ID

36475

Beschreibung

Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Stichworte

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  1. 16.05.19 16.05.19 -
  2. 16.05.19 16.05.19 -
  3. 16.05.19 16.05.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

16. Mai 2019

DOI

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Creative Commons BY-NC 3.0
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Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328

Englisch

Day 1 Pre-Dose -Vital Signs; Pharmacogenetic Research Consent/ Blood Sample Collection; Investigational Product Compliance (Pazopanib); Investigational Product (First Dose); Biomarker Samples

1 Formulare  
Date of visit/ assessment
Beschreibung

Date of visit/ assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/ assessment
Beschreibung

Date of visit/ assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual Date - Vital Signs
Beschreibung

Actual Date - Vital Signs

Datentyp

date

Alias
UMLS CUI [1]
C2826644
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Sitting Systolic blood pressure 1st reading
Beschreibung

Sitting Systolic blood pressure 1st reading

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C1319893
mm[Hg]
Sitting diastolic blood pressure 1st reading
Beschreibung

Sitting diastolic blood pressure 1st reading

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C1319894
mm[Hg]
Sitting Systolic blood pressure 2nd reading
Beschreibung

Sitting Systolic blood pressure 2nd reading

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C1319893
mm[Hg]
Sitting diastolic blood pressure 2nd reading
Beschreibung

Sitting diastolic blood pressure 2nd reading

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C1319894
mm[Hg]
Sitting Systolic blood pressure 3rd reading
Beschreibung

Sitting Systolic blood pressure 3rd reading

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C1319893
mm[Hg]
Sitting diastolic blood pressure 3rd reading
Beschreibung

Sitting diastolic blood pressure 3rd reading

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C1319894
mm[Hg]
Sitting Mean Systolic Blood pressure
Beschreibung

Sitting Mean Systolic Blood pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
mm[Hg]
Sitting Mean Diastolic Blood pressure
Beschreibung

Sitting Mean Diastolic Blood pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
mm[Hg]
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Pharmacogenetic Research Consent/ Blood Sample Collection
Beschreibung

Pharmacogenetic Research Consent/ Blood Sample Collection

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C2347500
UMLS CUI-3
C0005834
Has informed consent been obtained for PGx research?
Beschreibung

Has informed consent been obtained for PGx research?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
If informed consent has been obtained for PGx research, record date of informed consent obtained
Beschreibung

If informed consent has been obtained for PGx research, record date of informed consent obtained

Datentyp

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
If informed consent has been obtained for PGx research, has blood been collected for PGx research?
Beschreibung

Has blood been collected for PGx research?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C2347500
If blood sample has been collected for PGx reserach, record date sample taken
Beschreibung

If blood sample has been collected for PGx reserach, record date sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0011008
If informed consent has not been obtained for PGx research, check reason
Beschreibung

If informed consent has not been obtained for PGx research, check reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C2826287
If other reason for informed consent not beeing obtained for PGx research, please specify
Beschreibung

If other reason for informed consent not beeing obtained for PGx research, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C2826287
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Sample Type
Beschreibung

Sample Type

Datentyp

text

Alias
UMLS CUI [1]
C2347029
Genetics Type
Beschreibung

Genetics Type

Datentyp

text

Alias
UMLS CUI [1]
C0017399
Investigational Product Compliance - Pazopanib
Beschreibung

Investigational Product Compliance - Pazopanib

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
UMLS CUI-3
C1831796
Pazopanib Dispensed Date
Beschreibung

Pazopanib Dispensed Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0947323
UMLS CUI [1,3]
C1831796
Number of Tablets Dispensed
Beschreibung

Number of Tablets Dispensed

Datentyp

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Investigational Product - First Dose
Beschreibung

Investigational Product - First Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C3174092
UMLS CUI-3
C0205435
Dose Start Date
Beschreibung

Dose Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0808070
Biomarker Sample
Beschreibung

Biomarker Sample

Alias
UMLS CUI-1
C0005516
UMLS CUI-2
C0370003
Has biomarker sample been collected?
Beschreibung

Has biomarker sample been collected?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0005516
If biomarker sample has been collected, record date sample taken
Beschreibung

If biomarker sample has been collected, record date sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0005516
If biomarker sample has not been collected, provide reason
Beschreibung

If biomarker sample has not been collected, provide reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0005516
UMLS CUI [1,3]
C2826287
If other reason for sample not been collected, please specify
Beschreibung

If other reason for sample not been collected, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C2826287
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Biomarker Sample Type
Beschreibung

