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Fout:
ID
36382
Beschrijving
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 Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell
Trefwoorden
Versies (4)
- 08-05-19 08-05-19 -
- 14-08-19 14-08-19 -
- 14-08-19 14-08-19 -
- 15-03-21 15-03-21 - Dr. rer. medic Philipp Neuhaus
Houder van rechten
GlaxoSmithKline
Geüploaded op
8 mei 2019
DOI
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Licentie
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
Screening - Subject Identification; Demography; Eligibility Question; Disease Characteristics; Status at Screening; Anti-Cancer Therapy; Anti-Cancer Radiotherapy; Medical Conditions
Similar models
Screening - Subject Identification; Demography; Eligibility Question; Disease Characteristics; Status at Screening; Anti-Cancer Therapy; Anti-Cancer Radiotherapy; Medical Conditions
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Subject initials
Item
Subject initials
integer
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
Item
What is the primary method that prompted the subject's interest in the study?
integer
C0008976 (UMLS CUI [1,1])
C0543488 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0543488 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
What is the primary method that prompted the subject's interest in the study?
CL Item
Clinic patient (site actively reviews patient charts and/or databases and initiates contact with patient). (1)
CL Item
Physician referral (e.g., lunch-n—learn, letter to colleagues, etc.) (2)
CL Item
Referred by family member (3)
CL Item
Referred by study participant (4)
CL Item
Subject-initiated internet search (e.g. discovered findclinicalstudy.com) (5)
CL Item
Other Internet provider paid by GSK. (e.g., harrisinteractive.com), specify (6)
CL Item
Information in clinic (e.g., posters, brochure, etc.) (7)
CL Item
Community outreach (e.g., healthfair, advocacy groups, support groups, etc.) (8)
CL Item
Local newspaper advertisement (9)
CL Item
Local radio advertisement (10)
CL Item
Other local paid advertisement (e.g., local television, local direct mail, etc.) (11)
CL Item
Other, specify (12)
If other Internet provider paid by GSK. (e.g., harrisinteractive.com), specify
Item
If other Internet provider paid by GSK. (e.g., harrisinteractive.com), specify
text
C1138603 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
If other primary method that prompted the subject's interest in the study, please specify.
Item
If other primary method that prompted the subject's interest in the study, please specify.
text
C0008976 (UMLS CUI [1,1])
C0543488 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0543488 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item
Was this subject a screen failure?
integer
C1710476 (UMLS CUI [1])
CL Item
No (1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Item
Select the number of local laboratories used by the subject during the study.
integer
C0022877 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Code List
Select the number of local laboratories used by the subject during the study.
CL Item
One (1)
CL Item
Two (2)
CL Item
Three (3)
CL Item
Four (4)
CL Item
Five (5)
CL Item
Six (6)
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
Laboratory Address
Item
Laboratory Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])
Laboratory ID
Item
Laboratory ID
text
C2986056 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female: Record chi|d—bearing potential (2)
CL Item
Female: Post-menopausal (3)
CL Item
Female: Sterile (of child—bearing age) (4)
CL Item
Female: Potentially able to bear children (5)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
African American/African Heritage (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian — Central/South Asian Heritage (3)
CL Item
Asian — East Asian Heritage (4)
CL Item
Asian — Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic/ North African Heritage (8)
CL Item
White - White/Caucasian/European Heritage (9)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item
If subject did not meet all the entry criteria, please select all boxes corresponding to violations of any inclusion/exclusion criteria
integer
C1516637 (UMLS CUI [1])
Code List
If subject did not meet all the entry criteria, please select all boxes corresponding to violations of any inclusion/exclusion criteria
CL Item
Inclucion criteria 1 (1)
CL Item
Inclucion criteria 2 (2)
CL Item
Inclucion criteria 3 (3)
CL Item
Inclucion criteria 4 (4)
CL Item
Inclucion criteria 5 (5)
CL Item
Inclucion criteria 6 (6)
CL Item
Inclucion criteria 7 (7)
CL Item
Inclucion criteria 8 (8)
CL Item
Inclucion criteria 9 (9)
CL Item
Exclusion Criteria 1 (10)
CL Item
Exclusion Criteria 2 (11)
CL Item
Exclusion Criteria 3 (12)
CL Item
Exclusion Criteria 4 (13)
CL Item
Exclusion Criteria 5 (14)
CL Item
Exclusion Criteria 6 (15)
CL Item
Exclusion Criteria 7 (16)
CL Item
Exclusion Criteria 8 (17)
CL Item
Exclusion Criteria 9 (18)
CL Item
Exclusion Criteria 10 (19)
CL Item
Exclusion Criteria 11 (20)
CL Item
Exclusion Criteria 12 (21)
CL Item
Exclusion Criteria 13 (22)
CL Item
Exclusion Criteria 14 (23)
CL Item
Exclusion Criteria 15 (24)
CL Item
Exclusion Criteria 16 (25)
CL Item
Exclusion Criteria 17 (26)
CL Item
Exclusion Criteria 18 (27)
Item
Primary Tumour Type at Initial Diagnosis
integer
C0677930 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
CL Item
Non-Small Cell Lung (1)
Date of Initial Diagnosis
Item
Date of Initial Diagnosis
date
C2316983 (UMLS CUI [1])
Item
Stage at Initial Diagnosis
integer
C1300072 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
CL Item
I (1)
CL Item
II (2)
CL Item
IIIa (3)
CL Item
IIIb (4)
CL Item
IV (5)
Item
Histology at Initial Diagnosis
integer
C0019638 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
CL Item
Adenocarcinoma (1)
CL Item
Bronchioloalveolar (2)
CL Item
Large cell carcinoma (3)
CL Item
Squamous (4)
CL Item
Unknown (5)
CL Item
Other, Specify (6)
Date of Last Progression
Item
Date of Last Progression
date
C0242656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Date of Staging at Screening
Item
Date of Staging at Screening
date
C0011008 (UMLS CUI [1,1])
C0027646 (UMLS CUI [1,2])
C1710477 (UMLS CUI [2])
C0027646 (UMLS CUI [1,2])
C1710477 (UMLS CUI [2])
Item
Stage at Screening
integer
C1300072 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,2])
CL Item
IIIb (1)
CL Item
IV (2)
Lines of Therapy Completed at Screening
Item
Lines of Therapy Completed at Screening
integer
C1514463 (UMLS CUI [1])
Did the subject have metastatic disease at screening?
