ID

18593

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 Study Completion

Keywords

  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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Study Completion Study Galafold (migalastat) AT1001-012 NCT01218659

Study Completion Study Galafold (migalastat) AT1001-012 NCT01218659

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
Study Completion
Description

Study Completion

Alias
UMLS CUI-1
C2826674
Last day on study
Description

Last day on study

Data type

date

Alias
UMLS CUI [1,1]
C2826674
UMLS CUI [1,2]
C0011008
Did the subject complete the study?
Description

Study Completion

Data type

integer

Alias
UMLS CUI [1]
C2826674
Casebook Signature
Description

Casebook Signature

Has all data for this patient been entered in the EDC system?
Description

Patient data

Data type

integer

Alias
UMLS CUI [1]
C2707520

Similar models

Study Completion Study Galafold (migalastat) AT1001-012 NCT01218659

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
C2826674 (UMLS CUI-1)
Last day on study
Item
Last day on study
date
C2826674 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Did the subject complete the study?
integer
C2826674 (UMLS CUI [1])
Code List
Did the subject complete the study?
CL Item
Yes, all visits through Visit 9/Month 18 (1a)
CL Item
Yes, all visits through Visit 14/Month 30 (1b)
CL Item
No (3)
Item
Has all data for this patient been entered in the EDC system?
integer
C2707520 (UMLS CUI [1])
Code List
Has all data for this patient been entered in the EDC system?
CL Item
Yes (1)

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