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 @ 12:12 AM
Ignite Modification Date: 2025-12-25 @ 10:13 PM
NCT ID: NCT00758758
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00758758
Study Brief: Performance of the Hedrocel(R) Cervical Fusion Device
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Hedrocel 1 Level Without Plate Hedrocel 1 level without plate None None 2 14 2 14 View
Hedrocel 1 Level With Plate Hedrocel 1 level with plate None None 2 74 9 74 View
Hedrocel 2 Levels With Plate Hedrocel 2 levels with plate None None 1 53 15 53 View
Autograft Only - Illiac Crest Autograft only - Illiac crest None None 0 6 0 6 View
Autograft With Plate Autograft with plate None None 0 3 0 3 View
Allograft With Plate Allograft with plate None None 0 50 5 50 View
Autograft 2 Levels With Plate Autograft 2 levels with plate None None 0 0 0 0 View
Allograft 2 Levels With Plate Allograft 2 levels with plate None None 1 31 2 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dysphagia None Gastrointestinal disorders None View
Non-Fusion None Musculoskeletal and connective tissue disorders None View
Pain- Neck and shoulder None Musculoskeletal and connective tissue disorders None View
Headache None Nervous system disorders None View
Radiculopathy None Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Device Loosening None Surgical and medical procedures None View
Dysphagia None Gastrointestinal disorders None View
Neck and Shoulder pain None Musculoskeletal and connective tissue disorders None View
Headache None Nervous system disorders None View
Cervical Disc Degeneration None Musculoskeletal and connective tissue disorders None View
Radiculopathy None Musculoskeletal and connective tissue disorders None View
Temporomandibular joint and muscle disorder None Musculoskeletal and connective tissue disorders None View
Infection - Surgical None Infections and infestations None View
Device Malfunction None Surgical and medical procedures None View
Numbness and Tingling None Nervous system disorders None View
Pain - Non-specific None Nervous system disorders None View
Device Migration None Surgical and medical procedures None View
Pseudoarthrosis None Musculoskeletal and connective tissue disorders None View
Dysphonia None Musculoskeletal and connective tissue disorders None View
Carpal Tunnel Syndrome None Musculoskeletal and connective tissue disorders None View
Non-Fusion None Musculoskeletal and connective tissue disorders None View