Study: NCT00416494

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Acute Calculus Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Wound Dehisence
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Altered mental status
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 19 at risk

Adverse event: Abdominal Cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 19 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 19 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 19 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 19 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 19 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 19 at risk

Adverse event: Hand-foot syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 19 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 19 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 19 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 19 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 19 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 19 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 19 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 19 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Syncope
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 31 at risk

Adverse event: Abdominal Cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 31 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 31 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 31 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 31 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 31 at risk

Adverse event: Oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 23 affected / 31 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 31 at risk

Adverse event: Flatuance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Hand-foot syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 31 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 31 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 31 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 31 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 20 affected / 31 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 31 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 31 at risk