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 @ 2:15 AM
Ignite Modification Date: 2025-12-26 @ 12:44 AM
NCT ID: NCT02942160
Description: All (serious and nonserious) AEs, whether elicited or observed during study visits or spontaneously reported by the participant, including events that occurred from the time the participant signed the study-specific consent form until completion of or discharge from the study. One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.
Frequency Threshold: 5
Time Frame: All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201)
Study: NCT02942160
Study Brief: EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Observation Phase Observation of Buttock or Thigh Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum or with Placebo in Study EN3835-201 0 None 1 259 0 259 View
EN3835 Treatment Phase Buttock or Thigh Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum 1 None 4 200 176 200 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19.0 View
Breast Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 19.0 View
Spontaneous Miscarriage SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA Version 19.0 View
Hypertensive Urgency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 19.0 View
Death from Motor Vehicle Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Injection site nodule SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Injection site discolouration SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 19.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 19.0 View