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: 2025-12-26 @ 11:08 AM
Ignite Modification Date: 2025-12-26 @ 11:08 AM
NCT ID: NCT02574312
Description: Final assessment of adverse events were classified by system organ class in lieu of specific adverse event terms.
Frequency Threshold: 0
Time Frame: All participants had reached the 3 month follow-up visit at the time of uploading adverse events.
Study: NCT02574312
Study Brief: ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RUI (Reuseable Instrumentation) Patients were operated on using Reusable TKA Instrumentation 0 None 1 44 5 44 View
SUI (Single-Use Instrumentation) Patients were operated on using Single-Use TKA Instrumentation 0 None 0 44 2 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
Vascular SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 17.0 View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Immune System Disorder SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 17.0 View