natgillin/translations-raw huggingface dataset:
At the first sign of abdominal cramping, loose stools or onset of diarrhoea, it is recommended that the patient be treated with anti-diarrhoeal medicinal product (e.g. loperamide) or any additional treatment in accordance with local treatment guidelines. 
Pri prvih znakih trebušnih krčev, odvajanja redkega blata oziroma ob začetku diareje je priporočeno bolnika zdraviti z antidiaroiki (na primer z loperamidom) ali z drugimi dodatnimi zdravili v skladu z lokalno sprejetimi smernicami zdravljenja.
Five patients (1.3%) died of events associated with haemorrhage. 
Zaradi dogodkov v povezavi s krvavitvami je umrlo 5 bolnikov (1,3 %).
Complete blood counts should be frequently monitored during treatment (in particular before each injection of bortezomib, i.e. on days 1, 4, 8 and 11 of cycles 1 to 8 and on days 1 and 8 of cycles 9 to 16), especially for thrombocytopenia (see section 4.4). 
Med zdravljenjem je treba pogosto pregledovati celotno krvno sliko (zlasti pred vsako injekcijo bortezomiba, torej na 1., 4., 8. in 11. dan ciklusov 1 do 8 in na 1. in 8. dan ciklusov 9 do 16) s posebno pozornostjo glede pojava trombocitopenije (glejte poglavje 4.4).
Week 2 Days 
2. teden dnevi
Oxidative metabolism of panobinostat played a less prominent role, with approximately 40% of the dose eliminated by this pathway. 
Oksidativni metabolizem je pri panobinostatu nekoliko manj pomemben, saj se po tej presnovni poti izloči približno 40 % danega odmerka.
Novartis Pharma GmbH Roonstrasse 25 
Izdelovalec Novartis Pharma GmbH
If a diagnosis of invasive systemic fungal infection is made, panobinostat should be discontinued and appropriate anti-fungal therapy instituted. 
Ob postavitvi diagnoze invazivne sistemske glivične okužbe je treba uporabo panobinostata ukiniti in uvesti ustrezno antimikotično zdravljenje.
Overall response [95% CI] 
razmerje ogroženosti [95%
These medicines should be used with care or may need to be avoided during your treatment with Farydak. 
Navedena zdravila je treba v času zdravljenja z zdravilom Farydak uporabljati previdno ali pa se jim je treba izogibati.
The efficacy and safety of panobinostat in combination with bortezomib and dexamethasone were evaluated in a randomised, double-blind, placebo-controlled, multicentre phase III study in patients with relapsed or relapsed and refractory multiple myeloma who had received 1-3 prior lines of therapies. 
Učinkovitost in varnost panobinostata v kombinaciji z bortezomibom in deksametazonom so ocenjevali v randomizirani, dvojno slepi, s placebom kontrolirani multicentrični študiji faze III pri bolnikih z recidivom oziroma z recidivno in neodzivno obliko diseminiranega plazmocitoma, ki so predhodno že prejemali 1-3 vrste zdravljenja.
Week 1 Days 
1. teden dnevi
Farydak is a histone deacetylase (HDAC) inhibitor that inhibits the enzymatic activity of HDACs at nanomolar concentrations. 
Zdravilo Farydak je zaviralec histonske deacetilaze (angl. histone deacetylase inhibitor, HDAC) in zavira encimsko aktivnost histonske deacetilaze v nanomolarnih koncentracijah.
The most common non-haematological adverse reactions were diarrhoea, fatigue, nausea and vomiting. 
Najpogostejši nehematološki neželeni učinki so bili diareja, utrujenost, navzea in bruhanje.
If you are taking any of these medicines, your doctor might prescribe a different medicine for you during your treatment with Farydak. 
Če jemljete katero od navedenih zdravil, vam bo zdravnik za čas zdravljenja z zdravilom Farydak morda predpisal drugo zdravilo.
QTc prolongation was observed and was mostly mild in degree: QTcF interval >450 msec and ≤480 msec was reported in 10.8% of patients, with maximum increase from baseline >30 msec and ≤60 msec in 14.5% of patients. 
Opažali so podaljšanje intervala QTc, ki je bilo večinoma blago: o trajanju intervala QTcF >450 milisekund in ≤480 milisekund so poročali pri 10,8 % bolnikov, pri čemer je do največjega podaljšanja za >30 milisekund in ≤60 milisekund od izhodiščne vrednosti prišlo pri 14,5 % bolnikov.
ECOG performance status was 0-1 in 93% of patients. 
(Eastern Cooperative Oncology Group) 0-1 je imelo 93 % bolnikov.
For patients experiencing severe adverse drug reactions other than thrombocytopenia, gastrointestinal toxicity, neutropenia or QTc prolongation, the recommendation is the following: 
Za bolnike, pri katerih pride do hudih neželenih učinkov, ki niso trombocitopenija, gastrointestinalna toksičnost, nevtropenija ali podaljšanje intervala QTc, veljajo naslednja priporočila:
In addition, increased expression of the tumour suppressor gene p21CDKNIA (cyclin dependent kinase inhibitor 1/p21) gene, a key mediator of G1 arrest and differentiation, was triggered with panobinostat exposure. 
Poleg tega je izpostavljenost panobinostatu povečala izražanje tumor supresorskega gena p21CDKNIA (zaviralec od ciklinov odvisne kinaze 1/p21), ki je ključni mediator ustavitve celičnega ciklusa v fazi G1 in diferenciacije celic.
Discontinuation of treatment may be considered if neutropenia does not improve despite the dose modifications and/or despite the addition of granulocyte colony stimulating factor therapy according to local medical practice and treatment guidelines, and/or in the event of severe secondary infections. 
Če se nevtropenija ne izboljša kljub prilagoditvi odmerka in/ali dodatnemu zdravljenju z dejavnikom rasti kolonij granulocitov v skladu z lokalno zdravstveno prakso in smernicami zdravljenja in/ali če pride do hudih sekundarnih okužb, je treba razmisliti o ukinitvi zdravljenja.
- Store in the original package in order to protect from moisture. 
- Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
HDACs catalyse the removal of acetyl groups from the lysine residues of histones and some non-histone proteins. 
Histonska deacetilaza katalizira odcepitev acetilne skupine z lizinskih ostankov histonov in nekaterih nehistonskih proteinov.
Take Farydak on days 1, 3 and 5 and on days 8, 10 and 12. 
Zdravilo Farydak vzemite na 1., 3. in 5. dan ter na 8., 10. in 12. dan.
PAN= panobinostat PBO= placebo BTZ= bortezomib Dex = dexamethasone 
PAN = panobinostat PBO = placebo BTZ = bortezomib Dex = deksametazon
Grade 3-4 events more frequently observed in patients included the following (percentages presented for patients <65 years, 65-75 years and ≥75 years of age, respectively): thrombocytopenia (60%, 74%, and 91%), anaemia (16%, 17% and 29%), diarrhoea (21%, 27% and 47%), and fatigue (18%, 28% and 47%). 
Med neželenimi dogodki 3. do 4. stopnje, ki so jih pogosteje opažali pri teh bolnikih, so bili (v oklepajih so navedeni odstotki za bolnike stare manj kot 65 let, za bolnike stare od 65 do 75 let in za bolnike stare 75 let ali več): trombocitopenija (60 %, 74 % in 91 %), anemija (16 %, 17 % in 29 %), diareja (21 %, 27 % in 47 %) ter utrujenost (18 %, 28 % in 47 %).
When panobinostat is administered together with dexamethasone, which is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters, the risk for reduced efficacy of hormonal contraceptives needs to be considered. 
Kadar bolnica jemlje panobinostat sočasno z deksametazonom, za katerega je znano, da je šibak do zmeren induktor CYP3A4 in drugih encimov ter prenašalcev, je treba upoštevati, da se učinkovitost hormonskih kontraceptivov lahko zmanjša.
