ID
18345
Beschreibung
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
Stichworte
Versionen (2)
- 02.11.16 02.11.16 -
- 11.11.16 11.11.16 -
Hochgeladen am
2. November 2016
DOI
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Lizenz
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
Beschreibung
Demographics
Beschreibung
Informed Consent
Datentyp
date
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C0011008
Beschreibung
Subject number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348585
Beschreibung
Full subject number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348585
Beschreibung
Subject Initials
Datentyp
text
Alias
- UMLS CUI [1]
- C2986440
Beschreibung
Date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Sex
Datentyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Ethnicity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
Race
Datentyp
text
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Date of Diagnosis
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2316983
- UMLS CUI [1,2]
- C0002986
Beschreibung
Date of GLA Genotyping obtained
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1285573
- UMLS CUI [1,2]
- C1439334
- UMLS CUI [1,3]
- C0011008
Beschreibung
Inclusion and Exclusion Criteria
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C0680251
Beschreibung
Inclusion Criteria
Datentyp
integer
Alias
- UMLS CUI [1]
- C1512693
Beschreibung
Please reply if "Meet all eligibility criteria"=No
Datentyp
integer
Alias
- UMLS CUI [1]
- C1512693
Beschreibung
Please reply if "Meet all eligibility criteria"=No
Datentyp
integer
Alias
- UMLS CUI [1]
- C0680251
Beschreibung
medical history
Alias
- UMLS CUI-1
- C0262926
Beschreibung
Head/Eyes/Ears/Nose/Throat
Datentyp
integer
Alias
- UMLS CUI [1]
- C1512338
Beschreibung
Respiratory
Datentyp
integer
Alias
- UMLS CUI [1]
- C0035237
Beschreibung
Cardiovascular
Datentyp
integer
Alias
- UMLS CUI [1]
- C0007226
Beschreibung
Dermatological
Datentyp
integer
Alias
- UMLS CUI [1]
- C0037274
Beschreibung
Blood/Lymphatic
Datentyp
integer
Alias
- UMLS CUI [1]
- C0279810
- UMLS CUI [2]
- C0024235
Beschreibung
Immunological/Allergies
Datentyp
integer
Alias
- UMLS CUI [1]
- C0021053
- UMLS CUI [2]
- C0020517
Beschreibung
Gastrointestinal
Datentyp
integer
Alias
- UMLS CUI [1]
- C0017178
Beschreibung
Neurological
Datentyp
integer
Alias
- UMLS CUI [1]
- C0027765
Beschreibung
Hepatobiliary
Datentyp
integer
Alias
- UMLS CUI [1]
- C0267792
Beschreibung
Genitourinary
Datentyp
integer
Alias
- UMLS CUI [1]
- C0080276
Beschreibung
Psychiatric
Datentyp
integer
Alias
- UMLS CUI [1]
- C0004936
Beschreibung
Endocrine/Metabolic
Datentyp
integer
Alias
- UMLS CUI [1]
- C0014130
- UMLS CUI [2]
- C0025517
Beschreibung
Musculoskeletal
Datentyp
integer
Alias
- UMLS CUI [1]
- C0026857
Beschreibung
General
Datentyp
integer
Alias
- UMLS CUI [1]
- C1148438
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Date of Assessment
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Height
Datentyp
float
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Blood pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschreibung
Blood pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Respiration Rate
Datentyp
integer
Maßeinheiten
- /min
Alias
- UMLS CUI [1]
- C0231832
Beschreibung
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschreibung
physical examination
Datentyp
integer
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
Head/Eyes/Ears/Nose/Throat
Datentyp
integer
Alias
- UMLS CUI [1]
- C1512338
Beschreibung
Respiratory
Datentyp
integer
Alias
- UMLS CUI [1]
- C0035237
Beschreibung
Cardiovascular
Datentyp
integer
Alias
- UMLS CUI [1]
- C0007226
Beschreibung
Dermatological
Datentyp
integer
Alias
- UMLS CUI [1]
- C0037274
Beschreibung
Lymphatics/Lymph Nodes
Datentyp
integer
Alias
- UMLS CUI [1]
- C0024235
- UMLS CUI [2]
- C0024204
Beschreibung
Gastrointestinal
Datentyp
integer
Alias
- UMLS CUI [1]
- C0012240
Beschreibung
Neurological
Datentyp
integer
Alias
- UMLS CUI [1]
- C0027763
Beschreibung
Genitourinary
Datentyp
integer
Alias
- UMLS CUI [1]
- C0042066
Beschreibung
Musculoskeletal
Datentyp
integer
Alias
- UMLS CUI [1]
- C0026860
Beschreibung
General
Datentyp
integer
Alias
- UMLS CUI [1]
- C1148438
Beschreibung
12 Lead ECG
Alias
- UMLS CUI-1
- C1623258
Beschreibung
Hematology/Coagulation
Alias
- UMLS CUI-1
- C0474523
Beschreibung
Hematology Sample Collection Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0011008
Beschreibung
Hematology finding; Laboratory test finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0587081
Beschreibung
Hematology: clinically significant abnormal laboratory values, please sepcify
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C1853129
- UMLS CUI-3
- C2826293
Beschreibung
If lab abnormalities=Yes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1853129
- UMLS CUI [1,3]
- C2826293
Beschreibung
Chemistry, Laboratory findings
Alias
- UMLS CUI-1
- C0007996
- UMLS CUI-2
- C0022885
Beschreibung
Chemistry Sample Collection Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0007996
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0011008
Beschreibung
Science of Chemistry; Laboratory test finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0007996
- UMLS CUI [1,2]
- C0587081
Beschreibung
Chemistry: clinically significant abnormal laboratory values, please specify
Alias
- UMLS CUI-1
- C0005774
- UMLS CUI-2
- C2826293
Beschreibung
If lab abnormalities=Yes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0005774
- UMLS CUI [1,2]
- C2826293
Beschreibung
Urinanalysis
Alias
- UMLS CUI-1
- C0042014
Beschreibung
Urinalysis Sample Collection Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0011008
Beschreibung
Urinalysis; Laboratory test finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0587081
Beschreibung
Urinalysis: clinically significant abnormal laboratory values, please specify
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C1853129
- UMLS CUI-3
- C2826293
Beschreibung
If lab abnormalities=Yes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1853129
- UMLS CUI [1,3]
- C2826293
Beschreibung
24-Hr Urine Collection
Alias
- UMLS CUI-1
- C0455060
Beschreibung
24-Hr Urine Collection Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C0808070
Beschreibung
24-Hr Urine Collection Start Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C1301880
Beschreibung
24-Hr Urine Collection Stop Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C0806020
Beschreibung
24-Hr Urine Collection Stop Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C1522314
Beschreibung
24-Hr Urine Collection Total Volume
Datentyp
float
Maßeinheiten
- ml
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C2700258
Beschreibung
Date sent to Laboratory
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C1515023
- UMLS CUI [1,3]
- C0011008
Beschreibung
Additional Observations
Alias
- UMLS CUI-1
- C0700325
Beschreibung
reference date
Datentyp
date
Alias
- UMLS CUI [1]
- C1719096
Beschreibung
Visit
Datentyp
text
Alias
- UMLS CUI [1]
- C0545082
Beschreibung
eCRF
Datentyp
text
Alias
- UMLS CUI [1]
- C1516308
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Ähnliche Modelle
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])