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 @ 4:32 AM
Ignite Modification Date: 2025-12-26 @ 3:34 AM
NCT ID: NCT01832818
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were recorded over the 24 month follow-up period
Study: NCT01832818
Study Brief: Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NuNec Cervical Disc Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months. NuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7. 0 None 0 14 3 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
neurological impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in L forearm NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hand Paranesthesia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hyperesthesia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Limited shoulder movement NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View