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 Training | Online web-based training will provide online training primarily focused on family-based treatment and appropriate adaptations to the treatment model. Online training: Online web-based training will be divided into training modules that will be completed by participants over the course of 6-8 weeks. Training will include didactic training videos, knowledge checks, example sessions, and a library of resources. | 0 | None | 0 | 56 | 0 | 56 | View |
| Live Training | Live training will include two days of expert-led live training (via zoom). The content of the training will be similar to that provided in web-based training, primarily focused on family-based treatment and appropriate adaptations to the treatment model. Live training: The live training will be delivered by two trainers over the course of two days via Zoom. | 0 | None | 0 | 29 | 0 | 29 | View |