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 |
|---|---|---|---|---|---|---|---|---|
| Web-based Advance Care Planning (PATIENTS) | Patients randomized to this arm will participate in web-based ACP via the PREPARE website. Web-based advance care planning: Instructions for accessing and using the PREPARE website will be shared with participants upon randomization. Patients and their caregivers review the 5 steps of PREPARE (approximately 10 minutes per step) and create an action plan for each step. The PREPARE website includes a link to a written advance directive that participants are able to complete. The PREPARE website can be reviewed on a home computer or on a tablet in the oncology practice. | 112 | None | 0 | 203 | 0 | 203 | View |
| Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS) | Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model. Facilitated advance care planning (in-person or telephonic): The facilitator will contact the patient to schedule the ACP discussion. ACP discussions will be led by a nurse or social worker with supportive oncology experience who has been trained as a Respecting Choices facilitator, include the patient's caregiver when available, last 45-60 minutes, and be held in a private location at or near the patient's oncology clinic, or telephonically. Facilitators will use a structured interview tool as a discussion roadmap and provide guidance in choosing a medical decision maker, exploring serious illness understanding and experiences, identifying goals and values, and making future treatment decisions. Facilitators will provide a copy of a written advance directive, assist with completion when appropriate, and make recommendations for communicating goals and sharing written preferences. | 116 | None | 0 | 197 | 1 | 197 | View |
| Web-based Advance Care Planning (CAREGIVERS) | Enrolled caregivers of patients randomized to the web-based advance care planning arm. | 0 | None | 0 | 133 | 0 | 133 | View |
| Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS) | Enrolled caregivers of patients randomized to the facilitated advance care planning arm. | 0 | None | 0 | 139 | 0 | 139 | View |