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 @ 11:54 PM
Ignite Modification Date: 2025-12-25 @ 9:50 PM
NCT ID: NCT02396251
Description: Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.
Frequency Threshold: 5
Time Frame: 2 years, 9 months (from first subject screening to last subject's last visit).
Study: NCT02396251
Study Brief: Evaluation of Efficacy and Safety of Hyaluronic Acid (HA) Product for Cheek Augmentation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Both Cheeks Group HA product under investigation in both cheeks 0 None 4 36 23 36 View
Split-face Group HA product under investigation in one cheek and a comparator in the other cheek. 0 None 1 12 7 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Postoperative tachypnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Scar left cheek SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Anal prolapse SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Elevated TNT SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Epiglottitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Unstable patella SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Injection site oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Implant site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Implant site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Dark circles under eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View