Study: NCT00719888

Adverse event: Acute kidney injury (AKI)
Serious: yes
Organ System: Renal and urinary disorders
Notes: A disorder characterized by the acute loss of renal function (within 2 weeks) and is traditionally classified as pre-renal (low blood flow into kidney), renal (kidney damage) and post-renal causes (ureteral or bladder outflow obstruction).
Frequency: 3 affected / 108 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Chronic dialysis or renal transplant indicated.
Frequency: 3 affected / 108 at risk

Adverse event: Acute Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Acute respiratory distress syndrome (ARDS) is a serious lung condition that causes fluid to build up in the lungs, making it difficult to breathe and get oxygen into the body. Graded on whether intubation is indicated.
Frequency: 3 affected / 108 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 4 hyperbilirubinemia is bilirubin level raised by \>10.0 times the Upper Limit Number (ULN)
Frequency: 2 affected / 108 at risk

Adverse event: Cardiopulmonary arrest, cause unknown (non-fatal)
Serious: yes
Organ System: Cardiac disorders
Notes: Loss of heart activity due to irregular heart rhythm. Life-threatening.
Frequency: 1 affected / 108 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Inflammation of the gallbladder. Interventional radiology, endoscopic, or operative intervention indicated.
Frequency: 1 affected / 108 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Notes: Confusion or delirium interfering with activities of daily living (ADLs).
Frequency: 1 affected / 108 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Increase of ≥7 stools per day over baseline; incontinence; IV fluids ≥24 hrs; hospitalization; severe increase in output compared to baseline; interfering with ADL.
Frequency: 9 affected / 108 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Cognitive disturbance; depressed level of consciousness. Grade 3= signs or symptoms interfering with ADL; hospitalization indicated. Grade 4= life-threatening or disabling.
Frequency: 3 affected / 108 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Notes: A brief loss of consciousness that is followed by a quick and complete recovery.
Frequency: 2 affected / 108 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 109/L, fever ≥38.5°C).
Frequency: 3 affected / 108 at risk

Adverse event: Pain - Select: Head/headache
Serious: yes
Organ System: Nervous system disorders
Notes: Headache causing severe pain; pain or analgesics severely interfering with ADL.
Frequency: 1 affected / 108 at risk

Adverse event: Hemorrhage, pulmonary/ upper respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Bronchopulmonary hemorrhage. Grade 3=Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy. Grade 4=Life-threatening consequences; major urgent intervention indicated.
Frequency: 3 affected / 108 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 4= Potassium at a level \>7.0 mmol/L.
Frequency: 2 affected / 108 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3=Raised blood pressure with symptoms, requiring more than one drug or more intensive therapy than previously. Grade 4=Life-threatening consequences (e.g., hypertensive crisis).
Frequency: 3 affected / 108 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Low blood pressure, symptomatic; Grade 3=Sustained (≥24 hrs) therapy, resolves without persisting physiologic consequences. Grade 4=Shock (e.g., acidemia; impairment of vital organ function).
Frequency: 4 affected / 108 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by a decrease in the level of oxygen in the body. Grade 3=Decreased O2 saturation at rest; continuous oxygen indicated. Grade 4=Life-threatening; intubation or ventilation indicated. Grade 5=respiratory failure/death.
Frequency: 5 affected / 108 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Notes: A disorder characterized by an infectious process involving the lungs, including pneumonia. IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated.
Frequency: 8 affected / 108 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Blood
Serious: yes
Organ System: Infections and infestations
Notes: Also called sepsis; disorder characterized by the presence of pathogenic microorganisms in the blood stream that cause a rapidly progressing systemic reaction that may lead to shock. Blood culture positive with signs or symptoms; treatment indicated.
Frequency: 6 affected / 108 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Bladder or urinary tract
Serious: yes
Organ System: Infections and infestations
Notes: Infection documented clinically or microbiologically with ANC \<1.0 x 10\^9/L. A disorder characterized by an infectious process involving the bladder or urinary tract.
Frequency: 4 affected / 108 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils - Blood
Serious: yes
Organ System: Infections and infestations
Notes: Infection documented clinically or microbiologically with ANC \<1.0 x 10\^9/L. Sepsis; disorder characterized by the presence of pathogenic microorganisms in the blood stream that cause a rapidly progressing systemic reaction that may lead to shock.
Frequency: 1 affected / 108 at risk

