Adverse Events Module

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 @ 2:07 AM
Ignite Modification Date: 2025-12-26 @ 12:33 AM
NCT ID: NCT02553460
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
Study: NCT02553460
Study Brief: Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stratum 1 Patient is \< 365 days of age at the time of diagnosis. Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid. Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy. Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines. 17 None 27 50 50 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v4.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v4.0 View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v4.0 View
Left ventricular systolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v4.0 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v4.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Ileal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Typhlitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Peritoneal infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Rhinitis infective SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Small intestine infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications NCI CTCAE v4.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Metabolism and nutrition disorders - Other, specify SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Tumor lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Bronchopulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Laryngeal obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Pharyngeal mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Respiratory, thoracic and mediastinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE v4.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v4.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI CTCAE v4.0 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE v4.0 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v4.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v4.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v4.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Lower gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE v4.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE v4.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE v4.0 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v4.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders NCI CTCAE v4.0 View
Endocrine disorders - Other, specify SYSTEMATIC_ASSESSMENT Endocrine disorders NCI CTCAE v4.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders NCI CTCAE v4.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE v4.0 View
Eye disorders - Other, specify SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE v4.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Gastric hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Small intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Typhlitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.0 View
General disorders and administration site conditions - Other, specify SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.0 View
Irritability SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.0 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v4.0 View
Hepatobiliary disorders - Other, specify SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI CTCAE v4.0 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Penile infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Rhinitis infective SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v4.0 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications NCI CTCAE v4.0 View
Postoperative hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications NCI CTCAE v4.0 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications NCI CTCAE v4.0 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
GGT increased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Investigations - Other, specify SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE v4.0 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Tumor lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v4.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v4.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v4.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v4.0 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.0 View
Movements involuntary SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.0 View
Nervous system disorders - Other, specify SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.0 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.0 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v4.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE v4.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE v4.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE v4.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTCAE v4.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Laryngospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Pharyngeal mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Respiratory, thoracic and mediastinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v4.0 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v4.0 View
Periorbital edema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v4.0 View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v4.0 View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v4.0 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE v4.0 View