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 @ 3:28 AM
Ignite Modification Date: 2025-12-26 @ 2:08 AM
NCT ID: NCT05471505
Description: This study involved data that existed as structured data by the time of study start. In these data sources, individual participants data was not retrieved or validated, and it was not possible to link (i.e., identify a potential association between) a particular product and medical event for any individual. Thus, the minimum criteria for reporting an adverse event (AE) (i.e., identifiable patient, identifiable reporter, a suspect product, and event) could not be met.
Frequency Threshold: 0
Time Frame: Not applicable as safety data was not planned to be collected during the study
Study: NCT05471505
Study Brief: Safety and Effectiveness of Apixaban Compared to Warfarin in Patients With Non-valvular Atrial Fibrillation (a Type of Irregular Heart Rhythm) at Higher Chance of Bleeding
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Apixaban Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. 0 None 0 0 0 0 View
Warfarin Participants diagnosed with NVAF, who newly initiated warfarin, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):