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 @ 10:48 PM
Ignite Modification Date: 2025-12-25 @ 8:17 PM
NCT ID: NCT04500769
Description: AEs and SAEs were collected according to the standard definitions used by clinicaltrials.gov.
Frequency Threshold: 0
Time Frame: 3 weeks
Study: NCT04500769
Study Brief: Training Induced Muscle Exosome Release
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Acute Resistance Exercise Participants will perform four exercises: squat, knee extension, leg press, and lat pulldown at 80% of 1-RM determined during a previous visit. Acute Resistance Exercise: Participants will perform three sets of eight repetitions, with a 90-120 second rest between sets, with a fourth set performed to failure. All resistance exercise will be performed on pneumatic resistance devices (Keiser Sports Health Equipment, Fresno, CA). 0 None 0 38 12 38 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Light headed from blood draw NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea during exercise NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Persistent numbness around biopsy site NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blister from steri-strip NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View