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 |
|---|---|---|---|---|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component. | None | None | 0 | 2 | 0 | 2 | View |
| Educational Clinical Monitoring | Participants will receive educational clinical monitoring Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made. | None | None | 0 | 5 | 0 | 5 | View |