ID

24735

Beschreibung

A Study of Mapatumumab in Combination With Paclitaxel and Carboplatin in Subjects With Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00583830

Link

https://clinicaltrials.gov/show/NCT00583830

Stichworte

  1. 15.08.17 15.08.17 -
Hochgeladen am

15. August 2017

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Non Small Cell Lung Cancer NCT00583830

Eligibility Non Small Cell Lung Cancer NCT00583830

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically or cytologically confirmed stage iiib or stage iv advanced primary non-small cell lung cancinoma
Beschreibung

Non-Small Cell Lung Carcinoma Primary Advanced TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0205179
UMLS CUI [1,4]
C3258246
age 18 years or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat lung cancer
Beschreibung

Investigational New Drugs Carcinoma of lung | Pharmaceutical Preparations Carcinoma of lung

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0684249
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0684249
received radiation therapy within 4 weeks before randomization
Beschreibung

Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
major surgery within 4 weeks before randomization
Beschreibung

Major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
minor surgery within 2 weeks before randomizaiton
Beschreibung

Minor Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0038904
systemic steroids within 1 week before randomization
Beschreibung

systemic steroids

Datentyp

boolean

Alias
UMLS CUI [1]
C2825233
any grade 2 or greater neuropathy
Beschreibung

Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
history of severe (grade 4) hypersensitivity reaction to products containing cremophor el (cyclosporine, teniposide)
Beschreibung

Hypersensitivity Product Containing Cremophor EL | Hypersensitivity Severe CTCAE Grades | Hypersensitivity Cyclosporine | Hypersensitivity Teniposide

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1514468
UMLS CUI [1,3]
C0332256
UMLS CUI [1,4]
C0056476
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1516728
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0010592
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0039512
history of any infection requiring hospitalization or antibiotics within 2 weeks before randomization
Beschreibung

Communicable Disease Hospitalization Required | Communicable Disease Requirement Antibiotics

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1708385
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003232
known brain or spinal cord metastases
Beschreibung

Metastatic malignant neoplasm to brain | Secondary malignant neoplasm of spinal cord

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0347016
history of other cancers within 5 years before randomization
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
known hiv, hepatitis-b or hepatitis-c infection
Beschreibung

HIV Infection | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
pregnant or breast-feeding women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previously treated with mapatumumab
Beschreibung

mapatumumab

Datentyp

boolean

Alias
UMLS CUI [1]
C1665688

Ähnliche Modelle

Eligibility Non Small Cell Lung Cancer NCT00583830

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Primary Advanced TNM clinical staging
Item
patients with histologically or cytologically confirmed stage iiib or stage iv advanced primary non-small cell lung cancinoma
boolean
C0007131 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
Age
Item
age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs Carcinoma of lung | Pharmaceutical Preparations Carcinoma of lung
Item
received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat lung cancer
boolean
C0013230 (UMLS CUI [1,1])
C0684249 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0684249 (UMLS CUI [2,2])
Therapeutic radiology procedure
Item
received radiation therapy within 4 weeks before randomization
boolean
C1522449 (UMLS CUI [1])
Major surgery
Item
major surgery within 4 weeks before randomization
boolean
C0679637 (UMLS CUI [1])
Minor Surgical Procedures
Item
minor surgery within 2 weeks before randomizaiton
boolean
C0038904 (UMLS CUI [1])
systemic steroids
Item
systemic steroids within 1 week before randomization
boolean
C2825233 (UMLS CUI [1])
Neuropathy CTCAE Grades
Item
any grade 2 or greater neuropathy
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hypersensitivity Product Containing Cremophor EL | Hypersensitivity Severe CTCAE Grades | Hypersensitivity Cyclosporine | Hypersensitivity Teniposide
Item
history of severe (grade 4) hypersensitivity reaction to products containing cremophor el (cyclosporine, teniposide)
boolean
C0020517 (UMLS CUI [1,1])
C1514468 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0056476 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0010592 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0039512 (UMLS CUI [4,2])
Communicable Disease Hospitalization Required | Communicable Disease Requirement Antibiotics
Item
history of any infection requiring hospitalization or antibiotics within 2 weeks before randomization
boolean
C0009450 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003232 (UMLS CUI [2,3])
Metastatic malignant neoplasm to brain | Secondary malignant neoplasm of spinal cord
Item
known brain or spinal cord metastases
boolean
C0220650 (UMLS CUI [1])
C0347016 (UMLS CUI [2])
Malignant Neoplasms
Item
history of other cancers within 5 years before randomization
boolean
C0006826 (UMLS CUI [1])
HIV Infection | Hepatitis B | Hepatitis C
Item
known hiv, hepatitis-b or hepatitis-c infection
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
mapatumumab
Item
previously treated with mapatumumab
boolean
C1665688 (UMLS CUI [1])

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