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: The TAU Group / TAU vs TAU + TX | The Treatment as usual (TAU) group received only Cognitive Behavioral Therapy (CBT) and did not practice the Mindfulness as a group. | 0 | None | 0 | 32 | 0 | 32 | View |
| The TAU + TX Group / TAU vs TAU + TX | The TAU plus Mindfulness Training received CBT and Mindfulness Training, which included practice as a group | 0 | None | 0 | 32 | 0 | 32 | View |
| Younger Participants / Younger vs Older Scores | Younger vs Older participant scores were compared on pre/post-test scores | 0 | None | 0 | 26 | 0 | 26 | View |
| Older Participants / Younger vs Older Scores | Younger vs Older participant pre/post-test scores were compared | 0 | None | 0 | 26 | 0 | 26 | View |