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 @ 1:19 AM
Ignite Modification Date: 2025-12-25 @ 11:27 PM
NCT ID: NCT03850093
Description: hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
Frequency Threshold: 0
Time Frame: intra-operative and up to 6 hours postoperative
Study: NCT03850093
Study Brief: Preoperative Gabapentin Versus Bisoprolol for Hemodynamic Optimization During Sinus 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
Gabapentin gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative 0 None 0 21 0 21 View
Bisoprolol bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative 0 None 5 22 3 22 View
Control placebo was given to patients of control group 2 hours preoperative 0 None 11 17 10 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
postoperative nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
postoperative vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
agitation on recovery NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View