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 @ 3:55 AM
Ignite Modification Date: 2025-12-26 @ 2:46 AM
NCT ID: NCT00553202
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00553202
Study Brief: Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory or Relapsed Acute Myelogenous 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
Group 1 All patients None None 7 90 32 90 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab 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
Death NOS None General disorders None View
Hepatobiliary disorders - Other, specify None Hepatobiliary disorders None View
Renal and urinary disorders - Other, specify None Renal and urinary disorders None View
Respiratory failure None Respiratory, thoracic and mediastinal disorders None View
Respiratory, thoracic and mediastinal disorders - Other, specify None Respiratory, thoracic and mediastinal disorders None View
Atelectasis None Respiratory, thoracic and mediastinal disorders None View
Blood bilirubin increased None Investigations None View
Creatinine increased None Investigations None View
Hypercalcemia None Metabolism and nutrition disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Immune system disorders - Other, specify None Immune system disorders None View
Infections and infestations - Other, specify None Infections and infestations None View
Mucositis oral None Gastrointestinal disorders None View
Multi-organ failure None General disorders None View
Pleural effusion None Respiratory, thoracic and mediastinal disorders None View
Portal hypertension None Hepatobiliary disorders None View
Productive cough None Respiratory, thoracic and mediastinal disorders None View
Pulmonary edema None Respiratory, thoracic and mediastinal disorders None View
Sepsis None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension None Gastrointestinal disorders None View
Abdominal pain None Gastrointestinal 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
Allergic reaction None Immune system disorders None View
Ascites None Gastrointestinal disorders None View
Aspartate aminotransferase increased None Investigations None View
Bladder spasm None Renal and urinary disorders None View
Blood bilirubin increased None Investigations None View
Bronchopulmonary hemorrhage None Respiratory, thoracic and mediastinal disorders None View
Cardiac disorders - Other, specify None Cardiac disorders 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
Diarrhea None Gastrointestinal disorders None View
Electrocardiogram QT corrected interval prolonged None Investigations None View
Encephalitis infection None Infections and infestations None View
Febrile neutropenia None Blood and lymphatic system disorders None View
Gastric hemorrhage None Gastrointestinal disorders None View
Hematuria None Renal and urinary disorders None View
Hepatic pain None Hepatobiliary disorders None View
Hepatobiliary disorders - Other, specify None Hepatobiliary disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hypernatremia None Metabolism and nutrition disorders None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Hypoglycemia None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Ileus None Gastrointestinal disorders None View
Infections and infestations - Other, specify None Infections and infestations None View
Left ventricular systolic dysfunction None Cardiac disorders None View
Lower gastrointestinal hemorrhage None Gastrointestinal disorders 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
Pain None General disorders None View
Pericardial effusion None Cardiac disorders None View
Pharyngeal hemorrhage None Respiratory, thoracic and mediastinal disorders None View
Pleural effusion None Respiratory, thoracic and mediastinal disorders None View
Pneumothorax None Respiratory, thoracic and mediastinal disorders None View
Portal hypertension None Hepatobiliary disorders None View
Pulmonary edema None Respiratory, thoracic and mediastinal disorders None View
Rash maculo-papular None Skin and subcutaneous tissue disorders None View
Respiratory failure None Respiratory, thoracic and mediastinal disorders None View
Respiratory, thoracic and mediastinal disorders - Other, specify None Respiratory, thoracic and mediastinal disorders None View
Seizure None Nervous system disorders None View
Sepsis None Infections and infestations None View
Serum amylase increased None Investigations None View
Sinus tachycardia None Cardiac disorders None View
Sinusitis None Infections and infestations None View
Skin and subcutaneous tissue disorders - Other, specify None Skin and subcutaneous tissue disorders None View
Stevens-Johnson syndrome None Skin and subcutaneous tissue disorders None View
Tumor lysis syndrome None Metabolism and nutrition disorders None View
Upper gastrointestinal hemorrhage None Gastrointestinal disorders None View
Urinary tract infection None Infections and infestations None View
Urine output decreased None Investigations None View
Vaginal hemorrhage None Reproductive system and breast disorders None View
Vascular disorders - Other, specify None Vascular disorders None View
Weight gain None Investigations None View
White blood cell decreased None Investigations None View
Heart failure None Cardiac disorders None View
Hypophosphatemia None Metabolism and nutrition disorders None View
Hypotension None Vascular disorders None View