FrancophonIA/ELRC3.0 huggingface dataset:
English: Cochran Mantel-Haenszel test.
Slovenian: Cochran Mantel-Haenszelovega testa.
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Complete response (CR) was evaluated at the end of Block 1.
Slovenian: Popolni odgovor (CR - Complete Response) so ocenili na koncu 1. sklopa zdravljenja.
English: World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Spain
Slovenian: World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Španija
English: Do not use this medicine after the expiry date stated on the vial and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli za oznako EXP:.
English: Treatment duration (median=17 weeks) and duration of follow-up (median=40 months) were comparable in both treatment arms.
Slovenian: Trajanje zdravljenja (mediana=17 tednov) in trajanje nadaljnjega spremljanja bolnikov (mediana=40 mesecev) sta bila primerljiva v obeh zdravljenih skupinah.
English: Both men and women receiving Bortezomib Accord must use effective contraception during and for up to 3 months after treatment.
Slovenian: Moški in ženske, ki prejemajo zdravilo Bortezomib Accord, morajo uporabljati učinkovito kontracepcijo med in do 3 mesece po zdravljenju.
English: Bortezomib Accord should not be used in children and adolescents because it is not known how the medicine will affect them.
Slovenian: Zdravilo Bortezomib Accord se pri otrocih in mladostnikih ne sme uporabljati, ker njegovega vpliva nanje ne poznamo.
English: Incidence of PN (%) All GradePN ≥ Grade 2 PN ≥ Grade 3 PN
Slovenian: pojavnost PN (%) vse stopnje PN ≥ stopnja 2 PN ≥ stopnja 3 PN
English: Reduction in serum M-protein populationg n=667
Slovenian: Zmanjšanje serumskega M-proteina populacijag n=667
English: e Median duration of follow up is 11.8 months
Slovenian: e Mediano trajanje nadaljevanja zdravljenja je 11,8 mesecev.
English: a Based on Independent Review Committee (IRC) assessment (radiological data only).
Slovenian: a Na osnovi ocene neodvisnega odbora (Independent Review Committee-IRC) (samo podatki slikovnih diagnostičnih metod).
English: b b d d b b
Slovenian: b b d d
English: Exposure of bortezomib (dose-normalised AUC and Cmax) was comparable among all the groups (see section 4.2).
Slovenian: Izpostavljenost bortezomibu (AUC in Cmax normalizirana glede na odmerek) je bila primerljiva med vsemi skupinami (glejte poglavje 4.2).
English: Mediana response duration
Slovenian: Medianaa trajanja odziva
English: The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the BzDx group.
Slovenian: Mediani čas trajanja zdravljenja je bil 13 tednov v skupini BzDx in 11 tednov v skupini BzDx.
English: Bz= Bortezomib Accord; M=melphalan, P=prednisone
Slovenian: Bz=Bortezomib Accord ; M=melfalan, P=prednizolon
English: Similar proportions of patients had creatinine clearance ≤ 30 ml/min (3% in each arm).
Slovenian: Podobno razmerje bolnikov je imelo očistek kreatinina ≤ 30 ml/min (3 % v vsakem kraku študije).
English: - if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6) - if you have certain severe lung or heart problems.
Slovenian: - če ste alergični na bortezomib, bor ali katero koli sestavino tega zdravila (navedeno v poglavju - če imate določene hude težave s pljuči in srcem.
English: Potential benefit of the treatment should be carefully weighed against the risks, particularly in case of moderate to severe thrombocytopenia and risk factors for bleeding.
Slovenian: Skrbno pretehtajte potencialne koristi zdravljenja glede na tveganja, še posebno v primeru srednje do resne trombocitopenije in ob obstoječih dejavnikih tveganja za krvavitev.
English: Since patients with neutropenia are at increased risk of infections, they should be monitored for signs and symptoms of infection and treated promptly.
Slovenian: Bolniki z nevtropenijo so izpostavljeni zvečanemu tveganju za okužbe, zato jih je treba spremljati glede pojava znakov in simptomov okužbe in takoj zdraviti.
English: If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of bortezomib must be considered unless the benefit of treatment clearly outweighs the risk.
