Study: NCT00246519

Adverse event: Inflamed colon or colonitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 had inflamed colon; 1 had colon colitis
Frequency: 1 affected / 386 at risk

Adverse event: Tiredness/Fatigue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 386 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 386 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 386 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 12 affected / 386 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 386 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 386 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 386 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 386 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 386 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 386 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 23 affected / 386 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 386 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 123 affected / 386 at risk

Adverse event: Inflamed colon or colonitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 had inflamed colon; 1 had colon colitis
Frequency: 1 affected / 382 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 382 at risk

Adverse event: Tiredness/Fatigue
Serious: no
Organ System: General disorders
Frequency: 25 affected / 382 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 382 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 13 affected / 382 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 382 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 382 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 382 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 382 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 382 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 382 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 35 affected / 382 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 98 affected / 382 at risk