Date of subject completion or date of subject withdrawal
Item
Date of subject completion or date of subject withdrawal
date
C2983670 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
C0805732 (UMLS CUI [2])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If yes to withdrawn, plese select primary reason for withdrawal
integer
Code List
If yes to withdrawn, plese select primary reason for withdrawal
CL Item
Adverse evetn, record details on the Non-Serious Adverse Events or Serious Adverse Events forms 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 termined study (6)
CL Item
Disease progression (7)
CL Item
Invesitagor decision (26)
CL Item
Other, Specify (0)
Treatment Confirmation
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If no, please record reasons
Item
If no, please record reasons
text
C0087111 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
Did a female partner of the male subject become pregnant during the study?
integer
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Not Applicable (if female partner not of childbearing potential or no female partner) (3)
Is the subject alive?
Item
Is the subject alive?
boolean
C2584946 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
If no please enter date of death
Item
If no please enter date of death
date
C1148348 (UMLS CUI [1])
Item
Primary cause of death
integer
C0007465 (UMLS CUI [1])
Code List
Primary cause of death
CL Item
Disease under study (1)
CL Item
Other, specify (2)