natgillin/translations-raw huggingface dataset:
The most common infusion-related reaction symptoms/Preferred Terms included headaches, chills, high blood pressure, nausea, asthenia and pain. 
Najpogostejši simptomi/prednostni izrazi z infundiranjem povezane reakcije so bili glavobol, mrzlica, visok krvni tlak, slabost, astenija in bolečina.
Examples of these serious viral infections are infections caused by the herpes viruses (Cytomegalovirus, Varicella Zoster Virus and Herpes Simplex Virus), JC virus (progressive multifocal leukoencephalopathy (PML)) and hepatitis C virus. 
Primeri teh resnih virusnih okužb so okužbe, ki jih povzročajo herpesvirusi (citomegalovirus, virus varicela zoster in virus herpes simpleks), virus JC (progresivna multifokalna levkoencefalopatija) in virus hepatitisa C. O smrtnih primerih PML, do katerih je prišlo po napredovanju bolezni in ponovnem zdravljenju, so poročali tudi v kliničnih preskušanjih.
Very rare cases of progressive multifocal leukoencephalopathy (PML) have been reported during post-marketing use of rituximab in NHL and CLL (see section 4.8). 
V obdobju trženja so bili med uporabo rituksimaba pri zdravljenju NHL in KLL opisani zelo redki primeri progresivne multifokalne levkoencefalopatije (PML) (glejte poglavje 4.8).
Time to new lymphoma treatment 
Čas do ponovnega protilimfomskega zdravljenja
Subsequent doses of Ritemvia can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h. 
Nadaljnje odmerke zdravila Ritemvia lahko dajemo z začetno hitrostjo 100 mg/h, ki jo lahko vsakih 30 minut povečujemo po 100 mg/h, dokler ne dosežemo največje hitrosti infundiranja 400 mg/h.
Rituximab mean clearance and volume of distribution were 0.313 L/day (range, 0.116 to 0.726 L/day) and 4.50 L (range 2.25 to 7.39 L) respectively. 
Povprečni očistek rituksimaba je bil 0,313 l/dan (razpon: od 0,116 do 0,726 l/dan, volumen porazdelitve pa 4,50 l (razpon: od 2,25 do 7,39 l).
Other serious ADRs reported include hepatitis B reactivation and PML (see section 4.4.) 
Med drugimi resnimi neželenimi učinki so poročali tudi o reaktivaciji virusa hepatitisa B in o PML (glejte poglavje 4.4).
The number of rituximab plus low-dose prednisone patients off prednisone therapy or on minimal therapy (prednisone dose of 10 mg or less per day) compared to standard-dose prednisone patients over the 24-month treatment period shows a steroid-sparing effect of rituximab (Figure 4). 
Število bolnikov z rituksimabom in majhnim odmerkom prednizona (brez prednizonskega zdravljenja ali z minimalnim zdravljenjem (odmerek prednizona 10 mg ali manj na dan)) v primerjavi z bolniki s standardnim odmerkom prednizona v obdobju 24-mesečnega zdravljenja kaže, da zdravilo rituksimab zmanjša potrebo po kortikosteroidih (slika 4).
Persistent depressive disorder Major depression Irritability 
Psihiatrične motnje dolgotrajna depresivna motnja velika depresija razdražljivost
The overall response rate (ORR) in the intent-to-treat (ITT) population was 48% (CI95% 41% - 56%) with a 6% complete response (CR) and a 42% partial response (PR) rate. 
Celokupen odgovor (ORR, overall response rate) v populaciji z namenom zdraviti (ITT, the intent-totreat) je bil 48 % (95-% interval zaupanja 41−56 %), od tega popoln odgovor (CR, complete response) pri 6 %, delni odgovor (PR, partial response) pa pri 42 %.
The most commonly reported serious infection in the rituximab group was mild or moderate bronchitis. 
Najpogosteje zabeležena resna okužba v skupini bolnikov, ki so prejemali zdravilo rituksimab, je bil blag ali zmeren bronhitis.
The safety of immunisation with live viral vaccines following rituximab therapy has not been studied. 
Varnosti imunizacije z živimi virusnimi cepivi po zdravljenju z zdravilom Ritemviarituksimab niso proučevali.
Ritemvia contains sodium 
Zdravilo Ritemvia vsebuje natrij
There was no increased rate in overall infections or serious infections after the development of low IgG or IgM (see section 4.4). 
Potem, ko je prišlo do znižanja IgG in IgM, se delež vseh okužb ali resnih okužb ni povišal (glejte poglavje 4.4).
Maintenance doses of 500 mg IV were administered at months 12 and 18. 
Vzdrževalna odmerka 500 mg intravensko sta bila uporabljena 12. in 18. mesec.
Rituximab was administered at a dosage of 375 mg/m2 during the first cycle one day prior to chemotherapy and at a dosage of 500 mg/m2 on day 1 of each subsequent treatment cycle. 
Rituksimab so v prvem ciklu zdravljenja dajali v odmerku 375 mg/m2 en dan pred kemoterapijo in v odmerku 500 mg/m2 1. dan vsakega naslednjega cikla zdravljenja.
In the clinical trial evaluating rituximab maintenance treatment in relapsed/refractory follicular lymphoma, median IgG levels were below the lower limit of normal (LLN) (< 7 g/L) after induction treatment in both the observation and the rituximab groups. 
V kliničnem preskušanju za oceno vzdrževalnega zdravljenja z rituksimabom pri ponovitvi folikularnih limfomov ali neodzivni bolezni je bila mediana koncentracije IgG po indukcijskem zdravljenju pod spodnjo mejo normalne vrednosti (SMN) (< 7 g/L) tako v opazovani skupini kot v skupini z rituksimabom.
The clinical relevance of ADA formation in rituximab-treated PV patients is unclear. 
Klinični pomen nastanka ADA pri bolnikih z navadnim pemfigusom, zdravljenih z rituksimab, ni jasen.
Clinical experience in rheumatoid arthritis 
Klinične izkušnje pri revmatoidnem artritisu
95% CIb 
95-% IZb
Investigations decreased IgM levels4 
Preiskave zmanjšane koncentracije IgM4
Treatment with R-CVP significantly prolonged the time to disease progression or death compared to CVP, 33.6 months and 14.7 months, respectively (p < 0.0001, log-rank test). 
Zdravljenje z R-CVP je značilno podaljšalo čas do napredovanja bolezni ali smrti v primerjavi s CVP (33,6 meseca v primerjavi s 14,7 meseca, p < 0,0001, log-rang test).
In a trial designed to evaluate the safety of a more rapid rituximab infusion in patients with rheumatoid arthritis, patients with moderate-to-severe active RA who did not experience a serious IRR during or within 24 hours of their first studied infusion were allowed to receive a 2-hour intravenous infusion of rituximab. 
V študiji, osnovani za proučitev varnosti hitrejše infuzije rituksimaba pri bolnikih z revmatoidnim artritisom, so bolniki z zmerno do hudo aktivnim revmatoidnim artritisom, ki niso imeli resne reakcije, povezane z infuzijo, med ali v 24 urah po prvem infundiranju, lahko prejeli 2-urno intravensko infuzijo rituksimaba.
In studies evaluating rituximab in combination with chemotherapy, the incidence of grade 3 and 4 cardiac arrhythmias, predominantly supraventricular arrhythmias such as tachycardia and atrial flutter/fibrillation, was higher in the R-CHOP group (14 patients, 6.9%) as compared to the CHOP group (3 patients, 1.5%). 
V študijah z rituksimabom v kombinaciji s kemoterapijo je bila incidenca motenj srčnega ritma 3. ali 4. stopnje, predvsem supraventrikularnih aritmij, kot sta tahikardija in atrijska fibrilacija/undulacija, višja v skupini R-CHOP (14 bolnikov, 6,9%) kot pa v skupini CHOP (3 bolniki, 1,5%).
(≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100) and very rare (< 1/10000). 
(≥ 1/100 do < 1/10), občasna (> 1/1000 do ≤ 1/100) in zelo redka (≤ 1/10000).
2) Last tumour response as assessed by the investigator. 
1) Ocene so izračunane z razmerjem ogroženosti 2) Zadnji odgovor na zdravljenje, ki ga je določil raziskovalec.
Rituximab induces B-cell depletion in about 70-80% of patients, but was associated with decreased serum immunoglobulins only in a minority of patients. 
