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 @ 12:01 AM
Ignite Modification Date: 2025-12-25 @ 9:59 PM
NCT ID: NCT03726658
Description: NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
Frequency Threshold: 5
Time Frame: Two weeks = 14 days
Study: NCT03726658
Study Brief: AGN-241751 in the Treatment of 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
AGN-241751 3mg Two Times Per Day AGN-241751, oral administration, BID in Part B. AGN-241751: AGN-241751 is supplied in tablet form 0 None 0 41 15 41 View
AGN-241751 25mg Two Times Per Day AGN-241751, oral administration, BID in Part B. AGN-241751: AGN-241751 is supplied in tablet form 0 None 0 41 20 41 View
AGN-241751 3mg Daily AGN-241751, oral administration, once per day in Part A. AGN-241751: AGN-241751 is supplied in tablet form 0 None 0 26 6 26 View
AGN-241751 10mg Daily AGN-241751, oral administration, once per day in Part A. AGN-241751: AGN-241751 is supplied in tablet form 0 None 0 26 8 26 View
AGN-241751 25mg Daily AGN-241751, oral administration, once per day in Part A. AGN-241751: AGN-241751 is supplied in tablet form 0 None 0 26 6 26 View
Placebo Daily Placebo, oral administration, once per day in part A. Placebo: Placebo is supplied in tablet form 0 None 0 25 3 25 View
Placebo 2 Times Per Day Placebo, oral administration, two times per day in part B. Placebo: Placebo is supplied in tablet form 0 None 1 41 22 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abortion Induced SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abnormal Dreams SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View