ID

17938

Description

A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00585533

Link

https://clinicaltrials.gov/show/NCT00585533

Keywords

  1. 10/11/16 10/11/16 -
Uploaded on

October 11, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Lung Cancer NCT00585533

Eligibility Lung Cancer NCT00585533

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
performance status 0-1.
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
weight loss < 10% in preceding 3 months
Description

Weight decreased

Data type

boolean

Alias
UMLS CUI [1]
C1262477
age 18 years and older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
adjuvant chemotherapy allowed if > 6 months from protocol entry
Description

Chemotherapy, Adjuvant

Data type

boolean

Alias
UMLS CUI [1]
C0085533
adequate organ function
Description

organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
liver enzymes < 2x normal, bilirubin = normal
Description

Measurement of liver enzyme | Bilirubin normal

Data type

boolean

Alias
UMLS CUI [1]
C0428321
UMLS CUI [2]
C0858307
oxygen saturation> 89% on room air unless chronically oxygen dependent (not cancer related)
Description

Oxygen saturation measurement Room air | Dependence on long-term oxygen Related to Cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0523807
UMLS CUI [1,2]
C3846005
UMLS CUI [2,1]
C2911577
UMLS CUI [2,2]
C2826292
creatinine <2.0 mg
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
not pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
no clinical brain metastases
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
no prior chemotherapy for systemic disease
Description

Prior Chemotherapy Systemic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0442893
imminent need for chemotherapy for impending organ dysfunction is not allowed
Description

organ dysfunction Impending | Chemotherapy Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0349410
UMLS CUI [1,2]
C0332190
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0686904

Similar models

Eligibility Lung Cancer NCT00585533

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
performance status
Item
performance status 0-1.
boolean
C1518965 (UMLS CUI [1])
Weight decreased
Item
weight loss < 10% in preceding 3 months
boolean
C1262477 (UMLS CUI [1])
Age
Item
age 18 years and older.
boolean
C0001779 (UMLS CUI [1])
Chemotherapy, Adjuvant
Item
adjuvant chemotherapy allowed if > 6 months from protocol entry
boolean
C0085533 (UMLS CUI [1])
organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Measurement of liver enzyme | Bilirubin normal
Item
liver enzymes < 2x normal, bilirubin = normal
boolean
C0428321 (UMLS CUI [1])
C0858307 (UMLS CUI [2])
Oxygen saturation measurement Room air | Dependence on long-term oxygen Related to Cancer
Item
oxygen saturation> 89% on room air unless chronically oxygen dependent (not cancer related)
boolean
C0523807 (UMLS CUI [1,1])
C3846005 (UMLS CUI [1,2])
C2911577 (UMLS CUI [2,1])
C2826292 (UMLS CUI [2,2])
Creatinine measurement, serum
Item
creatinine <2.0 mg
boolean
C0201976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
not pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Metastatic malignant neoplasm to brain
Item
no clinical brain metastases
boolean
C0220650 (UMLS CUI [1])
Prior Chemotherapy Systemic disease
Item
no prior chemotherapy for systemic disease
boolean
C1514457 (UMLS CUI [1,1])
C0442893 (UMLS CUI [1,2])
organ dysfunction Impending | Chemotherapy Patient need for
Item
imminent need for chemotherapy for impending organ dysfunction is not allowed
boolean
C0349410 (UMLS CUI [1,1])
C0332190 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])

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