ID

41818

Description

Rituximab-HyperCVAD (R-HCVAD) Alternating With Rituximab-Methotrexate-Cytarabine- (R-MC) in Newly Diagnosed Patients With Diffuse Large B-Cell Lymphoma With MYC-Rearrangement.; ODM derived from: https://clinicaltrials.gov/show/NCT01854372

Link

https://clinicaltrials.gov/show/NCT01854372

Keywords

Versions (3)
  1. 1/21/21 1/21/21 - Ahmed Rafee, MD
  2. 1/21/21 1/21/21 - Ahmed Rafee, MD
  3. 1/22/21 1/22/21 - Sarah Riepenhausen
Copyright Holder

The University of Texas Health Science Center at San Antonio

Uploaded on

January 22, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Newly Diagnosed Diffuse Large B-Cell Lymphoma NCT01854372

English

Eligibility Newly Diagnosed Diffuse Large B-Cell Lymphoma NCT01854372

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diffuse large b-cell lymphoma or intermediate ("burkitt-like") lymphoma, newly diagnosed from an excisional biopsy or from a large core biopsy with sufficient diagnostic material to perform genetic testing for myc-r.
Description

Newly diagnosed large B-cell Lymphoma | Newly diagnosed Burkitt-like lymphoma, Histopathological Grade | Diagnosis confirmed by excisional biopsy | diagnosis confirmed by corde needle biopsy | Materials sufficient for genetic screening for MYC-Rearrangement

Data type

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C1518321
UMLS CUI [1,3]
C0184921
UMLS CUI [2,1]
C1368771
UMLS CUI [2,2]
C1512863
UMLS CUI [2,3]
C0184921
UMLS CUI [2,4]
C1518321
UMLS CUI [3,1]
C0079744
UMLS CUI [3,2]
C1518321
UMLS CUI [3,3]
C1318309
UMLS CUI [4,1]
C1368771
UMLS CUI [4,2]
C1512863
UMLS CUI [4,3]
C0184921
UMLS CUI [4,4]
C1318309
UMLS CUI [5,1]
C0005558
UMLS CUI [5,2]
C0205410
UMLS CUI [5,3]
C0807034
UMLS CUI [5,4]
C0679560
2. positivity for myc-r by fluorescent in-situ hybridization (fish) or by classical cytogenetics.
Description

MYC-R FISH positive | MYCR-R Cytogenetics positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0807034
UMLS CUI [1,2]
C0162789
UMLS CUI [1,3]
C1446409
UMLS CUI [2,1]
C0752095
UMLS CUI [2,2]
C0807034
UMLS CUI [2,3]
C1446409
3. no prior lymphoma treatment, with one exception: one cycle of r-chop regimen is permitted (consisting of one single dose each of rituximab, of cyclophosphamide, of doxorubicine, and of vincristine, as well as up to 5 doses of prednisone when part of chemotherapy).
Description

Lymphoma prior therapy absent | Exception R-CHOP of 1 Cycle Single Dose | Exception Prednisolon 5 cycles

Data type

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0393023
UMLS CUI [2,3]
C2045831
4.Prior radiation therapy?
Description

Prior radiation therapy is not permitted

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332197
5. age ≥ 18 years to 70 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
6. ct imaging of neck, chest, abdomen and pelvis within 28 days prior to registration. any additional imaging used to assess extent of disease must also have been done within 28 days prior to registration
Description

Recent CT of neck, chest, abdomen and pelvis | additional medical Imaging in time interval

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0040405
UMLS CUI [1,3]
C0027530
UMLS CUI [1,4]
C0817096
UMLS CUI [1,5]
C0000726
UMLS CUI [1,6]
C0030797
UMLS CUI [2,1]
C1524062
UMLS CUI [2,2]
C0025086
UMLS CUI [2,3]
C0332185
UMLS CUI [2,4]
C0449279
7. bidimensionally measurable disease by imaging within 28 days prior to registration
Description

Measurable disease, 2-D by diagnostic imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C0011923
UMLS CUI [1,4]
C0332185
8. adequate bone marrow biopsy, and aspiration performed for staging within 28 days before registration, and before start of any treatment
Description

Bone Marrow Biopsy, sufficient materials, performed within recent time interval.

