natgillin/translations-raw huggingface dataset:
Table 8 has been generated using Version 16 of the MedDRA.
Preglednica 8 je pripravljena skladno z MedDRA, različica 16.
Patients who had received 2 to 3 prior therapeutic regimens had a response rate of 32% (10/32) and patients who received greater than 7 prior therapeutic regimens had a response rate of 31% (21/67).
Bolniki, ki so prejeli 2 do 3 predhodne vrste zdravljenj, so imeli stopnjo odziva 32 % (10/32), tisti, ki so prejeli več kot 7 predhodnih vrst zdravljenj pa so imeli stopnjo odziva 31 %
The primary endpoint was best confirmed response to retreatment as assessed by EBMT criteria.
Primarni opazovani dogodek učinkovitosti je bil najboljši potrjeni odziv na ponovno zdravljenje, skladno z EBMT kriteriji.
• oral antidiabetics
• peroralne antidiabetike
• low numbers of red or white blood cells
• imate majhno število rdečih ali belih krvnih celic,
Rare side effects (may affect up to 1 in 1,000 people) Blood clot in small blood vessels (thrombotic microangiopathy)
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) • krvni strdek v majhnih krvnih žilah (trombotična mikroangiopatija)
• Increase of platelets or plasma cells (a type of white cell) in the blood
• povečanje števila krvnih ploščic ali plazemskih celic (vrsta belih krvnih celic) v krvi
The overall incidence of diarrhoea, gastrointestinal and abdominal pain, asthenic conditions, upper respiratory tract infections and peripheral neuropathies were 12%-15% lower in the subcutaneous group than in the intravenous group.
Celokupna pojavnost diareje, gastrointestinalne in abdominalne bolečine, asteničnih stanj, okužb zgornjih dihal in perifernih nevropatij je bila za 12 %-15 % manjša v subkutani kot v intravenski skupini.
Management of orthostatic/postural hypotension may include adjustment of antihypertensive medicinal products, rehydration or administration of mineralocorticosteroids and/or sympathomimetics.
Zdravljenje ortostatske/ posturalne hipotenzije lahko vključuje prilagoditev odmerjanja antihipertenzivov, rehidracijo bolnika ali dajanje mineralokortikosteroidov in/ali simpatikomimetikov.
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.
Pri koncentraciji 10 µM bortezomib ne zavira nobenega od številnih različnih preverjenih receptorjev in proteaz in je več kot 1.500-krat bolj selektiven za proteasom kot za njegov naslednji prednostni encim.
The duration of a treatment cycle is 21 days (3 weeks).
Trajanje enega cikla zdravljenja je 21 dni (3 tedne).
Neuropathy has been managed with supportive care and other therapies.
Nevropatijo so zdravili s podpornimi ukrepi in drugimi zdravljenji.
• Budd-Chiari syndrome (the clinical symptoms caused by blockage of the hepatic veins)
• Budd-Chiarijev sindrom (klinični simptomi, ki jih povzroča zapora ven v jetrih)
≥ Grade 3 PN
≥ stopnja 3 PN
Bortezomib Hospira must be reconstituted by a healthcare professional (see section 6.6).
Zdravilo Bortezomib Hospira mora rekonstituirati zdravstveno osebje (glejte poglavje 6.6).
Bortezomib Hospira may have a moderate influence on the ability to drive and use machines.
Zdravilo Bortezomib Hospira ima lahko zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Fluid retention may be a predisposing factor for signs and symptoms of heart failure.
Zastajanje tekočine v telesu je lahko dejavnik tveganja za pojav znakov in simptomov srčnega popuščanja.
Manufacturer Hospira UK Ltd.
Izdelovalec Hospira UK Ltd.
Experiments have demonstrated that bortezomib is cytotoxic to a variety of cancer cell types and that cancer cells are more sensitive to the pro-apoptotic effects of proteasome inhibition than normal cells.
Raziskave so potrdile, da je bortezomib citotoksičen za različne vrste rakavih celic in da so rakave celice bolj občutljive za proapoptotične učinke zaviranja proteasoma od normalnih.
A total of 218 patients were evaluable for response.
Odziv na zdravljenje ocenili pri skupno 218 bolnikih.
Therefore, patients must be cautious when driving or using machines and should be advised not to drive or operate machinery if they experience these symptoms (see section 4.8).
Bolnike je zato treba opozoriti, naj v primeru pojava teh simptomov ne vozijo ali upravljajo strojev (glejte poglavje 4.8).
