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 @ 12:10 AM
Ignite Modification Date: 2025-12-25 @ 10:11 PM
NCT ID: NCT00957658
Description: Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
Frequency Threshold: 5
Time Frame: This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Study: NCT00957658
Study Brief: Accolade® TMZF® Hip Stem Outcomes 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
Accolade TMZF Hip Stem Participants who received the Accolade TMZF Hip Stem None None 65 234 54 234 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Operative site NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Operative site NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Non-operative Site NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Operative site NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT General disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Operative site NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Non-operative site NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

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