smell disorders","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":82},{"groupId":"EG001","numAffected":4,"numAtRisk":86}],"term":"Electrolyte and fluid balance conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Elevated ALT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Endocrine disorders of gonadal function"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Enzyme investigations NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Epidermal and Dermal Conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":82},{"groupId":"EG001","numAffected":19,"numAtRisk":86}],"term":"Epidermal and Dermal Conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Exocrine pancreas conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":82},{"groupId":"EG001","numAffected":3,"numAtRisk":86}],"term":"Eye disorders NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Fatigue (asthenia, lethargy, malaise)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Fatigue or Tiredness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Fatigue or Tiredness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Flu-like symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Fungal infectious disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Gallbladder disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Gastrointestinal conditions NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":3,"numAtRisk":86}],"term":"Gastrointestinal infections"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Gastrointestinal inflammatory conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":82},{"groupId":"EG001","numAffected":20,"numAtRisk":86}],"term":"Gastrointestinal motility and defaecation conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":82},{"groupId":"EG001","numAffected":18,"numAtRisk":86}],"term":"Gastrointestinal signs and symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Gastrointestinal stenosis and obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Gastrointestinal vascular conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"General malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":82},{"groupId":"EG001","numAffected":42,"numAtRisk":86}],"term":"General system disorders NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Genitourinary tract disorders NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Gingival bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":82},{"groupId":"EG001","numAffected":3,"numAtRisk":86}],"term":"Glucose metabolism disorders (incl diabetes mellitus)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Glucose metabolism disorders (incl diabetes mellitus)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":82},{"groupId":"EG001","numAffected":12,"numAtRisk":86}],"term":"Haematology investigations (incl blood groups)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Haematopoietic neoplasms (excl leukaemias and lymphomas)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Hair loss/alopecia (scalp or body)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":82},{"groupId":"EG001","numAffected":11,"numAtRisk":86}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Hearing disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Heart failures"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Hepatic and hepatobiliary disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Hepatobiliary Disorders - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":82},{"groupId":"EG001","numAffected":5,"numAtRisk":86}],"term":"Hepatobiliary investigations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Hyperuricemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Infections - Pathogen Unspecified"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Infections - pathogen class unspecified"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":82},{"groupId":"EG001","numAffected":7,"numAtRisk":86}],"term":"Infections - pathogen unspecified"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Injection site reaction/extravasation changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":82},{"groupId":"EG001","numAffected":4,"numAtRisk":86}],"term":"Injuries NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Inner ear and VIIIth cranial nerve disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Investigations, imaging and histopathology procedures NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":82},{"groupId":"EG001","numAffected":9,"numAtRisk":86}],"term":"Joint Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Lipid analyses"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Lipid metabolism disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Lymphomas non-Hodgkin's T-cell"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Male reproductive tract infections and inflammations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Menstrual cycle and uterine bleeding disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Mental impairment disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":82},{"groupId":"EG001","numAffected":3,"numAtRisk":86}],"term":"Metabolic, nutritional and blood gas investigations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Metabolic/laboratory, other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":3,"numAtRisk":86}],"term":"Middle ear disorders (excl congenital)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Migraine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Mood disorders and disturbances NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Movement disorders (incl parkinsonism)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Mucositis Oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":82},{"groupId":"EG001","numAffected":6,"numAtRisk":86}],"term":"Muscle disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"dystonia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":82},{"groupId":"EG001","numAffected":17,"numAtRisk":86}],"term":"Musculoskeletal and connective tissue disorders NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Musculoskeletal and connective tissue neoplasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Myocardial disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by marked discomfort sensation in the neck area.","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Malignant neoplasm of colon"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve.","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Nervous system disorders, unspecified"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":82},{"groupId":"EG001","numAffected":15,"numAtRisk":86}],"term":"Neurological disorders NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Neurological signs and symptoms NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Neutrophil Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Blood/bone marrow","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Neutrophils/granulocytes (ANC/AGC)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Ocular haemorrhages and vascular disorders NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Ocular infections, irritations and inflammations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Ocular sensory symptoms NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Ocular surface disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":82},{"groupId":"EG001","numAffected":12,"numAtRisk":86}],"term":"Oral