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 @ 11:53 AM
Ignite Modification Date: 2025-12-24 @ 11:53 AM
NCT ID: NCT04936061
Description: None
Frequency Threshold: 0
Time Frame: 24 hours
Study: NCT04936061
Study Brief: Transnasal Cooling for 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
High Flow Treatment 15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack. CoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril. 0 None 0 6 3 6 View
Low Flow Treatment 15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack. CoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril. 0 None 0 9 3 9 View
Sham Flow Ambient Air 15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack. CoolStat sham device: The CoolStat sham device will administer a sham flow of ambient air into the nostril. 0 None 0 9 0 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Burning sensation in nostril NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Increased head pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT General disorders None View