FrancophonIA/ELRC3.0 huggingface dataset:
English: If a diagnosis of PML is suspected, patients should be referred to a specialist in PML and appropriate diagnostic measures for PML should be initiated.
Croatian: Ako se sumnja na PML, bolesnika je potrebno uputiti specijalisti za PML te započeti odgovarajuće dijagnostičke postupke za PML.
English: The other ingredient is mannitol (E421).
Croatian: Drugi sastojak je manitol (E421).
English: In the event of new or worsening pulmonary symptoms (e.g., cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients treated appropriately.
Croatian: U slučaju pojave novih ili pogoršanja postojećih plućnih simptoma (npr. kašalj, dispneja), bolesnicima se mora napraviti brza dijagnostička obrada te ih je potrebno liječiti na odgovarajući način.
English: * Grouping of more than one MedDRA preferred term.
Croatian: *Grupiranje više od jednog MedDRA preporučenog izraza.
English: A protocol-defined interim analysis (based on 249 TTP events) triggered early study termination for efficacy.
Croatian: Planom ispitivanja definirana privremena analiza (temeljeno na 249 TTP događaja) bila je okidač za prijevremeni završetak ispitivanja djelotvornosti.
English: Your doctor will work out your dose of bortezomib according to your height and weight (body surface area).
Croatian: Vaš će liječnik izračunati Vašu dozu lijeka bortezomib prema vašoj visini i težini (površini tijela).
English: Patients should be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML as part of the differential diagnosis of
Croatian: Bolesnike je potrebno redovito pratiti radi mogućnosti pojave novih ili pogoršanja postojećih neuroloških simptoma ili znakova koji mogu upućivati na PML, kao dio diferencijalne dijagnoze problema SŽS-a.
English: If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of Bortezomib Hospira must be considered unless the benefit of treatment clearly outweighs the risk.
Croatian: Ako se toksičnost ne povuče ili se ponovno pojavi pri najnižoj dozi, mora se razmotriti prestanak primjene lijeka Bortezomib Hospira, osim ako je korist od liječenja neupitno veća od rizika.
English: 56.4 mo (52.8, 60.9)
Croatian: 56,4 mjeseca (52,8; 60,9)
English: There was a trend towards prolonged overall survival favouring the BR-CAP group; the estimated 4-year survival rate was 53.9% in the R-CHOP group and 64.4% in the BR-CAP group.
Croatian: Postojao je trend prema produljenom ukupnom preživljenju u korist BR-CAP skupine; procijenjena stopa 4-godišnjeg preživljenja bila je 53,9% u R-CHOP skupini i 64,4% u BR-CAP skupini.
English: Thalidomide is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the thalidomide pregnancy prevention programme are met.
Croatian: Talidomid je kontraindiciran tijekom trudnoće i u žena s reproduktivnim potencijalom osim ako nisu zadovoljeni svi uvjeti talidomidskog programa prevencije trudnoće.
English: Vision abnormal*
Croatian: Često abnormalan vid*
English: Manufacturer Hospira UK Ltd.
Croatian: Proizvođač Hospira UK Ltd.
English: A vial is for single use only and the remaining solution must be discarded.
Croatian: Bočica je samo za jednokratnu primjenu, a preostalu otopinu treba baciti.
English: In the BTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
Croatian: U BTDx skupini 12% bolesnika bili su citogenetički svrstani u skupinu visokog rizika naspram 16% bolesnika u TDx skupini.
English: At 10 µM concentrations, bortezomib does not inhibit any of a wide variety of receptors and proteases screened and is more than 1,500-fold more selective for the proteasome than for its next preferable enzyme.
Croatian: U koncentraciji od 10 µM, bortezomib ne inhibira niti jedan od probranih raznih receptora i proteaza i pokazuje više nego 1500 puta veću selektivnost prema proteasomima nego sljedećem enzimu prema kojem ima afinitet.
