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])
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])