ID

40385

Beschrijving

A Phase II Study of Bendamustine in Combination With Rituximab as Initial Treatment for Patients With Indolent Non-follicular Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01929265

Link

https://clinicaltrials.gov/show/NCT01929265

Trefwoorden

Versies (1)
  1. 17-04-20 17-04-20 -
Houder van rechten

See clinicaltrials.gov

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17 april 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Indolent Non-follicular NCT01929265

Engels

Eligibility Indolent Non-follicular NCT01929265

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. understand and voluntarily sign an informed consent form
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
2. histological (bone marrow or lymph nodes biopsy) proven diagnosis of b-cell cd20-
Beschrijving

B-Cell Nonfollicular Non-Hodgkin's lymphoma CD20 positive | Bone marrow biopsy | Biopsy of lymph node

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348394
UMLS CUI [1,2]
C0004561
UMLS CUI [1,3]
C3888518
UMLS CUI [2]
C0005954
UMLS CUI [3]
C0193842
positive non-follicular nhl according to real/who classification:
Beschrijving

REAL classification | WHO classification

Datatype

boolean

Alias
UMLS CUI [1]
C1688661
UMLS CUI [2]
C4267671
i. small lymphocytic lymphoma-sll (bone marrow or lymph nodes biopsy ii. lymphoplasmacytic/citoid lymphoma/ waldenstrom macroglobulinemia(bone marrow or lymph nodes biopsy) iii. nodal marginal zone lymphoma (lymph nodes biopsy)
Beschrijving

Small Lymphocytic Lymphoma | Bone marrow biopsy | Biopsy of lymph node | Waldenstrom Macroglobulinemia | Nodal marginal zone lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0855095
UMLS CUI [2]
C0005954
UMLS CUI [3]
C0193842
UMLS CUI [4]
C0024419
UMLS CUI [5]
C0242647
3. untreated patients
Beschrijving

Patients Untreated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
4. stage iii or iv or stage ii with more than three involved sites
Beschrijving

Lymphoma stage | Sites Involved Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C1272836
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C1265611
5. presence of at least one of the following criteria for the definition of active disease:
Beschrijving

Criteria Quantity Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0012634
1. systemic symptoms
Beschrijving

Systemic symptoms

Datatype

boolean

Alias
UMLS CUI [1]
C2039684
2. hemoglobin less than 10 g/dl (due to lymphoma)
Beschrijving

Hemoglobin measurement | Etiology Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0024299
3. platelets less than 100 x 10 9/l (due to lymphoma)
Beschrijving

Platelet Count measurement | Etiology Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0024299
4. diffuse bone marrow infiltrate
Beschrijving

Bone Marrow Infiltrate Diffuse

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0332448
UMLS CUI [1,3]
C0205219
5. lymphocyte doubling time less than 12 months (in leukemic cases)
Beschrijving

Lymphocyte Doubling Time | Leukemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024264
UMLS CUI [1,2]
C2986483
UMLS CUI [2]
C0023418
6. bulky disease (>7 cm)
Beschrijving

Bulky Disease Size

Datatype

boolean

Alias
UMLS CUI [1,1]
C1511341
UMLS CUI [1,2]
C0456389
6. aged 18 - 75 life expectancy >6 months
Beschrijving

Age | Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0023671
7. ecog performance status 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
8. lvef ≥45% or fs ≥37%
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
9. anc ≥1 x 10 9/l and platelets count ≥75 x 10 9/l, unless due to bone marrow involvement by follicular lymphoma
Beschrijving

Absolute neutrophil count | Platelet Count measurement | Exception Bone Marrow Involvement Follicular Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1517677
UMLS CUI [3,3]
C0024301
10. creatinine up to 1.5 x uln
Beschrijving

Serum creatinine raised

Datatype

boolean

Alias
UMLS CUI [1]
C0700225
11. conjugated bilirubin up to 2 x uln
Beschrijving

Bilirubin conjugated increased

Datatype

boolean

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

Alkaline phosphatase raised | Transaminases increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151849
UMLS CUI [2]
C0438717
13. written informed content
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with diagnosis of marginal zone lymphoma of splenic or malt origin
Beschrijving

Splenic Marginal Zone B-Cell Lymphoma | Mucosa-Associated Lymphoid Tissue Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0349632
UMLS CUI [2]
C0242647
2. patients with diagnosis of typical chronic lymphocytic leukemia (cll)
Beschrijving

