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
Keywords
Versions (2)
- 11/2/16 11/2/16 -
- 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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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 (Electrocardiography)
- SNOMED
- 29303009
- LOINC
- LP6244-0
Description
ECG Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013798 (Electrocardiogram)
- LOINC
- LP149975-7
- UMLS CUI [1,2]
- C0011008 (Date in time)
- SNOMED
- 410671006
Description
ECG results
Data type
integer
Alias
- UMLS CUI [1]
- C1623258 (Electrocardiography)
- SNOMED
- 29303009
- LOINC
- LP6244-0
Description
Hematology/Coagulation
Alias
- UMLS CUI-1
- C0474523 (Hematology finding)
- SNOMED
- 250207003
Description
Hematology Sample Collection Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0474523 (Hematology finding)
- SNOMED
- 250207003
- UMLS CUI [1,2]
- C0011008 (Date in time)
- SNOMED
- 410671006
Description
Hematology finding; Laboratory test finding
Data type
integer
Alias
- UMLS CUI [1,1]
- C0474523 (Hematology finding)
- SNOMED
- 250207003
- UMLS CUI [1,2]
- C0587081 (Laboratory test finding)
- SNOMED
- 118246004
Description
Hematology: clinically significant abnormal laboratory values, please sepcify
Alias
- UMLS CUI-1
- C0474523 (Hematology finding)
- SNOMED
- 250207003
- UMLS CUI-2
- C1853129 (LABORATORY ABNORMALITIES)
- UMLS CUI-3
- C2826293 (Clinical Significance)
Description
If lab abnormalities=Yes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0474523 (Hematology finding)
- SNOMED
- 250207003
- UMLS CUI [1,2]
- C1853129 (LABORATORY ABNORMALITIES)
- UMLS CUI [1,3]
- C2826293 (Clinical Significance)
Description
Chemistry, Laboratory findings
Alias
- UMLS CUI-1
- C0007996 (Science of Chemistry)
- UMLS CUI-2
- C0022885 (Laboratory Procedures)
- SNOMED
- 269814003
Description
Chemistry Sample Collection Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0007996 (Science of Chemistry)
- UMLS CUI [1,2]
- C0022877 (Laboratory)
- SNOMED
- 261904005
- LOINC
- MTHU029808
- UMLS CUI [1,3]
- C0011008 (Date in time)
- SNOMED
- 410671006
Description
Science of Chemistry; Laboratory test finding
Data type
integer
Alias
- UMLS CUI [1,1]
- C0007996 (Science of Chemistry)
- UMLS CUI [1,2]
- C0587081 (Laboratory test finding)
- SNOMED
- 118246004
Description
Chemistry: clinically significant abnormal laboratory values, please specify
Alias
- UMLS CUI-1
- C0005774 (Blood Chemical Analysis)
- SNOMED
- 166312007
- UMLS CUI-2
- C2826293 (Clinical Significance)
Description
If lab abnormalities=Yes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005774 (Blood Chemical Analysis)
- SNOMED
- 166312007
- UMLS CUI [1,2]
- C2826293 (Clinical Significance)
Description
Urinanalysis
Alias
- UMLS CUI-1
- C0042014 (Urinalysis)
- SNOMED
- 167217005
- LOINC
- LP32744-2
Description
Urinalysis Sample Collection Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0042014 (Urinalysis)
- SNOMED
- 167217005
- LOINC
- LP32744-2
- UMLS CUI [1,2]
- C0022877 (Laboratory)
- SNOMED
- 261904005
- LOINC
- MTHU029808
- UMLS CUI [1,3]
- C0011008 (Date in time)
- SNOMED
- 410671006
Description
Urinalysis; Laboratory test finding
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042014 (Urinalysis)
- SNOMED
- 167217005
- LOINC
- LP32744-2
- UMLS CUI [1,2]
- C0587081 (Laboratory test finding)
- SNOMED
- 118246004
Description
Urinalysis: clinically significant abnormal laboratory values
Alias
- UMLS CUI-1
- C0042014 (Urinalysis)
- SNOMED
- 167217005
- LOINC
- LP32744-2
- UMLS CUI-2
- C1853129 (LABORATORY ABNORMALITIES)
- UMLS CUI-3
- C2826293 (Clinical Significance)
Description
If lab abnormalities=Yes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042014 (Urinalysis)
- SNOMED
- 167217005
- LOINC
- LP32744-2
- UMLS CUI [1,2]
- C1853129 (LABORATORY ABNORMALITIES)
- UMLS CUI [1,3]
- C2826293 (Clinical Significance)
Description
Additional Observations
Alias
- UMLS CUI-1
- C0700325 (Patient observation)
- SNOMED
- 103705002
Description
reference date
Data type
date
Alias
- UMLS CUI [1]
- C1719096 (Assessment reference date)
- LOINC
- MTHU029615
Description
Visit
Data type
text
Alias
- UMLS CUI [1]
- C0545082 (Visit)
Description
eCRF
Data type
text
Alias
- UMLS CUI [1]
- C1516308 (Case Report Form)
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611 (Comment)
- LOINC
- LP72293-1
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766 (Vital signs)
- LOINC
- LP30605-7
Description
Assessment Date
Data type
date
Alias
- UMLS CUI [1]
- C2985720 (Assessment Date)
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910 (Body Weight)
- SNOMED
- 27113001
Description
Blood pressure
Data type
text
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0005823 (Blood Pressure)
- SNOMED
- 75367002
Description
Blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0005823 (Blood Pressure)
- SNOMED
- 75367002
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810 (heart rate)
- SNOMED
- 364075005
- LOINC
- LP29713-2
Description
Respiration Rate
Data type
integer
Measurement units
- /min
Alias
- UMLS CUI [1]
- C0231832 (Respiratory rate)
- SNOMED
- 86290005
- LOINC
- LP20159-7
Description
Secondary Endpoint Criteria
Description
cardiovascular event
Data type
integer
Alias
- UMLS CUI [1]
- C1320716 (Cardiovascular event)
- SNOMED
- 405617006
Description
cardiac consult
Data type
integer
Alias
- UMLS CUI [1,1]
- C0009818 (Consultation)
- SNOMED
- 11429006
- LOINC
- LA7553-6
- UMLS CUI [1,2]
- C0007226 (Cardiovascular system)
- SNOMED
- 113257007
- LOINC
- LP7118-5
Description
cerebrovascular event
Data type
integer
Alias
- UMLS CUI [1]
- C0038454 (Cerebrovascular accident)
- SNOMED
- 230690007
- LOINC
- MTHU020801
Description
neurological consult
Data type
integer
Alias
- UMLS CUI [1]
- C0849229 (consult with specialist for neurological system)
Description
Physical Examination
Alias
- UMLS CUI-1
- C0031809 (Physical Examination)
- SNOMED
- 5880005
- LOINC
- MTHU028014
Description
Date of Examination
Data type
date
Alias
- UMLS CUI [1]
- C2826643 (Physical Examination Date)
Description
Physical Exam Status
Data type
integer
Alias
- UMLS CUI [1]
- C0031809 (Physical Examination)
- SNOMED
- 5880005
- LOINC
- MTHU028014
Description
If Clinically significant findings, please specify
Data type
integer
Alias
- UMLS CUI [1]
- C0031809 (Physical Examination)
- SNOMED
- 5880005
- LOINC
- MTHU028014
Description
If Clinically significant findings, please specify
Data type
text
Alias
- UMLS CUI [1]
- C0031809 (Physical Examination)
- SNOMED
- 5880005
- LOINC
- MTHU028014
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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