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 |
|---|---|---|---|---|---|---|---|---|
| Intervention | The intervention consists of (1) online self-management educational modules and (2) weekly peer mentor calls to facilitate engagement with the modules and offer specialized support over approximately six weeks. Managing Your Health: Self-Management + Peer Mentoring: The online educational component consists of 5 self-management educational modules: (1) Understanding Your Survivorship Care Plan; (2) Managing Your Healthcare; (3) Family and Significant Other Involvement in Your Healthcare; (4) Emotions about Your Health and Follow-Up Care; (5) Staying Healthy. Participants will be matched with a peer mentor and complete a total of six calls. The first call is to build a rapport and identify the participant's self-management strengths, weaknesses, and goals. The next five calls align with the topic of each module, which the mentee is expected to complete prior to their scheduled call. | 0 | None | 0 | 25 | 0 | 25 | View |
| Usual Care | Participants are not receiving the tested intervention. They continue to receive standard or routine psychosocial or transition care available to them as part of the normal practice. | 0 | None | 0 | 25 | 0 | 25 | View |
| Mentors | Peer Mentors were recruited and matched 1:1 with each participant randomized to RCT Intervention to facilitate engagement with the online modules and offer specialized support. | 0 | None | 0 | 10 | 0 | 10 | View |