Data type

boolean

Alias
UMLS CUI [1,1]
C0005954
UMLS CUI [1,2]
C0205410
UMLS CUI [1,3]
C0332185
9. indication for primary treatment with systemic multiagent chemotherapy
Description

Indication for primary multiagent systemic Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1883256
UMLS CUI [1,3]
C0205225
UMLS CUI [1,4]
C5205682
10. creatinine ≤ 2.0 mg/dl and estimated (cockroft-gault) creatinine clearance> 50 ml/min within 7 days prior to registration
Description

Creatinine | renal creatinine clearance predicted by Cockroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1,1]
C0201975
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C4064204
UMLS CUI [2,2]
C0332185
11. cardiac ejection fraction of ≥ 50% by muga scan or by 2-d echocardiogram , as well as ekg without significant abnormality within 28 days prior to registration
Description

Cardiac Ejection frction using MUGA Scan | Cardiac Ejection Fraction using 2D Echocardiogram | EKG with absent abnormal findings

Data type

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0521317
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C1317066
UMLS CUI [2,3]
C0332185
UMLS CUI [3,1]
C1623258
UMLS CUI [3,2]
C2826279
UMLS CUI [3,3]
C0332197
UMLS CUI [3,4]
C0332185
12. performance status of 0, of 1, or of 2 (ecog scale)
Description

ECOG Scale (Performance Status)

Data type

boolean

Alias
UMLS CUI [1]
C1520224
13. patient willing to have, and to maintain, a central venous line throughout the treatment phase (either picc line, or double lumen tunnelled catheter, or double lumen subcutaneous venous port system)
Description

Willingness to have and maintain a CVL | PICC Line | Double Lumen tunnelled catheter | double lumen subcutaneous venous port system

Data type

boolean

Alias
UMLS CUI [1,1]
C3521108
UMLS CUI [1,2]
C1321605
UMLS CUI [2]
C2049629
UMLS CUI [3,1]
C0441131
UMLS CUI [3,2]
C0878969
UMLS CUI [4,1]
C4534545
UMLS CUI [4,2]
C0441131
14. willing and logistically able to be followed as outpatient at least twice weekly, during the treatment phase.
Description

Clinical study follow up willingness | Clinical study follow up ability

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0085732
15. signed informed consent to accept transfusion of blood products as medically indicated
Description

Transfusion of blood products, infromed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C0021430
16. signed informed consent to participate in this trial
Description

Patient consented to clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age > 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. leukemic presentation, or no evidence of disease by imaging
Description

Clinical Presentation, Leukemina | Absent disease evidence by medical imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C2708283
UMLS CUI [1,2]
C0023418
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0025086
3. unwilling to be screened for hiv. hiv positive patients must receive combined antiretroviral treatment while on study. they are excluded from participation unless they show a cd4 count >250/ul and a viral load < 50 within 28 days of registration.
Description

HIV Screening unwillingness | HIV+, combined antiretroviral treatment | CD4-Count, Viral load, exclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0459958
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0019699
UMLS CUI [2,2]
C1963724
UMLS CUI [2,3]
C0205195
UMLS CUI [3,1]
C2698595
UMLS CUI [3,2]
C1168369
UMLS CUI [3,3]
C0332185
4. hepatic involvement and total serum bilirubin ≥ 5 mg/dl within 7 days prior to registration, or total serum bilirubin ≥ 1.6 mg/ dl without hepatic involvement within 7 days prior to registration
Description

Total serum bilirubin

Data type

boolean

Alias
UMLS CUI [1,1]
C1278039
UMLS CUI [1,2]
C0332185
5. patients with bone marrow involvement and either anc < 1000/ulor platelets < 50,000/ul, within 7 days before registration
Description

