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 |
|---|---|---|---|---|---|---|---|---|
| MSM 1000mg Twice a Day (6000 Mgs) | Group 1 will take by mouth three 1000 mg capsules twice a day (6000 mgs) of MSM plus standard of care naproxen MSM 1000mg twice a day (6000 mgs): MSM is believed to have anti-inflammatory properties. MSM is a largely tasteless, odorless, white, crystalline solid which is water soluble. It occurs naturally in the environment and is synthesized in the human body as a byproduct of dietary DMSO. | 0 | None | 0 | 50 | 2 | 50 | View |
| Placebo Capsules Twice a Day | Group 2 will take by mouth three placebo capsules twice a day plus standard of care naproxen Placebo capsules twice a day: Placebo is a capsule filled with rice flour. | 0 | None | 0 | 50 | 2 | 50 | View |