ID

24735

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00583830

Nyckelord

Versioner (1)
  1. 2017-08-15 2017-08-15 -
Uppladdad den

15 augusti 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT00583830

Engelsk

Eligibility Non Small Cell Lung Cancer NCT00583830

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Non-Small Cell Lung Carcinoma Primary Advanced TNM clinical staging

Datatyp

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
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

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

Datatyp

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
Beskrivning

Therapeutic radiology procedure

Datatyp

boolean

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

Major surgery

Datatyp

boolean

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

Minor Surgical Procedures

Datatyp

boolean

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

systemic steroids

Datatyp

boolean

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

Neuropathy CTCAE Grades

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Communicable Disease Hospitalization Required | Communicable Disease Requirement Antibiotics

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

Malignant Neoplasms

Datatyp

boolean

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

HIV Infection | Hepatitis B | Hepatitis C

Datatyp

boolean

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

Pregnancy | Breast Feeding

Datatyp

boolean

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

mapatumumab

Datatyp

boolean

Alias
UMLS CUI [1]
C1665688
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Similar models

Eligibility Non Small Cell Lung Cancer NCT00583830

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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