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 |
|---|---|---|---|---|---|---|---|---|
| Enhanced Usual Care | Because of the strong evidence documenting symptom burden in PC survivors, the investigators believe that providing control subjects with some information about symptom self-management is warranted. The investigators further believe, based on the investigators' prior experience conducting RCTs, that offering some type of educational material for Veterans randomized to the control arm will increase their willingness to enroll in the study (as opposed to a pure usual care arm where they would not receive any such materials). Therefore, survivors randomized to the control condition will receive written material at the time of enrollment designed to educate them about PC symptoms and symptom management. Material will be approximately six pages in length, also written at or below an 8th grade reading level, and will include a summary of common symptoms experienced by prostate cancer survivors. | 3 | None | 1 | 278 | 0 | 278 | View |
| IVR Intervention | The intervention will consist of two components, both with content design based on established theories for self-management support: 1) automated telephone monitoring of PC survivor symptoms and goals for symptom reduction, based on a patient empowerment approach, and 2) personally tailored newsletters that incorporate elements of CBT to improve survivors' identification with the material, confidence/self-efficacy in symptom management, and to reduce common cognitive distortions related to successful implementation of behavior change. Intervention-group participants will receive four automated assessment and self-management support calls over a 3-month period (at baseline, 1-month, 2-month, 3-months). Information collected during automated phone assessments will be used to construct tailored newsletters, which will be sent following each automated call. | 1 | None | 3 | 278 | 0 | 278 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hip arthroplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Subdural hematoma | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Kidney Failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Stroke | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |