A Multinational, Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS Trial
The SEAS Follow-up Study is a 21 month extension to the base protocol (2004_050,
MK0653A-043; NCT00092677). The main objective of the extension is to observe the incidence
rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up
period (from 04-March 2008 to 31-December 2009) in patients from the SEAS clinical trial.
The sources of study data will include data collected from national cancer and death
registries as well as data from the original clinical trial. No patient visits will occur.
National cancer and death registries exist in 5 of the 7 countries that participated in the
base SEAS trial. Registries do not exist in Ireland and Germany. As a result, data will be
collected only for all SEAS patients known to be alive at the end of the base study
originating from Sweden, Denmark, Norway, Finland, and the United Kingdom.
Observational Model: Cohort, Time Perspective: Retrospective
New Incidence of Cancer
21 Months after the end of the base study
Denmark: Danish Medicines Agency