Study: NCT00566696

Adverse event: Allergic reaction, micafungin
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Transplant failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 31 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Post-transplant lymphoproliferative disease
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Fever without neutropenia
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 31 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Vomiting (disorder)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hemorrhage, diffuse alveolar
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Failure, hepatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 31 at risk

Adverse event: Veno-occlusive disease, hepatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 31 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Adult respiratory distress syndrome (disorder)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Failure, renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 31 at risk

Adverse event: Cystitis haemorrhagic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 31 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 31 at risk

Adverse event: Fever without neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 31 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Infection, acinetobacter baumannii, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Infection, aceinetobacter calcoaceticus, baumannii, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Infection, coagulase negative staphylocuccus, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Infection, enterobacter cloacae, blood culture
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Infection, enterococcus faecalis, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Infection, influenza type A, respiratory tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Infection, staphylocuccus epidermidis, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Infection, urinary tract, gamma hemolytic streptococcus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Infection, vancomycin-resistant enterococcus, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Infection, vancomycin resistant enterococcus, blood/Hickman line
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 31 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 31 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Nausea (finding)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Vomiting (disorder)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 31 at risk

Adverse event: Cystitis haemorrhagic
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 31 at risk

Adverse event: Elevated ALT (SGPT)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 31 at risk

Adverse event: Elevated GGT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 31 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 31 at risk

Adverse event: Hypokalemia (disorder)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 31 at risk

Adverse event: Hypophosphatemia (disorder)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 31 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 31 at risk

Adverse event: Cystitis haemorrhagic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 31 at risk

Adverse event: Cytokine Release Syndrome (Campath) [10/20 (50%)]
Serious: no
Organ System: General disorders
Notes: 20 received Campath and were at risk
Frequency: 10 affected / 20 at risk

Adverse event: Cytokine Release Syndrome (muromonab) [3/11 (27.27%)]
Serious: no
Organ System: General disorders
Notes: 11 received muromonab and were at risk
Frequency: 3 affected / 11 at risk

Adverse event: Cytokine Release Syndrome (Stem Cell Infusion)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pain, generalized, multiple sites
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 31 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Infection, adenovirus, blood
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 31 at risk

Adverse event: Infection, adenovirus, respiratory tract
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Infection, adenovirus, stool
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 31 at risk

Adverse event: Infection, BK Virus, bladder
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Infection, BK Virus, blood
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 31 at risk

Adverse event: Infection, BK Virus, urine
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 31 at risk

Adverse event: Infection, Clostridium Difficile, stool
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 31 at risk

Adverse event: Infection, herpes simplex, lip
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Infection, Klebsiella pneumoniae, blood
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Infection, vancomycin-resistant enterococcus, rectum
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 31 at risk