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 @ 5:02 PM
Ignite Modification Date: 2025-12-25 @ 2:42 PM
NCT ID: NCT02062450
Description: None
Frequency Threshold: 0
Time Frame: 2 years postoperative
Study: NCT02062450
Study Brief: Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Total Safety Population All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions. None None 11 379 11 379 View
Primary Surgery Sub-group Patients who underwent a Primary Hip Replacement surgery None None 2 191 4 191 View
Revision Surgery Sub-group Patients who underwent a Revision Hip Replacement surgery None None 3 64 2 64 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dual Mobility Cup dislocation NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Revision surgery for Implant Mobilisation NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Revision surgery for Implant Loosening NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Revision surgery for Infection NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Revision surgery for Implant Malposition NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Revision surgery for Instability NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Transfemoral Amputation NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteosynthesis surgery NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteolysis surgery NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infection without revision surgery NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Recurrent Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Wound affection NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Asymptomatic implant mobilisation NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View