Human research participants
pulmonary embolism, venous thromboembolic, hyperplasia, stroke, malignancy, non-melanoma skin cancer, leukemic transformation, thrombotic, peripheral vascular ischemia, splanchnic venous thrombosis
PULMONARY EMBOLISM, SUPERFICIAL THROMBOPHLEBITIS, ENDOMETRIAL CANCER, MYOCARDIAL INFARCTION, SPLANCHNIC VENOUS THROMBOSIS, DEEP VEIN THROMBOSIS (DVT), TRANSIENT ISCHEMIC ATTACK, HYPERPLASIA, STROKE, DISEASE, ISCHEMIA CEREBROVASCULAR, VASCULAR ACCESS COMPLICATION, ACUTE CORONARY SYNDROME, CERVICAL CARCINOMA IN SITU, EVENTS, VISCERAL ARTERIAL ISCHEMIA
This study was approved by NHS Health Research Authority (IRAS 201126). The study was conducted in accordance with the Declaration of Helsinki and UK regulations (The Medicines for Human Use (Clinical Trials) Regulations 2004). The clinical trial authorization was provided by the Medicines and Healthcare products Regulatory Agency. The study was registered on ISRCTN on 20-Jun-2016 (Exclusion criteria included leukemic transformation (>20% blasts in blood, marrow or extramedullary site); accelerated phase of disease as indicated by ≥10% blasts in the peripheral blood); treatment of ET, PV, or MF with Interferon alpha or other investigational agents for their MPN within 6 months prior to trial entry (JAK inhibitors, such as ruxolitinib, were allowed if taken continuously for ≥6 months prior to registration); any of the following previous thrombotic events at any time: portal or other splanchnic venous thrombosis; vascular access complication; ischemia cerebrovascular; stroke; transient ischemic attack; superficial thrombophlebitis; venous thromboembolic events including pulmonary embolism (PE) and deep vein thrombosis (DVT); peripheral vascular ischemia; visceral arterial ischemia; acute coronary syndrome; myocardial infarction; previous malignancy within 5 years with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer; previous endometrial cancer, hyperplasia or polyps; prior treatment with hematopoietic stem cell transplantation; patients who did not carry The Trial Scheme for Eligibility and Central Analysis is summarized in Supp. Fig. 