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 @ 4:58 AM
Ignite Modification Date: 2025-12-26 @ 3:59 AM
NCT ID: NCT03455218
Description: We used the definitions of major and minor adverse events as described by the Pediatric Cardiac Critical Care Consortium Database as this is a validated method to describe adverse events in pediatric patients following cardiac surgery.
Frequency Threshold: 0
Time Frame: From the start of the operation till the time of hospital discharge. All patients were observed for adverse events from the start of the operation in which they were enrolled in the study till the time of hospital discharge following the operation. This ranged from 3 to 200 days.
Study: NCT03455218
Study Brief: Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Surgery to Prevent Platelet Activation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nitric Oxide 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator 0 None 3 18 8 18 View
Placebo INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator 0 None 1 22 10 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart block requiring pacemaker SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Unplanned reoperation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Arrhythmia requiring temporary pacemaker SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chylothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View