Adverse event: Acute infusion reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: A disorder characterized by adverse reaction to the infusion of pharmacological or biological substances.
Frequency: 2 affected / 108 at risk

Adverse event: Hemorrhage, GI - Abdominal NOS
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy. Life-threatening consequences; major urgent intervention indicated.
Frequency: 1 affected / 108 at risk

Adverse event: Acidosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: A disorder characterized by abnormally high acidity (high hydrogen-ion concentration) of the blood and other body tissues. Grade 4=pH \<7.3 with life-threatening consequences.
Frequency: 1 affected / 108 at risk

Adverse event: Mood alteration - Anxiety
Serious: yes
Organ System: Psychiatric disorders
Notes: A disorder characterized by new or increased apprehension of danger and dread accompanied by restlessness, tension, tachycardia, and dyspnea unattached to a clearly identifiable stimulus.
Frequency: 1 affected / 108 at risk

Adverse event: Death not associated with CTCAE term - Multi-organ failure
Serious: yes
Organ System: General disorders
Notes: A serious medical emergency that occurs when two or more organ systems in the body are no longer working properly. Grade 5 is the only appropriate grade.
Frequency: 4 affected / 108 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: A disorder characterized by necrotic changes in the bone tissue due to interruption of blood supply. Most often affecting the epiphysis of the long bones, the necrotic changes result in the collapse and the destruction of the bone structure.
Frequency: 1 affected / 108 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: yes
Organ System: Cardiac disorders
Notes: A disorder characterized by fluid collection within the pericardial sac, usually due to inflammation.
Frequency: 1 affected / 108 at risk

Adverse event: Death not associated with CTCAE term - Disease progression NOS
Serious: yes
Organ System: General disorders
Notes: Death resulting from a recurrence of disease in sites other than the bone marrow. Grade 5 is the only appropriate grade.
Frequency: 1 affected / 108 at risk

Adverse event: Infection with normal ANC - Throat/lymph nodes (retropharyngeal abscess)
Serious: yes
Organ System: Infections and infestations
Notes: A retropharyngeal abscess is a pus-filled collection in the back of the throat that can be life-threatening. It's caused by a bacterial infection in the lymph nodes behind the throat, which are part of the immune system.
Frequency: 1 affected / 108 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: A disorder characterized by a sudden, involuntary skeletal muscular contractions of cerebral or brain stem origin.
Frequency: 3 affected / 108 at risk

Adverse event: Liver dysfunction/failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Notes: A disorder characterized by severe hepatic injury as a result of the blood vessels of the liver becoming inflamed and/or blocked.
Frequency: 3 affected / 108 at risk

Adverse event: Supraventricular and nodal arrhythmia - Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: A disorder characterized by a dysrhythmia with a heart rate less than 60 beats per minute that originates in the sinus node. Symptomatic; intervention indicated.
Frequency: 1 affected / 108 at risk

Adverse event: Malabsorption
Serious: yes
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by inadequate absorption of nutrients in the small intestine. Symptoms include weight loss, abdominal marked discomfort, bloating and diarrhea.
Frequency: 1 affected / 108 at risk

Adverse event: Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura [TTP]
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: A disorder characterized by the presence of microangiopathic hemolytic anemia, thrombocytopenic purpura, fever, renal abnormalities and neurological abnormalities such as seizures, hemiplegia, and visual disturbances. An acute or subacute condition.
Frequency: 1 affected / 108 at risk

Adverse event: Allergic reaction/hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Urticaria with manifestations of allergic or hypersensitivity reaction is graded as Allergic reaction/hypersensitivity (including drug fever).
Frequency: 2 affected / 108 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Fever of unknown origin without clinically or microbiologically documented infection; ANC \<1.0 x 109/L, fever ≥38.5°C.
Frequency: 33 affected / 108 at risk

Adverse event: CD4 count
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: CD4 count \<50/mm3 \<0.05 x 109 /L.
Frequency: 2 affected / 108 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Leukocyte (total WBC) count \<1000/mm3 \<1.0 x 109 /L.
Frequency: 1 affected / 108 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: e.g., immune hemolytic anemia, drug-related hemolysis
Frequency: 5 affected / 108 at risk

Adverse event: Iron overload
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 108 at risk

Adverse event: Supraventricular and nodal arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 108 at risk

Adverse event: Prolonged QTc interval
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Cardiac General - Other (Heart failure)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 108 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 108 at risk

Adverse event: Cardiac troponin I (cTnI)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Coagulation, Other (Coagulopathy)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 108 at risk

Adverse event: Thrombotic microangiopathy (TMA)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: e.g., thrombotic thrombocytopenic purpura \[TTP\] or hemolytic uremic syndrome \[HUS\]
Frequency: 3 affected / 108 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 108 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 108 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 59 affected / 108 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 108 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 108 at risk

Adverse event: Acute kidney injury (AKI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 108 at risk

Adverse event: Alanine aminotransferase (ALT) increased, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 108 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 108 at risk

Adverse event: Adult respiratory distress syndrome (ARDS)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Aspartate aminotransferase increased (AST)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 108 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 10 affected / 108 at risk

Adverse event: Cytomegalovirus virus (CMV) reactivation
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 108 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 108 at risk

Adverse event: Thrombosis/thrombus/ embolism
Serious: no
Organ System: Vascular disorders
Notes: e.g. Deep vein thrombosis
Frequency: 1 affected / 108 at risk

Adverse event: Mood alteration - Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 108 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 108 at risk

Adverse event: Disseminated Adenovirus (ADV)
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 108 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 108 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 108 at risk

Adverse event: Renal/Genitourinary, Other (Veno-occlusive disease [VOD])
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 108 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 108 at risk

Adverse event: Hemorrhage/bleeding
Serious: no
Organ System: General disorders
Frequency: 8 affected / 108 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 108 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 108 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 108 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 108 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 108 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 108 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 108 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 108 at risk

Adverse event: Infection in blood
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 108 at risk

Adverse event: Infection in urinary tract (urinary tract infection; UTI)
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 108 at risk

Adverse event: Infection in respiratory tract
Serious: no
Organ System: Infections and infestations
Notes: e.g. pneumonia, RSV, etc.
Frequency: 13 affected / 108 at risk

Adverse event: Infection in gastrointestinal tract
Serious: no
Organ System: Infections and infestations
Notes: e.g. colitis infectious, enterocolitis infectious, C. Diff, etc.
Frequency: 6 affected / 108 at risk

Adverse event: Infection, Other
Serious: no
Organ System: Infections and infestations
Notes: e.g. skin/cellulitis, cerebral spinal fluid (CSF), mucosal (mouth, perianal, etc.), sinus/sinusitis, etc.
Frequency: 10 affected / 108 at risk

Adverse event: Distention/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 108 at risk

Adverse event: Irritable bowel syndrome (IBS)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Multi-organ failure (MOF)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Neutrophil count (ANC) decreased
Serious: no
Organ System: Investigations
Notes: Captured when occurring after post-transplant engraftment after post-transplant engraftment
Frequency: 1 affected / 108 at risk

Adverse event: Pain, Other - Bone pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 108 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 108 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 108 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 108 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 108 at risk

Adverse event: Acute kidney injury (AKI)
Serious: yes
Organ System: Renal and urinary disorders
Notes: A disorder characterized by the acute loss of renal function (within 2 weeks) and is traditionally classified as pre-renal (low blood flow into kidney), renal (kidney damage) and post-renal causes (ureteral or bladder outflow obstruction).
Frequency: 1 affected / 27 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Chronic dialysis or renal transplant indicated.
Frequency: 2 affected / 27 at risk

