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 @ 2:54 PM
Ignite Modification Date: 2025-12-25 @ 1:19 PM
NCT ID: NCT03777059
Description: All-Cause Mortality is reported for all randomized participants. Safety Population, all participants who received at least 1 dose of study intervention, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Frequency Threshold: 5
Time Frame: From first dose of study drug through end of study (Up to 16 weeks)
Study: NCT03777059
Study Brief: 12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic 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
Placebo Placebo-matching atogepant tablets orally once daily for 12 weeks. 0 None 2 222 15 222 View
Atogepant 10 mg Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks. 0 None 2 221 34 221 View
Atogepant 30 mg Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks. 0 None 0 228 37 228 View
Atogepant 60 mg Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks. 0 None 0 231 32 231 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA: 22.0 View
Brain injury SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA: 22.0 View
Negative pressure pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA: 22.0 View
Optic neuritis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA: 22.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA: 22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA: 22.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA: 22.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA: 22.0 View