Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 4:29 AM

Ignite Modification Date: 2025-12-26 @ 3:32 AM

NCT ID: NCT01690520

Description: None

Frequency Threshold: 0

Time Frame: 84 days

Study: NCT01690520

Study Brief: Donor Umbilical Cord Blood Transplant With or Without Ex-vivo Expanded Cord Blood Progenitor Cells in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, or Myelodysplastic Syndromes

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Arm I (Standard of Care)	CONDITIONING REGIMEN: One of two possible conditioning regimens is chosen by the attending physician: Patients receive fludarabine phosphate IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6., and undergo high dose TBI BID on days -4 to -1 OR Patients receive fludarabine phosphate IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo middle intensity TBI QD on days -2 to -1. TRANSPLANT: Patients undergo single-unit or double-unit unmanipulated UCB transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine IV over 1 hour BID (adults) or TID (children) or PO on days -3 to 100 with taper beginning on day 101. Patients also receive MMF IV TID a day on days 0-7 then may receive MMF PO TID. Patients remain on MMF TID for a minimum of 30 days, and then may begin a taper if there is no evidence of GVHD and are well-engrafted from one donor unit. Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given IV or PO Thiotepa: Given IV Total-Body Irradiation: Undergo high dose or middle intensity TBI Umbilical Cord Blood Transplantation: Undergo single-unit or double-unit unmanipulated umbilical cord blood transplant	25	None	48	78	71	78	View
Arm II (Experimental)	CONDITIONING REGIMEN: Patients receive the conditioning regimen chosen by the attending physician as in Standard of Care Arm. TRANSPLANT: Patients undergo single-unit or double-unit unmanipulated UCB transplant on day 0. Patients also undergo infusion of ex vivo-expanded cord blood progenitor cell infusion at least 4 hours after completion of UCB transplant. GVHD PROPHYLAXIS: Patients receive cyclosporine IV or PO and mycophenolate mofetil IV or PO as in Standard of Care Arm. Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion: Given IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given IV or PO Thiotepa: Given IV Total-Body Irradiation: Undergo high dose or middle intensity TBI Umbilical Cord Blood Transplantation: Undergo single-unit or double-unit unmanipulated umbilical cord blood transplant	21	None	55	82	73	82	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Pyrexia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Multiple organ dysfunction syndrome	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Chest pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Chills	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Complication associated with device	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Death	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Non-cardiac chest pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Clostridium difficile infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Cytomegalovirus gastritis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Cytomegalovirus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Eye infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Herpes virus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Klebsiella infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Oral infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia klebsiella	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pseudomonas infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Rhinovirus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Sinusitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Skin infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Systemic candida	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urinary tract infection enterococcal	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Staphylococcal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
BK virus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Cytomegalovirus viraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Lung infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia fungal	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Staphylococcal bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pulmonary embolism	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Acute respiratory distress syndrome	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Cough	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Organising pneumonia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pleural effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary alveolar haemorrhage	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary infarction	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary mass	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary oedema	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Hypoxia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory failure	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Abdominal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Jejunal perforation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Lower gastrointestinal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Pancreatitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Pneumatosis intestinalis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Diarrhoea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Colitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Nausea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Acute graft versus host disease in intestine	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Graft versus host disease in gastrointestinal tract	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Hypersensitivity	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Acute graft versus host disease in liver	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Graft versus host disease	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Haematuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Acute kidney injury	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Infusion related reaction	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Transplant failure	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Subdural haematoma	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Encephalopathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Haemorrhage intracranial	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Neuropathy peripheral	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Posterior reversible encephalopathy syndrome	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Seizure	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Atrial flutter	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Cardiac arrest	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Cardiac failure	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Pericardial effusion	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Sinus bradycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Disseminated intravascular coagulation	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Lymphatic disorder	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Febrile neutropenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Alanine aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Aspartate aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood bilirubin increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Platelet count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hepatic failure	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Hyperuricaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypokalemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypophosphataemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Delirium	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Skin ulcer	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Decreased appetite	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypokalemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperglycaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyponatraemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypophosphataemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypertriglyceridaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperkalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypocalcaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Acidosis	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypermagnesaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypernatraemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Iron overload	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Dehydration	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperuricaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypoalbuminaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypomagnesaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Colitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Enterocolitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastritis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastrointestinal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Ileus	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Large intestinal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastrointestinal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Impaired gastric emptying	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Lower gastrointestinal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Oesophagitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Periodontal disease	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Proctitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Stomatitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Nausea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Diarrhoea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Abdominal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Embolism	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Rash maculo-papular	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Rash	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Pruritis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Rash macular	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Rash pruritic	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Skin ulcer	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Enterococcal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Adenovirus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Alpha haemolytic streptococcal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Cystitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
BK virus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Device related infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Sinusitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Skin infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Candida infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Encephalitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Escherichia infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Human polyomavirus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pseudomonas infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Stomatococcal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Upper respiratory tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Actinomycotic sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Administration site cellulitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Bacillus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Coronavirus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Corynebacterium infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Cytomegalovirus colitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Enterobacter infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Enterocolitis infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Fusobacterium infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Gastric infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Influenza	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Leuconostoc infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Lip infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Osteomyelitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Wound infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Staphylococcal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Lung infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Human herpesvirus 6 infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Cytomegalovirus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Streptococcal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Bacterial infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Clostridium difficile infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Blood bilirubin increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Alanine aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Aspartate aminotransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood aluminium increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood alkaline phosphatase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Weight decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
White blood cell count increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Electrocardiogram QT prolonged	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Urine output decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Weight increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Platelet count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Neutrophil count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
White blood cell count decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood creatinine increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Pharyngeal inflammation	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pneumonitis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Acute respiratory distress syndrome	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Cough	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Organising pneumonia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pleural effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pneumothorax	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary oedema	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Stridor	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Epistaxis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Hypoxia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Seizure	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Tremor	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Cognitive disorder	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dysaesthesia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Myoclonus	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Somnolence	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Peripheral motor neuropathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Syncope	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Fatigue	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Oedema peripheral	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Chills	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Mucosal inflammation	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Multiple organ dysfunction syndrome	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pneumatosis	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Pyrexia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Haemolytic uraemic syndrome	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Febrile neutropenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Thrombotic microangiopathy	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Thrombotic thrombocytopenic purpura	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Haemolysis	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Anaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Acute kidney injury	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Chronic kidney disease	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Urinary tract pain	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Haematuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Depression	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Insomnia	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Anxiety	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Confusional state	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Delirium	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Bone pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Back pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Muscular weakness	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Myalgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Pain in extremity	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Pericardial effusion	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Cardiac failure	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Bradycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Myocardial infarction	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Menorrhagia	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Vulvovaginal inflammation	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Vaginal haemorrhage	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Infusion related reaction	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Post procedural haemorrhage	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Radiation skin injury	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Tracheal haemorrhage	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Adrenal insufficiency	SYSTEMATIC_ASSESSMENT	Endocrine disorders	None	View
Anaphylactic reaction	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Graft versus host disease	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Escherichia bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View