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 @ 12:41 AM
Ignite Modification Date: 2025-12-25 @ 10:52 PM
NCT ID: NCT03471767
Description: None
Frequency Threshold: 3
Time Frame: Approximately four weeks
Study: NCT03471767
Study Brief: AXS-05 Phase II Trial on Smoking Behavior
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bupropion SR Bupropion SR: Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal for 4 weeks 0 None 1 27 8 27 View
AXS-05 AXS-05: Dextromethorphan Immediate Release + Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal for 4 weeks. 0 None 2 31 4 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Broken Jaw NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia/Sleep Disturbance NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Abnormal/Vivid Dreams NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View