Study: NCT00809276

Adverse event: Primary graft failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 92 at risk

Adverse event: Death
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 92 at risk

Adverse event: ALT elevation grade 3-4
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 92 at risk

Adverse event: AST elevation grade 3-4
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 92 at risk

Adverse event: Hyperbilirubinemia grade 3-4
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 92 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 92 at risk

Adverse event: Alkaline phosphatase elevated grade 3-4
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 92 at risk

Adverse event: Dermatitis exfoliative generalised
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 92 at risk

Adverse event: Gastritis and ileitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Cystitis haemorrhagic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 92 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 92 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 92 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 92 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 92 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 92 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 92 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 92 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 92 at risk

Adverse event: Renal toxicity
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 92 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 92 at risk

Adverse event: Secondary graft failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 92 at risk

Adverse event: Pulmonary alveolar haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 92 at risk

Adverse event: Idiopathic pulmonary syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: AST elevation grade 3-4
Serious: no
Organ System: Investigations
Frequency: 11 affected / 92 at risk

Adverse event: ALT elevation grade 3-4
Serious: no
Organ System: Investigations
Frequency: 20 affected / 92 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 92 at risk

Adverse event: Engraftment > Day 28
Serious: no
Organ System: Investigations
Frequency: 11 affected / 92 at risk

Adverse event: Hyperbilirubinemia grade 3-4
Serious: no
Organ System: Investigations
Frequency: 7 affected / 92 at risk