Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

I. Known severe allergic reactions to TCZ or other monoclonal antibodies <br/ >II. Active tuberculosis (TB) infection. <br/ >III. Suspected or active bacterial, fungal, viral (except treated HCV or HBV infection), or other infection (besides COVID-19). <br/ >IV. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. <br/ >V. Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with in the past 6 months. <br/ >VI. Participating in other drug clinical trials <br/ >VII. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination <br/ >VIII. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization <br/ >IX. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigatorâ??s judgment, precludes the patient safe participation in and completion of the study. <br/ >X. Definite diagnosis of rheumatic immune related diseases. <br/ >XI. Administration of steroids equivalent to methylprednisolone at a dose >1mg/kg/day) at screening/baseline <br/ >XII. Absolute Neutrophil count <500, platelet count <50,000 per microliter at screening/baseline <br/ >XIII. Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) >10 times upper limit of normal detected with-in 24 hours at screening/baseline <br/ >

I. Known severe allergic reactions to TCZ or other monoclonal antibodies <br/ >II. Active tuberculosis (TB) infection. <br/ >III. Suspected or active bacterial, fungal, viral (except treated HCV or HBV infection), or other infection (besides COVID-19). <br/ >IV. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. <br/ >V. Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with in the past 6 months. <br/ >VI. Participating in other drug clinical trials <br/ >VII. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination <br/ >VIII. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization <br/ >IX. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigatorâ??s judgment, precludes the patient safe participation in and completion of the study. <br/ >X. Definite diagnosis of rheumatic immune related diseases. <br/ >XI. Administration of steroids equivalent to methylprednisolone at a dose >1mg/kg/day) at screening/baseline <br/ >XII. Absolute Neutrophil count <500, platelet count <50,000 per microliter at screening/baseline <br/ >XIII. Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) >10 times upper limit of normal detected with-in 24 hours at screening/baseline <br/ >

Nov. 13, 2021, 5:33 p.m. oms

N/A

N/A

Oct. 26, 2020, 8:29 a.m. oms

I. Known severe allergic reactions to TCZ or other monoclonal antibodies <br/ >II. Active tuberculosis (TB) infection. <br/ >III. Suspected or active bacterial, fungal, viral (except treated HCV or HBV infection), or other infection (besides COVID-19). <br/ >IV. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. <br/ >V. Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with in the past 6 months. <br/ >VI. Participating in other drug clinical trials <br/ >VII. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination <br/ >VIII. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization <br/ >IX. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigatorâ??s judgment, precludes the patient safe participation in and completion of the study. <br/ >X. Definite diagnosis of rheumatic immune related diseases. <br/ >XI. Administration of steroids equivalent to methylprednisolone at a dose >1mg/kg/day) at screening/baseline <br/ >XII. Absolute Neutrophil count <500, platelet count <50,000 per microliter at screening/baseline <br/ >XIII. Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) >10 times upper limit of normal detected with-in 24 hours at screening/baseline <br/ >

I. Known severe allergic reactions to TCZ or other monoclonal antibodies <br/ >II. Active tuberculosis (TB) infection. <br/ >III. Suspected or active bacterial, fungal, viral (except treated HCV or HBV infection), or other infection (besides COVID-19). <br/ >IV. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. <br/ >V. Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with in the past 6 months. <br/ >VI. Participating in other drug clinical trials <br/ >VII. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination <br/ >VIII. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization <br/ >IX. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigatorâ??s judgment, precludes the patient safe participation in and completion of the study. <br/ >X. Definite diagnosis of rheumatic immune related diseases. <br/ >XI. Administration of steroids equivalent to methylprednisolone at a dose >1mg/kg/day) at screening/baseline <br/ >XII. Absolute Neutrophil count <500, platelet count <50,000 per microliter at screening/baseline <br/ >XIII. Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) >10 times upper limit of normal detected with-in 24 hours at screening/baseline <br/ >