ID

21536

Descrição

Non-randomized Safety Study With Bortezomib/Rituximab in Relapsed/Refractory Indolent Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00509379

Link

https://clinicaltrials.gov/show/NCT00509379

Palavras-chave

Versões (1)
  1. 26/04/2017 26/04/2017 -
Transferido a

26 de abril de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00509379

Inglês

Eligibility Lymphoma NCT00509379

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00509379
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with naïve or sensitive rituximab indolent non-follicular and mantle cell non-hodgkin's lymphoma disease that had failed to respond or relapsed after primary therapy. there is a demonstrated progressive disease requiring further treatment. histological subtype included into the study are are as follows small lymphocytic/lymphoplasmocytic lymphoma; nodal marginal zone lymphoma (malt lymphoma are excluded) splenic marginal zone lymphoma mantle cell lymphoma a lymphnode biopsy is advisable if it is not harmful for the patients, before enrollment of the patient into the study in order to confirm diagnosis and to rule out histologic transformation. lymphnode biopsy should be performed within 6 months before study entry.
Descrição

Non-follicular lymphoma indolent | Mantle cell lymphoma | rituximab | Disease Therapy naive | Disease Therapy Sensitive | Absent response to treatment | Relapse Post First line treatment | Progressive Disease Requirement Additional Therapy | Small Lymphocytic Lymphoma | Monocytoid B-cell lymphoma | MALT Lymphoma Excluded | Splenic Marginal Zone B-Cell Lymphoma | Biopsy of lymph node | Cell transformation Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2853945
UMLS CUI [1,2]
C0234227
UMLS CUI [2]
C0334634
UMLS CUI [3]
C0393022
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0919936
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0087111
UMLS CUI [5,3]
C0332324
UMLS CUI [6]
C0438286
UMLS CUI [7,1]
C0277556
UMLS CUI [7,2]
C0687676
UMLS CUI [7,3]
C1708063
UMLS CUI [8,1]
C1335499
UMLS CUI [8,2]
C1514873
UMLS CUI [8,3]
C1706712
UMLS CUI [9]
C0855095
UMLS CUI [10]
C0855139
UMLS CUI [11,1]
C0242647
UMLS CUI [11,2]
C2828389
UMLS CUI [12]
C0349632
UMLS CUI [13]
C0193842
UMLS CUI [14,1]
C0040682
UMLS CUI [14,2]
C2828389
2. age >18-75
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
3. relapse or failure to respond after one or more (maximum three) lines of chemotherapy
Descrição

Chemotherapy Quantity Absent response to treatment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0438286
4. any type of prior chemotherapy, rituximab included. patients who had received high dose chemotherapy and asct can be enrolled into the study
Descrição

Chemotherapy | rituximab | High-Dose Chemotherapy with Autologous Stem Cell Transplant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0393022
UMLS CUI [3]
C1512429
5. naïve or sensitive rituximab disease. if the patient received rituximab, he/she must have responded and the ttp from the last dose to rituximab must have been 6 months or more.
Descrição

rituximab | Disease Therapy naive | Disease Therapy Sensitive | Disease Response | Thrombotic Thrombocytopenic Purpura Duration

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0393022
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0919936
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0332324
UMLS CUI [4]
C1704632
UMLS CUI [5,1]
C0034155
UMLS CUI [5,2]
C0449238
6. measurable and/or evaluable disease.
Descrição

Measurable Disease | Evaluable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
7. adequate haematological counts: anc> 1.0 x 109/l and plt counts> 75 x 109/l unless due to bone marrow involvement by lymphoma.
Descrição

Hematologic function | Absolute neutrophil count | Platelet Count measurement | Absolute neutrophil count Due to Lymphoma involves bone marrow | Platelet Count Due to Lymphoma involves bone marrow

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4,1]
C0948762
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C1301440
UMLS CUI [5,1]
C1287267
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C1301440
8. conjugated bilirubin up to 2 x uln.
Descrição

Bilirubin conjugated increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0855625
9. alkaline phosphatase and transaminases up to 2 x uln.
Descrição

Alkaline phosphatase raised | Transaminases increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151849
UMLS CUI [2]
C0438717
10. creatinine clearances> 30 m/min.
Descrição

Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
11. non peripheral neuropathy or cns disease.
Descrição

Peripheral Neuropathy Absent | CNS disorder Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0007682
UMLS CUI [2,2]
C0332197
12. life expectancy> 6 months.
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
13. performance status< 2 according to ecog scale.
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
14. written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. has known or suspected hypersensitivity or intolerance to rituximab, boron, mannitol, or heparin, if an indwelling catheter is used
Descrição

Hypersensitivity rituximab | Hypersensitivity Boron | Hypersensitivity Mannitol | Hypersensitivity Heparin | intolerance to rituximab | intolerance to Boron | intolerance to Mannitol | intolerance to Heparin | Indwelling Catheter Use of

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0393022
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0006030
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0024730
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0019134
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0393022
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0006030
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0024730
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0019134
UMLS CUI [9,1]
C0007439
UMLS CUI [9,2]
C1524063
2. history of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
Descrição

Hepatic Insufficiency | Renal Insufficiency | Heart Diseases | Vascular Diseases | Lung diseases | Gastrointestinal Diseases | Endocrine System Diseases | nervous system disorder | Rheumatologic disorder | Hematological Disease | Mental disorders | Metabolic Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0042373
UMLS CUI [5]
C0024115
UMLS CUI [6]
C0017178
UMLS CUI [7]
C0014130
UMLS CUI [8]
C0027765
UMLS CUI [9]
C0009326
UMLS CUI [10]
C0018939
UMLS CUI [11]
C0004936
UMLS CUI [12]
C0025517
3. uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug
Descrição

Diabetic - poor control | Antidiabetics Dose Stable

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
4. uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, new york heart association (nyha) class iii or iv heart failure (attachment 5, nyha classification of cardiac disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
Descrição

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

Tipo de dados

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
5. history of hypotension or has decreased blood pressure (sitting systolic blood pressure sbp 100 mmhg and/or sitting diastolic blood pressure dbp 60 mmhg)
Descrição

Hypotension | Decreased Blood Pressure | Sitting systolic blood pressure | Sitting diastolic blood pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C2917141
UMLS CUI [3]
C1319893
UMLS CUI [4]
C1319894
6. pregnant or breastfeeding
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. peripheral neuropathy or neuropathic pain grade 2
Descrição

Peripheral Neuropathy CTCAE Grades | Neuropathic pain CTCAE Grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C3714625
UMLS CUI [2,2]
C1516728
8. hiv positivity
Descrição

HIV Seropositivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
9. hbv positivity with the exception of patients with hbvcab +, hbsag -, hbs ab+/- with hbv-dna negative
Descrição

Hepatitis B virus test positive | Hepatitis B core antibody positive | Hepatitis B surface antigen negative | Hepatitis B Virus Surface Antibody Positive | Hepatitis B Virus Surface Antibody Negative | Hbv DNA Test Negative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2748184
UMLS CUI [2]
C0262506
UMLS CUI [3]
C0919711
UMLS CUI [4,1]
C0369334
UMLS CUI [4,2]
C1514241
UMLS CUI [5,1]
C0369334
UMLS CUI [5,2]
C1513916
UMLS CUI [6,1]
C1256114
UMLS CUI [6,2]
C1513916
10. hcv positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
Descrição

Hepatitis C virus test positive | Chronic Hepatitis Signs Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2748185
UMLS CUI [2,1]
C0019189
UMLS CUI [2,2]
C0311392
UMLS CUI [2,3]
C0332197
11. active opportunistic infection
Descrição

Opportunistic Infections

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029118
12. receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks before enrollment
Descrição

Extensive Radiation | Systemic Chemotherapy | cancer treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1517030
UMLS CUI [2]
C1883256
UMLS CUI [3]
C0920425
13. exposure to rituximab within 24 weeks before screening
Descrição

rituximab Exposure to

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0393022
UMLS CUI [1,2]
C0332157
14. have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study.
Descrição

Investigational New Drugs | Investigational Medical Device | Study Subject Participation Status Interference Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0332197
15. any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
Descrição

Comorbidity Study Subject Participation Status Exclusion | Mental condition Study Subject Participation Status Exclusion | Comorbidity compromises Informed Consent | Mental condition compromises Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C2828389
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C0021430
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Similar models

