ID

33653

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 Note: In the event of a subject experiencing a suspected drug induced rash, the subject should be withdrawn from the study immediately.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

Stichworte

Versionen (2)
  1. 03.12.18 03.12.18 -
  2. 18.12.18 18.12.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

18. Dezember 2018

DOI

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

Englisch

Dermatological Examination Form

1 Formulare  
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
Study Visit
Beschreibung

Study Visit

Datentyp

text

Alias
UMLS CUI [1]
C0545082
Dermatological Examination
Beschreibung

Dermatological Examination

Alias
UMLS CUI-1
C0560169
Protocol Time
Beschreibung

Protocol Time

Datentyp

text

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

Study Day

Datentyp

text

Alias
UMLS CUI [1]
C2826182
Date of Assessment
Beschreibung

Date of Assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Actual Time
Beschreibung

Actual Time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
Has a Dermatological examination been performed?
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0560169
Comment
Beschreibung

Comment

Datentyp

text

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

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

Datentyp

boolean

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

Time After Administration Exanthema Occurred

Datentyp

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?
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0458082
Was a dermatologist consulted?
Beschreibung

Dermatologist Consulted

Datentyp

boolean

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

Physician's Signature

Datentyp

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0031831
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Ähnliche Modelle

Dermatological Examination Form

1 Formulare
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])
Item
Study Visit
text
C0545082 (UMLS CUI [1])
Study Visit
Code List
Study Visit
CL Item
Treatment Period 1 (Treatment Period 1)
CL Item
Treatment Period 2 (Treatment Period 2)
CL Item
Treatment Period 3 (Treatment Period 3)
CL Item
Follow-Up Visit (Follow-Up Visit)
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
C2826182 (UMLS CUI [1])
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)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
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 [1,1])
C0458082 (UMLS CUI [1,2])
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 [1,1])
C0031831 (UMLS CUI [1,2])
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