ANC | Platelet count

Data type

boolean

Alias
UMLS CUI [1,1]
C0948762
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0032181
UMLS CUI [2,2]
C0332185
6. patients without bone marrow involvement by lymphoma, and either anc < 1500/ul or platelets < 100,000/ul within 7 days before registration
Description

ANC | Platelet count

Data type

boolean

Alias
UMLS CUI [1,1]
C0948762
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0032181
UMLS CUI [2,2]
C0332185
7. patients with myelodysplastic syndrome, with sickle cell disease, or with transfusion dependence for over 6 months antedating the diagnosis of lymphoma.
Description

Myelodysplastic Syndrome | Sickle Cell Disease | Transfusion Dependence

Data type

boolean

Alias
UMLS CUI [1,1]
C3463824
UMLS CUI [1,2]
C0444921
UMLS CUI [2,1]
C0002895
UMLS CUI [2,2]
C0444921
UMLS CUI [3,1]
C0005841
UMLS CUI [3,2]
C0439857
UMLS CUI [3,3]
C0444921
8. known hypersensitivity to e. coli derived proteins
Description

E. Coli-derived proteins; Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0950080
UMLS CUI [1,2]
C0020517
9. patients at risk of reactivation of hepatitis b who are unwilling to be treated with appropriate antivirals as medically indicated.
Description

Reactivation of hepatitis B viral hepatitis; high risk | Hepatitis antiviral therapy; unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C2960634
UMLS CUI [1,2]
C0332167
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C0280274
UMLS CUI [2,3]
C0558080
10. pregnant or nursing women, or any patient with reproductive potential and unwilling to use effective contraceptive method from study start to one year after the last dose of protocol therapy. adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method, or total abstinence.
Description

Pregnancy | Breast Feeding | Female; reproductive age; Contraception;Hormonal Contraception; Intrauterine Device; Double Barrier method; Total Abstinence; unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
11. additional or prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for ~ 5 years
Description

Additionl malignancy| prior malignancy; exception; other malignancies; disease free survival interval| exception; BCC; treated | exception; SCC; treated | exception; cervical cancer; in situ

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1524062
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0006826
UMLS CUI [3,3]
C0205394
UMLS CUI [3,4]
C0242793
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [4,3]
C0920425
UMLS CUI [4,4]
C0205411
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0553723
UMLS CUI [5,3]
C0920425
UMLS CUI [5,4]
C0205411
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0851140
12. unwilling to receive transfusions of blood products as medically indicated
Description

Transfusion of blood products; unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0085430
UMLS CUI [1,2]
C0558080
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Similar models

