ID
35564
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)
- 10-03-19 10-03-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
10 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
SRT501 + Bortezomib Cycle __ Day 8 (Pre Dose) - Vital Signs; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Bortezomib Administration
Beschrijving
Visit Date
Alias
- UMLS CUI-1
- C1320303
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
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
Bortezomib Administration
Alias
- UMLS CUI-1
- C1176309
- UMLS CUI-2
- C1533734
Beschrijving
Was bortezomib administered at this visit?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1176309
- UMLS CUI [1,2]
- C1533734
Beschrijving
Date administered
Datatype
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
Beschrijving
Lot #
Datatype
integer
Alias
- UMLS CUI [1]
- C1115660
Beschrijving
Time Administered
Datatype
time
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0040223
Beschrijving
Dose Level
Datatype
integer
Maateenheden
- mmg/m*2
Alias
- UMLS CUI [1]
- C0178602
Beschrijving
BSA
Datatype
integer
Maateenheden
- m*2
Alias
- UMLS CUI [1]
- C0005902
Beschrijving
Dose Admin
Datatype
integer
Maateenheden
- mg
Alias
- UMLS CUI [1]
- C3174092
Similar models
SRT501 + Bortezomib Cycle __ Day 8 (Pre Dose) - Vital Signs; Hematology; Clinical Chemistry, Coagulation and Electrolytes; 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)
C1533734 (UMLS CUI-2)
C1533734 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])