ID

24735

Beschrijving

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

Trefwoorden

  1. 15-08-17 15-08-17 -
Geüploaded op

15 augustus 2017

DOI

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Licentie

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
Beschrijving

Inclusion Criteria

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

Non-Small Cell Lung Carcinoma Primary Advanced TNM clinical staging

Datatype

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
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

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

Datatype

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
Beschrijving

Therapeutic radiology procedure

Datatype

boolean

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

Major surgery

Datatype

boolean

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

Minor Surgical Procedures

Datatype

boolean

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

systemic steroids

Datatype

boolean

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

Neuropathy CTCAE Grades

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

Communicable Disease Hospitalization Required | Communicable Disease Requirement Antibiotics

Datatype

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
Beschrijving

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

Datatype

boolean

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

Malignant Neoplasms

Datatype

boolean

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

HIV Infection | Hepatitis B | Hepatitis C

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

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

mapatumumab

Datatype

boolean

Alias
UMLS CUI [1]
C1665688

Similar models

Eligibility Non Small Cell Lung Cancer NCT00583830

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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