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 @ 5:08 AM
Ignite Modification Date: 2025-12-26 @ 4:12 AM
NCT ID: NCT02549027
Description: Analysis population is All Participants as Treated, defined as all participants who received at least one dose of study drug
Frequency Threshold: 5
Time Frame: Up to 14 days after the last dose of study drug (Up to approximately 42 days)
Study: NCT02549027
Study Brief: A Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG) (MK-1064-003)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MK-1064 50 mg Single dose of 50 mg MK-1064 None None 0 20 3 20 View
MK-1064 120 mg Single dose of 120 mg MK-1064 None None 0 20 2 20 View
MK-6096 20 mg Single dose of 20 mg MK-6096 None None 0 14 3 14 View
MK-1064 250 mg Single dose of 250 mg MK-1064 None None 0 20 5 20 View
Placebo Single dose of placebo None None 0 20 0 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View