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: 2025-12-25 @ 12:33 AM
Ignite Modification Date: 2025-12-25 @ 10:41 PM
NCT ID: NCT04897867
Description: Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
Frequency Threshold: 0
Time Frame: First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Study: NCT04897867
Study Brief: CoolSculpting® Elite for Non-Invasive Fat Reduction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CoolSculpting Elite: Treatment Session 1 Participants who received one CoolSculpting® Elite treatment session for the abdomen and flanks plus optional additional body areas. At the investigator's discretion, up to 8 treatment cycles were performed for the midsection and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs. 0 None 0 110 5 110 View
CoolSculpting Elite: Treatment Session 2 Participants who received a second CoolSculpting® Elite treatment session for the abdomen and flanks plus optional additional body areas. At the investigator's discretion, up to 8 treatment cycles were performed for the midsection and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs. 0 None 0 100 5 100 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABDOMINAL TENDERNESS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
MEDICAL DEVICE PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
TOOTH INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
HYPOAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View