Study: NCT01027702

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 24 affected / 38 at risk

Adverse event: HHV-6 reactivation
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 38 at risk

Adverse event: Graft vs Host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 5 affected / 38 at risk

Adverse event: EBV-related lymphoproliferative disease
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 38 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 38 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 38 at risk

Adverse event: Relapse
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 25 at risk

Adverse event: CMV reactivation
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Infection w/ unknown absolute neutrophil count (ANC)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: ALT/ AST elevated
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 38 at risk

Adverse event: Infection- eye NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Pulmonary/ Upper Respiratory- other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Blood tinged sputum following fungal pneumonia
Frequency: 1 affected / 38 at risk

Adverse event: BK virus/ hemorrhagic cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Infection- select
Serious: yes
Organ System: Infections and infestations
Notes: viral upper respiratory infection
Frequency: 1 affected / 38 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Notes: grade 4
Frequency: 12 affected / 38 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 38 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Notes: grade 4
Frequency: 8 affected / 38 at risk

Adverse event: Relapse
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 25 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 3
Frequency: 5 affected / 38 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 3
Frequency: 4 affected / 38 at risk

Adverse event: Thrombotic microangiopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 3
Frequency: 3 affected / 38 at risk

Adverse event: Thrombotic microangiopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 4
Frequency: 3 affected / 38 at risk

Adverse event: ALT elevated
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: grade 4
Frequency: 2 affected / 38 at risk

Adverse event: Hemorrage, GU- urinary NOS
Serious: no
Organ System: Renal and urinary disorders
Notes: Hemorrhagic cystitis
Frequency: 2 affected / 38 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: grade 4
Frequency: 2 affected / 38 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: grade 4
Frequency: 2 affected / 38 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: grade 3
Frequency: 2 affected / 38 at risk

Adverse event: Renal/ Genitorurinary NOS
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 3
Frequency: 2 affected / 38 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Notes: grade 3
Frequency: 2 affected / 38 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Notes: grade 4
Frequency: 3 affected / 38 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 4
Frequency: 3 affected / 38 at risk