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 @ 2:27 AM
Ignite Modification Date: 2025-12-26 @ 1:00 AM
NCT ID: NCT02700334
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected throughout the study (12 weeks)
Study: NCT02700334
Study Brief: Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dapagliflozin Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks. 0 None 0 12 7 12 View
Placebo Placebo capsules, one per day before breakfast during 12 weeks. Placebo: one per day before breakfast during 12 weeks. 0 None 0 12 6 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Edema in upper extremities SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Low back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View