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 @ 1:23 AM
Ignite Modification Date: 2025-12-25 @ 11:33 PM
NCT ID: NCT01338493
Description: Seriousness of AEs was not assessed when the data were collected so it is not possible to separate SAEs and Other (Non-serious) AEs for the Maverick Registry. The study is now closed and it would not be possible to go back to the sites to ask them to classify the AEs. All events are here-reported as SAEs.
Frequency Threshold: 0
Time Frame: 24 months
Study: NCT01338493
Study Brief: Maverick Total Disc Replacement in a 'Real World' Patient Population
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lumbar Spinal Arthroplasty + Maverick™ Patients requiring total disc replacement lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc. None None 57 134 0 134 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neurologic - Access-related None Nervous system disorders None View
Neurologic - Late radiculopathy (not access-related) None Nervous system disorders None View
Vascular None Vascular disorders None View
Visceral - Bowel or Peritoneum None General disorders None View
Visceral - Genito-Urinary tract None General disorders None View
Subsidence / Impaction None Musculoskeletal and connective tissue disorders None View
Early non-specific low BP None General disorders None View
Late non-specific low BP None General disorders None View
Other events None General disorders None View
Foreign body reaction None Immune system disorders None View
Abdominal wall related None General disorders None View
Other Events(If Any):