NCT02891551

An Observational Post Authorisation Study to Evaluate Safety and Efficacy in Patients Receiving Azacitidine in Daily Clinical Practice in the Netherlands

A Non-interventional Observational Post Authorization Study to Evaluate Safety and Efficacy in Patients Receiving Azacitidine in Daily Clinical Practice in the Netherlands (OCEAN)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 209 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study design is a prospective, non-interventional, observational single arm study. A minimum of 150 patients will be recruited from approximately 30 haematology/oncology sites in the Netherlands. In all cases, the decision to treat the patient with azacitidine was already made prior to the decision to enter the subject into the study. Recruitment will continue until end of June 2015, provided a minimum of 150 patients have been included in the study. When this date is reached, all patients on azacitidine will continue to be followed until the last patient enrolled has been followed for 12 months.

Conditions

• Myelodysplastic Syndromes
• Leukemia, Myelomonocytic, Chronic
• Leukemia, Myeloid, Acute

Timeline

• Start date: 2012-05-01
• Primary completion: 2016-06-30
• Completion: 2018-12-30
• First posted: 2016-09-07
• Last updated: 2019-07-24