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 @ 11:59 AM
Ignite Modification Date: 2025-12-25 @ 11:56 AM
NCT ID: NCT00588861
Description: None
Frequency Threshold: 5
Time Frame: 8 Years
Study: NCT00588861
Study Brief: Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Answer Stem Utilizing Palacos Cement Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation. None None 8 200 0 200 View
Answer Stem Utilizing Simplex Cement Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics None None 15 202 0 202 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Deep infection < 6 weeks NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Deep infection > 6 weeks NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Femoral, acetabular loosening and instability NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Revision with all components removed and re-implantation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Dislocation NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Femoral loosening NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stroke NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
I&D, exchange of poly liner NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):