Biomarker Sample Type

Datentyp

text

Alias
UMLS CUI [1,1]
C2347029
UMLS CUI [1,2]
C0005516
Biomarker sample Number
Beschreibung

Biomarker sample Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005516
UMLS CUI [1,2]
C1299222
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Ähnliche Modelle

Day 1 Pre-Dose -Vital Signs; Pharmacogenetic Research Consent/ Blood Sample Collection; Investigational Product Compliance (Pazopanib); Investigational Product (First Dose); Biomarker Samples

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of visit/ assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit/ assessment
Item
Date of visit/ assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Actual Date - Vital Signs
Item
Actual Date - Vital Signs
date
C2826644 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Sitting Systolic blood pressure 1st reading
Item
Sitting Systolic blood pressure 1st reading
integer
C1319893 (UMLS CUI [1])
Sitting diastolic blood pressure 1st reading
Item
Sitting diastolic blood pressure 1st reading
integer
C1319894 (UMLS CUI [1])
Sitting Systolic blood pressure 2nd reading
Item
Sitting Systolic blood pressure 2nd reading
integer
C1319893 (UMLS CUI [1])
Sitting diastolic blood pressure 2nd reading
Item
Sitting diastolic blood pressure 2nd reading
integer
C1319894 (UMLS CUI [1])
Sitting Systolic blood pressure 3rd reading
Item
Sitting Systolic blood pressure 3rd reading
integer
C1319893 (UMLS CUI [1])
Sitting diastolic blood pressure 3rd reading
Item
Sitting diastolic blood pressure 3rd reading
integer
C1319894 (UMLS CUI [1])
Sitting Mean Systolic Blood pressure
Item
Sitting Mean Systolic Blood pressure
integer
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Sitting Mean Diastolic Blood pressure
Item
Sitting Mean Diastolic Blood pressure
integer
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
Pharmacogenetic Research Consent/ Blood Sample Collection
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
Has informed consent been obtained for PGx research?
Item
Has informed consent been obtained for PGx research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
If informed consent has been obtained for PGx research, record date of informed consent obtained
Item
If informed consent has been obtained for PGx research, record date of informed consent obtained
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has blood been collected for PGx research?
Item
If informed consent has been obtained for PGx research, has blood been collected for PGx research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C2347500 (UMLS CUI [2,2])
If blood sample has been collected for PGx reserach, record date sample taken
Item
If blood sample has been collected for PGx reserach, record date sample taken
date
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If informed consent has not been obtained for PGx research, check reason
integer
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
If informed consent has not been obtained for PGx research, check reason
Code List
If informed consent has not been obtained for PGx research, check reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
If other reason for informed consent not beeing obtained for PGx research, please specify
Item
If other reason for informed consent not beeing obtained for PGx research, please specify
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Sample Type
Item
Sample Type
text
C2347029 (UMLS CUI [1])
Genetics Type
Item
Genetics Type
text
C0017399 (UMLS CUI [1])
Item Group
Investigational Product Compliance - Pazopanib
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
C1831796 (UMLS CUI-3)
Pazopanib Dispensed Date
Item
Pazopanib Dispensed Date
date
C0011008 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
C1831796 (UMLS CUI [1,3])
Number of Tablets Dispensed
Item
Number of Tablets Dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Item Group
Investigational Product - First Dose
C0304229 (UMLS CUI-1)
C3174092 (UMLS CUI-2)
C0205435 (UMLS CUI-3)
Dose Start Date
Item
Dose Start Date
date
C3174092 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item Group
Biomarker Sample
C0005516 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
Has biomarker sample been collected?
Item
Has biomarker sample been collected?
boolean
C0005834 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
If biomarker sample has been collected, record date sample taken
Item
If biomarker sample has been collected, record date sample taken
date
C1302413 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
Item
If biomarker sample has not been collected, provide reason
integer
C0200345 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
If sample has not been collected, provide reason
Code List
If biomarker sample has not been collected, provide reason
CL Item
Subject declined (1)
CL Item
Subject not asked by investigator (2)
CL Item
Other, specify (3)
If other reason for sample not been collected, please specify
Item
If other reason for sample not been collected, please specify
text
C0200345 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Biomarker Sample Type
Item
Biomarker Sample Type
text
C2347029 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
Biomarker sample Number
Item
Biomarker sample Number
integer
C0005516 (UMLS CUI [1,1])
C1299222 (UMLS CUI [1,2])
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