ID
18589
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 Follow-up
Mots-clés
Versions (2)
- 02/11/2016 02/11/2016 -
- 11/11/2016 11/11/2016 -
Téléchargé le
11 novembre 2016
DOI
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Licence
Creative Commons BY-NC 3.0
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Follow-up Galafold (migalastat) AT1001-012 NCT01218659
Follow-up Galafold (migalastat) AT1001-012 NCT01218659
- StudyEvent: ODM
Description
12 Lead ECG
Alias
- UMLS CUI-1
- C1623258
Description
Hematology/Coagulation
Alias
- UMLS CUI-1
- C0474523
Description
Hematology Sample Collection Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0011008
Description
Hematology finding; Laboratory test finding
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0587081
Description
Hematology: clinically significant abnormal laboratory values, please sepcify
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C1853129
- UMLS CUI-3
- C2826293
Description
If lab abnormalities=Yes
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1853129
- UMLS CUI [1,3]
- C2826293
Description
Chemistry, Laboratory findings
Alias
- UMLS CUI-1
- C0007996
- UMLS CUI-2
- C0022885
Description
Chemistry Sample Collection Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0007996
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0011008
Description
Science of Chemistry; Laboratory test finding
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0007996
- UMLS CUI [1,2]
- C0587081
Description
Chemistry: clinically significant abnormal laboratory values, please specify
Alias
- UMLS CUI-1
- C0005774
- UMLS CUI-2
- C2826293
Description
If lab abnormalities=Yes
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0005774
- UMLS CUI [1,2]
- C2826293
Description
Urinanalysis
Alias
- UMLS CUI-1
- C0042014
Description
Urinalysis Sample Collection Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0011008
Description
Urinalysis; Laboratory test finding
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0587081
Description
Urinalysis: clinically significant abnormal laboratory values
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C1853129
- UMLS CUI-3
- C2826293
Description
If lab abnormalities=Yes
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1853129
- UMLS CUI [1,3]
- C2826293
Description
Additional Observations
Alias
- UMLS CUI-1
- C0700325
Description
reference date
Type de données
date
Alias
- UMLS CUI [1]
- C1719096
Description
Visit
Type de données
text
Alias
- UMLS CUI [1]
- C0545082
Description
eCRF
Type de données
text
Alias
- UMLS CUI [1]
- C1516308
Description
Comment
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Assessment Date
Type de données
date
Alias
- UMLS CUI [1]
- C2985720
Description
Weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Blood pressure
Type de données
text
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Heart rate
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Respiration Rate
Type de données
integer
Unités de mesure
- /min
Alias
- UMLS CUI [1]
- C0231832
Description
Secondary Endpoint Criteria
Description
cardiovascular event
Type de données
integer
Alias
- UMLS CUI [1]
- C1320716
Description
cardiac consult
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0009818
- UMLS CUI [1,2]
- C0007226
Description
cerebrovascular event
Type de données
integer
Alias
- UMLS CUI [1]
- C0038454
Description
neurological consult
Type de données
integer
Alias
- UMLS CUI [1]
- C0849229
Description
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Description
Date of Examination
Type de données
date
Alias
- UMLS CUI [1]
- C2826643
Description
Physical Exam Status
Type de données
integer
Alias
- UMLS CUI [1]
- C0031809
Description
If Clinically significant findings, please specify
Type de données
integer
Alias
- UMLS CUI [1]
- C0031809
Description
If Clinically significant findings, please specify
Type de données
text
Alias
- UMLS CUI [1]
- C0031809
Similar models
Follow-up Galafold (migalastat) AT1001-012 NCT01218659
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C1853129 (UMLS CUI-2)
C2826293 (UMLS CUI-3)
C1853129 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0022885 (UMLS CUI-2)
C0022877 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0587081 (UMLS CUI [1,2])
C2826293 (UMLS CUI-2)
C2826293 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0587081 (UMLS CUI [1,2])
C1853129 (UMLS CUI-2)
C2826293 (UMLS CUI-3)
C1853129 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0007226 (UMLS CUI [1,2])
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