Created at Source Raw Value Validated value
June 25, 2024, noon usa

1. allergy or sensitivity to peg1 analog or components 2. arterial hypotension defined as blood pressure less than 90/60 mm of mercury or mean arterial pressure less than 65mm of mercury or bp requirement \<80/50 mmhg or tam 60 mmhg with norepinephrine requirement greater than 0.1 mcg / kg / min 3. severe hypertension defined as systolic blood pressure greater than or equal to 180 mm of mercury and / or diastolic blood pressure greater than or equal to 110 mm of mercury 4. bradycardia defined as heart rate less than 60 beats per minute 5. previous events of priapism or penile anatomical changes 6. sickle cell disease, multiple myeloma, leukemia, polycythemia vera, thrombocythemia predisposing to priapism 7. hemorrhagic diathesis 8. active peptic ulcer, trauma, or recent brain hemorrhage. 9. abnormal pulmonary venous return with obstruction 10. pregnancy: a pregnancy test will be performed upon admission of the patient to the study (if applicable). 11. heart failure with nyha functional class\> 1 12. hemodynamically relevant arrhythmia: that generates hypotension, chest pain, dysfunction, sensory disturbance or other signs of low output 13. mitral and / or aortic stenosis and / or insufficiency of either 14. unstable angina 15. acute myocardial infarction in the last 6 months 16. ischemic or hemorrhagic cerebrovascular event in the last 6 months 17. child b or c or decompensated liver cirrhosis 18. chronic kidney disease in renal replacement therapy 19. serious medical condition or laboratory findings that, in the investigator's judgment, may compromise patient safety during participation in the study

1. allergy or sensitivity to peg1 analog or components 2. arterial hypotension defined as blood pressure less than 90/60 mm of mercury or mean arterial pressure less than 65mm of mercury or bp requirement \<80/50 mmhg or tam 60 mmhg with norepinephrine requirement greater than 0.1 mcg / kg / min 3. severe hypertension defined as systolic blood pressure greater than or equal to 180 mm of mercury and / or diastolic blood pressure greater than or equal to 110 mm of mercury 4. bradycardia defined as heart rate less than 60 beats per minute 5. previous events of priapism or penile anatomical changes 6. sickle cell disease, multiple myeloma, leukemia, polycythemia vera, thrombocythemia predisposing to priapism 7. hemorrhagic diathesis 8. active peptic ulcer, trauma, or recent brain hemorrhage. 9. abnormal pulmonary venous return with obstruction 10. pregnancy: a pregnancy test will be performed upon admission of the patient to the study (if applicable). 11. heart failure with nyha functional class\> 1 12. hemodynamically relevant arrhythmia: that generates hypotension, chest pain, dysfunction, sensory disturbance or other signs of low output 13. mitral and / or aortic stenosis and / or insufficiency of either 14. unstable angina 15. acute myocardial infarction in the last 6 months 16. ischemic or hemorrhagic cerebrovascular event in the last 6 months 17. child b or c or decompensated liver cirrhosis 18. chronic kidney disease in renal replacement therapy 19. serious medical condition or laboratory findings that, in the investigator's judgment, may compromise patient safety during participation in the study

Nov. 16, 2021, 6:30 p.m. usa

allergy or sensitivity to peg1 analog or components arterial hypotension defined as blood pressure less than 90/60 mm of mercury or mean arterial pressure less than 65mm of mercury or bp requirement <80/50 mmhg or tam 60 mmhg with norepinephrine requirement greater than 0.1 mcg / kg / min severe hypertension defined as systolic blood pressure greater than or equal to 180 mm of mercury and / or diastolic blood pressure greater than or equal to 110 mm of mercury bradycardia defined as heart rate less than 60 beats per minute previous events of priapism or penile anatomical changes sickle cell disease, multiple myeloma, leukemia, polycythemia vera, thrombocythemia predisposing to priapism hemorrhagic diathesis active peptic ulcer, trauma, or recent brain hemorrhage. abnormal pulmonary venous return with obstruction pregnancy: a pregnancy test will be performed upon admission of the patient to the study (if applicable). heart failure with nyha functional class> 1 hemodynamically relevant arrhythmia: that generates hypotension, chest pain, dysfunction, sensory disturbance or other signs of low output mitral and / or aortic stenosis and / or insufficiency of either unstable angina acute myocardial infarction in the last 6 months ischemic or hemorrhagic cerebrovascular event in the last 6 months child b or c or decompensated liver cirrhosis chronic kidney disease in renal replacement therapy serious medical condition or laboratory findings that, in the investigator's judgment, may compromise patient safety during participation in the study

allergy or sensitivity to peg1 analog or components arterial hypotension defined as blood pressure less than 90/60 mm of mercury or mean arterial pressure less than 65mm of mercury or bp requirement <80/50 mmhg or tam 60 mmhg with norepinephrine requirement greater than 0.1 mcg / kg / min severe hypertension defined as systolic blood pressure greater than or equal to 180 mm of mercury and / or diastolic blood pressure greater than or equal to 110 mm of mercury bradycardia defined as heart rate less than 60 beats per minute previous events of priapism or penile anatomical changes sickle cell disease, multiple myeloma, leukemia, polycythemia vera, thrombocythemia predisposing to priapism hemorrhagic diathesis active peptic ulcer, trauma, or recent brain hemorrhage. abnormal pulmonary venous return with obstruction pregnancy: a pregnancy test will be performed upon admission of the patient to the study (if applicable). heart failure with nyha functional class> 1 hemodynamically relevant arrhythmia: that generates hypotension, chest pain, dysfunction, sensory disturbance or other signs of low output mitral and / or aortic stenosis and / or insufficiency of either unstable angina acute myocardial infarction in the last 6 months ischemic or hemorrhagic cerebrovascular event in the last 6 months child b or c or decompensated liver cirrhosis chronic kidney disease in renal replacement therapy serious medical condition or laboratory findings that, in the investigator's judgment, may compromise patient safety during participation in the study

Oct. 26, 2020, 11:31 p.m. usa

1. allergy or sensitivity to peg1 analog or components 2. arterial hypotension defined as blood pressure less than 90/60 mm of mercury or mean arterial pressure less than 65mm of mercury or bp requirement <80/50 mmhg or tam 60 mmhg with norepinephrine requirement greater than 0.1 mcg / kg / min 3. severe hypertension defined as systolic blood pressure greater than or equal to 180 mm of mercury and / or diastolic blood pressure greater than or equal to 110 mm of mercury 4. bradycardia defined as heart rate less than 60 beats per minute 5. previous events of priapism or penile anatomical changes 6. sickle cell disease, multiple myeloma, leukemia, polycythemia vera, thrombocythemia predisposing to priapism 7. hemorrhagic diathesis 8. active peptic ulcer, trauma, or recent brain hemorrhage. 9. abnormal pulmonary venous return with obstruction 10. pregnancy: a pregnancy test will be performed upon admission of the patient to the study (if applicable). 11. heart failure with nyha functional class> 1 12. hemodynamically relevant arrhythmia: that generates hypotension, chest pain, dysfunction, sensory disturbance or other signs of low output 13. mitral and / or aortic stenosis and / or insufficiency of either 14. unstable angina 15. acute myocardial infarction in the last 6 months 16. ischemic or hemorrhagic cerebrovascular event in the last 6 months 17. child b or c or decompensated liver cirrhosis 18. chronic kidney disease in renal replacement therapy 19. serious medical condition or laboratory findings that, in the investigator's judgment, may compromise patient safety during participation in the study

1. allergy or sensitivity to peg1 analog or components 2. arterial hypotension defined as blood pressure less than 90/60 mm of mercury or mean arterial pressure less than 65mm of mercury or bp requirement <80/50 mmhg or tam 60 mmhg with norepinephrine requirement greater than 0.1 mcg / kg / min 3. severe hypertension defined as systolic blood pressure greater than or equal to 180 mm of mercury and / or diastolic blood pressure greater than or equal to 110 mm of mercury 4. bradycardia defined as heart rate less than 60 beats per minute 5. previous events of priapism or penile anatomical changes 6. sickle cell disease, multiple myeloma, leukemia, polycythemia vera, thrombocythemia predisposing to priapism 7. hemorrhagic diathesis 8. active peptic ulcer, trauma, or recent brain hemorrhage. 9. abnormal pulmonary venous return with obstruction 10. pregnancy: a pregnancy test will be performed upon admission of the patient to the study (if applicable). 11. heart failure with nyha functional class> 1 12. hemodynamically relevant arrhythmia: that generates hypotension, chest pain, dysfunction, sensory disturbance or other signs of low output 13. mitral and / or aortic stenosis and / or insufficiency of either 14. unstable angina 15. acute myocardial infarction in the last 6 months 16. ischemic or hemorrhagic cerebrovascular event in the last 6 months 17. child b or c or decompensated liver cirrhosis 18. chronic kidney disease in renal replacement therapy 19. serious medical condition or laboratory findings that, in the investigator's judgment, may compromise patient safety during participation in the study