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 |
|---|---|---|---|---|---|---|---|---|
| Online New Beginnings Program (eNBP) | The eNBP is a five-hour, asynchronous, fully web-based adaptation of the group NBP. Separate versions for fathers and mothers consist of the same didactic content and interactive exercises, with gender appropriate references, testimonials and video skills demonstrations. Units are highly interactive. Sessions began with a check-in in which parents responded to questions about use of the program skills and were provided with ways to address the challenges they experienced. The skill was then taught using modeling videos, interactive exercises, and testimonials from prior participants. The program then prompted parents to set times to use the skill, identify barriers to using it and select strategies to reduce these barriers. Parents were provided with tip sheets to address challenges in using the skill, downloadable sheets to record use of and competence in using the skill and a downloadable handbook that summarized what was covered in the unit. Online New Beginnings Program (eNBP): The eNBP is a five-hour, asynchronous, fully web-based adaptation of the group-based NBP that can be used on a smart phone, tablet or computer. Separate versions for fathers and mothers consist of the same didactic content and interactive exercises, with gender appropriate references, testimonials and video skills demonstrations. | 0 | None | 0 | 140 | 0 | 140 | View |
| Wait-list Control Condition | Parents in the waitlist-control condition were told that they would have access to the eNBP 12 weeks after they completed the pre-test. Twelve weeks after assignment to condition, parents and children were sent links to the posttest | 0 | None | 0 | 93 | 0 | 93 | View |