Item
Did the subject become pregnant during the study treatment phase?
integer
C3828490 (UMLS CUI [1])
Code List
Did the subject become pregnant during the study treatment phase?
CL Item
Yes (Complete the Pregnancy Notification form) (2)
CL Item
Not Apllicable (not of childbearing potential or male) (3)
Was the patient withdrawn from investigational product or did the patient not attend concluding visit?
Item
Was the patient withdrawn from investigational product or did the patient not attend concluding visit?
boolean
C0422727 (UMLS CUI [1,1])
C1707478 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Item
Patient has been withdrawn from investigational attend Concluding Visit due to:
text
C0422727 (UMLS CUI [1])
C1707478 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
C0392360 (UMLS CUI [3])
Code List
Patient has been withdrawn from investigational attend Concluding Visit due to:
CL Item
Death (any cause) → Please complete Death Form section. (DEA)
CL Item
Serious adverse event: → Please complete and submit SAE report. Please specify SAE No. (SAE)
CL Item
Non-Serious adverse event: → Please complete Non-serious Adverse Event section. Please specify AE No. (AEX)
CL Item
Recurrence / Progressive disease → Please schedule a Yearly follow-up contact. (PD)
CL Item
Symptomatic deterioration without evidence of progressive disease (SYM)
CL Item
Consent withdrawal, not due to an adverse event (CWL)
CL Item
Protocol violation → please specify (PTV)
CL Item
Migrated / moved from the study area (MIG)
CL Item
Lost to follow-up (LFU)
CL Item
Other → please specify (OTH)
SAE No.
Item
SAE No.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE No.
Item
AE No.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Specify protocol violation
Item
Specify protocol violation
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Other reason Patient has been withdrawn from investigational attend Concluding Visit
Item
Other reason Patient has been withdrawn from investigational attend Concluding Visit
text
C0422727 (UMLS CUI [1])
C1707478 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
C3840932 (UMLS CUI [3])
Item
Who made the decision:
text
C0679006 (UMLS CUI [1])
Code List
Who made the decision: