English

Eligibility Carcinoma, Non-Small-Cell Lung NCT02047903

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
egfr- tyrosine kinase inhibitor (tki) naive patients with histologically confirmed locally advanced or metastatic nsclc with activating egfr-mutations
Description

EGFR tyrosine kinase inhibitor Absent | Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | EGFR Activating Mutation

Data type

boolean

Alias
UMLS CUI [1,1]
C1443775
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C1517927
UMLS CUI [3]
C0278987
UMLS CUI [4]
C2984891
age >= 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients for whom the treating physician has decided to initiate treatment with giotrif
Description

Therapeutic procedure Initiation | Afatinib

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1704686
UMLS CUI [2]
C2987648
written informed consent prior inclusion
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindication for afatinib according to the summary of product characteristics
Description

Medical contraindication Afatinib

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2987648
participation in another clinical study until 30 days after end of treatment
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
prior systemic chemotherapy (neo-/adjuvant therapy is permitted if at least 12 months has elapsed prior to disease progression)
Description

Systemic Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1883256
previous treatment with an egfr-tyrosine kinase inhibitor
Description

EGFR tyrosine kinase inhibitor Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1443775
UMLS CUI [1,2]
C0205156
patients not willing or not able to fill in quality of life questionnaires
Description

Quality of life Questionnaires Completion Unwilling | Quality of life Questionnaires Completion Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0034380
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C0205197
UMLS CUI [1,4]
C0558080
UMLS CUI [2,1]
C0034380
UMLS CUI [2,2]
C0034394
UMLS CUI [2,3]
C0205197
UMLS CUI [2,4]
C1299582
patients with missing or impaired legal capacity
Description

Legal capacity Missing | Legal capacity Impaired

Data type

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C1705492
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0221099
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT02047903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
EGFR tyrosine kinase inhibitor Absent | Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | EGFR Activating Mutation
Item
egfr- tyrosine kinase inhibitor (tki) naive patients with histologically confirmed locally advanced or metastatic nsclc with activating egfr-mutations
boolean
C1443775 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C0278987 (UMLS CUI [3])
C2984891 (UMLS CUI [4])
Age
Item
age >= 18 years
boolean
C0001779 (UMLS CUI [1])
Therapeutic procedure Initiation | Afatinib
Item
patients for whom the treating physician has decided to initiate treatment with giotrif
boolean
C0087111 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C2987648 (UMLS CUI [2])
Informed Consent
Item
written informed consent prior inclusion
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Afatinib
Item
contraindication for afatinib according to the summary of product characteristics
boolean
C1301624 (UMLS CUI [1,1])
C2987648 (UMLS CUI [1,2])
Study Subject Participation Status
Item
participation in another clinical study until 30 days after end of treatment
boolean
C2348568 (UMLS CUI [1])
Systemic Chemotherapy
Item
prior systemic chemotherapy (neo-/adjuvant therapy is permitted if at least 12 months has elapsed prior to disease progression)
boolean
C1883256 (UMLS CUI [1])
EGFR tyrosine kinase inhibitor Previous
Item
previous treatment with an egfr-tyrosine kinase inhibitor
boolean
C1443775 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Quality of life Questionnaires Completion Unwilling | Quality of life Questionnaires Completion Unable
Item
patients not willing or not able to fill in quality of life questionnaires
boolean
C0034380 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0558080 (UMLS CUI [1,4])
C0034380 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
Legal capacity Missing | Legal capacity Impaired
Item
patients with missing or impaired legal capacity
boolean
C0683673 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
C0683673 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
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