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: 2025-12-26 @ 10:46 PM
Ignite Modification Date: 2025-12-26 @ 10:46 PM
NCT ID: NCT00686712
Description: None
Frequency Threshold: 1
Time Frame: 6 months
Study: NCT00686712
Study Brief: Insulin Glargine at Bedtime or in AM Versus NPH
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Insulin Glargine at Bedtime Bedtime insulin glargine titrated to morning fasting glucose readings None None 0 30 23 30 View
Insulin Glargine in AM Morning insulin glargine titrated to pre-supper glucose readings None None 1 25 24 25 View
NPH Insulin Bedtime NPH insulin titrated to morning fasting glucose readings None None 0 30 23 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Foot Infection (Hospitalization) NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Symptomatic Hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Asymptomatic Retinal Hemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View