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 @ 2:04 AM
Ignite Modification Date: 2025-12-26 @ 12:30 AM
NCT ID: NCT04571060
Description: Treated Participants included enrolled participants who took study therapy (zavegepant or placebo).
Frequency Threshold: 5
Time Frame: Adverse events were assessed from study drug dosing up to the end of the study (up to 55 days).
Study: NCT04571060
Study Brief: Randomized Trial in Adult Participants With Acute Migraines
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zavegepant 10 mg Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. 0 None 0 629 129 629 View
Placebo Participants administered a single intranasal dose of zavegepant-matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device. 0 None 0 653 31 653 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (24.0) View