N/A
N=1,359
An Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) Trial (MK-0653A-043-10)
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01077830 ↗Enrolled (actual)
1,359
Serious AEs
—
Results posted
Feb 2014
Primary outcome: Primary: Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort — 1.14; 2.07 per 100 participant-years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort |
1.14; 2.07 | — |
| SECONDARY Crude Rate of Death (Any Cause) - Follow-up Total Cohort |
3.59; 2.70 | — |
| SECONDARY Crude Rate of Death Due to Cancer - Follow-up Primary Cohort |
0.38; 0.28 | — |
Summary
The purpose of this extension is to observe the incidence rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up period in patients from the SEAS trial (2004\_050, MK0653A-043; NCT00092677).
Eligibility Criteria
Inclusion Criteria
- The cohort will include all patients from the five participating countries (Sweden, Denmark, Norway, Finland, and United Kingdom) who were randomized into the SEAS base study and who were known to be alive at the end of the base study
Data sourced from ClinicalTrials.gov (NCT01077830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.