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 |
|---|---|---|---|---|---|---|---|---|
| Mindfulness Oriented Recovery Enhancement | Participants in the MORE plus usual care group attended 8 weekly, 2-hour group sessions, remotely, through video conferencing. Participants were provided with a tablet and data plan to ensure access to the internet. MORE sessions involved mindfulness to strengthen self-regulation of drug use and reduce pain, reappraisal to regulate negative emotions and reduce craving by contemplating drug use consequences, and savoring to increase positive emotions and augment natural reward processing.Participants were taught to replace the reward obtained from drug use by self-generating natural reward via mindfulness and savoring. MORE also included techniques designed to mindfully honor the recovery process and promote reflection on the reasons for taking MOUD. Each session began with a mindful breathing meditation, followed by group processing of the meditation. Next, therapists debriefed participants' weekly homework practice of mindfulness, reappraisal, and savoring skills. These group processing efforts involved social-behavioral learning principles including positive reinforcement and shaping to maximize learning and motivation. Psychoeducational material and experiential exercises were then introduced, and participants were asked to practice 15 minutes of mindfulness/reappraisal/savoring skills daily. | 2 | None | 0 | 77 | 0 | 77 | View |
| Methadone Treatment (MT) as Usual | In MT programs, patients take methadone daily and come to the clinic regularly to get their dose. However, at the time of the study, most participants received doses at home due to the COVID-19 pandemic. MT clinic individual and group therapy (neither involving mindfulness) was usually delivered through telehealth due to the COVID-19 pandemic. | 0 | None | 0 | 77 | 0 | 77 | View |