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 |
|---|---|---|---|---|---|---|---|---|
| Cross-over: OnabotulinumtoxinA/Saline Placebo | The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second. Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope. | 0 | None | 0 | 9 | 0 | 9 | View |
| Off Label Standard of Care: | Following unblinding, subject elected to a 24-week return to conservative management per standard-of-care protocols. | 0 | None | 0 | 3 | 0 | 3 | View |
| Cross-over: Saline Placebo/OnabotulinumtoxinA | The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope. | 0 | None | 0 | 6 | 0 | 6 | View |
| Off Label Botox: | Following unblinding, subject elected Botox treatment for 24 week open-label period where all subjects receive Botox treatment. | 0 | None | 0 | 9 | 0 | 9 | View |