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 @ 3:44 PM
Ignite Modification Date: 2025-12-25 @ 1:52 PM
NCT ID: NCT00805792
Description: None
Frequency Threshold: 3
Time Frame: Adverse events were collected during the 90-day course of therapy.
Study: NCT00805792
Study Brief: Mayo Acute Stroke Trial for Enhancing Recovery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Donepezil Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days. None None 10 33 33 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Recurrent stroke NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Transient ischemic attack NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Carotid angioplasty and stent placement NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain/leg cramps NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Loss of appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Muscle cramps NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View