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39090

Beschreibung

Study of RTXM83 Plus CHOP Chemotherapy Versus a Rituximab Plus CHOP Therapy in Patients With Non Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02268045

Link

https://clinicaltrials.gov/show/NCT02268045

Stichworte

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  1. 30.11.19 30.11.19 -
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See clinicaltrials.gov

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30. November 2019

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    Eligibility Diffuse Large B-cell Lymphoma NCT02268045

    Englisch

    Eligibility Diffuse Large B-cell Lymphoma NCT02268045

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients with measurable disease defined as existence of a unidimensional or bidimensional lesion greater than 2 cm in its longest diameter or malignant lymphocytosis greater than 5x109/l. any other procedure for measurable disease in particular cases, may be allowed upon sponsor approval
    Beschreibung

    Measurable Disease | Lesion Linear Longest Diameter | Lesion 2-Dimensional Longest Diameter | Lymphocytosis Malignant Measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    UMLS CUI [2,1]
    C0221198
    UMLS CUI [2,2]
    C0205132
    UMLS CUI [2,3]
    C0552406
    UMLS CUI [3,1]
    C0221198
    UMLS CUI [3,2]
    C1705052
    UMLS CUI [3,3]
    C0552406
    UMLS CUI [4,1]
    C0024282
    UMLS CUI [4,2]
    C0205282
    UMLS CUI [4,3]
    C0242485
    2. newly diagnosed patients with a confirmed pathologic diagnosis of large b cell-non-hodgkin's lymphoma (dlbcl) with untreated cd20+. defined by the local haematopathologist at the local laboratory according to who criteria
    Beschreibung

    Diffuse Large B-Cell Lymphoma CD20 positive WHO tumor classification | Diffuse Large B-Cell Lymphoma CD20 positive Untreated

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0079744
    UMLS CUI [1,2]
    C3888518
    UMLS CUI [1,3]
    C1301142
    UMLS CUI [2,1]
    C0079744
    UMLS CUI [2,2]
    C3888518
    UMLS CUI [2,3]
    C0332155
    3. stage ii-iii or iv or stage i with bulk defined by the referring physician on the basis of the cotswolds modification of the ann arbor classification 2
    Beschreibung

    Cotswolds Hodgkin's disease tumor staging system

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0474950
    4. age-adjusted international prognostic index (ipi) score 0 or 1
    Beschreibung

    International Prognostic Index adjusted for age

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1512894
    UMLS CUI [1,2]
    C4300468
    5. age ≥18 to ≤65 years of age
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    6. performance status (eastern cooperative oncology group [ecog]) of ≤2
    Beschreibung

    ECOG performance status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    7. written informed consent obtained before starting any study-specific procedure
    Beschreibung

    Informed Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    8. females of child-bearing potential must test negative on standard serum pregnancy test and must be willing to practice appropriate contraceptive methods for the duration of the study (e.g. oral contraceptive, double barrier method, intra-uterine device, intra-muscular contraceptive)
    Beschreibung

    Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods | Contraceptives, Oral | Barrier Contraception Double | Intrauterine Devices | Intramuscular injection for birth control

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0430061
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0700589
    UMLS CUI [3]
    C0009905
    UMLS CUI [4,1]
    C0004764
    UMLS CUI [4,2]
    C0205173
    UMLS CUI [5]
    C0021900
    UMLS CUI [6]
    C2078149
    9. all male patients must take adequate contraceptive precautions during the course of the study
    Beschreibung

    Gender Contraceptive methods

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399
    UMLS CUI [1,2]
    C0700589
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. life expectancy of less than three months
    Beschreibung

    Life Expectancy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    2. any other lymphoma other than cd20+ dlbcl
    Beschreibung

    Lymphoma | Exception Diffuse Large B-Cell Lymphoma CD20 antigen positive

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0024299
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0079744
    UMLS CUI [2,3]
    C3888518
    3. indolent lymphoma, primary central nervous system (cns) lymphoma or gastro-intestinal mucosa associated lymphoid tissue (malt) lymphoma
    Beschreibung

    Indolent Lymphoma | Primary central nervous system lymphoma | Mucosa-Associated Lymphoid Tissue Lymphoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1334170
    UMLS CUI [2]
    C0280803
    UMLS CUI [3]
    C0242647
    4. known hypersensitivity to active ingredients, excipients and murine and foreign proteins
    Beschreibung

    Hypersensitivity Active ingredient | Hypersensitivity Pharmaceutical Excipient | Hypersensitivity Murine protein | Hypersensitivity FOREIGN PROTEIN INJECTION

