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 @ 2:37 AM
Ignite Modification Date: 2025-12-26 @ 1:14 AM
NCT ID: NCT04188834
Description: None
Frequency Threshold: 0
Time Frame: Adverse events that occurred during the experimental sessions (up to 2h) and were conducted during the patient's hospital stay are reported. Participant's hospital stay duration was strictly determined by the clinical team based on clinical needs and typically lasted about 2 weeks.
Study: NCT04188834
Study Brief: Effects of Sensory Flicker and Electrical Flicker Stimulation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sensory Flicker Stimulation Participants will be exposed for about 10 to 60 minutes at a time, to a sequence of sensory flicker trials each lasting a few seconds to 5 minutes, while their eyes are open or closed. Each trial may include the following modalities and frequencies of flicker: * Modalities: auditory only, visual only, or audiovisual combined. * Frequencies: random, or anywhere from 3Hz to 200Hz. Additionally, subjects may be exposed to individual pulses of light and/or sound, i.e. around or less than 1 pulse /second, for up to 20 minutes at a time. Customized version of DAVID device: A customized version of the DAVID device will be used to expose participants to sensory flicker. The device consists of opaque glasses containing LEDs to present flickering light, as well as earbuds or headphones to present flickering sound. 0 None 0 23 16 23 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache or discomfort NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Miscellaneous NON_SYSTEMATIC_ASSESSMENT General disorders None View
Seizure likely unrelated to experiment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View