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ID
18360
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
Keywords
Versions (2)
- 11/2/16 11/2/16 -
- 11/11/16 11/11/16 -
Uploaded on
November 2, 2016
DOI
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License
Creative Commons BY-NC 3.0
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Drug Accountability Galafold (migalastat) AT1001-012 NCT0121865
Drug Accountability Galafold (migalastat) AT1001-012 NCT0121865
- StudyEvent: ODM
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Drug Accountability Galafold (migalastat) AT1001-012 NCT0121865
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
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])
C0947323 (UMLS CUI [1,2])
Date dispensed
Item
Date dispensed
date
C0011008 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
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])
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])
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])
C0178602 (UMLS CUI [1,2])
Number of Extra Doses Taken
Item
Number of Extra Doses Taken
integer
C3845824 (UMLS CUI [1])