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 @ 1:12 AM

Ignite Modification Date: 2025-12-25 @ 11:23 PM

NCT ID: NCT00372593

Description: SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.

Frequency Threshold: 0

Time Frame: None

Study: NCT00372593

Study Brief: Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia

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 A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome	Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.	None	None	26	511	482	511	View
Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome	Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.	None	None	32	511	479	511	View
Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome	Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.	None	None	2	6	5	6	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Acidosis	None	Metabolism and nutrition disorders	None	View
Acute kidney injury	None	Renal and urinary disorders	None	View
Adult respiratory distress syndrome	None	Respiratory, thoracic and mediastinal disorders	None	View
Alanine aminotransferase increased	None	Investigations	None	View
Ascites	None	Gastrointestinal disorders	None	View
Aspartate aminotransferase increased	None	Investigations	None	View
Atelectasis	None	Respiratory, thoracic and mediastinal disorders	None	View
Atrial flutter	None	Cardiac disorders	None	View
Blood bilirubin increased	None	Investigations	None	View
Cardiac disorders - Other	None	Cardiac disorders	None	View
Confusion	None	Psychiatric disorders	None	View
Creatinine increased	None	Investigations	None	View
Disseminated intravascular coagulation	None	Blood and lymphatic system disorders	None	View
Encephalopathy	None	Nervous system disorders	None	View
Enterocolitis infectious	None	Infections and infestations	None	View
Fibrinogen decreased	None	Investigations	None	View
Gastritis	None	Gastrointestinal disorders	None	View
Hyperglycemia	None	Metabolism and nutrition disorders	None	View
Hyperkalemia	None	Metabolism and nutrition disorders	None	View
Hypocalcemia	None	Metabolism and nutrition disorders	None	View
Hypokalemia	None	Metabolism and nutrition disorders	None	View
Hyponatremia	None	Metabolism and nutrition disorders	None	View
Hypotension	None	Vascular disorders	None	View
Hypoxia	None	Respiratory, thoracic and mediastinal disorders	None	View
Infections and infestations - Other	None	Infections and infestations	None	View
Intracranial hemorrhage	None	Nervous system disorders	None	View
Investigations - Other	None	Investigations	None	View
Left ventricular systolic dysfunction	None	Cardiac disorders	None	View
Nervous system disorders - Other	None	Nervous system disorders	None	View
Pain in extremity	None	Musculoskeletal and connective tissue disorders	None	View
Pericardial effusion	None	Cardiac disorders	None	View
Pericarditis	None	Cardiac disorders	None	View
Pleural effusion	None	Respiratory, thoracic and mediastinal disorders	None	View
Pleural hemorrhage	None	Respiratory, thoracic and mediastinal disorders	None	View
Pneumonitis	None	Respiratory, thoracic and mediastinal disorders	None	View
Portal hypertension	None	Hepatobiliary disorders	None	View
Respiratory, thoracic and mediastinal disorders - Other	None	Respiratory, thoracic and mediastinal disorders	None	View
Restrictive cardiomyopathy	None	Cardiac disorders	None	View
Right ventricular dysfunction	None	Cardiac disorders	None	View
Seizure	None	Nervous system disorders	None	View
Sepsis	None	Infections and infestations	None	View
Serum amylase increased	None	Investigations	None	View
Sudden death NOS	None	General disorders	None	View
Treatment related secondary malignancy	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Vascular disorders - Other	None	Vascular disorders	None	View
Bronchopulmonary hemorrhage	None	Respiratory, thoracic and mediastinal disorders	None	View
Bronchospasm	None	Respiratory, thoracic and mediastinal disorders	None	View
Death NOS	None	General disorders	None	View
Dyspnea	None	Respiratory, thoracic and mediastinal disorders	None	View
Electrocardiogram QT corrected interval prolonged	None	Investigations	None	View
Febrile neutropenia	None	Blood and lymphatic system disorders	None	View
Heart failure	None	Cardiac disorders	None	View
Hepatic failure	None	Hepatobiliary disorders	None	View
Hypoglycemia	None	Metabolism and nutrition disorders	None	View
Lipase increased	None	Investigations	None	View
Lung infection	None	Infections and infestations	None	View
Mucositis oral	None	Gastrointestinal disorders	None	View
