Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Study phase
integer
C0205390 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
CL Item
double-blind phase (1)
(Comment:en)
CL Item
single-blind phase (2)
(Comment:en)
Serious adverse event during clinical trial period
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Serious adverse event during clinical trial period count specification
Item
If yes, specify total number of SAEs.
integer
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
Subject unblinding event record during clinical trial period
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Subject unblinding event record date
Item
Date of breaking treatment blind
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason for breaking treatment blind
text
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Code List
Reason for breaking treatment blind
CL Item
Medical emergency requiring identification of investigational product for further treatments ([1])
Subject unblinding event record other reason to specify
Item
If other, please specify
text
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Elimination criteria during clinical trial period
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Elimination criteria to specify
Item
If yes, please specify.
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Patient withdrawn from trial
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If yes, indicate the major reason for withdrawal.
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Code List
If yes, indicate the major reason for withdrawal.
CL Item
Serious adverse event ([SAE])
CL Item
Protocol violation ([PTV])
CL Item
Consent withdrawal, not due to an adverse event ([CWS])
CL Item
Migrated / moved from the study area ([MIG])
CL Item
Lost to follow-up ([LFU])
Death-related serious adverse event number to specify
Item
If death [DEA], please specify SAE number.
integer
C1705232 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Serious adverse event number to specify
Item
If serious adverse event [SAE], please specify SAE number.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Protocol violation to specify
Item
If protocol violation [PTV], please specify.
text
C1709750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Withdrawal other reason to specify
Item
If other [OTH], please specify.
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Item
If subject was withdrawn from the study, indicate who made the decision.
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Code List
If subject was withdrawn from the study, indicate who made the decision.
CL Item
Investigator ([I])
CL Item
Parents/Guardians ([P])
Withdrawal date of last contact
Item
If subject was withdrawn from the study, indicate the date of the last contact.
date
C0422727 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
Withdrawal general physical condition date last contact
Item
If subject was withdrawn from the study, was the subject in good condition at date of last contact?
boolean
C0422727 (UMLS CUI [1,1])
C1142435 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,3])
Investigator signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Printed investigator's name
text
C2826892 (UMLS CUI [1])
Investigator signature date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])