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 |
|---|---|---|---|---|---|---|---|---|
| No Feedback | AGYW customer feedback will be collected but not shared with shopkeepers Harnessing prosocial and social image motivations for behavior change: The investigators will collect AGYW customer feedback using a short USSD-based survey and randomize whether shopkeepers receive 1) No feedback; 2) Private feedback; or 3) Public feedback | 0 | None | 0 | 44 | 0 | 44 | View |
| Private Feedback | Biweekly summarized reports of AGYW customer feedback will be given directly to shopkeepers Harnessing prosocial and social image motivations for behavior change: The investigators will collect AGYW customer feedback using a short USSD-based survey and randomize whether shopkeepers receive 1) No feedback; 2) Private feedback; or 3) Public feedback | 0 | None | 0 | 49 | 0 | 49 | View |
| Public Feedback | Shopkeepers will get biweekly summarized reports of AGYW customer feedback, gold stars reflecting the level of AGYW customer feedback (e.g., 1-5 star rating) will be placed in the shop in a visible location, and shopkeepers will be invited to an awards ceremony every 6 months to recognize shopkeepers who receive high levels of positive AGYW customer feedback Harnessing prosocial and social image motivations for behavior change: The investigators will collect AGYW customer feedback using a short USSD-based survey and randomize whether shopkeepers receive 1) No feedback; 2) Private feedback; or 3) Public feedback | 0 | None | 0 | 51 | 0 | 51 | View |