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Session 1 Day 1

1 forms  
  1. StudyEvent: ODM
    1. Session 1 Day 1
Dosing Details
Description

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Date and time of GW597599/Placebo dosing
Description

Date | Time

Data type

datetime

Alias
UMLS CUI [1,1]
C1986447
UMLS CUI [1,2]
C2987637
UMLS CUI [2,1]
C1986447
UMLS CUI [2,2]
C1696465
Dose checked and administered by:
Description

Drug Administered Identifier

Data type

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Description

Dose Witness

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
Date and time of Alprazolam/Placebo dosing
Description

Date | Time

Data type

datetime

Alias
UMLS CUI [1,1]
C1986447
UMLS CUI [1,2]
C0002333
UMLS CUI [2,1]
C1986447
UMLS CUI [2,2]
C1696465
Dose checked and administered by:
Description

Drug Administer Identifier

Data type

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Description

Dose Witness

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
Start Date and time of Paroxetine/Placebo dosing
Description

Date | Time

Data type

datetime

Alias
UMLS CUI [1,1]
C1986447
UMLS CUI [1,2]
C0070122
UMLS CUI [2,1]
C1986447
UMLS CUI [2,2]
C1696465
Dose checked and administered by:
Description

Drug Administer Identifier

Data type

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Description

Dose Witness

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
PK Sampling Instructions: Please collect a 5ml blood sample for phawmacokinetics at the times shown below.
Description

PK Sampling Instructions: Please collect a 5ml blood sample for phawmacokinetics at the times shown below.

Alias
UMLS CUI-1
C0201734
Time relative to start of dose
Description

Time to dose start

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C2348792
UMLS CUI [1,3]
C3174092
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Time

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1]
C0040223
24hr:min
Sample Taken
Description

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C1277698
Comments
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Neurosteroid Sampling
Description

Neurosteroid Sampling

Alias
UMLS CUI-1
C0815278
UMLS CUI-2
C0870078
Time relative to start of dose
Description

Time to dose start

Data type

text

Alias
UMLS CUI [1]
C0946444
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Sample Taken
Description

Sample Taken

Data type

boolean

Alias
UMLS CUI [1]
C1277698
Comments
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
5-Lead continous electrocardiographic monitoring
Description

5-Lead continous electrocardiographic monitoring

Alias
UMLS CUI-1
C3840770
UMLS CUI-2
C0420200
Monitoring Start Date
Description

Monitoring Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C0808070
Monitoring Start Time
Description

Monitoring Start Time

Data type

time

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C1301880
Monitoring Stop Date
Description

Monitoring Stop Date

Data type

date

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C0806020
Monitoring Stop Time
Description

Monitoring End Time

Data type

time

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C1522314
Rhythms of Concern
Description

Rhythms of Concern

Data type

boolean

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C0871269
UMLS CUI [1,3]
C2699424
Describe Rhythm
Description

Rhythm Description

Data type

text

Alias
UMLS CUI [1,1]
C0420200
UMLS CUI [1,2]
C0871269
UMLS CUI [1,3]
C2699424
UMLS CUI [1,4]
C0678257
CONTINUOUS RESP/RA TORY/CARDIAC/SKIN MONITORING
Description

CONTINUOUS RESP/RA TORY/CARDIAC/SKIN MONITORING

Alias
UMLS CUI-1
C0199438
UMLS CUI-3
C3845192
UMLS CUI-5
C0150350
Time relative to start of dose
Description

Time to last dose

Data type

time

Measurement units
  • hrs
Alias
UMLS CUI [1]
C0946444
hrs
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Start time
Description

Start time

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1]
C1301880
24hr:min
Stop Time
Description

Stop Time

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1]
C1522314
24hr:min
Respiratory Parameters Monitored
Description

Respiratory Parameters Monitored

Data type

boolean

Alias
UMLS CUI [1,1]
C0199438
UMLS CUI [1,2]
C0521346
UMLS CUI [1,3]
C0042295
Cardiac Parameters Monitored
Description

