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 |
|---|---|---|---|---|---|---|---|---|
| QPL (Question Prompt List) Brochure | Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon. QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon. | 8 | None | 0 | 223 | 0 | 223 | View |
| Usual Care | The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention. | 7 | None | 0 | 223 | 0 | 223 | View |