Study: NCT00254995

Adverse event: Thrombocytopenia (Chronic, Precedes)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 31561 at risk

Adverse event: Idiopathic thrombocytopenic purpura (Precedes)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 31561 at risk

Adverse event: Splenomegaly
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 12 affected / 31561 at risk

Adverse event: Congenital Heart Disease
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Sickle cell disease
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 31561 at risk

Adverse event: Pectus excavatum
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31561 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31561 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Cyst
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 31561 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 31561 at risk

Adverse event: Febrile Illness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 31561 at risk

Adverse event: Delirium tremens
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 31561 at risk

Adverse event: Hepatic steatosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Transplant rejection
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Abscess/Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 31561 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 31561 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 31561 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 31561 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 31561 at risk

Adverse event: Meningitis aseptic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31561 at risk

Adverse event: Encephalitis due to Epstein-Barr Virus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31561 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31561 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31561 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31561 at risk

Adverse event: Labyrinthitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31561 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31561 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31561 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31561 at risk

Adverse event: Toxic shock syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31561 at risk

Adverse event: Complications of transplant surgery
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 31561 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 31561 at risk

Adverse event: Poisoning/Ingestion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 31561 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 38 affected / 31561 at risk

Adverse event: Diabetes, Type 1 (New Onset)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 31561 at risk

Adverse event: Diabetes, Type 1 (Prior Onset)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 31561 at risk

Adverse event: Femoral Epiphysiolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Kyphosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Systemic Lupus Erythematosus (New dx, symptoms precede)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Systemic Lupus Erythematosus (Prior onset)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Scoliosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 31561 at risk

Adverse event: Temporomandibular pain and dysfunction syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 31561 at risk

Adverse event: Cancer, Cervix
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 31561 at risk

Adverse event: Cancer, Melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 31561 at risk

Adverse event: Cancer, Ovarian
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 31561 at risk

Adverse event: Cancer, Pancreatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 31561 at risk

Adverse event: Benign lesion NOS
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 31561 at risk

Adverse event: Cancer, R/O Cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 31561 at risk

Adverse event: Hodgkin's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 31561 at risk

Adverse event: Lymphocytic Leukemia (Chronic, Precedes)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 31561 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Cranial nerve paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Chronic Inflammatory Demyelinating Polyneuritis (Prior onset)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Epilepsy (Hx of Seizure Disorder, possible seizure)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Epilepsy (Seizure Event, w/hx of Seizure Disorder)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 31561 at risk

Adverse event: Horner's syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 31561 at risk

Adverse event: Syncope/LOC
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 31561 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Pregnancy - Stillborn Delivery post Prolapsed Cord
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Psychiatric
Serious: yes
Organ System: Psychiatric disorders
Frequency: 61 affected / 31561 at risk

Adverse event: Suicidal Ideation/Attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 31561 at risk

Adverse event: End-Stage Renal Disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Testicular torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Asthma/RAD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 31561 at risk

Adverse event: Asphyxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Elective procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 31561 at risk

Adverse event: Inguinal Hernia/Repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 31561 at risk

Adverse event: Tooth disorder (Dental)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31561 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 31561 at risk

Adverse event: Idiopathic Polycystic Splenomegaly
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 31561 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31561 at risk