ID
35539
Beskrivning
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma
Nyckelord
Versioner (1)
- 2019-03-07 2019-03-07 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
7 mars 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556
SRT501 + Bortezomib Cycle __ Day 1 (Pre Dose) - Vital Signs; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Bortezomib Administration
Beskrivning
Visit Date
Alias
- UMLS CUI-1
- C1320303
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
If Yes, complete below
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1516048
Beskrivning
Date of assessment
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
Check one box only
Datatyp
integer
Alias
- UMLS CUI [1]
- C1262869
Beskrivning
Systolic BP
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic BP
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Heart Rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Respiration Rate
Datatyp
integer
Måttenheter
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beskrivning
Temperature
Datatyp
float
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Check one box only
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Beskrivning
Weight
Datatyp
float
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Check one box only
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C0439148
Beskrivning
Hematology
Alias
- UMLS CUI-1
- C0474523
Beskrivning
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0200345
Beskrivning
Date and time of sample
Datatyp
datetime
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beskrivning
(if different from main hospital laboratory)
Datatyp
text
Alias
- UMLS CUI [1]
- C3258037
Beskrivning
Hematology
Alias
- UMLS CUI-1
- C0474523
Beskrivning
Parameter
Datatyp
integer
Alias
- UMLS CUI [1]
- C0549193
Beskrivning
Result
Datatyp
text
Alias
- UMLS CUI [1]
- C1274040
Beskrivning
Units
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0243095
Beskrivning
Not Done
Datatyp
integer
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
Clinical Chemistry, Coagulation and Electrolytes
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0005778
- UMLS CUI-3
- C0013832
Beskrivning
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0200345
Beskrivning
Date and time of sample
Datatyp
datetime
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beskrivning
(if different from main hospital laboratory)
Datatyp
text
Alias
- UMLS CUI [1]
- C3258037
Beskrivning
Clinical Chemistry, Coagulation and Electrolytes
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0005778
- UMLS CUI-3
- C0013832
Beskrivning
Parameter
Datatyp
integer
Alias
- UMLS CUI [1]
- C0549193
Beskrivning
Results
Datatyp
text
Alias
- UMLS CUI [1]
- C1254595
Beskrivning
Units
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0243095
Beskrivning
Not Done
Datatyp
integer
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
Urinalysis dipstick results
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C1274040
Beskrivning
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0200345
Beskrivning
Date of sample
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Time of sample
Datatyp
time
Alias
- UMLS CUI [1]
- C4064021
Beskrivning
(if different from main hospital laboratory)
Datatyp
text
Alias
- UMLS CUI [1]
- C3258037
Beskrivning
pH
Datatyp
integer
Alias
- UMLS CUI [1]
- C0042044
Beskrivning
If other pH, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042044
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Glucose
Datatyp
integer
Alias
- UMLS CUI [1]
- C0004076
Beskrivning
If other Glucose, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0004076
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Blood
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018965
Beskrivning
If other Blood, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0018965
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Protein
Datatyp
integer
Alias
- UMLS CUI [1]
- C0262923
Beskrivning
If other Protein, please specify.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262923
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Leucocytes
Datatyp
integer
Alias
- UMLS CUI [1]
- C1256582
Beskrivning
If other Leucocytes, please specify.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1256582
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Urinalysis microscopy results
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C1274040
Beskrivning
Check one box only. If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0200345
Beskrivning
Date of sample
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Time of sample
Datatyp
time
Alias
- UMLS CUI [1]
- C4064021
Beskrivning
If different from main hospital laboratory
Datatyp
text
Alias
- UMLS CUI [1]
- C3258037
Beskrivning
Urinalysis microscopy results
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C1274040
Beskrivning
Parameter
Datatyp
integer
Alias
- UMLS CUI [1]
- C0549193
Beskrivning
Result
Datatyp
text
Alias
- UMLS CUI [1]
- C1274040
Beskrivning
Units
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Not Done
Datatyp
integer
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
Clinically significant?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826293
Beskrivning
Bortezomib Administration
Alias
- UMLS CUI-1
- C1176309
- UMLS CUI-2
- C1533734
Beskrivning
Was bortezomib administered at this visit?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1176309
- UMLS CUI [1,2]
- C1533734
Beskrivning
Date administered
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
Beskrivning
Lot #
Datatyp
integer
Alias
- UMLS CUI [1]
- C1115660
Beskrivning
Time Administered
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0040223
Beskrivning
Dose Level
Datatyp
integer
Måttenheter
- mmg/m*2
Alias
- UMLS CUI [1]
- C0178602
Beskrivning
BSA
Datatyp
integer
Måttenheter
- m*2
Alias
- UMLS CUI [1]
- C0005902
Beskrivning
Dose Admin
Datatyp
integer
Måttenheter
- mg
Alias
- UMLS CUI [1]
- C3174092
Similar models
SRT501 + Bortezomib Cycle __ Day 1 (Pre Dose) - Vital Signs; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Bortezomib Administration
C1516048 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0005778 (UMLS CUI-2)
C0013832 (UMLS CUI-3)
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0005778 (UMLS CUI-2)
C0013832 (UMLS CUI-3)
C0430370 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1274040 (UMLS CUI-2)
C1274040 (UMLS CUI-2)
C1533734 (UMLS CUI-2)
C1533734 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])