Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient. active malignancy other than squamous cell carcinoma; anticancer treatment such as chemotherapy or radiation therapy within the past month. nursing women or women of childbearing potential (wocbp) with a positive pregnancy test. treatment with another dhodh inhibitor (e.g., leflunomide or teriflunomide), tacrolimus, sirolimus. platelets ≤150,000 cell/mm3. hemoglobin < 10 gm/dl absolute neutrophil count < 1500 cells/mm3 renal dysfunction, i.e., creatinine clearance < 30 ml/min ast and/or alt > 1.5 uln, or total bilirubin > uln history of bleeding disorders or recent surgery in the six weeks preceding enrollment concomitant use of agents known to cause bone marrow suppression leading to thrombocytopenia history of gastrointestinal ulcer, or history of gastrointestinal bleeding. history of hepatitis b and/or c infection, active liver disease and/or cirrhosis. heart failure, current uncontrolled cardiovascular disease, including unstable angina, uncontrolled arrhythmias, major adverse cardiac event within 6 months (e.g. stroke, myocardial infarction, hospitalization due to heart failure, or revascularization procedure). life expectancy of < 5 days in the judgment of the treating clinician. evidence of critical illness defined by at least one of the following: a. respiratory failure requiring at least one of the following: i. endotracheal intubation and mechanical ventilation, noninvasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies may not be able to be administered in setting of resource limitation) ii. shock (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg or requiring vasopressors) b. multi-organ dysfunction/failure.

any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient. active malignancy other than squamous cell carcinoma; anticancer treatment such as chemotherapy or radiation therapy within the past month. nursing women or women of childbearing potential (wocbp) with a positive pregnancy test. treatment with another dhodh inhibitor (e.g., leflunomide or teriflunomide), tacrolimus, sirolimus. platelets ≤150,000 cell/mm3. hemoglobin < 10 gm/dl absolute neutrophil count < 1500 cells/mm3 renal dysfunction, i.e., creatinine clearance < 30 ml/min ast and/or alt > 1.5 uln, or total bilirubin > uln history of bleeding disorders or recent surgery in the six weeks preceding enrollment concomitant use of agents known to cause bone marrow suppression leading to thrombocytopenia history of gastrointestinal ulcer, or history of gastrointestinal bleeding. history of hepatitis b and/or c infection, active liver disease and/or cirrhosis. heart failure, current uncontrolled cardiovascular disease, including unstable angina, uncontrolled arrhythmias, major adverse cardiac event within 6 months (e.g. stroke, myocardial infarction, hospitalization due to heart failure, or revascularization procedure). life expectancy of < 5 days in the judgment of the treating clinician. evidence of critical illness defined by at least one of the following: a. respiratory failure requiring at least one of the following: i. endotracheal intubation and mechanical ventilation, noninvasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies may not be able to be administered in setting of resource limitation) ii. shock (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg or requiring vasopressors) b. multi-organ dysfunction/failure.

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

1. any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient. 2. active malignancy other than squamous cell carcinoma; anticancer treatment such as chemotherapy or radiation therapy within the past month. 3. nursing women or women of childbearing potential (wocbp) with a positive pregnancy test. 4. treatment with another dhodh inhibitor (e.g., leflunomide or teriflunomide), tacrolimus, sirolimus. 5. platelets ≤150,000 cell/mm3. 6. hemoglobin < 10 gm/dl 7. absolute neutrophil count < 1500 cells/mm3 8. renal dysfunction, i.e., creatinine clearance < 30 ml/min 9. ast and/or alt > 1.5 uln, or total bilirubin > uln 10. history of bleeding disorders or recent surgery in the six weeks preceding enrollment 11. concomitant use of agents known to cause bone marrow suppression leading to thrombocytopenia 12. history of gastrointestinal ulcer, or history of gastrointestinal bleeding. 13. history of hepatitis b and/or c infection, active liver disease and/or cirrhosis. 14. heart failure, current uncontrolled cardiovascular disease, including unstable angina, uncontrolled arrhythmias, major adverse cardiac event within 6 months (e.g. stroke, myocardial infarction, hospitalization due to heart failure, or revascularization procedure). 15. life expectancy of < 5 days in the judgment of the treating clinician. 16. evidence of critical illness defined by at least one of the following: a. respiratory failure requiring at least one of the following: i. endotracheal intubation and mechanical ventilation, noninvasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies may not be able to be administered in setting of resource limitation) ii. shock (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg or requiring vasopressors) b. multi-organ dysfunction/failure.

1. any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient. 2. active malignancy other than squamous cell carcinoma; anticancer treatment such as chemotherapy or radiation therapy within the past month. 3. nursing women or women of childbearing potential (wocbp) with a positive pregnancy test. 4. treatment with another dhodh inhibitor (e.g., leflunomide or teriflunomide), tacrolimus, sirolimus. 5. platelets ≤150,000 cell/mm3. 6. hemoglobin < 10 gm/dl 7. absolute neutrophil count < 1500 cells/mm3 8. renal dysfunction, i.e., creatinine clearance < 30 ml/min 9. ast and/or alt > 1.5 uln, or total bilirubin > uln 10. history of bleeding disorders or recent surgery in the six weeks preceding enrollment 11. concomitant use of agents known to cause bone marrow suppression leading to thrombocytopenia 12. history of gastrointestinal ulcer, or history of gastrointestinal bleeding. 13. history of hepatitis b and/or c infection, active liver disease and/or cirrhosis. 14. heart failure, current uncontrolled cardiovascular disease, including unstable angina, uncontrolled arrhythmias, major adverse cardiac event within 6 months (e.g. stroke, myocardial infarction, hospitalization due to heart failure, or revascularization procedure). 15. life expectancy of < 5 days in the judgment of the treating clinician. 16. evidence of critical illness defined by at least one of the following: a. respiratory failure requiring at least one of the following: i. endotracheal intubation and mechanical ventilation, noninvasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies may not be able to be administered in setting of resource limitation) ii. shock (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg or requiring vasopressors) b. multi-organ dysfunction/failure.