In the BTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
V skupini BTDx je imelo 12 % bolnikov citogenetiko visokega tveganja v primerjavi s 16 % v skupini TDx.
It is specifically designed to inhibit the chymotrypsin-like activity of the 26S proteasome in mammalian cells.
Zasnovan je specifično za zaviranje kimotripsinske aktivnosti 26S proteasoma v sesalskih celicah.
In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure (such as fluids, pressors, and/or inotropic agents) and body temperature (see sections 4.2 and 4.4).
V primeru prevelikega odmerka je treba spremljati bolnikove vitalne znake in uvesti ustrezne podporne ukrepe za vzdrževanje krvnega tlaka (na primer tekočine, učinkovine, ki zvišujejo krvni tlak, in/ali inotropne učinkovine) in telesne temperature (glejte poglavji 4.2 in 4.4).
Pregnancy and breast-feeding You should not use bortezomib if you are pregnant, unless clearly necessary.
Nosečnost in dojenje Če ste noseči, bortezomiba ne smete prejeti, razen če je nujno potrebno.
n: ITT patients
n: bolniki (ITT)
Inhibition of the 26S proteasome prevents this targeted proteolysis and affects multiple signalling cascades within the cell, ultimately resulting in cancer cell death.
Zaviranje 26S proteasoma to ciljano proteolizo preprečuje in vpliva na več signalnih kaskad v celici, kar končno vodi do smrti rakave celice.
Your doctor will work out your dose of bortezomib according to your height and weight (body surface area).
Zdravnik bo določil odmerek bortezomiba na osnovi vaše telesne višine in mase (telesne površine).
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.
Če toksičnost ne mine ali če se ponovi tudi pri najmanjšem odmerku, morate razmisliti o ukinitvi zdravila Bortezomib Hospira, razen če koristi zdravljenja odtehtajo s tem povezano tveganje.
It is recommended that patients with at least partial response receive 2 additional cycles.
Priporočamo, da bolniki z najmanj delnim odzivom prejmejo 2 dodatna cikla zdravljenja.
Neuropathic pain and/or peripheral neuropathy
Nevropatska bolečina in/ali periferna nevropatija
The majority of the patients in both groups completed treatment, 80% in the BR-CAP group and 82% in the R-CHOP group.
Večina bolnikov v obeh skupinah je zdravljenje zaključila, 80 % v skupini BR-CAP in 82 % v skupini R-CHOP.
• carbamazepine, phenytoin or phenobarbital used to treat epilepsy
• karbamazepin, fenitoin ali fenobarbital, ki se uporabljajo za zdravljenje epilepsije
Cases resolved in a median of 6 days, dose modification was required in two patients.
Primere so rešili v mediano 6 dneh, dvema bolnikoma so morali prilagoditi odmerek zdravila.
Kaplan-Meier estimate.
c Ocena po metodi Kaplan-Meier.
The primary efficacy endpoint was progression-free survival based on Independent Review Committee (IRC) assessment.
Primarni opazovani dogodek učinkovitosti je bilo preživetje brez napredovanja bolezni, ki ga je ocenil neodvisni odbor za pregled (IRC - Independent Review Committee).
tiredness, confusion, blindness or other vision problems.
zmedenostjo, slepoto ali drugimi težavami z vidom
** 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.
** 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
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.
Ob predhodno določeni vmesni analizi je bil dosežen primarni cilj (čas do napredovanja bolezni) in bolnikom v M+P kraku preskušanja so ponudili zdravljenje z B+M+P.
• rifampicin, an antibiotic used to treat bacterial infections
• rifampicin, antibiotik, ki se uporablja za zdravljenje bakterijskih okužb
Secondary endpoints included, time to progression (TTP), time to next anti-lymphoma treatment (TNT), duration of treatment free interval (TFI), overall response rate (ORR) and complete response (CR/CRu) rate, overall survival (OS) and response duration.
Sekundarni opazovani dogodki so vključevali čas do napredovanja bolezni (TTP), čas do naslednjega zdravljenja limfoma (TNT), trajanje obdobja brez zdravljenja (TFI), celokupno stopnjo odziva (ORR) in stopnjo popolnega odziva (CR/CRu), celokupno preživetje (OS) in trajanje odziva.
OR e (95% CI)=1.688
OR e (95 % IZ) = 1,688 (1,148;
No information on possible sequelae or rates of peripheral neuropathy resolution were available in this study.
