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. 2016-06-08 2016-06-08 -
Subido en

8 juni 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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