ID

33257

Beskrivning

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form is for documentation of the measurement of vital signs in the semi-supine position. It should be filled out at each study visit. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Nyckelord

Versioner (4)
  1. 2018-12-03 2018-12-03 -
  2. 2018-12-16 2018-12-16 -
  3. 2019-01-08 2019-01-08 -
  4. 2019-01-11 2019-01-11 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

3 december 2018

DOI

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Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold

Engelsk

Semi-Supine Vital Signs

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beskrivning

Subject Screening No.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Subject no.
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Semi-supine Vital Signs
Beskrivning

Semi-supine Vital Signs

Alias
UMLS CUI-1
C0522019
UMLS CUI-2
C0518766
Study Day
Beskrivning

Study Day

Datatyp

integer

Alias
UMLS CUI [1]
C2826182
Protocol Time
Beskrivning

Protocol Time

Datatyp

text

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

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Pulse
Beskrivning

To be measured after 10 minutes in semi-supine position.

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Systolic Blood Pressure
Beskrivning

To be measured after 10 minutes in semi-supine position.

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beskrivning

To be measured after 10 minutes in semi-supine position.

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Comments
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Where the vital signs out of range?
Beskrivning

Vital Abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0277804
If out of range, have these been repeated?
Beskrivning

Vital Signs Repeated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0242485
Clinical Staff Initials
Beskrivning

Clinical Staff Initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Conclusion
Beskrivning

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Beskrivning

Staff initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Semi-Supine Vital Signs

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Item Group
Semi-supine Vital Signs
C0522019 (UMLS CUI-1)
C0518766 (UMLS CUI-2)
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Protocol Time
text
C0040223 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Protocol Time
Code List
Protocol Time
CL Item
1h30 post dose (1h30 post dose)
CL Item
5h00 post dose (5h00 post dose)
CL Item
12h00 post doe (12h00 post doe)
CL Item
24h00 post dose (24h00 post dose)
CL Item
48h00 post dose (48h00 post dose)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Vital Abnormal
Item
Where the vital signs out of range?
boolean
C0277804 (UMLS CUI [1])
Vital Signs Repeated
Item
If out of range, have these been repeated?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
Clinical Staff Initials
Item
Clinical Staff Initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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