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 @ 4:02 PM
Ignite Modification Date: 2025-12-25 @ 2:04 PM
NCT ID: NCT05347966
Description: The study protocol defines an adverse event (AE) as any unfavourable or unintended sign, symptom, or disease associated with study procedures that are both non-serious and either temporally or causally related to study procedures. To be reported as a Serious Adverse Event (SAE), the protocol requires that the event must be serious, unanticipated, and related to study procedures. All-cause mortality, SAEs, and Other (Not Including Serious) AEs not related to study procedures were not collected.
Frequency Threshold: 0
Time Frame: Adverse event data is collected from Baseline up to 30 days after study participation has ended. This is approximately 1 year for participants who remained in the study until the end and less time for those who withdrew early. Systematic collection of AEs occurred at the following study visits: Baseline, Month 6, Month 12. Non-systematic AE reporting, spontaneous reporting by participant, was also implemented.
Study: NCT05347966
Study Brief: Brain Health Support Program
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BHSP Main Brain Health PRO (BHPro) is an innovative online platform designed to help reduce the risk of dementia by providing individuals with the tools and knowledge needed to make positive lifestyle changes. The program offers a flexible, user-friendly interface that allows users to assess their risk and engage with educational modules specifically tailored to their needs. 0 None 0 353 3 353 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin Reaction likely related to EEG headband NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Headache likely related to EEG headband NON_SYSTEMATIC_ASSESSMENT General disorders None View