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

* alanine aminotransferase (alt)/aspartate aminotransferase (ast) \>5 × the upper limit of normal (uln). * known active infection with hiv or hepatitis b or c. * pulmonary oedema/respiratory failure due to cardiogenic insult. * previous to hospitalisation, on long-term oxygen therapy. * a confirmed baseline prolongation of qtc interval to greater than 450 ms in males or 470 ms in females according to the bazett formula, or any other relevant ecg finding at screening, or concomitant use of medication prolonging qt interval. * stage 4 severe chronic kidney disease or requiring dialysis (i.e., egfr \<30 ml/min/1.73 m2). history of the following cardiac conditions: * myocardial infarction within 3 months prior to the first dose * unstable angina * history of clinically significant long qt features on electrocardiogram (ecg) or history of familial long qt * anticipated transfer/discharge to another hospital or care facility other than their place of residence * further exclusion criteria apply

* alanine aminotransferase (alt)/aspartate aminotransferase (ast) \>5 × the upper limit of normal (uln). * known active infection with hiv or hepatitis b or c. * pulmonary oedema/respiratory failure due to cardiogenic insult. * previous to hospitalisation, on long-term oxygen therapy. * a confirmed baseline prolongation of qtc interval to greater than 450 ms in males or 470 ms in females according to the bazett formula, or any other relevant ecg finding at screening, or concomitant use of medication prolonging qt interval. * stage 4 severe chronic kidney disease or requiring dialysis (i.e., egfr \<30 ml/min/1.73 m2). history of the following cardiac conditions: * myocardial infarction within 3 months prior to the first dose * unstable angina * history of clinically significant long qt features on electrocardiogram (ecg) or history of familial long qt * anticipated transfer/discharge to another hospital or care facility other than their place of residence * further exclusion criteria apply

Oct. 27, 2020, 11:31 p.m. usa

- alanine aminotransferase (alt)/aspartate aminotransferase (ast) >5 × the upper limit of normal (uln). - known active infection with hiv or hepatitis b or c. - pulmonary oedema/respiratory failure due to cardiogenic insult. - previous to hospitalisation, on long-term oxygen therapy. - a confirmed baseline prolongation of qtc interval to greater than 450 ms in males or 470 ms in females according to the bazett formula, or any other relevant ecg finding at screening, or concomitant use of medication prolonging qt interval. - stage 4 severe chronic kidney disease or requiring dialysis (i.e., egfr <30 ml/min/1.73 m2). history of the following cardiac conditions: - myocardial infarction within 3 months prior to the first dose - unstable angina - history of clinically significant long qt features on electrocardiogram (ecg) or history of familial long qt - anticipated transfer/discharge to another hospital or care facility other than their place of residence - further exclusion criteria apply

- alanine aminotransferase (alt)/aspartate aminotransferase (ast) >5 × the upper limit of normal (uln). - known active infection with hiv or hepatitis b or c. - pulmonary oedema/respiratory failure due to cardiogenic insult. - previous to hospitalisation, on long-term oxygen therapy. - a confirmed baseline prolongation of qtc interval to greater than 450 ms in males or 470 ms in females according to the bazett formula, or any other relevant ecg finding at screening, or concomitant use of medication prolonging qt interval. - stage 4 severe chronic kidney disease or requiring dialysis (i.e., egfr <30 ml/min/1.73 m2). history of the following cardiac conditions: - myocardial infarction within 3 months prior to the first dose - unstable angina - history of clinically significant long qt features on electrocardiogram (ecg) or history of familial long qt - anticipated transfer/discharge to another hospital or care facility other than their place of residence - further exclusion criteria apply