Cohort Number
Item
cohort 1:
boolean
C0599755 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Canakinumab Dose | Systemic juvenile idiopathic arthritis
Item
• patients who are receiving canakinumab treatment (4 mg/kg every 4 weeks) for systemic juvenile idiopathic arthritis (sjia) and have inactive disease at the last visit in study cacz885g2301e1
boolean
C2718773 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1384600 (UMLS CUI [2])
Cohort Number
Item
cohort 2:
boolean
C0599755 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
SJIA | Onset of illness Age
Item
confirmed diagnosis of sjia as per international league against rheumatism (ilar) definition that must have occurred at least 2 months prior to enrollment with an onset of disease < 16 years of age.
boolean
C1384600 (UMLS CUI [1])
C0277793 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
SJIA | Criteria Quantity
Item
active sjia defined as having 2 or more of the following:
boolean
C1384600 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Spiking fever Intermittent Duration | Body temperature measurement
Item
documented spiking, intermittent fever (body temperature > 38°c) for at least 1 day within 1 week before first canakinumab dose;
boolean
C0424781 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0886414 (UMLS CUI [2])
Joints Quantity Arthritis
Item
at least 2 joints with active arthritis
boolean
C0022417 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0003864 (UMLS CUI [1,3])
C-reactive protein measurement
Item
c-reactive protein (crp) > 30 mg/l (normal range < 10 mg/l)
boolean
C0201657 (UMLS CUI [1])
Exanthema Due to SJIA
Item
rash due to sjia
boolean
C0015230 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1384600 (UMLS CUI [1,3])
Serositis
Item
serositis
boolean
C0036749 (UMLS CUI [1])
Lymphadenopathy
Item
lymphadenopathy
boolean
C0497156 (UMLS CUI [1])
Hepatosplenomegaly
Item
hepatosplenomegaly
boolean
C0019214 (UMLS CUI [1])
Tuberculosis screening Negative | QUANTIFERON-TB GOLD | Purified Protein Derivative
Item
negative tb screen (quantiferon or, if required by local guidelines, purified protein derivative).
boolean
C0420004 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C1875713 (UMLS CUI [2])
C0034131 (UMLS CUI [3])
Bacterial Infection | Recurrent bacterial infection | Mycoses | Mycoses Recurrent | Virus Disease | Recurrent viral infection | HIV Infection | Hepatitis B | Hepatitis C
Item
with active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of human immunodeficiency virus (hiv) infection, hepatitis b and hepatitis c infection.
boolean
C0004623 (UMLS CUI [1])
C1844383 (UMLS CUI [2])
C0026946 (UMLS CUI [3])
C0026946 (UMLS CUI [4,1])
C2945760 (UMLS CUI [4,2])
C0042769 (UMLS CUI [5])
C1837066 (UMLS CUI [6])
C0019693 (UMLS CUI [7])
C0019163 (UMLS CUI [8])
C0019196 (UMLS CUI [9])
Metabolic Disease Causing Immunocompromised patient | Kidney Disease Causing Immunocompromised patient | Liver disease Causing Immunocompromised patient | Communicable Disease Causing Immunocompromised patient | Gastrointestinal Disease Causing Immunocompromised patient | Metabolic Disease Study Subject Participation Status At risk | Kidney Disease Study Subject Participation Status At risk | Liver disease Study Subject Participation Status At risk | Communicable Disease Study Subject Participation Status At risk | Gastrointestinal Disease Study Subject Participation Status At risk
Item
with underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and /or places the patient at unacceptable risk for participation.
boolean
C0025517 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0085393 (UMLS CUI [1,3])
C0022658 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0085393 (UMLS CUI [2,3])
C0023895 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C0085393 (UMLS CUI [3,3])
C0009450 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C0085393 (UMLS CUI [4,3])
C0017178 (UMLS CUI [5,1])
C0678227 (UMLS CUI [5,2])
C0085393 (UMLS CUI [5,3])
C0025517 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C0022658 (UMLS CUI [7,1])
C2348568 (UMLS CUI [7,2])
C1444641 (UMLS CUI [7,3])
C0023895 (UMLS CUI [8,1])
C2348568 (UMLS CUI [8,2])
C1444641 (UMLS CUI [8,3])
C0009450 (UMLS CUI [9,1])
C2348568 (UMLS CUI [9,2])
C1444641 (UMLS CUI [9,3])
C0017178 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
Neutropenia | Absolute neutrophil count
Item
with neutropenia (absolute neutrophil count < 1500/mm3) at screening.
boolean
C0027947 (UMLS CUI [1])
C0948762 (UMLS CUI [2])