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 @ 10:47 PM
Ignite Modification Date: 2025-12-25 @ 8:17 PM
NCT ID: NCT04435769
Description: An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. FAS population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents. No medical dictionary was utilized in this study.
Frequency Threshold: 0
Time Frame: 6 Months (from retrospective data retrieved in the study)
Study: NCT04435769
Study Brief: Non-Interventional Study Describing Direct Costs Related to Anti-coagulation Treatment
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 with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study. 0 None 2 42 4 42 View
Warfarin Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study. 1 None 10 67 0 67 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac ischemia SYSTEMATIC_ASSESSMENT General disorders None View
Stroke/TIA SYSTEMATIC_ASSESSMENT General disorders None View
Intracranial bleeding SYSTEMATIC_ASSESSMENT General disorders None View
GI bleeding SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT General disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Intraparenchymal hematoma of the lower lobe SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Epistaxis SYSTEMATIC_ASSESSMENT General disorders None View
Muscle hematomas SYSTEMATIC_ASSESSMENT General disorders None View
Feeling sick SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Vertigo SYSTEMATIC_ASSESSMENT General disorders None View