Sexually active men taking Farydak and their female partners should use a highly effective method of contraception during the man's treatment and for six months after his last dose of Farydak. 
Spolno aktivni moški, ki jemljejo zdravilo Farydak, in njihove partnerke naj uporabljajo zelo učinkovito metodo kontracepcije v času, ko se moški zdravi, in še šest mesecev po zadnjem vzetem odmerku zdravila Farydak.
Efficacy results are summarised in Table 8 and the Kaplan-Meier curves for PFS are provided in Figure 2. 
Rezultati učinkovitosti so navedeni v preglednici 8 in prikazani s Kaplan-Meierjevima krivuljama preživetja brez napredovanja bolezni na sliki 2.
More than half (57.2%) of the patients had undergone prior stem cell transplantation and 62.8% of the patients were relapsed after previous anti-neoplastic therapies (e.g. melphalan 79.6%, dexamethasone 81.1%, thalidomide 51.2%, cyclophosphamide 45.3%, bortezomib 43.0%, combined bortezomib and dexamethasone 37.8%, lenalidomide 20.4%). 
Več kot polovici (57,2 %) bolnikov so predhodno že presadili krvotvorne matične celice, pri 62,8 % bolnikov pa je prišlo do recidiva po predhodni uporabi zdravil proti raku (kot so melfalan 79,6 %, deksametazon 81,1 %, talidomid 51,2 %, ciklofosfamid 45,3 %, bortezomib 43,0 %, kombinacija bortezomiba in deksametazona 37,8 %, lenalidomid 20,4 %).
What Farydak looks like and contents of the pack 
Izgled zdravila Farydak in vsebina pakiranja
Frequency of monitoring of these patients should be increased during treatment with panobinostat, particularly during the dose escalation phase. 
Med zdravljenjem s panobinostatom je treba te bolnike pogosteje nadzorovati, zlasti v času zviševanja odmerka.
Concomitant administration of medicinal products that are known to cause QTc prolongation should be used with caution (see section 4.5). 
Pri sočasnem odmerjanju zdravil, za katera je znano, da povzročajo podaljšanje intervala QTc, je potrebna previdnost (glejte poglavje 4.5).
Inhibition of HDAC activity results in increased acetylation of histone proteins, an epigenetic alteration that results in a relaxing of chromatin, leading to transcriptional activation. 
Zaradi zaviranja aktivnosti histonske deacetilaze se poveča delež acetiliranih histonskih proteinov, kar predstavlja epigenetsko spremembo, ki omogoča sproščanje kromatina, to pa povzroči aktivacijo transkripcije.
No pharmacokinetic data are available for patients with severe hepatic impairment. 
Pri bolnikih s hudo okvaro jeter farmakokinetičnih podatkov ni na voljo.
o How to use the compliance card: this section provides a general overview on how to use the compliance card. o How to take medication according to the prescription: this section provides guidance on how to fill in the compliance card. o Recommendation to bring compliance card to each visit: this section reminds the patient to bring the compliance card to the HCP at each visit. 
o kako jemati zdravilo na predpisan način: v tem delu so podana navodila za izpolnjevanje kartice za redno jemanje zdravil; o priporočilo, naj bolnik prinese kartico za redno jemanje zdravil na vsak pregled: ta del opominja bolnika, naj svojo kartico za redno jemanje zdravil prinese svojemu zdravniku ob vsakem pregledu; o preglednico s prikazom režima zdravljenja za vsak dan ciklusa in prostorom, kamor bolnik lahko vpiše, katera zdravila je vzel.
If you are a sexually active woman, you should have a pregnancy test before starting Farydak treatment and you must use a highly effective method of contraception during treatment with Farydak. 
Če ste spolno aktivna ženska, morate pred začetkom uporabe zdravila Farydak opraviti nosečnostni test, v času zdravljenja z zdravilom Farydak pa uporabljati zelo učinkovito kontracepcijsko metodo.
