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 @ 7:39 PM
Ignite Modification Date: 2025-12-25 @ 5:19 PM
NCT ID: NCT04580303
Description: Safety Population: All enrolled participants who received at least 1 injection of CCH. Adverse events are reported by participant and not treatment area. Participants who received injection in the either the buttocks or thighs are combined for each injection technique.
Frequency Threshold: 5
Time Frame: Day 1 (after dosing) through Day 180
Study: NCT04580303
Study Brief: CCH Treatment of Cellulite in the Presence of Dermal Laxity With Comparison Between Two (2) Different Injection Techniques
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks or Thighs) Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). 0 None 0 16 16 16 View
Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks or Thighs) Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). 0 None 0 19 19 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders 23.1 View
Implant site inflammation SYSTEMATIC_ASSESSMENT General disorders 23.1 View
Implant site pain SYSTEMATIC_ASSESSMENT General disorders 23.1 View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders 23.1 View
Injection site discolouration SYSTEMATIC_ASSESSMENT General disorders 23.1 View
Injection site mass SYSTEMATIC_ASSESSMENT General disorders 23.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders 23.1 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders 23.1 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders 23.1 View
Injection site urticaria SYSTEMATIC_ASSESSMENT General disorders 23.1 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations 23.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations 23.1 View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations 23.1 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 23.1 View
Device breakage SYSTEMATIC_ASSESSMENT Product Issues 23.1 View
Alcoholism SYSTEMATIC_ASSESSMENT Psychiatric disorders 23.1 View
Pityriasis rosea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 23.1 View