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

* suspected active or chronic bacterial (including mycobacterium tuberculosis), fungal, viral, or other infection (besides sars-cov-2). * in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment. * intubated prior to randomization. * previous treatment with anti-rejection and immunomodulatory drugs within the past 2 weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for immunomodulatory therapeutic antibodies or prohibited drugs, with the exception of hydroxychloroquine, chloroquine or corticosteroids: for covid-19 infection, ongoing corticosteroid treatment is permitted at doses as per local soc.for non-covid-19 disorders, ongoing corticosteroid treatment is permitted at doses up to and including prednisolone 10 mg daily or equivalent. in patients in the netherlands only, the use of hydroxychloroquine and/or chloroquine in the past 2 weeks are exclusionary. * serum alanine transaminase (alt) or aspartate transaminase (ast) \>5 times upper limit of normal detected within 24 hours at screening or at baseline (according to local laboratory reference ranges) or other evidence if severe hepatic impairment (child-pugh class c). * absolute peripheral blood neutrophil count of ≤1000/mm3. * estimated gfr (egfr) ≤30 ml/min/1.73m2 (based on ckd-epi formula). * patients currently being treated with drugs known to be strong or moderate inducers of isoenzyme cyp2c9 and/or strong inhibitors of cyp2c9 and/or strong inducers of cytochrome p450, family 3, subfamily a (cyp3a) and the treatment cannot be discontinued or switched to a different medication prior to starting study treatment. * patients with innate or acquired immunodeficiencies. * patients who have undergone solid organ or stem cell transplantation.

* suspected active or chronic bacterial (including mycobacterium tuberculosis), fungal, viral, or other infection (besides sars-cov-2). * in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment. * intubated prior to randomization. * previous treatment with anti-rejection and immunomodulatory drugs within the past 2 weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for immunomodulatory therapeutic antibodies or prohibited drugs, with the exception of hydroxychloroquine, chloroquine or corticosteroids: for covid-19 infection, ongoing corticosteroid treatment is permitted at doses as per local soc.for non-covid-19 disorders, ongoing corticosteroid treatment is permitted at doses up to and including prednisolone 10 mg daily or equivalent. in patients in the netherlands only, the use of hydroxychloroquine and/or chloroquine in the past 2 weeks are exclusionary. * serum alanine transaminase (alt) or aspartate transaminase (ast) \>5 times upper limit of normal detected within 24 hours at screening or at baseline (according to local laboratory reference ranges) or other evidence if severe hepatic impairment (child-pugh class c). * absolute peripheral blood neutrophil count of ≤1000/mm3. * estimated gfr (egfr) ≤30 ml/min/1.73m2 (based on ckd-epi formula). * patients currently being treated with drugs known to be strong or moderate inducers of isoenzyme cyp2c9 and/or strong inhibitors of cyp2c9 and/or strong inducers of cytochrome p450, family 3, subfamily a (cyp3a) and the treatment cannot be discontinued or switched to a different medication prior to starting study treatment. * patients with innate or acquired immunodeficiencies. * patients who have undergone solid organ or stem cell transplantation.

Dec. 1, 2021, 11 p.m. usa

suspected active or chronic bacterial (including mycobacterium tuberculosis), fungal, viral, or other infection (besides sars-cov-2). in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment. intubated prior to randomization. previous treatment with anti-rejection and immunomodulatory drugs within the past 2 weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for immunomodulatory therapeutic antibodies or prohibited drugs, with the exception of hydroxychloroquine, chloroquine or corticosteroids: for covid-19 infection, ongoing corticosteroid treatment is permitted at doses as per local soc.for non-covid-19 disorders, ongoing corticosteroid treatment is permitted at doses up to and including prednisolone 10 mg daily or equivalent. in patients in the netherlands only, the use of hydroxychloroquine and/or chloroquine in the past 2 weeks are exclusionary. serum alanine transaminase (alt) or aspartate transaminase (ast) >5 times upper limit of normal detected within 24 hours at screening or at baseline (according to local laboratory reference ranges) or other evidence if severe hepatic impairment (child-pugh class c). absolute peripheral blood neutrophil count of ≤1000/mm3. estimated gfr (egfr) ≤30 ml/min/1.73m2 (based on ckd-epi formula). patients currently being treated with drugs known to be strong or moderate inducers of isoenzyme cyp2c9 and/or strong inhibitors of cyp2c9 and/or strong inducers of cytochrome p450, family 3, subfamily a (cyp3a) and the treatment cannot be discontinued or switched to a different medication prior to starting study treatment. patients with innate or acquired immunodeficiencies. patients who have undergone solid organ or stem cell transplantation.

suspected active or chronic bacterial (including mycobacterium tuberculosis), fungal, viral, or other infection (besides sars-cov-2). in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment. intubated prior to randomization. previous treatment with anti-rejection and immunomodulatory drugs within the past 2 weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for immunomodulatory therapeutic antibodies or prohibited drugs, with the exception of hydroxychloroquine, chloroquine or corticosteroids: for covid-19 infection, ongoing corticosteroid treatment is permitted at doses as per local soc.for non-covid-19 disorders, ongoing corticosteroid treatment is permitted at doses up to and including prednisolone 10 mg daily or equivalent. in patients in the netherlands only, the use of hydroxychloroquine and/or chloroquine in the past 2 weeks are exclusionary. serum alanine transaminase (alt) or aspartate transaminase (ast) >5 times upper limit of normal detected within 24 hours at screening or at baseline (according to local laboratory reference ranges) or other evidence if severe hepatic impairment (child-pugh class c). absolute peripheral blood neutrophil count of ≤1000/mm3. estimated gfr (egfr) ≤30 ml/min/1.73m2 (based on ckd-epi formula). patients currently being treated with drugs known to be strong or moderate inducers of isoenzyme cyp2c9 and/or strong inhibitors of cyp2c9 and/or strong inducers of cytochrome p450, family 3, subfamily a (cyp3a) and the treatment cannot be discontinued or switched to a different medication prior to starting study treatment. patients with innate or acquired immunodeficiencies. patients who have undergone solid organ or stem cell transplantation.

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

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