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 |
|---|---|---|---|---|---|---|---|---|
| 1 Very Mild to Mild DAT Untreated | Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine | None | None | 0 | 14 | 0 | 14 | View |
| 2 Very Mild to Mild DAT Treated With Donepezil | Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with donepezil. Donepezil (Aricept®): 5mg/day for six weeks and if no serious side-effects increased to 10mg/dy. | None | None | 0 | 18 | 0 | 18 | View |
| 3 Very Mild to Mild DAT Treated With the Combination | Group 3) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with the combination of donepezil and memantine. Memantine (Namenda®): Drug treatment will begin with 5 mg/day of donepezil for six weeks. After six weeks of such treatment, the subjects symptoms will be re-evaluated and any side-effects of treatment assessed and recorded. If no serious side-effects of donepezil are encountered, the dose of donepezil will be increased to 10 mg/day. For subjects prescribed the combination of donepezil and memantine, memantine (20 mg/day) will be added to the drug treatment regimen after the dose of donepezil has been established (i.e., at six weeks). Again, memantine will be initially started at 10 mg/day and increased to its full dose only if no serious side-effects are encountered. Memantine (Namenda®): Initial dose of 10mg/day and increased to full dose of 20mg/day if no serious side-effects | None | None | 0 | 14 | 0 | 14 | View |
| 4 Nondemented Comparison Subjects. | Group 4) nondemented comparison subjects. | None | None | 0 | 56 | 0 | 56 | View |