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: 2025-12-25 @ 3:18 AM
Ignite Modification Date: 2025-12-26 @ 1:56 AM
NCT ID: NCT01462305
Description: None
Frequency Threshold: 5
Time Frame: 6 weeks
Study: NCT01462305
Study Brief: 30-Minute Light Exposure for the Treatment of Seasonal Affective Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks Control: light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks None None 0 17 9 17 View
goLITE light therapy using 467nm LED source, within 30 minutes of waking in the morning every day for 6 weeks goLITE: goLITE at 30 minutes per day, within 30 minutes of waking in the morning None None 0 18 12 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus Drainage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cold NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
facial warming NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eye Sensitivity NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
heartburn NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nasal sinus irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
muscle spasm NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
backache NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
sinus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
hot spot on eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
eye strain NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
GI upset NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
itchy/watery eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
perimenstrual symptoms NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
white flashing lights NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
bloody nose NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
body aches NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
lightheadedness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View