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 @ 3:23 AM
Ignite Modification Date: 2025-12-26 @ 2:01 AM
NCT ID: NCT04828005
Description: Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
Frequency Threshold: 5
Time Frame: Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Study: NCT04828005
Study Brief: Pharmacodynamic Evaluation of Intranasal Nalmefene
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 Nalmefene hydrochloride nasal spray, 3mg, 1 spray Nalmefene hydrochloride: 3mg Nasal spray 0 None 0 61 56 61 View
Intranasal Naloxone Naloxone hydrochloride nasal spray, 4mg, 1 spray Naloxone hydrochloride: 4mg Nasal Spray 0 None 0 60 52 60 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hypercapnia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal discomfort NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hyperhidosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hot Flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View