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 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
NCT ID:
NCT04577651
Description:
None
Frequency Threshold:
4
Time Frame:
Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
Study:
NCT04577651
Study Brief:
Cartesia eXTend 3D 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 |
|---|---|---|---|---|---|---|---|---|
| 16-contact Directional Deep Brain Stimulation | Deep Brain Stimulation with a 16-contact Directional Lead 16-contact Directional Deep Brain Stimulation: Deep Brain Stimulation with 16-contact Directional Lead | 1 | None | 14 | 58 | 25 | 58 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Joint dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| Enterovesical fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| Implant site paraesthesia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Epididymitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| Escherichia urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| Fine motor skill dysfunction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Hyperkinesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Parkinson's disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.0) | View |
| Dopamine dysregulation syndrome | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.0) | View |
| Impulse-control disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.0) | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| Skin erosion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.0) | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| Spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | View |
| Basal ganglia haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Brain oedema | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Cerebral Ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | View |
| Parkinson's disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Dyskinesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| Implant site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |