ID

18595

Description

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

Keywords

Versions (2)
  1. 11/2/16 11/2/16 -
  2. 11/11/16 11/11/16 -
Uploaded on

November 11, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Drug Accountability for Optional Open-Label Extension Galafold (migalastat) AT1001-012 NCT01218659

English

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

1 forms  
Additional Observations
Description

Additional Observations

Alias
UMLS CUI-1
C0700325
Reference date
Description

Reference date

Data type

date

Alias
UMLS CUI [1]
C1719096
Visit Type
Description

Visit

Data type

text

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

eCRF

Data type

text

Alias
UMLS CUI [1]
C1516308
Comment
Description

Comment

Data type

text

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

Drug Accountability for Optional Open-Label Extension

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

First dose date

Data type

date

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

Last Dose Date

Data type

date

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

Visit dispensed

Data type

integer

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

Date dispensed

Data type

date

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

Number of Blister packs dispensed

Data type

integer

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

Blister Pack ID(s) dispensed

Data type

text

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

Date returned

Data type

date

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

Number of Blister Packs Returned

Data type

integer

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

Number of Blister Packs Lost

Data type

integer

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

Number of Doses Missed

Data type

integer

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

Number of Extra Doses Taken

Data type

integer

Alias
UMLS CUI [1]
C3845824
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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