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 |
|---|---|---|---|---|---|---|---|---|
| Phase 1 | Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center. Approximately six focus groups (each with 5-10 participants) will be conducted at the Pennington Biomedical Research Center Demonstration Kitchen over the course of approximately 3 months. | 0 | None | 0 | 21 | 0 | 21 | View |
| Phase 2 Standard Instructions | Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using standard instructions. | 0 | None | 0 | 75 | 0 | 75 | View |
| Phase 2 Modified Instructions | Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using modified instructions. | 0 | None | 0 | 75 | 0 | 75 | View |