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 @ 3:40 PM
Ignite Modification Date: 2025-12-25 @ 1:50 PM
NCT ID: NCT04124692
Description: SP included all participants who were treated with Sculptra Aesthetic or randomized to the no treatment control group.
Frequency Threshold: 5
Time Frame: From start of study drug administration up to end of the study (up to Month 12)
Study: NCT04124692
Study Brief: Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Group: Sculptra Aesthetic Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved. 0 None 3 97 11 97 View
Control Group: No-treatment Participants were injected with Sculptra Aesthetic by treating investigator at Day 1 until optimal correction achieved. 0 None 0 52 0 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1. View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1. View
Obstruction gastric and small intestine adenocarcinoma NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site bruising NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1. View