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 |
|---|---|---|---|---|---|---|---|---|
| Treatment Group | Positive Peer Journaling (PPJ) Positive Peer Journaling (PPJ): PPJ is a journaling practice to support addiction recovery. PPJ encourages past 24 hour review and upcoming 24 hour planning to improve quality of life in recovery and reduce relapse. PPJ uses standard lined journals with column headings under which individuals make bullet-pointed lists. On the left hand page, past 24 hours is recalled, itemizing "good" and "bad" things that happened and things for which one is grateful. Wishes for others are also expressed on this page. On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as "recovery," "work/school," "spirituality," "home and household," and "health." | 0 | None | 0 | 10 | 0 | 10 | View |