English: • that Bortezomib Hospira is to be given only by IV or SC injections; no other route of administration is allowed
Croatian: • Bortezomib Hospira se primjenjuje samo putem i.v. ili s.c. injekcije; bilo koji drugi put primjene nije dozvoljen
English: The overall best response rate (CR + PR), to retreatment in 130 patients was 38.5% (95% CI: 30.1, 47.4).
Croatian: Ukupna najbolja stopa odgovora (CR + PR), na ponovljeno liječenje u 130 bolesnika, bila je 38,5% (95% CI: 30,1; 47,4).
English: ** Instrumental ADL: refers to preparing meals, shopping for groceries or clothes, using telephone, managing money, etc; *** Self care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medicinal products, and not bedridden.
Croatian: ** Instrumentalni ADL: odnosi se na pripremu obroka, kupnju namirnica ili odjeće, korištenje telefona, rukovanje novcem, itd; *** ADL samozbrinjavanja: odnosi se na kupanje, oblačenje i svlačenje, hranjenje, odlazak na toalet, uzimanje lijekova i ne odnosi se na bolesnike koji leže nepokretni u krevetu.
English: Sleep disorders and disturbances*
Croatian: Često poremećaji i smetnje spavanja*
English: The primary efficacy endpoint was TTP while the secondary efficacy endpoints were OS and ORR (CR+PR), using the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Croatian: Primarna mjera ishoda djelotvornosti bila je TTP dok su sekundarne mjere ishoda djelotvornosti bile OS i ORR (CR+PR), prema kriterijima Europske skupine za krv i transplantaciju srži (EBMT).
English: In the unlikely event of an overdose, your doctor will monitor you for side effects.
Croatian: U malo vjerojatnom slučaju predoziranja, liječnik će Vas pratiti radi nuspojava.
English: Treatment with bortezomib can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood.
Croatian: Liječenje bortezomibom vrlo često može uzrokovati smanjenje broja crvenih i bijelih krvnih stanica i krvnih pločica (trombocita) u krvi.
English: • If, after Bortezomib Hospira has been held, the toxicity does not resolve, as defined above, then Bortezomib Hospira must be discontinued.
Croatian: • Ako se, nakon prestanka primjene lijeka Bortezomib Hospira, toksičnost ne povuče, kako je definirano iznad, Bortezomib Hospira se mora prestati primjenjivati.
English: One hundred and thirty patients (≥ 18 years of age) with multiple myeloma who previously had at least partial response on a bortezomib -containing regimen were retreated upon progression.
Croatian: Stotinu i trideset bolesnika (≥ 18 godina starosti) s multiplim mijelomom koji su prethodno imali barem parcijalan odgovor na režim koji je uključivao bortezomib bili su ponovno liječeni nakon progresije.
English: This study met its primary objective of non-inferiority for response rate (CR+PR) after 4 cycles of single agent bortezomib for both the subcutaneous and intravenous routes, 42% in both groups.
Croatian: Ovo ispitivanje doseglo je svoj primarni cilj, neinferiornost u stopi odgovora (CR+PR) nakon 4 ciklusa samostalno primijenjenog bortezomiba i za supkutanu i za intravensku primjenu, 42% u obje skupine.
English: Decreased appetite
Croatian: Vrlo često smanjeni apetit
English: A hazard ratio < 1 indicates an advantage for BR-CAP.
Croatian: Omjer hazarda < 1 ukazuje na prednost za BR-CAP.
English: Bortezomib was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered medicinal product in Block 3.
Croatian: Bortezomib je bio primijenjen samo u 1. i 2. bloku zbog izbjegavanja mogućeg preklapanja toksičnosti s istodobno primijenjenim lijekovima u 3. bloku.
English: Bortezomib Hospira should be discontinued if serious reactions occur.
Croatian: Primjena bortezomiba mora se prekinuti ako se pojave ozbiljne reakcije.
