ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Pa... | NCT00090363

NCT00090363

Status Module

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Matching placebo oral tablet once daily, with best supportive care	Drug: Placebo
ZD4054 10 mg	Experimental	ZD4054 10 mg oral tablet once daily, with best supportive care	Drug: ZD4054 10 mg
ZD4054 15 mg	Experimental	ZD4054 15 mg oral tablet once daily, with best supportive care	Drug: ZD4054 15 mg

Name	Type	Description	Arm Group Labels	Other Names
ZD4054 15 mg	Drug	15 mg oral tablet once daily	ZD4054 15 mg	Zibotentan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Progression (TTP)	Median time (in days) from randomisation until disease progression, 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 or death using the Kaplan-Meier method.	Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).

Secondary Outcomes

Measure	Description	Time Frame
Time to Death	Median time (in days) from randomisation until death using the Kaplan-Meier method.	Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. After progression survival was assessed 6-monthly. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).

Name	Affiliation	Role
AstraZeneca Emerging Oncology Medical Science Director, MD	AstraZeneca	Study Director

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

PubMed Identifier	Type	Citation	Retractions
19042080	Derived	James ND, Caty A, Borre M, Zonnenberg BA, Beuzeboc P, Morris T, Phung D, Dawson NA. Safety and efficacy of the specific endothelin-A receptor antagonist ZD4054 in patients with hormone-resistant prostate cancer and bone metastases who were pain free or mildly symptomatic: a double-blind, placebo-controlled, randomised, phase 2 trial. Eur Urol. 2009 May;55(5):1112-23. doi: 10.1016/j.eururo.2008.11.002. Epub 2008 Nov 29.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Placebo	Matching placebo oral tablet once daily, with best supportive care
FG001	ZD4054 10 mg	ZD4054 10 mg oral tablet once daily, with best supportive care

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to Progression (TTP)

Median time (in days) from randomisation until disease progression, 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 or death using the Kaplan-Meier method.

Posted

Median

Inter-Quartile Range

Days

Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).

ID	Title	Description
OG000	Placebo	Matching placebo oral tablet once daily, with best supportive care
OG001	ZD4054 10 mg	ZD4054 10 mg oral tablet once daily, with best supportive care
OG002	ZD4054 15 mg	ZD4054 15 mg oral tablet once daily, with best supportive care

Units	Counts
Participants	OG000107 OG001107 OG00298

Title

Denominators

Categories

Title	Measurements
	OG000111(77 to 252) OG001138(80 to 247) OG002113(80 to 279)

Secondary

Time to Death

Median time (in days) from randomisation until death using the Kaplan-Meier method.

Posted

Median

Inter-Quartile Range

Days

Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. After progression survival was assessed 6-monthly. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).

ID	Title	Description
OG000	Placebo	Matching placebo oral tablet once daily, with best supportive care
OG001	ZD4054 10 mg	ZD4054 10 mg oral tablet once daily, with best supportive care
OG002	ZD4054 15 mg	ZD4054 15 mg oral tablet once daily, with best supportive care

Units	Counts
Participants	OG000

Secondary

Change in Total Prostate Specific Antigen (PSA) Over Time

Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.

The analysis population only includes patients with baseline and Week 12 PSA measurements

Posted

Mean

Standard Deviation

Percentage Change in PSA

Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).

ID	Title	Description
OG000	Placebo	Matching placebo oral tablet once daily, with best supportive care
OG001	ZD4054 10 mg	ZD4054 10 mg oral tablet once daily, with best supportive care
OG002	ZD4054 15 mg	ZD4054 15 mg oral tablet once daily, with best supportive care

Units	Counts
Participants

Secondary

Objective Response Rate (ORR)

Using the Response Evaluation Criteria in Solid Tumours (RECIST), an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR), which is subsequently confirmed as per RECIST. Objective Response Rate (ORR) is defined as the percentage of patients with OR.

Only patients with measurable disease at the baseline were included in the analysis.

Posted

Number

percentage of participants

For patients with measurable disease at baseline, Response Evaluation Criteria in Solid Tumours (RECIST) scans were 12-weekly from randomisation. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).

ID	Title	Description
OG000	Placebo	Matching placebo oral tablet once daily, with best supportive care
OG001	ZD4054 10 mg	ZD4054 10 mg oral tablet once daily, with best supportive care
OG002	ZD4054 15 mg	ZD4054 15 mg oral tablet once daily, with best supportive care

Secondary

Change in Number of Bone Metastases Over Time

Percentage change in the number of bone metastases from baseline to last available post-baseline scan prior to discontinuation.

Posted

Mean

Standard Deviation

Percentage Change

Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.

