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 @ 2:45 PM
Ignite Modification Date: 2025-12-25 @ 1:14 PM
NCT ID: NCT01517659
Description: An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device.
Frequency Threshold: 0
Time Frame: Adverse event data was collected from enrollment through the 16 week follow-up visit.
Study: NCT01517659
Study Brief: Non-Invasive Reduction of Fat in the Inner Thighs
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fat Reduction in Inner Thighs The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. 0 None 2 45 12 45 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Adrenal gland mass NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Herniated spinal disc NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Numbness, persistent numbness NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperpigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Left shoulder injury; capsular tear NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Discoloration on soles of feet NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Indentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View