Rituksimab je pri 70 do 80 % bolnikov povzročil zmanjšanje števila celic B, z zmanjšanjem koncentracije imunoglobulinov v serumu pa je bilo povezano le malo primerov.
The overall safety profile of rituximab in non-Hodgkin's lymphoma and CLL is based on data from patients from clinical trials and from post-marketing surveillance. 
Celotni varnostni profil rituksimaba pri ne-Hodgkinovem limfomu in kronični limfocitni levkemiji (KLL) temelji na podatkih bolnikov iz kliničnih preskušanj in iz nadzora med obdobjem trženja.
• The need to check, prior to Ritemvia treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system and recent history of, or planned, vaccination 
• informacije o nujnosti, da pred dajanjem zdravila Ritemvia preverijo, ali je bolnik morda okužen, imunsko oslabljen, ali jemlje zdravila, ki vplivajo na imunski sistem, ali jih je jemal v preteklosti, ali se je nedavno cepili oziroma to namerava,
53-months p=0.029 
53 mesecev p = 0,029
% HAQ‐DI MCID Mean change in FACIT‐T 
% bolnikov z MCID v HAQ-DI Povprečna sprememba FACIT-T
The rate of serious infections did not show any significant increase following multiple courses of rituximab. 
Delež resnih okužb se z nadaljnjimi cikli zdravljenja z rituksimabom ni pomembno povečeval.
Kaplan Meier estimates of the median duration of event-free survival were 35 months in the R-CHOP arm compared to 13 months in the CHOP arm, representing a risk reduction of 41%. 
Kaplan-Meierjeva ocena mediane trajanja preživetja brez dogodkov po Kaplan-Meierju je bila 35 mesecev v skupini R-CHOP v primerjavi s 13 meseci v skupini CHOP; to pomeni zmanjšanje tveganja za dogodke za 41%.
During this time, 81% of patients, from the original placebo group received rituximab between weeks 24 and 56, under an open label extension study protocol. 
Med tem časom je 81% bolnikov, ki so prvotno dobivali placebo, v sklopu odprte, podaljšane faze študije prejelo rituksimab med 24. in 56. tednom.
Events of neutropenia were observed with rituximab treatment, the majority of which were transient and mild or moderate in severity. 
Pri zdravljenju z rituksimabom so opazili dogodke nevtropenije, ki so bili večinoma prehodni in po resnosti blagi ali zmerni.
Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease (see section 4.4 regarding other cardiovascular diseases). 
neobvladljiva bolezen srca (glejte poglavje 4.4 glede drugih srčno-žilnih bolezni).
Whether rituximab is excreted in human milk is not known. 
Ni znano, ali se rituksimab izloča v materino mleko.
In a further clinical study, a total of 57 severe active GPA and MPA patients in disease remission were treated with rituximab for the maintenance of remission (see section 5.1) 
V nadaljnji klinični študiji so skupno 57 bolnikov s hudo aktivno GPA in MPA v remisiji bolezni zdravili z rituksimab za vzdrževanje remisije (glejte poglavje 5.1).
Infectious events (predominantly bacterial and viral) occurred in approximately 30-55% of patients during clinical trials in patients with NHL and in 30-50% of patients during clinical trials in patients with CLL 
Okužbe (predvsem bakterijske in virusne) so v kliničnih preskušanjih opazili pri 30-55 % bolnikov z neHodgkinovim limfomom in pri 30-50% bolnikov s KLL.
Infusion-related reactions2 1 Events were considered ADRs only after thorough assessment and where a causal relationship between the medicinal product and the adverse event was at least a reasonable possibility. 
1 Dogodke so kot neželene učinke ocenili šele po natančni oceni in v primerih, v katerih je bila vzročna povezanost med zdravilom in neželenim učinkom vsaj smiselna možnost.
• changes in the rhythm of the heart, or the heart beating faster than normal 
• spremembe v srčnem ritmu ali hitrejše (kot je običajno) bitje srca.
The complete response rate after cycle 8 was 76.2% in the R-CHOP group and 62.4% in the CHOP group (p=0.0028). 
Po 8 ciklih zdravljenja je bil popolni odgovor v skupini R-CHOP 76,2%, v skupini CHOP pa 62,4 % (p=0,0028).
The most frequently observed adverse drug reactions (ADRs) in patients receiving rituximab were IRRs which occurred in the majority of patients during the first infusion. 
