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 @ 10:44 PM
Ignite Modification Date: 2025-12-25 @ 8:14 PM
NCT ID: NCT04743635
Description: Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.
Frequency Threshold: 3
Time Frame: 1 year
Study: NCT04743635
Study Brief: CONtrolled Focal Fibrous Band Release Method Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT Modified intent to treat population (mITT), n=68. Cellulite can be treated across thighs and buttocks. Minimally invasive procedure: Procedure for reducing cellulite. 0 None 0 68 68 68 View
Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in Roll-in participants, n=6. Cellulite can be treated across thighs and buttocks. Minimally invasive procedure: Procedure for reducing cellulite. 0 None 0 6 6 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Tenderness SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Incision site bleeding SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Numbness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Fluid Discharge SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Hemosiderin stain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Burning sensation SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Tingling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Contact Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View