Eligibility Lymphoma NCT00509379

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00509379
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Non-follicular lymphoma indolent | Mantle cell lymphoma | rituximab | Disease Therapy naive | Disease Therapy Sensitive | Absent response to treatment | Relapse Post First line treatment | Progressive Disease Requirement Additional Therapy | Small Lymphocytic Lymphoma | Monocytoid B-cell lymphoma | MALT Lymphoma Excluded | Splenic Marginal Zone B-Cell Lymphoma | Biopsy of lymph node | Cell transformation Excluded
Item
1. patients with naïve or sensitive rituximab indolent non-follicular and mantle cell non-hodgkin's lymphoma disease that had failed to respond or relapsed after primary therapy. there is a demonstrated progressive disease requiring further treatment. histological subtype included into the study are are as follows small lymphocytic/lymphoplasmocytic lymphoma; nodal marginal zone lymphoma (malt lymphoma are excluded) splenic marginal zone lymphoma mantle cell lymphoma a lymphnode biopsy is advisable if it is not harmful for the patients, before enrollment of the patient into the study in order to confirm diagnosis and to rule out histologic transformation. lymphnode biopsy should be performed within 6 months before study entry.
boolean
C2853945 (UMLS CUI [1,1])
C0234227 (UMLS CUI [1,2])
C0334634 (UMLS CUI [2])
C0393022 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0919936 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C0332324 (UMLS CUI [5,3])
C0438286 (UMLS CUI [6])
C0277556 (UMLS CUI [7,1])
C0687676 (UMLS CUI [7,2])
C1708063 (UMLS CUI [7,3])
C1335499 (UMLS CUI [8,1])
C1514873 (UMLS CUI [8,2])
C1706712 (UMLS CUI [8,3])
C0855095 (UMLS CUI [9])
C0855139 (UMLS CUI [10])
C0242647 (UMLS CUI [11,1])
C2828389 (UMLS CUI [11,2])
C0349632 (UMLS CUI [12])
C0193842 (UMLS CUI [13])
C0040682 (UMLS CUI [14,1])
C2828389 (UMLS CUI [14,2])
Age
Item
2. age >18-75
boolean
C0001779 (UMLS CUI [1])
Chemotherapy Quantity Absent response to treatment
Item
3. relapse or failure to respond after one or more (maximum three) lines of chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0438286 (UMLS CUI [1,3])
Chemotherapy | rituximab | High-Dose Chemotherapy with Autologous Stem Cell Transplant
Item
4. any type of prior chemotherapy, rituximab included. patients who had received high dose chemotherapy and asct can be enrolled into the study
boolean
C0392920 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
C1512429 (UMLS CUI [3])
rituximab | Disease Therapy naive | Disease Therapy Sensitive | Disease Response | Thrombotic Thrombocytopenic Purpura Duration
Item
5. naïve or sensitive rituximab disease. if the patient received rituximab, he/she must have responded and the ttp from the last dose to rituximab must have been 6 months or more.
boolean
C0393022 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0919936 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0332324 (UMLS CUI [3,3])
C1704632 (UMLS CUI [4])
C0034155 (UMLS CUI [5,1])
C0449238 (UMLS CUI [5,2])
Measurable Disease | Evaluable Disease
Item
6. measurable and/or evaluable disease.
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Absolute neutrophil count Due to Lymphoma involves bone marrow | Platelet Count Due to Lymphoma involves bone marrow
Item
7. adequate haematological counts: anc> 1.0 x 109/l and plt counts> 75 x 109/l unless due to bone marrow involvement by lymphoma.
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0948762 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C1301440 (UMLS CUI [4,3])
C1287267 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C1301440 (UMLS CUI [5,3])
Bilirubin conjugated increased
Item
8. conjugated bilirubin up to 2 x uln.
boolean
C0855625 (UMLS CUI [1])
Alkaline phosphatase raised | Transaminases increased
Item
9. alkaline phosphatase and transaminases up to 2 x uln.
boolean
C0151849 (UMLS CUI [1])
C0438717 (UMLS CUI [2])
Creatinine measurement, serum
Item
10. creatinine clearances> 30 m/min.
boolean
C0201976 (UMLS CUI [1])
Peripheral Neuropathy Absent | CNS disorder Absent
Item
11. non peripheral neuropathy or cns disease.
boolean
C0031117 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0007682 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Life Expectancy
Item
12. life expectancy> 6 months.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
13. performance status< 2 according to ecog scale.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
