ID

32583

Beschreibung

Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01192243

Link

https://clinicaltrials.gov/show/NCT01192243

Stichworte

Versionen (1)
  1. 07.11.18 07.11.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. November 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Toxicity NCT01192243

Englisch

Eligibility Toxicity NCT01192243

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Toxicity NCT01192243
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who were diagnosed by the histologic, cytologic diagnosis of iv non-small cell lung cancer
Beschreibung

Non-Small Cell Lung Carcinoma TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
age from 18 to 70 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
at least one target lesion diameter spiral ct ≥ 1 cm, or the common ct ≥ 2 cm, and can be measured by imaging tools
Beschreibung

Target Lesion Quantity Diameter Spiral CT | Target Lesion Quantity Diameter CT | Measurable lesion Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1301886
UMLS CUI [1,4]
C0860888
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1301886
UMLS CUI [2,4]
C0040405
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0079595
ecog 0-1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
expected life time longer than 12 weeks
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
normal laboratory values:
Beschreibung

Normal Laboratory Test Result

Datentyp

boolean

Alias
UMLS CUI [1]
C0438214
leucocyte≥ 4×109/l neutrophil≥ 1.5×109/l platelet≥100×109/l hemoglobin≥ 10g/l alt and ast
Beschreibung

White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201899
≤2.5×uln (≤5×uln if liver metastasis)
Beschreibung

Relationship Secondary malignant neoplasm of liver

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0494165
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients have not used drugs according to protocol
Beschreibung

Pharmaceutical Preparations Inconsistent Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C2348563
patients were allergic to pemetrexed or cisplatin
Beschreibung

Hypersensitivity Pemetrexed | Cisplatin allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0210657
UMLS CUI [2]
C0570702
patients received radiotherapy or other biological treatment 4 weeks before the trial
Beschreibung

Therapeutic radiology procedure | Biological treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C1531518
uncontrolled hydrothorax or hydropericardium
Beschreibung

Hydrothorax Uncontrolled | Hydropericardium Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020312
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0349077
UMLS CUI [2,2]
C0205318
neuropathy toxicity ≥ ctc 3
Beschreibung

Neuropathy Toxicity CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0600688
UMLS CUI [1,3]
C1516728
severe symptomatic heart disease
Beschreibung

Heart Disease Symptomatic Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0205082
active upper gastrointestinal ulcer or digestive disfunction
Beschreibung

Peptic Ulcer Upper Gastrointestinal Tract | Dysfunction Digestive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030920
UMLS CUI [1,2]
C3203348
UMLS CUI [2,1]
C3887504
UMLS CUI [2,2]
C0012238
severe infection or metabolic disfunction
Beschreibung

Communicable Disease Severe | Dysfunction Metabolic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C3887504
UMLS CUI [2,2]
C0311400
patients with other malignant tumor
Beschreibung

Cancer Other

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
uncontrolled brain metastases
Beschreibung

Metastatic malignant neoplasm to brain Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205318
patients have accepted other clinical trials
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
female patients during their pregnant and lactation period, or patients without contraception
Beschreibung

Pregnancy | Breast Feeding | Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0332197
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Toxicity NCT01192243

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Toxicity NCT01192243
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
patients who were diagnosed by the histologic, cytologic diagnosis of iv non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Age
Item
age from 18 to 70 years old
boolean
C0001779 (UMLS CUI [1])
Target Lesion Quantity Diameter Spiral CT | Target Lesion Quantity Diameter CT | Measurable lesion Imaging
Item
at least one target lesion diameter spiral ct ≥ 1 cm, or the common ct ≥ 2 cm, and can be measured by imaging tools
boolean
C2986546 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0860888 (UMLS CUI [1,4])
C2986546 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0040405 (UMLS CUI [2,4])
C1513041 (UMLS CUI [3,1])
C0079595 (UMLS CUI [3,2])
ECOG performance status
Item
ecog 0-1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
expected life time longer than 12 weeks
boolean
C0023671 (UMLS CUI [1])
Normal Laboratory Test Result
Item
normal laboratory values:
boolean
C0438214 (UMLS CUI [1])
White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
leucocyte≥ 4×109/l neutrophil≥ 1.5×109/l platelet≥100×109/l hemoglobin≥ 10g/l alt and ast
boolean
C0023508 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
Relationship Secondary malignant neoplasm of liver
Item
≤2.5×uln (≤5×uln if liver metastasis)
boolean
C0439849 (UMLS CUI [1,1])
C0494165 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Inconsistent Study Protocol
Item
patients have not used drugs according to protocol
boolean
C0013227 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Hypersensitivity Pemetrexed | Cisplatin allergy
Item
patients were allergic to pemetrexed or cisplatin
boolean
C0020517 (UMLS CUI [1,1])
C0210657 (UMLS CUI [1,2])
C0570702 (UMLS CUI [2])
Therapeutic radiology procedure | Biological treatment
Item
patients received radiotherapy or other biological treatment 4 weeks before the trial
boolean
C1522449 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
Hydrothorax Uncontrolled | Hydropericardium Uncontrolled
Item
uncontrolled hydrothorax or hydropericardium
boolean
C0020312 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0349077 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Neuropathy Toxicity CTCAE Grades
Item
neuropathy toxicity ≥ ctc 3
boolean
C0442874 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Heart Disease Symptomatic Severe
Item
severe symptomatic heart disease
boolean
C0018799 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Peptic Ulcer Upper Gastrointestinal Tract | Dysfunction Digestive
Item
active upper gastrointestinal ulcer or digestive disfunction
boolean
C0030920 (UMLS CUI [1,1])
C3203348 (UMLS CUI [1,2])
C3887504 (UMLS CUI [2,1])
C0012238 (UMLS CUI [2,2])
Communicable Disease Severe | Dysfunction Metabolic
Item
severe infection or metabolic disfunction
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3887504 (UMLS CUI [2,1])
C0311400 (UMLS CUI [2,2])
Cancer Other
Item
patients with other malignant tumor
boolean
C1707251 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Uncontrolled
Item
uncontrolled brain metastases
boolean
C0220650 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Study Subject Participation Status
Item
patients have accepted other clinical trials
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding | Contraceptive methods Absent
Item
female patients during their pregnant and lactation period, or patients without contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Zum Seitenanfang zurückkehren 

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