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: 2025-12-24 @ 2:44 PM
Ignite Modification Date: 2025-12-25 @ 1:13 PM
NCT ID: NCT00667459
Description: The adverse events, originally collected in FDA proposed categories, were grouped into organ systems.
Frequency Threshold: 0
Time Frame: up to 24 months
Study: NCT00667459
Study Brief: Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Investigational PRESTIGE® LP Cervical Disc None None 133 280 242 280 View
Control Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876). None None 98 265 211 265 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cardiac Disorders NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dysphagia/Dysphonia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neurological NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Respiratory NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Trauma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Urogenital NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vascular NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Wound (Non-Infectious) NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dysphagia/Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Heterotopic Ossification NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Implant Events NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neck and/or Arm Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Non-Union NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Spinal Events NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal Events NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Spinal Events NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Other NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other NON_SYSTEMATIC_ASSESSMENT Investigations None View
Other NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Other Pain NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Other Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anatomical/technical difficulty NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cardiac Disorders NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dysphagia/Dysphonia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia/Dysphonia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysphagia/Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastrointestinal NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Heterotopic Ossification NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Implant Events NON_SYSTEMATIC_ASSESSMENT General disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neck and/or Arm Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neurological NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Non-Union NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other NON_SYSTEMATIC_ASSESSMENT Investigations None View
Other NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Other NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Pain NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Other Pain NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Other Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Pain NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Pain NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Respiratory NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Spinal Events NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Spinal Events NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Spinal Events NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Trauma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Urogenital NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vascular NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Wound(Non-Infectious) NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View