ID

33649

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 informations about the response of the subjects general practicioner. It should be filled out at the first treatment period. Only include this form if a recent GP response is required before dosing. 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 (1)
  1. 12/18/18 12/18/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 18, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Effect of Lamictal on Resting Motor Threshold Study-ID 107434

English

GP Response

1 forms  
  1. StudyEvent: ODM
    1. GP Response
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
GP Response
Description

GP Response

Alias
UMLS CUI-1
C0017319
UMLS CUI-2
C1706817
Has the Principal Investigator (or delegate) reviewed a recent* response from the subject’s primary Physician?
Description

*Recent = dated within 12 months of the first dose administration

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0017319
UMLS CUI [1,3]
C1706817
Is the subject suitable for study participation?
Description

If no, exclude

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3900053
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Conclusion
Description

Conclusion

Alias
UMLS CUI-1
C1707478
Physician's Initials
Description

Physician's Initials

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Back to the top of the page

Similar models

GP Response

1 forms
  1. StudyEvent: ODM
    1. GP Response
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 Group
GP Response
C0017319 (UMLS CUI-1)
C1706817 (UMLS CUI-2)
Recent Response from GP
Item
Has the Principal Investigator (or delegate) reviewed a recent* response from the subject’s primary Physician?
boolean
C0332185 (UMLS CUI [1,1])
C0017319 (UMLS CUI [1,2])
C1706817 (UMLS CUI [1,3])
Subject Suitable for Study Participation
Item
Is the subject suitable for study participation?
boolean
C2348568 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Physician's Initials
Item
Physician's Initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial