Sequence number
Item
Row number (HR and BP measurements to be taken prior to lung function tests.)
integer
C2348184 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Date of vital signs
Item
Date
date
C2826644 (UMLS CUI [1])
Item
Study day
integer
C2826182 (UMLS CUI [1])
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Time relative to dosing
Time of measurement
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
SBP
Item
Systolic blood pressure (Blood pressure measurements must be taken with the subject in a SUPINE position, having rested in this position for 10 minutes.)
integer
C0871470 (UMLS CUI [1])
DBP
Item
Diastolic blood pressure (Blood pressure measurements must be taken with the subject in a SUPINE position, having rested in this position for 10 minutes.)
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate (Heart rate measurement must be taken with the subject in a SUPINE position, having rested in this position for 10 minutes.)
integer
C0018810 (UMLS CUI [1])
Sequence number
Item
Row number (ECG measurements to be taken prior to lung function tests with the subject in a SUPINE position, having rested in this position for at least 10 minutes before each reading.)
integer
C2348184 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Date of ECG
Item
Date
date
C2826640 (UMLS CUI [1])
Item
Study day
integer
C2826182 (UMLS CUI [1])
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Time relative to dosing
Time of ECG
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Ventricular rate
Item
Ventricular rate
integer
C2189285 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
QT Interval
Item
QT Interval
integer
C0577807 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0855331 (UMLS CUI [1])
Item
ECG finding
integer
C0438154 (UMLS CUI [1])
CL Item
Abnormalities present (2)
ECG abnormality clinically significant
Item
Is the abnormality clinically significant?
boolean
C1832603 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Sequence number
Item
Row number
integer
C2348184 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Date of FEV1
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Item
Study day
integer
C2826182 (UMLS CUI [1])
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Time relative to dosing
Time of FEV1 measurement
Item
Actual time of first reading
time
C0040223 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Reading 1
Item
Reading 1
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Reading 2
Item
Reading 2
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Sequence number pharmacokinetic study
Item
Row number
integer
C2348184 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
Date of pharmacokinetic study
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
Item
Study day
integer
C2826182 (UMLS CUI [1])
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Time relative to dosing
Time of pharmacokinetic study
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
Sample number
Item
Sample number
integer
C1299222 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
Blood sample taken
Item
4mL blood sample taken
boolean
C1277698 (UMLS CUI [1])
Sequence number
Item
Row number
integer
C2348184 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
Date of measurement
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
Item
Study day
integer
C2826182 (UMLS CUI [1])
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Time relative to dosing
Time of measurement
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0337438 (UMLS CUI [2,2])
Test result
Item
Result
float
C0587081 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
Date of dose
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Study day
integer
C2826182 (UMLS CUI [1])
Start time of inhalation
Item
Start time of inhalation
time
C1301880 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
End time of inhalation
Item
End time of inhalation
time
C1522314 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
investigational product change of administration
Item
Were there any significant changes to investigational product (investigational product not administered as per the requirements of the protocol)?
boolean
C0304229 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
Specification investigational product change of administration
Item
If 'Yes', specify investigational product changes, dates, and reasons:
text
C2348235 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])