Entry criteria
Item
1. Did the subject meet all the entry criteria at the time of enrollment (see opposite page)
boolean
C1516637 (UMLS CUI [1])
Numbers of the corresponding criteria
Item
2. If no, please give line number(s) of the corresponding criteria not met
text
Date of randomisation
Item
3. Date of randomisation using IVRS (dd mon yy)
date
Trial medication kit
Item
4. Will the trial medication kit be dispensed to the patient
boolean
If yes
Item
5. If YES, provide patient with trial medication kit assigned by IVRS. Stick the label from trial medication kit below. If label is lost, please enter assigned medication number below:
text
Item
6. If NO, primary reason for not dispensing trial drug (indicate one)
integer
Code List
6. If NO, primary reason for not dispensing trial drug (indicate one)
CL Item
Adverse event (1)
CL Item
Inclusion / Exclusion criteria not met (2)
CL Item
Lost follow-up (3)
CL Item
Consent withdrawn (not due to adverse event) (4)
CL Item
Other (explain below) (5)
Other
Item
Explain other:
text
Investigator´s Declaration
Item
7. Investigator´s Declaration By signing and dating this page, I declare that I have reviewed for accuracy all the case report form pages for this patient; the information contained on these pages accurately reflects the medical record including the results of tests and evaluations performed on the specified dates.
text
Signature
Item
Signature by investigator
text
C1519316 (UMLS CUI [1])
Investigator Signature Date
Item
Date (dd mon yy)
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])