Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:30 AM
Ignite Modification Date: 2025-12-26 @ 1:05 AM
NCT ID: NCT02164734
Description: bradycardia
Frequency Threshold: 0
Time Frame: 3 months or NICU discharge
Study: NCT02164734
Study Brief: Surfactant Via Endotracheal Tube vs. Laryngeal Mask Airway (LMA) in Preterm Neonates With Respiratory Distress 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
Endotracheal Intubation Endotracheal intubation for surfactant administration, following remifentanil and atropine pre-medication Endotracheal intubation remifentanil: additional premedication in the endotracheal intubation/INSURE arm 1 None 1 42 3 42 View
Laryngeal Mask Airway Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication Laryngeal mask airway 0 None 0 51 1 51 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
cardiopulmonary resuscitation SYSTEMATIC_ASSESSMENT Cardiac disorders SNOMED CT View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders SNOMED CT View
airway obstruction NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders SNOMED CT View