Study: NCT00643617

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 112 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 112 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 112 at risk

Adverse event: CNS Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 112 at risk

Adverse event: Hemorrhage/Bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 112 at risk

Adverse event: Other Malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 112 at risk

Adverse event: Cervical Spine Stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Mood Alteration
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 112 at risk

Adverse event: Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Renal transplant
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 112 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 36 affected / 112 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 112 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 112 at risk

Adverse event: Urgency
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 112 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Inflammation of the rectal lining
Frequency: 8 affected / 112 at risk

Adverse event: Hemorrhage/Bleeding - GI
Serious: no
Organ System: Gastrointestinal disorders
Notes: Rectal bleeding, blood in stool
Frequency: 10 affected / 112 at risk

Adverse event: Gastrointestinal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Pain reported in the abdomen, rectum (proctalgia)
Frequency: 10 affected / 112 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 112 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 112 at risk

Adverse event: Urinary Frequency/Urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 75 affected / 112 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Notes: Hesitancy, decreased force, difficulty during urination
Frequency: 34 affected / 112 at risk

Adverse event: Hemorrhage/Bleeding - GU
Serious: no
Organ System: Renal and urinary disorders
Notes: Blood in urine (hematuria)
Frequency: 16 affected / 112 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 112 at risk

Adverse event: Pain - GU
Serious: no
Organ System: Renal and urinary disorders
Notes: Painful urination (dysuria), pain in genitourinary region
Frequency: 59 affected / 112 at risk

Adverse event: Pain - Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain reported in bone, joint, back, shoulder, hip
Frequency: 8 affected / 112 at risk

Adverse event: Pain - Reproductive/Sexual
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Pain in prostate, testes, pelvis, pain on ejaculation
Frequency: 2 affected / 112 at risk

Adverse event: Ejaculatory Dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 112 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 26 affected / 112 at risk

Adverse event: Cardiac Ischemia/Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 147 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 147 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 147 at risk

Adverse event: Valvular Heart Disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 147 at risk

Adverse event: CNS Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 147 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 147 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Obstruction (Small Bowel)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hemorrhage/Bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 147 at risk

Adverse event: Hemorrhage/Bleeding
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 147 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 147 at risk

Adverse event: Other Malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 147 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 147 at risk

Adverse event: Transverse Myelitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 147 at risk

Adverse event: Plane crash
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 147 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 147 at risk

Adverse event: Aortic Atheroma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 147 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 36 affected / 147 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 147 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 147 at risk

Adverse event: Urgency
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 147 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Inflammation of the rectal lining
Frequency: 17 affected / 147 at risk

Adverse event: Hemorrhage/Bleeding - GI
Serious: no
Organ System: Gastrointestinal disorders
Notes: Rectal bleeding, blood in stool
Frequency: 18 affected / 147 at risk

Adverse event: Gastrointestinal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Pain reported in the abdomen, rectum (proctalgia)
Frequency: 21 affected / 147 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 147 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 23 affected / 147 at risk

Adverse event: Urinary Frequency/Urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 110 affected / 147 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Notes: Hesitancy, decreased force, difficulty during urination
Frequency: 54 affected / 147 at risk

Adverse event: Hemorrhage/Bleeding - GU
Serious: no
Organ System: Renal and urinary disorders
Notes: Blood in urine (hematuria)
Frequency: 36 affected / 147 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 147 at risk

Adverse event: Pain - GU
Serious: no
Organ System: Renal and urinary disorders
Notes: Painful urination (dysuria), pain in genitourinary region
Frequency: 81 affected / 147 at risk

Adverse event: Pain - Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain reported in bone, joint, back, shoulder, hip
Frequency: 12 affected / 147 at risk

Adverse event: Haematospermia
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Blood in sperm
Frequency: 8 affected / 147 at risk

Adverse event: Pain - Reproductive/Sexual
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Pain in prostate, testes, pelvis, pain on ejaculation
Frequency: 8 affected / 147 at risk

Adverse event: Ejaculatory Dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 147 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 32 affected / 147 at risk