FrancophonIA/ELRC3.0 huggingface dataset:
English: d p-value from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+) NA=not applicable, NE=not estimated TTP-Time to Progression
Slovenian: c Populacija oz. skupina bolnikov, pri kateri so ovrednotili odziv na zdravljenje, vključuje bolnike, ki so imeli merljivo bolezen na začetku in so prejeli najmanj en odmerek raziskovalnega zdravila d P-vrednost iz Cochran-Mantel-Haenszelovega hi-kvadrat testa, korigiranega s faktorji stratifikacije; v analizi po vrsti terapije ni bila vključena stratifikacija po terapevtski anamnezi * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+) NA=ne velja za ta primer, NE=odziva ni bilo mogoče oceniti TTP=čas do napredovanja bolezni CI=interval zaupanja
English: In multi-cycle general toxicity studies conducted in the rat and monkey, the principal target organs included the gastrointestinal tract, resulting in vomiting and/or diarrhoea; haematopoietic and lymphatic tissues, resulting in peripheral blood cytopenias, lymphoid tissue atrophy and haematopoietic bone marrow hypocellularity; peripheral neuropathy (observed in monkeys, mice and dogs) involving sensory nerve axons; and mild changes in the kidneys.
Slovenian: V raziskavah splošne toksičnosti z več krogi zdravljenja na podganah in opicah so bili poglavitni tarčni organi prebavila s posledičnim bruhanjem in/ali drisko ter krvotvorni organi s posledičnim zmanjšanjem števila krvnih celic v periferni krvi, zmanjšanjem limfatičnega tkiva ter hipocelularnostjo kostnega mozga, periferno nevropatijo (ki so jo opažali pri opicah, miših in psih) s prizadetostjo senzoričnih živčnih končičev in blagimi spremembami ledvic.
English: In patients developing PRES, bortezomib should be discontinued.
Slovenian: Če se pri bolniku razvije PML, je treba zdravljenje z bortezomibom prekiniti.
English: Caution is advised when treating patients with a history of syncope receiving medicinal products known to be associated with hypotension; or who are dehydrated due to recurrent diarrhoea or vomiting.
Slovenian: ki prejemajo zdravila, za katera je znano, da so povezana s pojavom hipotenzije, ali pri tistih, ki so dehidrirani zaradi ponavljajoče se driske ali bruhanja, svetujemo previdnost.
English: Special populations
Slovenian: populacija)
English: Mediana response duration
Slovenian: Medianaa trajanja odziva CRf
English: Electrocardiogram investigations
Slovenian: Elektrokardiogram (EKG)
English: The primary efficacy endpoints of the study were post-induction and post-transplant response rates (CR+nCR).
Slovenian: Primarna ocena učinkovitosti je bila stopnja odziva po uvedbi zdravljenja in po presaditvi (CR+nCR).
English: The protocol allowed patients to receive dexamethasone if they had had a less than optimal response to bortezomib alone.
Slovenian: V skladu s protokolom so bolniki lahko prejeli deksametazon, če ni bilo optimalnega odziva na zdravljenje z bortezomibom v monoterapiji.
English: An effective reinduction multiagent chemotherapy regimen was administered in 3 blocks.
Slovenian: Bolnikom so uvedli učinkovito indukcijsko kemoterapijo z več zdravili v 3 sklopih.
English: Serious adverse reactions uncommonly reported during treatment with bortezomib include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy syndrome, acute diffuse infiltrative pulmonary disorders and rarely autonomic neuropathy.
Slovenian: Med zdravljenjem z bortezomibom so občasno poročali o resnih neželenih učinkih - srčno popuščanje, sindrom razpada tumorja, pljučna hipertenzija, sindrom reverzne posteriorne encefalopatije, akutna difuzna infiltracijska pljučna stanja - in redko o avtonomni nevropatiji.
English: Patients receiving bortezomib in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide.
Slovenian: Bolniki, ki prejemajo bortezomib v kombinaciji s talidomidom, morajo upoštevati program preprečevanja nosečnosti, kot je predpisan pri talidomidu.
