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 @ 9:19 PM
Ignite Modification Date: 2025-12-25 @ 7:06 PM
NCT ID: NCT04019704
Description: Safety Population
Frequency Threshold: 5
Time Frame: Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last dose.
Study: NCT04019704
Study Brief: A Trial of AXS-05 in Patients With Major Depressive Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AXS-05 AXS-05 (bupropion and dextromethorphan) oral tablets AXS-05: Oral AXS-05 tablets, taken daily for 6 weeks. 0 None 1 162 100 162 View
Placebo Placebo oral tablets to match AXS-05 Placebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks. 0 None 0 164 74 164 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Dictionary View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Dictionary View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Dictionary View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Dictionary View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Dictionary View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Dictionary View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Dictionary View
All Others, occurring in <5% of Subjects NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Dictionary View