ID
18345
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 1
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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Visit 1 CRFs Galafold (migalastat) AT1001-012 NCT0121865
Visit 1 CRFs Galafold (migalastat) AT1001-012 NCT0121865
- StudyEvent: ODM
Description
Demographics
Description
Informed Consent
Data type
date
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C0011008
Description
Subject number
Data type
integer
Alias
- UMLS CUI [1]
- C2348585
Description
Full subject number
Data type
integer
Alias
- UMLS CUI [1]
- C2348585
Description
Subject Initials
Data type
text
Alias
- UMLS CUI [1]
- C2986440
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
integer
Alias
- UMLS CUI [1]
- C0079399
Description
Ethnicity
Data type
integer
Alias
- UMLS CUI [1]
- C0015031
Description
Race
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
Date of Diagnosis
Data type
date
Alias
- UMLS CUI [1,1]
- C2316983
- UMLS CUI [1,2]
- C0002986
Description
Date of GLA Genotyping obtained
Data type
date
Alias
- UMLS CUI [1,1]
- C1285573
- UMLS CUI [1,2]
- C1439334
- UMLS CUI [1,3]
- C0011008
Description
Inclusion and Exclusion Criteria
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C0680251
Description
Inclusion Criteria
Data type
integer
Alias
- UMLS CUI [1]
- C1512693
Description
Please reply if "Meet all eligibility criteria"=No
Data type
integer
Alias
- UMLS CUI [1]
- C1512693
Description
Please reply if "Meet all eligibility criteria"=No
Data type
integer
Alias
- UMLS CUI [1]
- C0680251
Description
medical history
Alias
- UMLS CUI-1
- C0262926
Description
Head/Eyes/Ears/Nose/Throat
Data type
integer
Alias
- UMLS CUI [1]
- C1512338
Description
Respiratory
Data type
integer
Alias
- UMLS CUI [1]
- C0035237
Description
Cardiovascular
Data type
integer
Alias
- UMLS CUI [1]
- C0007226
Description
Dermatological
Data type
integer
Alias
- UMLS CUI [1]
- C0037274
Description
Blood/Lymphatic
Data type
integer
Alias
- UMLS CUI [1]
- C0279810
- UMLS CUI [2]
- C0024235
Description
Immunological/Allergies
Data type
integer
Alias
- UMLS CUI [1]
- C0021053
- UMLS CUI [2]
- C0020517
Description
Gastrointestinal
Data type
integer
Alias
- UMLS CUI [1]
- C0017178
Description
Neurological
Data type
integer
Alias
- UMLS CUI [1]
- C0027765
Description
Hepatobiliary
Data type
integer
Alias
- UMLS CUI [1]
- C0267792
Description
Genitourinary
Data type
integer
Alias
- UMLS CUI [1]
- C0080276
Description
Psychiatric
Data type
integer
Alias
- UMLS CUI [1]
- C0004936
Description
Endocrine/Metabolic
Data type
integer
Alias
- UMLS CUI [1]
- C0014130
- UMLS CUI [2]
- C0025517
Description
Musculoskeletal
Data type
integer
Alias
- UMLS CUI [1]
- C0026857
Description
General
Data type
integer
Alias
- UMLS CUI [1]
- C1148438
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Date of Assessment
Data type
date
Alias
- UMLS CUI [1]
- C2985720
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Height
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Respiration Rate
Data type
integer
Measurement units
- /min
Alias
- UMLS CUI [1]
- C0231832
Description
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Description
physical examination
Data type
integer
Alias
- UMLS CUI [1]
- C0031809
Description
Head/Eyes/Ears/Nose/Throat
Data type
integer
Alias
- UMLS CUI [1]
- C1512338
Description
Respiratory
Data type
integer
Alias
- UMLS CUI [1]
- C0035237
Description
Cardiovascular
Data type
integer
Alias
- UMLS CUI [1]
- C0007226
Description
Dermatological
Data type
integer
Alias
- UMLS CUI [1]
- C0037274
Description
Lymphatics/Lymph Nodes
Data type
integer
Alias
- UMLS CUI [1]
- C0024235
- UMLS CUI [2]
- C0024204
Description
Gastrointestinal
Data type
integer
Alias
- UMLS CUI [1]
- C0012240
Description
Neurological
Data type
integer
Alias
- UMLS CUI [1]
- C0027763
Description
Genitourinary
Data type
integer
Alias
- UMLS CUI [1]
- C0042066
Description
Musculoskeletal
Data type
integer
Alias
- UMLS CUI [1]
- C0026860
Description
General
Data type
integer
Alias
- UMLS CUI [1]
- C1148438
Description
12 Lead ECG
Alias
- UMLS CUI-1
- C1623258
Description
ECG Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0011008
Description
ECG Results
Data type
integer
Alias
- UMLS CUI [1]
- C1623258
Description
PR interval
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429087
Description
Hematology/Coagulation
Alias
- UMLS CUI-1
- C0474523
Description
Hematology Sample Collection Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0011008
Description
Hematology finding; Laboratory test finding
Data type
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
Data type
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
Data type
date
Alias
- UMLS CUI [1,1]
- C0007996
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0011008
Description
Science of Chemistry; Laboratory test finding
Data type
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
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005774
- UMLS CUI [1,2]
- C2826293
Description
Urinanalysis
Alias
- UMLS CUI-1
- C0042014
Description
Urinalysis Sample Collection Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0011008
Description
Urinalysis; Laboratory test finding
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0587081
Description
Urinalysis: clinically significant abnormal laboratory values, please specify
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C1853129
- UMLS CUI-3
- C2826293
Description
If lab abnormalities=Yes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1853129
- UMLS CUI [1,3]
- C2826293
Description
24-Hr Urine Collection
Alias
- UMLS CUI-1
- C0455060
Description
24-Hr Urine Collection Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C0808070
Description
24-Hr Urine Collection Start Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C1301880
Description
24-Hr Urine Collection Stop Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C0806020
Description
24-Hr Urine Collection Stop Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C1522314
Description
24-Hr Urine Collection Total Volume
Data type
float
Measurement units
- ml
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C2700258
Description
Date sent to Laboratory
Data type
date
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C1515023
- UMLS CUI [1,3]
- C0011008
Description
Additional Observations
Alias
- UMLS CUI-1
- C0700325
Description
reference date
Data type
date
Alias
- UMLS CUI [1]
- C1719096
Description
Visit
Data type
text
Alias
- UMLS CUI [1]
- C0545082
Description
eCRF
Data type
text
Alias
- UMLS CUI [1]
- C1516308
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
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Visit 1 CRFs Galafold (migalastat) AT1001-012 NCT0121865
- StudyEvent: ODM
C0011008 (UMLS CUI [2])
C0002986 (UMLS CUI [1,2])
C1439334 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0680251 (UMLS CUI-2)
C0020517 (UMLS CUI [2])
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C2826293 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
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