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 @ 9:28 PM
Ignite Modification Date: 2025-12-25 @ 7:14 PM
NCT ID: NCT02088632
Description: None
Frequency Threshold: 0
Time Frame: Adverse events collection was from start of consent to end of study - approximately 84 days
Study: NCT02088632
Study Brief: Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia
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 Comparator Placebo Comparator is 1-2 ml normal saline solution injected to chosen area one time. Placebo Comparator: Normal saline is sterile sodium chloride without and preservatives. 0 None 0 3 3 3 View
Incobotulinumtoxina Xeomin 25-100 units injected to chosen area one time. Incobotulinumtoxina: Incobotulinumtoxina (Xeomin) is botulinum toxin type A and is administered via intramuscular injection. 0 None 0 3 2 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Aphthous ulcers SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Standard terminology View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations Standard terminology View
Numbness left temple SYSTEMATIC_ASSESSMENT Nervous system disorders Standard terminology View
Insomnia SYSTEMATIC_ASSESSMENT General disorders Standard terminology View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders Standard terminology View
muscle weakness SYSTEMATIC_ASSESSMENT General disorders Standard terminology View