ID

33251

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 additional clinical laboratory safety tests. It should be filled out at each visit if any unscheduled laboratory safety tests have been performed. 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 (2)
  1. 12/3/18 12/3/18 -
  2. 1/21/19 1/21/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 3, 2018

DOI

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License

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

English

Clinical Laboratory Safety Tests 2

1 forms  
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
Blood Samples
Description

Blood Samples

Alias
UMLS CUI-1
C0178913
Has the subject fasted?
Description

Subject Fasting

Data type

boolean

Alias
UMLS CUI [1]
C0015663
Time Blood Samples Taken
Description

Time Blood Samples Taken

Data type

time

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0040223
Clinical Chemistry
Description

Clinical Chemistry

Data type

text

Alias
UMLS CUI [1]
C0008000
Haematology
Description

Haematology

Data type

text

Alias
UMLS CUI [1]
C0018941
Clinical Staff Initials
Description

Clinical Staff Initials

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Urine Sample
Description

Urine Sample

Alias
UMLS CUI-1
C0200354
Time Urine Samples Taken
Description

Time Urine Samples Taken

Data type

time

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0040223
Urinalysis
Description

Urinalysis

Data type

text

Alias
UMLS CUI [1]
C0042014
Drugs of Abuse & Alcohol Screen
Description

Drug and Alcohol Abuse

Data type

text

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0038586
Clinical Staff Initials
Description

Clinical Staff Initials

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Result Significance
Description

Result Significance

Alias
UMLS CUI-1
C2826633
Are any of the out of range results clinically significant?
Description

Results Clinically Significant

Data type

boolean

Alias
UMLS CUI [1]
C2826633
If results are clinically significant, comment below.
Description

Result Comments

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0947611
Conclusion
Description

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Description

Staff initials

Data type

text

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

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Clinical Laboratory Safety Tests 2

1 forms
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
Blood Samples
C0178913 (UMLS CUI-1)
Subject Fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Time Blood Samples Taken
Item
Time Blood Samples Taken
time
C1277698 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Clinical Chemistry
Item
Clinical Chemistry
text
C0008000 (UMLS CUI [1])
Haematology
Item
Haematology
text
C0018941 (UMLS CUI [1])
Clinical Staff Initials
Item
Clinical Staff Initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Item Group
Urine Sample
C0200354 (UMLS CUI-1)
Time Urine Samples Taken
Item
Time Urine Samples Taken
time
C0200354 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Urinalysis
Item
Urinalysis
text
C0042014 (UMLS CUI [1])
Drug and Alcohol Abuse
Item
Drugs of Abuse & Alcohol Screen
text
C0085762 (UMLS CUI [1,1])
C0038586 (UMLS CUI [1,2])
Clinical Staff Initials
Item
Clinical Staff Initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Item Group
Result Significance
C2826633 (UMLS CUI-1)
Results Clinically Significant
Item
Are any of the out of range results clinically significant?
boolean
C2826633 (UMLS CUI [1])
Result Comments
Item
If results are clinically significant, comment below.
text
C1274040 (UMLS CUI [1,1])
C0947611 (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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