Study: NCT00919503

Adverse event: Anaphylaxis reaction (rATG)
Serious: yes
Organ System: Immune system disorders
Notes: grade 4
Frequency: 2 affected / 84 at risk

Adverse event: Cardiac Asystole following central venous catheter placement
Serious: yes
Organ System: Cardiac disorders
Notes: grade 5
Frequency: 1 affected / 84 at risk

Adverse event: Hypotension: requiring intervention
Serious: yes
Organ System: Vascular disorders
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Hypotension: shock, pressors
Serious: yes
Organ System: Vascular disorders
Notes: grade 4
Frequency: 1 affected / 84 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Diarrhea (associated with GVHD): >15ml/kg per day with abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: grade 4
Frequency: 1 affected / 84 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Fever (not neutropenic): attributed to rATG
Serious: yes
Organ System: General disorders
Notes: grade 3
Frequency: 2 affected / 84 at risk

Adverse event: Fever (not neutropenic)
Serious: yes
Organ System: General disorders
Notes: grade 3
Frequency: 2 affected / 84 at risk

Adverse event: Febrile neutropenia: attributed to rATG
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Febrile Neutropenia: with life- threatening sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: grade 4
Frequency: 1 affected / 84 at risk

Adverse event: Infections and infestations -Other, specify: parainfluenza or sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Infections and infestations -Other, specify: CMV meningitis/encephalo
Serious: yes
Organ System: Infections and infestations
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Infections and infestations -Other, specify: Clostridium septicum sepsis
Serious: yes
Organ System: Infections and infestations
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Adult respiratory distress syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 4
Frequency: 1 affected / 84 at risk

Adverse event: Acute kidney injury (reversible, requiring CRRT/dialysis)
Serious: yes
Organ System: Renal and urinary disorders
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Hypoxia: Decreased O2 sat requiring support
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 4
Frequency: 4 affected / 84 at risk

Adverse event: Anaphylaxis reaction: Possible reaction to rATG
Serious: no
Organ System: Immune system disorders
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Diarrhea (associated with GVHD): >15ml/kg per day
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Oral mucositis: Requiring intervention
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 3
Frequency: 20 affected / 84 at risk

Adverse event: Elevated bilirubin (>3-10x ULN)
Serious: no
Organ System: Investigations
Notes: grade 3
Frequency: 2 affected / 84 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 3
Frequency: 14 affected / 84 at risk

Adverse event: Fever (not neutropenic): attributed to rATG
Serious: no
Organ System: General disorders
Notes: grade 3
Frequency: 6 affected / 84 at risk

Adverse event: Hypoxia: decreased O2 sat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 3
Frequency: 10 affected / 84 at risk

Adverse event: Hypoxia: requiring intubation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 4
Frequency: 1 affected / 84 at risk

Adverse event: Acute kidney injury (reversible, requiring CRRT/dialysis)
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Hemolysis (AIHA): Requiring transfusion and sterioids
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 3
Frequency: 2 affected / 84 at risk

Adverse event: Hypotension: requiring intervention
Serious: no
Organ System: Vascular disorders
Notes: grade 3
Frequency: 3 affected / 84 at risk

Adverse event: Cardiopulmonary arrest: Requiring intubation
Serious: no
Organ System: Cardiac disorders
Notes: grade 4
Frequency: 1 affected / 84 at risk

Adverse event: Thrombotic microangiopathy (not requiring intervention)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Rash (>50%)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 3
Frequency: 4 affected / 84 at risk

Adverse event: Colitis: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 3
Frequency: 3 affected / 84 at risk

Adverse event: Febrile neutropenia: attributed to rATG
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 3
Frequency: 7 affected / 84 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 3
Frequency: 2 affected / 84 at risk

Adverse event: Dysfunctional urerine (menstrual) bleeding: requiring transfusion
Serious: no
Organ System: Reproductive system and breast disorders
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Oral hemorrhage: Bleeding (requiring transfusion)
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: nfections and infestations -Other, specify: MSSA septic shock
Serious: no
Organ System: Infections and infestations
Notes: grade 4
Frequency: 1 affected / 84 at risk

Adverse event: Infections and infestations -Other, specify: Strep viridans, enterococcus bacteremia
Serious: no
Organ System: Infections and infestations
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Reversible posterior leukoencephalopathy syndrome (PRES)
Serious: no
Organ System: Nervous system disorders
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Seizure (conciousness altered)
Serious: no
Organ System: Nervous system disorders
Notes: grade 3
Frequency: 3 affected / 84 at risk

Adverse event: Carbon monoxide diffusing capacity decreased (DLCO)
Serious: no
Organ System: Investigations
Notes: grade 3
Frequency: 1 affected / 84 at risk

Adverse event: Gastrointestinal Other: Pneumatosis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: grade 3
Frequency: 1 affected / 14 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 4
Frequency: 1 affected / 14 at risk

Adverse event: Sepsis with multiorgan failure
Serious: yes
Organ System: Infections and infestations
Notes: grade 5
Frequency: 2 affected / 14 at risk

Adverse event: Apnea: Requiring intubation following BAL; attributed to underlying infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 4
Frequency: 1 affected / 14 at risk

Adverse event: Anaphylaxis reaction: Possible reaction to rATG
Serious: no
Organ System: Immune system disorders
Notes: grade 3
Frequency: 1 affected / 14 at risk

Adverse event: Pericardial effusion: Tamponade
Serious: no
Organ System: Cardiac disorders
Notes: grade 4
Frequency: 2 affected / 14 at risk

Adverse event: Thrombotic microangiopathy (requiring intervention) with acute renal fail: Hemolytic uremic syndrome
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 4
Frequency: 1 affected / 14 at risk

Adverse event: Fluid retention - evidence of ascites
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 3
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhea (associated with GVHD): >15ml/kg per day
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 3
Frequency: 1 affected / 14 at risk

Adverse event: Gastrointestinal disorders -Other, specify: pneumatosis
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 3
Frequency: 1 affected / 14 at risk

Adverse event: Oral mucositis: Requiring intervention
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 3
Frequency: 1 affected / 14 at risk

Adverse event: Esophageal ulcers: Presumed viral esophagitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 3
Frequency: 1 affected / 14 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 3
Frequency: 1 affected / 14 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 3
Frequency: 1 affected / 14 at risk

Adverse event: Elevated bilirubin (>3-10x ULN)
Serious: no
Organ System: Investigations
Notes: grade 3
Frequency: 2 affected / 14 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 3
Frequency: 4 affected / 14 at risk

Adverse event: Fever (not neutropenic): attributed to rATG
Serious: no
Organ System: General disorders
Notes: grade 3
Frequency: 1 affected / 14 at risk

Adverse event: Fever (not neutropenic)
Serious: no
Organ System: General disorders
Notes: grade 3
Frequency: 1 affected / 14 at risk

Adverse event: Infections and infestations -Other, specify: life-threatening disseminated Adenovirus
Serious: no
Organ System: Infections and infestations
Notes: grade 4
Frequency: 1 affected / 14 at risk

Adverse event: sleep apnea: Obstructive
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 3
Frequency: 1 affected / 14 at risk

Adverse event: Hypoxia: decreased O2 sat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 3
Frequency: 1 affected / 14 at risk

Adverse event: Hypoxia: requiring intubation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 4
Frequency: 2 affected / 14 at risk

Adverse event: Adult respiratory distress syndrome (ARDS)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 4
Frequency: 2 affected / 14 at risk

Adverse event: Acute kidney injury (reversible, requiring CRRT/dialysis)
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 3
Frequency: 1 affected / 14 at risk