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 |
|---|---|---|---|---|---|---|---|---|
| Health-E You Intervention Arm | Intervention arm. Participants answered baseline questions and received individually-tailored contraception and reproductive health information from a web-based computer application on an iPad at one of the 9 school-based health centers that was randomized to the intervention arm. | 0 | None | 0 | 693 | 0 | 693 | View |
| Control Arm | Control Arm. Participants in this arm of the study completed an online baseline questionnaire about their demographic information and sexual and reproductive health behavior on an iPad at one of the 9 school-based health centers randomly assigned to the control arm. | 0 | None | 0 | 667 | 0 | 667 | View |