Najpogosteje opaženi neželeni učinek pri prejemnikih rituksimaba so bile z infuzijo povezane reakcije, ki so se pri večini bolnikov pojavile med prvo infuzijo.
99 patients were treated for induction of remission of GPA and MPA in a clinical trial with rituximab (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see section 5.1). 
Devetindevetdeset bolnikov so za indukcijo remisije GPA in MPA zdravili z rituksimabom (375 mg/m2 enkrat na teden 4 tedne) in z glukokortikoidi (glejte poglavje 5.1).
Serious IRRs were uncommon (0.5% of patients) and were predominantly seen during the initial course. 
Resne z infuzijo povezane reakcije so bile občasne (0,5 % bolnikov) in so se večinoma pojavile med prvim ciklom zdravljenja.
Although subgroups were small, rituximab maintenance treatment provided a significant benefit in terms of overall survival for both patients responding to CHOP and patients responding to R-CHOP, although longer follow-up is required to confirm this observation. 
Čeprav so bile podskupine majhne, je vzdrževalno zdravljenje z rituksimabom pomembno povečalo korist v smislu celokupnega preživetja za bolnike, odzivne na CHOP in R-CHOP.
The most frequent ADRs following receipt of rituximab in clinical studies were IRRs (refer to Table 2). 
Najpogostejši neželeni učinki po prejemu rituksimaba v kliničnih preskušanjih so bile reakcije, povezane z infuzijo (glejte preglednico 2).
No patients in the rituximab arm had fatal adverse events. 
Noben bolnik v skupini z rituksimab ni imel neželenih učinkov s smrtnim izidom.
Hepatitis B virus (HBV) screening should be performed in all patients before initiation of treatment with rituximab. 
Pri vseh bolnikih je treba pred začetkom zdravljenja z zdravilom rituksimab narediti presejalni test na virus hepatitisa B (HBV).
• The importance of sharing this information with their partner or caregiver 
• pomembno dejstvo, da te informacije delijo s svojim partnerjem ali skrbnikom, • informacije o opozorilni kartici za bolnika.
Ritemvia, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA). 
Zdravilo Ritemvia je v kombinaciji z glukokortikoidi indicirano za zdravljenje odraslih bolnikov s hudo, aktivno granulomatozo s poliangiitisom (GPA, Wegenerjevo granulomatozo) in z mikroskopskim poliangiitisom (MPA).
Patients who experience overdose should have immediate interruption of their infusion and be closely monitored. 
Pri bolnikih, pri katerih pride do prevelikega odmerjanja, je treba infundiranje nemudoma prekiniti; bolnike pa skrbno nadzorovati.
The most common symptoms were allergic reactions like headache, pruritus, throat irritation, flushing, rash, urticaria, hypertension, and pyrexia. 
Najpogostejši simptomi so bile alergijske reakcije, kot so glavobol, pruritus, draženje žrela, pordevanje, kožni izpuščaj, urtikarija, hipertenzija in pireksija.
late neutropenia2 
pozna nevtropenija2
cranial neuropathy, loss of other senses5 
kranialna nevropatija, poslabšanje drugih čutov5
• The other ingredients are sodium chloride, tri-sodium citrate dihydrate, polysorbate 80 and water for injections. 
• Druge sestavine zdravila so natrijev klorid, trinatrijev citrat dihidrat, polisorbat 80 in voda za injekcije.
Rituximab is associated with infusion-related reactions, which may be related to release of cytokines and/or other chemical mediators. 
Zdravilo rituksimab lahko povzroči reakcije, povezane z infuzijo, ki nastanejo zaradi sprostitve citokinov in/ali drugih kemičnih mediatorjev.
late neutropenia2 serum sickness-like reaction 
pozna nevtropenija2 reakcija, podobna serumski bolezni
During maintenance treatment, the incidence of grade 3/4 cardiac disorders was comparable between patients treated with rituximab and observation. 
Med vzdrževalnim zdravljenjem je bila incidenca srčnih bolezni 3. ali 4. stopnje med bolniki, zdravljenimi z rituksimabom, in opazovano skupino primerljiva.
In the clinical trial on induction of remission, cardiac events occurred at a rate of approximately 273 per 100 patient years (95% CI 149-470) at the 6-month primary endpoint. 
V kliničnem preskušanju indukcije remisije je bil delež pojavljanja srčnih dogodkov na primarni končni točki po 6 mesecih približno 273 na 100 bolnik-let (95-% interval zaupanja, 149-470).
If you have granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris also tell your doctor 
Če imate granulomatozo s poliangiitisom, mikroskopski poliangiitis ali navadni pemfigus, zdravniku povejte tudi:
Body system Adverse Event 
Telesni sistem Neželeni učinek
Hazard ratio (95% CI) 
Razmerje ogroženosti (95% CI)
• reduced platelets number just after the infusion - this can be reversed, but can be fatal in rare cases 
zmanjšanje števila belih krvnih celic, ki se ne pojavi takoj, zmanjšanje števila trombocitov tik po infundiranju zdravila - to je mogoče odpraviti, a v redkih primerih je lahko smrtno,
serious viral infection2 pneumocystis jirovecii 
resna virusna okužba2, pnevmocisto za (Pneumocys tis jirovecii)
EFS - Event Free Survival TTP - Time to progression or death PFS - Progression-Free Survival TTF - Time to Treatment Failure OS rates - survival rates at the time of the analyses 
TTP: čas do napredovanja bolezni ali smrti (Time to progression or death) PFS: preživetje brez napredovanja bolezni (Progression-Free Survival) TTF: čas do neuspeha zdravljenja (Time to Treatment Failure) Deleži OS (celokupnega preživetja - Overall survival): deleži preživetja ob času analiz ORR: celokupni odgovor (Overall Response Rate)
The final analysis confirmed that RCHOP treatment was associated with a clinically relevant and statistically significant improvement in the duration of event-free survival (the primary efficacy parameter; where events were death, relapse or progression of lymphoma, or institution of a new anti-lymphoma treatment) (p=0.0001). 
Končna analiza je potrdila, da je bilo zdravljenje z R-CHOP povezano s klinično pomembnim in statistično značilnim podaljšanjem trajanja preživetja brez dogodkov (primarni parameter učinkovitosti; dogodki so bili smrt, ponovitev bolezni ali napredovanje limfoma, ali uvedba novega protilimfomskega zdravljenja) (p=0,0001).
• low number of red blood cells (anaemia), low number of all blood cells 
majhno število rdečih krvnih celic (anemija), majhno število vseh krvnih celic, alergijske reakcije (preobčutljivost),
Aseptically withdraw the necessary amount of Ritemvia, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/mL (0.9%) solution for injection or 5% D-Glucose in water. 
Aseptično odvzamemo potrebno količino rituksimaba in jo razredčimo, da dobimo izračunano koncentracijo od 1 do 4 mg/ml rituksimaba v infuzijski vrečki, ki vsebuje sterilno apirogeno 0,9-%
Serious infections, including fatalities, can occur during therapy with rituximab (see section 4.8). 
Med zdravljenjem z zdravilom rituksimab se lahko pojavijo resne okužbe, vključno s smrtnimi (glejte poglavje 4.8).
The recommended dosage is 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles after intravenous infusion of the glucocorticoid component of CHOP. 
Priporočeni odmerek 375 mg/m2 telesne površine damo prvi dan vsakega cikla kemoterapije po intravenski infuziji glukokortikoidne sestavine CHOP.
Exacerbations of pre-existing cardiac conditions such as angina pectoris or congestive heart failure or severe cardiac disorders (heart failure, myocardial infarction, atrial fibrillation), pulmonary oedema, multi-organ failure, tumour lysis syndrome, cytokine release syndrome, renal failure, and respiratory failure were reported at lower or unknown frequencies. 
Poslabšanje obstoječih bolezenskih stanj srca, kot je angina pektoris ali kongestivno srčno popuščanje, ali hude srčne bolezni (srčno popuščanje, miokardni infarkt, atrijska fibrilacija), pljučni edem, odpoved več organov, sindrom razpada tumorja, sindrom sproščanja citokinov, ledvična odpoved in odpoved dihal, so se pri bolnikih pojavili z nižjo ali neznano pogostnostjo.
In the first-line study, after a median observation time of 48.1 months, the median PFS was 55 months in the R-FC group and 33 months in the FC group (p < 0.0001, log-rank test). 
