ID

33454

Description

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 contains informations about the subjects vital signs. The subject should be resting in semi-supine position for 10 minutes before each reading. It should be filled out at the screening visit and updated at each subsequent 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

Keywords

Versions (4)
  1. 12/9/18 12/9/18 -
  2. 12/9/18 12/9/18 -
  3. 1/8/19 1/8/19 -
  4. 1/11/19 1/11/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

December 9, 2018

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License

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

English

Vital signs

1 forms  
  1. StudyEvent: ODM
    1. Vital signs
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Description

Subject Screening No.

Data type

integer

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

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date Information Collected
Description

Date Information Collected

Data type

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008
Vital Signs
Description

Vital Signs

Actual Time
Description

Actual Time

Data type

datetime

Alias
UMLS CUI [1]
C0040223
Pulse Rate
Description

Pulse Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Blood pressure systolic
Description

Blood pressure systolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic
Description

Blood pressure diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Were vital signs out of range?
Description

Vital Signs Abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205161
If out of range, have these been repeated ?
Description

If yes, please complete the unscheduled vitals form

Data type

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205161
UMLS CUI [2,1]
C0205341
UMLS CUI [2,2]
C0242485
Repeat required?
Description

Repeat if: - systolic pressure is <80mmHg or >150mmHg - diastolic pressure is <35mmHg and >105mmHg - pulse rate is outside of the range 35-100bpm

Data type

text

Conclusion
Description

Conclusion

Alias
UMLS CUI-1
C1707478
Clinical Staff initials
Description

Staff initials

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
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Similar models

Vital signs

1 forms
  1. StudyEvent: ODM
    1. Vital signs
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Date Information Collected
Item
Date Information Collected
date
C3244127 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Vital Signs
Actual Time
Item
Actual Time
datetime
C0040223 (UMLS CUI [1])
Pulse Rate
Item
Pulse Rate
integer
C0232117 (UMLS CUI [1])
Blood pressure systolic
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Vital Signs Abnormal
Item
Were vital signs out of range?
boolean
C0518766 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
If Abnormal Test Repeat
Item
If out of range, have these been repeated ?
boolean
C0518766 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0205341 (UMLS CUI [2,1])
C0242485 (UMLS CUI [2,2])
Item
Repeat required?
text
Repeat Required
Code List
Repeat required?
CL Item
No (asymptomatic) (No (asymptomatic))
CL Item
Yes (Yes)
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Staff initials
Item
Clinical Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
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