English: Bortezomib Hospira must be reconstituted by a healthcare professional (see section 6.6).
Croatian: Bortezomib Hospira mora rekonstituirati zdravstveni radnik (vidjeti dio 6.6).
English: Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BDx groups respectively; the majority of patients underwent one single transplant procedure.
Croatian: Autologne transplantate matičnih stanica primilo je 198 (82%) bolesnika, odnosno 208 (87%) bolesnika u VDDx, odnosno BDx skupinama; većina bolesnika prošla je samo jednu transplantaciju.
English: Exposure of bortezomib (dose-normalised AUC and Cmax) was comparable among all the groups (see section 4.2).
Croatian: Izloženost bortezomibu (prema dozi normalizirani AUC i Cmax) bila je usporediva unutar svih skupina (vidjeti dio
English: Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264).
Croatian: Periferna neuropatija stupnja ≥ 3 pojavila se u 6% bolesnika u skupini liječenoj supkutano, u usporedbi sa 16% u skupini liječenoj intravenski (p=0,0264).
English: Time to first response in CR + PR Median
Croatian: Vrijeme do prvog odgovora u CR + PR
English: Day 1, 4
Croatian: 1., 4. dan
English: Both in patients who were refractory to their last prior therapy and those who were not refractory, overall survival was significantly longer and response rate was significantly higher on the bortezomib arm.
Croatian: I u bolesnika koji su bili refraktorni na zadnje prethodno liječenje i onih koji nisu bili refraktorni, ukupno preživljenje bilo je značajno dulje i stopa odgovora bila je značajno viša u skupini koja je primala bortezomib.
English: 42.9% and 10.4% of patients in the BR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively.
Croatian: 42,9% i 10,4% bolesnika u BR-CAP skupini bilo je u dobi unutar raspona 65-74 godina odnosno ≥ 75 godina starosti.
English: When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see Pregnancy and breast-feeding in this section).
Croatian: Kada se primjenjuje talidomid, potrebna je posebna pažnja vezana uz testiranje na trudnoću i mjere prevencije (vidjeti Trudnoća i dojenje u ovom dijelu).
English: Table 11: Efficacy results following the final survival update to VISTA study Efficacy endpoint
Croatian: Tablica 11: Rezultati djelotvornosti nakon finalnog ažuriranja podataka o preživljenju u ispitivanju VISTA
English: Also included are adverse drug reactions identified in the BR-CAP arm that were considered by investigators to have at least a possible or probable causal relationship to bortezomib based on historical data in the multiple myeloma studies.
Croatian: Također su uključene nuspojave identificirane u skupini BR-CAP za koje su ispitivači smatrali da imaju barem moguću ili vjerojatnu uzročnu povezanost s bortezomibom na temelju podataka iz prošlosti u ispitivanjima multiplog mijeloma.
English: Median survival for the B+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Croatian: Medijan preživljenja za skupinu koja je primala B+M+P bio je 56,4 mjeseci u odnosu na 43,1 za skupinu koja je primala M+P.
English: Bortezomib Hospira should not be used during pregnancy unless the clinical condition of the woman requires treatment with Bortezomib Hospira.
Croatian: Bortezomib Hospira se ne smije primjenjivati tijekom trudnoće, osim ako kliničko stanje žene ne zahtijeva liječenje lijekom Bortezomib Hospira.
English: A statistically significant benefit (p < 0.001) in favour of the BR-CAP treatment group over the R-CHOP group was observed for TTP (median 30.5 versus 16.1 months), TNT (median 44.5 versus 24.8 months) and TFI (median 40.6 versus 20.5 months).
Croatian: Statistički značajna korist (p < 0,001) za BR-CAP liječenu skupinu u odnosu na R-CHOP skupinu bila je zapažena za TTP (medijan 30,5 naspram 16,1 mjesec), TNT (medijan 44,5 naspram 24,8 mjeseci) i TFI (medijan 40,6 naspram 20,5 mjeseci).
