ID

30424

Descrição

Aflibercept and Standard Chemotherapy (R-CHOP) in First Line of Non Hodgkin B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00644124

Link

https://clinicaltrials.gov/show/NCT00644124

Palavras-chave

Versões (1)
  1. 04/06/2018 04/06/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

4 de junho de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Lymphoma, Non-Hodgkin NCT00644124

Inglês

Eligibility Lymphoma, Non-Hodgkin NCT00644124

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with non-hodgkin b-cell lymphoma, good condition, not previously treated
Descrição

B-Cell Lymphomas | Patient condition is good | Prior Therapy Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079731
UMLS CUI [2]
C2051434
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindication to any drug contained in the r-chop (rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone +/- intrathecal methotrexate)
Descrição

Medical contraindication R-CHOP | Medical contraindication Rituximab | Medical contraindication Cyclophosphamide | Medical contraindication Doxorubicin | Medical contraindication Vincristine | Medical contraindication Prednisone | Medical contraindication Methotrexate Intrathecal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0393023
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0393022
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0010583
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0013089
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0042679
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0032952
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0025677
UMLS CUI [7,3]
C0677897
less than 42 days elapsed from prior major surgery (28 days from other prior surgery) to the time of inclusion
Descrição

Major surgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0679637
cerebral or leptomeningeal involvement.
Descrição

Involvement cerebral | Involvement Leptomeningeal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C0006104
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0521401
history of another neoplasm (adequately treated basal cell or squamous cell skin cancers, carcinoma in situ of the cervix, or any other cancer from which the patient has been disease free for > 5 years are allowed)
Descrição

Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Malignant Neoplasms Disease Free of

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0006826
UMLS CUI [5,3]
C0012634
UMLS CUI [5,4]
C0332296
participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to the first drug intake
Descrição

Study Subject Participation Status | Therapies, Investigational | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
UMLS CUI [3]
C0013230
any acute or chronic medical condition, which could impair the ability of the patient to participate to the study or could interfere with interpretation of study results
Descrição

Medical condition Impairing Study Subject Participation Status | Medical condition chronic Impairing Study Subject Participation Status | Medical condition Interferes with Interpretation Research results | Medical condition chronic Interferes with Interpretation Research results

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0221099
UMLS CUI [2,4]
C2348568
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0683954
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0205191
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C0459471
UMLS CUI [4,5]
C0683954
uncontrolled diabetes mellitus
Descrição

Diabetic - poor control

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0421258
uncontrolled hypertension
Descrição

Uncontrolled hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1868885
abnormal kidney function
Descrição

Abnormal renal function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151746
evidence of clinically significant bleeding diathesis, non-healing wound or underlying coagulopathy
Descrição

Bleeding tendency | Wound, non-healing | Blood Coagulation Disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0750433
UMLS CUI [3]
C0005779
pregnant or breast-feeding woman, or patient with reproductive potential (male, female) without an effective method of contraception
Descrição

Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
history of hypersensitivity to any trap agents or recombinant proteins
Descrição

Hypersensitivity TRAP | Hypersensitivity Recombinant Proteins

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0297331
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0034861
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Similar models

Eligibility Lymphoma, Non-Hodgkin NCT00644124

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
B-Cell Lymphomas | Patient condition is good | Prior Therapy Absent
Item
patients with non-hodgkin b-cell lymphoma, good condition, not previously treated
boolean
C0079731 (UMLS CUI [1])
C2051434 (UMLS CUI [2])
C1514463 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication R-CHOP | Medical contraindication Rituximab | Medical contraindication Cyclophosphamide | Medical contraindication Doxorubicin | Medical contraindication Vincristine | Medical contraindication Prednisone | Medical contraindication Methotrexate Intrathecal
Item
contraindication to any drug contained in the r-chop (rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone +/- intrathecal methotrexate)
boolean
C1301624 (UMLS CUI [1,1])
C0393023 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0393022 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0010583 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0013089 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C0042679 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0032952 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0025677 (UMLS CUI [7,2])
C0677897 (UMLS CUI [7,3])
Major surgery
Item
less than 42 days elapsed from prior major surgery (28 days from other prior surgery) to the time of inclusion
boolean
C0679637 (UMLS CUI [1])
Involvement cerebral | Involvement Leptomeningeal
Item
cerebral or leptomeningeal involvement.
boolean
C1314939 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
C1314939 (UMLS CUI [2,1])
C0521401 (UMLS CUI [2,2])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Malignant Neoplasms Disease Free of
Item
history of another neoplasm (adequately treated basal cell or squamous cell skin cancers, carcinoma in situ of the cervix, or any other cancer from which the patient has been disease free for > 5 years are allowed)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C0012634 (UMLS CUI [5,3])
C0332296 (UMLS CUI [5,4])
Study Subject Participation Status | Therapies, Investigational | Investigational New Drugs
Item
participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to the first drug intake
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Medical condition Impairing Study Subject Participation Status | Medical condition chronic Impairing Study Subject Participation Status | Medical condition Interferes with Interpretation Research results | Medical condition chronic Interferes with Interpretation Research results
Item
any acute or chronic medical condition, which could impair the ability of the patient to participate to the study or could interfere with interpretation of study results
boolean
C3843040 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0221099 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C0459471 (UMLS CUI [4,4])
C0683954 (UMLS CUI [4,5])
Diabetic - poor control
Item
uncontrolled diabetes mellitus
boolean
C0421258 (UMLS CUI [1])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Abnormal renal function
Item
abnormal kidney function
boolean
C0151746 (UMLS CUI [1])
Bleeding tendency | Wound, non-healing | Blood Coagulation Disorder
Item
evidence of clinically significant bleeding diathesis, non-healing wound or underlying coagulopathy
boolean
C1458140 (UMLS CUI [1])
C0750433 (UMLS CUI [2])
C0005779 (UMLS CUI [3])
Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods Absent
Item
pregnant or breast-feeding woman, or patient with reproductive potential (male, female) without an effective method of contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Hypersensitivity TRAP | Hypersensitivity Recombinant Proteins
Item
history of hypersensitivity to any trap agents or recombinant proteins
boolean
C0020517 (UMLS CUI [1,1])
C0297331 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0034861 (UMLS CUI [2,2])
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