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 |
|---|---|---|---|---|---|---|---|---|
| No Information on High Risk Factor Levels Nor Lifestyle Advice | In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline No information on high risk factor levels, nor lifestyle advice: In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels. | 0 | None | 0 | 199 | 0 | 199 | View |
| No Information on High Risk Factor Levels But Lifestyle Advice | This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks No information on high risk factor levels but lifestyle advice: In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks | 0 | None | 0 | 185 | 0 | 185 | View |
| Information on High Risk Factor Levels and Lifestyle Advice | This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks Information on high risk factor levels and lifestyle advice: This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks | 0 | None | 0 | 198 | 0 | 198 | View |