Prostate Cancer Study In Men Who Have Failed First-Line A... | NCT00470834

Label	Type	Description	Intervention Names
Arm 1	Experimental	50 mg bicalutamide and 3.5 mg Dutasteride (IP)	Drug: dutasteride Drug: bicalutamide
Arm 2	Placebo Comparator	50 mg bicalutamide and placebo	Drug: placebo Drug: bicalutamide

Name	Type	Description	Arm Group Labels	Other Names
dutasteride	Drug	0.5mg dutasteride (Investigation Product)	Arm 1
placebo

Measure	Description	Time Frame
Time to Disease Progression	Time to disease progression (PD) is defined as the interval of time between the date of the start of treatment and the date of PD. PD is defined as prostate specific antigen (PSA) progression from Baseline (PSA value is 25% and at least 2 nanograms per milliliter [ng/mL] above Baseline, confirmed by a second PSA value); PSA progression from nadir, without a 50% decrease from Baseline (PSA value is 25% and at least 2 ng/mL above nadir, confirmed by a second PSA value); PSA progression from nadir, with a 50% or more decrease from Baseline (PSA value is 50% and at least 2 ng/mL above nadir, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or the receipt of post-Baseline rescue medication. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.	Interval of time between the date of the start of treatment and the date of disease progression (up to Study Month 42)

Measure	Description	Time Frame
Time to Treatment Failure	Time to treatment failure is defined as the interval of time between the date of the start of treatment and the date of treatment failure. Treatment failure is defined as PSA progression from Baseline (PSA value is 25% and at least 2 ng/mL above Baseline, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or receipt of post-baseline rescue medications. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Men ≥40 and ≤90 years of age
Must have asymptomatic prostate cancer that has progressed during androgen deprivation therapy (rising PSA). PSA progression must have occurred after first-line treatment with GnRH analogues ( e.g. leuprolide, goserelin) or orchiectomy. PSA progression is defined by three rises in PSA each measured at least 4 weeks apart within the previous year.
Serum PSA ≥2 and ≤20ng/ml from central laboratory. One PSA retest from central laboratory is allowed if the value is <2 or >20ng/ml; or if the PSA value is not consistent with the previous rising PSA values that determined progression while on a GnRH analogue.
Serum Testosterone <50ng/ml from central laboratory.
Non-metastatic prostate cancer as confirmed on prior bone scan performed within 8 weeks of screening.
Expected survival ≥ 2 years
ECOG Performance status 0, 1, or 2

Exclusion criteria:

Additional hormonal therapy (excluding the current use of a GnRH analogue) within the past 6 months of:
Estrogens (e.g. megestrol, medroxyprogesterone, cyproterone, DES)
Drugs with antiandrogenic properties (e.g., spironolactone if >50mg/day, flutamide, bicalutamide*, ketoconazole**, progestational agents)

*The use of an antiandrogen during GnRH analogue induction for <6 weeks is acceptable, but none within the 3 months prior to study entry.

**The use of topical ketoconazole is permitted prior to and during the study. NOTE: Use of dietary and herbal supplements (e.g., selenium, Vitamin E, saw palmetto), excluding daily vitamins, during the study is discouraged, but not prohibited. All dietary and herbal supplement usage will be recorded in the eCRF.
Treatment with oral glucocorticoids during the 3 months prior to randomization or expectation of their use during the study.
Prior chemotherapy for prostate cancer. (prior prostatectomy or radiotherapy to the prostate are allowed)
Prostate surgery including TUNA, TURP, TUIP, laser treatment, thermotherapy, balloon dilatation, prosthesis, and cryosurgical ablation within 2 months prior to enrollment.
Current and/or previous use of the following medications:
Finasteride (Proscar, Propecia), or Dutasteride (GI198745, AVODART) exposure within 6 months prior to study entry
Anabolic steroids (within 6 months prior to study entry)
Participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or anytime during the study period.
Any unstable serious co-existing medical condition(s) including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes; or peptic ulcer disease which is uncontrolled by medical management.
Abnormal liver function test greater than 1.5 times the upper limit of normal for alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP] or bilirubin.
Serum creatinine >2.0 times the upper limit of normal.
History of another malignancy within five years that could affect the treatment of prostate cancer or survival of the subject.
History or current evidence of drug or alcohol abuse within the last 12 months.
History of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject.
Known hypersensitivity to any 5 alpha-reductase inhibitor or to any drug chemically related to dutasteride.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Homewood	Alabama	35209	United States
GSK Investigational Site

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
AVO108943	Clinical Study Report	View IPD

ID	Title	Description
FG000	Bicalutamide 50 mg/Placebo	Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).

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 Disease Progression

Time to disease progression (PD) is defined as the interval of time between the date of the start of treatment and the date of PD. PD is defined as prostate specific antigen (PSA) progression from Baseline (PSA value is 25% and at least 2 nanograms per milliliter [ng/mL] above Baseline, confirmed by a second PSA value); PSA progression from nadir, without a 50% decrease from Baseline (PSA value is 25% and at least 2 ng/mL above nadir, confirmed by a second PSA value); PSA progression from nadir, with a 50% or more decrease from Baseline (PSA value is 50% and at least 2 ng/mL above nadir, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or the receipt of post-Baseline rescue medication. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.

Intent-to-Treat (ITT) Population: all participants randomized to study treatment. Data were not summarized for censored participants (no disease progression).

Posted

Mean

Standard Deviation

Days

Interval of time between the date of the start of treatment and the date of disease progression (up to Study Month 42)

ID	Title	Description
OG000	Bicalutamide 50 mg/Placebo	Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
OG001	Bicalutamide 50 mg/Dutasteride 3.5 mg	Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).

