Study: NCT00800839

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 39 affected / 56 at risk

Adverse event: BK virus associated hemorrhagic cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 56 at risk

Adverse event: Cardio-renal syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 56 at risk

Adverse event: Chronic GI GvHD
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Chronic ocular GvHD
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 56 at risk

Adverse event: Delayed engraftment due to Cytoxan
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Elevated bilirubin due to Sepsis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 56 at risk

Adverse event: Delayed engraftment
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Elevated alanine aminotransferase due to drug related
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 56 at risk

Adverse event: Elevated bilirubin due to drug related
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 56 at risk

Adverse event: GI GvHD
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 56 at risk

Adverse event: Graft Failure due to Relapsed MDS
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Graft Failure due to micro-environment
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Graft Failure due to Rejection
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 56 at risk

Adverse event: Hemorrhage due to low PLT
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 56 at risk

Adverse event: Infections Viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 56 at risk

Adverse event: Liver GvHD
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 56 at risk

Adverse event: Infections Bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 56 at risk

Adverse event: Infections Fungal
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 56 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 56 at risk

Adverse event: Neutropenic colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Presumed viral encephalitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Primary Graft Failure
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Presumed fungal pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 56 at risk

Adverse event: Thrombocytopenia due to Valcyte
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Skin GVHD
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Abdominal pain due to Doxycycline
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Allergic reaction due to Platelet transfusion
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Allergic reaction due to Cell infusion
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Altered mental status changes due to drug related
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 56 at risk

Adverse event: Altered mental status changes due to ATG
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Altered mental status changes
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 56 at risk

Adverse event: Atrial fibrilation due to dexamethasone
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 56 at risk

Adverse event: Atrial fibrilation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 56 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: BK virus associated hemorrhagic cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 56 at risk

Adverse event: Bone pain due to Neupogen
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 56 at risk

Adverse event: Chronic ocular GvHD
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 56 at risk

Adverse event: Chronic skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Chronic upper GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 56 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 56 at risk

Adverse event: Demodex folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Dermatitis drug eruption vs GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 56 at risk

Adverse event: Dizziness due to Dilantin
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Dysphagia due to radiation treatment
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Elevated alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 56 at risk

Adverse event: Elevated alanine aminotransferase due to drug related
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 56 at risk

Adverse event: Elevated alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 56 at risk

Adverse event: Elevated alkaline phosphatase due to drug related
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 56 at risk

Adverse event: Elevated bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 56 at risk

Adverse event: Elevated bilirubin due to RBC transfusions
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 56 at risk

Adverse event: Elevated bilirubin due to drug related
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 56 at risk

Adverse event: Elevated lactate dehydrogenase due to Vancomycin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 56 at risk

Adverse event: Engraftment syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Fevers
Serious: no
Organ System: General disorders
Frequency: 10 affected / 56 at risk

Adverse event: Fevers due to ATG
Serious: no
Organ System: General disorders
Frequency: 19 affected / 56 at risk

Adverse event: Fevers due to Engraftment Syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Fevers due to Transfusion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 56 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 56 at risk

Adverse event: GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 56 at risk

Adverse event: GI bleed of undetermnined cause
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 56 at risk

Adverse event: Haemochromatosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Hemorrhage of undetermined etiology
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 56 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 56 at risk

Adverse event: Hypertension due to Tacrolimus
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 56 at risk

Adverse event: Hypotension due to Norvasc
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 56 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 56 at risk

Adverse event: Infections Bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 56 at risk

Adverse event: Infections Fungal
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 56 at risk

Adverse event: Infections Viral
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 56 at risk

Adverse event: Line related deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 56 at risk

Adverse event: Liver GvHD
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 56 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 56 at risk

Adverse event: Myopathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 56 at risk

Adverse event: Myopathy due to Tramadol
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Magnesium induced diarrhea
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 56 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 56 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 56 at risk

Adverse event: Nausea due to drug related
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 56 at risk

Adverse event: Nausea due to CMV infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Neutropenic fevers
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 56 at risk

Adverse event: Oral GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 56 at risk

Adverse event: Ocular GvHD
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 56 at risk

Adverse event: Propionibaterium acnes conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pruritus due to Bactrim
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 56 at risk

Adverse event: Rash due to ATG
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 56 at risk

Adverse event: Rash due to drug related
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 56 at risk

Adverse event: Red cell dysplasia due to ABO incompatibility
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 56 at risk

Adverse event: Renal insufficiency due to Nephrotoxins
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 56 at risk

Adverse event: Renal insufficiency due to Pyelonephritis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 56 at risk

Adverse event: Renal insufficiency due to Overt diuresis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 56 at risk

Adverse event: Renal insufficiency due to drug related
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 56 at risk

Adverse event: Renal insufficiency due to Obstructive neuropathy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 56 at risk

Adverse event: Renal insufficiency due to Obstructive uropathy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 56 at risk

Adverse event: Renal insufficiency due to Hemorrhagic cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 56 at risk

Adverse event: Shortness of breath due to platelet transfusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Severe vulvar discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 56 at risk

Adverse event: Skin GVHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 56 at risk

Adverse event: Steroid-Induced Myopathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 56 at risk

Adverse event: Small bowel obstruction from pneumatosis coli
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Steroid induced hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 56 at risk

Adverse event: Suspected cGvHD
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Suspected metabolic encephalopathy
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 56 at risk

Adverse event: Suspected migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Suspected Ganciclovir induced diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Suspected engraftment syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Ulcer
Serious: no
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Upper GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 56 at risk

Adverse event: Thrombocytopenia due to drug related
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 56 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 56 at risk