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: 2025-12-24 @ 3:57 PM
Ignite Modification Date: 2025-12-25 @ 2:00 PM
NCT ID: NCT02962492
Description: Patients were mainly monitored for 2 adverse events (also considered serious adverse events) throughout the study (12 weeks) related to: 1. severe hypoglycemia (blood sugar \<35mg/dl and requiring assistance) 2. diagnosis of diabetic ketoacidosis
Frequency Threshold: 5
Time Frame: 12 weeks
Study: NCT02962492
Study Brief: An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 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
Exenatide Extended Release Arm: subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks 0 None 0 15 0 15 View
Placebo Arm: dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection) Placebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks 0 None 0 11 0 11 View
Dapagliflozin Arm: dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection) Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks 0 None 0 15 0 15 View
Exenatide Extended Release & Dapagliflozin Arm: Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks 0 None 0 21 0 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Severe Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Diabetic Ketoacidosis NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Events(If Any):