Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Study Subject Participation Status
Item
Patient has successfully completed study 101468/188, 190, 194 (non-US subjects only) or 218 or met the definition for relapse in the double-blind treatment phase of Study 101468/188.
boolean
C2348568 (UMLS CUI [1])
Informed consent
Item
Patient has given written informed consent prior to any specific study procedures.
boolean
C0021430 (UMLS CUI [1])
Contraceptive method
Item
Patient is a woman, of child-bearing potential and is not practising a clinically accepted method of contraception such as oral contraception, surgical sterilisation, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner or systemic contraception (i.e., Norplant).
boolean
C0700589 (UMLS CUI [1])
Positive pregnancy test
Item
Patient is a woman who has a positive pregnancy test.
boolean
C0240802 (UMLS CUI [1])
Comorbidity
Item
Patient has developed a medically unstable illness
boolean
C0009488 (UMLS CUI [1])