ID

36590

Descripción

To Assess the Efficacy of Brentuximab Vedotin for Relapsed/Refractory CD30-positive Non-Hodgkin Lymphomas Other Than Anaplastic Large Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02280785

Link

https://clinicaltrials.gov/show/NCT02280785

Palabras clave

Versiones (1)
  1. 24/5/19 24/5/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

24 de mayo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Non-Hodgkin Lymphoma NCT02280785

Inglés

Eligibility Non-Hodgkin Lymphoma NCT02280785

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have histologically confirmed non-hodgkin lymphomas with cd 30 expression. criteria of positive cd30 expression are defined as in cases with membranous cd30 expression from more than 50% of neoplastic cells.
Descripción

Non-Hodgkin Lymphoma CD30 expression | CD30 expression Membranous Neoplastic Cells Percentage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C3888510
UMLS CUI [2,1]
C3888510
UMLS CUI [2,2]
C0205287
UMLS CUI [2,3]
C0597032
UMLS CUI [2,4]
C0439165
2. relapsed or progressed disease after two or more than two salvage chemotherapy
Descripción

Recurrent disease | Disease Progression | Status post Salvage Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0442967
UMLS CUI [3,3]
C0392920
3. patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
Descripción

Toxicity Due to Prior Chemotherapy | Toxicity Due to Prior Immunotherapy | Toxicity Due to Prior radiation therapy | Patient recovered

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514457
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1514461
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0279134
UMLS CUI [4]
C1115804
4. measurable disease > 1.5 cm evidenced by computed tomography (ct) scan of the neck/chest/abdomen/pelvis or ct/positron emission tomography (pet) scans
Descripción

Measurable Disease Size CT of Neck | Measurable Disease Size Chest CT | Measurable Disease Size CT of abdomen | Measurable Disease Size CT of Pelvis | Measurable Disease Size PET/CT scan

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0412604
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0456389
UMLS CUI [2,3]
C0202823
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0456389
UMLS CUI [3,3]
C0412620
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C0456389
UMLS CUI [4,3]
C0412628
UMLS CUI [5,1]
C1513041
UMLS CUI [5,2]
C0456389
UMLS CUI [5,3]
C1699633
5. life expectancy of greater than 3 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
6. ecog performance status ≤ 2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
7. male or female patients 18 - 75 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
8. female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
Descripción

Postmenopausal state | Female Sterilization | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Sexual Abstinence Heterosexual

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0036899
UMLS CUI [4,3]
C0019421
9. male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
Descripción

Gender Barrier Contraception | Male sterilization | Status post Vasectomy | Gender Sexual Abstinence Heterosexual

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0004764
UMLS CUI [2]
C0024559
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0042387
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0036899
UMLS CUI [4,3]
C0019421
10. voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
11. clinical laboratory values as specified below within 7 days before the first dose of study drug:
Descripción

Laboratory Results

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1254595
12. serum creatinine must be < 2.0 mg/dl and/or creatinine clearance or calculated creatinine clearance > 40 ml/minute.
Descripción

Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
UMLS CUI [3]
C2711451
13. hemoglobin must be ≥ 8g/dl.
Descripción

Hemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518015
14. absolute neutrophil count (anc) ≥ 1500/ul
Descripción

Absolute neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
15. platelets (plts) ≥ 75,000/; g-csf can be given prior to start of brentuximab vedotin and during brentuximab vedotin treatment to achieve target anc; platelet transfusion can also be given prior to the start of brentuximab vedotin and during brentuximab vedotin treatment to achieve a target platelet ≥ 75,000/ul
Descripción

Platelet Count measurement | G-CSF | brentuximab vedotin | Absolute neutrophil count | Platelet Transfusion

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0079459
UMLS CUI [3]
C2973446
UMLS CUI [4]
C0948762
UMLS CUI [5]
C0086818
16. total bilirubin within 1.5 x of the upper limit of normal (uln) institutional limits, patients with elevation of unconjugated bilirubin alone, as in gilbert's disease, are eligible
Descripción

SERUM TOTAL BILIRUBIN ELEVATED | SERUM UNCONJUGATED BILIRUBIN ELEVATED | Gilbert Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0595866
UMLS CUI [2]
C0241024
UMLS CUI [3]
C0017551
17. aspartate aminotransferase (ast)/alanine aminotransferase (alt) < 2.5 x institutional uln. ast and alt may be elevated up to 5 times the uln if their elevation can be reasonably ascribed to the presence of hematologic/solid tumor in liver
Descripción

