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 @ 3:02 PM
Ignite Modification Date: 2025-12-25 @ 1:25 PM
NCT ID: NCT00780559
Description: The definition of adverse events and/or serious adverse events does not differ from that which is listed here on clinicaltrials.gov. Adverse Events were collected from patient reports and phone call follow-ups.
Frequency Threshold: 0
Time Frame: Adverse event data for each participant was collected over one year per study patient, or the duration of the study for each participant.
Study: NCT00780559
Study Brief: Improving Neuropathy and Mobility in People With Early Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard of Care Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program. 0 None 0 40 0 40 View
Tailored Diet and Physical Activity Subjects will receive an individually tailored diet and physical activity enhancement program 1 None 0 32 1 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin Irritation NON_SYSTEMATIC_ASSESSMENT Product Issues None View