English: Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration (see section 4.2).
Slovenian: Če se zakasnitve krogov zdravljenja ponavljajo, je treba razmisliti o profilaktični uporabi granulocitne kolonije spodbujajočih faktorjev (glejte poglavje 4.2).
English: Such changes may be reversible upon discontinuation of bortezomib (see section 4.8).
Slovenian: Po prekinitvi zdravljenja z bortezomibom so te spremembe lahko reverzibilne (glejte poglavje 4.8).
English: There was a trend towards prolonged overall survival favouring the BzmbR-CAP group; the estimated 4-year survival rate was 53.9% in the R-CHOP group and 64.4% in the BzmbR-CAP group.
Slovenian: Ocenjena stopnja 4-letnega preživetja je bila v skupini R-CHOP 53,9 % in v skupini BzmbR-CAP
English: Your doctor will work out your dose of Bortezomib SUN according to your height and weight (body surface area).
Slovenian: Zdravnik bo določil odmerek na podlagi vaše telesne višine in mase (telesne površine).
English: Haematological toxicity during a cycle - If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle
Slovenian: Hematološka toksičnost med zdravljenjem - Če je bila v prejšnjem krogu zdravljenja opažena dolgotrajna nevtropenija 4. stopnje, trombocitopenija ali trombocitopenija in
English: Bilirubin level
Slovenian: Koncentracija bilirubina
English: For bortezomib-related neuropathic pain and/or peripheral neuropathy, hold and/or modify Bortezomib SUN as outlined in Table 1.
Slovenian: V primeru nevropatske bolečine in/ali periferne nevropatije, povezane z bortezomibom, zakasnite in/ali prilagodite odmerek zdravila Bortezomib SUN, kot je opisano v preglednici 1.
English: There have been isolated cases of QT-interval prolongation in clinical studies, causality has not been established.
Slovenian: Vzroka za podaljšanje QT-intervala niso ugotovili.
English: In study MMY-3010 induction treatment with bortezomib combined with thalidomide and dexamethasone [BzmbTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
Slovenian: V študiji MMY-3010 so primerjali uvajalno zdravljenje z bortezomibom v kombinaciji s talidomidom in deksametazonom [BzmbTDx, n=130] s kombinacijo talidomid-deksametazon [TDx, n=127].
English: MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV
Slovenian: 69 % bolnikov je imelo pozitivno aspiracijo kostnega mozga in/ali pozitivno biopsijo kostnega mozga za MCL, 54 % bolnikov je imelo vrednost mednarodnega prognostičnega indeksa (International Prognostic Index-IPI) ≥ 3 in 76 % bolnikov je bilo v IV. stadiju bolezni.
English: In the 6-month rat study, degenerative effects in both the testes and the ovary have been observed.
Slovenian: V 6-mesečni raziskavi na podganah so opažali degenerativne učinke tako na testise kot na ovarije, zato je verjetno, da bi bortezomib lahko vplival na plodnost samic ali samcev.
English: - Platelet counts should be ≥ 100,000 cells/μl and the absolute neutrophils count (ANC) should be ≥ 1,500 cells/μl
Slovenian: - Število trombocitov mora biti ≥ 100.000 celic/μl in celokupno število nevtrofilcev (ANC
English: The pharmacokinetics of bortezomib are not influenced in patients with mild to moderate renal impairment (Creatinine Clearance [CrCL] > 20 ml/min/1.73 m2); therefore, dose adjustments are not necessary for these patients.
Slovenian: Pri bolnikih z blago do zmerno okvaro ledvic (očistek kreatinina [CrCL] > 20 ml/min/1,73 m2) farmakokinetika bortezomiba ni spremenjena, zato pri njih ni treba prilagajati odmerka.
English: In trials in which bortezomib was administered as induction treatment in combination with dexamethasone (study IFM-2005-01), and dexamethasone-thalidomide (study MMY-3010), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Slovenian: Pojavnost periferne nevropatije v preskušanjih bortezomiba pri uvajalnem zdravljenju v kombinaciji z deksametazonom (študija IFM-2005-01) ter deksametazonom in talidomidom (študija MMY-3010) je navedena v spodnji preglednici:
English: Mediana (95% CI)
Slovenian: % (95 % CI)
English: • to report any adverse event, or medication error experienced with the administration of Bortezomib SUN 3.5 mg.
Slovenian: • Pomembnost sporočanja kakršnihkoli neželenih učinkov ali napak pri uporabi zdravila Bortezomib SUN 3,5 mg.
English: Patients should be instructed to seek medical advice if they experience symptoms of dizziness, light-headedness or fainting spells.
Slovenian: naj se posvetujejo z zdravnikom, če imajo simptome omotice, vrtoglavice ali napade nezavesti.
English: 18.3 mo
Slovenian: 18,3 meseca
English: Each carton of Bortezomib SUN 3.5 mg powder for solution for injection contains a clear glass 10 ml vial closed with a light green aluminium cap, in a transparent blister pack.
Slovenian: Ena škatla zdravila Bortezomib SUN 3,5 mg prašek za raztopino za injiciranje vsebuje prozorno stekleno 10 ml vialo s svetlo zeleno aluminijasto zaporko v prozornem pretisnem omotu.
English: The mean platelet count nadir measured was approximately 40% of baseline in the single-agent multiple myeloma studies and 50% in the MCL study.
Slovenian: Povprečna vrednost najnižjega izmerjenega števila trombocitov je v študijah diseminiranega plazmocitoma z uporabo ene učinkovine znašala približno 40 % in v študiji MCL 50 % začetne vrednosti.
English: T 100 mga
Slovenian: T 100 mga na dan na dan
English: In studies in patients with relapsed multiple myeloma treated with bortezomib and in patients with previously untreated MCL treated with bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
Slovenian: V študijah zdravljenja z bortezomibom pri bolnikih s ponovitvijo diseminiranega plazmocitoma in pri bolnikih z nezdravljenim MCL, v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (BzmbR-CAP), je bil eden od najpogostejših toksičnih učinkov na hematološki sistem prehodna trombocitopenija.
English: - Platelet counts should be ≥ 70 x 109/l and the absolute neutrophils count should be ≥ 1.0 x 109/l
Slovenian: Neutrophil Count) mora biti ≥ 1,0 x 109/l.
English: T 50 mg
Slovenian: T 50 mg na dan na dan
English: Dose adjustments for combination therapy for patients with progressive multiple myeloma For Bortezomib SUN dosage adjustments for combination therapy follow dose modification guidelines described under monotherapy above.
Slovenian: Prilagoditev odmerjanja pri kombiniranem zdravljenju bolnikov z diseminiranim plazmocitomom Za prilagoditev odmerjanja zdravila Bortezomib SUN pri kombiniranem zdravljenju upoštevajte navodila za samostojno zdravljenje, opisana zgoraj.
English: Deboronated-bortezomib metabolites are inactive as 26S proteasome inhibitors.
Slovenian: Presnovka, ki nastaneta po odcepitvi bora, ne delujeta kot zaviralca 26S-proteasoma.
English: Intent to Treat Populationb n=74
Slovenian: Populacija bolnikov, ki naj bi jo zdravili (ITT)b n=74
English: You may experience a reduction in the number of: - platelets, which may make you be more prone to bruising, or to bleeding without obvious injury (e.g., bleeding from your bowels, stomach, mouth and gum or bleeding in the brain or bleeding from the liver) - red blood cells, which can cause anaemia, with symptoms such as tiredness and paleness - white blood cells may make you more prone to infections or flu-like symptoms.
Slovenian: - krvnih ploščic, zaradi česar ste lahko bolj dovzetni za podplutbe ali krvavitve brez očitnih poškodb (npr.: krvavitve v črevesju, želodcu, ustih in dlesnih ali krvavitve v možganih ali jetrih); - rdečih krvnih celic, kar lahko vodi v anemijo, s simptomi, kot sta utrujenost in bledica; - belih krvnih celic, zato boste bolj dovzetni za okužbe ali gripi podobne simptome.
