Study: NCT00914940

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 2 affected / 41 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grades 2-4
Frequency: 4 affected / 41 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 3 affected / 41 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3
Frequency: 1 affected / 41 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3
Frequency: 1 affected / 41 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 2 affected / 41 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 4
Frequency: 2 affected / 41 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 9 affected / 41 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 41 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 3 affected / 41 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 41 at risk

Adverse event: Enteritis infectious
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 41 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 41 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 2 affected / 41 at risk

Adverse event: Oesophageal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 41 at risk

Adverse event: Generalized muslce weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3
Frequency: 1 affected / 41 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 41 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Grades 3-4
Frequency: 7 affected / 41 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grades 3-4
Frequency: 3 affected / 41 at risk

Adverse event: Coagulase-negative staph bacteremia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 8 affected / 41 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 3 affected / 41 at risk

Adverse event: CMV reactivation
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 20 affected / 41 at risk

Adverse event: E Coli Bacteremia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 2 affected / 41 at risk

Adverse event: Leptotrichia infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 41 at risk

Adverse event: MRSA bacteremia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 41 at risk

Adverse event: Candida Glabrata
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 41 at risk

Adverse event: Enterococcus faecium
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 41 at risk

Adverse event: Strep mitis
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 2 affected / 41 at risk

Adverse event: Strep Viridans
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 2 affected / 41 at risk

Adverse event: VRE bacteremia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 2 affected / 41 at risk

Adverse event: Laryngeal oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 4
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 2 affected / 41 at risk

Adverse event: Mucositis, oral
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 36 affected / 41 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 3 affected / 41 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: bilateral LE leg pain requiring PCA - Grade 3
Frequency: 1 affected / 41 at risk

Adverse event: Palmar-plantar erythrodysesthesia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 2 affected / 41 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 4
Frequency: 1 affected / 41 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 4
Frequency: 1 affected / 41 at risk

Adverse event: Proctalgia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 41 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 5
Frequency: 2 affected / 41 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 4
Frequency: 1 affected / 41 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Grade 4
Frequency: 3 affected / 41 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 41 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 41 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 41 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 34 affected / 41 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 41 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 41 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 41 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 41 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 41 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 41 at risk

Adverse event: CD4 lymphocytes decreased
Serious: no
Organ System: Investigations
Frequency: 33 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 41 at risk

Adverse event: Hypertenstion
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 41 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 8 affected / 41 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 5 affected / 41 at risk