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 |
|---|---|---|---|---|---|---|---|---|
| Lumen Treatment | Participants will complete functional magnetic resonance imaging (fMRI) and self-report questionnaires at baseline and 16 weeks. Participant will receive an encrypted study iPad enabled with Lumen at baseline. They will complete 8 PST sessions beginning with 4 weekly and then 4 biweekly intervals (i.e., on weeks 1, 2, 3, 4, 6, 8, 10, 12) over 12 weeks on their assigned iPad. Participants will also complete naturalistic end-of-day assessments for 7 days every 2 weeks (on weeks 0, 2, 4, 6, 8, 10, 12, 16), that is, 8 time series. Additionally, participants will complete depressive and anxiety symptoms questionnaire and user experience surveys at all PST sessions. Lumen Treatment: the virtual AI agent, Lumen, via an iPad-based application. Each participant will receive a locked, encrypted study iPad installed with Lumen. They will complete 8 problem solving therapy (PST) sessions beginning with 4 weekly and then 4 biweekly intervals over 12 weeks on their assigned iPad. | 0 | None | 0 | 42 | 9 | 42 | View |
| Waitlist Control | Participants will complete functional magnetic resonance imaging (fMRI) and self-report questionnaires at Baseline and 16 weeks. Participant will receive an encrypted study iPad at baseline. Participants will complete naturalistic end-of-day assessments for 7 days every 2 weeks (on weeks 0, 2, 4, 6, 8, 10, 12, 16), that is, 8 time series. Participants in the waitlist control arm will only complete assessments but will have the option to receive Lumen at the end of the study. The PST module on the study iPad will be disabled until their 16-week assessment is completed, at which time they will have the option to complete 8 PST sessions on their assigned iPads. | 0 | None | 2 | 21 | 7 | 21 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Reproductive system | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Gastrointestinal system | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Neurological system | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hematological system | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Musculoskeletal system | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Reproductive system | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Neurological | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Gastrointestinal system | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Renal/Urologic system | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Immunologic system | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| General disorders | SYSTEMATIC_ASSESSMENT | General disorders | None | View |