Subject number
Item
Subject number:
integer
C1709561 (UMLS CUI-1)
Subject initial
Item
Subject initial:
text
C2986440 (UMLS CUI-1)
Visit date
Item
Visit date:
date
C0011008 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Date of birth
Item
Date of birth:
date
C0421451 (UMLS CUI-1)
Item
Gender at birth:
text
C0079399 (UMLS CUI-1)
Code List
Gender at birth:
Item
Race:
text
C0034510 (UMLS CUI-1)
CL Item
Black or African American (2)
CL Item
American Indian or Alaska Native (4)
CL Item
Native Hawaiian or Other Pacific Islander (5)
Race
Item
If you chose the option "Other race" above, please specify:
text
C0034510 (UMLS CUI-1)
Item
Ethnicity (For United states only):
text
Code List
Ethnicity (For United states only):
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Informed consent
Item
Was informed consent obtained prior to any study related procedures?
boolean
C0021430 (UMLS CUI-1)
Date
Item
If you chose "Yes" above, please enter the date subject or legally authorized representative signed informed consent.
date
C0011008 (UMLS CUI-1)
Eligibility criteria
Item
Did the subject fail any eligibility criteria?
boolean
C0332307 (UMLS CUI-1)
C0030705 (UMLS CUI-2)
C1513905 (UMLS CUI-3)
C1516637 (UMLS CUI-4)
Failed criteria
Item
If you chose "Yes" above, record the failed criteria number(s) as specified in the protocol or on the Eligibility criteria worksheet as follow: Inclusion Number(s), Exclusion Number(s).
text
C0231175 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
C1512693 (UMLS CUI-3)
C0680251 (UMLS CUI-4)
Randomization
Item
Will the subject be randomized?
boolean
C0034656 (UMLS CUI-1)
Item
If you chose "No" above, please indicate primary reason for not being randomized?
text
C0034656 (UMLS CUI-1)
Code List
If you chose "No" above, please indicate primary reason for not being randomized?
CL Item
Adverse event (1)
CL Item
Subject withdrew consent (2)
CL Item
Lost to follow-up (4)
CL Item
Poor/ Non-compliance (5)
CL Item
Subject no longer meets study criteria (7)
CL Item
Administrative reason by sponsor (8)
Reason
Item
Please specify if you chose "Subject withdrew consent" , "Poor/ Non-Compliance" , "Subject no longer meets study criteria" or "Other":
text
C0392360 (UMLS CUI-1)
Date
Item
Please specify the date of last contact, if you chose "Lost to follow-up":
date
C0011008 (UMLS CUI-1)
Item
Please choose the treatment group the subject is assigned:
text
C1522541 (UMLS CUI-1)
Code List
Please choose the treatment group the subject is assigned:
CL Item
70 mg twice daily (1)
CL Item
140 mg once daily (2)
Investigator's name
Item
Name of the investigator:
text
C2346576 (UMLS CUI-1)
C0027365 (UMLS CUI-2)