14. written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity rituximab | Hypersensitivity Boron | Hypersensitivity Mannitol | Hypersensitivity Heparin | intolerance to rituximab | intolerance to Boron | intolerance to Mannitol | intolerance to Heparin | Indwelling Catheter Use of
Item
1. has known or suspected hypersensitivity or intolerance to rituximab, boron, mannitol, or heparin, if an indwelling catheter is used
boolean
C0020517 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0006030 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0024730 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0019134 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0393022 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0006030 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0024730 (UMLS CUI [7,2])
C1744706 (UMLS CUI [8,1])
C0019134 (UMLS CUI [8,2])
C0007439 (UMLS CUI [9,1])
C1524063 (UMLS CUI [9,2])
Hepatic Insufficiency | Renal Insufficiency | Heart Diseases | Vascular Diseases | Lung diseases | Gastrointestinal Diseases | Endocrine System Diseases | nervous system disorder | Rheumatologic disorder | Hematological Disease | Mental disorders | Metabolic Diseases
Item
2. history of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
boolean
C1306571 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0042373 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0009326 (UMLS CUI [9])
C0018939 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
C0025517 (UMLS CUI [12])
Diabetic - poor control | Antidiabetics Dose Stable
Item
3. uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug
boolean
C0421258 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (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
4. uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, new york heart association (nyha) class iii or iv heart failure (attachment 5, nyha classification of cardiac disease), 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])
Hypotension | Decreased Blood Pressure | Sitting systolic blood pressure | Sitting diastolic blood pressure
Item
5. history of hypotension or has decreased blood pressure (sitting systolic blood pressure sbp 100 mmhg and/or sitting diastolic blood pressure dbp 60 mmhg)
boolean
C0020649 (UMLS CUI [1])
C2917141 (UMLS CUI [2])
C1319893 (UMLS CUI [3])
C1319894 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
6. pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Peripheral Neuropathy CTCAE Grades | Neuropathic pain CTCAE Grades
Item
7. peripheral neuropathy or neuropathic pain grade 2
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C3714625 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
HIV Seropositivity
Item
8. hiv positivity
boolean
C0019699 (UMLS CUI [1])
Hepatitis B virus test positive | Hepatitis B core antibody positive | Hepatitis B surface antigen negative | Hepatitis B Virus Surface Antibody Positive | Hepatitis B Virus Surface Antibody Negative | Hbv DNA Test Negative
Item
9. hbv positivity with the exception of patients with hbvcab +, hbsag -, hbs ab+/- with hbv-dna negative
boolean
C2748184 (UMLS CUI [1])
C0262506 (UMLS CUI [2])
C0919711 (UMLS CUI [3])
C0369334 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0369334 (UMLS CUI [5,1])
C1513916 (UMLS CUI [5,2])
C1256114 (UMLS CUI [6,1])
C1513916 (UMLS CUI [6,2])
Hepatitis C virus test positive | Chronic Hepatitis Signs Absent
Item
10. hcv positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
boolean
C2748185 (UMLS CUI [1])
C0019189 (UMLS CUI [2,1])
C0311392 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Opportunistic Infections
Item
11. active opportunistic infection
boolean
C0029118 (UMLS CUI [1])
Extensive Radiation | Systemic Chemotherapy | cancer treatment
Item
12. receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks before enrollment
boolean
C1517030 (UMLS CUI [1])
C1883256 (UMLS CUI [2])
C0920425 (UMLS CUI [3])
rituximab Exposure to
Item
13. exposure to rituximab within 24 weeks before screening
boolean
C0393022 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
Investigational New Drugs | Investigational Medical Device | Study Subject Participation Status Interference Absent
Item
14. have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study.
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C2348568 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Comorbidity Study Subject Participation Status Exclusion | Mental condition Study Subject Participation Status Exclusion | Comorbidity compromises Informed Consent | Mental condition compromises Informed Consent
Item
15. any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
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