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 @ 12:03 AM
Ignite Modification Date: 2025-12-25 @ 10:01 PM
NCT ID: NCT02715258
Description: None
Frequency Threshold: 3
Time Frame: Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.
Study: NCT02715258
Study Brief: Safety and Efficacy of Bexagliflozin as Monotherapy in Patients With Type 2 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
Bexagliflozin Tablets, 20 mg Each subject was to take bexagliflozin tablets, 20 mg once daily for 24 weeks. 0 None 1 138 41 138 View
Placebo Tablets Each subject was to take placebo (inactive tablet) once daily for 24 weeks. 1 None 1 69 25 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tenosynovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Polyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View