ID

36477

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 (2)
  1. 08-05-19 08-05-19 -
  2. 16-05-19 16-05-19 -
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GlaxoSmithKline

Geüploaded op

16 mei 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

Engels

Screening - Prior Cancer and Non-Cancer related surgical procedures; Concomitant Medications; Tumor Tissue Biopsy Sample; Tumor Tissue Biopsy Sample Details

1 Formulieren  
Date of visit/ assessment
Beschrijving

Date of visit/ assessment

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

Date of visit/ assessment

Datatype

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Prior Cancer and Non-Cancer related surgical procedures
Beschrijving

Prior Cancer and Non-Cancer related surgical procedures

Alias
UMLS CUI-1
C0543467
UMLS CUI-2
C2826292
Sequence Number
Beschrijving

Sequence Number

Datatype

integer

Alias
UMLS CUI [1]
C2348184
Specific Procedure
Beschrijving

Specific Procedure

Datatype

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2348235
Modified Term
Beschrijving

Modified Term

Datatype

text

Alias
UMLS CUI [1]
C2826302
MedDRA Synonym
Beschrijving

MedDRA Synonym

Datatype

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Beschrijving

MedDRA lower level term code

Datatype

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Beschrijving

Failed coding

Datatype

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Date of Procedure
Beschrijving

Date of Procedure

Datatype

date

Alias
UMLS CUI [1]
C2584899
Classification
Beschrijving

Classification

Datatype

integer

Alias
UMLS CUI [1]
C0008902
Concomitant Medications
Beschrijving

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Sequence Number
Beschrijving

Sequence Number

Datatype

integer

Alias
UMLS CUI [1]
C2348184
Drug Name
Beschrijving

(Trade Name preferred)

Datatype

text

Alias
UMLS CUI [1]
C0013227
Modified reported term
Beschrijving

Modified reported term

Datatype

text

Alias
UMLS CUI [1]
C2826819
GSK Drug synonym
Beschrijving

GSK Drug synonym

Datatype

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0871468
GSK Drug Collection code
Beschrijving

GSK Drug Collection code

Datatype

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0805701
Failed coding
Beschrijving

Failed coding

Datatype

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Units
Beschrijving

Units

Datatype

text

Alias
UMLS CUI [1]
C1519795
Route
Beschrijving

Route

Datatype

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Beschrijving

Reason for Medication

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Medication Start Date
Beschrijving

Medication Start Date

Datatype

date

Alias
UMLS CUI [1]
C2826734
Medication Ongoing?
Beschrijving

Medication Ongoing?

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
If Medication not Ongoing, specify End Date.
Beschrijving

If Medication not Ongoing, specify End Date.

Datatype

date

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0806020
Total Daily Dose
Beschrijving

Total Daily Dose

Datatype

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439810
Medication Type
Beschrijving

Medication Type

Datatype

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332307
Tumor Tissue Biopsy Sample
Beschrijving

Tumor Tissue Biopsy Sample

Alias
UMLS CUI-1
C0475358
UMLS CUI-2
C0005558
Has a tissue sample been collected?
Beschrijving

Has a tissue sample been collected?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1516698
If tissue sample has not been collected, select reason.
Beschrijving

If tissue sample has not been collected, select reason

Datatype

integer

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1516698
UMLS CUI [2]
C0392360
If other reason for tissue sample has not been collected, specify.
Beschrijving

If other reason for tissue sample has not been collected, specify.

Datatype

text

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1516698
UMLS CUI [2,1]
C0392360
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C2348235
Tumor Tissue Biopsy Sample Details
Beschrijving

Tumor Tissue Biopsy Sample Details

Alias
UMLS CUI-1
C0475358
UMLS CUI-2
C0005558
UMLS CUI-3
C1522508
Type of Tissue Biopsy
Beschrijving

Type of Tissue Biopsy

Datatype

integer

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C0332307
Organ Code
Beschrijving

Organ Code

Datatype

text

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0805701
Tissue Source
Beschrijving

Tissue Source

Datatype

integer

Alias
UMLS CUI [1,1]
C0040300
UMLS CUI [1,2]
C0449416
Date Biopsy Taken
Beschrijving

Date Biopsy Taken

Datatype

date

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011008
Terug naar het begin van de pagina

Similar models

Screening - Prior Cancer and Non-Cancer related surgical procedures; Concomitant Medications; Tumor Tissue Biopsy Sample; Tumor Tissue Biopsy Sample Details

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Prior Cancer and Non-Cancer related surgical procedures
C0543467 (UMLS CUI-1)
C2826292 (UMLS CUI-2)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Specific Procedure
Item
Specific Procedure
text
C0087111 (UMLS CUI [1,1])
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])
Date of Procedure
Item
Date of Procedure
date
C2584899 (UMLS CUI [1])
Item
Classification
integer
C0008902 (UMLS CUI [1])
Classification
Code List
Classification
CL Item
Cancer related (1)
CL Item
Other (2)
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
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
C2826819 (UMLS CUI [1])
GSK Drug synonym
Item
GSK Drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
GSK Drug Collection code
Item
GSK Drug Collection code
text
C0013227 (UMLS CUI [1,1])
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])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication Ongoing?
Item
Medication Ongoing?
boolean
C2826666 (UMLS CUI [1])
If Medication not Ongoing, specify End Date.
Item
If Medication not Ongoing, specify End Date.
date
C2826666 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Medication Type
Item
Medication Type
text
C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Item Group
Tumor Tissue Biopsy Sample
C0475358 (UMLS CUI-1)
C0005558 (UMLS CUI-2)
Has a tissue sample been collected?
Item
Has a tissue sample been collected?
boolean
C0475358 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
Item
If tissue sample has not been collected, select reason.
integer
C0475358 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
If tissue sample has not been collected, select reason
Code List
If tissue sample has not been collected, select reason.
CL Item
Subject declined (1)
CL Item
Subject not asked by investigator (2)
CL Item
Other, specify (3)
If other reason for tissue sample has not been collected, specify.
Item
If other reason for tissue sample has not been collected, specify.
text
C0475358 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Item Group
Tumor Tissue Biopsy Sample Details
C0475358 (UMLS CUI-1)
C0005558 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Item
Type of Tissue Biopsy
integer
C0475358 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Type of Tissue Biopsy
Code List
Type of Tissue Biopsy
CL Item
Core (1)
CL Item
Excisional (2)
CL Item
FNA (fine needle aspiration) (3)
CL Item
Punch (4)
CL Item
Other (5)
Organ Code
Item
Organ Code
text
C0178784 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Item
Tissue Source
integer
C0040300 (UMLS CUI [1,1])
C0449416 (UMLS CUI [1,2])
Tissue Source
Code List
Tissue Source
CL Item
Primary (1)
CL Item
Secondary/ Metastatic (2)
CL Item
Unknown (3)
Date Biopsy Taken
Item
Date Biopsy Taken
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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