Chronic Lymphocytic Leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C0023434
3. men not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy
Beschrijving

Gender Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
4. history of other malignancies within 3 years prior to study entry except for: adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage, localized prostate cancer treated surgically with curative intent; good prognosis dcis of the breast treated with lumpectomy alone with curative intent
Beschrijving

Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Curative Surgery Prostate carcinoma Low grade | Exception Curative Surgery Prostate carcinoma Early stage | Exception Curative Surgery Prostate carcinoma Localized | Exception Prognosis good DCIS | Segmental Mastectomy Curative DCIS

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1511562
UMLS CUI [5,3]
C0600139
UMLS CUI [5,4]
C1282907
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1511562
UMLS CUI [6,3]
C0600139
UMLS CUI [6,4]
C2363430
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1511562
UMLS CUI [7,3]
C0600139
UMLS CUI [7,4]
C0392752
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0278250
UMLS CUI [8,3]
C0007124
UMLS CUI [9,1]
C0024885
UMLS CUI [9,2]
C1276305
UMLS CUI [9,3]
C0007124
5. medical condition requiring long term use (>1 months) of systemic corticosteroids
Beschrijving

Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE Long-term

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3653708
UMLS CUI [1,4]
C0443252
6. active bacterial, viral, or fungal infection requiring systemic therapy
Beschrijving

Bacterial Infections Requirement Systemic therapy | Virus Diseases Requirement Systemic therapy | Mycoses Requirement Systemic therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C1515119
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C1515119
7. concurrent medical condition which might exclude administration of therapy
Beschrijving

Comorbidity Excludes Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0087111
8. cardiac insufficiency (nyha grade iii/iv)
Beschrijving

Heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
9. myocardial infarction within 6 months of entry on study
Beschrijving

Myocardial Infarction Recent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0332185
10. severe chronic obstructive pulmonary disease with hypoxemia
Beschrijving

Severe chronic obstructive pulmonary disease with Hypoxemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0730607
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0700292
11. severe diabetes mellitus difficult to control with adequate insulin therapy
Beschrijving

Diabetes Mellitus Severe | Insulin regime Difficult

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0332218
12. hypertension that is difficult to control
Beschrijving

Hypertensive disease | Control Difficult

Datatype

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2,1]
C2587213
UMLS CUI [2,2]
C0332218
13. impaired renal function with creatinine clearance <30 ml/min
Beschrijving

Renal Insufficiency | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0373595
14. hiv positivity
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
15. hbv positivity with the exception of patients hbsag negative and ab anti-hbcore positive(these patientes need to receive prophylaxis with lamivudine)
Beschrijving

Hepatitis B positive | Exception Hepatitis B surface antigen negative | Exception Antibody to hepatitis B core antigen Positive

Datatype

boolean

Alias
UMLS CUI [1]
C0856706
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0919711
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0312631
UMLS CUI [3,3]
C1514241
16. hcv positivity with the exception of patients with hcv rna negative.
Beschrijving

Hepatitis C Virus Positive | Exception Hepatitis C RNA negative

Datatype

boolean

Alias
UMLS CUI [1]
C4330254
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0855841
17. cns involvement by lymphoma
Beschrijving

Central Nervous System Involvement Lymphoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0024299
18. participation at the same time in another study in with investiogational drugs are used
Beschrijving

Study Subject Participation Status | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
19. known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
Beschrijving

Hypersensitivity Mouse monoclonal antibody | Anaphylaxis Mouse monoclonal antibody | Hypersensitivity Mouse protein | Anaphylaxis Mouse protein

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0359168
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0359168
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1334805
UMLS CUI [4,1]
C0002792
UMLS CUI [4,2]
C1334805
20. any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
Beschrijving

Comorbidity Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded | Comorbidity At risk Informed Consent | Mental condition At risk Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0021430
21. women in pregnancy or breastfeeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Indolent Non-follicular NCT01929265

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. understand and voluntarily sign an informed consent form
boolean
C0021430 (UMLS CUI [1])
B-Cell Nonfollicular Non-Hodgkin's lymphoma CD20 positive | Bone marrow biopsy | Biopsy of lymph node
Item
2. histological (bone marrow or lymph nodes biopsy) proven diagnosis of b-cell cd20-
boolean
C0348394 (UMLS CUI [1,1])
C0004561 (UMLS CUI [1,2])
C3888518 (UMLS CUI [1,3])
C0005954 (UMLS CUI [2])
C0193842 (UMLS CUI [3])
REAL classification | WHO classification
Item
positive non-follicular nhl according to real/who classification:
boolean
C1688661 (UMLS CUI [1])
C4267671 (UMLS CUI [2])
Small Lymphocytic Lymphoma | Bone marrow biopsy | Biopsy of lymph node | Waldenstrom Macroglobulinemia | Nodal marginal zone lymphoma
Item
i. small lymphocytic lymphoma-sll (bone marrow or lymph nodes biopsy ii. lymphoplasmacytic/citoid lymphoma/ waldenstrom macroglobulinemia(bone marrow or lymph nodes biopsy) iii. nodal marginal zone lymphoma (lymph nodes biopsy)
boolean
C0855095 (UMLS CUI [1])
C0005954 (UMLS CUI [2])
C0193842 (UMLS CUI [3])
C0024419 (UMLS CUI [4])
C0242647 (UMLS CUI [5])
Patients Untreated
Item
3. untreated patients
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Lymphoma stage | Sites Involved Quantity
Item
4. stage iii or iv or stage ii with more than three involved sites
boolean
C1272836 (UMLS CUI [1])
C1515974 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Criteria Quantity Disease
Item
5. presence of at least one of the following criteria for the definition of active disease:
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
Systemic symptoms
Item
1. systemic symptoms
boolean
C2039684 (UMLS CUI [1])
Hemoglobin measurement | Etiology Lymphoma
Item
2. hemoglobin less than 10 g/dl (due to lymphoma)
boolean
C0518015 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0024299 (UMLS CUI [2,2])
Platelet Count measurement | Etiology Lymphoma
Item
3. platelets less than 100 x 10 9/l (due to lymphoma)
boolean
C0032181 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0024299 (UMLS CUI [2,2])
Bone Marrow Infiltrate Diffuse
Item
4. diffuse bone marrow infiltrate
boolean
C0005953 (UMLS CUI [1,1])
C0332448 (UMLS CUI [1,2])
C0205219 (UMLS CUI [1,3])
Lymphocyte Doubling Time | Leukemia
Item
5. lymphocyte doubling time less than 12 months (in leukemic cases)
boolean
C0024264 (UMLS CUI [1,1])
C2986483 (UMLS CUI [1,2])
C0023418 (UMLS CUI [2])
Bulky Disease Size
Item
6. bulky disease (>7 cm)
boolean
C1511341 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Age | Life Expectancy
Item
6. aged 18 - 75 life expectancy >6 months
boolean
C0001779 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
ECOG performance status
Item
7. ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction
Item
8. lvef ≥45% or fs ≥37%
boolean
C0428772 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Exception Bone Marrow Involvement Follicular Lymphoma
Item
9. anc ≥1 x 10 9/l and platelets count ≥75 x 10 9/l, unless due to bone marrow involvement by follicular lymphoma
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1517677 (UMLS CUI [3,2])
C0024301 (UMLS CUI [3,3])
Serum creatinine raised
Item
10. creatinine up to 1.5 x uln
boolean
C0700225 (UMLS CUI [1])
Bilirubin conjugated increased
Item
11. conjugated bilirubin up to 2 x uln
boolean
C0855625 (UMLS CUI [1])
Alkaline phosphatase raised | Transaminases increased
Item
12. alkaline phosphatase and transaminases up to 2 x uln
boolean
C0151849 (UMLS CUI [1])
C0438717 (UMLS CUI [2])
Informed Consent
Item
13. written informed content
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Splenic Marginal Zone B-Cell Lymphoma | Mucosa-Associated Lymphoid Tissue Lymphoma
Item
1. patients with diagnosis of marginal zone lymphoma of splenic or malt origin
boolean
C0349632 (UMLS CUI [1])
C0242647 (UMLS CUI [2])
Chronic Lymphocytic Leukemia
Item
2. patients with diagnosis of typical chronic lymphocytic leukemia (cll)
boolean
C0023434 (UMLS CUI [1])
Gender Contraceptive methods Unwilling
Item
3. men not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Curative Surgery Prostate carcinoma Low grade | Exception Curative Surgery Prostate carcinoma Early stage | Exception Curative Surgery Prostate carcinoma Localized | Exception Prognosis good DCIS | Segmental Mastectomy Curative DCIS
Item
4. history of other malignancies within 3 years prior to study entry except for: adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage, localized prostate cancer treated surgically with curative intent; good prognosis dcis of the breast treated with lumpectomy alone with curative intent
