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 |
|---|---|---|---|---|---|---|---|---|
| Placebo | Some subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received. Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand. The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study. | 0 | None | 0 | 6 | 0 | 6 | View |
| Botulinum Toxin Commonly Known as BOTOX® | Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received. Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand. The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study. | 0 | None | 0 | 10 | 0 | 10 | View |