V študiji pri bolnikih v prvi liniji zdravljenja po mediani opazovanja 48,1 meseca je bila mediana preživetja brez napredovanja bolezni 55 mesecev v skupini R-FC in 33 mesecev v skupini FC (p < 0,0001, test log rank).
Rituximab was administered on the first day of the treatment cycle. 
Zdravilo rituksimab so prejeli prvi dan cikla zdravljenja.
Physicians should review the patient's vaccination status and follow current immunisation guidelines prior to rituximab therapy. 
Zdravniki morajo pred zdravljenjem z zdravilom rituksimab pregledati status cepljenja bolnikov in upoštevati veljavne smernice za cepljenje.
Table 8 Induction phase: overview of efficacy results for CHOP vs. R-CHOP (31 months median observation time) 
Indukcijsko zdravljenje: pregled rezultatov učinkovitosti CHOP v primerjavi z R-CHOP (mediana časa opazovanja 31 mesecev)
Ritemvia is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy. 
Zdravilo Ritemvia je indicirano za zdravljenje predhodno nezdravljenih bolnikov s III. in IV. stadijem folikularnih limfomov v kombinaciji s kemoterapijo.
Table 1 ADRs reported in clinical trials or during post-marketing surveillance in patients with NHL and CLL disease treated with rituximab monotherapy/maintenance or in combination with chemotherapy 
Neželeni učinki, opaženi med kliničnimi preskušanji ali med nadzorom v obdobju trženja pri bolnikih z NHL in KLL, ki so se zdravili z rituksimabom kot samostojnim/vzdrževalnim zdravljenjem ali v kombinaciji s kemoterapijo
The majority of these subjects were also exposed to cytotoxic chemotherapy. 
Večina teh bolnikov je hkrati prejemala tudi citotoksično kemoterapijo.
Infusion-related adverse reactions of all kinds have been observed in 77% of patients treated with rituximab (including cytokine release syndrome accompanied by hypotension and bronchospasm in 10% of patients) see section 4.8. 
Z infuzijo povezane neželene reakcije vseh vrst so opazili pri 77% bolnikov, ki so se zdravili z rituksimabom (vključno s sindromom sproščanja citokinov, ki sta ga spremljala hipotenzija in bronhospazem pri 10% bolnikov), glejte poglavje 4.8.
Rituximab maintenance treatment significantly prolonged median PFS in patients responding to CHOP induction therapy (median PFS 37.5 months vs. 11.6 months, p< 0.0001) as well as in those responding to R-CHOP induction (median PFS 51.9 months vs. 22.1 months, p=0.0071). 
Vzdrževalno zdravljenje z rituksimabom je pomembno podaljšalo mediano PFS pri bolnikih, odzivnih na indukcijsko zdravljenje s CHOP (mediana PFS 37,5 meseca v primerjavi z 11,6 meseca, p < 0,0001), kot tudi pri bolnikih, odzivnih na indukcijsko zdravljenje z R-CHOP (mediana PFS 51,9 meseca v primerjavi z 22,1 meseca, p=0,0071).
The difference between the treatment groups with respect to overall survival showed a significant clinical difference (p=0.029, log-rank test stratified by centre): survival rates at 53 months were 80.9% for patients in the R-CVP group compared to 71.1% for patients in the CVP group． 
Razlika med terapevtskima skupinama glede celokupnega preživetja je pokazala značilno klinično razliko (p = 0,029, log-rang test s stratifikacijo po centru): po 53 mesecih je bil delež preživetja v skupini z R-CVP 80,9 % in v skupini s CVP 71,1 %.
Hazard Ratio (95% CI) 
Razmerje ogroženosti (95-% CI)
Induction of remission 
Indukcija remisije
Should non-live vaccinations be required whilst receiving rituximab therapy, these should be completed at least 4 weeks prior to commencing the next course of rituximab. 
Če je potrebno cepljenje z mrtvimi cepivi med zdravljenjem z zdravilom rituksimab, mora biti zaključeno najmanj 4 tedne pred začetkom naslednjega cikla zdravila rituksimab.
Overall, 4% of patients in the rituximab arm experienced adverse events leading to discontinuation. 
V celoti so 4% bolnikov v skupini z zdravilom rituksimab imeli takšne neželene učinke, ki so povzročili prenehanje uporabe zdravila.