Multiple Sclerosis, Relapsing-Remitting | Adult | Start time Lemtrada
Item
adult rrms patients who will be initiating treatment with lemtrada according to local approved label.
boolean
C0751967 (UMLS CUI [1])
C0001675 (UMLS CUI [2])
C1301880 (UMLS CUI [3,1])
C3860145 (UMLS CUI [3,2])
Informed Consent
Item
signed written informed consent.
boolean
C0021430 (UMLS CUI [1])
Prior Therapy Lemtrada
Item
previously treated with lemtrada.
boolean
C1514463 (UMLS CUI [1,1])
C3860145 (UMLS CUI [1,2])
Medical contraindication Lemtrada
Item
contraindications to lemtrada according to the labeling in the country.
boolean
C1301624 (UMLS CUI [1,1])
C3860145 (UMLS CUI [1,2])
Medical contraindication Therapy Symptomatic
Item
any known contraindications to the symptomatic therapy used in the infusion management guidance based on their local approved label.
boolean
C1301624 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
Study Subject Participation Status | Interventional Study Investigational
Item
currently participating in another investigational interventional study.
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Technical Problem Study Subject Participation Status Excluded | Factor Administrative Study Subject Participation Status Excluded
Item
any technical/administrative reason that makes it impossible to enroll the patient in the study.
boolean
C1710348 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C1521761 (UMLS CUI [2,1])
C3845829 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0332196 (UMLS CUI [2,4])
Persons Involved Completion of clinical trial | Research Personnel | Research Personnel Relative
Item
patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
boolean
C0027361 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0035173 (UMLS CUI [2])
C0035173 (UMLS CUI [3,1])
C0080103 (UMLS CUI [3,2])
Consent Withdrawn
Item
patient who has withdrawn consent before enrollment (starting from signed informed consent form).
boolean
C1707492 (UMLS CUI [1])
Enrollment Discontinued
Item
despite screening of the patient, enrolment is stopped at the study level.
boolean
C1516879 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Test Unwilling | Childbearing Potential Pregnancy Test Unable
Item
woman of childbearing potential not protected by highly-effective method(s) of birth control (as defined in a local protocol amendment in case of specific local requirement) and/or who are unwilling or unable to be tested for pregnancy.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Pregnancy | Hematologic Test Beta HCG positive | Breast Feeding
Item
pregnancy (defined as positive beta human chorionic gonadotropin (β-hcg) blood test), breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0018941 (UMLS CUI [2,1])
C0813152 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
Latent Tuberculosis | Tuberculosis
Item
known infection with latent tuberculosis or active tuberculosis.
boolean
C1609538 (UMLS CUI [1])
C0041296 (UMLS CUI [2])
Hepatitis B | Hepatitis C
Item
known infection with hepatitis b, hepatitis c.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Study Subject Participation Status | Considerations Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])