ID

36605

Description

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

Keywords

Versions (1)
  1. 5/26/19 5/26/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 26, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT02062515

English

Eligibility Non-small Cell Lung Cancer NCT02062515

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed diagnosis of iiib/iv stage nsclc patients who are not suitable for surgery or radiotherapy
Description

Non-Small Cell Lung Carcinoma TNM clinical staging | Patients Inappropriate Operative Surgical Procedures | Patients Inappropriate Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0543467
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C1522449
ecog performance status points (ps) is 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
liver function:
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
a (mild hepatic dysfunction):
Description

Liver dysfunction, mild

Data type

boolean

Alias
UMLS CUI [1]
C3279149
a1) total bilirubin within normal limit (uln), while ast> uln;
Description

Serum bilirubin normal | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0428443
UMLS CUI [2]
C0151904
a2) total bilirubin within1.0-1 .5 × uln;
Description

Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0741494
b (moderate hepatic dysfunction): total bilirubin within1.5-3 .0 × uln
Description

Liver Dysfunction Moderate | Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205081
UMLS CUI [2]
C0741494
no malabsorption or other gastrointestinal disorders effecting drug absorption
Description

Malabsorption Absent | Absence Gastrointestinal Disease Effect Drug absorption

Data type

boolean

Alias
UMLS CUI [1,1]
C3714745
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0017178
UMLS CUI [2,3]
C1280500
UMLS CUI [2,4]
C0678745
life expectancy: more than 12 weeks.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous usage of her/egfr inhibitors or other target molecule drugs ( small molecule drugs or monoclonal antibody therapy )
Description

HER2 Inhibitor | EGFR inhibitor | Target Molecule Agent | Small Molecule Agent | Monoclonal Antibody Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C1999216
UMLS CUI [2]
C1443775
UMLS CUI [3,1]
C1521840
UMLS CUI [3,2]
C0567416
UMLS CUI [3,3]
C1254351
UMLS CUI [4,1]
C1328819
UMLS CUI [4,2]
C1254351
UMLS CUI [5]
C0279694
patients requires liver shunt , stent placement, or radiotherapy when 2 weeks before the start of the study or research process .
Description

Patient need for Liver Shunt | Patient need for Placement of stent | Patient need for Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0542331
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0522776
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C1522449
patients with active hepatitis and cirrhosis.
Description

Hepatitis | Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0023890
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Similar models

Eligibility Non-small Cell Lung Cancer NCT02062515

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
Life Expectancy
Item
life expectancy: more than 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
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])
Hepatitis | Liver Cirrhosis
Item
patients with active hepatitis and cirrhosis.
boolean
C0019158 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
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