ID

18576

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 Visit 4

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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Visit 4 Galafold (migalastat) AT1001-012 NCT01218659

English

Visit 4 Galafold (migalastat) AT1001-012 NCT01218659

1 forms  
Date of visit
Description

Date of visit

Alias
UMLS CUI-1
C1320303
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
12 Lead ECG
Description

12 Lead ECG

Alias
UMLS CUI-1
C1623258
Date ECG was performed
Description

ECG Date

Data type

date

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0011008
ECG Results
Description

ECG Results

Data type

integer

Alias
UMLS CUI [1]
C1623258
PR interval
Description

PR interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
Hematology/Coagulation
Description

Hematology/Coagulation

Alias
UMLS CUI-1
C0474523
Hematology Sample Collection Date
Description

Hematology Sample Collection Date

Data type

date

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0011008
Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Hematology?
Description

Hematology finding; Laboratory test finding

Data type

integer

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0587081
Hematology: clinically significant abnormal laboratory values, please sepcify
Description

Hematology: clinically significant abnormal laboratory values, please sepcify

Alias
UMLS CUI-1
C0474523
UMLS CUI-2
C1853129
UMLS CUI-3
C2826293
Hematology: clinically significant abnormal laboratory values, please sepcify
Description

If lab abnormalities=Yes

Data type

integer

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1853129
UMLS CUI [1,3]
C2826293
Chemistry, Laboratory findings
Description

Chemistry, Laboratory findings

Alias
UMLS CUI-1
C0007996
UMLS CUI-2
C0022885
Chemistry Sample Collection Date
Description

Chemistry Sample Collection Date

Data type

date

Alias
UMLS CUI [1,1]
C0007996
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0011008
Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Chemistry?
Description

Science of Chemistry; Laboratory test finding

Data type

integer

Alias
UMLS CUI [1,1]
C0007996
UMLS CUI [1,2]
C0587081
Chemistry: clinically significant abnormal laboratory values, please specify
Description

Chemistry: clinically significant abnormal laboratory values, please specify

Alias
UMLS CUI-1
C0005774
UMLS CUI-2
C2826293
Chemistry: clinically significant abnormal laboratory values, please specify
Description

If lab abnormalities=Yes

Data type

integer

Alias
UMLS CUI [1,1]
C0005774
UMLS CUI [1,2]
C2826293
Urinanalysis
Description

Urinanalysis

Alias
UMLS CUI-1
C0042014
Urinalysis Sample Collection Date
Description

Urinalysis Sample Collection Date

Data type

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0011008
Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Urinalysis?
Description

Urinalysis; Laboratory test finding

Data type

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0587081
Urinalysis: clinically significant abnormal laboratory values, please specify
Description

Urinalysis: clinically significant abnormal laboratory values, please specify

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C1853129
UMLS CUI-3
C2826293
Urinalysis: clinically significant abnormal laboratory values, please specify
Description

If lab abnormalities=Yes

Data type

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1853129
UMLS CUI [1,3]
C2826293