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 |
|---|---|---|---|---|---|---|---|---|
| Arm 1 | Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks. | None | None | 0 | 50 | 0 | 50 | View |
| Arm 2 | Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study. | None | None | 0 | 69 | 0 | 69 | View |