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C1292749
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0015237
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C1699668
    UMLS CUI [4,1]
    C0020517
    UMLS CUI [4,2]
    C0239684
    5. concurrent disease or general status that would exclude giving the treatment as outlined in the protocol
    Beschreibung

    Comorbidity Excludes Treatment Protocol | General status Excludes Treatment Protocol

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0332196
    UMLS CUI [1,3]
    C0040808
    UMLS CUI [2,1]
    C0947124
    UMLS CUI [2,2]
    C0332196
    UMLS CUI [2,3]
    C0040808
    6. active uncontrolled infection requiring systemic treatment with antibiotics or antiviral agents at screening or history of documented recurrent clinically significant infection (e.g. 2 or more viral, bacterial or fungal infections requiring inpatient treatment)
    Beschreibung

    Communicable Disease Uncontrolled | Requirement Antibiotic therapy Systemic | Requirement Antiviral Agents Systemic | Recurrent infections | Virus Diseases Quantity | Bacterial Infections Quantity | Mycoses Quantity | Hospitalization Required

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2,1]
    C1514873
    UMLS CUI [2,2]
    C0338237
    UMLS CUI [2,3]
    C0205373
    UMLS CUI [3,1]
    C1514873
    UMLS CUI [3,2]
    C0003451
    UMLS CUI [3,3]
    C0205373
    UMLS CUI [4]
    C0239998
    UMLS CUI [5,1]
    C0042769
    UMLS CUI [5,2]
    C1265611
    UMLS CUI [6,1]
    C0004623
    UMLS CUI [6,2]
    C1265611
    UMLS CUI [7,1]
    C0026946
    UMLS CUI [7,2]
    C1265611
    UMLS CUI [8]
    C1708385
    7. cardiac contra-indication to doxorubicin therapy: non-compensated heart failure, dilated cardiomyopathy, coronary heart disease with st segment depression on electrocardiogram (ecg), myocardial infarction in the last 6 months
    Beschreibung

    Medical contraindication Cardiac Doxorubicin | Decompensated cardiac failure | Cardiomyopathy, Dilated | Coronary heart disease | ST segment depression ECG | Myocardial Infarction

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0018787
    UMLS CUI [1,3]
    C0013089
    UMLS CUI [2]
    C0581377
    UMLS CUI [3]
    C0007193
    UMLS CUI [4]
    C0010068
    UMLS CUI [5,1]
    C0520887
    UMLS CUI [5,2]
    C1623258
    UMLS CUI [6]
    C0027051
    8. neurologic contra-indication to vincristine as it is indicated in the smpc: (e.g. peripheral neuropathy)
    Beschreibung

    Medical contraindication Neurologic Vincristine | Peripheral Neuropathy

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0205494
    UMLS CUI [1,3]
    C0042679
    UMLS CUI [2]
    C0031117
    9. chronic lung disease with hypoxemia measured by saturometer (gasometry is not mandatory)
    Beschreibung

    Chronic lung disease | Hypoxemia Measurement | Other Coding

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0746102
    UMLS CUI [2,1]
    C0700292
    UMLS CUI [2,2]
    C0242485
    UMLS CUI [3]
    C3846158
    10. severe uncontrolled hypertension, despite optimal medical treatment
    Beschreibung

    Uncontrolled hypertension Severe | Treatment Optimal

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1868885
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C2698651
    11. severe uncontrolled diabetes mellitus, despite optimal medical treatment
    Beschreibung

    Uncontrolled diabetes mellitus Severe | Treatment Optimal

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0421258
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C2698651
    12. renal insufficiency (serum creatinine>2xunl)
    Beschreibung

    Renal Insufficiency | Serum creatinine raised

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1565489
    UMLS CUI [2]
    C0700225
    13. hepatic insufficiency (aspartate aminotransferase [ast]/alanine aminotransferase [alt] >3xunl or >5xunl with involvement of the liver, total bilirubin >34.2 µmol/l, or both) not related to lymphoma
    Beschreibung

    Hepatic Insufficiency Independent of Lymphoma | Aspartate aminotransferase increased | Alanine aminotransferase increased | Involvement with Liver | Serum total bilirubin measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1306571
    UMLS CUI [1,2]
    C0332291
    UMLS CUI [1,3]
    C0024299
    UMLS CUI [2]
    C0151904
    UMLS CUI [3]
    C0151905
    UMLS CUI [4,1]
    C1314939
    UMLS CUI [4,2]
    C0023884
    UMLS CUI [5]
    C1278039
    14. clinical signs of cerebral dysfunction
    Beschreibung

