ID
18577
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 6
Stichworte
Versionen (2)
- 02.11.16 02.11.16 -
- 11.11.16 11.11.16 -
Hochgeladen am
11. November 2016
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Visit 6 Galafold (migalastat) AT1001-012 NCT01218659
Visit 6 Galafold (migalastat) AT1001-012 NCT01218659
- StudyEvent: ODM
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
24-Hr Urine Collection 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
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Assessment Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
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
Secondary Endpoint Criteria
Beschreibung
cardiovascular event
Datentyp
integer
Alias
- UMLS CUI [1]
- C1320716
Beschreibung
cardiac consult
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0009818
- UMLS CUI [1,2]
- C0007226
Beschreibung
cerebrovascular event
Datentyp
integer
Alias
- UMLS CUI [1]
- C0038454
Beschreibung
neurological consult
Datentyp
integer
Alias
- UMLS CUI [1]
- C0849229
Beschreibung
Enzyme Replacement Therapy
Alias
- UMLS CUI-1
- C0598391
Beschreibung
Enzyme Replacement Therapy Infusion procedures Count
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0598391
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0750480
Beschreibung
Enzyme Replacement Therapy
Datentyp
integer
Alias
- UMLS CUI [1]
- C0598391
Beschreibung
Drug name
Datentyp
integer
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Date of infusion
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0011008
Beschreibung
Prescribed Dose
Datentyp
float
Maßeinheiten
- mg/kg
Alias
- UMLS CUI [1]
- C0678766
Beschreibung
infusion volume
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Beschreibung
Drug log
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0920316
Beschreibung
Date and time of dose of last active drug
Datentyp
text
Beschreibung
Did the subject take all required active study drug over the last 7 days
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205177
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0008972
Beschreibung
Number of actives capsules the subject should have taken over the last 7 days
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205177
- UMLS CUI [1,2]
- C0006935
Beschreibung
Number of actives capsules actually taken by the subject over the last 7 days
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205177
- UMLS CUI [1,2]
- C0006935
Beschreibung
compliant when taking active drug
Datentyp
text
Alias
- UMLS CUI [1]
- C1321605
Beschreibung
Lot number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826710
Beschreibung
Blister pack number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1706080
- UMLS CUI [1,2]
- C0449788
Beschreibung
Date Dispensed
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
Number of active capsules dispensed
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0205177
- UMLS CUI [1,3]
- C0006935
Beschreibung
Date of first dose from blister pack
Datentyp
date
Alias
- UMLS CUI [1]
- C3173309
Beschreibung
Date blister pack returned
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
Number of active drug capsules to be taken
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205177
- UMLS CUI [1,2]
- C0006935
Beschreibung
Actual number of active drug capsules taken
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205177
- UMLS CUI [1,2]
- C0006935
Beschreibung
Number of active capsules returned
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205177
- UMLS CUI [1,2]
- C0006935
Beschreibung
Dates of missed active doses
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705492
- UMLS CUI [1,3]
- C0178602
Ähnliche Modelle
Visit 6 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])
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])
C0007226 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C2700258 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
C0006935 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C0006935 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,2])
C1705492 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])