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 @ 4:50 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT01607450
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01607450
Study Brief: Modulation of Human Myocardial Metabolism by GLP-1 Dose Response
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lean GLP-1 0.5 Pmol/kg/Min GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study None None 0 11 1 11 View
Type 2 DM GLP-1 0.5 Pmol/kg/Min GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study None None 0 1 0 1 View
Type 2 DM GLP-1 1.5 Pmol/kg/Min GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study None None 0 7 0 7 View
Lean GLP-1 4.0 Pmol/kg/Min GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study None None 0 0 0 0 View
Type 2 DM GLP-1 4.0 Pmol/kg/Min GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study None None 0 0 0 0 View
Lean Saline 12 hour placebo (saline) infusion prior to PET study Placebo: Saline placebo infusion for 12 hours prior to PET study None None 0 6 0 6 View
Lean GLP-1 1.5 Pmol/kg/Min GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study None None 0 8 0 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View