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 |
|---|---|---|---|---|---|---|---|---|
| PTx (Placebo) | Subjects randomized to this arm will be asked to discontinue their current pain medications and take two placebo pills (lactose) twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants are receiving (blind to active versus placebo treatment). Placebo: Take two placebo capsule twice a day. | 0 | None | 0 | 52 | 0 | 52 | View |
| MTx (Naproxen & Omeprazole) | Subjects randomized to this arm will be asked to discontinue their current pain medications and take one 500mg naproxen capsule and one 40mg omeprazole capsule twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants are receiving (blind to active versus placebo treatment). Naproxen: Take one 500mg naproxen capsule twice a day. Omeprazole: Take one 20mg omeprazole capsule twice a day. | 0 | None | 0 | 5 | 0 | 5 | View |
| Observational- NoTx | Subjects randomized to this arm will be asked to discontinue their current pain medications for the length of the study. This arm is not blinded, as both study staff and participants will be aware that they are not receiving a study treatment. | 0 | None | 0 | 25 | 0 | 25 | View |