Adverse event: Acute Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Acute respiratory distress syndrome (ARDS) is a serious lung condition that causes fluid to build up in the lungs, making it difficult to breathe and get oxygen into the body. Graded on whether intubation is indicated.
Frequency: 1 affected / 27 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Cognitive disturbance; depressed level of consciousness. Grade 3= signs or symptoms interfering with ADL; hospitalization indicated. Grade 4= life-threatening or disabling.
Frequency: 2 affected / 27 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Low blood pressure, symptomatic; Grade 3=Sustained (≥24 hrs) therapy, resolves without persisting physiologic consequences. Grade 4=Shock (e.g., acidemia; impairment of vital organ function).
Frequency: 1 affected / 27 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A disorder characterized by a decrease in the level of oxygen in the body. Grade 3=Decreased O2 saturation at rest; continuous oxygen indicated. Grade 4=Life-threatening; intubation or ventilation indicated. Grade 5=respiratory failure/death.
Frequency: 4 affected / 27 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Notes: A disorder characterized by an infectious process involving the lungs, including pneumonia. IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated.
Frequency: 1 affected / 27 at risk

Adverse event: Death not associated with CTCAE term - Multi-organ failure
Serious: yes
Organ System: General disorders
Notes: A serious medical emergency that occurs when two or more organ systems in the body are no longer working properly. Grade 5 is the only appropriate grade.
Frequency: 1 affected / 27 at risk

Adverse event: Myelitis
Serious: yes
Organ System: Infections and infestations
Notes: A disorder characterized by inflammation involving the spinal cord. Symptoms include weakness, paresthesia, sensory loss, marked discomfort and incontinence.
Frequency: 1 affected / 27 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: A disorder characterized by a sudden, involuntary skeletal muscular contractions of cerebral or brain stem origin.
Frequency: 2 affected / 27 at risk

Adverse event: Allergic reaction/hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Urticaria with manifestations of allergic or hypersensitivity reaction is graded as Allergic reaction/hypersensitivity (including drug fever).
Frequency: 1 affected / 27 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Fever of unknown origin without clinically or microbiologically documented infection; ANC \<1.0 x 109/L, fever ≥38.5°C.
Frequency: 14 affected / 27 at risk

Adverse event: Iron overload
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Supraventricular and nodal arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 27 at risk

Adverse event: Prolonged QTc interval
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 27 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 27 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 27 at risk

Adverse event: Cardiac ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Thrombotic microangiopathy (TMA)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: e.g., thrombotic thrombocytopenic purpura \[TTP\] or hemolytic uremic syndrome \[HUS\]
Frequency: 1 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 27 at risk

Adverse event: Acute kidney injury (AKI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 27 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 27 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 27 at risk

Adverse event: Cytomegalovirus virus (CMV) reactivation
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 27 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Renal/Genitourinary, Other (Veno-occlusive disease [VOD])
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hemorrhage/bleeding
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Infection in blood
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 27 at risk

Adverse event: Infection in respiratory tract
Serious: no
Organ System: Infections and infestations
Notes: e.g. pneumonia, RSV, etc.
Frequency: 4 affected / 27 at risk

Adverse event: Infection in gastrointestinal tract
Serious: no
Organ System: Infections and infestations
Notes: e.g. colitis infectious, enterocolitis infectious, C. Diff, etc.
Frequency: 3 affected / 27 at risk

Adverse event: Infection, Other
Serious: no
Organ System: Infections and infestations
Notes: e.g. skin/cellulitis, cerebral spinal fluid (CSF), mucosal (mouth, perianal, etc.), sinus/sinusitis, etc.
Frequency: 1 affected / 27 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Neutrophil count (ANC) decreased
Serious: no
Organ System: Investigations
Notes: Captured when occurring after post-transplant engraftment after post-transplant engraftment
Frequency: 2 affected / 27 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk