ID

36583

Description

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

Keywords

Versions (1)
  1. 5/23/19 5/23/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 23, 2019

DOI

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License

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

English

Death; Study Conclusion; Pharmacogenetic Research Withdrawal of Consent; Pregnancy Information; Investigatoinal Product Discontinuation; Investigational Product Compliance - Pazopanib; Log Status

1 forms  
Death
Description

Death

Alias
UMLS CUI-1
C0011065
Is the subject alive?
Description

Is the subject alive?

Data type

boolean

Alias
UMLS CUI [1,1]
C2584946
UMLS CUI [1,2]
C2348568
If subject is not alive, enter date of death
Description

If subject is not alive, enter date of death

Data type

date

Alias
UMLS CUI [1]
C1148348
Indicate the primary cause of death
Description

Indicate the primary cause of death

Data type

integer

Alias
UMLS CUI [1]
C0007465
If other cause of death, please specify
Description

If other cause of death, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or date of subject withdrawal
Description

Date of subject completion or date of subject withdrawal

Data type

date

Alias
UMLS CUI [1]
C2983670
UMLS CUI [2,1]
C1710677
UMLS CUI [2,2]
C0011008
Was the subject withdrawn from the study?
Description

Was the subject withdrawn from the study?

Data type

boolean

Alias
UMLS CUI [1]
C0422727
If subject was withdrawn from study, select primary reson for withdrawal
Description

If subject was withdrawn from study, select primary reson for withdrawal

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1549995
If other reason for withdrawal, please specify
Description

If other reason for withdrawal, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1549995
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Tick or untick this box to require the investigator to re-sign the case book
Description

For Data Managers or Monitors only By ticking or unticking this box you are evoking a change to this form that will invalidate the original signature and will revert the form back to an unsigned state. This should be done when significant changes (e.g. those that require medical opinion or other significant situations) occur after the original signature. If the box is already ticked upon arrival on this form, unticking and submitting it accomplishes the same task as ticking and submitting it; that is, the signature will be in validated in both instances.

Data type

integer

Alias
UMLS CUI [1]
C2346576
Pharmacogenetic Research Withdrawal of Consent
Description

Pharmacogenetic Research Withdrawal of Consent

Alias
UMLS CUI-1
C1707492
UMLS CUI-2
C0031325
Has subject withdrawn consent for PGx research?
Description

Has subject withdrawn consent for PGx research?

Data type

boolean

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
If subject has withdrawn consent for PGx research, enter date informed consent withdrawn.
Description

If subject has withdrawn consent for PGx research, enter date informed consent withdrawn.

Data type

date

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
UMLS CUI [1,3]
C0011008
Has a request been made for blood sample destruction?
Description

Has a request been made for blood sample destruction?

Data type

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
If a request has been made for blood sample destruction, check reason
Description

If a request has been made for blood sample destruction, check reason

Data type

integer

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
If other reason for request for blood sample destruction, please specify
Description

If other reason for request for blood sample destruction, please specify

Data type

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
UMLS CUI [1,5]
C0205394
UMLS CUI [1,6]
C2348235
Sample type
Description

Sample type

Data type

text

Alias
UMLS CUI [1]
C2347029
Genetics Type
Description

Genetics Type

Data type

text

Alias
UMLS CUI [1,1]
C0017399
UMLS CUI [1,2]
C0332307
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Description

Did the subject become pregnant during the study?

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Investigational Product Discontinuation
Description

Investigational Product Discontinuation

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0457454
Give primary reason Investigational Product was discontinued permanently:
Description

Give primary reason Investigational Product was discontinued permanently

Data type

integer

Alias
UMLS CUI [1,1]
C4288399
UMLS CUI [1,2]
C1549995
If other primary reason Investigational Product was discontinued permanently, please specify:
Description

If other primary reason Investigational Product was discontinued permanently, please specify

Data type

text

Alias
UMLS CUI [1,1]
C4288399
UMLS CUI [1,2]
C1549995
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Investigational Product Compliance
Description

Investigational Product Compliance

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
Pazopanib Returned Date
Description

Pazopanib Returned Date

Data type

date

Alias
UMLS CUI [1,1]
C1831796
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0332156
Number of Tablets Returned
Description

Number of Tablets Returned

Data type

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0039225
Log Status
Description

Log Status

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0449438
Did the subject experience any non-serious adverse events during the study?
Description

Did the subject experience any non-serious adverse events during the study?

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Were any concomitant medications taken by the subject during the study?
Description

Were any concomitant medications taken by the subject during the study?

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Did the subject experience a serious adverse event during the study?
Description

Did the subject experience a serious adverse event during the study?

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Any blood products taken?
Description

Any blood products taken?

Data type

boolean

Alias
UMLS CUI [1]
C0456388
Has subject had surgery/procedure?
Description

Has subject had surgery/procedure?

