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 @ 10:33 PM
Ignite Modification Date: 2025-12-25 @ 8:06 PM
NCT ID: NCT03014635
Description: Adverse event incidence rates were based on the Safety population which includes 205 subjects exposed to DaxibotulinumtoxinA 40 units and 101 subjects who received placebo. Note 1 subject randomized to placebo was treated with DaxibotulinumtoxinA.
Frequency Threshold: 5
Time Frame: Adverse events were collected throughout the entire study, up to 36 weeks
Study: NCT03014635
Study Brief: Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DaxibotulinumtoxinA 40 Units Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular injection 0 None 2 205 30 205 View
Placebo Biological/Vaccine: Placebo Intramuscular injection Placebo: Intramuscular injection 0 None 1 101 5 101 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Uterine perforation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Leiomyosarcoma recurrent NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Uterine leiomyosarcoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View