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 @ 4:49 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT02787850
Description: Adverse events (AE) will be assessed continuously throughout the study. 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 were collected from enrollment through the 12-week final follow-up visit.
Study: NCT02787850
Study Brief: CoolSculpting in the Abdomen Using Applicator With and Without CCI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort A-Abdomen Side 2 Abdomen side 2 will be treated using the CoolMax applicator and the Crown Cooling Insert for 45 minutes at a protocol-defined temperature. 0 None 0 10 0 10 View
Cohort B-Abdomen Side 1 Cohort B will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 45 minutes with the CoolMax Applicator and Crown Cooling Insert. 0 None 0 10 0 10 View
Cohort B- Abdomen Side 2 Abdomen side 2 will be treated with the CoolMAx applicator at a second protocol-defined temperature for 60 minutes, with the Crown Cooling Insert. 0 None 0 10 0 10 View
Cohort A-Abdomen Side 1 Cohort A will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 60 minutes without the Crown Cooling Insert. 0 None 0 10 1 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View