ID

34781

Beschreibung

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 recorded neurological abnormalities during the study. It should be filled out at screening and anytime an additional neurological examination is performed.

Stichworte

Versionen (2)
  1. 05.12.18 05.12.18 -
  2. 28.01.19 28.01.19 - Sarah Riepenhausen
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GlaxoSmithKline

Hochgeladen am

28. Januar 2019

DOI

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

Englisch

Neurological Examination Record

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschreibung

Subject Screening No.

Datentyp

integer

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

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Type of neurological Examination
Beschreibung

Form is mandatory for Screening. If additional, unscheduled neurological examinations are performed during the study, please choose "additional".

Datentyp

integer

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0332307
Neurological Examination
Beschreibung

Neurological Examination

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

Only necessary for additional neurological examinations.

Datentyp

boolean

Alias
UMLS CUI [1]
C0027853
Staff initials
Beschreibung

Only necessary for additional neurological examinations.

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Date of Assessment
Beschreibung

Date of Assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Neurological Examination Results
Beschreibung

Neurological Examination Results

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

Neurological Examination

Datentyp

text

Alias
UMLS CUI [1]
C0027853
Finding
Beschreibung

Neurological Examination Finding

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0243095
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Neurological Examination Conclusion
Beschreibung

Neurological Examination Conclusion

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

For Screening: If NO, the subject is not eligible to participate in the study. For additional examinations: If no, comment.

Datentyp

boolean

Alias
UMLS CUI [1]
C1112287
Comment
Beschreibung

Only relevant for additional examinations.

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Physician's Initials
Beschreibung

Physician's Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
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Ähnliche Modelle

Neurological Examination Record

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
Type of neurological Examination
integer
C0027853 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of neurological Examination
Code List
Type of neurological Examination
CL Item
Screening (1)
CL Item
Additional Examination (2)
Item Group
Neurological Examination
C0027853 (UMLS CUI-1)
Neurological Examination
Item
Has a Full Neurological Examination been performed?
boolean
C0027853 (UMLS CUI [1])
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
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])
Neurological Examination
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)
Item
Finding
text
C0027853 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Neurological Examination Finding
Code List
Finding
CL Item
Normal (0)
CL Item
Abnormal (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])
Physician's Initials
Item
Physician's Initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
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