Slovenian: Če toksičnost ne mine ali če se ponovi tudi pri najmanjšem odmerku, morate premisliti o ukinitvi bortezomiba, razen če koristi zdravljenja odtehtajo s tem povezano tveganje.
English: Day 1, 4
Slovenian: dan 1, 4
English: Patients with pre-existing severe neuropathy may be treated with bortezomib only after careful risk/benefit assessment.
Slovenian: Bolnike z obstoječo hudo nevropatijo lahko zdravite z bortezomibom šele po skrbnem pretehtanju razmerja koristi in tveganj.
English: rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: 2 years (for Bortezomib Accord 1 mg) 3 years (for Bortezomib Accord 3.5 mg)
Slovenian: 2 leti (za Bortezomib Accord 1 mg) 3 leta (za Bortezomib Accord 3,5 mg)
English: Mannitol (E 421)
Slovenian: manitol (E 421)
English: Patients achieving a complete response can continue treatment for at least 2 cycles after the first evidence of complete response, even if this requires treatment for more than
Slovenian: Bolniki s popolnim odgovorom lahko z zdravljenjem nadaljujejo še najmanj dva kroga po prvi ugotovitvi popolnega odgovora, tudi če to zahteva zdravljenje, daljše od 8 krogov.
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
Slovenian: • Navodila za predpisovanje in odmerjanje, vključno z dolžino in številom krogov zdravljenja z namenom zmanjšati tveganje za napake pri zdravljenju in dajanju zdravila, ki bi jih lahko povzročile različne kombinacije režima uvajanja bortezomiba pred transplantacijo (zdravilo
English: Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2 g/m2 per day) by continuous infusion over 24 hours is not recommended.
Slovenian: Zato ta režim dajanja s sočasnim visokim odmerkom citarabina v 24 urni kontinuirani infuziji (2 g/m2 na dan) ni priporočljiv.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: If bortezomib is used during pregnancy, or if the patient becomes pregnant while receiving this medicinal product, the patient should be informed of potential for hazard to the foetus.
Slovenian: Če se bortezomib uporablja v času nosečnosti ali če bolnica zanosi med jemanjem tega zdravila, jo morate obvestiti o potencialnem tveganju za plod.
English: Name and address of the manufacturers responsible for batch release Accord Healthcare Ltd
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije Accord Healthcare Ltd
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če se rekonstituirane raztopine ne uporabi takoj, je za rok uporabe in pogoje shranjevanja po pripravi odgovoren uporabnik.
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.
Slovenian: Pri koncentraciji 10 µM bortezomib ne zavira nobenega od številnih različnih pregledanih receptorjev in proteaz in je več kot 1500-krat bolj selektiven za proteasom kot za njegov drugouvrščeni prednostni encim.
English: It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of bortezomib therapy.
Slovenian: Priporočamo tudi, da odzivni bolniki, ki ne dosežejo popolne remisije, prejmejo skupno 8 krogov zdravljenja z bortezomibom.
English: Medianc(95% CI) (months) Response rate n: response-evaluable patients 229
Slovenian: medianac(95% CI) (meseci) Stopnja odziva n: odgovor preiskovanih bolnikov
English: Bortezomib combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001)
Slovenian: Bortezomib v kombinaciji s pegiliranim liposomskim doksorubicinom (študija DOXIL-MMY-3001)
English: In the BzTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
Slovenian: V skupini BzTDx je imelo 12% bolnikov citogenetiko visokega tveganja v primerjavi s 16% v skupini TDx.
English: Since dialysis may reduce bortezomib concentrations, Bortezomib Accord should be administered after the dialysis procedure (see section 5.2).
Slovenian: Ker dializa lahko zmanjša koncentracijo bortezomiba, je treba zdravilo Bortezomib Accord injicirati po zaključku dializnega postopka (glejte poglavje 5.2).
English: • Hypersensitivity (allergic reaction)
Slovenian: • glivične okužbe • preobčutljivostne (alergijske reakcije)
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 Bz+M+P treatment.
Slovenian: Ob predhodno določenem času vmesne analize je bil dosežen primarni cilj (čas do napredovanja bolezni) in bolnikom v M+P kraku študije so ponudili zdravljenje z Bz+M+P.
