ID

34723

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 information about any additional, unscheduled laboratory safety tests. It should be checked at each visit if any unscheduled laboratory safety tests were 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 (3)
  1. 12/3/18 12/3/18 -
  2. 1/23/19 1/23/19 -
  3. 1/25/19 1/25/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

January 25, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study ID 107434

English

Unscheduled Laboratory Safety Test

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
Study Day
Description

Study Day

Data type

text

Alias
UMLS CUI [1]
C2826182
Were any unscheduled laboratory safety tests conducted?
Description

Unscheduled Laboratory Safety Tests

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C3854240
Unscheduled Laboratory Safety Tests
Description

Unscheduled Laboratory Safety Tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C3854240
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

Actual Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample Taken (e.g. biochemistry, haematology, urinalysis and volume)
Description

Sample Taken (Biochemistry, Haematology, Urinalysis, Volume)

Data type

text

Alias
UMLS CUI [1]
C0200345
UMLS CUI [2]
C0005477
UMLS CUI [3]
C0018941
UMLS CUI [4]
C0042014
UMLS CUI [5]
C1287298
Sample Volume
Description

Sample Volume

Data type

text

Measurement units
  • ml
Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C0449468
ml
Reason for Test
Description

Reason for Test

Data type

text

Alias
UMLS CUI [1]
C0566251
Clinical Staff Initials
Description

Clinical Staff Initials

Data type

text

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

Unscheduled Laboratory Safety Test

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
Study Day
text
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
Screening (Screening)
CL Item
Post-Screening (Post-Screening)
Unscheduled Laboratory Safety Tests
Item
Were any unscheduled laboratory safety tests conducted?
boolean
C0022885 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Item Group
Unscheduled Laboratory Safety Tests
C0022885 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Sample Taken (Biochemistry, Haematology, Urinalysis, Volume)
Item
Sample Taken (e.g. biochemistry, haematology, urinalysis and volume)
text
C0200345 (UMLS CUI [1])
C0005477 (UMLS CUI [2])
C0018941 (UMLS CUI [3])
C0042014 (UMLS CUI [4])
C1287298 (UMLS CUI [5])
Sample Volume
Item
Sample Volume
text
C0370003 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
Reason for Test
Item
Reason for Test
text
C0566251 (UMLS CUI [1])
Clinical Staff Initials
Item
Clinical Staff Initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
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