ID

33216

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 informations about the subjects diagnostic EEG results. It should be filled out at 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

Stichworte

Versionen (3)
  1. 12/1/18 12/1/18 -
  2. 12/11/18 12/11/18 -
  3. 12/11/18 12/11/18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

December 1, 2018

DOI

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Lizenz

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

Englisch

EEG

1 Formulare  
  1. StudyEvent: ODM
    1. EEG
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
Date Information Collected
Beschreibung

Date Information Collected

Datentyp

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008
Diagnostic EEG
Beschreibung

Diagnostic EEG

Alias
UMLS CUI-1
C0013819
Actual Time
Beschreibung

Actual Time

Datentyp

datetime

Alias
UMLS CUI [1]
C0040223
EEG Comments
Beschreibung

EEG Comments

Datentyp

text

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

Neurophysiologist Staff Initials

Datentyp

text

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

Clinical Interpretation of EEG

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

EEG Recording

Datentyp

boolean

Alias
UMLS CUI [1]
C0013819
If No, is the abnormality clinically significant?
Beschreibung

EEG Abnormality Clinically Significant

Datentyp

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.
Beschreibung

EEG Abnormality Comment

Datentyp

text

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

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Beschreibung

Staff initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
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Ähnliche Modelle

EEG

1 Formulare
  1. StudyEvent: ODM
    1. EEG
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])
Date Information Collected
Item
Date Information Collected
date
C3244127 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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
Item
Is the EEG recording normal?
boolean
C0013819 (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)
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
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