Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:31 AM
NCT ID:
NCT03159260
Group ID:
EG001
Title:
Placebo
Description:
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.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
29
Other Number Affected:
0
Other Number At Risk:
29
Study:
NCT03159260
Results Section:
NCT03159260
Adverse Events Module:
NCT03159260