Study: NCT00643994

Adverse event: car accident
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 310 at risk

Adverse event: Conduction abnormality/ atrioventricular heart block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 310 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 310 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 310 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 310 at risk

Adverse event: Valvular heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 310 at risk

Adverse event: Disease progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 310 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 310 at risk

Adverse event: Dermatology/skin other - cancer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 310 at risk

Adverse event: GI - other - cancer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 310 at risk

Adverse event: Liver dysfunction/failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 310 at risk

Adverse event: Hepatobiliary/pancreas - other - cancer
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 310 at risk

Adverse event: Hepatobiliary/pancreas - other cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 310 at risk

Adverse event: Infection - heart endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 310 at risk

Adverse event: infection with unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 310 at risk

Adverse event: Potassium serum -low
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 310 at risk

Adverse event: Musculoskeletal/soft tissue - fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 310 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 310 at risk

Adverse event: Neurology - other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 310 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 310 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 310 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 310 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 310 at risk

Adverse event: Pulmonary/upper respiratory - cancer
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 310 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 310 at risk

Adverse event: Urinary obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 310 at risk

Adverse event: Renal/GU - other - cancer
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 310 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 310 at risk

Adverse event: Other malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 310 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 310 at risk

Adverse event: vessel-injury artery - aorta
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 310 at risk

Adverse event: GI - other, diverticulosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 310 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 113 affected / 310 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 310 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 120 affected / 310 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 310 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 310 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 310 at risk

Adverse event: GI Hemorrhage/Bleeding
Serious: no
Organ System: Gastrointestinal disorders
Notes: rectal bleeding, blood in stool
Frequency: 52 affected / 310 at risk

Adverse event: Gastrointestinal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal pain, stomach pain, rectal pain
Frequency: 25 affected / 310 at risk

Adverse event: GU Pain
Serious: no
Organ System: Renal and urinary disorders
Notes: Pain with urination (dysuria)
Frequency: 184 affected / 310 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 28 affected / 310 at risk

Adverse event: Urinary Frequency/Urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 232 affected / 310 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 157 affected / 310 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 310 at risk

Adverse event: GU Hemorrhage/Bleeding
Serious: no
Organ System: Renal and urinary disorders
Notes: Blood in urine (hematuria), GU hemorrhage
Frequency: 49 affected / 310 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 310 at risk

Adverse event: Ejaculatory Dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 16 affected / 310 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 66 affected / 310 at risk

Adverse event: Sexual/Reproductive Pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Groin/pelvic pain, pain with ejaculation
Frequency: 23 affected / 310 at risk