Study: NCT00354432

Adverse event: Erectile dysfunction
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 30 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Mood alteration - Agitation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Mood alteration- Anxiety
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Obstruction - Ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pain - joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Allergic Reaction/hypersensitivity including drug reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 30 at risk

Adverse event: Constitutional Symptioms - Nightmares
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Diarrhea - without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 30 at risk

Adverse event: Distension/Bloating, Abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 30 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 30 at risk

Adverse event: Ejaculatory Dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 17 affected / 30 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 17 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 30 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 30 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 30 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 30 at risk

Adverse event: Mood Alteration - Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 30 at risk

Adverse event: Mood Alteration - Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 30 at risk

Adverse event: Neurology - Nervousness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Neuropathy - Sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 15 affected / 30 at risk

Adverse event: Pain - joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Petechiae/purpura - hemorrhage/bleeding into skin or mucosa
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sweating - Diaphoresis
Serious: no
Organ System: General disorders
Frequency: 20 affected / 30 at risk

Adverse event: Urinary Frequency/Urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Erectile dysfunction
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 27 at risk

Adverse event: Pain - Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Allergic Reaction/hypersensitivity including drug reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 27 at risk

Adverse event: Constitutional Symptioms - Nightmares
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Diarrhea - without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Distension/Bloating, Abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 27 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 27 at risk

Adverse event: Ejaculatory Dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 27 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 12 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 27 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 27 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 27 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 27 at risk

Adverse event: Mood Alteration - Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 27 at risk

Adverse event: Mood Alteration - Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 13 affected / 27 at risk

Adverse event: Pain - Back
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pain - joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Petechiae/purpura - hemorrhage/bleeding into skin or mucosa
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Sweating - Diaphoresis
Serious: no
Organ System: General disorders
Frequency: 20 affected / 27 at risk

Adverse event: Urinary Frequency/Urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Erectile dysfunction
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 29 at risk

Adverse event: Infection - Rectum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Pain - Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Somnolence
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Allergic Reaction/hypersensitivity including drug reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 29 at risk

Adverse event: Constitutional Symptioms - Nightmares
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Diarrhea - without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 29 at risk

Adverse event: Distension/Bloating, Abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 29 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 29 at risk

Adverse event: Ejaculatory Dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 13 affected / 29 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 13 affected / 29 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 29 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 29 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 29 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 29 at risk

Adverse event: Mood Alteration - Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 29 at risk

Adverse event: Mood Alteration - Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 29 at risk

Adverse event: Neurology - Nervousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Neuropathy - Sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 11 affected / 29 at risk

Adverse event: Pain - Back
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Renal/Genitourinary - Other (Specify, __)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 29 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Sweating - Diaphoresis
Serious: no
Organ System: General disorders
Frequency: 24 affected / 29 at risk

Adverse event: Urinary Frequency/Urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 29 at risk

Adverse event: Erectile dysfunction
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 28 at risk

Adverse event: Insomnia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pain - chest NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Vascular - other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 28 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 5 affected / 28 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 28 at risk

Adverse event: Constitutional Symptioms - Nightmares
Serious: no
Organ System: General disorders
Frequency: 3 affected / 28 at risk

Adverse event: Diarrhea - without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Distension/Bloating, Abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 28 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 28 at risk

Adverse event: Ejaculatory Dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 12 affected / 28 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 12 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 28 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 28 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 28 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 28 at risk

Adverse event: Mood Alteration - Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 28 at risk

Adverse event: Mood Alteration - Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 28 at risk

Adverse event: Neurology - Nervousness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 28 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 8 affected / 28 at risk

Adverse event: Pain - Extremity - Limb
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Pain - joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: Petechiae/purpura - hemorrhage/bleeding into skin or mucosa
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 28 at risk

Adverse event: Sweating - Diaphoresis
Serious: no
Organ System: General disorders
Frequency: 25 affected / 28 at risk

Adverse event: Urinary Frequency/Urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 28 at risk