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: 2025-12-24 @ 2:21 PM
Ignite Modification Date: 2025-12-25 @ 12:58 PM
NCT ID: NCT01245595
Description: Systematic Assessment: each patient was evaluated daily for an adverse event.
Frequency Threshold: 0
Time Frame: Data were collected over the first five postoperative hospital days.
Study: NCT01245595
Study Brief: Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Aminophylline Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours None None 1 72 10 72 View
Placebo Normal Saline Placebo Placebo: Normal Saline None None 2 72 11 72 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Low Cardiac Output requiring Cardiopulmonary resuscitation or Extracorporeal Membrane Oxygenation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Arrhythmia Leading to Cardiopulmonary Resuscitation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Accelerated Junctional Rhythm SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Junctional Ectopic Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ectopic Atrial Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Unspecified Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary Hypertension with low cardiac output SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arm and jaw pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Acute Kidney Injury (AKI) SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View