ID
33653
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 is for documentation of the dermatological examination. It should be filled out at each treatment period and follow-up visit. Note: In the event of a subject experiencing a suspected drug induced rash, the subject should be withdrawn from the study immediately. 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 (2)
- 12/3/18 12/3/18 -
- 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.
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
Dermatological Examination Form
- StudyEvent: ODM
Description
Dermatological Examination
Alias
- UMLS CUI-1
- C0560169
Description
Protocol Time
Data type
text
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2348563
Description
Study Day
Data type
text
Alias
- UMLS CUI [1]
- C2826182
Description
Date of Assessment
Data type
date
Alias
- UMLS CUI [1]
- C2985720
Description
Actual Time
Data type
time
Alias
- UMLS CUI [1]
- C0040223
Description
If no, please comment If yes, The following need to be completed: - Add a comment on the “Additional Information” page of the CRF - Complete the Adverse Event source document. - Complete the Dermatological / Hypersensitivity Adverse Event page
Data type
boolean
Alias
- UMLS CUI [1]
- C0560169
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
If yes, complete the subject’s Adverse Event source document book.
Data type
boolean
Alias
- UMLS CUI [1]
- C0015230
Description
Time After Administration Exanthema Occurred
Data type
text
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0439568
Description
If yes, complete the “Record of Rash” page at the back of the CRF.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C0458082
Description
Dermatologist Consulted
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0259831
- UMLS CUI [1,2]
- C0009818
Description
Physician's Signature
Data type
text
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C0031831
Similar models
Dermatological Examination Form
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0458082 (UMLS CUI [1,2])
C0009818 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,2])
No comments