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: 2025-12-24 @ 4:15 PM
Ignite Modification Date: 2025-12-25 @ 2:13 PM
NCT ID: NCT03869866
Description: Analysis was performed on SafAS population.
Frequency Threshold: 5
Time Frame: AEs and SAEs were collected from Day 0 up to end of study, approximately 44 days. All-cause mortality (death) was collected from signing of the informed consent form to the end of safety follow-up, a maximum of 35 months.
Study: NCT03869866
Study Brief: Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) in Older Adults in Turkey and Lebanon
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MenACYW Participants received a single dose of meningococcal polysaccharide \[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\] 0.5 mL IM injection on Day 0. 1 None 6 288 69 288 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 25.0 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 25.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 25.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 25.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 25.0 View
Hypertensive Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 25.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 25.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 25.0 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 25.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDra 25.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDra 25.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 25.0 View