ID
35539
Description
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
Keywords
Versions (1)
- 3/7/19 3/7/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
March 7, 2019
DOI
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License
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
Description
Visit Date
Alias
- UMLS CUI-1
- C1320303
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
If Yes, complete below
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1516048
Description
Date of assessment
Data type
date
Alias
- UMLS CUI [1]
- C2985720
Description
Check one box only
Data type
integer
Alias
- UMLS CUI [1]
- C1262869
Description
Systolic BP
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic BP
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart Rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
Respiration Rate
Data type
integer
Measurement units
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Description
Temperature
Data type
float
Alias
- UMLS CUI [1]
- C0005903
Description
Check one box only
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Description
Weight
Data type
float
Alias
- UMLS CUI [1]
- C0005910
Description
Check one box only
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C0439148
Description
Hematology
Alias
- UMLS CUI-1
- C0474523
Description
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Data type
boolean
Alias
- UMLS CUI [1]
- C0200345
Description
Date and time of sample
Data type
datetime
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Description
(if different from main hospital laboratory)
Data type
text
Alias
- UMLS CUI [1]
- C3258037
Description
Hematology
Alias
- UMLS CUI-1
- C0474523
Description
Parameter
Data type
integer
Alias
- UMLS CUI [1]
- C0549193
Description
Result
Data type
text
Alias
- UMLS CUI [1]
- C1274040
Description
Units
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.
Data type
integer
Alias
- UMLS CUI [1]
- C0243095
Description
Not Done
Data type
integer
Alias
- UMLS CUI [1]
- C1272696
Description
Clinical Chemistry, Coagulation and Electrolytes
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0005778
- UMLS CUI-3
- C0013832
Description
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Data type
boolean
Alias
- UMLS CUI [1]
- C0200345
Description
Date and time of sample
Data type
datetime
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Description
(if different from main hospital laboratory)
Data type
text
Alias
- UMLS CUI [1]
- C3258037
Description
Clinical Chemistry, Coagulation and Electrolytes
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0005778
- UMLS CUI-3
- C0013832
Description
Parameter
Data type
integer
Alias
- UMLS CUI [1]
- C0549193
Description
Results
Data type
text
Alias
- UMLS CUI [1]
- C1254595
Description
Units
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.
Data type
integer
Alias
- UMLS CUI [1]
- C0243095
Description
Not Done
Data type
integer
Alias
- UMLS CUI [1]
- C1272696
Description
Urinalysis dipstick results
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C1274040
Description
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Data type
boolean
Alias
- UMLS CUI [1]
- C0200345
Description
Date of sample
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Time of sample
Data type
time
Alias
- UMLS CUI [1]
- C4064021
Description
(if different from main hospital laboratory)
Data type
text
Alias
- UMLS CUI [1]
- C3258037
Description
pH
Data type
integer
Alias
- UMLS CUI [1]
- C0042044
Description
If other pH, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0042044
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Glucose
Data type
integer
Alias
- UMLS CUI [1]
- C0004076
Description
If other Glucose, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0004076
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Blood
Data type
integer
Alias
- UMLS CUI [1]
- C0018965
Description
If other Blood, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0018965
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Protein
Data type
integer
Alias
- UMLS CUI [1]
- C0262923
Description
If other Protein, please specify.
Data type
text
Alias
- UMLS CUI [1,1]
- C0262923
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Leucocytes
Data type
integer
Alias
- UMLS CUI [1]
- C1256582
Description
If other Leucocytes, please specify.
Data type
text
Alias
- UMLS CUI [1,1]
- C1256582
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Urinalysis microscopy results
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C1274040
Description
Check one box only. If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Data type
integer
Alias
- UMLS CUI [1]
- C0200345
Description
Date of sample
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Time of sample
Data type
time
Alias
- UMLS CUI [1]
- C4064021
Description
If different from main hospital laboratory
Data type
text
Alias
- UMLS CUI [1]
- C3258037
Description
Urinalysis microscopy results
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C1274040
Description
Parameter
Data type
integer
Alias
- UMLS CUI [1]
- C0549193
Description
Result
Data type
text
Alias
- UMLS CUI [1]
- C1274040
Description
Units
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Not Done
Data type
integer
Alias
- UMLS CUI [1]
- C1272696
Description
Clinically significant?
Data type
boolean
Alias
- UMLS CUI [1]
- C2826293
Description
Bortezomib Administration
Alias
- UMLS CUI-1
- C1176309
- UMLS CUI-2
- C1533734
Description
Was bortezomib administered at this visit?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1176309
- UMLS CUI [1,2]
- C1533734
Description
Date administered
Data type
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
Description
Lot #
Data type
integer
Alias
- UMLS CUI [1]
- C1115660
Description
Time Administered
Data type
time
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0040223
Description
Dose Level
Data type
integer
Measurement units
- mmg/m*2
Alias
- UMLS CUI [1]
- C0178602
Description
BSA
Data type
integer
Measurement units
- m*2
Alias
- UMLS CUI [1]
- C0005902
Description
Dose Admin
Data type
integer
Measurement units
- 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])