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 |
|---|---|---|---|---|---|---|---|---|
| Cognitive Restructuring & Alcohol Condition | Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then receive an alcoholic beverage. Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations. | 0 | None | 0 | 35 | 0 | 35 | View |
| Mindfulness & Alcohol Condition | Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive an alcoholic beverage. Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations. | 0 | None | 0 | 35 | 0 | 35 | View |
| Nutrition Information & Alcohol Condition | Participants will receive general information about nutrition, then receive an alcoholic beverage. | 0 | None | 0 | 37 | 0 | 37 | View |
| Cognitive Restrucuring & No Alcohol Condition | Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions, then receive a non-alcoholic beverage. Cognitive Restructuring: Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations. | 0 | None | 0 | 34 | 0 | 34 | View |
| Nutrition Information & No Alcohol Condition | Participants will receive general information about nutrition, then receive a non-alcoholic beverage. | 0 | None | 0 | 34 | 0 | 34 | View |
| Mindfulness & No Alcohol Condition | Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions, then receive a non-alcoholic beverage. Mindfulness: Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations. | 0 | None | 0 | 34 | 0 | 34 | View |