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 @ 11:28 PM
Ignite Modification Date: 2025-12-25 @ 9:15 PM
NCT ID: NCT04321356
Description: None
Frequency Threshold: 0
Time Frame: Adverse events would occur and therefore are collected only during the single day of data collection. Thus, we would know right away, and therefore the specific time period is 1 day. There is no participant follow up after data collection, and participants were not monitored after data collection.
Study: NCT04321356
Study Brief: Analysis of Competitive Posterior Cruciate Retaining (PCR) and Posterior Stabilized (PS) Total Knee Arthroplasty (TKA)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stryker Triathlon PCR TKA Subjects implanted with a Stryker Triathlon PCR TKA Triathlon PCR TKA: Total Knee Arthroplasty System 0 None 0 31 0 31 View
Stryker Triathlon PS TKA Subjects implanted with a Stryker Triathlon PS TKA Triathlon PS TKA: Total Knee Arthroplasty System 0 None 0 26 0 26 View
Zimmer Persona PCR TKA Subjects implanted with a Zimmer Persona PCR TKA Persona PCR TKA: Total Knee Arthroplasty System 0 None 0 29 0 29 View
Zimmer Persona PS TKA Subjects implanted with a Zimmer Persona PS TKA Persona PS TKA: Total Knee Arthroplasty System 0 None 0 14 0 14 View
Serious Events(If Any):
Other Events(If Any):