ID

40385

Description

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

Keywords

Versions (1)
  1. 4/17/20 4/17/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 17, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Indolent Non-follicular NCT01929265

English

Eligibility Indolent Non-follicular NCT01929265

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Informed Consent

Data type

boolean

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

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

Data type

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:
Description

REAL classification | WHO classification

Data type

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)
Description

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

Data type

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
Description

Patients Untreated

Data type

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
Description

Lymphoma stage | Sites Involved Quantity

Data type

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:
Description

Criteria Quantity Disease

Data type

boolean

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

Systemic symptoms

Data type

boolean

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

Hemoglobin measurement | Etiology Lymphoma

Data type

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)
Description

Platelet Count measurement | Etiology Lymphoma

Data type

boolean

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

Bone Marrow Infiltrate Diffuse

Data type

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)
Description

Lymphocyte Doubling Time | Leukemia

Data type

boolean

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

Bulky Disease Size

Data type

boolean

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

Age | Life Expectancy

Data type

boolean

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

ECOG performance status

Data type

boolean

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

Left ventricular ejection fraction

Data type

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
Description

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

Data type

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
Description

Serum creatinine raised

Data type

boolean

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

Bilirubin conjugated increased

Data type

boolean

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

Alkaline phosphatase raised | Transaminases increased

Data type

boolean

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

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

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

Data type

boolean

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

Chronic Lymphocytic Leukemia

Data type

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
Description

Gender Contraceptive methods Unwilling

Data type

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
Description

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

Data type

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
Description

Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE Long-term

Data type

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
Description

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

Data type

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
Description

Comorbidity Excludes Therapeutic procedure

Data type

boolean

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

Heart failure New York Heart Association Classification

Data type

boolean

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

Myocardial Infarction Recent

Data type

boolean

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

Severe chronic obstructive pulmonary disease with Hypoxemia

Data type

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
Description

Diabetes Mellitus Severe | Insulin regime Difficult

Data type

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
Description

Hypertensive disease | Control Difficult

Data type

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
Description

Renal Insufficiency | Creatinine clearance measurement

Data type

boolean

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

HIV Seropositivity

Data type

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)
Description

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

Data type

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.
Description

Hepatitis C Virus Positive | Exception Hepatitis C RNA negative

Data type

boolean

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

Central Nervous System Involvement Lymphoma

Data type

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
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

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

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

Data type

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
Description

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

Data type

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
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Back to the top of the page

Similar models

Eligibility Indolent Non-follicular NCT01929265

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial