A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A An... | NCT00626548

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Matching Placebo	Drug: Palcebo
ZD4054	Experimental	ZD4054 (Zibotentan)	Drug: ZD4054

Name	Type	Description	Arm Group Labels	Other Names
ZD4054	Drug	10 mg once daily oral dose	ZD4054	Zibotentan

Measure	Description	Time Frame
Overall Survival	Number of participants who have died at early analysis data cut off (DCO)	From date of randomization until date of death, assessed up to 33 months
Progression Free Survival	Number of participants who have a progression event at the early analysis DCO, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline	Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks

Measure	Description	Time Frame
Health Related Quality of Life		Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Time to Prostate-specific Antigen (PSA) Progression		Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks

Name	Affiliation	Role
Kurt Miller, Prof., M.D.	Charite University, Berlin, Germany	Principal Investigator
Tia Higano, MD	University of Washington	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Tucson	Arizona		United States
Research Site

ID	Title	Description
FG000	ZD4054	ZD4054 10 mg oral tablet once daily
FG001	Placebo	Placebo oral tablet once daily

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Disseminated Intravascular Coagulation	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0010 affected712 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Hilar Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Cardiac Failure	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0009 affected703 at risk EG0013 affected712 at risk
Angina Pectoris	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0017 affected712 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0005 affected703 at risk EG0013 affected712 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0004 affected703 at risk EG0012 affected712 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected703 at risk EG0010 affected712 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0012 affected712 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0012 affected712 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0011 affected712 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0012 affected712 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Angina Unstable	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Atrial Flutter	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Bradycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Cardiac Disorder	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Cardiac Failure Chronic	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Diastolic Dysfunction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Hypertensive Cardiomyopathy	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Prinzmetal Angina	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Sinus Bradycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Ventricular Fibrillation	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Congenital Aortic Valve Stenosis	Congenital, familial and genetic disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0010 affected712 at risk
Hypothyroidism	Endocrine disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Cataract	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0011 affected712 at risk
Macular Hole	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0010 affected712 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0011 affected712 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0012 affected712 at risk
Abdominal Hernia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Abdominal Wall Haematoma	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Food Poisoning	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Gastric Haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Gastric Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Gastritis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Gastritis Haemorrhagic	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Large Intestine Perforation	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Mallory-Weiss Syndrome	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Peptic Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Pneumatosis Intestinalis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Rectourethral Fistula	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Oedema Peripheral	General disorders	MedDRA 14.0	Systematic Assessment	EG0004 affected703 at risk EG0010 affected712 at risk
Death	General disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0011 affected712 at risk
Pyrexia	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0012 affected712 at risk
Asthenia	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Chest Pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Device Dislocation	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
General Physical Health Deterioration	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Granuloma	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Hypothermia	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Impaired Healing	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Malaise	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Medical Device Complication	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Multi-Organ Failure	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Hepatic Failure	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Hepatic Function Abnormal	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Liver Disorder	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0007 affected703 at risk EG0015 affected712 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0013 affected712 at risk
Bronchopneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0010 affected712 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0010 affected712 at risk
Pyelonephritis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0012 affected712 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0010 affected712 at risk
Anal Abscess	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Appendicitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Cellulitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Chronic Sinusitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Cystitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Diverticulitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Lung Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Parainfluenzae Virus Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Pneumonia Bacterial	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Pyelonephritis Acute	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Scrotal Abscess	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Septic Shock	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Sinusitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Staphylococcal Sepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Tooth Abscess	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Urosepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Wound Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Chest Injury	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0012 affected712 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0012 affected712 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0011 affected712 at risk
Cystitis Radiation	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Gastroenteritis Radiation	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Heat Illness	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Open Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Patella Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Radiation Proctopathy	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Thoracic Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Ulna Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Wrist Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Haemoglobin Decreased	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
International Normalised Ratio Increased	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0012 affected712 at risk
Diabetic Foot	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0012 affected712 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Osteoporotic Fracture	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Spinal Column Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Systemic Lupus Erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0015 affected712 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0004 affected703 at risk EG0011 affected712 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0013 affected712 at risk
Rectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0012 affected712 at risk
Benign Urinary Tract Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Bladder Transitional Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Bladder Transitional Cell Carcinoma Recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Colorectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Gastrointestinal Tract Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Hepatic Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Myelodysplastic Syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Neuroendocrine Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Pancreatic Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Pancreatic Carcinoma Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Porocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Renal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Small Cell Lung Cancer Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Transitional Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0011 affected712 at risk
Dizziness	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0011 affected712 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0012 affected712 at risk
Syncope	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0010 affected712 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0011 affected712 at risk
Brain Stem Stroke	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Cerebellar Haemorrhage	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Cerebral Infarction	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Cerebral Ischaemia	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0011 affected712 at risk
Cerebrovascular Disorder	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Cerebrovascular Insufficiency	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Leukoencephalopathy	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Parkinsonism	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Subarachnoid Haemorrhage	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Completed Suicide	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Delirium	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Suicidal Ideation	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0017 affected712 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0005 affected703 at risk EG0012 affected712 at risk
Calculus Ureteric	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected703 at risk EG0010 affected712 at risk
Renal Failure	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0013 affected712 at risk
Urinary Tract Obstruction	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0013 affected712 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0012 affected712 at risk
Renal Impairment	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0010 affected712 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0011 affected712 at risk
Azotaemia	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Bladder Stenosis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Calculus Bladder	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Calculus Urinary	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Cystitis Haemorrhagic	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Renal Disorder	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Urethral Stenosis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Calculus Prostatic	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Pelvic Haematoma	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Prostatic Haemorrhage	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected703 at risk EG0014 affected712 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected703 at risk EG0010 affected712 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected703 at risk EG0010 affected712 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0010 affected712 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0010 affected712 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Lung Consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Pulmonary Infarction	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Sleep Apnoea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Peau D'orange	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected703 at risk EG0013 affected712 at risk
Aortic Aneurysm	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Arterial Stenosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Arteritis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Femoral Arterial Stenosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected703 at risk EG0010 affected712 at risk
Iliac Artery Occlusion	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Intermittent Claudication	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Temporal Arteritis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
Thrombosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk
twqVenous Thrombosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected703 at risk EG0011 affected712 at risk

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Title	Description
BG000	ZD4054	ZD4054 10 mg oral tablet once daily
BG001	Placebo	Placebo oral tablet once daily
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ZD4054	ZD4054 10 mg oral tablet once daily			148	703	531	703
EG001	Placebo	Placebo oral tablet once daily			138	712	392	712