ID
35367
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
Mots-clés
Versions (1)
- 03/03/2019 03/03/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
3 mars 2019
DOI
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Licence
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 (Pre Dose) - Eligibility Summary; Physical Examination; Vital Signs; Serum beta-hCG Pregnancy Test; PK Sampling - Plasma Samples; SRT501 Administration
Description
Visit Date
Alias
- UMLS CUI-1
- C1320303
Description
Eligibility Summary
Alias
- UMLS CUI-1
- C0013893
Description
If No, complete below
Type de données
boolean
Alias
- UMLS CUI [1]
- C0013893
Description
List all Inclusion criteria subject did not meet
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1512693
- UMLS CUI [1,2]
- C1550543
Description
List all Exclusion criteria subject did not meet
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1550543
Description
Was an Exemption granted?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1516637
- UMLS CUI [1,2]
- C2348482
Description
Was a physical examination performed?
Alias
- UMLS CUI-1
- C0031809
Description
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Description
Clinical Assessment
Type de données
integer
Alias
- UMLS CUI [1]
- C4534461
Description
If other Clinical Assessment, please specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C4534461
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Check one box only
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
Description
If clinically significant, please record on the adverse event page
Type de données
text
Alias
- UMLS CUI [1,1]
- C0348080
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C2348235
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
If Yes, complete below
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1516048
Description
Date of assessment
Type de données
date
Alias
- UMLS CUI [1]
- C2985720
Description
Check one box only
Type de données
integer
Alias
- UMLS CUI [1]
- C1262869
Description
Systolic BP
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic BP
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart Rate
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
Respiration Rate
Type de données
integer
Unités de mesure
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Description
Temperature
Type de données
float
Alias
- UMLS CUI [1]
- C0005903
Description
Check one box only
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Description
Height
Type de données
float
Alias
- UMLS CUI [1]
- C0005890
Description
Check one box only
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0439148
Description
Weight
Type de données
float
Alias
- UMLS CUI [1]
- C0005910
Description
Check one box only
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C0439148
Description
Serum beta-hCG Pregnancy Test
Alias
- UMLS CUI-1
- C0430060
Description
If Yes, complete below
Type de données
boolean
Alias
- UMLS CUI [1]
- C1960468
Description
If a serum β-hCG pregnancy test has been performed please give details.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0430060
Description
Date of pregnancy test
Type de données
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Description
Check one box only
Type de données
integer
Alias
- UMLS CUI [1]
- C0427777
Description
PK Sampling - Plasma Samples
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C1277698
- UMLS CUI-3
- C1609077
Description
Date of Sampling
Type de données
date
Alias
- UMLS CUI [1,1]
- C0870078
- UMLS CUI [1,2]
- C0011008
Description
Time of Sampling
Type de données
time
Alias
- UMLS CUI [1,1]
- C0870078
- UMLS CUI [1,2]
- C0040223
Description
Check if Not Done
Type de données
integer
Alias
- UMLS CUI [1]
- C1272696
Description
SRT501 Administration
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C1533734
Description
Was SRT501 administered at this visit?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1533734
Description
Date administered
Type de données
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
Description
Kit #
Type de données
integer
Alias
- UMLS CUI [1]
- C2981406
Description
Time administered
Type de données
time
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0040223
Similar models
Cycle 1 Day 1 (Pre Dose) - Eligibility Summary; Physical Examination; Vital Signs; Serum beta-hCG Pregnancy Test; PK Sampling - Plasma Samples; SRT501 Administration
C1550543 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,2])
C2348482 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0243095 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1277698 (UMLS CUI-2)
C1609077 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])