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 @ 5:05 AM
Ignite Modification Date: 2025-12-26 @ 4:08 AM
NCT ID: NCT00291018
Description: All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Frequency Threshold: 5
Time Frame: 84 Months (i.e. 7 years)
Study: NCT00291018
Study Brief: Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ProDisc-C ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group None None 45 103 98 103 View
ProDisc-C Continued Access ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group None None 58 136 121 136 View
Control Anterior Cervical Discectomy and Fusion ACDF Randomized Group None None 53 106 100 106 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT General disorders Syncode View
Pain - Neck SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Pain - Other SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders Syncode View
Surgery - Index Level SYSTEMATIC_ASSESSMENT Surgical and medical procedures Syncode View
Surgery - Other SYSTEMATIC_ASSESSMENT Surgical and medical procedures Syncode View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Syncode View
Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Syncode View
Pain - Shoulder SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Pain - Back SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Pain - Neck and Upper Extremities SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Genitourinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders Syncode View
Pain - Back and Lower Extremities SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain - Neck SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Syncode View
Headaches SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Pain - Back SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Surgery - Other SYSTEMATIC_ASSESSMENT Surgical and medical procedures Syncode View
Pain - Shoulder SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Pain - Upper Extremities SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Syncode View
Neurological SYSTEMATIC_ASSESSMENT Psychiatric disorders Syncode View
Other SYSTEMATIC_ASSESSMENT General disorders Syncode View
Numbness Non-Index Level Related SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Pain - Back and Lower Extremities SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Pain - Other SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Dysphagia SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Pain - Neck and Upper Extremities with Numbness SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders Syncode View
Genitourinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders Syncode View
Insomnia SYSTEMATIC_ASSESSMENT General disorders Syncode View
Pain - Neck and Shoulder SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Pain - Neck and Upper Extremities SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Syncode View
Infection - Other Non-Wound Related SYSTEMATIC_ASSESSMENT Infections and infestations Syncode View
Pain - Upper Extremities with Numbness SYSTEMATIC_ASSESSMENT Nervous system disorders Syncode View
Musculoskeletal Spasms - Neck SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Syncode View
Psychological SYSTEMATIC_ASSESSMENT Psychiatric disorders Syncode View
Surgery - Index Level SYSTEMATIC_ASSESSMENT Surgical and medical procedures Syncode View