Rollover Protocol for Prior SU011248 Protocols | NCT00798889

Label	Type	Description	Intervention Names
Sunitinib	Experimental		Drug: Sunitinib

Name	Type	Description	Arm Group Labels	Other Names
Sunitinib	Drug	Sunitinib dose varies according to the doses allowed in previous protocol. It is given once a day, orally with various schedules depending on the parent protocol	Sunitinib

Measure	Description	Time Frame
Duration of Treatment		Baseline up to Day 28 after last dose of study treatment

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Birmingham	Alabama	35233-2115	United States
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Sunitinib	Sunitinib 50 milligram (mg) capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator's discretion.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00014 affected311 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00011 affected311 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00010 affected311 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0007 affected311 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected311 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected311 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Caecitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Cyclic vomiting syndrome	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Gastrointestinal fistula	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Ileus	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Melaena	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Rectal obstruction	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Retching	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Pneumonia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0005 affected311 at risk
Sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0004 affected311 at risk
Infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0003 affected311 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0003 affected311 at risk
Cellulitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Liver abscess	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Wound infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Abdominal abscess	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Bronchitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Clostridial infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Empyema	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Infectious peritonitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Muscle abscess	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Pancreatic abscess	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Perirectal abscess	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Pyelonephritis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Septic shock	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Disease progression	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0009 affected311 at risk
Pyrexia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0006 affected311 at risk
Chest pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected311 at risk
Asthenia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Fatigue	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Adverse drug reaction	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Chest discomfort	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Sudden death	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG00013 affected311 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Convulsion	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Spinal cord compression	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Syncope	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Cognitive disorder	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Dizziness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Headache	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Paraplegia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Presyncope	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0008 affected311 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected311 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected311 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected311 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected311 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Biliary fistula	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Hepatic haemorrhage	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected311 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Thrombosis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Intra-abdominal haemorrhage	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Arrhythmia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Myocardial infarction	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Cardiac failure	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0008 affected311 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected311 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Incontinence	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Renal impairment	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Urinary retention	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Mental status changes	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected311 at risk
Confusional state	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Depression	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Blood bilirubin increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Haemoglobin decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Weight decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0002 affected311 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected311 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG00071 affected311 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG00032 affected311 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG00054 affected311 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG00048 affected311 at risk
Hypothyroidism	Endocrine disorders	MedDRA 14.1	Non-systematic Assessment	EG00039 affected311 at risk
Periorbital oedema	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG00023 affected311 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00018 affected311 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00029 affected311 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00073 affected311 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00041 affected311 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00066 affected311 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG000179 affected311 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00025 affected311 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00056 affected311 at risk
Flatulence	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00031 affected311 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00036 affected311 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00022 affected311 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG000141 affected311 at risk
Oral pain	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00034 affected311 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00045 affected311 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00093 affected311 at risk
Asthenia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00023 affected311 at risk
Chest pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00029 affected311 at risk
Chills	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00030 affected311 at risk
Fatigue	General disorders	MedDRA 14.1	Non-systematic Assessment	EG000206 affected311 at risk
Mucosal inflammation	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00058 affected311 at risk
Oedema	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00024 affected311 at risk
Oedema peripheral	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00068 affected311 at risk
Pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00025 affected311 at risk
Pyrexia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00060 affected311 at risk
Sinusitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG00018 affected311 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG00033 affected311 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00016 affected311 at risk
Blood creatinine increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00020 affected311 at risk
Haemoglobin decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00020 affected311 at risk
Weight decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00028 affected311 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG000103 affected311 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG00025 affected311 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG00016 affected311 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00055 affected311 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00065 affected311 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00028 affected311 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00022 affected311 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00023 affected311 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00064 affected311 at risk
Dizziness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00039 affected311 at risk
Dysgeusia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00048 affected311 at risk
Headache	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00073 affected311 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00025 affected311 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00016 affected311 at risk
Anxiety	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG00024 affected311 at risk
Depression	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG00021 affected311 at risk
Insomnia	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG00049 affected311 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00073 affected311 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00079 affected311 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00019 affected311 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00036 affected311 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00025 affected311 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00035 affected311 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00019 affected311 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00081 affected311 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00019 affected311 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00055 affected311 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00058 affected311 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00018 affected311 at risk
Flushing	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG00021 affected311 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG00054 affected311 at risk

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring