ID

15688

Descripción

Nerventra Study (Eudra CT 2007-003226-19) Study MS-LAQ-301: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS)

Palabras clave

Versiones (1)
  1. 8/6/16 8/6/16 -
Subido en

8 de junio de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Nerventra Study Study drug dispensing and return

Inglés

Nerventra Study Study drug dispensing and return

1 formularios  
Demographic Information
Descripción

Demographic Information

Protocol Number
Descripción

Protocol Number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008971
UMLS CUI [1,2]
C0600091
Visit Type
Descripción

i.e "Screening"

Tipo de datos

text

Alias
UMLS CUI [1]
C0545082
Date of visit
Descripción

Visit date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Study site number
Descripción

Study site

Tipo de datos

integer

Alias
UMLS CUI [1]
C2825164
Subject number:
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1709561
No data to report
Descripción

Blank

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0750479
Drug dispensed Baseline
Descripción

Drug dispensed Baseline

Date Study drug dispensed
Descripción

Date Study drug dispensed

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0947323
No. of capsules dispensed
Descripción

Amount dispensed

Tipo de datos

integer

Alias
UMLS CUI [1]
C0805077
Bottle number
Descripción

Bottle number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1300638
Batch code
Descripción

Batch code

Tipo de datos

integer

Alias
UMLS CUI [1]
C3641829
Expiry date
Descripción

Expiry date

Tipo de datos

date

Alias
UMLS CUI [1]
C3669020
Drug dispensing and return
Descripción

Drug dispensing and return

Date study drug returned from previous visit
Descripción

Drug returned

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2699071
Number of unused capsules
Descripción

Drug returned

Tipo de datos

integer

Alias
UMLS CUI [1]
C2699071
Date Study drug dispensed
Descripción

Date Study drug dispensed

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0947323
No. of capsules dispensed
Descripción

Amount dispensed

Tipo de datos

integer

Alias
UMLS CUI [1]
C0805077
Bottle number
Descripción

Bottle number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1300638
Batch code
Descripción

Batch code

Tipo de datos

integer

Alias
UMLS CUI [1]
C3641829
Expiry date
Descripción

Expiry date

Tipo de datos

date

Alias
UMLS CUI [1]
C3669020
Was study drug temporarily discontinued? If yes, complete below
Descripción

Discontinued

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1444662
Start date of temporary discontinuation
Descripción

Start date

Tipo de datos

date

Unidades de medida
  • dd/mm/yy
Alias
UMLS CUI [1]
C0808070
dd/mm/yy
End date of temporary discontinuation
Descripción

End date

Tipo de datos

date

Unidades de medida
  • dd/mm/yy
Alias
UMLS CUI [1]
C0806020
dd/mm/yy
Reason for temporary discontinuation
Descripción

Reason

Tipo de datos

text

Alias
UMLS CUI [1]
C0392360
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Similar models

Nerventra Study Study drug dispensing and return

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Demographic Information
Protocol Number
Item
Protocol Number
text
C0008971 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Visit
Item
Visit Type
text
C0545082 (UMLS CUI [1])
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Study site
Item
Study site number
integer
C2825164 (UMLS CUI [1])
Subject number
Item
Subject number:
integer
C1709561 (UMLS CUI [1])
Blank
Item
No data to report
boolean
C0750479 (UMLS CUI [1])
Item Group
Drug dispensed Baseline
Date Study drug dispensed
Item
Date Study drug dispensed
date
C0011008 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
Amount dispensed
Item
No. of capsules dispensed
integer
C0805077 (UMLS CUI [1])
Bottle number
Item
Bottle number
integer
C1300638 (UMLS CUI [1])
Batch code
Item
Batch code
integer
C3641829 (UMLS CUI [1])
Expiry date
Item
Expiry date
date
C3669020 (UMLS CUI [1])
Item Group
Drug dispensing and return
Drug returned
Item
Date study drug returned from previous visit
date
C0011008 (UMLS CUI [1,1])
C2699071 (UMLS CUI [1,2])
Drug returned
Item
Number of unused capsules
integer
C2699071 (UMLS CUI [1])
Date Study drug dispensed
Item
Date Study drug dispensed
date
C0011008 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
Amount dispensed
Item
No. of capsules dispensed
integer
C0805077 (UMLS CUI [1])
Bottle number
Item
Bottle number
integer
C1300638 (UMLS CUI [1])
Batch code
Item
Batch code
integer
C3641829 (UMLS CUI [1])
Expiry date
Item
Expiry date
date
C3669020 (UMLS CUI [1])
Discontinued
Item
Was study drug temporarily discontinued? If yes, complete below
boolean
C1444662 (UMLS CUI [1])
Start date
Item
Start date of temporary discontinuation
date
C0808070 (UMLS CUI [1])
End date
Item
End date of temporary discontinuation
date
C0806020 (UMLS CUI [1])
Reason
Item
Reason for temporary discontinuation
text
C0392360 (UMLS CUI [1])
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