Study: NCT00465101

Adverse event: Allergic Reaction / Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Infection (other than UTI)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Perforation - Prostate
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 136 at risk

Adverse event: Injury - Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Pain / Discomfort - Leg
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 136 at risk

Adverse event: Pain / Discomfort - Other
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 136 at risk

Adverse event: Bladder Neck Contracture / Outlet Obstruct
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 136 at risk

Adverse event: Hematuria - Gross
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 136 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 136 at risk

Adverse event: Deep Venous Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 136 at risk

Adverse event: Other: Prostate Cancer
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 136 at risk

Adverse event: Other: Renal Failure - Acute
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other: Atrial Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 136 at risk

Adverse event: Other: Hernia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other: Lymphoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other: Coronary Artery Disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 136 at risk

Adverse event: Other: Multiple Myeloma
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other: Rotator Cuff Tear
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 136 at risk

Adverse event: Other: Sleep Apnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other: Epistaxis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other: Stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 136 at risk

Adverse event: Other: Knee Replacement
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other: Obesity - Worsening
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 136 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 30 affected / 136 at risk

Adverse event: Retrograde Ejaculation - De Novo
Serious: no
Organ System: Renal and urinary disorders
Frequency: 30 affected / 136 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 24 affected / 136 at risk

Adverse event: Retrograde ejaculation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 23 affected / 136 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 136 at risk

Adverse event: Urinary Tract Infection (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 136 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 136 at risk

Adverse event: Hematuria - Gross
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 136 at risk

Adverse event: Erectile Dysfunction - De Novo
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 136 at risk

Adverse event: Urinary Incontinence - De Novo
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 136 at risk

Adverse event: Pain / Discomfort - Other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 136 at risk

Adverse event: Allergic Reaction / Hypersensitivity Reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Bladder Neck Contracture / Outlet Obstruct
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 136 at risk

Adverse event: Prostatitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 136 at risk

Adverse event: Urinary Retention - Acute
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 136 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 136 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 136 at risk

Adverse event: Erectile Dysfunction - Worsening
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 136 at risk

Adverse event: Perforation - Prostate
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 136 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 136 at risk

Adverse event: Urethral stenosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 136 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 136 at risk

Adverse event: Other: Urinary Dribbling
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 136 at risk

Adverse event: Other: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other: Bladder Spasm
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 136 at risk

Adverse event: Other: Lack of Sensation During Ejaculation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 136 at risk

Adverse event: Other: Overactive Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 136 at risk

Adverse event: Other: Paraphimosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other: Urethral Burning at Foley Catheter Site
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 136 at risk

Adverse event: Other: Urine Flow Decreased Force
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other: Bladder Pressure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other: Clot Retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other: Decrease Sense of Emptying Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other: Sexual Dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 136 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 136 at risk