English: When Bortezomib Accord is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Slovenian: Če jemljete zdravilo Bortezomib Accord skupaj s talidomidom in deksametazonom, traja en krog zdravljenja 28 dni (4 tedne).
English: The majority of the patients in both groups completed treatment, 80% in the BzR-CAP group and 82% in the R-CHOP group.
Slovenian: Večina bolnikov v obeh skupinah je zdravljenje zaključila, 80% v skupini BzR-CAP in 82% v skupini R-CHOP.
English: This leaflet was last revised in
Slovenian: Navodilo je bilo nazadnje revidirano dne <datum>
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.
Slovenian: ** Instrumentalna ADL: zajema pripravo obrokov, nakup živil ali oblačil, uporabo telefona, upravljanje z denarjem, itd; *** Fizična ADL: zajema kopanje, oblačenje in slačenje, hranjenje, uporabo stranišča, jemanje zdravil, ne zajema pa bolnikov priklenjenih na posteljo zaradi bolezni.
English: Subcutaneous or Intravenous use.
Slovenian: Za subkutano ali intravensko uporabo.
English: 1 year survival, [95% CI]
Slovenian: 1-letno preživetje,% [95% CI]
English: b Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin, albumin, and region.
Slovenian: b Ocena razmerjetveganja na osnovi Coxovega proporcionalnega modela, prilagojena na osnovi stratifikacijskih dejavnikov: β2-mikroglobulin, albumin in regija.
English: Table 13: Efficacy results from study MMY-3010
Slovenian: Preglednica 13: rezultati učinkovitosti študije MMY-3010 Ocena učinkovitosti
English: Bortezomib Accord therapy should be withheld for up to 2 weeks until the patient has an ANC
Slovenian: Zdravljenje z Bortezomib Accord je treba prekiniti za največ 2 tedna, dokler nima bolnik
English: Secondary efficacy endpoints included post-transplant response rates (CR+nCR, CR+nCR+VGPR+PR), Progression Free Survival and Overall Survival.
Slovenian: Sekundarna ocena učinkovitosti je zajemala stopnje odgovora po presaditvi (CR+nCR, CR+nCR+VGPR+PR), Čas preživetja brez napredovanja bolezni in celokupni čas preživetja.
English: OR; 95% CI; P value a
Slovenian: OR; 95% CI; p vrednost a
English: • that Bortezomib Accord is to be given only by intravenous or subcutaneous injections; no other route of administration is allowed
Slovenian: • Zdravilo Bortezomib Accord se lahko injicira samo intravensko ali subkutano, nobena druga uporaba ni dovoljena.
English: Median age of the patients in the study was 57 years, 55% were male and 48% of patients had high-risk cytogenetics.
Slovenian: Mediana starost bolnikov v študiji je bila 57 let, 55% je bilo moških in 48% bolnikov je imelo citogenetiko visokega tveganja.
English: As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Slovenian: Če ste prejeli večji odmerek zdravila Bortezomib Accord, kot bi smeli To zdravilo injiciral vaš zdravnik ali medicinska sestra zato ni verjetno, da bi ga lahko prejeli preveč.
English: d Log rank test adjusted for stratification factors: ISS staging and number of prior lines.
Slovenian: d Log- rank test prilagojen na osnovi stratifikacijaskih faktorjev: ISS razvrstitvi in številu predhodnih zdravljenj.
English: Table 12: Efficacy results from study IFM-2005-01
Slovenian: Preglednica 12: rezultati učinkovitosti študije IFM-2005-01 Ocena učinkovitosti
English: Caution should be exercised when bortezomib is combined with CYP3A4- or CYP2C19 substrates (see section 4.5).
Slovenian: Še posebna previdnost je potrebna, kadar se daje bortezomib v kombinaciji s substrati encima CYP3A4 ali CYP2C19 (glejte poglavje4.5).
English: Response Evaluable Population n=73
Slovenian: Odgovor preiskovane populacije n=73
English: A statistically significant benefit (p < 0.001) in favour of the BzR-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).
