ID

39584

Description

Velcade, Nipent, Rituxan (VNR) in Subjects With Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01460602

Link

https://clinicaltrials.gov/show/NCT01460602

Keywords

  1. 2/1/20 2/1/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 1, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility Follicular Lymphoma NCT01460602

Eligibility Follicular Lymphoma NCT01460602

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. voluntary written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. male or female subject 18 years of age and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. karnofsky performance status (kps) score of 50%. ecog performance status score greater than 2.
Description

Karnofsky Performance Status | ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1520224
4. histologically confirmed follicular grade 1-3a, marginal zone or mantle cell nhl.
Description

Follicular Lymphoma Ann Arbor lymphoma staging system | Marginal Zone B-Cell Lymphoma | Mantle cell lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0432516
UMLS CUI [2]
C1367654
UMLS CUI [3]
C0334634
5. relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment.
Description

Recurrent disease | Progressive Disease | Prior Chemotherapy Quantity | Treatment required

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1335499
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0332121
6. bi-dimensionally measurable disease with at least 1 lesion 2 cm in a single dimension
Description

Measurable Disease 2-Dimensional | Lesion size Linear | Lesion Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [2,1]
C0449453
UMLS CUI [2,2]
C0205132
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1265611
7. hematologic, hepatic, and renal function parameters.
Description

Hematologic function parameters | Liver function parameters | Renal function parameters

Data type

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0449381
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C0449381
UMLS CUI [3,1]
C0232804
UMLS CUI [3,2]
C0449381
8. recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs
Description

Toxicity Patient recovered | Prior surgery | Therapeutic radiology procedure | Chemotherapy | Biological treatment | Autologous bone marrow transplant | Autologous hematopoietic stem cell transplant | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1115804
UMLS CUI [2]
C0455610
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0392920
UMLS CUI [5]
C1531518
UMLS CUI [6]
C0194037
UMLS CUI [7]
C2193200
UMLS CUI [8]
C0013230
9. expected survival of 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
10. accepted birth control methods during treatment and for 12 months after completion of treatment.
Description

Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. follicular lymphoma grade 3b
Description

Follicular Lymphoma Ann Arbor lymphoma staging system

Data type

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0432516
2. history of allergy to any of the study medications, their analogues, murine proteins, or excipients in the various formulations
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Analogue | Hypersensitivity Murine protein | Hypersensitivity Drug Formulation Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0243071
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1699668
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0524527
UMLS CUI [4,3]
C0015237
3. grade 2 peripheral neuropathy or clinical examination within 14 days before enrollment
Description

Peripheral Neuropathy CTCAE Grades | Peripheral Neuropathy Clinical examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0031117
UMLS CUI [2,2]
C1456356
4. serum creatinine 2.5 mg/dl within 14 days before enrollment.
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
5. absolute neutrophil count (anc) < 1,000/l, platelet count < 70,000/l within 14 days before enrollment
Description

Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
6. aspartate transaminase (ast [sgot]) and alanine transaminase (alt/sgpt]) > 2 x the upper limit of normal (uln), total bilirubin > 3 uln
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0741494
7. rituxan refractory or refractory to anti-cd20 radioimmunotherapy (no response to prior rituxan or prior rituxan-containing regimen, or a response with a ttp of less than 6 months)
Description

Unresponsive to Rituxan | Unresponsive to Radioimmunotherapy Against CD20 Antigens

Data type

boolean

Alias
UMLS CUI [1,1]
C0205269
UMLS CUI [1,2]
C0732355
UMLS CUI [2,1]
C0205269
UMLS CUI [2,2]
C0085101
UMLS CUI [2,3]
C0521124
UMLS CUI [2,4]
C0054946
8. cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to study day 1 (6 weeks if nitrosurea or mytomycin-c)
Description

Therapeutic radiology procedure Malignant Neoplasms | Biological treatment Malignant Neoplasms | Chemotherapy Malignant Neoplasms | Nitrosourea | Mitomycin

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C0006826
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0006826
UMLS CUI [4]
C0028210
UMLS CUI [5]
C0002475
9. prior lymphoma vaccine therapy within 12 months to study day 1
Description

Vaccine Therapy Previous Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0042209
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0024299
10. prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to study day 1
Description

Antibody therapy Lymphoma | Radioimmunotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0281176
UMLS CUI [1,2]
C0024299
UMLS CUI [2]
C0085101
11. autologous bone marrow or stem cell transplant within 6 months prior to study day 1
Description

Autologous bone marrow transplant | Autologous hematopoietic stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C0194037
UMLS CUI [2]
C2193200
12. known history of hepatitis or hepatic disease.
Description

Hepatitis | Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0023895
13. presence of central nervous system (cns) lymphoma
Description

Central nervous system lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0742472
14. known history of hiv infection or aids
Description

HIV Infection | AIDS

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0001175
15. histologic transformation (follicular or marginal zone to diffuse large b cell lymphoma [dlbcl]
Description

Transformation Histologic | Follicular Lymphoma Diffuse Large B-Cell Lymphoma | Marginal Zone B-Cell Lymphoma Diffuse Large B-Cell Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C3714584
UMLS CUI [1,2]
C0205462
UMLS CUI [2,1]
C0024301
UMLS CUI [2,2]
C0079744
UMLS CUI [3,1]
C1367654
UMLS CUI [3,2]
C0079744
16. presence of pleural or peritoneal effusion with positive cytology for lymphoma
Description

Pleural effusion | Peritoneal effusion | Positive Cytology Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0032227
UMLS CUI [2]
C0003964
UMLS CUI [3,1]
C3846509
UMLS CUI [3,2]
C0024299
17. another primary malignancy requiring active treatment
Description

Primary tumor Other Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0332121
18. serious non-malignant disease (e.g., congestive heart failure [chf], hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions (including psychiatric), which would compromise protocol objectives n the opinion of the investigator and/or sponsor
Description

Disease Serious | Congestive heart failure | Hydronephrosis | Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Condition compromises Completion of clinical trial | Mental condition compromises Completion of clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0020295
UMLS CUI [4,1]
C0004623
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0042769
UMLS CUI [5,2]
C0205318
UMLS CUI [6,1]
C0026946
UMLS CUI [6,2]
C0205318
UMLS CUI [7,1]
C0348080
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C2732579
UMLS CUI [8,1]
C3840291
UMLS CUI [8,2]
C2945640
UMLS CUI [8,3]
C2732579
19. new york heart association class iii or iv (appendix d) cardiac disease
Description

Heart Disease New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
20. major surgery, other than diagnostic surgery, within 4 weeks prior to study day 1
Description

Major surgery | Exception Operative Surgical Procedure Diagnostic

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C0348026
21. female subject who is pregnant or currently breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
23. hypersensitivity to bortezomib, pentostatin, rituximab, boron or mannitol.
Description

Hypersensitivity Bortezomib | Pentostatin allergy | Hypersensitivity Rituximab | Hypersensitivity Boron | Mannitol allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
UMLS CUI [2]
C0570696
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0393022
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0006030
UMLS CUI [5]
C0571922

Similar models

Eligibility Follicular Lymphoma NCT01460602

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. voluntary written informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. male or female subject 18 years of age and older
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status | ECOG performance status
Item
3. karnofsky performance status (kps) score of 50%. ecog performance status score greater than 2.
boolean
C0206065 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Follicular Lymphoma Ann Arbor lymphoma staging system | Marginal Zone B-Cell Lymphoma | Mantle cell lymphoma
Item
4. histologically confirmed follicular grade 1-3a, marginal zone or mantle cell nhl.
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
C1367654 (UMLS CUI [2])
C0334634 (UMLS CUI [3])
Recurrent disease | Progressive Disease | Prior Chemotherapy Quantity | Treatment required
Item
5. relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment.
boolean
C0277556 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
C1514457 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0332121 (UMLS CUI [4])
Measurable Disease 2-Dimensional | Lesion size Linear | Lesion Quantity
Item
6. bi-dimensionally measurable disease with at least 1 lesion 2 cm in a single dimension
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C0449453 (UMLS CUI [2,1])
C0205132 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Hematologic function parameters | Liver function parameters | Renal function parameters
Item
7. hematologic, hepatic, and renal function parameters.
boolean
C0221130 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2,1])
C0449381 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3,1])
C0449381 (UMLS CUI [3,2])
Toxicity Patient recovered | Prior surgery | Therapeutic radiology procedure | Chemotherapy | Biological treatment | Autologous bone marrow transplant | Autologous hematopoietic stem cell transplant | Investigational New Drugs
Item
8. recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs
boolean
C0600688 (UMLS CUI [1,1])
C1115804 (UMLS CUI [1,2])
C0455610 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
C0194037 (UMLS CUI [6])
C2193200 (UMLS CUI [7])
C0013230 (UMLS CUI [8])
Life Expectancy
Item
9. expected survival of 3 months
boolean
C0023671 (UMLS CUI [1])
Contraceptive methods
Item
10. accepted birth control methods during treatment and for 12 months after completion of treatment.
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Follicular Lymphoma Ann Arbor lymphoma staging system
Item
1. follicular lymphoma grade 3b
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Analogue | Hypersensitivity Murine protein | Hypersensitivity Drug Formulation Excipient
Item
2. history of allergy to any of the study medications, their analogues, murine proteins, or excipients in the various formulations
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0243071 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C1699668 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0524527 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Peripheral Neuropathy CTCAE Grades | Peripheral Neuropathy Clinical examination
Item
3. grade 2 peripheral neuropathy or clinical examination within 14 days before enrollment
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0031117 (UMLS CUI [2,1])
C1456356 (UMLS CUI [2,2])
Creatinine measurement, serum
Item
4. serum creatinine 2.5 mg/dl within 14 days before enrollment.
boolean
C0201976 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement
Item
5. absolute neutrophil count (anc) < 1,000/l, platelet count < 70,000/l within 14 days before enrollment
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin
Item
6. aspartate transaminase (ast [sgot]) and alanine transaminase (alt/sgpt]) > 2 x the upper limit of normal (uln), total bilirubin > 3 uln
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0741494 (UMLS CUI [3])
Unresponsive to Rituxan | Unresponsive to Radioimmunotherapy Against CD20 Antigens
Item
7. rituxan refractory or refractory to anti-cd20 radioimmunotherapy (no response to prior rituxan or prior rituxan-containing regimen, or a response with a ttp of less than 6 months)
boolean
C0205269 (UMLS CUI [1,1])
C0732355 (UMLS CUI [1,2])
C0205269 (UMLS CUI [2,1])
C0085101 (UMLS CUI [2,2])
C0521124 (UMLS CUI [2,3])
C0054946 (UMLS CUI [2,4])
Therapeutic radiology procedure Malignant Neoplasms | Biological treatment Malignant Neoplasms | Chemotherapy Malignant Neoplasms | Nitrosourea | Mitomycin
Item
8. cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to study day 1 (6 weeks if nitrosurea or mytomycin-c)
boolean
C1522449 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0028210 (UMLS CUI [4])
C0002475 (UMLS CUI [5])
Vaccine Therapy Previous Lymphoma
Item
9. prior lymphoma vaccine therapy within 12 months to study day 1
boolean
C0042209 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
Antibody therapy Lymphoma | Radioimmunotherapy
Item
10. prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to study day 1
boolean
C0281176 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C0085101 (UMLS CUI [2])
Autologous bone marrow transplant | Autologous hematopoietic stem cell transplant
Item
11. autologous bone marrow or stem cell transplant within 6 months prior to study day 1
boolean
C0194037 (UMLS CUI [1])
C2193200 (UMLS CUI [2])
Hepatitis | Liver disease
Item
12. known history of hepatitis or hepatic disease.
boolean
C0019158 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
Central nervous system lymphoma
Item
13. presence of central nervous system (cns) lymphoma
boolean
C0742472 (UMLS CUI [1])
HIV Infection | AIDS
Item
14. known history of hiv infection or aids
boolean
C0019693 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
Transformation Histologic | Follicular Lymphoma Diffuse Large B-Cell Lymphoma | Marginal Zone B-Cell Lymphoma Diffuse Large B-Cell Lymphoma
Item
15. histologic transformation (follicular or marginal zone to diffuse large b cell lymphoma [dlbcl]
boolean
C3714584 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
C0024301 (UMLS CUI [2,1])
C0079744 (UMLS CUI [2,2])
C1367654 (UMLS CUI [3,1])
C0079744 (UMLS CUI [3,2])
Pleural effusion | Peritoneal effusion | Positive Cytology Lymphoma
Item
16. presence of pleural or peritoneal effusion with positive cytology for lymphoma
boolean
C0032227 (UMLS CUI [1])
C0003964 (UMLS CUI [2])
C3846509 (UMLS CUI [3,1])
C0024299 (UMLS CUI [3,2])
Primary tumor Other Treatment required for
Item
17. another primary malignancy requiring active treatment
boolean
C0677930 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
Disease Serious | Congestive heart failure | Hydronephrosis | Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Condition compromises Completion of clinical trial | Mental condition compromises Completion of clinical trial
Item
18. serious non-malignant disease (e.g., congestive heart failure [chf], hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions (including psychiatric), which would compromise protocol objectives n the opinion of the investigator and/or sponsor
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0020295 (UMLS CUI [3])
C0004623 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0042769 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0026946 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0348080 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C2732579 (UMLS CUI [7,3])
C3840291 (UMLS CUI [8,1])
C2945640 (UMLS CUI [8,2])
C2732579 (UMLS CUI [8,3])
Heart Disease New York Heart Association Classification
Item
19. new york heart association class iii or iv (appendix d) cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Major surgery | Exception Operative Surgical Procedure Diagnostic
Item
20. major surgery, other than diagnostic surgery, within 4 weeks prior to study day 1
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0348026 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
21. female subject who is pregnant or currently breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
22. received other investigational drugs with 14 days before enrollment
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Bortezomib | Pentostatin allergy | Hypersensitivity Rituximab | Hypersensitivity Boron | Mannitol allergy
Item
23. hypersensitivity to bortezomib, pentostatin, rituximab, boron or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0570696 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0393022 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0006030 (UMLS CUI [4,2])
C0571922 (UMLS CUI [5])

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