ID
35367
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)
- 03.03.19 03.03.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
3. März 2019
DOI
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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
Beschreibung
Visit Date
Alias
- UMLS CUI-1
- C1320303
Beschreibung
Eligibility Summary
Alias
- UMLS CUI-1
- C0013893
Beschreibung
If No, complete below
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013893
Beschreibung
List all Inclusion criteria subject did not meet
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1512693
- UMLS CUI [1,2]
- C1550543
Beschreibung
List all Exclusion criteria subject did not meet
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1550543
Beschreibung
Was an Exemption granted?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1516637
- UMLS CUI [1,2]
- C2348482
Beschreibung
Was a physical examination performed?
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Clinical Assessment
Datentyp
integer
Alias
- UMLS CUI [1]
- C4534461
Beschreibung
If other Clinical Assessment, please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C4534461
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
Check one box only
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
Beschreibung
If clinically significant, please record on the adverse event page
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0348080
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C2348235
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
Height
Datentyp
float
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Check one box only
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0439148
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
Serum beta-hCG Pregnancy Test
Alias
- UMLS CUI-1
- C0430060
Beschreibung
If Yes, complete below
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1960468
Beschreibung
If a serum β-hCG pregnancy test has been performed please give details.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0430060
Beschreibung
Date of pregnancy test
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Beschreibung
Check one box only
Datentyp
integer
Alias
- UMLS CUI [1]
- C0427777
Beschreibung
PK Sampling - Plasma Samples
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C1277698
- UMLS CUI-3
- C1609077
Beschreibung
Date of Sampling
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0870078
- UMLS CUI [1,2]
- C0011008
Beschreibung
Time of Sampling
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0870078
- UMLS CUI [1,2]
- C0040223
Beschreibung
Check if Not Done
Datentyp
integer
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
SRT501 Administration
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C1533734
Beschreibung
Was SRT501 administered at this visit?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1533734
Beschreibung
Date administered
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
Beschreibung
Kit #
Datentyp
integer
Alias
- UMLS CUI [1]
- C2981406
Beschreibung
Time administered
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0040223
Ähnliche Modelle
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])