English: • instructions for prescribing and administration including the cycles' length and number of cycles, to minimise the risk of medication and dispensing errors potentially induced by the existence of the two different bortezomib combination regimens in the Transplant Induction Setting (Bortezomib plus dexamethasone, and Bortezomib plus dexamethasone and thalidomide).
Croatian: • upute za propisivanje i primjenu koje uključuju duljinu i broj ciklusa, radi smanjenja rizika medikacijskih pogrešaka i pogrešaka pri pripremi moguće uzrokovane zbog postojanja dva različita režima kombinacije s bortezomibom u transplantiranih bolesnika (bortezomib plus deksametazon i bortezomib plus deksametazon i talidomid).
English: Normal liver function should be confirmed and caution should be exercised in patients receiving oral hypoglycaemics (see section 4.5).
Croatian: Potrebno je potvrditi normalnu funkciju jetre i s oprezom pristupiti bolesnicima koji uzimaju oralne hipoglikemike (vidjeti dio 4.5).
English: The primary efficacy endpoint was progression-free survival based on Independent Review Committee (IRC) assessment.
Croatian: Primarni ishod djelotvornosti bilo je preživljenje bez progresije na temelju ocjene Neovisnog ocjenjivačkog povjerenstva (od engl.
English: In the BR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
Croatian: U BR-CAP skupini, 22,5% bolesnika primilo je transfuzije trombocita u usporedbi s 2,9% bolesnika u R-CHOP skupini.
English: Peripheral neuropathy in combination regimens
Croatian: Periferna neuropatija u kombiniranim režimima Multipli mijelom
English: Since dialysis may reduce bortezomib concentrations, Bortezomib Hospira should be administered after the dialysis procedure (see section 5.2).
Croatian: Budući da dijaliza može smanjiti koncentracije bortezomiba, Bortezomib Hospira se treba primijeniti nakon postupka dijalize (vidjeti dio 5.2).
English: It is recommended that patients receive 2 cycles of Bortezomib Hospira following a confirmation of a complete response.
Croatian: Preporučuje se da bolesnici prime još 2 ciklusa liječenja lijekom Bortezomib Hospira nakon potvrđenog kompletnog odgovora.
English: All grade peripheral neuropathy and grade ≥ 3 peripheral neuropathy were observed in 40% and 8.5% of patients, respectively.
Croatian: Periferna neuropatija svih stupnjeva i periferna neuropatija stupnja ≥ 3 bile su uočene u 40%, odnosno 8,5% bolesnika.
English: # Post-marketing adverse reaction regardless of indication
Croatian: # Nuspojave nakon stavljanja lijeka u promet bez obzira na indikaciju
English: The majority of the patients in both groups completed treatment, 80% in the BR-CAP group and 82% in the R-CHOP group.
Croatian: Većina bolesnika u obje skupine završila je liječenje, 80% u BR-CAP skupini i 82% u RCHOP skupini.
English: Response rate population e n=668
Croatian: Stopa odgovora populacija e n = 668
English: Carriers of hepatitis B and patients with a history of hepatitis B must be closely monitored for clinical and laboratory signs of active HBV infection during and following rituximab combination treatment with Bortezomib Hospira.
Croatian: Nositelji hepatitisa B i bolesnici s hepatitisom B u anamnezi moraju se strogo nadzirati na kliničke i laboratorijske znakove aktivne infekcije HBV-om tijekom i nakon kombiniranog liječenja rituksimabom i lijekom Bortezomib Hospira.
English: One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the BTDx and TDx groups, respectively.
Croatian: Samo jednu autolognu transplantaciju matičnih stanica primilo je 105 (81%) bolesnika, odnosno 78 (61%) bolesnika u BTDx i TDx skupini.
English: • Once dissolved, withdraw the appropriate amount of the reconstituted solution according to calculated dose based upon the patient´s Body Surface Area.