Multi-organ failure	None	General disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Abdominal distension	None	Gastrointestinal disorders	None	View
Abdominal infection	None	Infections and infestations	None	View
Abdominal pain	None	Gastrointestinal disorders	None	View
Abducens nerve disorder	None	Nervous system disorders	None	View
Acidosis	None	Metabolism and nutrition disorders	None	View
Activated partial thromboplastin time prolonged	None	Investigations	None	View
Acute kidney injury	None	Renal and urinary disorders	None	View
Adrenal insufficiency	None	Endocrine disorders	None	View
Agitation	None	Psychiatric disorders	None	View
Alanine aminotransferase increased	None	Investigations	None	View
Alkalosis	None	Metabolism and nutrition disorders	None	View
Allergic reaction	None	Immune system disorders	None	View
Anal mucositis	None	Gastrointestinal disorders	None	View
Anaphylaxis	None	Immune system disorders	None	View
Anemia	None	Blood and lymphatic system disorders	None	View
Anorectal infection	None	Infections and infestations	None	View
Anorexia	None	Metabolism and nutrition disorders	None	View
Anxiety	None	Psychiatric disorders	None	View
Appendicitis	None	Infections and infestations	None	View
Arachnoiditis	None	Nervous system disorders	None	View
Blood and lymphatic system disorders - Other	None	Blood and lymphatic system disorders	None	View
Blood bilirubin increased	None	Investigations	None	View
Blurred vision	None	Eye disorders	None	View
Bone infection	None	Infections and infestations	None	View
Bone pain	None	Musculoskeletal and connective tissue disorders	None	View
Bronchial infection	None	Infections and infestations	None	View
Bronchopulmonary hemorrhage	None	Respiratory, thoracic and mediastinal disorders	None	View
Bronchospasm	None	Respiratory, thoracic and mediastinal disorders	None	View
Burn	None	Injury, poisoning and procedural complications	None	View
Buttock pain	None	Musculoskeletal and connective tissue disorders	None	View
Capillary leak syndrome	None	Vascular disorders	None	View
Cardiac arrest	None	Cardiac disorders	None	View
Cardiac disorders - Other	None	Cardiac disorders	None	View
Cardiac troponin T increased	None	Investigations	None	View
Catheter related infection	None	Infections and infestations	None	View
Cheilitis	None	Gastrointestinal disorders	None	View
Chest wall pain	None	Musculoskeletal and connective tissue disorders	None	View
Chills	None	General disorders	None	View
Cholecystitis	None	Hepatobiliary disorders	None	View
Chronic kidney disease	None	Renal and urinary disorders	None	View
Colitis	None	Gastrointestinal disorders	None	View
Colonic fistula	None	Gastrointestinal disorders	None	View
Colonic hemorrhage	None	Gastrointestinal disorders	None	View
Confusion	None	Psychiatric disorders	None	View
Conjunctivitis	None	Eye disorders	None	View
Constipation	None	Gastrointestinal disorders	None	View
Cough	None	Respiratory, thoracic and mediastinal disorders	None	View
CPK increased	None	Investigations	None	View
Creatinine increased	None	Investigations	None	View
Cystitis noninfective	None	Renal and urinary disorders	None	View
Cytokine release syndrome	None	Immune system disorders	None	View
Death NOS	None	General disorders	None	View
Dehydration	None	Metabolism and nutrition disorders	None	View
Dental caries	None	Gastrointestinal disorders	None	View
Depressed level of consciousness	None	Nervous system disorders	None	View
Depression	None	Psychiatric disorders	None	View
Diarrhea	None	Gastrointestinal disorders	None	View
Disseminated intravascular coagulation	None	Blood and lymphatic system disorders	None	View
Dizziness	None	Nervous system disorders	None	View
Duodenal hemorrhage	None	Gastrointestinal disorders	None	View
Dyspepsia	None	Gastrointestinal disorders	None	View
Dysphagia	None	Gastrointestinal disorders	None	View
Dyspnea	None	Respiratory, thoracic and mediastinal disorders	None	View
Ear pain	None	Ear and labyrinth disorders	None	View
Edema face	None	General disorders	None	View
Edema limbs	None	General disorders	None	View
Edema trunk	None	General disorders	None	View
Electrocardiogram QT corrected interval prolonged	None	Investigations	None	View
Encephalopathy	None	Nervous system disorders	None	View
Endocrine disorders - Other	None	Endocrine disorders	None	View
Enterocolitis	None	Gastrointestinal disorders	None	View
Enterocolitis infectious	None	Infections and infestations	None	View
Epistaxis	None	Respiratory, thoracic and mediastinal disorders	None	View
Erythema multiforme	None	Skin and subcutaneous tissue disorders	None	View
Esophageal hemorrhage	None	Gastrointestinal disorders	None	View
Esophageal pain	None	Gastrointestinal disorders	None	View
Esophagitis	None	Gastrointestinal disorders	None	View
Euphoria	None	Psychiatric disorders	None	View
External ear pain	None	Ear and labyrinth disorders	None	View
Eye disorders - Other	None	Eye disorders	None	View
Eye infection	None	Infections and infestations	None	View
Eye pain	None	Eye disorders	None	View
Facial nerve disorder	None	Nervous system disorders	None	View
Facial pain	None	General disorders	None	View
Fatigue	None	General disorders	None	View
Febrile neutropenia	None	Blood and lymphatic system disorders	None	View
Fever	None	General disorders	None	View
Fibrinogen decreased	None	Investigations	None	View
Fracture	None	Injury, poisoning and procedural complications	None	View
Gallbladder infection	None	Infections and infestations	None	View
Gallbladder necrosis	None	Hepatobiliary disorders	None	View
Gallbladder obstruction	None	Hepatobiliary disorders	None	View
Gallbladder pain	None	Hepatobiliary disorders	None	View
Gastric hemorrhage	None	Gastrointestinal disorders	None	View
Gastritis	None	Gastrointestinal disorders	None	View
Gastrointestinal disorders - Other	None	Gastrointestinal disorders	None	View
Gastrointestinal pain	None	Gastrointestinal disorders	None	View
General disorders and administration site conditions - Other	None	General disorders	None	View
Generalized muscle weakness	None	Musculoskeletal and connective tissue disorders	None	View
GGT increased	None	Investigations	None	View
Gingival pain	None	Gastrointestinal disorders	None	View
Glucose intolerance	None	Metabolism and nutrition disorders	None	View
Gum infection	None	Infections and infestations	None	View
Headache	None	Nervous system disorders	None	View
Hearing impaired	None	Ear and labyrinth disorders	None	View
Heart failure	None	Cardiac disorders	None	View
Hematoma	None	Vascular disorders	None	View
Hematuria	None	Renal and urinary disorders	None	View
Hemorrhoids	None	Gastrointestinal disorders	None	View
Hepatic failure	None	Hepatobiliary disorders	None	View
Hepatic pain	None	Hepatobiliary disorders	None	View
Hepatobiliary disorders - Other	None	Hepatobiliary disorders	None	View
Hydrocephalus	None	Nervous system disorders	None	View
Hypercalcemia	None	Metabolism and nutrition disorders	None	View
Hyperglycemia	None	Metabolism and nutrition disorders	None	View
Hyperkalemia	None	Metabolism and nutrition disorders	None	View
Hypermagnesemia	None	Metabolism and nutrition disorders	None	View
Hypernatremia	None	Metabolism and nutrition disorders	None	View
Hypertension	None	Vascular disorders	None	View
Hypertriglyceridemia	None	Metabolism and nutrition disorders	None	View
Hyperuricemia	None	Metabolism and nutrition disorders	None	View
Hypoalbuminemia	None	Metabolism and nutrition disorders	None	View
Hypocalcemia	None	Metabolism and nutrition disorders	None	View
Hypoglycemia	None	Metabolism and nutrition disorders	None	View
Hypokalemia	None	Metabolism and nutrition disorders	None	View
Hypomagnesemia	None	Metabolism and nutrition disorders	None	View
Hyponatremia	None	Metabolism and nutrition disorders	None	View
Hypophosphatemia	None	Metabolism and nutrition disorders	None	View
Hypotension	None	Vascular disorders	None	View
Hypoxia	None	Respiratory, thoracic and mediastinal disorders	None	View
Ileus	None	Gastrointestinal disorders	None	View
Immune system disorders - Other	None	Immune system disorders	None	View
Infections and infestations - Other	None	Infections and infestations	None	View
Infective myositis	None	Infections and infestations	None	View
Injury, poisoning and procedural complications - Other	None	Injury, poisoning and procedural complications	None	View
INR increased	None	Investigations	None	View
Insomnia	None	Psychiatric disorders	None	View
Intra-abdominal hemorrhage	None	Gastrointestinal disorders	None	View
Intracranial hemorrhage	None	Nervous system disorders	None	View
Intraoperative gastrointestinal injury	None	Injury, poisoning and procedural complications	None	View
Intraoperative respiratory injury	None	Injury, poisoning and procedural complications	None	View
Investigations - Other	None	Investigations	None	View
Joint effusion	None	Musculoskeletal and connective tissue disorders	None	View
Kidney infection	None	Infections and infestations	None	View
Laryngeal edema	None	Respiratory, thoracic and mediastinal disorders	None	View
Left ventricular systolic dysfunction	None	Cardiac disorders	None	View
Lip infection	None	Infections and infestations	None	View
