ID
18363
Beskrivning
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 Early Termination
Nyckelord
Versioner (2)
- 2016-11-02 2016-11-02 -
- 2016-11-11 2016-11-11 -
Uppladdad den
2 november 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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Early Termination Galafold (migalastat) AT1001-012 NCT0121865
Early Termination Galafold (migalastat) AT1001-012 NCT0121865
- StudyEvent: ODM
Beskrivning
12 Lead ECG
Alias
- UMLS CUI-1
- C1623258
Beskrivning
Hematology/Coagulation
Alias
- UMLS CUI-1
- C0474523
Beskrivning
Hematology Sample Collection Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0011008
Beskrivning
Hematology finding; Laboratory test finding
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0587081
Beskrivning
Hematology: clinically significant abnormal laboratory values, please sepcify
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C1853129
- UMLS CUI-3
- C2826293
Beskrivning
If lab abnormalities=Yes
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1853129
- UMLS CUI [1,3]
- C2826293
Beskrivning
Chemistry, Laboratory findings
Alias
- UMLS CUI-1
- C0005774
Beskrivning
Chemistry Sample Collection Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0005774
Beskrivning
Science of Chemistry; Laboratory test finding
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005774
- UMLS CUI [1,2]
- C0587081
Beskrivning
Chemistry: clinically significant abnormal laboratory values, please specify
Alias
- UMLS CUI-1
- C0005774
- UMLS CUI-2
- C2826293
Beskrivning
If lab abnormalities=Yes
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005774
- UMLS CUI [1,2]
- C2826293
Beskrivning
Urinanalysis
Alias
- UMLS CUI-1
- C0042014
Beskrivning
Urinalysis Sample Collection Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0011008
Beskrivning
Urinalysis; Laboratory test finding
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0587081
Beskrivning
Urinalysis: clinically significant abnormal laboratory values
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C1853129
- UMLS CUI-3
- C2826293
Beskrivning
If lab abnormalities=Yes
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1853129
- UMLS CUI [1,3]
- C2826293
Beskrivning
24-Hr Urine Collection
Alias
- UMLS CUI-1
- C0455060
Beskrivning
24-Hr Urine Collection Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C0808070
Beskrivning
24-Hr Urine Collection Start Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C1301880
Beskrivning
24-Hr Urine Collection Stop Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C0806020
Beskrivning
24-Hr Urine Collection Stop Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C1522314
Beskrivning
24-Hr Urine Collection Total Volume
Datatyp
float
Måttenheter
- ml
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C2700258
Beskrivning
24-Hr Urine Collection Date Sent to Laboratory
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0455060
- UMLS CUI [1,2]
- C1515023
- UMLS CUI [1,3]
- C0011008
Beskrivning
Additional Observations
Alias
- UMLS CUI-1
- C0700325
Beskrivning
reference date
Datatyp
date
Alias
- UMLS CUI [1]
- C1719096
Beskrivning
Visit
Datatyp
text
Alias
- UMLS CUI [1]
- C0545082
Beskrivning
eCRF
Datatyp
text
Alias
- UMLS CUI [1]
- C1516308
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Assessment Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beskrivning
Blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Respiration Rate
Datatyp
integer
Måttenheter
- /min
Alias
- UMLS CUI [1]
- C0231832
Beskrivning
GFR of Iohexol
Alias
- UMLS CUI-1
- C0017654
Beskrivning
Echocardiography
Alias
- UMLS CUI-1
- C0013516
Beskrivning
SF-36 Health Survey
Alias
- UMLS CUI-1
- C0451287
Beskrivning
Modified Brief Pain Inventory
Beskrivning
Assessment Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
pain at its worst
Datatyp
integer
Alias
- UMLS CUI [1]
- C0030193
Beskrivning
Pain at its least
Datatyp
integer
Alias
- UMLS CUI [1]
- C0030193
Beskrivning
pain on average
Datatyp
integer
Alias
- UMLS CUI [1]
- C0030193
Beskrivning
pain right now
Datatyp
integer
Alias
- UMLS CUI [1]
- C0030193
Beskrivning
Secondary Endpoint Criteria
Beskrivning
cardiovascular event
Datatyp
integer
Alias
- UMLS CUI [1]
- C1320716
Beskrivning
cardiac consult
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0009818
- UMLS CUI [1,2]
- C0007226
Beskrivning
cerebrovascular event
Datatyp
integer
Alias
- UMLS CUI [1]
- C0038454
Beskrivning
neurological consult
Datatyp
integer
Alias
- UMLS CUI [1]
- C0849229
Beskrivning
Enzyme Replacement Therapy
Alias
- UMLS CUI-1
- C0598391
Beskrivning
Enzyme Replacement Therapy Infusion procedures Count
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0598391
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0750480
Beskrivning
Enzyme Replacement Therapy
Datatyp
integer
Alias
- UMLS CUI [1]
- C0598391
Beskrivning
Drug name
Datatyp
integer
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Date of infusion
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0011008
Beskrivning
Prescribed Dose
Datatyp
float
Måttenheter
- mg/kg
Alias
- UMLS CUI [1]
- C0678766
Beskrivning
infusion volume
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Beskrivning
Drug log
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0920316
Beskrivning
Date and time of dose of last active drug
Datatyp
text
Beskrivning
Did the subject take all required active study drug over the last 7 days
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205177
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0008972
Beskrivning
Number of actives capsules the subject should have taken over the last 7 days
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0205177
- UMLS CUI [1,2]
- C0006935
Beskrivning
Number of actives capsules actually taken by the subject over the last 7 days
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0205177
- UMLS CUI [1,2]
- C0006935
Beskrivning
compliant when taking active drug
Datatyp
text
Alias
- UMLS CUI [1]
- C1321605
Beskrivning
Lot number
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826710
Beskrivning
Blister pack number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1706080
- UMLS CUI [1,2]
- C0449788
Beskrivning
Date Dispensed
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Number of active capsules dispensed
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0205177
- UMLS CUI [1,3]
- C0006935
Beskrivning
Date of first dose from blister pack
Datatyp
date
Alias
- UMLS CUI [1]
- C3173309
Beskrivning
Date blister pack returned
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Number of active drug capsules to be taken
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0205177
- UMLS CUI [1,2]
- C0006935
Beskrivning
Actual number of active drug capsules taken
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0205177
- UMLS CUI [1,2]
- C0006935
Beskrivning
Number of active capsules returned
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0205177
- UMLS CUI [1,2]
- C0006935
Beskrivning
Dates of missed active doses
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705492
- UMLS CUI [1,3]
- C0178602
Beskrivning
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beskrivning
Date of Examination
Datatyp
date
Alias
- UMLS CUI [1]
- C2826643
Beskrivning
Physical Exam Status
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
If Clinically significant findings, please specify
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
If Clinically significant findings, please specify
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
Similar models
Early Termination Galafold (migalastat) AT1001-012 NCT0121865
- 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])
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])
C0013516 (UMLS CUI [1,2])
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])