Data type

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C0199171
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Similar models

Death; Study Conclusion; Pharmacogenetic Research Withdrawal of Consent; Pregnancy Information; Investigatoinal Product Discontinuation; Investigational Product Compliance - Pazopanib; Log Status

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Death
C0011065 (UMLS CUI-1)
Is the subject alive?
Item
Is the subject alive?
boolean
C2584946 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
If subject is not alive, enter date of death
Item
If subject is not alive, enter date of death
date
C1148348 (UMLS CUI [1])
Item
Indicate the primary cause of death
integer
C0007465 (UMLS CUI [1])
Indicate the primary cause of death
Code List
Indicate the primary cause of death
CL Item
Disease under study (1)
CL Item
Toxicity (2)
CL Item
Other, specify (3)
If other cause of death, please specify
Item
If other cause of death, please specify
text
C0007465 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of subject completion or date of subject withdrawal
Item
Date of subject completion or date of subject withdrawal
date
C2983670 (UMLS CUI [1])
C1710677 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If subject was withdrawn from study, select primary reson for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
If subject was withdrawn from study, select primary reson for withdrawal
Code List
If subject was withdrawn from study, select primary reson for withdrawal
CL Item
Adverse Event (1)
CL Item
Record detaiis on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate (2)
CL Item
Lost to follow-up (2)
CL Item
Death (3)
CL Item
Investigator decision (4)
CL Item
Subject withdrew from treatment (5)
CL Item
Subject decided to withdraw from the study (6)
CL Item
Subject reached protocol defined stopping criteria (7)
CL Item
Sponsor terminated study (8)
CL Item
Disease progression (9)
CL Item
Other, specify (10)
If other reason for withdrawal, please specify
Item
If other reason for withdrawal, please specify
text
C0422727 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Tick or untick this box to require the investigator to re-sign the case book
integer
C2346576 (UMLS CUI [1])
Tick or untick this box to require the investigator to re-sign the case book
Code List
Tick or untick this box to require the investigator to re-sign the case book
CL Item
Require the investigator to re-sign the case book (1)
Item Group
Pharmacogenetic Research Withdrawal of Consent
C1707492 (UMLS CUI-1)
C0031325 (UMLS CUI-2)
Has subject withdrawn consent for PGx research?
Item
Has subject withdrawn consent for PGx research?
boolean
C1707492 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
If subject has withdrawn consent for PGx research, enter date informed consent withdrawn.
Item
If subject has withdrawn consent for PGx research, enter date informed consent withdrawn.
date
C1707492 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has a request been made for blood sample destruction?
Item
Has a request been made for blood sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Item
If a request has been made for blood sample destruction, check reason
integer
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
If a request has been made for blood sample destruction, check reason
Code List
If a request has been made for blood sample destruction, check reason
CL Item
Subject withdrew consent for PGx (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
If other reason for request for blood sample destruction, please specify
Item
If other reason for request for blood sample destruction, please specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C2348235 (UMLS CUI [1,6])
Sample type
Item
Sample type
text
C2347029 (UMLS CUI [1])
Genetics Type
Item
Genetics Type
text
C0017399 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
C0032961 (UMLS CUI [1])
Item Group
Investigational Product Discontinuation
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Item
Give primary reason Investigational Product was discontinued permanently:
integer
C4288399 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Give primary reason Investigational Product was discontinued permanently
Code List
Give primary reason Investigational Product was discontinued permanently:
CL Item
Adverse event (1)
CL Item
Record detaiis on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. (2)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (i.e. subject has withdrawn consent) (4)
CL Item
Complete the Study Conciusion form. (6)
CL Item
Subject decided to withdraw from IP but is to be followed for survival per protocol (5)
CL Item
Do not complete the Study Conciusion form untii foiiow-up is cornpiete. (8)
CL Item
Disease progression (6)
CL Item
Death (7)
CL Item
Investigator decision (8)
CL Item
Other, specify (9)
If other primary reason Investigational Product was discontinued permanently, please specify
Item
If other primary reason Investigational Product was discontinued permanently, please specify:
text
C4288399 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Investigational Product Compliance
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
Pazopanib Returned Date
Item
Pazopanib Returned Date
date
C1831796 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0332156 (UMLS CUI [1,3])
Number of Tablets Returned
Item
Number of Tablets Returned
integer
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Item Group
Log Status
C1708728 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
Did the subject experience a serious adverse event during the study?
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Any blood products taken?
Item
Any blood products taken?
boolean
C0456388 (UMLS CUI [1])
Has subject had surgery/procedure?
Item
Has subject had surgery/procedure?
boolean
C0543467 (UMLS CUI [1])
C0199171 (UMLS CUI [2])
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