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 |
|---|---|---|---|---|---|---|---|---|
| PERC Program- Patients Participants | Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to experimental condition will receive access to the PERC website. Prostate Cancer Education and Resources for Couples (PERC): PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home. | 1 | None | 3 | 141 | 0 | 141 | View |
| Usual Care Plus NCI Website- Patients Participants | Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage. Usual care plus NCI website: The usual Care plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll-free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking. | 0 | None | 1 | 139 | 0 | 139 | View |