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 @ 10:55 PM
Ignite Modification Date: 2025-12-25 @ 8:23 PM
NCT ID: NCT05219669
Description: None
Frequency Threshold: 5
Time Frame: Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
Study: NCT05219669
Study Brief: Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intranasal Nalmefene 1 Spray in Each Nostril 6 mg IN Nalmefene Hydrochloride dose (one 0.1 mL spray of a 30 mg/mL solution in each nostril) 0 None 0 23 12 23 View
Intranasal Nalmefene 1 Spray in 1 Nostril 3 mg IN Nalmefene Hydrochloride dose (one 0.1 mL spray of a 30 mg/mL solution in one nostril) 0 None 0 23 9 23 View
Intranasal Nalmefene 2 Sprays in 1 Nostril 6 mg IN Nalmefene Hydrochloride dose (two 0.1 mL sprays of a 30 mg/mL solution in one nostril) 0 None 0 24 16 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rhinalgia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal Congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nasal discomfort NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vessel puncture site pain NON_SYSTEMATIC_ASSESSMENT General disorders None View