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 @ 4:04 AM
Ignite Modification Date: 2025-12-26 @ 2:58 AM
NCT ID: NCT04506502
Description: Safety data is presented here as planned and collected per protocol, by the total As-Treated Population (defined as all treated participants regardless of weight change).
Frequency Threshold: 0
Time Frame: Adverse event data was collected from the time of enrollment through the 4-week post final treatment follow-up visit, approximately 4 months.
Study: NCT04506502
Study Brief: Functional Change With MMS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Magnetic Muscle Stimulation (MMS) Treatment Group Each subject received two MMS treatment sessions, at least two days apart, per week for a four-week period. Treatment was performed on the abdominal region. The treatments are designed to evaluate muscle toning, firming and strengthening in the abdomen. The ZELTIQ System: The MMS device was used to perform the treatments. 0 None 0 16 6 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back Alignment Flare-up NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Abdominal Discomfort (Right Side) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Upper Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cold (Virus) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tingling Sensation in Lower Leg (Right) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rash on Wrist (Right) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Menstrual Cycle Irregularity NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View