Adverse Events Module

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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 @ 4:48 AM
Ignite Modification Date: 2025-12-26 @ 3:50 AM
NCT ID: NCT02920918
Description: An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.
Frequency Threshold: 0
Time Frame: 12 weeks
Study: NCT02920918
Study Brief: Treatment of Diabetes in Patients With Systolic Heart Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Canagliflozin Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks. Canagliflozin 0 None 3 17 7 17 View
Sitagliptin Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks. Sitagliptin 0 None 1 19 6 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Influenza B NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Occlusion superficial femoral artery NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dizziness and acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Genital infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypotensive event NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arrhythmic events NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View