Slovenian: Opazili so statistično značilno korist (p < 0,001) v skupini BzR-CAP v primerjavi s skupino R-CHOP za TTP (mediana 30,5 proti 16,1 mesecev), TNT (mediana 44,5 proti 24,8 mesecev) in TFI (mediana 40,6 proti 20,5 mesecev).
English: Median survival for the Bz+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Slovenian: Mediana preživetja v tretirani skupini Bz+M+P je bila 56,4 mesecev, v skupini M+P pa 43,1 mesecev.
English: Cardiovascular safety pharmacology studies in monkeys and dogs show that intravenous doses approximately two to three times the recommended clinical dose on a mg/m2 basis are associated with increases in heart rate, decreases in contractility, hypotension and death.
Slovenian: Farmakološka preskušanja kardiovaskularne varnosti zdravila pri opicah in psih kažejo povezavo med intravenskimi odmerki, ki so bili dva- do trikrat višji od priporočenega kliničnega odmerka (v mg/m2), in povišanjem srčne frekvence, zmanjšanjem kontraktilnosti srca, hipotenzijo in smrtjo.
English: Most cases of PML were diagnosed within 12 months of their first dose of bortezomib.
Slovenian: je bila diagnosticirana v 12 mesecih po prvem odmerku bortezomiba.
English: Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib bortezomib intravenous arm bortezomib subcutaneous arm
Slovenian: Preglednica 15: Povzetek analize učinkovitosti subkutanega in intravenskega dajanja bortezomiba bortezomib intravensko bortezomib subkutano
English: Bortezomib Accord should not be given by other routes.
Slovenian: Zdravilo Bortezomib Accord se ne sme dajati po nobeni drugi poti.
English: Regardless of β2-microglobulin levels at baseline, all efficacy parameters (time to progression and overall survival, as well as response rate) were significantly improved on the bortezomib arm.
Slovenian: Neglede na koncentracijo β2- mikroglobulina ob začetku zdravljenja, so se tudi vsi parametri učinkovitosti (čas do napredovanja bolezni in celokupno preživetje, kot tudi odziv na zdravljenje) v delu preskušanja z bortezomibom statistično značilno izboljšali.
English: What you need to know before you use Bortezomib Accord Do not use Bortezomib Accord
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Bortezomib Accord Ne uporabljajte zdravila Bortezomib Accord
English: tiredness, confusion, blindness or other vision problems.
Slovenian: zmedenostjo, slepoto in drugimi težavami z vidom.
English: Geometric mean (%CV) clearance was 7.79 (25%) L/hr/m2, volume of distribution at steady-state was 834 (39%) L/m2, and the elimination half-life was 100 (44%) hours.
Slovenian: Geometrični povprečni očistek (%CV) je bil 7,79 l/h/m2 (25 %), volumen porazdelitve v dinamičnem ravnovesju 834 l/m2 (39 %), razpolovni čas izločanja pa 100 ur (44 %).
English: Fall, Contusion
Slovenian: Občasni padci, kontuzije
English: ORR (CR+PR) p-valuea
Slovenian: ORR (CR+PR) p-vrednosta
English: Very Common Musculoskeletal pain* Common
Slovenian: Zelo pogosti mišično-skeletna bolečina*
English: Additional adverse drug reactions identified associated with the use of the combination therapy (BzR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Slovenian: Dodatno ugotovljena neželena učinka, povezana z uporabo kombiniranega zdravljenja (BzR-CAP), sta bila okužba z virusom hepatitisa B (< 1%) in ishemija miokarda (1,3%).
English: Instructions for reconstitution Bortezomib Accord must be reconstituted by a healthcare professional.
Slovenian: Navodila za rekonstitucijo raztopine Zdravilo Bortezomib Accord mora rekonstuirati zdravstveno osebje.
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.
Slovenian: Vmesna analiza je pokazala zmanjšanje tveganja za TTP za 45% (95% CI; od 29 do 57%, p < 0,0001) pri bolnikih, ki so prejemali kombinirano terapijo z bortezomibom in pegiliranim liposomskim doksorubicinom.
English: The following medicinal products are given on day 1 of each Bortezomib Accord 21-day treatment cycle as intravenous infusions:
Slovenian: Naslednja zdravila boste prejeli 1. dan vsakega 21-dnevnega kroga zdravljenja z zdravilom Bortezomib Accord v obliki intravenske infuzije:
English: Thalidomide is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the thalidomide pregnancy prevention programme are met.
