ID

33529

Beskrivning

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 diagnostic EEG results. It should be filled out at the screening 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

Nyckelord

Versioner (3)
  1. 2018-12-01 2018-12-01 -
  2. 2018-12-11 2018-12-11 -
  3. 2018-12-11 2018-12-11 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

11 december 2018

DOI

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Licens

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

Engelsk

EEG

1 Formulär  
  1. StudyEvent: ODM
    1. EEG
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beskrivning

Subject Screening No.

Datatyp

integer

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

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Assessment
Beskrivning

Date of Assessment

Datatyp

date

Alias
UMLS CUI [1]
C2985720
Diagnostic EEG
Beskrivning

Diagnostic EEG

Alias
UMLS CUI-1
C0013819
Actual Time
Beskrivning

Actual Time

Datatyp

datetime

Alias
UMLS CUI [1]
C0040223
EEG Comments
Beskrivning

EEG Comments

Datatyp

text

Alias
UMLS CUI [1,1]
C0013819
UMLS CUI [1,2]
C0947611
EEG Performed By
Beskrivning

Neurophysiologist Staff Initials

Datatyp

text

Alias
UMLS CUI [1,1]
C0013819
UMLS CUI [1,2]
C1550369
Clinical Interpretation of EEG
Beskrivning

Clinical Interpretation of EEG

Alias
UMLS CUI-1
C4086187
UMLS CUI-2
C0013819
Is the EEG recording normal?
Beskrivning

EEG Recording Normal

Datatyp

boolean

Alias
UMLS CUI [1]
C0560017
If No, is the abnormality clinically significant?
Beskrivning

EEG Abnormality Clinically Significant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013819
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2985739
If the EEG recording is abnormal and the abnormality is clinically significant, please comment below and exclude the subject from the trial.
Beskrivning

EEG Abnormality Comment

Datatyp

text

Alias
UMLS CUI [1,1]
C0013819
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0947611
Conclusion
Beskrivning

Conclusion

Alias
UMLS CUI-1
C1707478
Neurophysiologist Staff initials
Beskrivning

Neurophysiologist Staff initials

Datatyp

text

Alias
UMLS CUI [1,1]
C1552089
UMLS CUI [1,2]
C2986440
UMLS CUI [1,3]
C0586861
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Similar models

EEG

1 Formulär
  1. StudyEvent: ODM
    1. EEG
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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 of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item Group
Diagnostic EEG
C0013819 (UMLS CUI-1)
Actual Time
Item
Actual Time
datetime
C0040223 (UMLS CUI [1])
EEG Comments
Item
EEG Comments
text
C0013819 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
EEG Performed By
Item
EEG Performed By
text
C0013819 (UMLS CUI [1,1])
C1550369 (UMLS CUI [1,2])
Item Group
Clinical Interpretation of EEG
C4086187 (UMLS CUI-1)
C0013819 (UMLS CUI-2)
EEG Recording Normal
Item
Is the EEG recording normal?
boolean
C0560017 (UMLS CUI [1])
EEG Abnormality Clinically Significant
Item
If No, is the abnormality clinically significant?
boolean
C0013819 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
EEG Abnormality Comment
Item
If the EEG recording is abnormal and the abnormality is clinically significant, please comment below and exclude the subject from the trial.
text
C0013819 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Neurophysiologist Staff initials
Item
Neurophysiologist Staff initials
text
C1552089 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C0586861 (UMLS CUI [1,3])
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