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 |
|---|---|---|---|---|---|---|---|---|
| ACP Video Decision Aid - Patient | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits. * In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care * 10 minute video decision aid: describing the goals-of-care options . * Follow telephone interview at 3 months ACP video decision aid: 10 minute video decision aid describing the goals-of-care options | 0 | None | 0 | 25 | 0 | 25 | View |
| ACP Video Decision Aid - Caregiver | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits. * In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care * 10 minute video decision aid: describing the goals-of-care options . * Follow telephone interview at 3 months ACP video decision aid: 10 minute video decision aid describing the goals-of-care options | 0 | None | 0 | 25 | 0 | 25 | View |
| Standard Care - Patient | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits. * In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care * Receive the verbal description of the three types of care * Follow telephone interview at 3 months Usual Care-: Verbal description of the three types of care | 2 | None | 0 | 25 | 0 | 25 | View |
| Standard Care - Caregiver | The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits. * In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care * Receive the verbal description of the three types of care * Follow telephone interview at 3 months Usual Care-: Verbal description of the three types of care | 0 | None | 0 | 25 | 0 | 25 | View |