Item
Did the subject have metastatic disease at screening?
boolean
C0027627 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,2])
If subject had metastatic disease at screening, complete date metastatic disease was first diagnosed
Item
If subject had metastatic disease at screening, complete date metastatic disease was first diagnosed
date
C0027627 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Did the subject receive prior chemo, immuno, hormonal or biologic therapies for the cancer under study?
Item
Did the subject receive prior chemo, immuno, hormonal or biologic therapies for the cancer under study?
boolean
C0392920 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C1531518 (UMLS CUI [3,1])
C0920425 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
C0021083 (UMLS CUI [4,1])
C0920425 (UMLS CUI [4,2])
C0332152 (UMLS CUI [4,3])
C0920425 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C1531518 (UMLS CUI [3,1])
C0920425 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
C0021083 (UMLS CUI [4,1])
C0920425 (UMLS CUI [4,2])
C0332152 (UMLS CUI [4,3])
Did the subject receive prior radiotherapy for the cancer under study?
Item
Did the subject receive prior radiotherapy for the cancer under study?
boolean
C1522449 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0920425 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Has subject had prior surgery/ procedure?
Item
Has subject had prior surgery/ procedure?
boolean
C0744961 (UMLS CUI [1])
Were any concomitant medications taken by the subject prior to screening?
Item
Were any concomitant medications taken by the subject prior to screening?
boolean
C2347852 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Modified reported term
Item
Modified reported term
text
C2826302 (UMLS CUI [1])
GSK Drug synonym
Item
GSK Drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,2])
GSR Drug Collection code
Item
GSR Drug Collection code
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
Regimen Sequence
Item
Regimen Sequence
integer
C1276413 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
CL Item
Biologic Therapy (antibodies, cytokines) (1)
CL Item
Chemotherapy (cytotoxics, non-cytotoxics) (2)
CL Item
Hormonal Therapy (3)
CL Item
Immunotherapy (4)
Number of Cycles/Doses
Item
Number of Cycles/Doses
integer
C0178602 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
CL Item
Cycles (1)
CL Item
Doses (2)
CL Item
Neo-adjuvant (1)
CL Item
Adjuva nt (2)
CL Item
Advanced or Metastatic (3)
Therapy Start Date
Item
Therapy Start Date
date
C1531783 (UMLS CUI [1])
Therapy Stop Date
Item
Therapy Stop Date
date
C1531784 (UMLS CUI [1])
CL Item
Complete Response (1)
CL Item
Partial Response (2)
CL Item
Stable Disease (3)
CL Item
Prog ressive Disease (4)
CL Item
Unknown (5)
Duration of Response
Item
Duration of Response
durationDatetime
C0237585 (UMLS CUI [1])
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Cumulative Dose
Item
Cumulative Dose
float
C2986497 (UMLS CUI [1])
CL Item
Grays (1)
CL Item
Centigrays (2)
CL Item
x100 Rads (3)
CL Item
Neo-adjuvant (1)
CL Item
Adjuvant (2)
CL Item
Advanced or Metastatic (3)
CL Item
Local/ Regional (4)
CL Item
Other (5)
Radiotherapy Start Date
Item
Radiotherapy Start Date
date
C0436382 (UMLS CUI [1])
Radiotherapy Stop Date
Item
Radiotherapy Stop Date
date
C1522449 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
CL Item
Complete Response (1)
CL Item
Partial Response (2)
CL Item
Stable Disease (3)
CL Item
Progressive Disease (4)
CL Item
Not Evaluable (5)
Duration of Response
Item
Duration of Response
durationDatetime
C0237585 (UMLS CUI [1])
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Specific Condition
Item
Specific Condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Modified Term
Item
Modified Term
text
C2826302 (UMLS CUI [1])
MedDRA Synonym
Item
MedDRA Synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Not Applicable (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Cancer related (1)
CL Item
Other (general) (2)