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 @ 12:36 PM
Ignite Modification Date: 2025-12-25 @ 12:11 PM
NCT ID: NCT02147561
Description: The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs). The Safety Population included patients enrolled in the study who received study drug.
Frequency Threshold: 5
Time Frame: None
Study: NCT02147561
Study Brief: A Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Botulinum Toxin Type A Botulinum toxin Type A injected across specific head and neck muscles on Day 0. None None 4 279 38 279 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Haemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART 092 View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART 092 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART 092 View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WHO-ART 092 View
Common Cold NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART 092 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Muscle Weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders WHO-ART 092 View
Ptosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WHO-ART 092 View