ID

36477

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 Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

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  1. 08.05.19 08.05.19 -
  2. 16.05.19 16.05.19 -
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GlaxoSmithKline

Hochgeladen am

16. Mai 2019

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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

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

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
Prior Cancer and Non-Cancer related surgical procedures
Beschreibung

Prior Cancer and Non-Cancer related surgical procedures

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

Sequence Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348184
Specific Procedure
Beschreibung

Specific Procedure

Datentyp

text

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

Modified Term

Datentyp

text

Alias
UMLS CUI [1]
C2826302
MedDRA Synonym
Beschreibung

MedDRA Synonym

Datentyp

text

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

MedDRA lower level term code

Datentyp

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Beschreibung

Failed coding

Datentyp

text

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

Date of Procedure

Datentyp

date

Alias
UMLS CUI [1]
C2584899
Classification
Beschreibung

Classification

Datentyp

integer

Alias
UMLS CUI [1]
C0008902
Concomitant Medications
Beschreibung

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Sequence Number
Beschreibung

Sequence Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348184
Drug Name
Beschreibung

(Trade Name preferred)

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Modified reported term
Beschreibung

Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826819
GSK Drug synonym
Beschreibung

GSK Drug synonym

Datentyp

text

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

GSK Drug Collection code

Datentyp

text

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

Failed coding

Datentyp

text

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

Units

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

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

Medication Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Medication Ongoing?
Beschreibung

Medication Ongoing?

Datentyp

boolean

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

If Medication not Ongoing, specify End Date.

Datentyp

date

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

Total Daily Dose

Datentyp

text

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

Medication Type

Datentyp

text

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

Tumor Tissue Biopsy Sample

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

Has a tissue sample been collected?

Datentyp

boolean

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

If tissue sample has not been collected, select reason

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Tumor Tissue Biopsy Sample Details

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

Type of Tissue Biopsy

Datentyp

integer

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

Organ Code

Datentyp

text

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

Tissue Source

Datentyp

integer

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

Date Biopsy Taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

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

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
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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