Investigational Product
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Investigational Product
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Date Investigational Product Dispensed
Item
Date Investigational Product Dispensed
date
C0011008 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Number of Tablets Dispensed
Item
Number of Tablets/Caplets Dispensed
integer
C0805077 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Date Investigational Product Returned
Item
Date Investigational Product Returned
date
C0011008 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Number of Tablets Returned
Item
Number of Tablets/Caplets Returned
integer
C2699071 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item
Was the investigational product stopped permanently before the end of the scheduled treatment period?
text
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Code List
Was the investigational product stopped permanently before the end of the scheduled treatment period?
Item
If Yes, check the primary reason the investigational product was stopped:
integer
C0392360 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
Code List
If Yes, check the primary reason the investigational product was stopped:
CL Item
Adverse event , 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)
reason the investigational product was stopped
Item
If other reason, please specify
text
C0392360 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])