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 @ 2:17 PM
Ignite Modification Date: 2025-12-25 @ 12:54 PM
NCT ID: NCT00846495
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00846495
Study Brief: Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of 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
Topiramate Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg. None None 0 28 17 28 View
Frovatriptan Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome. None None 0 27 5 27 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cold Symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Concentration Problems SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Irritability SYSTEMATIC_ASSESSMENT General disorders None View
Memory Problems SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Numbness in Extremities SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stomach Flu SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Taste Aversion SYSTEMATIC_ASSESSMENT General disorders None View
Tingling in Extremities SYSTEMATIC_ASSESSMENT Nervous system disorders None View