Croatian: Nakon što je otopljena, izvucite odgovarajuću količinu rekonstituirane otopine prema dozi izračunatoj na temelju bolesnikove površine tijela.
English: B= bortezomib M=melphalan, P=prednisone
Croatian: B =bortezomib; M = melfalan, P = prednizon
English: Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m2 dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations.
Croatian: Nakon intravenske bolusne ili supkutane injekcije u dozi od 1,3 mg/m primijenjene bolesnicima s multiplim mijelomom (n=14 u intravenskoj skupini, n=17 u supkutanoj skupini), ukupna sistemska izloženost nakon primjene ponovljenih doza (AUCtrajanja) bila je jednaka za supkutane i intravenske primjene.
English: As a result of a pre-planned interim analysis, the dexamethasone arm was halted at the recommendation of the data monitoring committee and all patients randomised to dexamethasone were then offered bortezomib, regardless of disease status.
Croatian: Kao posljedica unaprijed planirane privremene analize, skupini koja je primala deksametazon liječenje je zaustavljeno na preporuku povjerenstva za nadzor podataka i svim je bolesnicima nakon toga ponuđeno liječenje bortezomibom bez obzira na stanje bolesti.
English: • If several Bortezomib Hospira doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
Croatian: • Ako se prekine primjena nekoliko doza lijeka Bortezomib Hospira u jednom ciklusu (≥ 3 doze tijekom primjene dva puta tjedno ili ≥ 2 doze tijekom primjene jedanput na tjedan)
English: At the time of a pre-specified interim analysis, the primary endpoint, time to progression, was met and patients in the M+P arm were offered B+M+P treatment.
Croatian: U vrijeme unaprijed planirane privremene analize postigla se primarna mjera ishoda, vrijeme do progresije te je bolesnicima u M+P kraku ispitivanja bilo ponuđeno liječenje B+M+P.
English: 14.0 mo (11.1, 15.0)
Croatian: 14,0 mjeseci (11,1; 15,0)
English: Female patients of childbearing potential and male patients must use effective contraceptive measures during and for 3 months following treatment.
Croatian: Bolesnice reproduktivne dobi i muški bolesnici moraju koristiti učinkovitu kontracepciju tijekom liječenja i do 3 mjeseca nakon liječenja.
English: Hospira 1 mg, 2.5 mg, 3 mg and 3.5 mg.
Croatian: Hospira 1 mg, 2,5 mg, 3 mg i 3,5 mg.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing bortezomib in all subsets of the paediatric population in multiple myeloma and in mantle cell lymphoma (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja referentnog lijeka koji sadrži bortezomib u svim podskupinama pedijatrijske populacije u multiplom mijelomu i u limfomu plaštenih stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: This interim analysis showed a TTP risk reduction of 45 % (95 % CI; 29-57 %, p < 0.0001) for patients treated with combination therapy of bortezomib and pegylated liposomal doxorubicin.
Croatian: Ova privremena analiza je pokazala redukciju TTP rizika za 45% (95% CI; 29-57%, p < 0,0001) za bolesnike koji su liječeni kombinacijskom terapijom bortezomiba i pegiliranog liposomalnog doksorubicina.
English: OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p values by Cochran Mantel-Haenszel test.
Croatian: OR za stope odgovora temeljeno na Mantel-Haenszel procjeni zajedničkog omjera izlgleda za stratificirane tablice; pvrijednosti po Cochran Mantel-Haenszelovom testu.
English: A statistically significant survival benefit in favour of the B+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including bortezomib-based regimens.
Croatian: Primijećeno je statistički značajno veće preživljenje u skupini liječenoj s B+M+P (HR=0,695; p=0,00043) usprkos naknadnim terapijama koje uključuju liječenje bortezomibom.
English: PRES is a rare, often reversible, rapidly evolving neurological condition, which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances.
