Study: NCT00469144

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 114 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Due to Diffuse Alveolar Hemorrhage
Frequency: 1 affected / 114 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Chronic Oral GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 114 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: Due to antibiotics/Tacrolimus
Frequency: 1 affected / 114 at risk

Adverse event: Beta Hemolytic Streptococcus Upper Respiratory Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Streptococcus Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Cytomegalovirus Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Respiratory Syncytial Virus Upper Respiratory Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Chronic Ocular GvHD
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 114 at risk

Adverse event: Chronic Vaginal GvHD
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 114 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Chronic Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Ocular GvHD
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 114 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 114 at risk

Adverse event: Esophageal Dysmotility
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 114 at risk

Adverse event: Liver GvHD
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 114 at risk

Adverse event: Oral GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 114 at risk

Adverse event: Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 114 at risk

Adverse event: Cystitis haemorrhagic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 114 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 114 at risk

Adverse event: GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Vagina GvHD
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 114 at risk

Adverse event: Lung GvHD
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Engraftment syndrome
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 114 at risk

Adverse event: Herpes Simplex Virus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Cytomegalovirus Reactivation
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Parainfluenza Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Fungal Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Influenza A Virus Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 114 at risk

Adverse event: Herpes Simplex Virus Oral Lesion
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Invasive Candida Glabrata/Fusarium Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Escherichia Coli Urinary Tract Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Branhamella Catarrhalis Upper Respiratory Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Corynebacterium/Bacil/Microbacterium Bacteremia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Stenotrophomonas Maltophilia Bacteremia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Epstein-Barr Virus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Methicillin-Resistant Staphylococcus Aureus Urinary Tract Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Parvovirus Viremia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Pseudomonas Aeruginosa Bacteremia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Herpes Zoster Eruption
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Acinetobacter Calcoaceticus Bacteremia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Human Herpes Virus-6
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 114 at risk

Adverse event: Klebsiella bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Enterococcus Bacteremia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Acinetobacter Ursingii Bacteremia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Parovirus B19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Stenotrophomonas (Xanthomonas) Bacteremia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Bacillus Species Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Periorbital haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 114 at risk

Adverse event: Pneumonitis aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 111 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Due to Pneumonia/Septic Shock
Frequency: 1 affected / 111 at risk

Adverse event: Chronic Oral GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 111 at risk

Adverse event: Respiratory Syncytial Virus Upper Respiratory Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 111 at risk

Adverse event: Pneumonia staphylococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Influenza A Upper Respiratory Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Chronic Ocular GvHD
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 111 at risk

Adverse event: Chronic Lung GvHD
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 111 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 111 at risk

Adverse event: Chronic Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 111 at risk

Adverse event: Ocular GvHD
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 111 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 111 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 111 at risk

Adverse event: Liver GvHD
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 111 at risk

Adverse event: Oral GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 111 at risk

Adverse event: Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 111 at risk

Adverse event: Cystitis haemorrhagic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 111 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 111 at risk

Adverse event: GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 111 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 111 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 111 at risk

Adverse event: Lung GvHD
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 111 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 111 at risk

Adverse event: Autoimmune haemolytic anaemia
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 111 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 111 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 111 at risk

Adverse event: Engraftment syndrome
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 111 at risk

Adverse event: Upper GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 111 at risk

Adverse event: BK Virus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Aspergillus Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Herpes Simplex Virus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Influenza B Upper Respiratory Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Cytomegalovirus Reactivation
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 111 at risk

Adverse event: Micrococcus Line Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Parainfluenza Upper Respiratory Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Pseudomonas Aeruginosa/Enterococcus Urinary Tract Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 111 at risk

Adverse event: Clostridum Difficile
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Enterococcus Faecalis Line Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Herpes Simplex Virus Esophagitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Alpha Hemolytic Strep Line Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Vulva GvHD
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 111 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 111 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 111 at risk

Adverse event: Hand-Foot Syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 111 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk