ID

21632

Description

Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL; ODM derived from: https://clinicaltrials.gov/show/NCT00379574

Lien

https://clinicaltrials.gov/show/NCT00379574

Mots-clés

Versions (1)
  1. 27/04/2017 27/04/2017 -
Téléchargé le

27 avril 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Lymphoma, Large-Cell, Diffuse NCT00379574

Anglais

Eligibility Lymphoma, Large-Cell, Diffuse NCT00379574

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed dlbcl
Description

Diffuse Large B-Cell Lymphoma

Type de données

boolean

Alias
UMLS CUI [1]
C0079744
age 70 years or less
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
previously untreated
Description

Untreated

Type de données

boolean

Alias
UMLS CUI [1]
C0332155
performance status: ecog 0-2
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
advanced stage: stage iii, iv, or non-contiguous stage ii
Description

advanced disease Ann Arbor lymphoma staging system | Non-Contiguous Disease Ann Arbor lymphoma staging system

Type de données

boolean

Alias
UMLS CUI [1,1]
C0679246
UMLS CUI [1,2]
C0432516
UMLS CUI [2,1]
C1518352
UMLS CUI [2,2]
C0432516
measurable disease: 1 cm or more by spiral ct
Description

Measurable Disease Diameter Spiral CT

Type de données

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0860888
normal liver function
Description

Liver function

Type de données

boolean

Alias
UMLS CUI [1]
C0232741
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
platelet count less than 75,000/microl within 14 days before enrollment.
Description

Platelet Count measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0032181
absolute neutrophil count of less than 1,500/microll within 14 days before enrollment.
Description

Absolute neutrophil count

Type de données

boolean

Alias
UMLS CUI [1]
C0948762
cr more than 2.0 mg/dl and/or calculated or measured creatinine clearance less than 50 ml/min within 14 days before enrollment.
Description

Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
UMLS CUI [3]
C0373595
peripheral neuropathy of grade 2 or worse within 14 days before enrollment.
Description

Peripheral Neuropathy CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
hypersensitivity to bortezomib, boron or mannitol.
Description

Hypersensitivity bortezomib | Hypersensitivity Boron | Hypersensitivity Mannitol

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0006030
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0024730
female subject is pregnant or breast-feeding.
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
other investigational drugs with 14 days before enrollment
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Description

Illness Serious Interferes with Study Subject Participation Status | Serious mental illness Interferes with Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C3841614
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
uncontrolled or severe cardiovascular disease, including mi within 6 months of enrolment, new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
Description

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina control - poor | Disorder of pericardium | Cardiac amyloidosis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C1275491
UMLS CUI [5]
C0421196
UMLS CUI [6]
C0265122
UMLS CUI [7]
C0268407
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Similar models

Eligibility Lymphoma, Large-Cell, Diffuse NCT00379574

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse Large B-Cell Lymphoma
Item
histologically confirmed dlbcl
boolean
C0079744 (UMLS CUI [1])
Age
Item
age 70 years or less
boolean
C0001779 (UMLS CUI [1])
Untreated
Item
previously untreated
boolean
C0332155 (UMLS CUI [1])
ECOG performance status
Item
performance status: ecog 0-2
boolean
C1520224 (UMLS CUI [1])
advanced disease Ann Arbor lymphoma staging system | Non-Contiguous Disease Ann Arbor lymphoma staging system
Item
advanced stage: stage iii, iv, or non-contiguous stage ii
boolean
C0679246 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
C1518352 (UMLS CUI [2,1])
C0432516 (UMLS CUI [2,2])
Measurable Disease Diameter Spiral CT
Item
measurable disease: 1 cm or more by spiral ct
boolean
C1513041 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0860888 (UMLS CUI [1,3])
Liver function
Item
normal liver function
boolean
C0232741 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Platelet Count measurement
Item
platelet count less than 75,000/microl within 14 days before enrollment.
boolean
C0032181 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count of less than 1,500/microll within 14 days before enrollment.
boolean
C0948762 (UMLS CUI [1])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement
Item
cr more than 2.0 mg/dl and/or calculated or measured creatinine clearance less than 50 ml/min within 14 days before enrollment.
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy of grade 2 or worse within 14 days before enrollment.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hypersensitivity bortezomib | Hypersensitivity Boron | Hypersensitivity Mannitol
Item
hypersensitivity to bortezomib, boron or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0006030 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0024730 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
female subject is pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
other investigational drugs with 14 days before enrollment
boolean
C0013230 (UMLS CUI [1])
Illness Serious Interferes with Study Subject Participation Status | Serious mental illness Interferes with Study Subject Participation Status
Item
serious medical or psychiatric illness likely to interfere with participation in this clinical study.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3841614 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina control - poor | Disorder of pericardium | Cardiac amyloidosis
Item
uncontrolled or severe cardiovascular disease, including mi within 6 months of enrolment, new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0421196 (UMLS CUI [5])
C0265122 (UMLS CUI [6])
C0268407 (UMLS CUI [7])
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