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

1. age \< 18 years 2. in the opinion of the investigator, not expected to survive for more than 48 hours from screening 3. presence of any of the following abnormal laboratory values at screening 1. absolute neutrophil count (anc) \< 2,000mm3 2. alanine transferase (alt) or aspartate transferase (ast) \> 5 times upper limit of normal 4. use of systemic corticosteroid therapy within 7 days of study enrollment 5. known or suspected active bacterial, fungal or mycobacterial infections including tuberculosis (tb) 6. participation in a double-blind clinical research study evaluating an investigational product or therapy within 3 months and less than 5 half-lives of investigational product prior to the screening visit. exception: the use of remdesivir, hydroxychloroquine, or other treatments being used for covid-19 infection in the context of an open-label study or compassionate use protocol is permitted 7. any physical examination findings, and/or history of any illness, concomitant medication or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study 8. prisoner 9. pregnancy

1. age \< 18 years 2. in the opinion of the investigator, not expected to survive for more than 48 hours from screening 3. presence of any of the following abnormal laboratory values at screening 1. absolute neutrophil count (anc) \< 2,000mm3 2. alanine transferase (alt) or aspartate transferase (ast) \> 5 times upper limit of normal 4. use of systemic corticosteroid therapy within 7 days of study enrollment 5. known or suspected active bacterial, fungal or mycobacterial infections including tuberculosis (tb) 6. participation in a double-blind clinical research study evaluating an investigational product or therapy within 3 months and less than 5 half-lives of investigational product prior to the screening visit. exception: the use of remdesivir, hydroxychloroquine, or other treatments being used for covid-19 infection in the context of an open-label study or compassionate use protocol is permitted 7. any physical examination findings, and/or history of any illness, concomitant medication or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study 8. prisoner 9. pregnancy

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

age < 18 years in the opinion of the investigator, not expected to survive for more than 48 hours from screening presence of any of the following abnormal laboratory values at screening absolute neutrophil count (anc) < 2,000mm3 alanine transferase (alt) or aspartate transferase (ast) > 5 times upper limit of normal use of systemic corticosteroid therapy within 7 days of study enrollment known or suspected active bacterial, fungal or mycobacterial infections including tuberculosis (tb) participation in a double-blind clinical research study evaluating an investigational product or therapy within 3 months and less than 5 half-lives of investigational product prior to the screening visit. exception: the use of remdesivir, hydroxychloroquine, or other treatments being used for covid-19 infection in the context of an open-label study or compassionate use protocol is permitted any physical examination findings, and/or history of any illness, concomitant medication or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study prisoner pregnancy

age < 18 years in the opinion of the investigator, not expected to survive for more than 48 hours from screening presence of any of the following abnormal laboratory values at screening absolute neutrophil count (anc) < 2,000mm3 alanine transferase (alt) or aspartate transferase (ast) > 5 times upper limit of normal use of systemic corticosteroid therapy within 7 days of study enrollment known or suspected active bacterial, fungal or mycobacterial infections including tuberculosis (tb) participation in a double-blind clinical research study evaluating an investigational product or therapy within 3 months and less than 5 half-lives of investigational product prior to the screening visit. exception: the use of remdesivir, hydroxychloroquine, or other treatments being used for covid-19 infection in the context of an open-label study or compassionate use protocol is permitted any physical examination findings, and/or history of any illness, concomitant medication or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study prisoner pregnancy

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

1. age < 18 years 2. in the opinion of the investigator, not expected to survive for more than 48 hours from screening 3. presence of any of the following abnormal laboratory values at screening 1. absolute neutrophil count (anc) < 2,000mm3 2. alanine transferase (alt) or aspartate transferase (ast) > 5 times upper limit of normal 4. use of systemic corticosteroid therapy within 7 days of study enrollment 5. known or suspected active bacterial, fungal or mycobacterial infections including tuberculosis (tb) 6. participation in a double-blind clinical research study evaluating an investigational product or therapy within 3 months and less than 5 half-lives of investigational product prior to the screening visit. exception: the use of remdesivir, hydroxychloroquine, or other treatments being used for covid-19 infection in the context of an open-label study or compassionate use protocol is permitted 7. any physical examination findings, and/or history of any illness, concomitant medication or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study 8. prisoner 9. pregnancy

1. age < 18 years 2. in the opinion of the investigator, not expected to survive for more than 48 hours from screening 3. presence of any of the following abnormal laboratory values at screening 1. absolute neutrophil count (anc) < 2,000mm3 2. alanine transferase (alt) or aspartate transferase (ast) > 5 times upper limit of normal 4. use of systemic corticosteroid therapy within 7 days of study enrollment 5. known or suspected active bacterial, fungal or mycobacterial infections including tuberculosis (tb) 6. participation in a double-blind clinical research study evaluating an investigational product or therapy within 3 months and less than 5 half-lives of investigational product prior to the screening visit. exception: the use of remdesivir, hydroxychloroquine, or other treatments being used for covid-19 infection in the context of an open-label study or compassionate use protocol is permitted 7. any physical examination findings, and/or history of any illness, concomitant medication or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study 8. prisoner 9. pregnancy