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 @ 11:14 PM
Ignite Modification Date: 2025-12-25 @ 8:50 PM
NCT ID: NCT03597256
Description: Safety population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
Frequency Threshold: 5
Time Frame: From baseline up to 20 months
Study: NCT03597256
Study Brief: Restylane Defyne for Correction of Chin Retrusion
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Restylane Defyne (Treatment Group) Participants received an initial treatment with maximum 2 milliliter (mL) of Restylane Defyne on Day 1 for chin retrusion and, if other areas of the chin were treated for optimal chin augumentation, another maximum dosage of 2 mL were recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. An optional touch-up treatment of maximum 2 mL Restylane Defyne were given at 4 weeks after initial treatment if optimal chin augmentation had not been achieved. 0 None 2 111 19 111 View
Control (No Treatment) Participants did not receive treatment at baseline and month 6 follow up visit. 0 None 1 37 4 37 View
Control (Restylane Defyne) Participants received initial treatment with 2 mL Restylane Defyne at Month 6 follow-up visit after randomization and optional touch-up treatment at 4 Weeks after initial treatment. 0 None 1 34 5 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abnormal liver function NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (21.0) View
Cervical squamous cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (21.0) View
Uterine subserosal leiomyoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (21.0) View
Lumbar disc herniation NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View