ID
35369
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)
- 2019-03-03 2019-03-03 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
3 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
Cycle 1 Day 1 (Post Dose) - Vital Signs; PK Sampling - Plasma Samples; Study Treatment Compliance (Issue); New Adverse Events and Concomitant Treatment
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
Height
Datatyp
float
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Check one box only
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0439148
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
PK Sampling - Plasma Samples
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C1277698
- UMLS CUI-3
- C1609077
Beskrivning
Time points are relative to study drug administration. Any deviations in the times of collection should be recorded on the comments page or the protocol deviations page.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0040223
Beskrivning
Date of Sampling
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0870078
- UMLS CUI [1,2]
- C0011008
Beskrivning
Time of Sampling
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0870078
- UMLS CUI [1,2]
- C0040223
Beskrivning
Check if Not Done
Datatyp
integer
Alias
- UMLS CUI [1]
- C1272696
Beskrivning
Study Treatment Compliance (Issue)
Alias
- UMLS CUI-1
- C0949266
- UMLS CUI-2
- C1321605
Beskrivning
If No, please complete the comments page or the protocol deviations page.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3890583
Beskrivning
If No, please complete the comments page or the protocol deviations page.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C2698559
Beskrivning
If No, please complete the comments page or the protocol deviations page.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0750563
- UMLS CUI [1,2]
- C0683176
- UMLS CUI [1,3]
- C0073096
- UMLS CUI [2]
- C0458244
- UMLS CUI [3]
- C0949399
- UMLS CUI [4]
- C0018208
- UMLS CUI [5]
- C0453284
- UMLS CUI [6]
- C0001948
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]
- C0877248
Beskrivning
If Yes, please record details on Concomitant Treatment page.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2,1]
- C0178602
- UMLS CUI [2,2]
- C0205217
- UMLS CUI [3,1]
- C0178602
- 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
Cycle 1 Day 1 (Post Dose) - Vital Signs; PK Sampling - Plasma Samples; Study Treatment Compliance (Issue); New Adverse Events and Concomitant Treatment
C1516048 (UMLS CUI [1,2])
C1277698 (UMLS CUI-2)
C1609077 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1321605 (UMLS CUI-2)
C2698559 (UMLS CUI [1,2])
C0683176 (UMLS CUI [1,2])
C0073096 (UMLS CUI [1,3])
C0458244 (UMLS CUI [2])
C0949399 (UMLS CUI [3])
C0018208 (UMLS CUI [4])
C0453284 (UMLS CUI [5])
C0001948 (UMLS CUI [6])
C2347852 (UMLS CUI-2)
C0178602 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C0178602 (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])