ID
36382
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
Stichworte
Versionen (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
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
8. Mai 2019
DOI
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Lizenz
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
Beschreibung
Subject number
Alias
- UMLS CUI-1
- C2348585
Beschreibung
Date of Visit/ Assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Beschreibung
Local Laboratories
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C0205276
Beschreibung
If another local laboratory is used after you have already selected a response and submitted fjjjl Th the form, change your response and an additional local laboratory form will be created.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0237753
Beschreibung
Laboratory Name
Datentyp
text
Alias
- UMLS CUI [1]
- C3258037
Beschreibung
Laboratory Address
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Beschreibung
Laboratory ID
Datentyp
text
Alias
- UMLS CUI [1]
- C2986056
Beschreibung
Subject identification
Alias
- UMLS CUI-1
- C2348585
Beschreibung
Demography
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Sex
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Ethnicity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
Check all that apply
Datentyp
integer
Alias
- UMLS CUI [1]
- C3841890
Beschreibung
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Beschreibung
Did the subject meet all the entry criteria?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1516637
Beschreibung
Select all boxes corresponding to violations of any inclusion/exclusion criteria
Datentyp
integer
Alias
- UMLS CUI [1]
- C1516637
Beschreibung
Disease Characteristics
Alias
- UMLS CUI-1
- C1705348
Beschreibung
Primary Tumour Type at Initial Diagnosis
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0677930
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C4071762
Beschreibung
Date of Initial Diagnosis
Datentyp
date
Alias
- UMLS CUI [1]
- C2316983
Beschreibung
Stage at Initial Diagnosis
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [1,3]
- C0205265
Beschreibung
Histology at Initial Diagnosis
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0019638
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [1,3]
- C0205265
Beschreibung
Date of Last Progression
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0242656
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C1517741
Beschreibung
Date of Staging at Screening
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0027646
- UMLS CUI [2]
- C1710477
Beschreibung
Stage at Screening
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0220908
Beschreibung
Lines of Therapy Completed at Screening
Datentyp
integer
Alias
- UMLS CUI [1]
- C1514463
Beschreibung
Metastatic Disease
Alias
- UMLS CUI-1
- C0027627
Beschreibung
Did the subject have metastatic disease at screening?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C0220908
Beschreibung
If subject had metastatic disease at screening, complete date metastatic disease was first diagnosed
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C0220908
- UMLS CUI [1,3]
- C0011008
Beschreibung
Status at Screening
Alias
- UMLS CUI-1
- C0220908
- UMLS CUI-2
- C0449438
Beschreibung
Did the subject receive prior chemo, immuno, hormonal or biologic therapies for the cancer under study?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0392920
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [2,1]
- C0279025
- UMLS CUI [2,2]
- C0920425
- UMLS CUI [2,3]
- C0332152
- UMLS CUI [3,1]
- C1531518
- UMLS CUI [3,2]
- C0920425
- UMLS CUI [3,3]
- C0332152
- UMLS CUI [4,1]
- C0021083
- UMLS CUI [4,2]
- C0920425
- UMLS CUI [4,3]
- C0332152
Beschreibung
Did the subject receive prior radiotherapy for the cancer under study?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1522449
- UMLS CUI [1,2]
- C0920425
- UMLS CUI [1,3]
- C0332152
Beschreibung
Has subject had prior surgery/ procedure?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0744961
Beschreibung
Were any concomitant medications taken by the subject prior to screening?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0220908
Beschreibung
Anti-Cancer Therapy
Alias
- UMLS CUI-1
- C0920425
Beschreibung
Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
(Trade Name preferred)
Datentyp
text
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Modified reported term
Datentyp
text
Alias
- UMLS CUI [1]
- C2826302
Beschreibung
GSK Drug synonym
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0871468
Beschreibung
GSR Drug Collection code
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Beschreibung
Failed coding
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
Regimen Sequence
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1276413
- UMLS CUI [1,2]
- C2348184
Beschreibung
Therapy Type
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0332307
- UMLS CUI [1,2]
- C0087111
Beschreibung
Number of Cycles/Doses
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0750480
Beschreibung
Units
Datentyp
integer
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Intent
Datentyp
integer
Alias
- UMLS CUI [1]
- C1283828
Beschreibung
Therapy Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C1531783
Beschreibung
Therapy Stop Date
Datentyp
date
Alias
- UMLS CUI [1]
- C1531784
Beschreibung
Best Response
Datentyp
integer
Alias
- UMLS CUI [1]
- C2986560
Beschreibung
Duration of Response
Datentyp
durationDatetime
Maßeinheiten
- Weeks
Alias
- UMLS CUI [1]
- C0237585
Beschreibung
Anti-Cancer Therapy
Alias
- UMLS CUI-1
- C0920425
Beschreibung
Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
Site
Datentyp
text
Alias
- UMLS CUI [1]
- C2825164
Beschreibung
Cumulative Dose
Datentyp
float
Alias
- UMLS CUI [1]
- C2986497
Beschreibung
Units
Datentyp
integer
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Intent
Datentyp
integer
Alias
- UMLS CUI [1]
- C1283828
Beschreibung
Radiotherapy Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0436382
Beschreibung
Radiotherapy Stop Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1522449
- UMLS CUI [1,2]
- C0806020
Beschreibung
Best Response
Datentyp
integer
Alias
- UMLS CUI [1]
- C2986560
Beschreibung
Duration of Response
Datentyp
durationDatetime
Maßeinheiten
- Weeks
Alias
- UMLS CUI [1]
- C0237585
Beschreibung
Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Beschreibung
Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
Specific Condition
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschreibung
Modified Term
Datentyp
text
Alias
- UMLS CUI [1]
- C2826302
Beschreibung
MedDRA Synonym
Datentyp
text
Alias
- UMLS CUI [1]
- C1140263
Beschreibung
MedDRA lower level term code
Datentyp
text
Alias
- UMLS CUI [1]
- C3898442
Beschreibung
Failed coding
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
NCI CTCAE v.3 Grade
Datentyp
integer
Alias
- UMLS CUI [1]
- C3887242
Beschreibung
Status
Datentyp
integer
Alias
- UMLS CUI [1]
- C0449438
Beschreibung
Classification
Datentyp
integer
Alias
- UMLS CUI [1]
- C0008902
Ähnliche Modelle
Screening - Subject Identification; Demography; Eligibility Question; Disease Characteristics; Status at Screening; Anti-Cancer Therapy; Anti-Cancer Radiotherapy; Medical Conditions
C2986440 (UMLS CUI [1,2])
C0543488 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0543488 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C0027646 (UMLS CUI [1,2])
C1710477 (UMLS CUI [2])
C0220908 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
C0920425 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C0871468 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])