Adverse Events Module

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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 @ 9:11 PM
Ignite Modification Date: 2025-12-25 @ 7:01 PM
NCT ID: NCT03983304
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 12-week post-treatment follow-up visit, approximately 4 months.
Study: NCT03983304
Study Brief: EMS for Abdominal and Gluteal Muscle Toning
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
EMS Device Treatment Group All eligible subjects for whom informed consent is obtained were treated with the study device, an electromagnetic muscle stimulation device. Adverse event information was collected from the time of enrollment through the 12-week post-treatment follow-up visit. Per protocol 110 subjects were enrolled to have EMS treatments on the abdomen and/or buttocks in this single arm study. At no point in the conduct of the study were subjects assigned to a treatment group; the investigator determined the area(s) to be treated. 0 None 1 110 11 110 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lymphoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Elective surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Uterine Fibroid NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Coughing NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cold (virus) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sprained ankle NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Menstrual Cycle Irregularity NON_SYSTEMATIC_ASSESSMENT General disorders None View
Soreness and discomfort in left chest NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cramping in lower abdomen NON_SYSTEMATIC_ASSESSMENT General disorders None View