ID

33261

Descripción

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 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 Note: In the event of a subject experiencing a suspected drug induced rash, the subject should be withdrawn from the study immediately.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

Palabras clave

Versiones (2)
  1. 3/12/18 3/12/18 -
  2. 18/12/18 18/12/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

3 de diciembre de 2018

DOI

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Licencia

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

Inglés

Dermatological Examination Form

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Descripción

Subject Screening No.

Tipo de datos

integer

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

Subject Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Date of Assessment
Descripción

Date of Assessment

Tipo de datos

date

Alias
UMLS CUI [1]
C2985720
Actual Time
Descripción

Actual Time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Dermatological Examination
Descripción

Dermatological Examination

Alias
UMLS CUI-1
C0560169
Protocol Time
Descripción

Protocol Time

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2348563
Study Day
Descripción

Study Day

Tipo de datos

text

Has a Dermatological examination been performed?
Descripción

If no, please comment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0560169
Comment
Descripción

Comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Has the subject experienced any type of rash?
Descripción

If yes, complete the subject’s Adverse Event source document book.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015230
How long after administration of the drug did the rash occur?
Descripción

Time After Administration Exanthema Occurred

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0439568
In the opinion of the physician, is the subject experiencing a suspected drug induced rash?
Descripción

If yes, complete the “Record of Rash” page at the back of the CRF.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015230
Was a dermatologist consulted?
Descripción

Dermatologist Consulted

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0259831
UMLS CUI [1,2]
C0009818
Physician's Signature
Descripción

Physician's Signature

Tipo de datos

text

Alias
UMLS CUI [1]
C1519316
Conclusion
Descripción

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Descripción

Staff initials

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Dermatological Examination Form

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item Group
Dermatological Examination
C0560169 (UMLS CUI-1)
Item
Protocol Time
text
C0040223 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Protocol Time
Code List
Protocol Time
CL Item
Pre Dose (Pre Dose)
CL Item
48h00 post dose (48h00 post dose)
CL Item
24h00 post dose (24h00 post dose)
CL Item
216h00 post dose (216h00 post dose)
Item
Study Day
text
Study Day
Code List
Study Day
CL Item
Day 1 (Day 1)
CL Item
Day 3 (Day 3)
CL Item
Day 2 (Day 2)
CL Item
Day 10 (Day 10)
Dermatological Examination Performed
Item
Has a Dermatological examination been performed?
boolean
C0560169 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Rashes
Item
Has the subject experienced any type of rash?
boolean
C0015230 (UMLS CUI [1])
Time After Administration Exanthema Occurred
Item
How long after administration of the drug did the rash occur?
text
C0015230 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Sespected Drug induced Rash
Item
In the opinion of the physician, is the subject experiencing a suspected drug induced rash?
boolean
C0015230 (UMLS CUI [1])
Dermatologist Consulted
Item
Was a dermatologist consulted?
boolean
C0259831 (UMLS CUI [1,1])
C0009818 (UMLS CUI [1,2])
Physician's Signature
Item
Physician's Signature
text
C1519316 (UMLS CUI [1])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Volver a la parte superior de la página 

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