Lip pain	None	Gastrointestinal disorders	None	View
Lipase increased	None	Investigations	None	View
Localized edema	None	General disorders	None	View
Lower gastrointestinal hemorrhage	None	Gastrointestinal disorders	None	View
Lung infection	None	Infections and infestations	None	View
Lymph gland infection	None	Infections and infestations	None	View
Malabsorption	None	Gastrointestinal disorders	None	View
Meningitis	None	Infections and infestations	None	View
Middle ear inflammation	None	Ear and labyrinth disorders	None	View
Mucosal infection	None	Infections and infestations	None	View
Mucositis oral	None	Gastrointestinal disorders	None	View
Multi-organ failure	None	General disorders	None	View
Muscle weakness left-sided	None	Musculoskeletal and connective tissue disorders	None	View
Musculoskeletal and connective tissue disorder - Other	None	Musculoskeletal and connective tissue disorders	None	View
Myalgia	None	Musculoskeletal and connective tissue disorders	None	View
Myocarditis	None	Cardiac disorders	None	View
Myositis	None	Musculoskeletal and connective tissue disorders	None	View
Nausea	None	Gastrointestinal disorders	None	View
Neck pain	None	Musculoskeletal and connective tissue disorders	None	View
Nervous system disorders - Other	None	Nervous system disorders	None	View
Neuralgia	None	Nervous system disorders	None	View
Neutrophil count decreased	None	Investigations	None	View
Non-cardiac chest pain	None	General disorders	None	View
Oculomotor nerve disorder	None	Nervous system disorders	None	View
Oral hemorrhage	None	Gastrointestinal disorders	None	View
Oral pain	None	Gastrointestinal disorders	None	View
Otitis media	None	Infections and infestations	None	View
Pain	None	General disorders	None	View
Pain in extremity	None	Musculoskeletal and connective tissue disorders	None	View
Pain of skin	None	Skin and subcutaneous tissue disorders	None	View
Palmar-plantar erythrodysesthesia syndrome	None	Skin and subcutaneous tissue disorders	None	View
Pancreatitis	None	Gastrointestinal disorders	None	View
Paroxysmal atrial tachycardia	None	Cardiac disorders	None	View
Pelvic pain	None	Reproductive system and breast disorders	None	View
Penile infection	None	Infections and infestations	None	View
Penile pain	None	Reproductive system and breast disorders	None	View
Pericardial effusion	None	Cardiac disorders	None	View
Pericarditis	None	Cardiac disorders	None	View
Perineal pain	None	Reproductive system and breast disorders	None	View
Peripheral motor neuropathy	None	Nervous system disorders	None	View
Peripheral sensory neuropathy	None	Nervous system disorders	None	View
Personality change	None	Psychiatric disorders	None	View
Pharyngeal hemorrhage	None	Respiratory, thoracic and mediastinal disorders	None	View
Pharyngeal mucositis	None	Respiratory, thoracic and mediastinal disorders	None	View
Pharyngeal stenosis	None	Respiratory, thoracic and mediastinal disorders	None	View
Pharyngitis	None	Infections and infestations	None	View
Pharyngolaryngeal pain	None	Respiratory, thoracic and mediastinal disorders	None	View
Photophobia	None	Eye disorders	None	View
Platelet count decreased	None	Investigations	None	View
Pleural effusion	None	Respiratory, thoracic and mediastinal disorders	None	View
Pleuritic pain	None	Respiratory, thoracic and mediastinal disorders	None	View
Pneumonitis	None	Respiratory, thoracic and mediastinal disorders	None	View
Pneumothorax	None	Respiratory, thoracic and mediastinal disorders	None	View
Portal hypertension	None	Hepatobiliary disorders	None	View
Postoperative hemorrhage	None	Injury, poisoning and procedural complications	None	View
Proctitis	None	Gastrointestinal disorders	None	View
Proteinuria	None	Renal and urinary disorders	None	View
Pruritus	None	Skin and subcutaneous tissue disorders	None	View
Psychosis	None	Psychiatric disorders	None	View
Pulmonary hypertension	None	Respiratory, thoracic and mediastinal disorders	None	View
Purpura	None	Skin and subcutaneous tissue disorders	None	View
Rash maculo-papular	None	Skin and subcutaneous tissue disorders	None	View
Rectal fistula	None	Gastrointestinal disorders	None	View
Rectal hemorrhage	None	Gastrointestinal disorders	None	View
Rectal mucositis	None	Gastrointestinal disorders	None	View
Rectal pain	None	Gastrointestinal disorders	None	View
Renal and urinary disorders - Other	None	Renal and urinary disorders	None	View
Respiratory failure	None	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory, thoracic and mediastinal disorders - Other	None	Respiratory, thoracic and mediastinal disorders	None	View
