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 |
|---|---|---|---|---|---|---|---|---|
| Alcoholic Beverage, High Provocation Manipulation | Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: Participants will consume an alcoholic beverage (vodka mixed with fruit juice) that is the equivalent of 3-4 standard alcoholic drinks based on their body weight. | 0 | None | 0 | 74 | 0 | 74 | View |
| Non-alcoholic Beverage, High Provocation Manipulation | Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight. | 0 | None | 0 | 75 | 0 | 75 | View |
| Alcoholic Beverage, Low Provocation Manipulation | Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants receive an experimental manipulation designed to evoke positive emotions. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: Participants will consume an alcoholic beverage (vodka mixed with fruit juice) that is the equivalent of 3-4 standard alcoholic drinks based on their body weight. | 0 | None | 0 | 74 | 0 | 74 | View |
| Non-alcoholic Beverage, Low Provocation Manipulation | Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke positive emotions. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight. | 0 | None | 0 | 70 | 0 | 70 | View |