Site number
Item
Site Number
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Inclusion Criteria
Item
Did the patient meet all of the screening inclusion criteria?
boolean
C1512693 (UMLS CUI [1])
Inclusion Criteria
Item
lf No, which was/were not met? Inclusion Letter(s):
text
C1512693 (UMLS CUI [1])
Exclusion Criteria
Item
Did the patient meet any of the screening exclusion criteria?
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
If Yes, which was/were met? Exclusion Letter(s):
text
C0680251 (UMLS CUI [1])
Item
lf any screening eligibility criteria were not met, was an exemption granted by OSI?
integer
C1516637 (UMLS CUI [1,1])
C2348482 (UMLS CUI [1,2])
Code List
lf any screening eligibility criteria were not met, was an exemption granted by OSI?
Date screening consent was signed
Item
Date screening consent was signed:
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
IVRS Screening Number
Item
IVRS Screening Number
text
C1710477 (UMLS CUI [1])
Inclusion Criteria
Item
Did the patient meet all of the treatment inclusion criteria?
boolean
C1512693 (UMLS CUI [1])
Inclusion Criteria
Item
lf No, which was/were not met? Inclusion Number(s):
text
C1512693 (UMLS CUI [1])
Exclusion Criteria
Item
Did the patient meet any of the treatment exclusion criteria?
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
If Yes, which was/were met? Exclusion Number(s):
text
C0680251 (UMLS CUI [1])
Item
lf any treatment eligibility criteria were not met, was an exemption granted by OSI?
integer
C1516637 (UMLS CUI [1,1])
C2348482 (UMLS CUI [1,2])
Code List
lf any treatment eligibility criteria were not met, was an exemption granted by OSI?
Date main study consent was signed
Item
Date main study consent was signed:
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Randomization Date
Item
Date randomized through IVRS:
date
C0011008 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])