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 @ 4:26 AM
Ignite Modification Date: 2025-12-26 @ 3:29 AM
NCT ID: NCT04492020
Description: Safety Population, all treated participants who take ≥1 administration of study intervention. Participants will be summarized according to the study intervention they actually received.
Frequency Threshold: 0
Time Frame: From first dose through 30 days after the last dose of study drug (approximately 30 days)
Study: NCT04492020
Study Brief: Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants
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: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours 0 None 1 462 35 462 View
Ubrogepant 100 mg Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours 0 None 0 456 50 456 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
RHABDOMYOLYSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View