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 @ 10:21 PM
Ignite Modification Date: 2025-12-25 @ 7:54 PM
NCT ID: NCT04209335
Description: All possible health risks were excluded in recruitment phase as it was considered as exclusion criteria. Also, each participant was allowed to stop at any time during the testing. All possible other events were recorded from participants' feedback during and right after testing.
Frequency Threshold: 0
Time Frame: Data was collected on a nonspecific time of the day, in 1 hour
Study: NCT04209335
Study Brief: Isometric Core Muscle Endurance in Healthy Active and Non-active Working Age Populations
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Healthy Working Age Population the sum of 4 isometric core muscle endurance tests (McGill V-sit, Biering-Sorensen and sideplank on each side) isometric core muscle endurance testing: holding previously described isometric positions until fatigue 0 None 0 48 12 48 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Shoulder, elbow, lower back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders pain View