ID
35464
Beschrijving
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
Trefwoorden
Versies (1)
- 05-03-19 05-03-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
5 maart 2019
DOI
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Licentie
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
Unscheduled - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment
Beschrijving
Was a physical examination performed?
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Clinical Assessment
Datatype
integer
Alias
- UMLS CUI [1]
- C4534461
Beschrijving
If other Clinical Assessment, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C4534461
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Check one box only
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
Beschrijving
If clinically significant, please record on the adverse event page
Datatype
text
Alias
- UMLS CUI [1,1]
- C0348080
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C2348235
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
If Yes, complete below
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1516048
Beschrijving
Date of assessment
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Check one box only
Datatype
integer
Alias
- UMLS CUI [1]
- C1262869
Beschrijving
Systolic BP
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic BP
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Respiration Rate
Datatype
integer
Maateenheden
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beschrijving
Temperature
Datatype
float
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Check one box only
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Beschrijving
Weight
Datatype
float
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Check one box only
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C0439148
Beschrijving
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Was a 12-lead ECG performed?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0430456
Beschrijving
Date of ECG
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Beschrijving
Check one box only
Datatype
integer
Alias
- UMLS CUI [1]
- C1262869
Beschrijving
ECG Result
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1274040
Beschrijving
Ventriculat rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
QT
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
QTc Formula
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1882512
- UMLS CUI [1,2]
- C1882513
Beschrijving
ECG Findings
Alias
- UMLS CUI-1
- C0438154
Beschrijving
Hematology
Alias
- UMLS CUI-1
- C0474523
Beschrijving
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0200345
Beschrijving
Date and time of sample
Datatype
datetime
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beschrijving
(if different from main hospital laboratory)
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
Hematology
Alias
- UMLS CUI-1
- C0474523
Beschrijving
Parameter
Datatype
integer
Alias
- UMLS CUI [1]
- C0549193
Beschrijving
Result
Datatype
text
Alias
- UMLS CUI [1]
- C1274040
Beschrijving
Units
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.
Datatype
integer
Alias
- UMLS CUI [1]
- C0243095
Beschrijving
Not Done
Datatype
integer
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
Clinical Chemistry, Coagulation and Electrolytes
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0005778
- UMLS CUI-3
- C0013832
Beschrijving
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0200345
Beschrijving
Date and time of sample
Datatype
datetime
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beschrijving
(if different from main hospital laboratory)
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
Clinical Chemistry, Coagulation and Electrolytes
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0005778
- UMLS CUI-3
- C0013832
Beschrijving
Parameter
Datatype
integer
Alias
- UMLS CUI [1]
- C0549193
Beschrijving
Results
Datatype
text
Alias
- UMLS CUI [1]
- C1254595
Beschrijving
Units
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.
Datatype
integer
Alias
- UMLS CUI [1]
- C0243095
Beschrijving
Not Done
Datatype
integer
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
Urinalysis dipstick results
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C1274040
Beschrijving
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0200345
Beschrijving
Date of sample
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Time of sample
Datatype
time
Alias
- UMLS CUI [1]
- C4064021
Beschrijving
(if different from main hospital laboratory)
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
pH
Datatype
integer
Alias
- UMLS CUI [1]
- C0042044
Beschrijving
If other pH, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042044
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Glucose
Datatype
integer
Alias
- UMLS CUI [1]
- C0004076
Beschrijving
If other Glucose, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0004076
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Blood
Datatype
integer
Alias
- UMLS CUI [1]
- C0018965
Beschrijving
If other Blood, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0018965
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Protein
Datatype
integer
Alias
- UMLS CUI [1]
- C0262923
Beschrijving
If other Protein, please specify.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262923
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Leucocytes
Datatype
integer
Alias
- UMLS CUI [1]
- C1256582
Beschrijving
If other Leucocytes, please specify.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1256582
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Urinalysis microscopy results
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C1274040
Beschrijving
Check one box only. If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datatype
integer
Alias
- UMLS CUI [1]
- C0200345
Beschrijving
Date of sample
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Time of sample
Datatype
time
Alias
- UMLS CUI [1]
- C4064021
Beschrijving
If different from main hospital laboratory
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
Urinalysis microscopy results
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C1274040
Beschrijving
Parameter
Datatype
integer
Alias
- UMLS CUI [1]
- C0549193
Beschrijving
Result
Datatype
text
Alias
- UMLS CUI [1]
- C1274040
Beschrijving
Units
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Not Done
Datatype
integer
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
Clinically significant?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826293
Beschrijving
Serum beta-hCG Pregnancy Test
Alias
- UMLS CUI-1
- C0430060
Beschrijving
If Yes, complete below
Datatype
boolean
Alias
- UMLS CUI [1]
- C1960468
Beschrijving
If a serum β-hCG pregnancy test has been performed please give details.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0430060
Beschrijving
Date of pregnancy test
Datatype
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beschrijving
Check one box only
Datatype
integer
Alias
- UMLS CUI [1]
- C0427777
Beschrijving
Radiographic Assessment
Alias
- UMLS CUI-1
- C0444708
- UMLS CUI-2
- C1516048
Beschrijving
If Yes, complete the following page
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0444708
- UMLS CUI [1,2]
- C0441633
Beschrijving
Date of Assessment
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Time of Assessment
Datatype
time
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C0040223
Beschrijving
Radiographic Assessment
Alias
- UMLS CUI-1
- C0444708
- UMLS CUI-2
- C1516048
Beschrijving
Lesion #
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0237753
Beschrijving
Site of Lesion
Datatype
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0221198
Beschrijving
Site Code
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0805701
Beschrijving
If other Site, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Method of Evaluation
Datatype
integer
Alias
- UMLS CUI [1]
- C2911685
Beschrijving
If other Method of Evaluation, please specify.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2911685
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Best Response
Datatype
integer
Alias
- UMLS CUI [1]
- C2986560
Beschrijving
Target Lesion
Datatype
boolean
Alias
- UMLS CUI [1]
- C2986546
Beschrijving
Measurable Lesion
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1513040
Beschrijving
Only record diameter if the lesion is measurable
Datatype
float
Maateenheden
- cm
Alias
- UMLS CUI [1,1]
- C1301886
- UMLS CUI [1,2]
- C1522425
Beschrijving
Evaluation
Datatype
text
Alias
- UMLS CUI [1]
- C0220825
Beschrijving
Disease Marker Assessment
Alias
- UMLS CUI-1
- C1511983
- UMLS CUI-2
- C1516048
Beschrijving
If Yes, complete below
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1511983
- UMLS CUI [1,2]
- C1516048
Beschrijving
Date of assessment
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
(if different from main hospital laboratory)
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
Disease Marker Assessment
Alias
- UMLS CUI-1
- C1511983
- UMLS CUI-2
- C1516048
Beschrijving
Marker
Datatype
integer
Alias
- UMLS CUI [1]
- C0005516
Beschrijving
If other Marker, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005516
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Result
Datatype
float
Alias
- UMLS CUI [1]
- C1274040
Beschrijving
Check one box only
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
If other Unit, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Upper Limit of Normal Range
Datatype
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C2827740
Beschrijving
Not Done
Datatype
integer
Alias
- UMLS CUI [1]
- C1272696
Similar models
Unscheduled - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment
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])