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Hematologic Neoplasm Liver | Relationship Solid Neoplasm Liver

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
UMLS CUI [5,1]
C0439849
UMLS CUI [5,2]
C0376545
UMLS CUI [5,3]
C0023884
UMLS CUI [6,1]
C0439849
UMLS CUI [6,2]
C0280100
UMLS CUI [6,3]
C0023884
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. hodgkin lymphoma
Descripción

Hodgkin lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019829
2. anaplastic large cell lymphoma
Descripción

Anaplastic Large Cell Lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206180
3. female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on day 1 before first dose of study drug
Descripción

Lactating | Breast Feeding | Serum pregnancy test positive | Pregnancy test positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2828358
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0430063
UMLS CUI [4]
C0240802
4. any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
Descripción

Illness Serious Interferes with Treatment completion | Mental disorder Serious Interferes with Treatment completion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0580352
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0580352
5. known cerebral or meningeal disease (hl or any other etiology), including signs or symptoms of pml
Descripción

Cerebral disorder | Meningeal disorder | Etiology Hodgkin lymphoma | Etiology Other | Sign or Symptom PML

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0234387
UMLS CUI [2]
C0154728
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0019829
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0205394
UMLS CUI [5,1]
C3540840
UMLS CUI [5,2]
C0023524
6. symptomatic neurologic disease compromising normal activities of daily living or requiring medications
Descripción

Nervous system disorder Symptomatic compromises Activities of Daily Living | Nervous system disorder Symptomatic Requirement Pharmaceutical Preparations

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C0001288
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0013227
7. any sensory or motor peripheral neuropathy greater than or equal to grade 2
Descripción

Peripheral sensory neuropathy CTCAE Grades | Peripheral motor neuropathy CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0151313
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0235025
UMLS CUI [2,2]
C1516728
8. any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose
Descripción

Systemic viral infection Requirement Antibiotics for systemic use | Systemic bacterial infection Requirement Antibiotics for systemic use | Systemic mycosis Requirement Antibiotics for systemic use

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4285789
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3540704
UMLS CUI [2,1]
C4285778
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C3540704
UMLS CUI [3,1]
C0553576
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C3540704
9. any prior treatment with chemotherapy and/or investigational agents completed less than 5 half-lives
Descripción

Prior Chemotherapy | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0013230
10. known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.
Descripción

Hypersensitivity Recombinant Proteins | Hypersensitivity Murine protein | Hypersensitivity Brentuximab vedotin Excipient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0034861
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1699668
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2973446
UMLS CUI [3,3]
C0015237
11. known hiv antibody-positive
Descripción

HIV antibody positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0920548
12. known hepatitis b surface antigen-positive, or known or suspected active hepatitis c infection
Descripción

Hepatitis B surface antigen positive | Hepatitis C | Hepatitis C Suspected

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0019196
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C0750491
13. diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Descripción

Cancer Other | Residual Tumor | Exception Complete excision Skin carcinoma | Exception Complete excision Carcinoma in Situ

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2]
C0543478
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0015250
UMLS CUI [3,3]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0015250
UMLS CUI [4,3]
C0007099
14. known history of any of the following cardiovascular conditions:
Descripción

Condition Cardiovascular

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C3887460
myocardial infarction within 2 years of first dose of study drug
Descripción

Myocardial Infarction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
new york heart association (nyha) class iii or iv heart failure (see appendix 3)
Descripción

Heart failure New York Heart Association Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (chf), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
Descripción

Condition Cardiovascular Uncontrolled | Cardiac Arrhythmia | Congestive heart failure | Angina Pectoris | Ischemia Electrocardiography | Conduction system abnormalities Electrocardiography

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C3887460
UMLS CUI [1,3]
C0205318
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0002962
UMLS CUI [5,1]
C0022116
UMLS CUI [5,2]
C1623258
UMLS CUI [6,1]
C0151236
UMLS CUI [6,2]
C1623258
a left-ventricular ejection fraction <50% documented within 6 months before first dose of study drug
Descripción

Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428772
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Similar models

