Adult | Rheumatoid arthritis, moderate | Rheumatoid Arthritis Severe
Item
adults diagnosed with moderate to severe ra (rheumatoid arthritis)
boolean
C0001675 (UMLS CUI [1])
C2368567 (UMLS CUI [2])
C0003873 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Rheumatoid Arthritis
Item
diagnosis of ra based on the american college of rheumatology 1987 revised criteria.
boolean
C0003873 (UMLS CUI [1])
Methotrexate Oral Dose Stable U/week | Dose Single Quantity Minimum
Item
treatment with an oral stable weekly dose of methotrexate (mtx) (15-25 mg/week, administered as a single dose [sd]) for a minimum of 4 doses (4 weeks)
boolean
C3216566 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
C0178602 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1524031 (UMLS CUI [2,4])
Hematological Disease | Hemoglobin measurement | Hematocrit level | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement
Item
blood dyscrasias including confirmed: hemoglobin <9 g/dl or hematocrit <30%; white blood cell count <3.0 x 109/l; absolute neutrophil count <1.2 x 109/l; platelet count <100 x 109/l
boolean
C0018939 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0518014 (UMLS CUI [3])
C0023508 (UMLS CUI [4])
C0948762 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
Communicable Diseases | Hospitalization Required | Requirement Therapy Antimicrobial Parenteral | ORAL HERPES RECURRENT | Recurrent genital herpes | HERPES ZOSTER RECURRENT | Communicable Disease Worsening Due to Clinical Trial Participation
Item
evidence or history of clinically significant infections within the past 6 months (eg, those requiring hospitalization, requiring parenteral antimicrobial therapy, or those with recurrent oral or genital herpes, recurrent herpes zoster, or any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the trial.
boolean
C0009450 (UMLS CUI [1])
C1708385 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0443071 (UMLS CUI [3,3])
C1518896 (UMLS CUI [3,4])
C0747043 (UMLS CUI [4])
C1274323 (UMLS CUI [5])
C0744893 (UMLS CUI [6])
C0009450 (UMLS CUI [7,1])
C0332271 (UMLS CUI [7,2])
C0678226 (UMLS CUI [7,3])
C0008976 (UMLS CUI [7,4])
C0679823 (UMLS CUI [7,5])
Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased | Increased liver function tests During Methotrexate Dose | Chronic liver disease | Hepatitis
Item
total bilirubin, ast (aspartate aminotransferase) or alt (alanine aminotransferase) more than 1.2 times the upper limit of normal at the screening visit, or a history of clinically significant elevated liver function tests (lfts) while on current mtx dose or chronic liver disease, recent or active hepatitis.
boolean
C0741494 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0877359 (UMLS CUI [4,1])
C0347984 (UMLS CUI [4,2])
C0025677 (UMLS CUI [4,3])
C0178602 (UMLS CUI [4,4])
C0341439 (UMLS CUI [5])
C0019158 (UMLS CUI [6])