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 |
|---|---|---|---|---|---|---|---|---|
| Rent Subsidies + Mentorship | Participants in this arm (n = 13) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as part of the intervention and be matched with an adult mentor recruited by one of the community partners. Mentorship: The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor. Rent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months. | 0 | None | 0 | 13 | 0 | 13 | View |
| Rent Subsidies Only | Participants in this arm (n = 11) will receive rent subsidies only (ranging from $400 - $500/month) for 24 months as part of the comparator group intervention. This group will not receive mentorship. Rent Subsidies: Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months. | 0 | None | 0 | 11 | 0 | 11 | View |