Eligibility Non-Hodgkin Lymphoma NCT02280785

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Hodgkin Lymphoma CD30 expression | CD30 expression Membranous Neoplastic Cells Percentage
Item
1. patients must have histologically confirmed non-hodgkin lymphomas with cd 30 expression. criteria of positive cd30 expression are defined as in cases with membranous cd30 expression from more than 50% of neoplastic cells.
boolean
C0024305 (UMLS CUI [1,1])
C3888510 (UMLS CUI [1,2])
C3888510 (UMLS CUI [2,1])
C0205287 (UMLS CUI [2,2])
C0597032 (UMLS CUI [2,3])
C0439165 (UMLS CUI [2,4])
Recurrent disease | Disease Progression | Status post Salvage Chemotherapy
Item
2. relapsed or progressed disease after two or more than two salvage chemotherapy
boolean
C0277556 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0442967 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
Toxicity Due to Prior Chemotherapy | Toxicity Due to Prior Immunotherapy | Toxicity Due to Prior radiation therapy | Patient recovered
Item
3. patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514457 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1514461 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0279134 (UMLS CUI [3,3])
C1115804 (UMLS CUI [4])
Measurable Disease Size CT of Neck | Measurable Disease Size Chest CT | Measurable Disease Size CT of abdomen | Measurable Disease Size CT of Pelvis | Measurable Disease Size PET/CT scan
Item
4. measurable disease > 1.5 cm evidenced by computed tomography (ct) scan of the neck/chest/abdomen/pelvis or ct/positron emission tomography (pet) scans
boolean
C1513041 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0412604 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0202823 (UMLS CUI [2,3])
C1513041 (UMLS CUI [3,1])
C0456389 (UMLS CUI [3,2])
C0412620 (UMLS CUI [3,3])
C1513041 (UMLS CUI [4,1])
C0456389 (UMLS CUI [4,2])
C0412628 (UMLS CUI [4,3])
C1513041 (UMLS CUI [5,1])
C0456389 (UMLS CUI [5,2])
C1699633 (UMLS CUI [5,3])
Life Expectancy
Item
5. life expectancy of greater than 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
6. ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Age
Item
7. male or female patients 18 - 75 years
boolean
C0001779 (UMLS CUI [1])
Postmenopausal state | Female Sterilization | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Sexual Abstinence Heterosexual
Item
8. female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
C0019421 (UMLS CUI [4,3])
Gender Barrier Contraception | Male sterilization | Status post Vasectomy | Gender Sexual Abstinence Heterosexual
Item
9. male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
boolean
C0079399 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0024559 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0042387 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
C0019421 (UMLS CUI [4,3])
Informed Consent
Item
10. voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
boolean
C0021430 (UMLS CUI [1])
Laboratory Results
Item
11. clinical laboratory values as specified below within 7 days before the first dose of study drug:
boolean
C1254595 (UMLS CUI [1])
Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
12. serum creatinine must be < 2.0 mg/dl and/or creatinine clearance or calculated creatinine clearance > 40 ml/minute.
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Hemoglobin measurement
Item
13. hemoglobin must be ≥ 8g/dl.
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
14. absolute neutrophil count (anc) ≥ 1500/ul
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement | G-CSF | brentuximab vedotin | Absolute neutrophil count | Platelet Transfusion
Item
15. platelets (plts) ≥ 75,000/; g-csf can be given prior to start of brentuximab vedotin and during brentuximab vedotin treatment to achieve target anc; platelet transfusion can also be given prior to the start of brentuximab vedotin and during brentuximab vedotin treatment to achieve a target platelet ≥ 75,000/ul
boolean
C0032181 (UMLS CUI [1])
C0079459 (UMLS CUI [2])
C2973446 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0086818 (UMLS CUI [5])
SERUM TOTAL BILIRUBIN ELEVATED | SERUM UNCONJUGATED BILIRUBIN ELEVATED | Gilbert Disease
Item
16. total bilirubin within 1.5 x of the upper limit of normal (uln) institutional limits, patients with elevation of unconjugated bilirubin alone, as in gilbert's disease, are eligible
boolean
C0595866 (UMLS CUI [1])
C0241024 (UMLS CUI [2])
C0017551 (UMLS CUI [3])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Hematologic Neoplasm Liver | Relationship Solid Neoplasm Liver
Item
17. aspartate aminotransferase (ast)/alanine aminotransferase (alt) < 2.5 x institutional uln. ast and alt may be elevated up to 5 times the uln if their elevation can be reasonably ascribed to the presence of hematologic/solid tumor in liver
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0439849 (UMLS CUI [5,1])
C0376545 (UMLS CUI [5,2])
C0023884 (UMLS CUI [5,3])
C0439849 (UMLS CUI [6,1])
C0280100 (UMLS CUI [6,2])
C0023884 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
Hodgkin lymphoma
Item
1. hodgkin lymphoma
boolean