Podatkov o možnih posledicah ali ozdravitvah periferne nevropatije v tem preskušanju ni na voljo.
For single use only
za enkratno uporabo
No clinical data are available for bortezomib with regard to exposure during pregnancy.
Za bortezomib ni na voljo kliničnih podatkov glede izpostavljenosti zdravilu med nosečnostjo.
1-year Overall Survival (%) (95% CI)
1-letno celokupno preživetje (%) (95 % IZ)
Posology for treatment of progressive multiple myeloma (patients who have received at least one prior therapy)
Odmerjanje pri zdravljenju napredovalega diseminiranega plazmocitoma (bolniki, ki so pred tem že prejeli vsaj eno vrsto terapije)
Your doctor may give you another medicine to control diarrhoea
Zdravnik vam bo lahko dal tudi zdravilo za obvladovanje driske.
This minimises the effects of observed confounders when estimating treatment effects using non-randomised data.
To pri oceni učinkov zdravljenja na osnovi nerandomiziranih podatkov zmanjša učinke opaženih motečih dejavnikov.
Bortezomib Hospira should not be used during pregnancy unless the clinical condition of the woman requires treatment with Bortezomib Hospira.
Zdravila Bortezomib Hospira se med nosečnostjo ne sme uporabljati, razen če klinično stanje ženske zahteva zdravljenje z zdravilom Bortezomib Hospira.
In non-clinical studies, bortezomib had no effects on embryonal/foetal development in rats and rabbits at the highest maternally tolerated doses.
V nekliničnih študijah bortezomib ni imel nobenih učinkov na embrionalni/fetalni razvoj pri podganah in kuncih pri največjih odmerkih, ki so jih samice še lahko prenašale.
Over a bortezomib concentration range of 0.01 to 1.0 μg/ml, the in vitro protein binding averaged 82.9% in human plasma.
V razponu koncentracij bortezomiba od 0,01 do 1,0 μg/ml je bila in vitro vezava na beljakovine v človeški plazmi povprečno 82,9 %.
Most patients required treatment for their orthostatic hypotension.
Pri večini bolnikov je bilo potrebno zdravljenje ortostatske hipotenzije.
Injection under the skin is in either the thighs or the abdomen.
Injiciranje pod kožo je možno na stegnih ali trebuhu.
p-value is for the non-inferiority hypothesis that the SC arm retains at least 60% of the response rate in the IV arm.
a Vrednost p podpira hipotezo, da s.c. krak zadrži najmanj 60 % stopnje odziva i.v.
• bleeding problems and/or low number of platelets in your blood
• imate težave s strjevanjem krvi in/ali majhno število krvnih ploščic,
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.
Ne glede 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 pomembno izboljšali.
When bortezomib is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Če boste prejeli bortezomib skupaj z talidomidom in deksametazonom, traja en cikel zdravljenja 28 dni (4 tedne).
the combined 1-year survival rate was 88.1%.
Skupna stopnja 1-letnega preživetja za skupini bolnikov, ki sta prejemali ta dva odmerka, je bila 88,1 %.
The incidence of death on treatment was 5% in the subcutaneous treatment group and 7% in the intravenous treatment group.
Pojavnost smrti med zdravljenjem je bila v subkutani skupini 5 % in v intravenski skupini 7 %.
Table 12: Efficacy results from study IFM-2005-01 Endpoints
Preglednica 12: Rezultati učinkovitosti v preskušanju IFM-2005-01 Opazovani dogodki
Patients whose levels of paraprotein continue to decrease after 8 cycles can also continue for as long as treatment is tolerated and they continue to respond.
Bolniki, pri katerih se koncentracija paraproteinov po 8 ciklih še znižuje, lahko z zdravljenjem nadaljujejo, dokler zdravljenje dobro prenašajo in se odzivajo nanj.
Bortezomib might cause tiredness, dizziness, fainting, or blurred vision.
Bortezomib lahko povzroči utrujenost, omotičnost, omedlevico ali zamegljen vid.
p-value g=0.275
vrednost p g = 0,275
• ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μL
• nevtropenija z zvišano telesno temperaturo stopnje ≥ 3, nevtropenija 4. stopnje, ki traja več kot 7 dni, število trombocitov < 10.000 celic/μl
In addition to peripheral neuropathy, there may be a contribution of autonomic neuropathy to some adverse reactions such as postural hypotension and severe constipation with ileus.
Poleg periferne nevropatije lahko avtonomna nevropatija prispeva k nastanku nekaterih neželenih učinkov, npr. posturalne hipotenzije in hudega zaprtja z ileusom.
Hypersensitivity to the active substance, to boron or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino, bor ali katerokoli pomožno snov, navedeno v poglavju 6.1.
• Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.
• Raztopino injicirajte v obliki 3-5 sekund trajajoče bolusne intravenske injekcije skozi periferni ali centralni intravenski kateter v veno.
• ritonavir, used to treat HIV infection
• ritonavir, ki se uporablja za zdravljenje okužbe z virusom HIV
Bortezomib should not be used in children and adolescents because it is not known how the medicine will affect them.
Otroci in mladostniki Bortezomib se pri otrocih in mladostnikih ne sme uporabljati, ker njegov vpliva nanje ni znan.
The resulting solution is then either injected into a vein or under the skin.
Nastalo raztopino se nato injicira v veno ali pod kožo.
• potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
• Možna tveganja napak pri dajanju zdravila, vključno z informacijami o prevelikem odmerjanju, premajhnem odmerjanju in, da se je nenamerno intratekalno dajanje zdravila končalo s smrtnimi primeri.
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 disease.
Bolniki v obeh skupinah so na splošno imeli podobne demografske značilnosti in značilnosti bolezni od začetku preskušanja: 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 % bolnikov je imelo vrednost mednarodnega prognostičnega indeksa (IPI - International Prognostic Index) ≥ 3 in 76 % bolnikov je bilo v IV. stadiju bolezni.
Data from in vitro, ex-vivo, and animal models with bortezomib suggest that it increases osteoblast differentiation and activity and inhibits osteoclast function.
In vitro, ex vivo in podatki iz živalskih modelov kažejo, da bortezomib spodbuja diferenciacijo in aktivnost osteoblastov ter zavira delovanje osteoklastov.
Secondary efficacy endpoints included Progression Free Survival and Overall Survival.
Sekundarni opazovani dogodki učinkovitosti so vključevali čas preživetja brez napredovanja bolezni in celokupni čas preživetja.
≥ 1,500 cells/μL
≥ 75.000 celic/μl.
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.
Bolniki, ki niso dosegli optimalnega odziva (manj kot popoln odziv [CR]) na zdravljenje z bortezomibom samim po 4 ciklih zdravljenja, so lahko prejeli 20 mg deksametazona na dan dajanja in po dajanju bortezomiba.
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).
Opazili so statistično pomembno korist (p < 0,001) v skupini BR-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).
Overall response (CR+CRu+PR)
Celokupen odziv (CR+CRu+PR)
• Platelet counts should be ≥ 100,000 cells/μL and the absolute neutrophils count (ANC) should be
• mora biti število trombocitov ≥ 100.000 celic/μl in celokupno število nevtrofilcev (ANC
Median survival for the B+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Mediano preživetje v skupini B+M+P je bilo 56,4 mesecev, v skupini M+P pa 43,1 mesecev.
The median duration of treatment was 24.0 weeks and the median number of treatment cycles received was 6.0, and was consistent across treatment groups.
Mediani čas trajanja zdravljenja je bil 24 tednov in mediano število ciklov zdravljenja je bilo 6,0 v obeh skupinah.
Since dialysis may reduce bortezomib concentrations, Bortezomib Hospira should be administered after the dialysis procedure (see section 5.2).
Ker dializa lahko zmanjša koncentracijo bortezomiba, je treba zdravilo Bortezomib Hospira injicirati po zaključku dializnega postopka (glejte poglavje 5.2).
Bortezomib mediated proteasome inhibition affects cancer cells in a number of ways, including, but not limited to, altering regulatory proteins, which control cell cycle progression and nuclear factor kappa B (NF-kB) activation.
Zaviranje proteasoma z bortezomibom vpliva na rakave celice na več načinov, vključno s spremembo regulatornih proteinov, ki nadzorujejo napredovanje celičnega ciklusa in aktivacijo nuklearnega faktorja kapa B (NF-kB).
These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with bortezomib at 1.3 mg/m2 and included in Table 7.
Ti neželeni učinki so navedeni na podlagi celotnega nabora podatkov 5.476 bolnikov, od katerih je bilo 3.996 bolnikov zdravljenih z bortezomibom v odmerku 1,3 mg/m2 telesne površine in so vključeni v preglednico 7.
