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 @ 1:12 PM
Ignite Modification Date: 2025-12-25 @ 12:23 PM
NCT ID: NCT03442595
Description: The definition of adverse events used was the same as from clinicaltrials.gov. Deaths and adverse events were not monitored/assessed for the matched controls as these patients were receiving diabetes standard of care and the matching was performed once the cases had completed the intervention.
Frequency Threshold: 1
Time Frame: Adverse events were collected during the 90 days that patients were enrolled in the diabetes boot camp
Study: NCT03442595
Study Brief: MedStar Diabetes Pathway Chart Reviews
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cases patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks. 0 None 5 460 3 460 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
worsening pre-existing heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain requiring hospitalization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
New diagnosis of breast cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Deep vein Thrombosis requiring intervention NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diabetic neuropathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View