Slovenian: Uporaba talidomida je med nosečnostjo in pri ženskah v rodni dobi kontraindicirana, razen če so doseženi vsi pogoji programa preprečevanja nosečnosti za talidomid (Thalidomide
English: In patients aged ≥ 75 years, both regimens, BzR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Slovenian: Bolniki, stari ≥ 75 let so oba režima zdravljenja, BzR-CAP in R-CHOP, slabše prenašali (glejte poglavje 4.8).
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).
Slovenian: Periferna nevropatija ≥ 3. stopnje se je pojavila pri 6% bolnikov v skupini s subkutanim dajanjem v primerjavi s 16% bolnikov v skupini, ki je prejemala bortezomib intravensko (p=0,0264).
English: Hypersensitivity to the active substance, to boron or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na zdravilno učinkovino, bor ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Patients who did not obtain an optimal response (less than Complete Response [CR]) to therapy with bortezomib alone after 4 cycles were allowed to receive dexamethasone 20 mg daily on the day of and after bortezomib administration.
Slovenian: Bolniki, ki niso dosegli optimalnega odgovora (manj kot popolni odgovor [CR]) na zdravljenje z bortezomibom v monoterapiji po 4 krogih zdravljenja, so prejeli 20 mg deksametazona na dan brez zdravila in po dajanju bortezomiba.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določenev seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: Male patients and female patients of childbearing potential must use effective contraceptive measures during and for 3 months following treatment.
Slovenian: Bolniki in bolnice v rodni dobi morajo uporabljati ustrezno kontracepcijsko metodo med in še 3 mesece po zdravljenju.
English: The overall incidence of hepatitis B infections was similar in patients treated with BzR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Slovenian: Celokupna pogostnost okužbe z virusom hepatitisa B je bila podobna pri bolnikih, zdravljenih z BzR-CAP ali s R-CHOP (0,8% v primerjavi z 1,2%).
English: HRb (95% CI)=0.63 (0.50; 0.79) p-valued < 0.001
Slovenian: HRb (95% CI)=0,63 (0,50; 0,79) p-vrednostd < 0,001
English: Hepatitis B virus (HBV) reactivation and infection
Slovenian: Reaktivacija in okužba z virusom hepatitisa B (HBV)
English: The demographic and baseline disease characteristics were generally well balanced between the two treatment arms: median patient age was 66 years, 74% were male, 66% were Caucasian and 32% Asian, 69% of patients had a positive bone marrow aspirate and/or a positive bone marrow biopsy for MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV
Slovenian: Bolniki v obeh skupinah so na splošno imeli podobne demografske in bolezenske značilnosti: mediana starost bolnikov je bila 66 let, 74% je bilo moških, 66% je bilo belcev in 32% azijcev, 69% bolnikov je imelo pozitivno aspiracijo kostnega mozga in/ali pozitivno biopsijo kostnega mozga za MCL, 54%
English: Contents of the pack and other information What Bortezomib Accord contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Bortezomib Accord
English: 1.3 The reconstituted product is preservative free and should be used immediately after preparation.
Slovenian: Rekonstituirana raztopina ne vsebuje konzervansov in ga je treba porabiti takoj po raztapljanju.
English: The European Medicines Agency has waived the obligation to submit the results of studies with 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).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov z bortezomibom za vse skupine pediatrične populacije za indikacijo diseminirani plazmocitom in limfom plaščnih celic (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Slovenian: Cushingov sindrom*, hipertiroidizem*, motnje izločanja antidiuretičnega hormona
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.
Slovenian: Analiza je dokazala izboljšan ORR (CR+PR) (razmerje obetov 3,769; 95% IZ 2,045-6,947; p < 0,001), PFS (stopnja tveganja 0,511; 95% IZ 0,309-0,845; p=0,008), TTP (stopnja tveganja 0,385; 95% IZ 0,212-0,698; p=0,001) pri zdravljenju z bortezomibom v kombinaciji z deksametazonom v primerjavi z zdravljenjem z bortezomibom v monoterapiji.