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 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
NCT ID:
NCT02667067
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Study:
NCT02667067
Study Brief:
Investigation of the Simplify® Cervical Artificial Disc
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Anterior Cervical Discectomy & Fusion (ACDF) | Anterior Cervical Discectomy \& Fusion: This study utilized a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\|C Disc trial. | 0 | None | 16 | 117 | 65 | 117 | View |
| Simplify Disc | Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine. | 0 | None | 17 | 150 | 89 | 150 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Pseduoarthrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Trauma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Other | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Radiculopathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Psychological Illness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Pain (narcotic given) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Adjacent Segment Degeneration | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Surgery at a location other than the spine | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Gastrointestinal Complications | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Spinal Stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Inflammation Conditions | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Esophageal Perforation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Infection; localized to cervical surgical site | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Ischemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Deep wound infection; localized to cervical surgical site | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Implant Collapse or Subsidence | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Pain (No Narcotic Given) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Infections (all other infections - NOT at cervical surgical site) | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Trauma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Infections (All other infections NOT at cervical surgical site) | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Compressive Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| GI Complications | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Spasm | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Other | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Inflammation | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Adjacent Segment Degeneration | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Radiculopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Pain (No narcotic given) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Pain (Narcotic given) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |