ID

15688

Beschreibung

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)

Stichworte

Versionen (1)
  1. 08.06.16 08.06.16 -
Hochgeladen am

8. Juni 2016

DOI

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

Englisch

Nerventra Study Study drug dispensing and return

1 Formulare  
Demographic Information
Beschreibung

Demographic Information

Protocol Number
Beschreibung

Protocol Number

Datentyp

text

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

i.e "Screening"

Datentyp

text

Alias
UMLS CUI [1]
C0545082
Date of visit
Beschreibung

Visit date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Study site number
Beschreibung

Study site

Datentyp

integer

Alias
UMLS CUI [1]
C2825164
Subject number:
Beschreibung

Subject number

Datentyp

integer

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

Blank

Datentyp

boolean

Alias
UMLS CUI [1]
C0750479
Drug dispensed Baseline
Beschreibung

Drug dispensed Baseline

Date Study drug dispensed
Beschreibung

Date Study drug dispensed

Datentyp

date

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

Amount dispensed

Datentyp

integer

Alias
UMLS CUI [1]
C0805077
Bottle number
Beschreibung

Bottle number

Datentyp

integer

Alias
UMLS CUI [1]
C1300638
Batch code
Beschreibung

Batch code

Datentyp

integer

Alias
UMLS CUI [1]
C3641829
Expiry date
Beschreibung

Expiry date

Datentyp

date

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

Drug dispensing and return

Date study drug returned from previous visit
Beschreibung

Drug returned

Datentyp

date

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

Drug returned

Datentyp

integer

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

Date Study drug dispensed

Datentyp

date

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

Amount dispensed

Datentyp

integer

Alias
UMLS CUI [1]
C0805077
Bottle number
Beschreibung

Bottle number

Datentyp

integer

Alias
UMLS CUI [1]
C1300638
Batch code
Beschreibung

Batch code

Datentyp

integer

Alias
UMLS CUI [1]
C3641829
Expiry date
Beschreibung

Expiry date

Datentyp

date

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

Discontinued

Datentyp

boolean

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

Start date

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C0808070
dd/mm/yy
End date of temporary discontinuation
Beschreibung

End date

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C0806020
dd/mm/yy
Reason for temporary discontinuation
Beschreibung

Reason

Datentyp

text

Alias
UMLS CUI [1]
C0392360
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Ähnliche Modelle

Nerventra Study Study drug dispensing and return

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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