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: 2025-12-25 @ 12:05 AM
Ignite Modification Date: 2025-12-25 @ 10:04 PM
NCT ID: NCT00510458
Description: Censored protocol deviations were not included as risk participants. Industry standard AE terms not used;specific AE terms not used for all AEs. Elective procedures not included, e.g. non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular and bunion procedures,total shoulder repair,laminectomy, microdiscectomy,breast reduction, cervical spine fusion, mid-foot/flat-foot surgery.
Frequency Threshold: 5
Time Frame: Adverse event data was collected to the 5 year postoperative interval. Reportable AEs for this study include those that are serious or related to surgery and/or to the operative site.
Study: NCT00510458
Study Brief: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Operative Site Events LFIT™ Femoral Heads With X3® Insert. Operative site events are reported by hip because in the case of bilateral participants (this is when one participant has both hips enrolled in the study), an event can occur in one hip, both hips or the same hip at different times and are counted separately for this reason. None None 2 78 20 78 View
Non-operative Site Events LFIT™ Femoral Heads With X3® Insert. Non-operative site events are reported by participant. None None 2 74 0 74 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Operative Site NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Operative Site NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Non-Operative NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Operative Site NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View