    Sign or Symptom Cerebral dysfunction

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3540840
    UMLS CUI [1,2]
    C0262405
    15. severe psychiatric disease
    Beschreibung

    Mental Disorder, Severe

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C4046029
    16. known human immunodeficiency virus (hiv) infection or active chronic hepatitis b or c
    Beschreibung

    HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    UMLS CUI [2]
    C0524909
    UMLS CUI [3]
    C0524910
    17. abnormal bone marrow function (platelets <100x109/l, neutrophils <1.5x109/l and haemoglobin <9g/dl)
    Beschreibung

    Bone Marrow function Abnormal | Platelet Count measurement | Neutrophil count | Hemoglobin measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953
    UMLS CUI [1,2]
    C0031843
    UMLS CUI [1,3]
    C0205161
    UMLS CUI [2]
    C0032181
    UMLS CUI [3]
    C0200633
    UMLS CUI [4]
    C0518015
    18. post-transplantation lymphoproliferative disease
    Beschreibung

    Post-transplant lymphoproliferative disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2367985
    19. pregnant or lactating women or women that intend to get pregnant during study or within 12 months following the last infusion
    Beschreibung

    Pregnancy | Breast Feeding | Pregnancy intended

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C0032961
    UMLS CUI [3,2]
    C1283828
    20. treatment with any investigational product in the 30 days period before inclusion in the study
    Beschreibung

    Investigational New Drugs

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    21. prior radiotherapy to treat the dlbcl nhl
    Beschreibung

    Prior radiation therapy Diffuse Large B-Cell Lymphoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0279134
    UMLS CUI [1,2]
    C0079744
    22. limitation of the patient's ability to comply with the treatment or follow-up protocol
    Beschreibung

    Protocol Compliance Limited

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C0439801
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    Ähnliche Modelle

