Created at Source Raw Value Validated value
Oct. 26, 2020, 8:29 a.m. oms

1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5x the upper limit of normal, result within 72 h of randomization (the result closest to randomization should be used if several results are available) 2. History of severe liver disease 3. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30), result within 72 h of randomization (the result closest to randomization should be used if several results are available) 4. Absolute neutrophil count less than 1.0 x 10(9) cells/l within 72 h of randomization (the result closest to randomization should be used if several results are available) 5. Current treatment with itraconazole, ketoconazole, diltiazem or verapamil 6. Pregnant or breast feeding 7. Anticipated transfer to another hospital which is not a trial site within 24 hours 8. Allergy to brensocatib 9. Use of any investigational drug within 5 times the elimination half-life after the last trial dose or within 30 days, whichever is longer

1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5x the upper limit of normal, result within 72 h of randomization (the result closest to randomization should be used if several results are available) 2. History of severe liver disease 3. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30), result within 72 h of randomization (the result closest to randomization should be used if several results are available) 4. Absolute neutrophil count less than 1.0 x 10(9) cells/l within 72 h of randomization (the result closest to randomization should be used if several results are available) 5. Current treatment with itraconazole, ketoconazole, diltiazem or verapamil 6. Pregnant or breast feeding 7. Anticipated transfer to another hospital which is not a trial site within 24 hours 8. Allergy to brensocatib 9. Use of any investigational drug within 5 times the elimination half-life after the last trial dose or within 30 days, whichever is longer