ID
35572
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)
- 2019-03-10 2019-03-10 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
10 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 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment; Disease Response; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment
Beskrivning
Visit Date
Alias
- UMLS CUI-1
- C1320303
Beskrivning
Was a physical examination performed?
Alias
- UMLS CUI-1
- C0031809
Beskrivning
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beskrivning
Clinical Assessment
Datatyp
integer
Alias
- UMLS CUI [1]
- C4534461
Beskrivning
If other Clinical Assessment, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C4534461
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Check one box only
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
Beskrivning
If clinically significant, please record on the adverse event page
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0348080
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C2348235
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
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beskrivning
Was a 12-lead ECG performed?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0430456
Beskrivning
Date of ECG
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Beskrivning
Check one box only
Datatyp
integer
Alias
- UMLS CUI [1]
- C1262869
Beskrivning
ECG Result
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1274040
Beskrivning
Ventriculat rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
PR Interval
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C0429087
Beskrivning
QRS Duration
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C0429025
Beskrivning
QT
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C1287082
Beskrivning
QTc
Datatyp
integer
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C0489625
Beskrivning
QTc Formula
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1882512
- UMLS CUI [1,2]
- C1882513
Beskrivning
ECG Findings
Alias
- UMLS CUI-1
- C0438154
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
Serum beta-hCG Pregnancy Test
Alias
- UMLS CUI-1
- C0430060
Beskrivning
If Yes, complete below
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1960468
Beskrivning
If a serum β-hCG pregnancy test has been performed please give details.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0430060
Beskrivning
Date of pregnancy test
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beskrivning
Check one box only
Datatyp
integer
Alias
- UMLS CUI [1]
- C0427777
Beskrivning
Radiographic Assessment
Alias
- UMLS CUI-1
- C0444708
- UMLS CUI-2
- C1516048
Beskrivning
If Yes, complete the following page
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0444708
- UMLS CUI [1,2]
- C0441633
Beskrivning
Date of Assessment
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
Time of Assessment
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C0040223
Beskrivning
Radiographic Assessment
Alias
- UMLS CUI-1
- C0444708
- UMLS CUI-2
- C1516048
Beskrivning
Lesion #
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0237753
Beskrivning
Site of Lesion
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0221198
Beskrivning
Site Code
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0805701
Beskrivning
If other Site, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Method of Evaluation
Datatyp
integer
Alias
- UMLS CUI [1]
- C2911685
Beskrivning
If other Method of Evaluation, please specify.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2911685
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Best Response
Datatyp
integer
Alias
- UMLS CUI [1]
- C2986560
Beskrivning
Target Lesion
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2986546
Beskrivning
Measurable Lesion
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1513040
Beskrivning
Only record diameter if the lesion is measurable
Datatyp
float
Måttenheter
- cm
Alias
- UMLS CUI [1,1]
- C1301886
- UMLS CUI [1,2]
- C1522425
Beskrivning
Evaluation
Datatyp
text
Alias
- UMLS CUI [1]
- C0220825
Beskrivning
Disease Marker Assessment
Alias
- UMLS CUI-1
- C1511983
- UMLS CUI-2
- C1516048
Beskrivning
If Yes, complete below
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1511983
- UMLS CUI [1,2]
- C1516048
Beskrivning
Date of assessment
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
(if different from main hospital laboratory)
Datatyp
text
Alias
- UMLS CUI [1]
- C3258037
Beskrivning
Disease Marker Assessment
Alias
- UMLS CUI-1
- C1511983
- UMLS CUI-2
- C1516048
Beskrivning
Marker
Datatyp
integer
Alias
- UMLS CUI [1]
- C0005516
Beskrivning
If other Marker, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005516
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Result
Datatyp
float
Alias
- UMLS CUI [1]
- C1274040
Beskrivning
Check one box only
Datatyp
integer
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
If other Unit, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Upper Limit of Normal Range
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Beskrivning
Not Done
Datatyp
integer
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
Disease Response
Alias
- UMLS CUI-1
- C1704632
Beskrivning
If Yes, complete below
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1704632
- 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 [1,1]
- C1704632
- UMLS CUI [1,2]
- C0545082
Beskrivning
Date of progression
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0242656
- UMLS CUI [1,2]
- C0011008
Beskrivning
Progression not applicable
Datatyp
integer
Alias
- UMLS CUI [1]
- C0242656
Beskrivning
Study Treatment Compliance (Return)
Alias
- UMLS CUI-1
- C1321605
Beskrivning
Check one box only If No, please complete the comments page or the protocol deviations page.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3890583
- UMLS CUI [1,2]
- C0332156
Beskrivning
If No, please provide the number of missed doses and the dates that the doses were missed
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0178602
Beskrivning
Number of missed dates
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1705492
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0237753
Beskrivning
Dates dose missed
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705492
- UMLS CUI [1,3]
- C0178602
Beskrivning
New Adverse Events and Concomitant Treatment
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2347852
Beskrivning
If Yes, please record details on Adverse Events page.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
If Yes, please record details on Concomitant Treatment page.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2,1]
- C0678766
- UMLS CUI [2,2]
- C0205217
- UMLS CUI [3,1]
- C0678766
- UMLS CUI [3,2]
- C0205216
- UMLS CUI [4,1]
- C0439603
- UMLS CUI [4,2]
- C0205217
- UMLS CUI [5,1]
- C0439603
- UMLS CUI [5,2]
- C0205216
Similar models
SRT501 + Bortezomib Cycle __ Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment; Disease Response; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,2])
C0011008 (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)
C0011008 (UMLS CUI [1,2])
C1516048 (UMLS CUI-2)
C0441633 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1516048 (UMLS CUI-2)
C0237753 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1513040 (UMLS CUI [1,2])
C1522425 (UMLS CUI [1,2])
C1516048 (UMLS CUI-2)
C1516048 (UMLS CUI [1,2])
C1516048 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C2827740 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0332156 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C1705492 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C2347852 (UMLS CUI-2)
C0678766 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C0678766 (UMLS CUI [3,1])
C0205216 (UMLS CUI [3,2])
C0439603 (UMLS CUI [4,1])
C0205217 (UMLS CUI [4,2])
C0439603 (UMLS CUI [5,1])
C0205216 (UMLS CUI [5,2])