Carole Miller, MD, discusses the REVEAL trial design, an observational study on mortality and causes of death in patients with polycythemia vera.
Carole Miller, MD, director of the Cancer Institute at Ascension Saint Agnes, discusses the REVEAL trial (NCT02252159) design, an observational study on mortality and causes of death in patients with polycythemia vera.
According to Miller, Reveal was conducted across 270 sites across the United States in both the academic and community settings. During clinical visits, patients had their quality of life measured using a myeloproliferative neoplasms (MPN) symptom scale prospectively. Patients were enrolled over a 2-year period and followed until 36 months from the date of the last patient enrollment.
Some patients had up to 5 years of follow-up, according to Miller. In total, 2510 patients were included in the database, and 244 patients died during the course of the study. Investigators aim to determine the predictors and causes of death, along with the clinical information that was available to them 1 year prior to their death.
0:08 | REVEAL is a prospective trial where 270 sites in the US both academic and in the community agreed to participate in this prospective database. The study enrolled patients who were seen at their general clinic visits, they had quality of life measures using the MPN symptom scale done prospectively, and clinical details about their disease and its treatment and outcomes were collected. But the patients were enrolled in over a 2-year period and were followed until 36 months from the date of the last patient enrollment.
Generally, all patients had at least 3 years of follow-up, and some of the patients had up to 5 years of follow-up. Once we collected all the data, the database will be locked. And now we're looking at the data from the patients and the actual number of patients was a total of 2510 patients. There's lots of different data to collect, so when we are done with this data set, this particular study focused on the 244 patients who died during the course of the study.