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

* participants who have previously had a score of 6 or 7 on the 9-point ordinal scale. * inability to swallow capsules (administration via nasogastric tube is permitted in participants who become unable to swallow after starting the study drug). * history of the following cardiac conditions: 1. myocardial infarction within 3 months prior to the first dose 2. unstable angina 3. history of clinically significant dysrhythmias (long qt features on electrocardiogram \[ecg\], sustained bradycardia \[less than or equal to {\<=} 55 beats per minute {bpm}\]), left bundle branch block, or ventricular arrhythmia) or history of familial long qt. participants with an implantable cardioverter defibrillator device in place, will be allowed to enroll. atrial fibrillation will not be a reason for exclusion. * screening 12-lead ecg with a measurable qt interval according to fridericia correction (qtcf) greater than (\>) 470 msec. * clinically significant hypokalaemia. * therapeutic anticoagulation with vitamin k antagonists. * previous bowel resection that would interfere with drug absorption. * any participant whose interests are not best served by study participation, as determined by a senior attending clinician. * alanine aminotransferase/aspartate aminotransferase \>5 × the upper limit of normal. * current treatment for human immunodeficiency virus (hiv) or tuberculosis (tb). * positive serologic assay at screening for hepatitis b virus (hep b surface antigen) or hepatitis c virus (hepatitis c pcr or hepatitis c core antigen) at local laboratory. * stage 4 severe chronic kidney disease. * anticipated transfer to another hospital that is not a study center within 72 hours. * allergy to any study treatment. * experimental off-label usage of medicinal products as treatments for covid-19 at the time of enrolment. * participants participating in another clinical study of an investigational medicinal product. * current or planned treatment for tb.

* participants who have previously had a score of 6 or 7 on the 9-point ordinal scale. * inability to swallow capsules (administration via nasogastric tube is permitted in participants who become unable to swallow after starting the study drug). * history of the following cardiac conditions: 1. myocardial infarction within 3 months prior to the first dose 2. unstable angina 3. history of clinically significant dysrhythmias (long qt features on electrocardiogram \[ecg\], sustained bradycardia \[less than or equal to {\<=} 55 beats per minute {bpm}\]), left bundle branch block, or ventricular arrhythmia) or history of familial long qt. participants with an implantable cardioverter defibrillator device in place, will be allowed to enroll. atrial fibrillation will not be a reason for exclusion. * screening 12-lead ecg with a measurable qt interval according to fridericia correction (qtcf) greater than (\>) 470 msec. * clinically significant hypokalaemia. * therapeutic anticoagulation with vitamin k antagonists. * previous bowel resection that would interfere with drug absorption. * any participant whose interests are not best served by study participation, as determined by a senior attending clinician. * alanine aminotransferase/aspartate aminotransferase \>5 × the upper limit of normal. * current treatment for human immunodeficiency virus (hiv) or tuberculosis (tb). * positive serologic assay at screening for hepatitis b virus (hep b surface antigen) or hepatitis c virus (hepatitis c pcr or hepatitis c core antigen) at local laboratory. * stage 4 severe chronic kidney disease. * anticipated transfer to another hospital that is not a study center within 72 hours. * allergy to any study treatment. * experimental off-label usage of medicinal products as treatments for covid-19 at the time of enrolment. * participants participating in another clinical study of an investigational medicinal product. * current or planned treatment for tb.

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

participants who have previously had a score of 6 or 7 on the 9-point ordinal scale. inability to swallow capsules (administration via nasogastric tube is permitted in participants who become unable to swallow after starting the study drug). history of the following cardiac conditions: myocardial infarction within 3 months prior to the first dose unstable angina history of clinically significant dysrhythmias (long qt features on electrocardiogram [ecg], sustained bradycardia [less than or equal to {<=} 55 beats per minute {bpm}]), left bundle branch block, or ventricular arrhythmia) or history of familial long qt. participants with an implantable cardioverter defibrillator device in place, will be allowed to enroll. atrial fibrillation will not be a reason for exclusion. screening 12-lead ecg with a measurable qt interval according to fridericia correction (qtcf) greater than (>) 470 msec. clinically significant hypokalaemia. therapeutic anticoagulation with vitamin k antagonists. previous bowel resection that would interfere with drug absorption. any participant whose interests are not best served by study participation, as determined by a senior attending clinician. alanine aminotransferase/aspartate aminotransferase >5 × the upper limit of normal. current treatment for human immunodeficiency virus (hiv) or tuberculosis (tb). positive serologic assay at screening for hepatitis b virus (hep b surface antigen) or hepatitis c virus (hepatitis c pcr or hepatitis c core antigen) at local laboratory. stage 4 severe chronic kidney disease. anticipated transfer to another hospital that is not a study center within 72 hours. allergy to any study treatment. experimental off-label usage of medicinal products as treatments for covid-19 at the time of enrolment. participants participating in another clinical study of an investigational medicinal product. current or planned treatment for tb.

participants who have previously had a score of 6 or 7 on the 9-point ordinal scale. inability to swallow capsules (administration via nasogastric tube is permitted in participants who become unable to swallow after starting the study drug). history of the following cardiac conditions: myocardial infarction within 3 months prior to the first dose unstable angina history of clinically significant dysrhythmias (long qt features on electrocardiogram [ecg], sustained bradycardia [less than or equal to {<=} 55 beats per minute {bpm}]), left bundle branch block, or ventricular arrhythmia) or history of familial long qt. participants with an implantable cardioverter defibrillator device in place, will be allowed to enroll. atrial fibrillation will not be a reason for exclusion. screening 12-lead ecg with a measurable qt interval according to fridericia correction (qtcf) greater than (>) 470 msec. clinically significant hypokalaemia. therapeutic anticoagulation with vitamin k antagonists. previous bowel resection that would interfere with drug absorption. any participant whose interests are not best served by study participation, as determined by a senior attending clinician. alanine aminotransferase/aspartate aminotransferase >5 × the upper limit of normal. current treatment for human immunodeficiency virus (hiv) or tuberculosis (tb). positive serologic assay at screening for hepatitis b virus (hep b surface antigen) or hepatitis c virus (hepatitis c pcr or hepatitis c core antigen) at local laboratory. stage 4 severe chronic kidney disease. anticipated transfer to another hospital that is not a study center within 72 hours. allergy to any study treatment. experimental off-label usage of medicinal products as treatments for covid-19 at the time of enrolment. participants participating in another clinical study of an investigational medicinal product. current or planned treatment for tb.

May 19, 2021, 12:31 a.m. usa

- participants who have previously had a score of 6 or 7 on the 9-point ordinal scale. - inability to swallow capsules (administration via nasogastric tube is permitted in participants who become unable to swallow after starting the study drug). - history of the following cardiac conditions: 1. myocardial infarction within 3 months prior to the first dose 2. unstable angina 3. history of clinically significant dysrhythmias (long qt features on electrocardiogram [ecg], sustained bradycardia [less than or equal to {<=} 55 beats per minute {bpm}]), left bundle branch block, or ventricular arrhythmia) or history of familial long qt. participants with an implantable cardioverter defibrillator device in place, will be allowed to enroll. atrial fibrillation will not be a reason for exclusion. - screening 12-lead ecg with a measurable qt interval according to fridericia correction (qtcf) greater than (>) 470 msec. - clinically significant hypokalaemia. - therapeutic anticoagulation with vitamin k antagonists. - previous bowel resection that would interfere with drug absorption. - any participant whose interests are not best served by study participation, as determined by a senior attending clinician. - alanine aminotransferase/aspartate aminotransferase >5 × the upper limit of normal. - current treatment for human immunodeficiency virus (hiv) or tuberculosis (tb). - positive serologic assay at screening for hepatitis b virus (hep b surface antigen) or hepatitis c virus (hepatitis c pcr or hepatitis c core antigen) at local laboratory. - stage 4 severe chronic kidney disease. - anticipated transfer to another hospital that is not a study center within 72 hours. - allergy to any study treatment. - experimental off-label usage of medicinal products as treatments for covid-19 at the time of enrolment. - participants participating in another clinical study of an investigational medicinal product. - current or planned treatment for tb.

- participants who have previously had a score of 6 or 7 on the 9-point ordinal scale. - inability to swallow capsules (administration via nasogastric tube is permitted in participants who become unable to swallow after starting the study drug). - history of the following cardiac conditions: 1. myocardial infarction within 3 months prior to the first dose 2. unstable angina 3. history of clinically significant dysrhythmias (long qt features on electrocardiogram [ecg], sustained bradycardia [less than or equal to {<=} 55 beats per minute {bpm}]), left bundle branch block, or ventricular arrhythmia) or history of familial long qt. participants with an implantable cardioverter defibrillator device in place, will be allowed to enroll. atrial fibrillation will not be a reason for exclusion. - screening 12-lead ecg with a measurable qt interval according to fridericia correction (qtcf) greater than (>) 470 msec. - clinically significant hypokalaemia. - therapeutic anticoagulation with vitamin k antagonists. - previous bowel resection that would interfere with drug absorption. - any participant whose interests are not best served by study participation, as determined by a senior attending clinician. - alanine aminotransferase/aspartate aminotransferase >5 × the upper limit of normal. - current treatment for human immunodeficiency virus (hiv) or tuberculosis (tb). - positive serologic assay at screening for hepatitis b virus (hep b surface antigen) or hepatitis c virus (hepatitis c pcr or hepatitis c core antigen) at local laboratory. - stage 4 severe chronic kidney disease. - anticipated transfer to another hospital that is not a study center within 72 hours. - allergy to any study treatment. - experimental off-label usage of medicinal products as treatments for covid-19 at the time of enrolment. - participants participating in another clinical study of an investigational medicinal product. - current or planned treatment for tb.