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 |
|---|---|---|---|---|---|---|---|---|
| Systane Complete PF (Treatment) | Masked subjects assigned to Arm 1 will use Systane Complete PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period. Systane Complete PF: 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product | 0 | None | 0 | 18 | 0 | 18 | View |
| Run-in Period Participants | All subjects participate in a 1-week run-in period during which they used a common over-the-counter non-lipid artificial tear (Systane Ultra PF). Upon completion of the run-in period, participants will then be randomized to one of the 4 study solutions. | 0 | None | 0 | 81 | 0 | 81 | View |
| Refresh Relieva PF (Control) | Masked subjects assigned to Arm 2 will use Refresh Relieva PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period. Refresh Relieva PF: 3 month use, 4 times daily, of Refresh Relieva PF, a non-lipid-based, preservative-free artificial tear product | 0 | None | 0 | 21 | 0 | 21 | View |
| Refresh Optive Mega-3 PF (Active Comparator 1) | Masked subjects assigned to Arm 3 will use Refresh Optive Mega-3 PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period. Refresh Optive Mega-3 PF: 3 month use, 4 times daily, of Refresh Optive Mega-3 PF, a lipid-based, preservative-free artificial tear product | 0 | None | 0 | 19 | 0 | 19 | View |
| CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2) | Masked subjects assigned to Arm 4 will use CVS Health Lubricant Eye Drop (PG 0.6%) artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period. CVS Health Lubricant Eye Drop (PG 0.6%): 3 month use, 4 times daily, of CVS Health Lubricant Eye Drop (PG 0.6%), a lipid-based, preserved artificial tear product | 0 | None | 0 | 23 | 0 | 23 | View |