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 |
|---|---|---|---|---|---|---|---|---|
| Girls Invest Intervention | Girls Invest intervention participants were randomized by site to receive the intervention immediately upon completion of the baseline survey. Intervention participants will also complete the 6 month follow-up survey. (n=217 total participants) Girls Invest Mobile App Intervention: App-based trainings focused on financial and health literacy. Trainings included app features such as gaming dynamics, and quizzes. Each module estimates 25 minutes to complete. Savings Account Subsidies: Participants receive savings deposits upon completion of the app-based trainings. | 0 | None | 0 | 138 | 0 | 138 | View |
| Wait-List Control Condition Participants | Control condition participants will be randomized upon completion of the baseline survey and put on a wait-list to receive Girls Invest behavioral intervention after the 6 month follow-up survey. (n=50 dyads; 100 total participants) | 0 | None | 0 | 102 | 0 | 102 | View |