Safety of Flonoltinib Maleate Tablets for the Treatment of Patients With Myeloproliferative

You may not qualify if:

• The toxicity of previous anticancer therapy does not recover to grade I or below (except for hair loss), or does not fully recover from previous surgery (major surgery within 4 weeks);
• Allergic constitution, allergy to test drugs and their excipients;
• Any significant clinical or laboratory abnormalities that the investigator considers to affect the safety reviewer, such as: A. Uncontrolled diabetes - fasting glucose \> 250 mg/dL (13.9 mmol/L), b. Patients with hypertension who cannot be reduced to the following range after treatment with two or less antihypertensive drugs (systolic blood pressure \< 160 mmHg, diastolic blood pressure \< 100 mmHg), c. Peripheral neuropathy (NCI-CTC AE V5.0 Grade 2 or above);
• Patients with a history of congestive heart failure, unstable angina pectoris or myocardial infarction, cerebrovascular accidents, or pulmonary embolism within the first 6 months were screened;
• Patients with impaired heart function (Ejection fraction measured by ultrasonic electrocardiogram; ST segment descending in two or more channels in 45% or complete left bundle branch block \> 1 mm or T wave inverted; Congenital ventricular arrhythmia, clinically significant tachycardia (\>; 100 beats/min), bradycardia (lt; 50 times/min), ECG QTc \> 450 ms (male), QTc \> 480 MS (female) or clinically significant heart disease (such as unstable angina pectoris, congestive heart failure, myocardial infarction within 6 months);
• Arrhythmic disease requiring treatment, or QTC interphase (QTCB) \> 480 ms;
• Any active infections requiring treatment at the time of screening;
• Patients who had previously undergone splenectomy or who had received radiotherapy in the splenic region within 12 months prior to screening;
• Positive HIV antibody, positive active hepatitis B virus (HBsAg positive, HBV-DNA positive or ≥1000 copies/mL), positive anti-HCV antibody or HCV-RNA at screening time;
• Screening patients with epilepsy or using psychotropic drugs or sedatives;
• Pregnant or lactating women, fertile women/men who refuse to use contraceptives during the trial and within 6 months after the trial;
• Patients who have had malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) in the past 5 years;
• Concomitant with other serious diseases that the investigator believes may affect patient safety or compliance;
• Screening patients who participated in other new drugs or medical devices and took study drugs or used study devices within the previous 1 months;
• Within 2 weeks before randomization and into the group to use any drug for MF (JAK inhibitor, hydroxyurea), any immune modulators (such as Sally degree amine), any immune inhibitors, 10 mg/day or prednisone or equivalent strength of biological effect of glucocorticoid, growth factors, such as EPO therapy, or within six drug half-life of patients;
• +5 more criteria