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 @ 9:44 PM
Ignite Modification Date: 2025-12-25 @ 7:25 PM
NCT ID: NCT03993132
Description: This is a non-interventional study using electronic health care records, with data retrieved from Danish National Patient Registry, Danish National Prescription Registry and Danish Register of Causes of Death. No adverse events were collected on an individual case level. "0" in the Serious Adverse Events, and Other Adverse Events parts refer to not applicable. All-cause death for ITT analysis is reported.
Frequency Threshold: 0
Time Frame: From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.
Study: NCT03993132
Study Brief: A Study Using Medical Records of Danish People With Type 2 Diabetes Comparing Empagliflozin and Glucagon-Like Peptide-1 Receptor Agonists (GLP1-RA) in the Occurrence of Serious Cardiovascular Outcomes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Empagliflozin - PS Balanced Cohort All eligible adult patients (\>18 years) with type 2 diabetes (T2D) initiating treatment with empagliflozin in Denmark between 2015 and 2018, who were included in danish population-based linked registries (Civil Registration System, Danish National Patient Register, National Database of Reimbursed Prescriptions, LABKA Database). Patients were followed-up through 2020. Propensity score (PS) balancing was applied to match new users of empagliflozin to new users of liraglutide. 881 None 0 0 0 0 View
Liraglutide - PS Balanced Cohort All eligible adult patients (\>18 years) with type 2 diabetes (T2D) initiating treatment with liraglutide in Denmark between 2015 to 2018, who were included in danish population-based linked registries (Civil Registration System, Danish National Patient Register, National Database of Reimbursed Prescriptions, LABKA Database). Patients were followed-up through 2020. Propensity score (PS) balancing was applied to match new users of empagliflozin to new users of liraglutide. 765 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):