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1511562 (UMLS CUI [5,2])
C0600139 (UMLS CUI [5,3])
C1282907 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C1511562 (UMLS CUI [6,2])
C0600139 (UMLS CUI [6,3])
C2363430 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C1511562 (UMLS CUI [7,2])
C0600139 (UMLS CUI [7,3])
C0392752 (UMLS CUI [7,4])
C1705847 (UMLS CUI [8,1])
C0278250 (UMLS CUI [8,2])
C0007124 (UMLS CUI [8,3])
C0024885 (UMLS CUI [9,1])
C1276305 (UMLS CUI [9,2])
C0007124 (UMLS CUI [9,3])
Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE Long-term
Item
5. medical condition requiring long term use (>1 months) of systemic corticosteroids
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3653708 (UMLS CUI [1,3])
C0443252 (UMLS CUI [1,4])
Bacterial Infections Requirement Systemic therapy | Virus Diseases Requirement Systemic therapy | Mycoses Requirement Systemic therapy
Item
6. active bacterial, viral, or fungal infection requiring systemic therapy
boolean
C0004623 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
C0042769 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1515119 (UMLS CUI [2,3])
C0026946 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C1515119 (UMLS CUI [3,3])
Comorbidity Excludes Therapeutic procedure
Item
7. concurrent medical condition which might exclude administration of therapy
boolean
C0009488 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Heart failure New York Heart Association Classification
Item
8. cardiac insufficiency (nyha grade iii/iv)
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction Recent
Item
9. myocardial infarction within 6 months of entry on study
boolean
C0027051 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Severe chronic obstructive pulmonary disease with Hypoxemia
Item
10. severe chronic obstructive pulmonary disease with hypoxemia
boolean
C0730607 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0700292 (UMLS CUI [1,3])
Diabetes Mellitus Severe | Insulin regime Difficult
Item
11. severe diabetes mellitus difficult to control with adequate insulin therapy
boolean
C0011849 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2,1])
C0332218 (UMLS CUI [2,2])
Hypertensive disease | Control Difficult
Item
12. hypertension that is difficult to control
boolean
C0020538 (UMLS CUI [1])
C2587213 (UMLS CUI [2,1])
C0332218 (UMLS CUI [2,2])
Renal Insufficiency | Creatinine clearance measurement
Item
13. impaired renal function with creatinine clearance <30 ml/min
boolean
C1565489 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
HIV Seropositivity
Item
14. hiv positivity
boolean
C0019699 (UMLS CUI [1])
Hepatitis B positive | Exception Hepatitis B surface antigen negative | Exception Antibody to hepatitis B core antigen Positive
Item
15. hbv positivity with the exception of patients hbsag negative and ab anti-hbcore positive(these patientes need to receive prophylaxis with lamivudine)
boolean
C0856706 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0919711 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0312631 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
Hepatitis C Virus Positive | Exception Hepatitis C RNA negative
Item
16. hcv positivity with the exception of patients with hcv rna negative.
boolean
C4330254 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0855841 (UMLS CUI [2,2])
Central Nervous System Involvement Lymphoma
Item
17. cns involvement by lymphoma
boolean
C4050309 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs
Item
18. participation at the same time in another study in with investiogational drugs are used
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Hypersensitivity Mouse monoclonal antibody | Anaphylaxis Mouse monoclonal antibody | Hypersensitivity Mouse protein | Anaphylaxis Mouse protein
Item
19. known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
boolean
C0020517 (UMLS CUI [1,1])
C0359168 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C0359168 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1334805 (UMLS CUI [3,2])
C0002792 (UMLS CUI [4,1])
C1334805 (UMLS CUI [4,2])
Comorbidity Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded | Comorbidity At risk Informed Consent | Mental condition At risk Informed Consent
Item
20. 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])
C0332196 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
21. women in pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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