ID
35369
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)
- 03-03-19 03-03-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
3 maart 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
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
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
Height
Datatype
float
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Check one box only
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0439148
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
PK Sampling - Plasma Samples
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C1277698
- UMLS CUI-3
- C1609077
Beschrijving
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.
Datatype
integer
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
Date of Sampling
Datatype
date
Alias
- UMLS CUI [1,1]
- C0870078
- UMLS CUI [1,2]
- C0011008
Beschrijving
Time of Sampling
Datatype
time
Alias
- UMLS CUI [1,1]
- C0870078
- UMLS CUI [1,2]
- C0040223
Beschrijving
Check if Not Done
Datatype
integer
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
Study Treatment Compliance (Issue)
Alias
- UMLS CUI-1
- C0949266
- UMLS CUI-2
- C1321605
Beschrijving
If No, please complete the comments page or the protocol deviations page.
Datatype
boolean
Alias
- UMLS CUI [1]
- C3890583
Beschrijving
If No, please complete the comments page or the protocol deviations page.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C2698559
Beschrijving
If No, please complete the comments page or the protocol deviations page.
Datatype
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
Beschrijving
New Adverse Events and Concomitant Treatment
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2347852
Beschrijving
If Yes, please record details on Adverse Events page.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
If Yes, please record details on Concomitant Treatment page.
Datatype
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])