Units	Counts
Participants	OG00041 OG00140

Title

Denominators

Categories

Title	Measurements
	OG000376.9± 333.94 OG001433.1± 324.25

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.79							95						No	Superiority or Other
OG000 OG001						Relative Risk

Secondary

Time to Treatment Failure

Time to treatment failure is defined as the interval of time between the date of the start of treatment and the date of treatment failure. Treatment failure is defined as PSA progression from Baseline (PSA value is 25% and at least 2 ng/mL above Baseline, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or receipt of post-baseline rescue medications. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.

ITT Population. Data were not summarized for censored participants (no treatment failure).

Posted

Mean

Standard Deviation

Days

Interval of time between the date of the start of treatment and the date of treatment failure (up to Study Month 42)

ID	Title	Description
OG000	Bicalutamide 50 mg/Placebo	Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
OG001	Bicalutamide 50 mg/Dutasteride 3.5 mg

Secondary

Number of Participants With PSA Response

PSA response is defined as a 50% or greater decrease in PSA from Baseline, confirmed by a second PSA measurement. The time of this response was the date of the first PSA measurement that showed a 50% or greater decrease from the Baseline PSA measurement. PSA confirmation was not required if no subsequent PSA values were available.

ITT Population

Posted

Number

participants

Time from Baseline PSA measurement until the first PSA measurement with a 50% or greater reduction in PSA values (up to Study Month 42)

ID	Title	Description
OG000	Bicalutamide 50 mg/Placebo	Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
OG001	Bicalutamide 50 mg/Dutasteride 3.5 mg	Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).

Secondary

Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42

Change from Baseline in total PSA was measured at each scheduled post-baseline visit using a general linear model with effects for treatment and Baseline total PSA. Analysis was done using the last observation carried forward (LOCF) approach, in which missing post-Baseline values were imputed with earlier non-missing values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.

Posted

Median

Full Range

Nanograms per milliliter (ng/mL)

Baseline and Months 6, 12, 18, 21, and 42

ID	Title	Description
OG000	Bicalutamide 50 mg/Placebo	Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
OG001	Bicalutamide 50 mg/Dutasteride 3.5 mg

Secondary

Number of Participants With Metastatic Disease

Metastatic disease is that evidenced by a radiographic assessment. The time of metastatic disease was the date of radiographic evidence.

ITT Population

Posted

Number

participants

Interval of time between the date of the start of treatment and the date of radiographic evidence of metastatic disease (up to Study Month 42)

ID	Title	Description
OG000	Bicalutamide 50 mg/Placebo	Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
OG001	Bicalutamide 50 mg/Dutasteride 3.5 mg	Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0012 affected62 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0012 affected62 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Loss of consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Presyncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Parkinson's disease	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0012 affected62 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0012 affected62 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Cardiac arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected65 at risk EG0010 affected62 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0012 affected62 at risk
Lobar pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected62 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected62 at risk
Orchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Urosepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Sepsis syndrome	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0010 affected62 at risk
Urinary retention	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0010 affected62 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Postrenal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0012 affected62 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected62 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Heat stroke	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0011 affected62 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0011 affected62 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected62 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected62 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected62 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0010 affected62 at risk
Faecaloma	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected62 at risk
Colitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0012 affected62 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Refractory anaemia with an excess of blasts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Malignant lymphoid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Mental status changes	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0011 affected62 at risk
Completed suicide	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Aortic aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Lymphoedema	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0010 affected62 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0011 affected62 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected62 at risk
Blood pressure increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected62 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0008 affected65 at risk EG00110 affected62 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0008 affected65 at risk EG0019 affected62 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0009 affected65 at risk EG0017 affected62 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0008 affected65 at risk EG0016 affected62 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0007 affected65 at risk EG0016 affected62 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0008 affected65 at risk EG0015 affected62 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected65 at risk EG0016 affected62 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0007 affected65 at risk EG0015 affected62 at risk
Hot flush	Vascular disorders	MedDRA	Systematic Assessment	EG0009 affected65 at risk EG0013 affected62 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0006 affected65 at risk EG0015 affected62 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0006 affected65 at risk EG0015 affected62 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0018 affected62 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0006 affected65 at risk EG0013 affected62 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected65 at risk EG0014 affected62 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0006 affected65 at risk EG0012 affected62 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0006 affected65 at risk EG0012 affected62 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected65 at risk EG0013 affected62 at risk
Urinary retention	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0005 affected65 at risk EG0012 affected62 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected65 at risk EG0014 affected62 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected65 at risk EG0012 affected62 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0015 affected62 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0006 affected65 at risk EG0010 affected62 at risk
Pollakiuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0014 affected62 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0004 affected65 at risk EG0012 affected62 at risk
Breast tenderness	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0004 affected65 at risk EG0012 affected62 at risk
Ear infection	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected65 at risk EG0011 affected62 at risk
Nocturia	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0005 affected65 at risk EG0010 affected62 at risk
Nipple pain	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0014 affected62 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	Term
D001378	Azasteroids
D013260	Steroids, Heterocyclic
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Title	Description
BG000	Bicalutamide 50 mg/Placebo	Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
BG001	Bicalutamide 50 mg/Dutasteride 3.5 mg	Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
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	Bicalutamide 50 mg/Placebo	Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).			31	65	48	65
EG001	Bicalutamide 50 mg/Dutasteride 3.5 mg	Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).			30	62	51	62