English: b Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
Slovenian: b Ocena razmerja tveganja na podlagi Coxovega modela, stratificirana z IPI-tveganjem in stadijem bolezni.
English: Bortezomib combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001) A Phase III randomised, parallel-group, open-label, multicentre study was conducted in 646 patients comparing the safety and efficacy of bortezomib plus pegylated liposomal doxorubicin versus bortezomib monotherapy in patients with multiple myeloma who had received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy.
Slovenian: Bortezomib v kombinaciji s pegiliranim liposomskim doksorubicinom (študija DOXIL-MMY-3001) Pri 646 bolnikih je bila opravljena randomizirana, odprta, multicentrična študija faze III pri vzporednih skupinah, v kateri so primerjali varnost in učinkovitost kombinirane terapije z bortezomibom in pegiliranim liposomskim doksorubicinom z monoterapijo z bortezomibom pri bolnikih z diseminiranim plazmocitomom, ki so že prejeli najmanj eno vrsto terapije in pri katerih bolezen ni napredovala med prejemanjem antraciklinske terapije.
English: No new safety concerns were observed during the study, and in particular bortezomib did not exacerbate target organ damage (heart, kidney and liver).
Slovenian: Uporaba bortezomiba ni povečala poškodb tarčnih organov (srce, ledvice, jetra).
English: Notable differences in the safety profile of bortezomib administered subcutaneously versus intravenously as single agent
Slovenian: Pomembne razlike v varnostnem profilu uporabe bortezomiba v monoterapiji subkutano oz.
English: Aseptic technique must be strictly observed throughout the handling of Bortezomib SUN, since it contains no preservative.
Slovenian: MED RAVNANJEM Z ZDRAVILOM BORTEZOMIB SUN MORATE VES ČAS STROGO UPOŠTEVATI ASEPTIČNO PRIPRAVO, SAJ ZDRAVILO NE VSEBUJE KONZERVANSA.
English: Clinical efficacy in relapsed or refractory multiple myeloma The safety and efficacy of bortezomib (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment.
Slovenian: Varnost in učinkovitost bortezomiba (injicirano intravensko) v priporočenem odmerku 1,3 mg/m2 so ovrednotili v dveh preskušanjih: v randomiziranem, primerjalnem (primerjava z deksametazonom (Dex)) preskušanju faze III (APEX) pri 669 bolnikih z relapsom ali z diseminiranim plazmocitomom, odpornim na zdravljenje, ki so pred tem že prejeli 1 do 3 vrste terapije ter v enodelnem preskušanju druge faze pri 202 bolnikih z relapsom ali z diseminiranim plazmocitomom, odpornim na zdravljenje, ki so pred tem že prejeli najmanj 2 vrsti terapije in je bolezen ob zadnji vrsti terapije napredovala.
English: Each vial contains 3.5 mg of bortezomib (as a mannitol boronic ester).
Slovenian: Ena viala vsebuje 3,5 mg bortezomiba (v obliki estra manitola in borove kisline).
English: (listed in section 6) - if you have certain severe lung or heart problems.
Slovenian: - če imate določene hude težave s pljuči ali srcem.
English: These may be signs of a serious brain infection and your doctor may suggest further testing and follow-up.
Slovenian: To so lahko znaki resne okužbe možganov.
English: Week Bzmb (1.3 mg/m2) Day 1, 4
Slovenian: Teden Bzmb (1,3 mg/m2) dan 1, 4
English: The most commonly reported adverse reactions during treatment with bortezomib are nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia, peripheral neuropathy (including sensory), headache, paraesthesia, decreased appetite, dyspnoea, rash, herpes zoster and myalgia.
Slovenian: Med zdravljenjem z bortezomibom so najpogosteje poročali o navzei, diareji, zaprtosti, bruhanju, utrujenosti, pireksiji, trombocitopeniji, anemiji, nevtropeniji, periferni nevropatiji (vključno s senzorično nevropatijo), glavobolu, paresteziji, zmanjšanem apetitu, dispneji, izpuščaju, virusu herpes zostru in mialgiji.