ID	Title	Description
OG000	Placebo	Matching placebo oral tablet once daily, with best supportive care
OG001	ZD4054 10 mg	ZD4054 10 mg oral tablet once daily, with best supportive care
OG002	ZD4054 15 mg	ZD4054 15 mg oral tablet once daily, with best supportive care

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected107 at risk EG0013 affected107 at risk EG0021 affected98 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0022 affected98 at risk
Left Ventricular Dysfunction	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Cardiac Failure	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0013 affected107 at risk EG0020 affected98 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Cardiopulmonary Failure	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0012 affected107 at risk EG0020 affected98 at risk
Sick Sinus Syndrome	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Macular Hole	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0021 affected98 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0010 affected107 at risk EG0021 affected98 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0010 affected107 at risk EG0021 affected98 at risk
Gastric Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0010 affected107 at risk EG0021 affected98 at risk
Proctitis Haemorrhagic	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Small Intestinal Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Fatigue	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Feeling Hot	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Oedema Peripheral	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Catheter Related Complication	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0010 affected107 at risk EG0021 affected98 at risk
Chest Discomfort	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0010 affected107 at risk EG0021 affected98 at risk
Death	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0010 affected107 at risk EG0021 affected98 at risk
Pyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Cellulitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Lung Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Neutropenic Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0010 affected107 at risk EG0021 affected98 at risk
Pneumonia Bacterial	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Urosepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0010 affected107 at risk EG0021 affected98 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Soft Tissue Injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0010 affected107 at risk EG0021 affected98 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0010 affected107 at risk EG0021 affected98 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Metastases To Bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Metastases To Central Nervous System	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Benign Colonic Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Metastases To Lymph Nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0010 affected107 at risk EG0021 affected98 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0010 affected107 at risk EG0021 affected98 at risk
Rectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Dysarthria	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Loss Of Consciousness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0010 affected107 at risk EG0021 affected98 at risk
Spinal Cord Compression	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0010 affected107 at risk EG0021 affected98 at risk
Haematuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0022 affected98 at risk
Bladder Neck Obstruction	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Bladder Obstruction	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Dysuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Urinary Incontinence	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Calculus Bladder	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Pyelocaliectasis	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected107 at risk EG0010 affected107 at risk EG0020 affected98 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Aortic Aneurysm Rupture	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected107 at risk EG0011 affected107 at risk EG0020 affected98 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected107 at risk EG0010 affected107 at risk EG0022 affected98 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected107 at risk EG0010 affected107 at risk EG0023 affected98 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected107 at risk EG0016 affected107 at risk EG0023 affected98 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG00010 affected107 at risk EG00112 affected107 at risk EG0028 affected98 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG00012 affected107 at risk EG00110 affected107 at risk EG0028 affected98 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG00019 affected107 at risk EG00118 affected107 at risk EG00217 affected98 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected107 at risk EG00110 affected107 at risk EG0028 affected98 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00011 affected107 at risk EG00113 affected107 at risk EG00218 affected98 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected107 at risk EG0015 affected107 at risk EG0027 affected98 at risk
Depression	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0016 affected107 at risk EG0020 affected98 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected107 at risk EG0017 affected107 at risk EG0027 affected98 at risk
Dizziness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected107 at risk EG0018 affected107 at risk EG0028 affected98 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0009 affected107 at risk EG0017 affected107 at risk EG0028 affected98 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected107 at risk EG00117 affected107 at risk EG0026 affected98 at risk
Fatigue	General disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected107 at risk EG00118 affected107 at risk EG00210 affected98 at risk
Flushing	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected107 at risk EG0015 affected107 at risk EG0020 affected98 at risk
Groin Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected107 at risk EG0010 affected107 at risk EG0027 affected98 at risk
Haematuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected107 at risk EG0016 affected107 at risk EG0024 affected98 at risk
Headache	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00044 affected107 at risk EG00139 affected107 at risk EG00213 affected98 at risk
Hot Flush	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0008 affected107 at risk EG0015 affected107 at risk EG0026 affected98 at risk
Influenza	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0004 affected107 at risk EG0016 affected107 at risk EG0025 affected98 at risk
Insomnia	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG00011 affected107 at risk EG0016 affected107 at risk EG00210 affected98 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected107 at risk EG0013 affected107 at risk EG0026 affected98 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0008 affected107 at risk EG0014 affected107 at risk EG0029 affected98 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0008 affected107 at risk EG0016 affected107 at risk EG0023 affected98 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG00034 affected107 at risk EG00131 affected107 at risk EG0024 affected98 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0008 affected107 at risk EG0015 affected107 at risk EG0028 affected98 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00013 affected107 at risk EG00119 affected107 at risk EG00220 affected98 at risk
Oedema Peripheral	General disorders	MedDRA 11.1	Systematic Assessment	EG00047 affected107 at risk EG00142 affected107 at risk EG00211 affected98 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected107 at risk EG00110 affected107 at risk EG00212 affected98 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected107 at risk EG0017 affected107 at risk EG0023 affected98 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected107 at risk EG0011 affected107 at risk EG0025 affected98 at risk
Pyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected107 at risk EG0015 affected107 at risk EG0025 affected98 at risk
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG00015 affected107 at risk EG00117 affected107 at risk EG0023 affected98 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected107 at risk EG0013 affected107 at risk EG0028 affected98 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected107 at risk EG0016 affected107 at risk EG0029 affected98 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	Placebo	Matching placebo oral tablet once daily, with best supportive care
BG001	ZD4054 10 mg	ZD4054 10 mg oral tablet once daily, with best supportive care
BG002	ZD4054 15 mg	ZD4054 15 mg oral tablet once daily, with best supportive care
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Matching placebo oral tablet once daily, with best supportive care	26	107	93	107
EG001	ZD4054 10 mg	ZD4054 10 mg oral tablet once daily, with best supportive care	18	107	86	107
EG002	ZD4054 15 mg	ZD4054 15 mg oral tablet once daily, with best supportive care	16	98	87	98