Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Code List
Did the subject become pregnant during the study?
CL Item
Not Applicable (not of childbearing potential or male) (X)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Time of withdrawal
Item
Time of withdrawal
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If subject was withdrawn from the study, check the primary reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Code List
If subject was withdrawn from the study, check the primary reason for withdrawal
CL Item
Adverse events (Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate.) (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Sponsor terminated study (5)
CL Item
Non-compliance (17)
CL Item
Other, specify (Z)
Specify other reason for withdrawal
Item
Specify other reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
CRF page number if applicable
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature - Date
Item
Investigator's Signature - Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])