English: No clinical data are available for bortezomib with regard to exposure during pregnancy.
Slovenian: Nosečnost Za bortezomib ni na voljo kliničnih podatkov nosečnic, ki so bile izpostavljene zdravilu.
English: Bortezomib was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered drugs in Block 3.
Slovenian: Bolniki so prejeli zdravilo bortezomib le v 1. in 2. sklopu zdravljenja, da so izognili prekrivanju toksičnih učinkov z drugimi, sočasno danimi zdravili v 3. sklopu zdravljenja.
English: N=242 (ITT population)
Slovenian: n=242 (ITT
English: How to use Bortezomib SUN
Slovenian: Kako uporabljati zdravilo Bortezomib SUN
English: Bortezomib SUN will be administered by a health care professional experienced in the use of cytotoxic medicines.
Slovenian: Zdravilo Bortezomib SUN vam bo injiciral zdravstveni delavec, izkušen v uporabi citotoksičnih zdravil.
English: Medianc(95% CI) (months) Response rate n: response-evaluable patients Overall complete response (CR+CRu)f n(%)
Slovenian: medianac(95 % CI) (meseci) Stopnja odziva n: odziv preiskovanih bolnikov
English: Hepatic failure, Hepatomegaly, Budd-Chiari syndrome, Cytomegalovirus hepatitis, Hepatic haemorrhage, Cholelithiasis
Slovenian: Redki odpoved jeter, hepatomegalija, Budd-Chiarijev sindrom, citomegalovirusni hepatitis, krvavitev v jetrih, holelitiaza
English: Bortezomib therapy should be withheld when the platelet count is < 25,000/μl or in combination with melphalan and prednisone when the platelet count is ≤ 30,000/μl (see section 4.2).
Slovenian: < 25.000/μl ali če se bolnik zdravi z bortezomibom v kombinaciji z melfalanom in prednizonom ter je število trombocitov ≤ 30.000/μl (glejte poglavje 4.2).
English: This 3-week period is considered a treatment cycle.
Slovenian: To 3-tedensko obdobje predstavlja en krog zdravljenja.
English: 24.0 mo
Slovenian: 24,0 meseca
English: Bortezomib SUN dose should be reduced by 1 dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2)
Slovenian: Odmerek zdravila Bortezomib SUN je treba zmanjšati za 1 stopnjo (z 1,3 mg/m2 na 1 mg/m2 ali z 1 mg/m2 na 0,7 mg/m2)
English: PHARMACEUTICAL FORM Powder for solution for injection.
Slovenian: Prašek za raztopino za injiciranje.
English: - In cycles 1 to 4, Bortezomib SUN is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29
Slovenian: - V krogih od 1 do 4 se zdravilo Bortezomib SUN daje dvakrat na teden, 1., 4., 8., 11., 22., 25.,
English: Neutrophils were lowest at Day 11 of each cycle of bortezomib treatment and typically recovered to baseline by the next cycle.
Slovenian: Število trombocitov je bilo najmanjše 11. dan vsakega kroga zdravljenja z bortezomibom in se je do naslednjega kroga zdravljenja navadno povrnilo na začetno vrednost.
English: Common Weight decreased Uncommon Hyperbilirubinaemia*, Protein analyses abnormal*, Weight increased, Blood test abnormal*, C-reactive protein increased
Slovenian: Občasni hiperbilirubinemija*, nenormalni izvidi analiz proteinov*, zvečana telesna masa, nenormalni izvidi krvnih preiskav*, zvišana koncentracija C-reaktivnega proteina
English: Table 5: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma
Slovenian: Preglednica 5: Prilagajanje odmerkov med zdravljenjem pri bolnikih s predhodno nezdravljenim limfomom plaščnih celic Toksičnost
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.
