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 @ 2:09 PM
Ignite Modification Date: 2025-12-25 @ 12:50 PM
NCT ID: NCT01197495
Description: 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.
Frequency Threshold: 5
Time Frame: None
Study: NCT01197495
Study Brief: Safety and Effectiveness of Juvederm(R) Ultra XC Injectable Gel for Lip 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
Onset Prior to Repeat Treatment Juvederm(R) Ultra XC Injectable Gel None None 4 208 63 208 View
Onset After Repeat Treatment Juvederm(R) Ultra XC Injectable Gel None None 2 114 28 114 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Development Hip Dysplasia SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA version 18.0 View
Drug Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA version 18.0 View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 18.0 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 18.0 View
Squamous Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 18.0 View
Premature Baby NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA version 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection Site Mass NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 18.0 View
Injection Site Induration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 18.0 View
Injection Site Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 18.0 View