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

* pregnant or breastfeeding, or positive pregnancy test at screening * any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study * in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments * participating in another clinical drug trial * treatment with investigational therapy (other than for covid-19) within 5 half-lives or 30 days (whichever is longer) prior to initiation of study drug * use of janus kinase (jak) inhibitor within 30 days or 5 drug elimination half-lives (whichever is longer) prior to screening * have received high-dose systemic corticosteroids (≥1 mg/kg/day methylprednisolone or equivalent) within 72 hours prior to day 1 * known hiv infection with cd4 \<200 cells/microlitre (ul) or \<14% of all lymphocytes * alt or ast \>10 times the upper limit of normal (uln) detected at screening * history of anaplastic large-cell lymphoma or mantle-cell lymphoma * history of cancer within the previous 5 years unless it has been adequately treated and considered cured or remission-free in the investigator's judgment * clinical evidence of active or unstable cardiovascular disease (e.g., acute myocardial ischemia or decompensated heart failure), as determined by investigator assessment, ecg, laboratory assessment, or echocardiographic data * history of moderate or severe allergic, anaphylactic, or anaphylactoid reactions or hypersensitivity to any component of study treatment

* pregnant or breastfeeding, or positive pregnancy test at screening * any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study * in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments * participating in another clinical drug trial * treatment with investigational therapy (other than for covid-19) within 5 half-lives or 30 days (whichever is longer) prior to initiation of study drug * use of janus kinase (jak) inhibitor within 30 days or 5 drug elimination half-lives (whichever is longer) prior to screening * have received high-dose systemic corticosteroids (≥1 mg/kg/day methylprednisolone or equivalent) within 72 hours prior to day 1 * known hiv infection with cd4 \<200 cells/microlitre (ul) or \<14% of all lymphocytes * alt or ast \>10 times the upper limit of normal (uln) detected at screening * history of anaplastic large-cell lymphoma or mantle-cell lymphoma * history of cancer within the previous 5 years unless it has been adequately treated and considered cured or remission-free in the investigator's judgment * clinical evidence of active or unstable cardiovascular disease (e.g., acute myocardial ischemia or decompensated heart failure), as determined by investigator assessment, ecg, laboratory assessment, or echocardiographic data * history of moderate or severe allergic, anaphylactic, or anaphylactoid reactions or hypersensitivity to any component of study treatment

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

- pregnant or breastfeeding, or positive pregnancy test at screening - any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study - in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments - participating in another clinical drug trial - treatment with investigational therapy (other than for covid-19) within 5 half-lives or 30 days (whichever is longer) prior to initiation of study drug - use of janus kinase (jak) inhibitor within 30 days or 5 drug elimination half-lives (whichever is longer) prior to screening - have received high-dose systemic corticosteroids (≥1 mg/kg/day methylprednisolone or equivalent) within 72 hours prior to day 1 - known hiv infection with cd4 <200 cells/microlitre (ul) or <14% of all lymphocytes - alt or ast >10 times the upper limit of normal (uln) detected at screening - history of anaplastic large-cell lymphoma or mantle-cell lymphoma - history of cancer within the previous 5 years unless it has been adequately treated and considered cured or remission-free in the investigator's judgment - clinical evidence of active or unstable cardiovascular disease (e.g., acute myocardial ischemia or decompensated heart failure), as determined by investigator assessment, ecg, laboratory assessment, or echocardiographic data - history of moderate or severe allergic, anaphylactic, or anaphylactoid reactions or hypersensitivity to any component of study treatment

- pregnant or breastfeeding, or positive pregnancy test at screening - any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study - in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments - participating in another clinical drug trial - treatment with investigational therapy (other than for covid-19) within 5 half-lives or 30 days (whichever is longer) prior to initiation of study drug - use of janus kinase (jak) inhibitor within 30 days or 5 drug elimination half-lives (whichever is longer) prior to screening - have received high-dose systemic corticosteroids (≥1 mg/kg/day methylprednisolone or equivalent) within 72 hours prior to day 1 - known hiv infection with cd4 <200 cells/microlitre (ul) or <14% of all lymphocytes - alt or ast >10 times the upper limit of normal (uln) detected at screening - history of anaplastic large-cell lymphoma or mantle-cell lymphoma - history of cancer within the previous 5 years unless it has been adequately treated and considered cured or remission-free in the investigator's judgment - clinical evidence of active or unstable cardiovascular disease (e.g., acute myocardial ischemia or decompensated heart failure), as determined by investigator assessment, ecg, laboratory assessment, or echocardiographic data - history of moderate or severe allergic, anaphylactic, or anaphylactoid reactions or hypersensitivity to any component of study treatment