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 |
|---|---|---|---|---|---|---|---|---|
| Usual Care | Clinicians and patients will receive no further interventions beyond usual practice. Usual care for clinicians includes a nudge consisting of targeted text messages identifying patients at high risk of predicted 6-month mortality based on a validated machine learning prognostic algorithm. Usual Care: Individual clinicians will receive an automated weekly email detailing a weekly roster of their upcoming repeat-patient visits (Index Visit) with patients at high risk of 6-month mortality as determined by a validated machine learning prognostic algorithm. Clinicians will receive a HIPAA compliant text message on the morning of the appointment reminding them to consider a serious illness conversation with patients on the list. | 162 | None | 0 | 1004 | 0 | 1004 | View |
| Clinician Nudge | Clinicians receive a nudge consisting of targeted text messages identifying patients at high risk of predicted 6-month mortality based on a validated machine learning prognostic algorithm as well as performance feedback compared to peers. Clinician Nudge: Clinicians will receive the usual care weekly email and text message described above under Usual Care. In addition, embedded in the weekly email, clinicians will receive performance feedback information detailing their documented SICs relative to those documented by peers. | 227 | None | 0 | 1179 | 0 | 1179 | View |
| Patient Nudge | Patients receive a nudge consisting of a normalizing message prompting patients to complete an electronic questionnaire designed to prime patients towards having an SIC. Patient Nudge: Ahead of the Index Visit, high risk patients as identified by the prognostic algorithm will receive a nudge via personal text message and email consisting of a normalizing message prompting patients with a personalized link to a short electronic questionnaire on SIC topics. | 157 | None | 0 | 997 | 0 | 997 | View |
| Clinician and Patient Nudge | Both strategies described above will be used. Clinician Nudge: Clinicians will receive the usual care weekly email and text message described above under Usual Care. In addition, embedded in the weekly email, clinicians will receive performance feedback information detailing their documented SICs relative to those documented by peers. Patient Nudge: Ahead of the Index Visit, high risk patients as identified by the prognostic algorithm will receive a nudge via personal text message and email consisting of a normalizing message prompting patients with a personalized link to a short electronic questionnaire on SIC topics. | 227 | None | 0 | 1270 | 0 | 1270 | View |