    Eligibility Diffuse Large B-cell Lymphoma NCT02268045

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Measurable Disease | Lesion Linear Longest Diameter | Lesion 2-Dimensional Longest Diameter | Lymphocytosis Malignant Measurement
    Item
    1. patients with measurable disease defined as existence of a unidimensional or bidimensional lesion greater than 2 cm in its longest diameter or malignant lymphocytosis greater than 5x109/l. any other procedure for measurable disease in particular cases, may be allowed upon sponsor approval
    boolean
    C1513041 (UMLS CUI [1])
    C0221198 (UMLS CUI [2,1])
    C0205132 (UMLS CUI [2,2])
    C0552406 (UMLS CUI [2,3])
    C0221198 (UMLS CUI [3,1])
    C1705052 (UMLS CUI [3,2])
    C0552406 (UMLS CUI [3,3])
    C0024282 (UMLS CUI [4,1])
    C0205282 (UMLS CUI [4,2])
    C0242485 (UMLS CUI [4,3])
    Diffuse Large B-Cell Lymphoma CD20 positive WHO tumor classification | Diffuse Large B-Cell Lymphoma CD20 positive Untreated
    Item
    2. newly diagnosed patients with a confirmed pathologic diagnosis of large b cell-non-hodgkin's lymphoma (dlbcl) with untreated cd20+. defined by the local haematopathologist at the local laboratory according to who criteria
    boolean
    C0079744 (UMLS CUI [1,1])
    C3888518 (UMLS CUI [1,2])
    C1301142 (UMLS CUI [1,3])
    C0079744 (UMLS CUI [2,1])
    C3888518 (UMLS CUI [2,2])
    C0332155 (UMLS CUI [2,3])
    Cotswolds Hodgkin's disease tumor staging system
    Item
    3. stage ii-iii or iv or stage i with bulk defined by the referring physician on the basis of the cotswolds modification of the ann arbor classification 2
    boolean
    C0474950 (UMLS CUI [1])
    International Prognostic Index adjusted for age
    Item
    4. age-adjusted international prognostic index (ipi) score 0 or 1
    boolean
    C1512894 (UMLS CUI [1,1])
    C4300468 (UMLS CUI [1,2])
    Age
    Item
    5. age ≥18 to ≤65 years of age
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status
    Item
    6. performance status (eastern cooperative oncology group [ecog]) of ≤2
    boolean
    C1520224 (UMLS CUI [1])
    Informed Consent
    Item
    7. written informed consent obtained before starting any study-specific procedure
    boolean
    C0021430 (UMLS CUI [1])
    Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods | Contraceptives, Oral | Barrier Contraception Double | Intrauterine Devices | Intramuscular injection for birth control
    Item
    8. females of child-bearing potential must test negative on standard serum pregnancy test and must be willing to practice appropriate contraceptive methods for the duration of the study (e.g. oral contraceptive, double barrier method, intra-uterine device, intra-muscular contraceptive)
    boolean
    C3831118 (UMLS CUI [1,1])
    C0430061 (UMLS CUI [1,2])
    C3831118 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    C0009905 (UMLS CUI [3])
    C0004764 (UMLS CUI [4,1])
    C0205173 (UMLS CUI [4,2])
    C0021900 (UMLS CUI [5])
    C2078149 (UMLS CUI [6])
    Gender Contraceptive methods
    Item
    9. all male patients must take adequate contraceptive precautions during the course of the study
    boolean
    C0079399 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Life Expectancy
    Item
    1. life expectancy of less than three months
    boolean
    C0023671 (UMLS CUI [1])
    Lymphoma | Exception Diffuse Large B-Cell Lymphoma CD20 antigen positive
    Item
    2. any other lymphoma other than cd20+ dlbcl
    boolean
    C0024299 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0079744 (UMLS CUI [2,2])
    C3888518 (UMLS CUI [2,3])
    Indolent Lymphoma | Primary central nervous system lymphoma | Mucosa-Associated Lymphoid Tissue Lymphoma
    Item
    3. indolent lymphoma, primary central nervous system (cns) lymphoma or gastro-intestinal mucosa associated lymphoid tissue (malt) lymphoma
    boolean
    C1334170 (UMLS CUI [1])
    C0280803 (UMLS CUI [2])
    C0242647 (UMLS CUI [3])
    Hypersensitivity Active ingredient | Hypersensitivity Pharmaceutical Excipient | Hypersensitivity Murine protein | Hypersensitivity FOREIGN PROTEIN INJECTION
    Item
    4. known hypersensitivity to active ingredients, excipients and murine and foreign proteins
    boolean
    C0020517 (UMLS CUI [1,1])
    C1292749 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0015237 (UMLS CUI [2,2])
    C0020517 (UMLS CUI [3,1])
    C1699668 (UMLS CUI [3,2])
    C0020517 (UMLS CUI [4,1])
    C0239684 (UMLS CUI [4,2])
    Comorbidity Excludes Treatment Protocol | General status Excludes Treatment Protocol
    Item
    5. concurrent disease or general status that would exclude giving the treatment as outlined in the protocol
    boolean
    C0009488 (UMLS CUI [1,1])
    C0332196 (UMLS CUI [1,2])
    C0040808 (UMLS CUI [1,3])
    C0947124 (UMLS CUI [2,1])
    C0332196 (UMLS CUI [2,2])
    C0040808 (UMLS CUI [2,3])
    Communicable Disease Uncontrolled | Requirement Antibiotic therapy Systemic | Requirement Antiviral Agents Systemic | Recurrent infections | Virus Diseases Quantity | Bacterial Infections Quantity | Mycoses Quantity | Hospitalization Required
    Item
