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 @ 12:09 PM
Ignite Modification Date:
2025-12-25 @ 11:59 AM
NCT ID:
NCT00882661
Description:
The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Frequency Threshold:
.5
Time Frame:
24 months
Study:
NCT00882661
Study Brief:
SECURE®-C Cervical Artificial Disc Clinical Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SECURE-C Cervical Artificial Disc | Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc | None | None | 46 | 236 | 121 | 236 | View |
| ASSURE Cervical Plate and an Allograft Interbody Spacer | Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion | None | None | 34 | 144 | 80 | 144 | 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 |
| Cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Carpal Tunnel Syndrome (CTS) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cerebrovascular | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Compressive Periph Neuro (Non-CTS) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Gastrointestinal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Infection - Other | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Musculoskeletal | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Neurological | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Other | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain - Back and/or Lower Extremities | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain - Upper Extremities | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Psychological | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Surgery - Adjacent Level | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Surgery - Index Level | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Surgery - Lumbar Level | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Surgery - Other Cervical | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Surgery - Thoracic Level | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Trauma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Urogenital | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cancer | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Carpal Tunnel Syndrome (CTS) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cerebrovascular | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Compressive Peripheral Neuropathy (Non-CTS) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dysesthesia - Lower Extremities | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dysesthesia - Other | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dysesthesia - Upper Extremities | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dysphonia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Gastrointestinal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Infection - Other | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infection - Superficial Wound | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Muscle Spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Musculoskeletal | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Neurological | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Other | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain - Back and/or Lower Extremities | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain - Neck | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain - Neck and Upper Extremities | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain - Neck and Upper Extremities with Dysesthesia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain - Neck with Dysesthesia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain - Other | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain - Upper Extremities | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain - Upper Extremities with Dysesthesia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Psychological | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Trauma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Weakness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Wound Issue | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |