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 |
|---|---|---|---|---|---|---|---|---|
| Usual Care | Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of either step 1 or 2 to usual care. | 0 | None | 0 | 0 | 0 | 0 | View |
| Parent Reminder-Recall Letter | Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 2 or 3 to the parent reminder-recall letter intervention. | 0 | None | 0 | 0 | 0 | 0 | View |
| Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions | Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 3 and 4 to the combination of parent reminder-recall letter and provider audit-feedback interventions. | 0 | None | 0 | 0 | 0 | 0 | View |
| Provider Audit-Feedback Intervention. | Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 2 or 3 to the provider audit-feedback intervention. | 0 | None | 0 | 0 | 0 | 0 | View |