Clinical Trial Specified Completed | Eligibility Criteria Specified Fulfill
Item
subjects who had successfully completed the previous dose finding study and were fully compliant to the inclusion/exclusion criteria described in the previous dsc/08/2357/36
boolean
C0008976 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1516637 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Fever Relationship Juvenile arthritis | Feature Systemic Juvenile arthritis
Item
patients with fever related to jia or other systemic features of jia during 12 months before entering the study
boolean
C0015967 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C3495559 (UMLS CUI [1,3])
C2348519 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C3495559 (UMLS CUI [2,3])
Bacterial Infections Requirement Antibiotic therapy | Mycoses Requirement Antibiotic therapy
Item
active bacterial or mycotic infection requiring antimicrobial treatment
boolean
C0004623 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0338237 (UMLS CUI [1,3])
C0026946 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0338237 (UMLS CUI [2,3])
Episode of Macrophage Activation Syndrome
Item
episode of macrophage activation syndrome over the last 6 months
boolean
C0332189 (UMLS CUI [1,1])
C1096155 (UMLS CUI [1,2])
Prolonged QT interval | Prolonged QTc interval | Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Causing Prolonged QTc interval | Risk factors Additional Torsades de Pointes
Item
baseline prolongation of qt/qtc interval, use of concomitant medications that prolong the qt/qtc interval or history of additional risk factors for tdp.
boolean
C0151878 (UMLS CUI [1])
C1560305 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C0151878 (UMLS CUI [3,3])
C0013227 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C1560305 (UMLS CUI [4,3])
C0035648 (UMLS CUI [5,1])
C1524062 (UMLS CUI [5,2])
C0040479 (UMLS CUI [5,3])
Cardiovascular Disease
Item
clinically significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Illness Study Subject Participation Status At risk | Condition Study Subject Participation Status At risk
Item
clinically significant illness i.e. any condition that in the opinion of the investigator places the patient to unacceptable risk for adverse outcome if he/she were to participate in the study
boolean
C0221423 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
Mental disorders Limiting Medication Compliance | Social situation Limiting Medication Compliance | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
psychiatric illness/social situation that would limit compliance with study medication and protocol requirements
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C3489773 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C3489773 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0748872 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Metabolic Diseases Hereditary
Item
inherited metabolic diseases
boolean
C0025517 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
Malignant Neoplasms
Item
presence of malignancy
boolean
C0006826 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hematologic Test Positive HIV
Item
positive blood test for hiv
boolean
C0018941 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0019682 (UMLS CUI [1,3])
Epstein-Barr Virus Infection | Hepatitis B | Hepatitis C
Item
active ebv infection, active b and/or c hepatitis
boolean
C0149678 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Platelet Count measurement
Item
platelet count <100x10(9)/l
boolean
C0032181 (UMLS CUI [1])