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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Enrolled But Not Randomized | Subjects selected for participation from the investigator's patient population who have signed the Informed Consent Form and have confirmation of the initial enrollment criteria but have not yet been randomized. | 0 | None | 0 | 59 | 2 | 59 | View |
| Therapy A | Subjects meeting all eligibility criteria who have been randomized to the Therapy A (\~600-1500Hz) spinal cord stimulation parameter set. | 0 | None | 0 | 38 | 3 | 38 | View |
| Therapy B | Subjects meeting all eligibility criteria who have been randomized to the Therapy B (\~300-600Hz) spinal cord stimulation parameter set. | 0 | None | 0 | 39 | 3 | 39 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lead migration | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Reaction from wound dressing | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Neurostimulator device entered "safe mode" | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Irritation from wound dressing | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Reaction from wound dressing | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Persistent post-surgical site pain | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |