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 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:35 PM
NCT ID: NCT04639193
Description: None
Frequency Threshold: 0
Time Frame: During the trial subjects were asked at each visit whether any adverse events had occurred during that 3-day study phase.
Study: NCT04639193
Study Brief: Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dual-Therapy * Day 1: Acetazolamide 250mg at bedtime at home. * Day 2: Acetazolamide 500mg at bedtime at home. * Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory. 0 None 0 20 11 20 View
Placebo * Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home. * Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home. * Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory. 0 None 0 20 10 20 View
Triple-Therapy * Day 1: Acetazolamide 250mg at bedtime at home. * Day 2: Acetazolamide 500mg at bedtime at home. * Day 3: Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory. 0 None 0 18 16 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bad Dreams SYSTEMATIC_ASSESSMENT General disorders None View
Cloudy Urine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abnormal Taste when Drinking Carbonated Beverages SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal Upset SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hand Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hot Flashes SYSTEMATIC_ASSESSMENT General disorders None View
Itchiness SYSTEMATIC_ASSESSMENT General disorders None View
Metallic Taste SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Polyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Shoulder Cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sleepiness SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View