Croatian: PRES je rijetko neurološko stanje koje je često reverzibilno, brzo se razvija, a može biti predstavljeno napadajima, hipertenzijom, glavoboljom, letargijom, konfuzijom, sljepoćom i drugim poremećajima vida i neurološkim poremećajima.
English: Electrocardiogram investigations
Croatian: Elektrokardiografske pretrage
English: Suicidal ideation*, Adjustment disorder, Delirium, Libido decreased
Croatian: Rijetko suicidne misli*, poremećaj prilagodbe, delirij, smanjen libido
English: 1 mg/m 2, or from 1 mg/m 2 to 0.7 mg/m 2).
Croatian: 1 mg/m 2, ili s 1 mg/m 2 na 0,7 mg/m 2).
English: What Bortezomib Hospira looks like and contents of the pack Bortezomib Hospira powder for solution for injection is a white to off-white cake or powder.
Croatian: Kako Bortezomib Hospira izgleda i sadržaj pakiranja Bortezomib Hospira prašak za otopinu za injekciju je bijeli do gotovo bijeli kolačić ili prašak.
English: Additional adverse drug reactions identified associated with the use of the combination therapy (BR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Croatian: Dodatne identificirane nuspojave povezane s primjenom kombiniranog liječenja (BR-CAP) bile su infekcija hepatitisom B (< 1%) i ishemija miokarda (1,3%).
English: The following adverse reactions (Grade ≥ 3) were observed at a higher incidence in the bortezomib containing treatment regimen as compared with a historical control study in which the backbone regimen was given alone: in Block 1 peripheral sensory neuropathy (3% versus 0%); ileus (2.1% versus 0%); hypoxia (8% versus 2%).
Croatian: Sljedeće nuspojave (stupnja ≥ 3) zabilježene su u većoj incidenciji kod režima liječenja koji sadrži bortezomib u usporedbi s ispitivanjem s povijesnom kontrolom u kojem je osnovni režim davan samostalno: u 1. bloku periferna senzorna neuropatija (3% naspram 0%); ileus (2,1% naspram 0%); hipoksija (8% naspram 2%).
English: ≥ 1,500 cells/μL
Croatian: 1500 stanica/μl
English: The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511;95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Croatian: Analiza je pokazala poboljšani ORR (CR+PR) (omjer izgleda 3,769; 95% CI 2,045-6,947; p < 0,001), PFS (omjer hazarda 0,511; 95% CI 0,3090,845; p=0,008), TTP (omjer hazarda 0,385; 95% CI 0,212-0,698; p=0,001) za bortezomib u kombinaciji s deksametazonom nad monoterapijom bortezomibom.
English: • The reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Croatian: - Rekonstituirana otopina primjenjuje se supkutano u bedro (desno ili lijevo) ili abdomen (desnu ili lijevu stranu).
English: Kaplan-Meier estimate.
Croatian: c Temeljeno na Kaplan-Meierovim procjenama.
English: EBMT criteria All randomised patients with secretory disease
Croatian: EBMT kriteriji g Svi randomizirani bolesnici sa sekrecijskom bolešću.
English: Once weekly Bortezomib Hospira (cycles 5-9)
Croatian: Bortezomib Hospira jednom tjedno (5.-9. ciklus)
English: With a median duration of follow-up of 40 months, median OS (56.3 months in the R-CHOP group, and not reached in the BR-CAP group) favoured the BR-CAP group, (estimated HR=0.80; p=0.173).
Croatian: S medijanom trajanja praćenja od 40 mjeseci, medijan OS (56,3 mjeseci u R-CHOP skupini, i nije postignut u BRCAP skupini) bio je u korist BR-CAP skupine, (procijenjeni HR=0,80; p=0,173).
English: Bortezomib treatment is very commonly associated with haematological toxicities (thrombocytopenia, neutropenia and anaemia).
Croatian: Liječenje bortezomibom vrlo je često povezano s hematološkim toksičnostima (trombocitopenija, neutropenija i anemija).