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 @ 4:10 AM
Ignite Modification Date: 2025-12-26 @ 3:08 AM
NCT ID: NCT02064920
Description: All participants who received study medication.
Frequency Threshold: 5
Time Frame: Up to Week 18 (approximately up to 129 days)
Study: NCT02064920
Study Brief: Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks. None None 0 6 3 6 View
Donepezil During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability. None None 1 28 9 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View