Study: NCT00896493

Adverse event: Secondary Malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Acute lymphoblastic leukemia
Frequency: 1 affected / 38 at risk

Adverse event: Secondary Malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Metastatic cutaneous squamous cell carcinoma
Frequency: 1 affected / 38 at risk

Adverse event: Hepatitis viral
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Hepatitis B infection
Frequency: 1 affected / 38 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Liver failure due to disease progression
Frequency: 1 affected / 38 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: GI Bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Acute GI GVHD
Frequency: 1 affected / 38 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Acute Liver GVHD
Frequency: 1 affected / 38 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Notes: Secondary to acute GVHD
Frequency: 1 affected / 38 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: General disorders
Notes: Internal bleeding from anti-coagulation
Frequency: 1 affected / 38 at risk

Adverse event: Serum sickness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Serum sickness from ATG infusion
Frequency: 3 affected / 38 at risk

Adverse event: Disease Relapse
Serious: no
Organ System: General disorders
Notes: Relapse of lymphoma
Frequency: 20 affected / 38 at risk

Adverse event: Secondary Malignancy
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Localized cutaneous squamous cell carcinoma
Frequency: 2 affected / 38 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia needing transfusion
Frequency: 16 affected / 38 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Neutrophil \<0.5
Frequency: 6 affected / 38 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Platelet count \<10,000
Frequency: 2 affected / 38 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 38 at risk

Adverse event: Infection, non-specified
Serious: no
Organ System: Infections and infestations
Notes: Central-line related infection
Frequency: 4 affected / 38 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 38 at risk

Adverse event: Post transplant lymphoproliferative disorder (PTLD)
Serious: no
Organ System: Infections and infestations
Notes: Post-transplant lymphoproliferative disorder (PTLD) secondary to Epstein Barr virus (EBV) reactivation
Frequency: 2 affected / 38 at risk

Adverse event: Cytomegalovirus viraemia
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 38 at risk

Adverse event: Epstein-Barr viraemia
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 38 at risk