soft tissue conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Skin disorders, Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Penile and scrotal disorders (excl infections and inflammations)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Peripheral neuropathies"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Physical examination topics"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":3,"numAtRisk":86}],"term":"Pigmentation disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":82},{"groupId":"EG001","numAffected":8,"numAtRisk":86}],"term":"Platelet disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Procedural related injuries and complications NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Prostatic disorders (excl infections and inflammations)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Protein and amino acid metabolism disorders NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":82},{"groupId":"EG001","numAffected":3,"numAtRisk":86}],"term":"Purine and pyrimidine metabolism disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Renal and urinary tract investigations and urinalyses"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Renal and urinary tract neoplasms benign"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Renal disorders (excl nephropathies)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Reproductive neoplasms female benign"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":82},{"groupId":"EG001","numAffected":12,"numAtRisk":86}],"term":"Respiratory disorders NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":82},{"groupId":"EG001","numAffected":10,"numAtRisk":86}],"term":"Respiratory tract infections"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Retina, choroid, and vitreous haemorrhages and vascular disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Salivary gland conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Sensory Abnormalities NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Sexual dysfunctions, disturbances and gender identity disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Sexual function and fertility disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Skin and subcutaneous tissue disorders - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Skin and subcutaneous tissue disorders NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Skin and subcutaneous tissue infections and infestations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":82},{"groupId":"EG001","numAffected":7,"numAtRisk":86}],"term":"Skin appendage conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Skin investigations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Skin neoplasms malignant and unspecified"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Skin vascular abnormalities"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Sleep disorders and disturbances"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":82},{"groupId":"EG001","numAffected":4,"numAtRisk":86}],"term":"Sleep disturbances (incl subtypes)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Arthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Spinal osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Spleen, lymphatic and reticuloendothelial system disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Synovial and bursal disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Tendon, ligament and cartilage disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Thyroid gland disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Tongue conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":82},{"groupId":"EG001","numAffected":5,"numAtRisk":86}],"term":"Upper respiratory tract disorders (excl infections)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Upper respiratory tract infections - pathogen class unspecified"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Urinary Incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":82},{"groupId":"EG001","numAffected":3,"numAtRisk":86}],"term":"Urinary tract signs and symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Urolithiases"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Vascular disorders NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":3,"numAtRisk":86}],"term":"Vascular haemorrhagic disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":82},{"groupId":"EG001","numAffected":3,"numAtRisk":86}],"term":"Vascular hypertensive disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Venous varices"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Viral infectious disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Vision disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":82},{"groupId":"EG001","numAffected":3,"numAtRisk":86}],"term":"Vision disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Vitamin related disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Water, electrolyte and mineral investigations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":82},{"groupId":"EG001","numAffected":6,"numAtRisk":86}],"term":"White blood cell disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"blurred vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"flu like symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"kidney stone"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"muscle, tendon, and ligament injuries"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"rashes, eruptions, and exanthems NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"skin and subcutaneous conditions NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"skin appendage conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"skin appendage disorders"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Bile Duct Disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Cardiac arrhythmias"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Cardiac disorder signs and symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Electrolyte and fluid balance conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Exocrine pancreas conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Gastrointestinal haemorrahges NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Gastrointestinal signs and symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"General system disorders NEC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Headaches"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":2,"numAtRisk":86}],"term":"Infections - pathogen unspecified"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Neoplasms benign, malignant and unspecified - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Platelet disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Pregnancy, puerperium and perinatal conditions","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Pregnancy, labour, delivery and postpartum conditions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":82},{"groupId":"EG001","numAffected":1,"numAtRisk":86}],"term":"Respiratory and mediastinal neoplasms malignant and unspecified"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Skin and subcutaneous tissue infections and infestations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":82},{"groupId":"EG001","numAffected":0,"numAtRisk":86}],"term":"Gallbladder disorders"}],"timeFrame":"4 years"}