ID
18345
Beschrijving
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
Trefwoorden
Versies (2)
- 02-11-16 02-11-16 -
- 11-11-16 11-11-16 -
Geüploaded op
2 november 2016
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
Demographics
Beschrijving
Informed Consent
Datatype
date
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C0011008
Beschrijving
Subject number
Datatype
integer
Alias
- UMLS CUI [1]
- C2348585
Beschrijving
Full subject number
Datatype
integer
Alias
- UMLS CUI [1]
- C2348585
Beschrijving
Subject Initials
Datatype
text
Alias
- UMLS CUI [1]
- C2986440
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Sex
Datatype
integer
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Ethnicity
Datatype
integer
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
Race
Datatype
text
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Date of Diagnosis
Datatype
date
Alias
- UMLS CUI [1,1]
- C2316983
- UMLS CUI [1,2]
- C0002986
Beschrijving
Date of GLA Genotyping obtained
Datatype
date
Alias
- UMLS CUI [1,1]
- C1285573
- UMLS CUI [1,2]
- C1439334
- UMLS CUI [1,3]
- C0011008
Beschrijving
Inclusion and Exclusion Criteria
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C0680251
Beschrijving
Inclusion Criteria
Datatype
integer
Alias
- UMLS CUI [1]
- C1512693
Beschrijving
Please reply if "Meet all eligibility criteria"=No
Datatype
integer
Alias
- UMLS CUI [1]
- C1512693
Beschrijving
Please reply if "Meet all eligibility criteria"=No
Datatype
integer
Alias
- UMLS CUI [1]
- C0680251
Beschrijving
medical history
Alias
- UMLS CUI-1
- C0262926
Beschrijving
Head/Eyes/Ears/Nose/Throat
Datatype
integer
Alias
- UMLS CUI [1]
- C1512338
Beschrijving
Respiratory
Datatype
integer
Alias
- UMLS CUI [1]
- C0035237
Beschrijving
Cardiovascular
Datatype
integer
Alias
- UMLS CUI [1]
- C0007226
Beschrijving
Dermatological
Datatype
integer
Alias
- UMLS CUI [1]
- C0037274
Beschrijving
Blood/Lymphatic
Datatype
integer
Alias
- UMLS CUI [1]
- C0279810
- UMLS CUI [2]
- C0024235
Beschrijving
Immunological/Allergies
Datatype
integer
Alias
- UMLS CUI [1]
- C0021053
- UMLS CUI [2]
- C0020517
Beschrijving
Gastrointestinal
Datatype
integer
Alias
- UMLS CUI [1]
- C0017178
Beschrijving
Neurological
Datatype
integer
Alias
- UMLS CUI [1]
- C0027765
Beschrijving
Hepatobiliary
Datatype
integer
Alias
- UMLS CUI [1]
- C0267792
Beschrijving
Genitourinary
Datatype
integer
Alias
- UMLS CUI [1]
- C0080276
Beschrijving
Psychiatric
Datatype
integer
Alias
- UMLS CUI [1]
- C0004936
Beschrijving
Endocrine/Metabolic
Datatype
integer
Alias
- UMLS CUI [1]
- C0014130
- UMLS CUI [2]
- C0025517
Beschrijving
Musculoskeletal
Datatype
integer
Alias
- UMLS CUI [1]
- C0026857
Beschrijving
General
Datatype
integer
Alias
- UMLS CUI [1]
- C1148438
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Date of Assessment
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Height
Datatype
float
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Respiration Rate
Datatype
integer
Maateenheden
- /min
Alias
- UMLS CUI [1]
- C0231832
Beschrijving
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
physical examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Head/Eyes/Ears/Nose/Throat
Datatype
integer
Alias
- UMLS CUI [1]
- C1512338
Beschrijving
Respiratory
Datatype
integer
Alias
- UMLS CUI [1]
- C0035237
Beschrijving
Cardiovascular
Datatype
integer
Alias
- UMLS CUI [1]
- C0007226
Beschrijving
Dermatological
Datatype
integer
Alias
- UMLS CUI [1]
- C0037274
Beschrijving
Lymphatics/Lymph Nodes
Datatype
integer
Alias
- UMLS CUI [1]
- C0024235
- UMLS CUI [2]
- C0024204
Beschrijving
Gastrointestinal
Datatype
integer
Alias
- UMLS CUI [1]
- C0012240
Beschrijving
Neurological
Datatype
integer
Alias
- UMLS CUI [1]
- C0027763
Beschrijving
Genitourinary
Datatype
integer
Alias
- UMLS CUI [1]
- C0042066
Beschrijving
Musculoskeletal
Datatype
integer
Alias
- UMLS CUI [1]
- C0026860
Beschrijving
General
Datatype
integer
Alias
- UMLS CUI [1]
- C1148438
Beschrijving
12 Lead ECG
Alias
- UMLS CUI-1
- C1623258
Beschrijving
Hematology/Coagulation
Alias
- UMLS CUI-1
- C0474523
Beschrijving
Hematology Sample Collection Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0011008
Beschrijving
Hematology finding; Laboratory test finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0587081
Beschrijving
Hematology: clinically significant abnormal laboratory values, please sepcify
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C1853129
- UMLS CUI-3
- C2826293
Beschrijving
If lab abnormalities=Yes
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1853129
- UMLS CUI [1,3]
- C2826293
Beschrijving
Chemistry, Laboratory findings
Alias
- UMLS CUI-1
- C0007996
- UMLS CUI-2
- C0022885
Beschrijving
Chemistry Sample Collection Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0007996
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0011008
Beschrijving
Science of Chemistry; Laboratory test finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0007996
- UMLS CUI [1,2]
- C0587081
Beschrijving
Chemistry: clinically significant abnormal laboratory values, please specify
Alias
- UMLS CUI-1
- C0005774
- UMLS CUI-2
- C2826293
Beschrijving
If lab abnormalities=Yes
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005774
- UMLS CUI [1,2]
- C2826293
Beschrijving
Urinanalysis
Alias
- UMLS CUI-1
- C0042014
Beschrijving
Urinalysis Sample Collection Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0011008
Beschrijving
Urinalysis; Laboratory test finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0587081
Beschrijving
Urinalysis: clinically significant abnormal laboratory values, please specify
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C1853129
- UMLS CUI-3
- C2826293
Beschrijving
If lab abnormalities=Yes
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1853129
- UMLS CUI [1,3]
- C2826293
Beschrijving
24-Hr Urine Collection
Alias
- UMLS CUI-1
- C0455060
Beschrijving
24-Hr Urine Collection Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C0808070
Beschrijving
24-Hr Urine Collection Start Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C1301880
Beschrijving
24-Hr Urine Collection Stop Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C0806020
Beschrijving
24-Hr Urine Collection Stop Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C1522314
Beschrijving
24-Hr Urine Collection Total Volume
Datatype
float
Maateenheden
- ml
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C2700258
Beschrijving
Date sent to Laboratory
Datatype
date
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C1515023
- UMLS CUI [1,3]
- C0011008
Beschrijving
Additional Observations
Alias
- UMLS CUI-1
- C0700325
Beschrijving
reference date
Datatype
date
Alias
- UMLS CUI [1]
- C1719096
Beschrijving
Visit
Datatype
text
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
eCRF
Datatype
text
Alias
- UMLS CUI [1]
- C1516308
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Similar models
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])
C0025517 (UMLS CUI [2])
C0024204 (UMLS CUI [2])
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])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C2700258 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])