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 @ 2:34 AM
Ignite Modification Date: 2025-12-26 @ 1:10 AM
NCT ID: NCT04862234
Description: None
Frequency Threshold: 0
Time Frame: Information on adverse events was collected from the time that individuals gave consent to participate in the study through the final assessment at hospital discharge, up to 5 days postoperatively.
Study: NCT04862234
Study Brief: Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dulaglutide Participants randomized to receive dulaglutide within 72 hours prior to a planned surgery. 0 None 1 8 3 8 View
Placebo Participants randomized to receive a placebo to match dulaglutide within 72 hours prior to a planned surgery. 0 None 0 8 2 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Prolonged hospital length of stay due to tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea, vomiting, constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoglycemia, prior to study medication administration NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View