Eligibility Newly Diagnosed Diffuse Large B-Cell Lymphoma NCT01854372

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Newly diagnosed large B-cell Lymphoma | Newly diagnosed Burkitt-like lymphoma, Histopathological Grade | Diagnosis confirmed by excisional biopsy | diagnosis confirmed by corde needle biopsy | Materials sufficient for genetic screening for MYC-Rearrangement
Item
1. diffuse large b-cell lymphoma or intermediate ("burkitt-like") lymphoma, newly diagnosed from an excisional biopsy or from a large core biopsy with sufficient diagnostic material to perform genetic testing for myc-r.
boolean
C0079744 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0184921 (UMLS CUI [1,3])
C1368771 (UMLS CUI [2,1])
C1512863 (UMLS CUI [2,2])
C0184921 (UMLS CUI [2,3])
C1518321 (UMLS CUI [2,4])
C0079744 (UMLS CUI [3,1])
C1518321 (UMLS CUI [3,2])
C1318309 (UMLS CUI [3,3])
C1368771 (UMLS CUI [4,1])
C1512863 (UMLS CUI [4,2])
C0184921 (UMLS CUI [4,3])
C1318309 (UMLS CUI [4,4])
C0005558 (UMLS CUI [5,1])
C0205410 (UMLS CUI [5,2])
C0807034 (UMLS CUI [5,3])
C0679560 (UMLS CUI [5,4])
MYC-R FISH positive | MYCR-R Cytogenetics positive
Item
2. positivity for myc-r by fluorescent in-situ hybridization (fish) or by classical cytogenetics.
boolean
C0807034 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
C0752095 (UMLS CUI [2,1])
C0807034 (UMLS CUI [2,2])
C1446409 (UMLS CUI [2,3])
Lymphoma prior therapy absent | Exception R-CHOP of 1 Cycle Single Dose | Exception Prednisolon 5 cycles
Item
3. no prior lymphoma treatment, with one exception: one cycle of r-chop regimen is permitted (consisting of one single dose each of rituximab, of cyclophosphamide, of doxorubicine, and of vincristine, as well as up to 5 doses of prednisone when part of chemotherapy).
boolean
C0024299 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0393023 (UMLS CUI [2,2])
C2045831 (UMLS CUI [2,3])
Prior radiation
Item
4.Prior radiation therapy?
boolean
C1522449 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Age
Item
5. age ≥ 18 years to 70 years of age
boolean
C0001779 (UMLS CUI [1])
Recent CT of neck, chest, abdomen and pelvis | additional medical Imaging in time interval
Item
6. ct imaging of neck, chest, abdomen and pelvis within 28 days prior to registration. any additional imaging used to assess extent of disease must also have been done within 28 days prior to registration
boolean
C0332185 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C0027530 (UMLS CUI [1,3])
C0817096 (UMLS CUI [1,4])
C0000726 (UMLS CUI [1,5])
C0030797 (UMLS CUI [1,6])
C1524062 (UMLS CUI [2,1])
C0025086 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C0449279 (UMLS CUI [2,4])
Measurable disease, 2-D by diagnostic imaging
Item
7. bidimensionally measurable disease by imaging within 28 days prior to registration
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,4])
Bone Marrow Biopsy, sufficient materials, performed within recent time interval.
Item
8. adequate bone marrow biopsy, and aspiration performed for staging within 28 days before registration, and before start of any treatment
boolean
C0005954 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Indication for primary multiagent systemic Chemotherapy
Item
9. indication for primary treatment with systemic multiagent chemotherapy
boolean
C3146298 (UMLS CUI [1,1])
C1883256 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C5205682 (UMLS CUI [1,4])
Creatinine | renal creatinine clearance predicted by Cockroft-Gault formula
Item
10. creatinine ≤ 2.0 mg/dl and estimated (cockroft-gault) creatinine clearance> 50 ml/min within 7 days prior to registration
boolean
C0201975 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C4064204 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Cardiac Ejection frction using MUGA Scan | Cardiac Ejection Fraction using 2D Echocardiogram | EKG with absent abnormal findings
Item
11. cardiac ejection fraction of ≥ 50% by muga scan or by 2-d echocardiogram , as well as ekg without significant abnormality within 28 days prior to registration
boolean
C0232174 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0232174 (UMLS CUI [2,1])
C1317066 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C1623258 (UMLS CUI [3,1])
C2826279 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0332185 (UMLS CUI [3,4])
ECOG Scale (Performance Status)
Item
12. performance status of 0, of 1, or of 2 (ecog scale)
boolean
C1520224 (UMLS CUI [1])
Willingness to have and maintain a CVL | PICC Line | Double Lumen tunnelled catheter | double lumen subcutaneous venous port system
Item
13. patient willing to have, and to maintain, a central venous line throughout the treatment phase (either picc line, or double lumen tunnelled catheter, or double lumen subcutaneous venous port system)
boolean
