Study: NCT00101361

Adverse event: elective bladder stone removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 108 at risk

Adverse event: myocutaneous flap surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 108 at risk

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 104 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 108 at risk

Adverse event: constipation or diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 108 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 35 affected / 108 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 108 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: cellulitis, sepsis, clostridial
Frequency: 13 affected / 108 at risk

Adverse event: nausea / vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 108 at risk

Adverse event: non-Target Pressure Ulcer (TPU) skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 108 at risk

Adverse event: osteomylitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 108 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 108 at risk

Adverse event: skin rash / complication
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 108 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 108 at risk

Adverse event: oral cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 104 at risk

Adverse event: small bowel obstruction, renal failure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 104 at risk

Adverse event: myocutaneous flap surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 9 affected / 104 at risk

Adverse event: Death
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 104 at risk

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 104 at risk

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 104 at risk

Adverse event: constipation or diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 104 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 104 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 104 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: cellulitis, sepsis, clostridial
Frequency: 9 affected / 104 at risk

Adverse event: nausea / vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 104 at risk

Adverse event: non-Target Pressure Ulcer (TPU) skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 104 at risk

Adverse event: osteomylitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 104 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 104 at risk

Adverse event: skin rash / complication
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 104 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 104 at risk