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 |
|---|---|---|---|---|---|---|---|---|
| Memory Training | Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information. | None | None | 0 | 711 | 0 | 711 | View |
| Reasoning Training | Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem. | None | None | 0 | 705 | 0 | 705 | View |
| Speed of Processing Training | Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer. | None | None | 0 | 712 | 0 | 712 | View |
| Control | This group did not complete any cognitive training interventions | None | None | 0 | 704 | 0 | 704 | View |