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: 2025-12-25 @ 12:39 AM
Ignite Modification Date: 2025-12-25 @ 10:49 PM
NCT ID: NCT02261467
Description: The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess adverse events and serious adverse events. Subjects randomized to receive placebo in Period 1 who subsequently received open-label onabotulinumtoxinA in Period 2 are included in the onabotulinumtoxinA group for the Safety analysis.
Frequency Threshold: 5
Time Frame: None
Study: NCT02261467
Study Brief: A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Followed by OnabotulinumtoxinA in Period 2 Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas. None None 0 100 12 100 View
OnabotulinumtoxinA OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. None None 5 374 92 374 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 19.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 19.0 View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA version 19.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 19.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site bruising NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 19.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 19.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 19.0 View