ID

18595

Beschreibung

A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT Drug Accountability for Optional Open-Label Extension

Stichworte

  1. 02.11.16 02.11.16 -
  2. 11.11.16 11.11.16 -
Hochgeladen am

11. November 2016

DOI

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Lizenz

Creative Commons BY-NC 3.0

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Drug Accountability for Optional Open-Label Extension Galafold (migalastat) AT1001-012 NCT01218659

Drug Accountability for Optional Open-Label Extension Galafold (migalastat) AT1001-012 NCT01218659

Additional Observations
Beschreibung

Additional Observations

Alias
UMLS CUI-1
C0700325
Reference date
Beschreibung

Reference date

Datentyp

date

Alias
UMLS CUI [1]
C1719096
Visit Type
Beschreibung

Visit

Datentyp

text

Alias
UMLS CUI [1]
C0545082
electronic case report form
Beschreibung

eCRF

Datentyp

text

Alias
UMLS CUI [1]
C1516308
Comment
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Drug Accountability for Optional Open-Label Extension
Beschreibung

Drug Accountability for Optional Open-Label Extension

Alias
UMLS CUI-1
C1704643
Date of first dose of AT1001 for Optional Open-Label Extension
Beschreibung

First dose date

Datentyp

date

Alias
UMLS CUI [1]
C3173309
Date of last dose of AT1001 for Optional Open-Label Extension
Beschreibung

Last Dose Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0011008
Visit dispensed
Beschreibung

Visit dispensed

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0947323
Date dispensed
Beschreibung

Date dispensed

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0947323
Number of Blister packs dispensed
Beschreibung

Number of Blister packs dispensed

Datentyp

integer

Alias
UMLS CUI [1]
C1706080
Blister Pack ID(s) dispensed
Beschreibung

Blister Pack ID(s) dispensed

Datentyp

text

Alias
UMLS CUI [1,1]
C1706080
UMLS CUI [1,2]
C1300638
Date returned
Beschreibung

Date returned

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Number of Blister Packs Returned
Beschreibung

Number of Blister Packs Returned

Datentyp

integer

Alias
UMLS CUI [1]
C1706080
Number of Blister Packs Lost
Beschreibung

Number of Blister Packs Lost

Datentyp

integer

Alias
UMLS CUI [1,1]
C1706080
UMLS CUI [1,2]
C0745777
Number of Doses Missed
Beschreibung

Number of Doses Missed

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705492
UMLS CUI [1,2]
C0178602
Number of Extra Doses Taken
Beschreibung

Number of Extra Doses Taken

Datentyp

integer

Alias
UMLS CUI [1]
C3845824

Ähnliche Modelle

Drug Accountability for Optional Open-Label Extension Galafold (migalastat) AT1001-012 NCT01218659

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Additional Observations
C0700325 (UMLS CUI-1)
Reference date
Item
Reference date
date
C1719096 (UMLS CUI [1])
Visit
Item
Visit Type
text
C0545082 (UMLS CUI [1])
eCRF
Item
electronic case report form
text
C1516308 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Drug Accountability for Optional Open-Label Extension
C1704643 (UMLS CUI-1)
First dose date
Item
Date of first dose of AT1001 for Optional Open-Label Extension
date
C3173309 (UMLS CUI [1])
Last Dose Date
Item
Date of last dose of AT1001 for Optional Open-Label Extension
date
C0178602 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Visit dispensed
Item
Visit dispensed
integer
C0545082 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
Date dispensed
Item
Date dispensed
date
C0011008 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
Number of Blister packs dispensed
Item
Number of Blister packs dispensed
integer
C1706080 (UMLS CUI [1])
Blister Pack ID(s) dispensed
Item
Blister Pack ID(s) dispensed
text
C1706080 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Date returned
Item
Date returned
date
C0011008 (UMLS CUI [1])
Number of Blister Packs Returned
Item
Number of Blister Packs Returned
integer
C1706080 (UMLS CUI [1])
Number of Blister Packs Lost
Item
Number of Blister Packs Lost
integer
C1706080 (UMLS CUI [1,1])
C0745777 (UMLS CUI [1,2])
Number of Doses Missed
Item
Number of Doses Missed
integer
C1705492 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Number of Extra Doses Taken
Item
Number of Extra Doses Taken
integer
C3845824 (UMLS CUI [1])

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