Philadelphia-negative myeloproliferative neoplasms are frequent and chronic myeloid malignancies including Polycythemia Vera (PV), essential thrombocythemia (ET), Primary Myelofibrosis (PMF) and Prefibrotic myelofibrosis (PreMF).
Conditions
Brief summary
Time to occurrence of arterial or venous thromboembolic events
Detailed description
Time to occurrence of major and clinically relevant non-major bleedings as defined by ISTH, Time to occurrence of arterial thromboembolic events, Time to occurrence of venous thromboembolic events, Time to occurrence of thromboembolic and bleeding events according to PV or ET or PreMF status, Time to occurrence of thromboembolic and bleeding events according to the cytoreductive associated drugs, Time to occurrence of serious adverse events others than thromboses and hemorrhages, Occurrence of atrial fibrillation episodes (time to occurrence), Overall survival and event free survival (events defined above) at 24 months, Adjudicated mortality (non-cardiovascular and cardiovascular), time to occurence, Therapeutic adherence will be studied (Girerd auto-questionnaire) during the study treatment period of 24 months, Quality of life will be studied (EQ-5D-5L and MPN-SAF-TSS auto-questionnaire) during the study treatment period of 24 months, Evaluation of costs and incremental cost utility ratio (cost per QALY) of low-dose DOAC compared to LDA
Interventions
Sponsors
Centre Hospitalier Regional Et Universitaire De Brest
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to occurrence of arterial or venous thromboembolic events | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to occurrence of major and clinically relevant non-major bleedings as defined by ISTH, Time to occurrence of arterial thromboembolic events, Time to occurrence of venous thromboembolic events, Time to occurrence of thromboembolic and bleeding events according to PV or ET or PreMF status, Time to occurrence of thromboembolic and bleeding events according to the cytoreductive associated drugs, Time to occurrence of serious adverse events others than thromboses and hemorrhages, Occurrence of atrial fibrillation episodes (time to occurrence), Overall survival and event free survival (events defined above) at 24 months, Adjudicated mortality (non-cardiovascular and cardiovascular), time to occurence, Therapeutic adherence will be studied (Girerd auto-questionnaire) during the study treatment period of 24 months, Quality of life will be studied (EQ-5D-5L and MPN-SAF-TSS auto-questionnaire) during the study treatment period of 24 months, Evaluation of costs and incremental cost utility r | — |
Countries
France
Outcome results
None listed