Study: NCT00350545

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 35 at risk

Adverse event: Nocardiosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: on leg, fore-arm and lower extremities. Includes superficial
Frequency: 3 affected / 35 at risk

Adverse event: Abscess
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Including: Incision, drainage, right paraspinous muscle
Frequency: 3 affected / 35 at risk

Adverse event: Low absolute neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Notes: Including: fungal
Frequency: 1 affected / 35 at risk

Adverse event: bilirubin levels increasing
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Blood
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Large amounts of blood seen in ET tube and trachea
Frequency: 2 affected / 35 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Inlcudes pulseless electrical activity
Frequency: 1 affected / 35 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 35 at risk

Adverse event: Graft versus host disease
Serious: yes
Organ System: General disorders
Notes: Including: of the- mouth, liver, skin lung and chronic
Frequency: 12 affected / 35 at risk

Adverse event: Confusional state
Serious: yes
Organ System: General disorders
Notes: (worsening)
Frequency: 1 affected / 35 at risk

Adverse event: Conjunctivitis
Serious: yes
Organ System: Eye disorders
Notes: ( viral )
Frequency: 1 affected / 35 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes: severe and prodcutive
Frequency: 3 affected / 35 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 35 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Renal and urinary disorders
Notes: (bloody)
Frequency: 1 affected / 35 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes: worsening
Frequency: 1 affected / 35 at risk

Adverse event: Rash erythematous
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Includes: Dry and flaky
Frequency: 1 affected / 35 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: H1N1
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 35 at risk

Adverse event: Veno-occlusive disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Tbili
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 35 at risk

Adverse event: Syncope
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: Sespis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 35 at risk

Adverse event: Respiratory syncytial virus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Multi-organ system failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Disseminated aspergillus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: inlcudes Isolated events
Frequency: 3 affected / 35 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 35 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Includes: Superficial
Frequency: 1 affected / 35 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Decrease in diffusing capacity of the lungs for carbon monoxide
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes: pain in abdomin, on forearm,
Frequency: 3 affected / 35 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Notes: Includes: E.Coli
Frequency: 2 affected / 35 at risk

Adverse event: Erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 35 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: influenza A
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Paranasal sinus disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: slight decrease in her forced expiratory volume in 1 second
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk