ID

35129

Descrição

GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations; ODM derived from: https://clinicaltrials.gov/show/NCT02047903

Link

https://clinicaltrials.gov/show/NCT02047903

Palavras-chave

  1. 19/02/2019 19/02/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

19 de fevereiro de 2019

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Carcinoma, Non-Small-Cell Lung NCT02047903

Eligibility Carcinoma, Non-Small-Cell Lung NCT02047903

Inclusion Criteria
Descrição

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
Descrição

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

Tipo de dados

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
Descrição

Age

Tipo de dados

boolean

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

Therapeutic procedure Initiation | Afatinib

Tipo de dados

boolean

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

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

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

Medical contraindication Afatinib

Tipo de dados

boolean

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

Study Subject Participation Status

Tipo de dados

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)
Descrição

Systemic Chemotherapy

Tipo de dados

boolean

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

EGFR tyrosine kinase inhibitor Previous

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Legal capacity Missing | Legal capacity Impaired

Tipo de dados

boolean

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

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT02047903

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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