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 @ 3:01 PM
Ignite Modification Date: 2025-12-25 @ 1:25 PM
NCT ID: NCT00900159
Description: Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. " Systematic methods included regular investigator assessment.
Frequency Threshold: 0
Time Frame: None
Study: NCT00900159
Study Brief: Effects of Daytime Eszopiclone Administration in Shift Workers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Eszopiclone eszopiclone: 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab) None None 0 24 16 24 View
Placebo eszopiclone: 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab) placebo: matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab) None None 0 24 10 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Head cold SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hunger SYSTEMATIC_ASSESSMENT General disorders None View
Leg cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Listlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Short-term memory loss SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Tunnel vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Bad taste SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Abnormal dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremities SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Application site dryness SYSTEMATIC_ASSESSMENT General disorders None View
Dry eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Gagging SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View