GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dextrometorphan Urine Collection, Vital Signs 4, 12-Lead ECG Monitoring 4, Laboratory Collections 6

Dextrometorphan Urine Collection (0-8 hrs)
Description

Dextrometorphan Urine Collection (0-8 hrs)

Alias
UMLS CUI-1
C0200354
Start Date and Time
Description

urine collection start date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C3897500
Stop Date and Time
Description

urine collection stop date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C2746065
UMLS CUI [1,3]
C1264639
Volume of Urine
Description

urine volume

Data type

text

Alias
UMLS CUI [1]
C1287298
Result
Description

urine flow

Data type

float

Measurement units
  • mL/min
Alias
UMLS CUI [1]
C0232851
mL/min
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Study Time
Description

study time

Data type

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0040223
Date
Description

vital signs date

Data type

date

Alias
UMLS CUI [1]
C2826644
Actua Time
Description

vital signs time

Data type

time

Alias
UMLS CUI [1]
C2826762
Systolic BP
Description

systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic BP
Description

diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
HR
Description

heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
12-Lead ECG Monitoring
Description

12-Lead ECG Monitoring

Alias
UMLS CUI-1
C0430456
Study Time
Description

study time

Data type

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0040223
Date
Description

ecg date

Data type

date

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0011008
Actual Time
Description

ecg time

Data type

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
Heart Rate (bpm)
Description

heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Description

pr duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880446
msec
QRS
Description

qrs duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT
Description

qt duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880452
msec
QTC
Description

qtc interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0855331
msec
ECG Normal?
Description

ecg normal

Data type

boolean

Alias
UMLS CUI [1]
C0522054
Comments
Description

ecg comment

Data type

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0947611
Clinical Chemistry And Haematology
Description

Clinical Chemistry And Haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Exact date and time of blood sampling
Description

blood sampling date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Comments:
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on the Adverse Events page.
Description

clinical chemistry and hematology normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C0205307
Urinanalysis
Description

Urinanalysis

Alias
UMLS CUI-1
C0042014
Exact date and time of urine sampling
Description

urine sampling date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Comments:
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on the Adverse Events page.
Description

urinanalysis normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0205307

Similar models

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dextrometorphan Urine Collection, Vital Signs 4, 12-Lead ECG Monitoring 4, Laboratory Collections 6

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Dextrometorphan Urine Collection (0-8 hrs)
C0200354 (UMLS CUI-1)
urine collection start date and time
Item
Start Date and Time
datetime
C0200354 (UMLS CUI [1,1])
C3897500 (UMLS CUI [1,2])
urine collection stop date and time
Item
Stop Date and Time
datetime
C0200354 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
urine volume
Item
Volume of Urine
text
C1287298 (UMLS CUI [1])
urine flow
Item
Result
float
C0232851 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Study Time
text
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Code List
Study Time
CL Item
Pre-dose (Pre-dose)
CL Item
+0.5 hrs (+0.5 hrs)
CL Item
+1 hrs (+1 hrs)
CL Item
+4 hrs (+4 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+24 hrs (+24 hrs)
CL Item
Unscheduled (Unscheduled)
vital signs date
Item
Date
date
C2826644 (UMLS CUI [1])
vital signs time
Item
Actua Time
time
C2826762 (UMLS CUI [1])
systolic blood pressure
Item
Systolic BP
integer
C0871470 (UMLS CUI [1])
diastolic blood pressure
Item
Diastolic BP
integer
C0428883 (UMLS CUI [1])
heart rate
Item
HR
integer
C0018810 (UMLS CUI [1])
Item Group
12-Lead ECG Monitoring
C0430456 (UMLS CUI-1)
Item
Study Time
text
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Code List
Study Time
CL Item
Pre-dose (Pre-dose)
CL Item
+0.5 hrs (+0.5 hrs)
CL Item
+1 hrs (+1 hrs)
CL Item
+4 hrs (+4 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+24 hrs (+24 hrs)
CL Item
Unscheduled (Unscheduled)
ecg date
Item
Date
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
ecg time
Item
Actual Time
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart Rate (bpm)
integer
C0018810 (UMLS CUI [1])
pr duration
Item
PR
float
C1880446 (UMLS CUI [1])
qrs duration
Item
QRS
float
C0429025 (UMLS CUI [1])
qt duration
Item
QT
float
C1880452 (UMLS CUI [1])
qtc interval
Item
QTC
float
C0855331 (UMLS CUI [1])
ecg normal
Item
ECG Normal?
boolean
C0522054 (UMLS CUI [1])
ecg comment
Item
Comments
text
C1623258 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Clinical Chemistry And Haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
blood sampling date and time
Item
Exact date and time of blood sampling
datetime
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
comment
Item
Comments:
text
C0947611 (UMLS CUI [1])
clinical chemistry and hematology normal
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on the Adverse Events page.
boolean
C0008000 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Item Group
Urinanalysis
C0042014 (UMLS CUI-1)
urine sampling date and time
Item
Exact date and time of urine sampling
datetime
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
comment
Item
Comments:
text
C0947611 (UMLS CUI [1])
urinanalysis normal
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on the Adverse Events page.
boolean
C0042014 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])