ID

33451

Beschrijving

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 miscellaneous information about the subject. 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

Trefwoorden

Versies (4)
  1. 01-12-18 01-12-18 -
  2. 09-12-18 09-12-18 -
  3. 09-12-18 09-12-18 -
  4. 18-12-18 18-12-18 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

9 december 2018

DOI

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Licentie

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

Engels

Miscellaneous Information

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschrijving

Subject Screening No.

Datatype

integer

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

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Date Information Collected
Beschrijving

Date Information Collected

Datatype

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008
Miscellaneous Information
Beschrijving

Miscellaneous Information

Alias
UMLS CUI-1
C0205395
UMLS CUI-2
C1955348
Has the subject an adequate command of the English language (written and verbal)?
Beschrijving

Able to Read and Write English

Datatype

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
Details If Not Able to Speak or Write English
Beschrijving

To be filled out if the subject has no adequate command of the English language

Datatype

text

Alias
UMLS CUI [1,1]
C1522508
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C0586740
UMLS CUI [1,4]
C0376245
UMLS CUI [2,1]
C1522508
UMLS CUI [2,2]
C1299582
UMLS CUI [2,3]
C0584993
UMLS CUI [2,4]
C0376245
Has the subject contracted any tropical diseases?
Beschrijving

Tropical Diseases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1336827
Details if the subject contracted any tropical diseases, including dates if possible
Beschrijving

To be filled out if the subject contracted any tropical diseases

Datatype

text

Alias
UMLS CUI [1,1]
C1522508
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1336827
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1336827
Has the subject travelled to tropical countries (other than country of origin)?
Beschrijving

Travels to Tropical Countries

Datatype

boolean

Alias
UMLS CUI [1]
C2938902
If the subject has travelled to tropical countries, give details including dates if possible.
Beschrijving

Details to Travels to Tropical Countries

Datatype

text

Alias
UMLS CUI [1,1]
C2938902
UMLS CUI [1,2]
C1522508
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C2938902
Conclusion
Beschrijving

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Beschrijving

Staff initials

Datatype

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Physician's Initials
Beschrijving

Physician's Initials

Datatype

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
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Similar models

Miscellaneous Information

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Miscellaneous Information
C0205395 (UMLS CUI-1)
C1955348 (UMLS CUI-2)
Able to Read and Write English
Item
Has the subject an adequate command of the English language (written and verbal)?
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Details If Not Able to Speak or Write English
Item
Details If Not Able to Speak or Write English
text
C1522508 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0586740 (UMLS CUI [1,3])
C0376245 (UMLS CUI [1,4])
C1522508 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0584993 (UMLS CUI [2,3])
C0376245 (UMLS CUI [2,4])
Tropical Diseases
Item
Has the subject contracted any tropical diseases?
boolean
C0262926 (UMLS CUI [1,1])
C1336827 (UMLS CUI [1,2])
Tropical Diseases
Item
Details if the subject contracted any tropical diseases, including dates if possible
text
C1522508 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1336827 (UMLS CUI [1,3])
C0011008 (UMLS CUI [2,1])
C1336827 (UMLS CUI [2,2])
Travels to Tropical Countries
Item
Has the subject travelled to tropical countries (other than country of origin)?
boolean
C2938902 (UMLS CUI [1])
Details to Travels to Tropical Countries
Item
If the subject has travelled to tropical countries, give details including dates if possible.
text
C2938902 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C2938902 (UMLS CUI [2,2])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Physician's Initials
Item
Physician's Initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
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