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 |
|---|---|---|---|---|---|---|---|---|
| Control Arm | Usual Care, no intervention. The control arm received usual care. Usual care for veteran organ transplant recipients across the 10 study sites is not standardized but generally includes the following: at most sites, nurse coordinators and/ or midlevel practitioners are responsible for general transplant patient oversight, including ensuring laboratory assessments are scheduled/reviewed and medication regimens are accurate and up to date. However, large patient numbers and workload constraints preclude these health care professionals from prospective detailed daily monitoring of patients. Within usual follow-up care, pharmacists do not conduct routine daily surveillance of all transplant patients | 144 | None | 412 | 896 | 0 | 0 | View |
| Intervention Arm | Technology-enabled pharmacist intervention Health services delivery: Technology-enabled pharmacist intervention | 195 | None | 436 | 1300 | 0 | 0 | View |