C0019829 (UMLS CUI [1])
Anaplastic Large Cell Lymphoma
Item
2. anaplastic large cell lymphoma
boolean
C0206180 (UMLS CUI [1])
Lactating | Breast Feeding | Serum pregnancy test positive | Pregnancy test positive
Item
3. female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on day 1 before first dose of study drug
boolean
C2828358 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430063 (UMLS CUI [3])
C0240802 (UMLS CUI [4])
Illness Serious Interferes with Treatment completion | Mental disorder Serious Interferes with Treatment completion
Item
4. any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0580352 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0580352 (UMLS CUI [2,4])
Cerebral disorder | Meningeal disorder | Etiology Hodgkin lymphoma | Etiology Other | Sign or Symptom PML
Item
5. known cerebral or meningeal disease (hl or any other etiology), including signs or symptoms of pml
boolean
C0234387 (UMLS CUI [1])
C0154728 (UMLS CUI [2])
C0015127 (UMLS CUI [3,1])
C0019829 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0205394 (UMLS CUI [4,2])
C3540840 (UMLS CUI [5,1])
C0023524 (UMLS CUI [5,2])
Nervous system disorder Symptomatic compromises Activities of Daily Living | Nervous system disorder Symptomatic Requirement Pharmaceutical Preparations
Item
6. symptomatic neurologic disease compromising normal activities of daily living or requiring medications
boolean
C0027765 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C0001288 (UMLS CUI [1,4])
C0027765 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0013227 (UMLS CUI [2,4])
Peripheral sensory neuropathy CTCAE Grades | Peripheral motor neuropathy CTCAE Grades
Item
7. any sensory or motor peripheral neuropathy greater than or equal to grade 2
boolean
C0151313 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0235025 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Systemic viral infection Requirement Antibiotics for systemic use | Systemic bacterial infection Requirement Antibiotics for systemic use | Systemic mycosis Requirement Antibiotics for systemic use
Item
8. any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose
boolean
C4285789 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3540704 (UMLS CUI [1,3])
C4285778 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C3540704 (UMLS CUI [2,3])
C0553576 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C3540704 (UMLS CUI [3,3])
Prior Chemotherapy | Investigational New Drugs
Item
9. any prior treatment with chemotherapy and/or investigational agents completed less than 5 half-lives
boolean
C1514457 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Hypersensitivity Recombinant Proteins | Hypersensitivity Murine protein | Hypersensitivity Brentuximab vedotin Excipient
Item
10. known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.
boolean
C0020517 (UMLS CUI [1,1])
C0034861 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1699668 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C2973446 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
HIV antibody positive
Item
11. known hiv antibody-positive
boolean
C0920548 (UMLS CUI [1])
Hepatitis B surface antigen positive | Hepatitis C | Hepatitis C Suspected
Item
12. known hepatitis b surface antigen-positive, or known or suspected active hepatitis c infection
boolean
C0149709 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019196 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
Cancer Other | Residual Tumor | Exception Complete excision Skin carcinoma | Exception Complete excision Carcinoma in Situ
Item
13. diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
boolean
C1707251 (UMLS CUI [1])
C0543478 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0015250 (UMLS CUI [3,2])
C0699893 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0015250 (UMLS CUI [4,2])
C0007099 (UMLS CUI [4,3])
Condition Cardiovascular
Item
14. known history of any of the following cardiovascular conditions:
boolean
C0348080 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
Myocardial Infarction
Item
myocardial infarction within 2 years of first dose of study drug
boolean
C0027051 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
new york heart association (nyha) class iii or iv heart failure (see appendix 3)
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Condition Cardiovascular Uncontrolled | Cardiac Arrhythmia | Congestive heart failure | Angina Pectoris | Ischemia Electrocardiography | Conduction system abnormalities Electrocardiography
Item
evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (chf), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
boolean
C0348080 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0003811 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0002962 (UMLS CUI [4])
C0022116 (UMLS CUI [5,1])
C1623258 (UMLS CUI [5,2])
C0151236 (UMLS CUI [6,1])
C1623258 (UMLS CUI [6,2])
Left ventricular ejection fraction
Item
a left-ventricular ejection fraction <50% documented within 6 months before first dose of study drug
boolean
C0428772 (UMLS CUI [1])
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