ID

33331

Beschrijving

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 any recorded neurological abnormalities during the study. It should be filled out everytime a neurological examination is performed.

Trefwoorden

  1. 05-12-18 05-12-18 -
  2. 28-01-19 28-01-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

5 december 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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Effect of Lamictal on Resting Motor Threshold

Neurological Examination Record

Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschrijving

Subject Screening No.

Datatype

integer

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

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Neurological Examination
Beschrijving

Neurological Examination

Alias
UMLS CUI-1
C0027853
Has a Full Neurological Examination been performed?
Beschrijving

Neurological Examination

Datatype

boolean

Alias
UMLS CUI [1]
C0027853
Date of Assessment
Beschrijving

Date of Assessment

Datatype

date

Alias
UMLS CUI [1]
C2985720
Neurological Examination Results
Beschrijving

Neurological Examination Results

Alias
UMLS CUI-1
C1274040
UMLS CUI-2
C0027853
Neurological Examination
Beschrijving

Neurological Examination

Datatype

text

Alias
UMLS CUI [1]
C0027853
Normal
Beschrijving

Normal

Datatype

boolean

Alias
UMLS CUI [1]
C0205307
Abnormal
Beschrijving

Abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0205161
Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
Neurological Examination Conclusion
Beschrijving

Neurological Examination Conclusion

Alias
UMLS CUI-1
C0027853
UMLS CUI-2
C1707478
Is the neurological examination normal?
Beschrijving

Neurological Examination Normal

Datatype

boolean

Alias
UMLS CUI [1]
C1112287
Comment
Beschrijving

Comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
Conclusion
Beschrijving

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Beschrijving

Staff initials

Datatype

text

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

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008

Similar models

Neurological Examination Record

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Neurological Examination
C0027853 (UMLS CUI-1)
Neurological Examination
Item
Has a Full Neurological Examination been performed?
boolean
C0027853 (UMLS CUI [1])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item Group
Neurological Examination Results
C1274040 (UMLS CUI-1)
C0027853 (UMLS CUI-2)
Item
Neurological Examination
text
C0027853 (UMLS CUI [1])
Code List
Neurological Examination
CL Item
Mental Status (Mental Status)
CL Item
Gait (Gait)
CL Item
Balance (Balance)
CL Item
Coordination (Coordination)
CL Item
Cranial Nerves (Cranial Nerves)
CL Item
Motor (Motor)
CL Item
Reflexes (Reflexes)
CL Item
Sensory (Sensory)
Normal
Item
Normal
boolean
C0205307 (UMLS CUI [1])
Abnormal
Item
Abnormal
boolean
C0205161 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Neurological Examination Conclusion
C0027853 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
Neurological Examination Normal
Item
Is the neurological examination normal?
boolean
C1112287 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
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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