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 @ 6:37 PM
Ignite Modification Date: 2025-12-25 @ 4:07 PM
NCT ID: NCT03282357
Description: The investigator asked the participant for adverse events (AEs) systematically at each visit. The SES was used for AE assessment. The SES was defined as all participants who received an investigational product. As all participants received Radiesse in either of the two nasolabial folds and Restylane in the respective other, adverse events are reported in a combined group.
Frequency Threshold: 5
Time Frame: Baseline up to Month 12
Study: NCT03282357
Study Brief: Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Nasolabial Folds in China
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Radiesse and Restylane Participants received split-face NLF treatment with study product Radiesse, subdermal injection, in one of the two NLFs and control product Restylane, subdermal injection, in the contralateral NLF on Day 1. Participants received an optional touch-up injection in one or both the NLFs at Month 1. 0 None 4 176 56 176 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 20.0 View
Cervical dysplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 20.0 View
Endometrial thickening SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 20.0 View
Uterine haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 20.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders 20.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 20.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 20.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 20.0 View
Injection site nodule SYSTEMATIC_ASSESSMENT General disorders 20.0 View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 20.0 View