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 |
|---|---|---|---|---|---|---|---|---|
| Theraworx | Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/\[pH\]uel (treatment) and the other contained a physiologically inert substance (placebo control). Theraworx: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm. | 0 | None | 0 | 28 | 0 | 28 | View |
| Placebo | Participants received 2, 3 ounce foam dispensers corresponding to their group (FoamA or FoamB) and a 2-week Compliance and Symptom Log. The participants were blind to the contents of the foam and the investigators until the study was completed. One foam contained Theraworx/\[pH\]uel (treatment) and the other contained a physiologically inert substance (placebo control). Placebo: Participants were instructed to apply the assigned foam to their entire upper and lower legs and feet using 8 pumps from the dispenser per leg before retiring each evening for 14 days. If participants experienced leg cramps or spasms after retiring they were instructed to reapply 2 pumps of the foam to the affected area in response to each event. Each morning participants applied the foam they also completed the Compliance and Symptom Log, documenting the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm. | 0 | None | 0 | 29 | 0 | 29 | View |