Cardiac Parameters Monitored

Data type

boolean

Alias
UMLS CUI [1,1]
C0204899
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0042295
Skin Conductance Monitored
Description

Skin Conductance Monitored

Data type

boolean

Alias
UMLS CUI [1,1]
C0814024
UMLS CUI [1,2]
C1283169
7% CO2 Challenge
Description

7% CO2 Challenge

Alias
UMLS CUI-1
C1378652
UMLS CUI-2
C0805586
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Start time
Description

Start time

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1]
C1301880
24hr:min
Stop Time
Description

Stop Time

Data type

time

Measurement units
  • 24hr:min
Alias
UMLS CUI [1]
C1522314
24hr:min
Treatment Assessment for Cohort 1
Description

Treatment Assessment for Cohort 1

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0220825
UMLS CUI-3
C0599755
UMLS CUI-4
C0205447
In your opinion, which drug did you receive before the CO2 challenge?
Description

Drug received

Data type

text

Alias
UMLS CUI [1,1]
C0871010
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1514756
Treatment Assessment for Cohort 2
Description

Treatment Assessment for Cohort 2

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0220825
UMLS CUI-3
C0599755
UMLS CUI-4
C0205447
In your opinion, which drug did you receive before the CO2 challenge?
Description

Drug received

Data type

integer

Alias
UMLS CUI [1,1]
C0871010
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1514756
PSL III-R/VAS-A
Description

PSL III-R/VAS-A

Alias
UMLS CUI-1
C2945698
UMLS CUI-2
C0745732
UMLS CUI-4
C3536884
UMLS CUI-5
C0003467
Questionnaire Type
Description

Questionnaire Type

Data type

text

Alias
UMLS CUI [1,1]
C2826974
UMLS CUI [1,2]
C0332307
Planned Relative Time
Description

Planned Relative Time

Data type

text

Alias
UMLS CUI [1]
C0439564
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Questionnaire administered
Description

Questionnaire administered

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C0449851
UMLS CUI [1,4]
C1521801
UMLS CUI [1,5]
C0332307
Comments
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Session 1 Day 1