    6. active uncontrolled infection requiring systemic treatment with antibiotics or antiviral agents at screening or history of documented recurrent clinically significant infection (e.g. 2 or more viral, bacterial or fungal infections requiring inpatient treatment)
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C1514873 (UMLS CUI [2,1])
    C0338237 (UMLS CUI [2,2])
    C0205373 (UMLS CUI [2,3])
    C1514873 (UMLS CUI [3,1])
    C0003451 (UMLS CUI [3,2])
    C0205373 (UMLS CUI [3,3])
    C0239998 (UMLS CUI [4])
    C0042769 (UMLS CUI [5,1])
    C1265611 (UMLS CUI [5,2])
    C0004623 (UMLS CUI [6,1])
    C1265611 (UMLS CUI [6,2])
    C0026946 (UMLS CUI [7,1])
    C1265611 (UMLS CUI [7,2])
    C1708385 (UMLS CUI [8])
    Medical contraindication Cardiac Doxorubicin | Decompensated cardiac failure | Cardiomyopathy, Dilated | Coronary heart disease | ST segment depression ECG | Myocardial Infarction
    Item
    7. cardiac contra-indication to doxorubicin therapy: non-compensated heart failure, dilated cardiomyopathy, coronary heart disease with st segment depression on electrocardiogram (ecg), myocardial infarction in the last 6 months
    boolean
    C1301624 (UMLS CUI [1,1])
    C0018787 (UMLS CUI [1,2])
    C0013089 (UMLS CUI [1,3])
    C0581377 (UMLS CUI [2])
    C0007193 (UMLS CUI [3])
    C0010068 (UMLS CUI [4])
    C0520887 (UMLS CUI [5,1])
    C1623258 (UMLS CUI [5,2])
    C0027051 (UMLS CUI [6])
    Medical contraindication Neurologic Vincristine | Peripheral Neuropathy
    Item
    8. neurologic contra-indication to vincristine as it is indicated in the smpc: (e.g. peripheral neuropathy)
    boolean
    C1301624 (UMLS CUI [1,1])
    C0205494 (UMLS CUI [1,2])
    C0042679 (UMLS CUI [1,3])
    C0031117 (UMLS CUI [2])
    Chronic lung disease | Hypoxemia Measurement | Other Coding
    Item
    9. chronic lung disease with hypoxemia measured by saturometer (gasometry is not mandatory)
    boolean
    C0746102 (UMLS CUI [1])
    C0700292 (UMLS CUI [2,1])
    C0242485 (UMLS CUI [2,2])
    C3846158 (UMLS CUI [3])
    Uncontrolled hypertension Severe | Treatment Optimal
    Item
    10. severe uncontrolled hypertension, despite optimal medical treatment
    boolean
    C1868885 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C2698651 (UMLS CUI [2,2])
    Uncontrolled diabetes mellitus Severe | Treatment Optimal
    Item
    11. severe uncontrolled diabetes mellitus, despite optimal medical treatment
    boolean
    C0421258 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C2698651 (UMLS CUI [2,2])
    Renal Insufficiency | Serum creatinine raised
    Item
    12. renal insufficiency (serum creatinine>2xunl)
    boolean
    C1565489 (UMLS CUI [1])
    C0700225 (UMLS CUI [2])
    Hepatic Insufficiency Independent of Lymphoma | Aspartate aminotransferase increased | Alanine aminotransferase increased | Involvement with Liver | Serum total bilirubin measurement
    Item
    13. hepatic insufficiency (aspartate aminotransferase [ast]/alanine aminotransferase [alt] >3xunl or >5xunl with involvement of the liver, total bilirubin >34.2 µmol/l, or both) not related to lymphoma
    boolean
    C1306571 (UMLS CUI [1,1])
    C0332291 (UMLS CUI [1,2])
    C0024299 (UMLS CUI [1,3])
    C0151904 (UMLS CUI [2])
    C0151905 (UMLS CUI [3])
    C1314939 (UMLS CUI [4,1])
    C0023884 (UMLS CUI [4,2])
    C1278039 (UMLS CUI [5])
    Sign or Symptom Cerebral dysfunction
    Item
    14. clinical signs of cerebral dysfunction
    boolean
    C3540840 (UMLS CUI [1,1])
    C0262405 (UMLS CUI [1,2])
    Mental Disorder, Severe
    Item
    15. severe psychiatric disease
    boolean
    C4046029 (UMLS CUI [1])
    HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic
    Item
    16. known human immunodeficiency virus (hiv) infection or active chronic hepatitis b or c
    boolean
    C0019693 (UMLS CUI [1])
    C0524909 (UMLS CUI [2])
    C0524910 (UMLS CUI [3])
    Bone Marrow function Abnormal | Platelet Count measurement | Neutrophil count | Hemoglobin measurement
    Item
    17. abnormal bone marrow function (platelets <100x109/l, neutrophils <1.5x109/l and haemoglobin <9g/dl)
    boolean
    C0005953 (UMLS CUI [1,1])
    C0031843 (UMLS CUI [1,2])
    C0205161 (UMLS CUI [1,3])
    C0032181 (UMLS CUI [2])
    C0200633 (UMLS CUI [3])
    C0518015 (UMLS CUI [4])
    Post-transplant lymphoproliferative disease
    Item
    18. post-transplantation lymphoproliferative disease
    boolean
    C2367985 (UMLS CUI [1])
    Pregnancy | Breast Feeding | Pregnancy intended
    Item
    19. pregnant or lactating women or women that intend to get pregnant during study or within 12 months following the last infusion
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0032961 (UMLS CUI [3,1])
    C1283828 (UMLS CUI [3,2])
    Investigational New Drugs
    Item
    20. treatment with any investigational product in the 30 days period before inclusion in the study
    boolean
    C0013230 (UMLS CUI [1])
    Prior radiation therapy Diffuse Large B-Cell Lymphoma
    Item
    21. prior radiotherapy to treat the dlbcl nhl
    boolean
    C0279134 (UMLS CUI [1,1])
    C0079744 (UMLS CUI [1,2])
    Protocol Compliance Limited
    Item
    22. limitation of the patient's ability to comply with the treatment or follow-up protocol
    boolean
    C0525058 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
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