Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:55 PM
Ignite Modification Date: 2025-12-25 @ 1:20 PM
NCT ID: NCT03060759
Description: 4 participants were withdrawn from the study prior to collection of adverse event data.
Frequency Threshold: 5
Time Frame: Adverse event data was collected over 4 weeks of light therapy, with collection at 2 and 4 weeks after starting light therapy.
Study: NCT03060759
Study Brief: Light Therapy as Treatment for Fatigue in Multiple Sclerosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Light Therapy-Spectrum 1 Light from 'active' spectrum Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5" tall x 23" wide x 3.25" deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs. 0 None 0 17 15 17 View
Light Therapy-Spectrum 2 Light from 'placebo' spectrum Light Therapy box: The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5" tall x 23" wide x 3.25" deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs. 0 None 0 14 3 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye issues NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hot flash NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Difficulty Sleeping NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View