Informações:
Falhas:
ID
36671
Descrição
A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02450539
Link
https://clinicaltrials.gov/show/NCT02450539
Palavras-chave
Versões (1)
- 31/05/2019 31/05/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
31 de maio de 2019
DOI
Para um pedido faça login.
Licença
Creative Commons BY 4.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Eligibility Non-Small Cell Lung Cancer Stage IV NCT02450539
Eligibility Non-Small Cell Lung Cancer Stage IV NCT02450539
- StudyEvent: Eligibility
Similar models
Eligibility Non-Small Cell Lung Cancer Stage IV NCT02450539
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
confirmed diagnosis of stage iv nsclc.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,2])
Disease Progression | Chemotherapy Platinum-Based Advanced disease
Item
have progressed during or after platinum-based chemotherapy for advanced disease.
boolean
C0242656 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C0679246 (UMLS CUI [2,3])
C0392920 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C0679246 (UMLS CUI [2,3])
Docetaxel Absent
Item
have not received prior treatment with docetaxel.
boolean
C0246415 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
Availability of Tumor tissue sample Formalin-fixed paraffin-embedded
Item
have availability of adequate formalin-fixed paraffin-embedded (ffpe) tumor derived material.
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C2711483 (UMLS CUI [1,3])
C0475358 (UMLS CUI [1,2])
C2711483 (UMLS CUI [1,3])
Organ function | Hematologic function | Renal function | Liver function
Item
have adequate organ function including hematology, renal, and liver.
boolean
C0678852 (UMLS CUI [1])
C0221130 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
C0221130 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
Performance status
Item
have good performance score (0-1).
boolean
C1518965 (UMLS CUI [1])
Measurable Disease
Item
have measureable disease per recist 1.1.
boolean
C1513041 (UMLS CUI [1])
Use of Contraceptive methods
Item
agree to use a reliable medically approved method of birth control.
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,2])
INK4 Cyclin-Dependent Kinase Inhibitors | Study Subject Participation Status
Item
have received prior treatment with any cyclin dependent kinase (cdk) 4 and 6 inhibitor or participated in a clinical trial with a cdk 4 and 6 inhibitor and the treatment administered is not known.
boolean
C1564584 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C2348568 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
are currently receiving treatment in a clinical trial involving an investigational product or non-approved use of a drug or device.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
CNS metastases Unstable
Item
have the presence of unstable central nervous system (cns) metastasis.
boolean
C0686377 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,2])
Major surgery | Exception Biopsy
Item
have had major surgery (excluding biopsy) < 28 days of the initial dose of study drug.
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C1705847 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])