Informações:
Falhas:
ID
36605
Descrição
Icotinib in Advanced Non-small Cell Lung Cancer (NSCLC) With Hepatic Insufficiency; ODM derived from: https://clinicaltrials.gov/show/NCT02062515
Link
https://clinicaltrials.gov/show/NCT02062515
Palavras-chave
Versões (1)
- 26/05/2019 26/05/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
26 de maio de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT02062515
Eligibility Non-small Cell Lung Cancer NCT02062515
- StudyEvent: Eligibility
Similar models
Eligibility Non-small Cell Lung Cancer NCT02062515
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Non-Small Cell Lung Carcinoma TNM clinical staging | Patients Inappropriate Operative Surgical Procedures | Patients Inappropriate Therapeutic radiology procedure
Item
histologically or cytologically confirmed diagnosis of iiib/iv stage nsclc patients who are not suitable for surgery or radiotherapy
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
C3258246 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
ECOG performance status
Item
ecog performance status points (ps) is 0-2
boolean
C1520224 (UMLS CUI [1])
Liver function
Item
liver function:
boolean
C0232741 (UMLS CUI [1])
Liver dysfunction, mild
Item
a (mild hepatic dysfunction):
boolean
C3279149 (UMLS CUI [1])
Serum bilirubin normal | Aspartate aminotransferase increased
Item
a1) total bilirubin within normal limit (uln), while ast> uln;
boolean
C0428443 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151904 (UMLS CUI [2])
Elevated total bilirubin
Item
a2) total bilirubin within1.0-1 .5 × uln;
boolean
C0741494 (UMLS CUI [1])
Liver Dysfunction Moderate | Elevated total bilirubin
Item
b (moderate hepatic dysfunction): total bilirubin within1.5-3 .0 × uln
boolean
C0086565 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0741494 (UMLS CUI [2])
C0205081 (UMLS CUI [1,2])
C0741494 (UMLS CUI [2])
Malabsorption Absent | Absence Gastrointestinal Disease Effect Drug absorption
Item
no malabsorption or other gastrointestinal disorders effecting drug absorption
boolean
C3714745 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0017178 (UMLS CUI [2,2])
C1280500 (UMLS CUI [2,3])
C0678745 (UMLS CUI [2,4])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0017178 (UMLS CUI [2,2])
C1280500 (UMLS CUI [2,3])
C0678745 (UMLS CUI [2,4])
Life Expectancy
Item
life expectancy: more than 12 weeks.
boolean
C0023671 (UMLS CUI [1])
HER2 Inhibitor | EGFR inhibitor | Target Molecule Agent | Small Molecule Agent | Monoclonal Antibody Therapy
Item
previous usage of her/egfr inhibitors or other target molecule drugs ( small molecule drugs or monoclonal antibody therapy )
boolean
C0069515 (UMLS CUI [1,1])
C1999216 (UMLS CUI [1,2])
C1443775 (UMLS CUI [2])
C1521840 (UMLS CUI [3,1])
C0567416 (UMLS CUI [3,2])
C1254351 (UMLS CUI [3,3])
C1328819 (UMLS CUI [4,1])
C1254351 (UMLS CUI [4,2])
C0279694 (UMLS CUI [5])
C1999216 (UMLS CUI [1,2])
C1443775 (UMLS CUI [2])
C1521840 (UMLS CUI [3,1])
C0567416 (UMLS CUI [3,2])
C1254351 (UMLS CUI [3,3])
C1328819 (UMLS CUI [4,1])
C1254351 (UMLS CUI [4,2])
C0279694 (UMLS CUI [5])
Patient need for Liver Shunt | Patient need for Placement of stent | Patient need for Therapeutic radiology procedure
Item
patients requires liver shunt , stent placement, or radiotherapy when 2 weeks before the start of the study or research process .
boolean
C0686904 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0542331 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0522776 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C0023884 (UMLS CUI [1,2])
C0542331 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0522776 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
Hepatitis | Liver Cirrhosis
Item
patients with active hepatitis and cirrhosis.
boolean
C0019158 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0023890 (UMLS CUI [2])