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 @ 10:34 PM
Ignite Modification Date: 2025-12-25 @ 8:06 PM
NCT ID: NCT02889835
Description: This was a split person design where each Subject received all three treatments. Only one Subject died, unrelated to study treatment. This death is reported for each of the three arms and so the sum total column indicates three deaths but it is actually only one.
Frequency Threshold: 0
Time Frame: Baseline through 36 months
Study: NCT02889835
Study Brief: Clinical Performance of Incremental and Bulk Fill Composites in Class II Restorations
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Universal Composite Supreme Universal Restorative 1 None 1 53 3 53 View
Flowable Composite Supreme Flowable Restorative 1 None 1 53 2 53 View
Bulk Fill Flowable Composite Bulk Fill Flowable Restorative 1 None 1 53 4 53 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Loss of retention NON_SYSTEMATIC_ASSESSMENT General disorders None View
Restoration fracture NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pulpitis NON_SYSTEMATIC_ASSESSMENT General disorders None View