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 |
|---|---|---|---|---|---|---|---|---|
| Control - Alcohol Use Reduction Content | Alcohol use reduction content alcohol use reduction content: The control condition will be a previously tested TM-delivered alcohol use reduction intervention. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. high risk drinking feedback). | 0 | None | 0 | 92 | 0 | 92 | View |
| Intervention - Sexual Violence and Alcohol Use Harm Reduction Content | sexual violence and alcohol use harm reduction content sexual violence and alcohol use harm reduction text message content: The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented. Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes. As with the control condition, post-drinking assessment happens weekly on Sundays. Monday thru Saturday participants will randomly receive or not receive one appropriate message pathway from the message library using the pre-determined pathways for messages. | 0 | None | 0 | 91 | 0 | 91 | View |