ID
35541
Beschreibung
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
Stichworte
Versionen (1)
- 07.03.19 07.03.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
7. März 2019
DOI
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Lizenz
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 4 (Pre Dose) - Vital Signs; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Bortezomib Administration
Beschreibung
Visit Date
Alias
- UMLS CUI-1
- C1320303
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
If Yes, complete below
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1516048
Beschreibung
Date of assessment
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
Check one box only
Datentyp
integer
Alias
- UMLS CUI [1]
- C1262869
Beschreibung
Systolic BP
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic BP
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Heart Rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Respiration Rate
Datentyp
integer
Maßeinheiten
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beschreibung
Temperature
Datentyp
float
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Check one box only
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Beschreibung
Weight
Datentyp
float
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Check one box only
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C0439148
Beschreibung
Hematology
Alias
- UMLS CUI-1
- C0474523
Beschreibung
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0200345
Beschreibung
Date and time of sample
Datentyp
datetime
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beschreibung
(if different from main hospital laboratory)
Datentyp
text
Alias
- UMLS CUI [1]
- C3258037
Beschreibung
Hematology
Alias
- UMLS CUI-1
- C0474523
Beschreibung
Parameter
Datentyp
integer
Alias
- UMLS CUI [1]
- C0549193
Beschreibung
Result
Datentyp
text
Alias
- UMLS CUI [1]
- C1274040
Beschreibung
Units
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0243095
Beschreibung
Not Done
Datentyp
integer
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
Clinical Chemistry, Coagulation and Electrolytes
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0005778
- UMLS CUI-3
- C0013832
Beschreibung
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0200345
Beschreibung
Date and time of sample
Datentyp
datetime
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beschreibung
(if different from main hospital laboratory)
Datentyp
text
Alias
- UMLS CUI [1]
- C3258037
Beschreibung
Clinical Chemistry, Coagulation and Electrolytes
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0005778
- UMLS CUI-3
- C0013832
Beschreibung
Parameter
Datentyp
integer
Alias
- UMLS CUI [1]
- C0549193
Beschreibung
Results
Datentyp
text
Alias
- UMLS CUI [1]
- C1254595
Beschreibung
Units
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0243095
Beschreibung
Not Done
Datentyp
integer
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
Bortezomib Administration
Alias
- UMLS CUI-1
- C1176309
- UMLS CUI-2
- C1533734
Beschreibung
Was bortezomib administered at this visit?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1176309
- UMLS CUI [1,2]
- C1533734
Beschreibung
Date administered
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
Beschreibung
Lot #
Datentyp
integer
Alias
- UMLS CUI [1]
- C1115660
Beschreibung
Time Administered
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0040223
Beschreibung
Dose Level
Datentyp
integer
Maßeinheiten
- mmg/m*2
Alias
- UMLS CUI [1]
- C0178602
Beschreibung
BSA
Datentyp
integer
Maßeinheiten
- m*2
Alias
- UMLS CUI [1]
- C0005902
Beschreibung
Dose Admin
Datentyp
integer
Maßeinheiten
- mg
Alias
- UMLS CUI [1]
- C3174092
Ähnliche Modelle
SRT501 + Bortezomib Cycle __ Day 4 (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)
C1533734 (UMLS CUI-2)
C1533734 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])