Slovenian: Tako pri bolnikih s plazmocitomom, odpornim na zdravljenje, po prejšnji vrsti zdravljenja, kot pri tistih, ki so se odzvali na zdravljenje, je bilo celokupno preživetje v skupini, ki je prejemala bortezomib, statistično značilno daljše in odziv na zdravljenje je bil statistično značilno boljši.
English: In B-ALL patients with relapse 18 36 months from diagnosis (n = 33) the CR rate was 79% (95% CI: 61, 91) and the 4-month event free survival rate was 73% (95% CI: 54, 85).
Slovenian: Pri bolnikih z B-celično ALL in relapsom po 18-36 mesecev po diagnozi (n = 33) je bil delež popolnih odgovorov 79% (95% CI: 61, 91) in delež 4-mesečnega preživetja bolnikov brez dogodkov 73% (95% CI: 54, 85).
English: Hepatitis B Virus (HBV) reactivation and infection When rituximab is used in combination with bortezomib, HBV screening must always be performed in patients at risk of infection with HBV before initiation of treatment.
Slovenian: Reaktivacija in okužba z virusom hepatitisa B (HBV) Pri bolnikih s tveganjem za okužbo s HBV je treba pred uporabo rituksimaba v kombinaciji z bortezomibom vedno opraviti presejalni test za HBV. Prenašalce virusa hepatitisa B in bolnike, ki so že bili okuženi z virusom hepatitisa B, je treba med zdravljenjem in v nadaljevanju zdravljenja z rituksimabom v kombinaciji z bortezomibom skrbno spremljati glede kliničnih in laboratorijskih znakov aktivne okužbe s HBV.
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 SUN plus dexamethasone, and Bortezomib SUN plus dexamethasone and thalidomide).
Slovenian: • Navodila za predpisovanje in odmerjanje, vključno z dolžino in številom krogov zdravljenja z namenom zmanjšati tveganje za napake pri izdajanju in uporabi zdravila, ki bi jih lahko povzročile različne kombinacije režima uvajanja bortezomiba pred transplantacijo (zdravilo
English: Peripheral embolism, Lymphoedema, Pallor, Erythromelalgia, Vasodilatation, Vein discolouration, Venous insufficiency
Slovenian: Redki periferni embolizem, limfedem, bledica, eritromelalgija, vazodilatacija, sprememba barve ven, venska insuficienca
English: A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone and thalidomide group.
Slovenian: Pri CR+nCR so opazili statistično značilno razliko v prid kombinaciji bortezomiba z deksametazonom in talidomidom.
English: Patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors.
Slovenian: Sočasno jemanje zdravil Bolnike, ki prejemajo bortezomib v kombinaciji z močnimi inhibitorji encima CYP3A4, je treba skrbno spremljati.
English: > 1.5 x - 3 x ULN Any
Slovenian: > 1,5-3x ULN katera koli
English: In Cycles 1-4, Bortezomib SUN is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Slovenian: V krogih 1 do 4 se zdravilo Bortezomib SUN daje dvakrat na teden, 1., 4., 8., 11., 22., 25., 29. in 32. dan.
English: In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of Grade ≥ 3 thrombocytopenia in the bortezomib treatment group (BzmbR-CAP) as compared to the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
Slovenian: Pri bolnikih z MCL (študija LYM-3002) je bila pojavnost trombocitopenije stopnje 3 ali več v skupini, ki je prejemala bortezomib (BzmbR-CAP), večja (56,7 % proti 5,8 %), v primerjavi s skupino, ki bortezomiba ni prejemala (rituksimab, ciklofosfamid, doksorubicin, vinkristin in prednizon [R-CHOP]).
English: CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Bzmb=bortezomib; BzmbDx=bortezomib, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
Slovenian: CI= interval zaupanja; CR= popoln odziv; nCR= skoraj popoln odziv; ITT=populacija, ki so jo nameravali zdraviti; RR=stopnja odziva; Bzmb=bortezomib; BzmbDx=bortezomib in deksametazon; VDDx=vinkristin, doksorubicin in deksametazon; VGPR=zelo dober delni odziv; PR=delni odziv; OR=razmerje obetov.