Restrictive cardiomyopathy	None	Cardiac disorders	None	View
Rhinitis infective	None	Infections and infestations	None	View
Right ventricular dysfunction	None	Cardiac disorders	None	View
Scrotal infection	None	Infections and infestations	None	View
Seizure	None	Nervous system disorders	None	View
Sepsis	None	Infections and infestations	None	View
Serum amylase increased	None	Investigations	None	View
Sinus bradycardia	None	Cardiac disorders	None	View
Sinus disorder	None	Respiratory, thoracic and mediastinal disorders	None	View
Sinus tachycardia	None	Cardiac disorders	None	View
Sinusitis	None	Infections and infestations	None	View
Skin and subcutaneous tissue disorders - Other	None	Skin and subcutaneous tissue disorders	None	View
Skin induration	None	Skin and subcutaneous tissue disorders	None	View
Skin infection	None	Infections and infestations	None	View
Skin ulceration	None	Skin and subcutaneous tissue disorders	None	View
Small intestinal mucositis	None	Gastrointestinal disorders	None	View
Small intestinal obstruction	None	Gastrointestinal disorders	None	View
Small intestine infection	None	Infections and infestations	None	View
Soft tissue infection	None	Infections and infestations	None	View
Stevens-Johnson syndrome	None	Skin and subcutaneous tissue disorders	None	View
Stomach pain	None	Gastrointestinal disorders	None	View
Supraventricular tachycardia	None	Cardiac disorders	None	View
Syncope	None	Nervous system disorders	None	View
Thromboembolic event	None	Vascular disorders	None	View
Tinnitus	None	Ear and labyrinth disorders	None	View
Tooth infection	None	Infections and infestations	None	View
Toothache	None	Gastrointestinal disorders	None	View
Tracheal hemorrhage	None	Injury, poisoning and procedural complications	None	View
Tracheitis	None	Infections and infestations	None	View
Tumor lysis syndrome	None	Metabolism and nutrition disorders	None	View
Typhlitis	None	Gastrointestinal disorders	None	View
Upper gastrointestinal hemorrhage	None	Gastrointestinal disorders	None	View
Upper respiratory infection	None	Infections and infestations	None	View
Urinary frequency	None	Renal and urinary disorders	None	View
Urinary tract infection	None	Infections and infestations	None	View
Urinary tract obstruction	None	Renal and urinary disorders	None	View
Urinary tract pain	None	Renal and urinary disorders	None	View
Urticaria	None	Skin and subcutaneous tissue disorders	None	View
Uterine hemorrhage	None	Reproductive system and breast disorders	None	View
Uterine pain	None	Reproductive system and breast disorders	None	View
Uveitis	None	Eye disorders	None	View
Vaginal hemorrhage	None	Reproductive system and breast disorders	None	View
Vaginal infection	None	Infections and infestations	None	View
Vaginal pain	None	Reproductive system and breast disorders	None	View
Vascular access complication	None	Injury, poisoning and procedural complications	None	View
Vascular disorders - Other	None	Vascular disorders	None	View
Vasculitis	None	Vascular disorders	None	View
Venous injury	None	Injury, poisoning and procedural complications	None	View
Ventricular tachycardia	None	Cardiac disorders	None	View
Vitreous hemorrhage	None	Eye disorders	None	View
Vomiting	None	Gastrointestinal disorders	None	View
Vulval infection	None	Infections and infestations	None	View
Weight gain	None	Investigations	None	View
Weight loss	None	Investigations	None	View
White blood cell decreased	None	Investigations	None	View
Wound infection	None	Infections and infestations	None	View
Ascites	None	Gastrointestinal disorders	None	View
Aspartate aminotransferase increased	None	Investigations	None	View
Aspiration	None	Respiratory, thoracic and mediastinal disorders	None	View
Ataxia	None	Nervous system disorders	None	View
Atelectasis	None	Respiratory, thoracic and mediastinal disorders	None	View
Avascular necrosis	None	Musculoskeletal and connective tissue disorders	None	View
Back pain	None	Musculoskeletal and connective tissue disorders	None	View
Bladder infection	None	Infections and infestations	None	View
Adult respiratory distress syndrome	None	Respiratory, thoracic and mediastinal disorders	None	View
Alkaline phosphatase increased	None	Investigations	None	View
Anal pain	None	Gastrointestinal disorders	None	View
Anal ulcer	None	Gastrointestinal disorders	None	View
Apnea	None	Respiratory, thoracic and mediastinal disorders	None	View
Arthralgia	None	Musculoskeletal and connective tissue disorders	None	View
Arthritis	None	Musculoskeletal and connective tissue disorders	None	View