Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Leukemia, Myelomonocytic, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients receiving Azacitidine per daily clinical practice
Primary outcomes (1)
- measure
- Adverse Events (AEs)
- timeFrame
- Up to approximately 4 years
- description
- Adverse events will be classified using the Medical Drug Regulatory Activities (MedDRA) classification system. The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible
Secondary outcomes (5)
- measure
- Fact-Anemia Quality of life questionnaire
- timeFrame
- Up to approximately 4 years
- description
- The Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire was used to assess health-related quality of life (HRQoL). In addition to general HRQoL, the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 years of age who understand and voluntarily sign an informed consent form. * Patients who are treated with azacitidine in accordance with registered indication and clinical practice. Exclusion Criteria: * Refusal to participate in the study. * Participation in an interventional clinical study. * Patients previously treated with azacitidine except when given as induction therapy for a maximum of three courses. * Women who are pregnant or breast-feeding. * Hypersensitivity to the active substance or to any of the excipients. * Advanced malignant hepatic tumors.
References
Publications (0)
Data not yet available