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 |
|---|---|---|---|---|---|---|---|---|
| Episodic Future Thinking | Parents who are receiving residential substance use disorder (SUD) treatment will receive an adapted episodic future thinking focused condition. Parents will meet with peer recovery coaches (PRCs) who will administer the intervention, focused on generating future, pleasant events with their children. After the intervention session, parents will receive a daily postcard over the course of two weeks including a reminder cue generated as part of the episodic future thinking (EFT) intervention and a prompt to remember these episodes in vivid detail. Episodic Future Thinking: The adapted episodic future thinking (EFT) intervention will focus on generation of vivid, substance-free, rewarding events that could happen in the future with their children. | 0 | None | 0 | 38 | 0 | 38 | View |