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
Mots-clés
Versions (2)
- 02/11/2016 02/11/2016 -
- 11/11/2016 11/11/2016 -
Téléchargé le
2 novembre 2016
DOI
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Licence
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
Type de données
date
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C0011008
Description
Subject number
Type de données
integer
Alias
- UMLS CUI [1]
- C2348585
Description
Full subject number
Type de données
integer
Alias
- UMLS CUI [1]
- C2348585
Description
Subject Initials
Type de données
text
Alias
- UMLS CUI [1]
- C2986440
Description
Date of birth
Type de données
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Type de données
integer
Alias
- UMLS CUI [1]
- C0079399
Description
Ethnicity
Type de données
integer
Alias
- UMLS CUI [1]
- C0015031
Description
Race
Type de données
text
Alias
- UMLS CUI [1]
- C0034510
Description
Date of Diagnosis
Type de données
date
Alias
- UMLS CUI [1,1]
- C2316983
- UMLS CUI [1,2]
- C0002986
Description
Date of GLA Genotyping obtained
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1]
- C1512693
Description
Please reply if "Meet all eligibility criteria"=No
Type de données
integer
Alias
- UMLS CUI [1]
- C1512693
Description
Please reply if "Meet all eligibility criteria"=No
Type de données
integer
Alias
- UMLS CUI [1]
- C0680251
Description
medical history
Alias
- UMLS CUI-1
- C0262926
Description
Head/Eyes/Ears/Nose/Throat
Type de données
integer
Alias
- UMLS CUI [1]
- C1512338
Description
Respiratory
Type de données
integer
Alias
- UMLS CUI [1]
- C0035237
Description
Cardiovascular
Type de données
integer
Alias
- UMLS CUI [1]
- C0007226
Description
Dermatological
Type de données
integer
Alias
- UMLS CUI [1]
- C0037274
Description
Blood/Lymphatic
Type de données
integer
Alias
- UMLS CUI [1]
- C0279810
- UMLS CUI [2]
- C0024235
Description
Immunological/Allergies
Type de données
integer
Alias
- UMLS CUI [1]
- C0021053
- UMLS CUI [2]
- C0020517
Description
Gastrointestinal
Type de données
integer
Alias
- UMLS CUI [1]
- C0017178
Description
Neurological
Type de données
integer
Alias
- UMLS CUI [1]
- C0027765
Description
Hepatobiliary
Type de données
integer
Alias
- UMLS CUI [1]
- C0267792
Description
Genitourinary
Type de données
integer
Alias
- UMLS CUI [1]
- C0080276
Description
Psychiatric
Type de données
integer
Alias
- UMLS CUI [1]
- C0004936
Description
Endocrine/Metabolic
Type de données
integer
Alias
- UMLS CUI [1]
- C0014130
- UMLS CUI [2]
- C0025517
Description
Musculoskeletal
Type de données
integer
Alias
- UMLS CUI [1]
- C0026857
Description
General
Type de données
integer
Alias
- UMLS CUI [1]
- C1148438
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Date of Assessment
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
Height
Type de données
float
Unités de mesure
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Blood pressure
Type de données
integer
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
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Description
physical examination
Type de données
integer
Alias
- UMLS CUI [1]
- C0031809
Description
Head/Eyes/Ears/Nose/Throat
Type de données
integer
Alias
- UMLS CUI [1]
- C1512338
Description
Respiratory
Type de données
integer
Alias
- UMLS CUI [1]
- C0035237
Description
Cardiovascular
Type de données
integer
Alias
- UMLS CUI [1]
- C0007226
Description
Dermatological
Type de données
integer
Alias
- UMLS CUI [1]
- C0037274
Description
Lymphatics/Lymph Nodes
Type de données
integer
Alias
- UMLS CUI [1]
- C0024235
- UMLS CUI [2]
- C0024204
Description
Gastrointestinal
Type de données
integer
Alias
- UMLS CUI [1]
- C0012240
Description
Neurological
Type de données
integer
Alias
- UMLS CUI [1]
- C0027763
Description
Genitourinary
Type de données
integer
Alias
- UMLS CUI [1]
- C0042066
Description
Musculoskeletal
Type de données
integer
Alias
- UMLS CUI [1]
- C0026860
Description
General
Type de données
integer
Alias
- UMLS CUI [1]
- C1148438
Description
12 Lead ECG
Alias
- UMLS CUI-1
- C1623258
Description
ECG Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0011008
Description
ECG Results
Type de données
integer
Alias
- UMLS CUI [1]
- C1623258
Description
PR interval
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1]
- C0429087
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, please specify
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
24-Hr Urine Collection
Alias
- UMLS CUI-1
- C0455060
Description
24-Hr Urine Collection Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C0808070
Description
24-Hr Urine Collection Start Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C1301880
Description
24-Hr Urine Collection Stop Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C0806020
Description
24-Hr Urine Collection Stop Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C1522314
Description
24-Hr Urine Collection Total Volume
Type de données
float
Unités de mesure
- ml
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C2700258
Description
Date sent to Laboratory
Type de données
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
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
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])