Study: NCT00580970

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Blood/Bone Marrow
Frequency: 1 affected / 72 at risk

Adverse event: Cardiac General
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Gastrointestinal/Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Hemorrhage/Bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Colon
Frequency: 1 affected / 72 at risk

Adverse event: Hemorrhage/Bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Lower GI NOS
Frequency: 1 affected / 72 at risk

Adverse event: Hemorrhage/Bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Notes: GI - Rectum
Frequency: 1 affected / 72 at risk

Adverse event: Hepatobiliary/Pancreas
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Pancreatitis
Frequency: 1 affected / 72 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: Chest/thorax Not Otherwise Specified (NOS)
Frequency: 1 affected / 72 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 72 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 72 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 72 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 72 at risk

Adverse event: Hemorrhage, GI - Anus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 72 at risk

Adverse event: Hemorrhage, GI - Lower GI NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 72 at risk

Adverse event: Hemorrhage, GI - Rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 72 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 72 at risk

Adverse event: Incontinence, anal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 72 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 72 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 72 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 72 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 72 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 72 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 72 at risk

Adverse event: Bladder spasms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 26 affected / 72 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 41 affected / 72 at risk

Adverse event: Hemorrhage, GU - Urinary NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 72 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 33 affected / 72 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 72 at risk

Adverse event: Stricture/stenosis (including anastomotic), GU - Prostate
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 72 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 52 affected / 72 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 72 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 72 at risk

Adverse event: Pain - Penis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 72 at risk

Adverse event: Pain - Urethra
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 72 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 72 at risk