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 @ 2:59 PM
Ignite Modification Date: 2025-12-25 @ 1:23 PM
NCT ID: NCT05399459
Description: Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set consisted of participants in the enrolled analysis set who took the study drug (rimegepant 25 mg, rimegepant 75 mg, or placebo).
Frequency Threshold: 1
Time Frame: From the day of signing informed consent up to end of treatment visit (approximately maximum up to 11 weeks)
Study: NCT05399459
Study Brief: Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)
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 Participants were randomized to receive ODT of placebo (each matched to rimegepant 25 and 75 mg) sublingually when they experienced a migraine headache of moderate to severe intensity, within 45 days of randomization on Day 1. 0 None 0 229 2 229 View
Rimegepant 25 mg Participants were randomized to receive ODT of rimegepant 25 mg and of placebo (matched to rimegepant 75 mg) sublingually when they experienced a migraine headache of moderate to severe intensity, within 45 days of randomization on Day 1. 0 None 0 239 3 239 View
Rimegepant 75 mg Participants were randomized to receive ODT of rimegepant 75 mg and of placebo (matched to rimegepant 25 mg) sublingually when they experienced a migraine headache of moderate to severe intensity, within 45 days of randomization on Day 1. 0 None 1 238 3 238 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v26.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View