Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C0011008 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
C1549507 (UMLS CUI [2])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Code List
Was the subject withdrawn from the study?
Item
If subject was withdrawn from the study, complete primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Code List
If subject was withdrawn from the study, complete primary reason for withdrawal
CL Item
Adverse event (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Subject reached protocol-defined stopping criteria (4)
CL Item
Study closed/terminated (5)
CL Item
Lost to follow-up (6)
CL Item
Investigator discretion (7)
CL Item
Withdrew consent (8)
Pregnancy
Item
If Subject reached protocol defined stopping criteria: Pregnancy?
boolean
C0032961 (UMLS CUI [1])
Reason for withdrawal: Investigator discretion
Item
If Reason for withdrawal was Investigator discretion, specify.
text
C0422727 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
Reason for withdrawal: Withdrew consent
Item
If Reason for withdrawal was "Withdrew consent", specify
text
C0422727 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
Item
Investigational product
integer
C0304229 (UMLS CUI [1])
Code List
Investigational product
CL Item
Topical study drug (1)
CL Item
Oral study drug (2)
Date of first Dose
Item
Date of first Dose
date
C3173309 (UMLS CUI [1])
Time of first Dose
Item
Time of first Dose
time
C0304229 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Date of last Dose
Item
Date of last Dose
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
Time of last Dose
Item
Time of last Dose
time
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
Total number of applications
Item
Total number of applications
integer
C0185125 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Total number of doses
Item
Total number of doses
integer
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Item
Was the treatment blind broken during the study?
text
C3897431 (UMLS CUI [1])
Code List
Was the treatment blind broken during the study?
Date blind broken
Item
Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason blind broken
integer
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Progressive disease (2)
Other reason blind broken
Item
If other reason blind broken, please specify
text
C3897431 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Code List
Did the subject become pregnant during the study?
Item
Subject product preference
integer
C3854006 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0558295 (UMLS CUI [1,3])
Code List
Subject product preference
CL Item
Prefer oral medication (1)
CL Item
Prefer topical medication (2)
CL Item
No preference (3)