An odds ratio (OR) > 1 indicates an advantage for BR-CAP.
Razmerje obetov (odds ratio-OR) > 1 predstavlja prednost za skupino BR-CAP.
Secondary efficacy endpoints included post-transplant response rates (CR+nCR, CR+nCR+VGPR+PR), Progression Free Survival and Overall Survival.
Sekundarni opazovani dogodki učinkovitosti so vključevali stopnjo odziva po presaditvi (CR+nCR, CR+nCR+VGPR+PR), čas preživetja brez napredovanja bolezni in celokupni čas preživetja.
The usual starting dose of bortezomib is 1.3 mg/m2 body surface area twice a week.
Običajni začetni odmerek bortezomiba je 1,3 mg/m2 telesne površine dvakrat na teden.
Post-marketing adverse reactions not seen in clinical trials are also included.
Vključeni so tudi neželeni učinki iz obdobja trženja, ki se v kliničnih preskušanjih niso pojavili.
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%).
Dodatno ugotovljena neželena učinka, povezana z uporabo kombiniranega zdravljenja (BR-CAP), sta bila okužba z virusom hepatitisa B (< 1 %) in ishemija miokarda (1,3 %).
This 21-day period (3 weeks) corresponds to one treatment cycle.
To 21-dnevno obdobje (3 tedni) je en cikel zdravljenja.
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.
Geometrijska sredina (% CV) očistka je bila 7,79 l/h/m2 (25 %), volumen porazdelitve v dinamičnem ravnovesju 834 l/m2 (39 %), razpolovni čas izločanja pa 100 ur (44 %).
Median age of the patients in the study was 57 years, 55% were male and 48% of patients had high-risk cytogenetics.
Mediana starost bolnikov v preskušanju je bila 57 let, 55 % je bilo moških in 48 % bolnikov je imelo citogenetiko visokega tveganja.
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.
Vmesna analiza je pokazala zmanjšanje tveganja za TTP za 45 % (95 % IZ; 29-57 %, p < 0,0001) pri bolnikih, ki so prejemali kombinirano zdravljenje z bortezomibom in pegiliranim liposomskim doksorubicinom.
p-value g=0.007
vrednost p g = 0,007
In patients aged ≥ 75 years, both regimens, BR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Bolniki, stari ≥ 75 let, so oba režima zdravljenja, BR-CAP in R-CHOP, slabše prenašali (glejte poglavje 4.8).
B= bortezomib M=melphalan, P=prednisone
B = bortezomib; M = melfalan, P = prednizon
Higher incidences were also noted for infections with Grade ≥ 3 neutropenia (24% versus 19% in Block 1 and 22% versus 11% in Block 2), increased ALT (17% versus 8% in Block 2), hypokalaemia (18% versus 6% in Block 1 and 21% versus 12% in Block 2) and hyponatraemia (12% versus 5% in Block 1 and 4% versus 0 in Block 2).
Večja je bila tudi pojavnost okužb z nevtropenijo stopnje ≥ 3 (24 % proti 19 % v 1. sklopu in 22 % proti 11 % v 2. sklopu), povečane koncentracije ALT (17 % proti 8 % v 2. sklopu), hipokaliemije (18 % proti 6 % v 1. sklopu in 21 % proti 12 % v 2. sklopu) in hiponatriemije (12 % proti 5 % v 1. sklopu in 4 % proti 0 v 2. sklopu).
The incidence of peripheral neuropathy increases early in the treatment and has been observed to peak during cycle 5.
Pojavnost periferne nevropatije se poveča v začetku zdravljenja in doseže najvišjo vrednost v 5. ciklu zdravljenja.
It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of Bortezomib Hospira therapy.
Priporočamo tudi, da odzivni bolniki, ki ne dosežejo popolne remisije, prejmejo skupno 8 ciklov zdravljenja z zdravilom Bortezomid Hospira.
> 3 x ULN
> 3 x ULN katerakoli
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.
Analiza je pokazala izboljšan ORR (CR+PR) (razmerje obetov 3,769; 95 % IZ 2,045-6,947; p < 0,001), PFS (razmerje ogroženosti 0,511; 95 % IZ 0,309-0,845; p = 0,008), TTP (razmerje ogroženosti 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 samim.
Log rank test adjusted for stratification factors: ISS staging and number of prior lines.
d Log-rank test prilagojen na osnovi stratifikacijaskih faktorjev: ISS razvrstitvi in številu predhodnih zdravljenj.