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 @ 1:02 AM
Ignite Modification Date: 2025-12-25 @ 11:15 PM
NCT ID: NCT02521493
Description: Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Frequency Threshold: 0
Time Frame: While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles
Study: NCT02521493
Study Brief: Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome
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 B (High Risk) Patients with MRD ≥ 0.05% 8 None 1 43 37 43 View
Arm A (Standard Risk) Patients with MRD \<0.05% (This arm was closed to accrual and treatment with amendment #4A 01/07/2019) 12 None 3 114 84 114 View
No Risk Stratification No Risk Stratification 1 None 2 122 54 122 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Adult respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Infections and infestations - Other, specify: Metapneumovirus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ischemia cerebrovascular SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anaphylaxis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood and lymphatic system disorders - Other, specify SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Duodenal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Electrocardiogram QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations None View
GGT increased SYSTEMATIC_ASSESSMENT Investigations None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infusion site extravasation SYSTEMATIC_ASSESSMENT General disorders None View
Laryngospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Oral hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary valve disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Renal and urinary disorders - Other, specify SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Small intestine infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stoma site infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Typhlitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vasovagal reaction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vulval infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View