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 |
|---|---|---|---|---|---|---|---|---|
| Group-Cognitive Behavioral Therapy (G-CBT): Caregivers | Group Cognitive Behavioral Therapy (G-CBT): G-CBT consists of 10-session for HIV/AIDS-associated stigma, utilizing core components of CBT, including psychoeducation, cognitive restructuring, and skill-building to increase adaptive coping mechanisms. | 0 | None | 0 | 26 | 0 | 26 | View |
| Usual Care: Children | Usual care consists of the traditional clinic intervention that focuses on testing services, ART treatment, and information about disease management. | 0 | None | 0 | 29 | 0 | 29 | View |
| Group-Cognitive Behavioral Therapy (G-CBT): Children | Group Cognitive Behavioral Therapy (G-CBT): G-CBT consists of 10-session for HIV/AIDS-associated stigma, utilizing core components of CBT, including psychoeducation, cognitive restructuring, and skill-building to increase adaptive coping mechanisms. | 0 | None | 0 | 26 | 0 | 26 | View |
| Multiple Family Group (MFG): Children | Multiple Family Group (MFG): MFG consists of 10-sessions that strengthen family relationships intended to address HIV/AIDS-associated stigma at the individual level and within families. The core components of MFG are known as 4Rs and 2S's: rules, responsibility, relationships, respectful communication, stress and social support. | 1 | None | 0 | 34 | 0 | 34 | View |
| Usual Care: Caregivers | Usual care consists of the traditional clinic intervention that focuses on testing services, ART treatment, and information about disease management. | 1 | None | 0 | 29 | 0 | 29 | View |
| Multiple Family Group (MFG): Caregivers | Multiple Family Group (MFG): MFG consists of 10-sessions that strengthen family relationships intended to address HIV/AIDS-associated stigma at the individual level and within families. The core components of MFG are known as 4Rs and 2S's: rules, responsibility, relationships, respectful communication, stress and social support. | 0 | None | 0 | 34 | 0 | 34 | View |