Date of visit, Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Vital signs, Semi-erect, Date in time, Time
Item
Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Systolic Pressure, Semi-erect
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Diastolic blood pressure, Semi-erect
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Heart rate, Semi-erect
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Respiratory rate, Semi-erect
Item
Respiration rate
integer
C0231832 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Vital signs, Erect, Date in time, Time
Item
Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Systolic Pressure, Erect
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
Diastolic blood pressure, Erect
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
Heart rate, Erect
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
Pulmonary function tests, Date in time, Time
Item
Date/time of test
datetime
C0024119 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pulmonary function tests; Forced expiratory volume in 1 second finding
Item
FEV1
text
C0024119 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Pulmonary function tests, Vital capacity, Forced Vital Capacity
Item
VC/FVC
text
C0024119 (UMLS CUI [1,1])
C0042834 (UMLS CUI [1,2])
C3714541 (UMLS CUI [1,3])
Pulmonary function tests, Forced expired volume in one second/vital capacity ratio
Item
FEV1/VC
text
C0024119 (UMLS CUI [1,1])
C0429744 (UMLS CUI [1,2])
Subject Unblinding Event Record
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Subject Unblinding Event Record, Date in time, Time
Item
Yes, Date/time blind broken
datetime
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Yes, Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Code List
Yes, Reason blind broken
CL Item
Medical emergency requiring indication of investigational product for further treatment (1)
CL Item
Other, specify (2)
Subject Unblinding Event Record, Reason and justification
Item
Other, specify
text
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Date last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Patient withdrawn from trial
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Patient withdrawn from trial, Decision, Date in time
Item
Yes, Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Yes, Primary reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Code List
Yes, Primary reason for withdrawal
CL Item
Adverse Event (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Subject reached protocol defined stopping criteria (4)
CL Item
Study closed/terminated (5)
CL Item
Lost to Follow-up (6)
CL Item
Investigator discretion, specify (7)
CL Item
Withdrew consent (8)
Patient withdrawn from trial, Reason and justification, Primary
Item
Specify
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Clinical Study Case, Signature
Item
Case book ready for signature
boolean
C1706256 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Pregnancy, During, Clinical Trials
Item
Did the subject become pregnant during the study?
boolean
C0032961 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Not applicable (3)
Hematology finding, Sampling, Date in time, Time
Item
Haematology Date and time sample taken
datetime
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Hematology finding, Sampling, Not Done
Item
Not Done
boolean
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item
Clinical Chemistry Date and time sample taken
text
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Code List
Clinical Chemistry Date and time sample taken
CL Item
Same as the Haematology sample (1)
Chemistry, Clinical, Sampling, Date in time, Time
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Chemistry, Clinical, Sampling, Not Done
Item
Not Done
boolean
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Urinalysis, Sampling, Date in time, Time
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Urinalysis, Sampling, Not Done
Item
Not Done
boolean
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])