1 forms
  1. StudyEvent: ODM
    1. Session 1 Day 1
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Date | Time
Item
Date and time of GW597599/Placebo dosing
datetime
C1986447 (UMLS CUI [1,1])
C2987637 (UMLS CUI [1,2])
C1986447 (UMLS CUI [2,1])
C1696465 (UMLS CUI [2,2])
Drug Administered Identifier
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
Dose Witness
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Date | Time
Item
Date and time of Alprazolam/Placebo dosing
datetime
C1986447 (UMLS CUI [1,1])
C0002333 (UMLS CUI [1,2])
C1986447 (UMLS CUI [2,1])
C1696465 (UMLS CUI [2,2])
Drug Administer Identifier
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
Dose Witness
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Date | Time
Item
Start Date and time of Paroxetine/Placebo dosing
datetime
C1986447 (UMLS CUI [1,1])
C0070122 (UMLS CUI [1,2])
C1986447 (UMLS CUI [2,1])
C1696465 (UMLS CUI [2,2])
Drug Administer Identifier
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
Dose Witness
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
PK Sampling Instructions: Please collect a 5ml blood sample for phawmacokinetics at the times shown below.
C0201734 (UMLS CUI-1)
Item
Time relative to start of dose
text
C0005834 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Time to dose start
Code List
Time relative to start of dose
CL Item
Pre-dose (Pre-dose)
CL Item
+45 min (+45 min)
CL Item
+1 hr (+1 hr)
CL Item
+1.35 hrs (+1.35 hrs)
CL Item
+2.30 hrs (+2.30 hrs)
CL Item
+3.30 hrs (+3.30 hrs)
CL Item
+6.30 hrs (+6.30 hrs)
CL Item
+9.30 hrs (+9.30 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+24.30 hrs (+24.30 hrs)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Sample taken
Item
Sample Taken
boolean
C1277698 (UMLS CUI [1])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Neurosteroid Sampling
C0815278 (UMLS CUI-1)
C0870078 (UMLS CUI-2)
Item
Time relative to start of dose
text
C0946444 (UMLS CUI [1])
Time to dose start
Code List
Time relative to start of dose
CL Item
Pre-dose (Pre-dose)
CL Item
+1.35 hrs (+1.35 hrs)
CL Item
+2.20 hrs (+2.20 hrs)
CL Item
+2.30 hrs (+2.30 hrs)
CL Item
+2.50 hrs (+2.50 hrs)
CL Item
+3.30 hrs (+3.30 hrs)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Sample Taken
Item
Sample Taken
boolean
C1277698 (UMLS CUI [1])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
5-Lead continous electrocardiographic monitoring
C3840770 (UMLS CUI-1)
C0420200 (UMLS CUI-2)
Monitoring Start Date
Item
Monitoring Start Date
date
C0420200 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Monitoring Start Time
Item
Monitoring Start Time
time
C0420200 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Monitoring Stop Date
Item
Monitoring Stop Date
date
C0420200 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Monitoring End Time
Item
Monitoring Stop Time
time
C0420200 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Rhythms of Concern
Item
Rhythms of Concern
boolean
C0420200 (UMLS CUI [1,1])
C0871269 (UMLS CUI [1,2])
C2699424 (UMLS CUI [1,3])
Rhythm Description
Item
Describe Rhythm
text
C0420200 (UMLS CUI [1,1])
C0871269 (UMLS CUI [1,2])
C2699424 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,4])
Item Group
CONTINUOUS RESP/RA TORY/CARDIAC/SKIN MONITORING
C0199438 (UMLS CUI-1)
C3845192 (UMLS CUI-3)
C0150350 (UMLS CUI-5)
Time to last dose
Item
Time relative to start of dose
time
C0946444 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
Respiratory Parameters Monitored
Item
Respiratory Parameters Monitored
boolean
C0199438 (UMLS CUI [1,1])
C0521346 (UMLS CUI [1,2])
C0042295 (UMLS CUI [1,3])
Cardiac Parameters Monitored
Item
Cardiac Parameters Monitored
boolean
C0204899 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0042295 (UMLS CUI [1,3])
Skin Conductance Monitored
Item
Skin Conductance Monitored
boolean
C0814024 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
Item Group
C1378652 (UMLS CUI-1)
C0805586 (UMLS CUI-2)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
Item Group
Treatment Assessment for Cohort 1
C0087111 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0599755 (UMLS CUI-3)
C0205447 (UMLS CUI-4)
Item
In your opinion, which drug did you receive before the CO2 challenge?
text
C0871010 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
undefined item
Code List
In your opinion, which drug did you receive before the CO2 challenge?
CL Item
Alprazolam (1)
CL Item
GW597599 + Paroxetine (2)
CL Item
Paroxetine (3)
CL Item
Placebo (4)
CL Item
I do not know (5)
Item Group
Treatment Assessment for Cohort 2
C0087111 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0599755 (UMLS CUI-3)
C0205447 (UMLS CUI-4)
Item
In your opinion, which drug did you receive before the CO2 challenge?
integer
C0871010 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
Drug received
Code List
In your opinion, which drug did you receive before the CO2 challenge?
CL Item
Alprazolam (1)
CL Item
GW597599 + Paroxetine (2)
CL Item
GW597599 (3)
CL Item
Placebo (4)
CL Item
I do not know (5)
Item Group
PSL III-R/VAS-A
C2945698 (UMLS CUI-1)
C0745732 (UMLS CUI-2)
C3536884 (UMLS CUI-4)
C0003467 (UMLS CUI-5)
Item
Questionnaire Type
text
C2826974 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Questionnaire Type
Code List
Questionnaire Type
CL Item
PSL III R (PSL III R)
CL Item
VAS-A (VAS-A)
Item
Planned Relative Time
text
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
+1.58 hrs (+1.58 hrs)
CL Item
+2.10 hrs (+2.10 hrs)
CL Item
+2.20 hrs (+2.20 hrs)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Questionnaire administered
Item
Questionnaire administered
boolean
C0030705 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0449851 (UMLS CUI [1,3])
C1521801 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,5])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
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