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 |
|---|---|---|---|---|---|---|---|---|
| Social Support + Stigma Reduction + SBCM + Tech Detailing | Group-Based Social Support Intervention + Group-Based HIV Stigma Reduction Intervention + Individual Strengths-Based Case Management Intervention + Individual Personalized Technology Detailing Intervention | 0 | None | 0 | 4 | 0 | 4 | View |
| Social Support + Stigma Reduction + SBCM | Group-Based Social Support Intervention + Group-Based HIV Stigma Reduction Intervention + Individual Strengths-Based Case Management Intervention | 0 | None | 0 | 4 | 0 | 4 | View |
| Social Support + Stigma Reduction | Group-Based Social Support Intervention + Group-Based HIV Stigma Reduction Intervention | 0 | None | 0 | 3 | 0 | 3 | View |
| Social Support + SBCM + Technology Detailing | Group-Based Social Support Intervention + Individual Strengths-Based Case Management Intervention + Individual Personalized Technology Detailing Intervention | 0 | None | 0 | 4 | 0 | 4 | View |
| Social Support + SBCM | Group-Based Social Support Intervention + Individual Strengths-Based Case Management Intervention | 0 | None | 0 | 4 | 0 | 4 | View |
| Social Support + Technology Detailing | Group-Based Social Support Intervention + Individual Personalized Technology Detailing Intervention | 0 | None | 0 | 4 | 0 | 4 | View |
| Social Support | Group-Based Social Support Intervention | 0 | None | 0 | 4 | 0 | 4 | View |
| Stigma Reduction + SBCM + Technology Detailing | Group-Based HIV Stigma Reduction Intervention + Individual Strengths-Based Case Management Intervention + Individual Personalized Technology Detailing Intervention | 0 | None | 0 | 4 | 0 | 4 | View |
| Stigma Reduction + SBCM | Group-Based HIV Stigma Reduction Intervention + Individual Strengths-Based Case Management Intervention | 0 | None | 0 | 3 | 0 | 3 | View |
| Stigma Reduction + Technology Detailing | Group-Based HIV Stigma Reduction Intervention + Individual Personalized Technology Detailing Intervention | 0 | None | 0 | 4 | 0 | 4 | View |
| Stigma Reduction | Group-Based HIV Stigma Reduction Intervention | 0 | None | 0 | 4 | 0 | 4 | View |
| SBCM + Technology Detailing | Individual Strengths-Based Case Management Intervention + Individual Personalized Technology Detailing Intervention | 0 | None | 0 | 4 | 0 | 4 | View |
| SBCM | Individual Strengths-Based Case Management Intervention | 0 | None | 0 | 4 | 0 | 4 | View |
| Technology Detailing | Individual Personalized Technology Detailing Intervention | 0 | None | 0 | 4 | 0 | 4 | View |
| HIV Information Only | This arm will not receive any of the 4 intervention components but will receive information on successfully aging with HIV. | 0 | None | 0 | 4 | 0 | 4 | View |
| Social Support + Stigma Reduction + Technology Detailing | Group-Based Social Support Intervention + Group-Based HIV Stigma Reduction Intervention + Individual Personalized Technology Detailing Intervention | 0 | None | 0 | 3 | 0 | 3 | View |