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 @ 4:55 AM
Ignite Modification Date: 2025-12-26 @ 3:55 AM
NCT ID: NCT01951118
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected beginning at study start through study conclusion, an average of 5 years.
Study: NCT01951118
Study Brief: Olfactory Deficits and Donepezil Treatment in Cognitively Impaired Elderly
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 Treatment & Atropine Challenge Atropine nasal spray is administered at baseline for the atropine challenge which involves administration of the 40-item UPSIT immediately before and 45 minutes after atropine administration. Immediately after the atropine challenge, donepezil treatment is started and continues for 52 weeks. Donepezil: Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease. For patients who do not tolerate donepezil or have a history of intolerance to donepezil or cannot take donepezil for other reasons, treatment with other cholinesterase inhibitors (galantamine or rivastigmine) is permitted at any stage of the protocol. Data will be analyzed in two ways: for donepezil alone, and for any cholinesterase inhibitor (donepezil or rivastigmine or galantamine). 3 None 8 121 0 121 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Low platelet level NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Broken Femur NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Wrist Fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):