Study: NCT00605657

Adverse event: Pneumomediastinum
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: not treatment related
Frequency: 1 affected / 5 at risk

Adverse event: low serum IgG
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: possibly related to treatment
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: unrelated
Frequency: 2 affected / 5 at risk

Adverse event: decreased platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Only probably related in one patient. Other patients had baseline low platelets.
Frequency: 3 affected / 5 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: unlikely or unrelated in all patients
Frequency: 3 affected / 5 at risk

Adverse event: decreased neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: unlikely or unrelated in all cases
Frequency: 4 affected / 5 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: General disorders
Notes: unrelated
Frequency: 1 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: vomiting unrelated, due to the flu in one case. Possibly related in other
Frequency: 1 affected / 5 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unrelated
Frequency: 2 affected / 5 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unrelated
Frequency: 2 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: not related in two cases, possibly related in one case.
Frequency: 5 affected / 5 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: General disorders
Notes: unrelated
Frequency: 1 affected / 5 at risk

Adverse event: elevated AST
Serious: no
Organ System: Gastrointestinal disorders
Notes: one probably related and one unlikely related
Frequency: 2 affected / 5 at risk

Adverse event: elevated ALT
Serious: no
Organ System: Gastrointestinal disorders
Notes: probably related
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: possibly related
Frequency: 1 affected / 5 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: possibly related
Frequency: 1 affected / 5 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: probably related
Frequency: 1 affected / 5 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: unlikely or unrelated
Frequency: 2 affected / 5 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: possibly related
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: possibly related
Frequency: 1 affected / 5 at risk

Adverse event: elevated alkaline phosphatase
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: unrelated
Frequency: 1 affected / 5 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: probably related
Frequency: 2 affected / 5 at risk