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 |
|---|---|---|---|---|---|---|---|---|
| Tutorial Workbook | Tutorial Workbook Group only receives a Tutorial Workbook Group Tutuorial workbook: A work book about their addiciton | None | None | 0 | 33 | 0 | 33 | View |
| Tutorial Workbook Group Plus Webinar | Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource. Webinar: Some clients will receive a webinar as part of their treatment. Tutuorial workbook: A work book about their addiciton | None | None | 0 | 26 | 0 | 26 | View |