ID

18586

Beschrijving

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

Trefwoorden

  1. 02-11-16 02-11-16 -
  2. 11-11-16 11-11-16 -
Geüploaded op

11 november 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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Drug Accountability Galafold (migalastat) AT1001-012 NCT01218659

Drug Accountability Galafold (migalastat) AT1001-012 NCT01218659

Additional Observations
Beschrijving

Additional Observations

Alias
UMLS CUI-1
C0700325
Reference date
Beschrijving

Reference date

Datatype

date

Alias
UMLS CUI [1]
C1719096
Visit Type
Beschrijving

Visit

Datatype

text

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

eCRF

Datatype

text

Alias
UMLS CUI [1]
C1516308
Comment
Beschrijving

Comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
Drug Accountability
Beschrijving

Drug Accountability

Alias
UMLS CUI-1
C1704643
Date of first dose of AT1001 for Treatment Period
Beschrijving

First dose date

Datatype

date

Alias
UMLS CUI [1]
C3173309
Date of last dose of AT1001 for Treatment Period
Beschrijving

Last Dose Date

Datatype

date

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

Visit dispensed

Datatype

integer

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

Date dispensed

Datatype

date

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

Number of Blister packs dispensed

Datatype

integer

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

Blister Pack ID(s) dispensed

Datatype

text

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

Date returned

Datatype

date

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

Number of Blister Packs Returned

Datatype

integer

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

Number of Blister Packs Lost

Datatype

integer

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

Number of Doses Missed

Datatype

integer

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

Number of Extra Doses Taken

Datatype

integer

Alias
UMLS CUI [1]
C3845824

Similar models

Drug Accountability Galafold (migalastat) AT1001-012 NCT01218659

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
C1704643 (UMLS CUI-1)
First dose date
Item
Date of first dose of AT1001 for Treatment Period
date
C3173309 (UMLS CUI [1])
Last Dose Date
Item
Date of last dose of AT1001 for Treatment Period
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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