C3521108 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C2049629 (UMLS CUI [2])
C0441131 (UMLS CUI [3,1])
C0878969 (UMLS CUI [3,2])
C4534545 (UMLS CUI [4,1])
C0441131 (UMLS CUI [4,2])
Clinical study follow up willingness | Clinical study follow up ability
Item
14. willing and logistically able to be followed as outpatient at least twice weekly, during the treatment phase.
boolean
C3274571 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
Transfusion of blood products, infromed consent
Item
15. signed informed consent to accept transfusion of blood products as medically indicated
boolean
C0005841 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Patient consented to clinical trial
Item
16. signed informed consent to participate in this trial
boolean
C0008976 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. age > 70 years
boolean
C0001779 (UMLS CUI [1])
Clinical Presentation, Leukemina | Absent disease evidence by medical imaging
Item
2. leukemic presentation, or no evidence of disease by imaging
boolean
C2708283 (UMLS CUI [1,1])
C0023418 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0025086 (UMLS CUI [2,3])
HIV Screening unwillingness | HIV+, combined antiretroviral treatment | CD4-Count, Viral load, exclusion criteria
Item
3. unwilling to be screened for hiv. hiv positive patients must receive combined antiretroviral treatment while on study. they are excluded from participation unless they show a cd4 count >250/ul and a viral load < 50 within 28 days of registration.
boolean
C0459958 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0019699 (UMLS CUI [2,1])
C1963724 (UMLS CUI [2,2])
C0205195 (UMLS CUI [2,3])
C2698595 (UMLS CUI [3,1])
C1168369 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
Total serum bilirubin
Item
4. hepatic involvement and total serum bilirubin ≥ 5 mg/dl within 7 days prior to registration, or total serum bilirubin ≥ 1.6 mg/ dl without hepatic involvement within 7 days prior to registration
boolean
C1278039 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
ANC | Platelet count
Item
5. patients with bone marrow involvement and either anc < 1000/ulor platelets < 50,000/ul, within 7 days before registration
boolean
C0948762 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
ANC | Platelet count
Item
6. patients without bone marrow involvement by lymphoma, and either anc < 1500/ul or platelets < 100,000/ul within 7 days before registration
boolean
C0948762 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Myelodysplastic Syndrome | Sickle Cell Disease | Transfusion Dependence
Item
7. patients with myelodysplastic syndrome, with sickle cell disease, or with transfusion dependence for over 6 months antedating the diagnosis of lymphoma.
boolean
C3463824 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0002895 (UMLS CUI [2,1])
C0444921 (UMLS CUI [2,2])
C0005841 (UMLS CUI [3,1])
C0439857 (UMLS CUI [3,2])
C0444921 (UMLS CUI [3,3])
E. Coli-derived proteins; Hypersensitivity
Item
8. known hypersensitivity to e. coli derived proteins
boolean
C0950080 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Reactivation of hepatitis B viral hepatitis; high risk | Hepatitis antiviral therapy; unwilling
Item
9. patients at risk of reactivation of hepatitis b who are unwilling to be treated with appropriate antivirals as medically indicated.
boolean
C2960634 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2,1])
C0280274 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Female; reproductive age; Contraception;Hormonal Contraception; Intrauterine Device; Double Barrier method; Total Abstinence; unwilling
Item
10. pregnant or nursing women, or any patient with reproductive potential and unwilling to use effective contraceptive method from study start to one year after the last dose of protocol therapy. adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method, or total abstinence.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
Additionl malignancy| prior malignancy; exception; other malignancies; disease free survival interval| exception; BCC; treated | exception; SCC; treated | exception; cervical cancer; in situ
Item
11. additional or prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for ~ 5 years
boolean
C0006826 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0205394 (UMLS CUI [3,3])
C0242793 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C0920425 (UMLS CUI [4,3])
C0205411 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0553723 (UMLS CUI [5,2])
C0920425 (UMLS CUI [5,3])
C0205411 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0851140 (UMLS CUI [6,2])
Transfusion of blood products; unwilling
Item
12. unwilling to receive transfusions of blood products as medically indicated
boolean
C0085430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
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