If you have questions about how long to take Farydak, talk to your doctor or pharmacist. 
Če vas zanima, kako dolgo je treba jemati zdravilo Farydak, se obrnite na zdravnika ali farmacevta.
Grade 3 asthenia was observed in 9.4% of the patients, with no patients experiencing asthenia at CTC grade 4. 
Astenijo 3. stopnje so opažali pri 9,4 % bolnikov, pri nobenem pa ni prišlo do astenije 4. stopnje po CTC.
The median time to onset for grade 3 and 4 thrombocytopenia was one month and the median time to recovery was 12 days. 
Mediani čas do pojava trombocitopenije 3. in 4. stopnje je bil en mesec, izzvenela pa je po mediano 12 dneh.
The recommended starting dose of panobinostat is 20 mg, taken orally once a day, on days 1, 3, 5, 8, 10 and 12 of a 21-day cycle. 
Priporočeni začetni odmerek panobinostata je 20 mg, bolnik pa ga vzame peroralno enkrat na dan na 1., 3., 5., 8., 10. in 12. dan ciklusa, ki traja 21 dni.
• muscle weakness, muscle spasms, unusual heartbeat (signs of changes in the level of potassium in the blood) 
- šibkost mišic, mišični spazmi, neobičajen srčni utrip (znaki pri spremembah koncentracije kalija v krvi).
A clinical study in cancer patients with impaired hepatic function showed that plasma exposure of panobinostat increased by 43% (1.4-fold) and 105% (2-fold) in patients with mild and moderate hepatic impairment, respectively. 
Klinična študija z bolniki z rakom in zmanjšanim delovanjem jeter je pokazala, da je izpostavljenost panobinostatu v plazmi pri bolnikih z blago okvaro jeter povečana za 43 % (1,4-krat), pri bolnikih z zmerno okvaro jeter pa za 105 % (2-krat).
Regardless of events chronology, syncope was reported in 9% of patients with ST-T depression and 7.2% of patients with T wave change and 4.9% of patients with neither of these ECG abnormalities. 
Ne glede na zaporedje dogodkov so o sinkopi poročali pri 9 % bolnikov z denivelacijo segmenta ST-T, pri 7,2 % bolnikov s spremembami vala T in pri 4,9 % bolnikov, ki na EKG posnetku niso imeli navedenih sprememb.
For patients >75 years of age, depending on the patient's general condition and concomitant diseases, an adjustment of the starting doses or schedule of the components of the combination regimen may be considered. 
Pri bolnikih, ki so stari več kot 75 let, je glede na njihovo splošno stanje in sočasne bolezni smiselno razmisliti o prilagoditvi začetnega odmerka ali razporeda odmerjanja posameznih učinkovin kombinirane sheme zdravljenja.
Prior to initiating any cycle of therapy with panobinostat in combination with bortezomib and dexamethasone, platelet count should be at least ≥100 x 109/l (see section 4.4). 
Pred začetkom vsakega ciklusa zdravljenja s panobinostatom v kombinaciji z bortezomibom in deksametazonom naj bo koncentracija trombocitov najmanj 100 x 109/l (glejte poglavje 4.4).
Bortezomib may be started at 1.3 mg/m2 once weekly on days 1 and 8, and dexamethasone at 20 mg on days 1 and 8. 
Zdravljenje z bortezomibom se lahko začne z odmerkom 1,3 mg/m2 enkrat na teden, in sicer na 1. in 8. dan ciklusa, zdravljenje z deksametazonom pa z odmerkom 20 mg na 1. in 8. dan ciklusa.
- Do not take this medicine if you notice any damage to the packaging or if there are any signs of tampering. 
- Ne uporabljajte tega zdravila, če opazite, da je ovojnina poškodovana ali da je bila že odprta.
Panobinostat is administered in combination with bortezomib and dexamethasone, as shown in Tables 1 and 2. 
Panobinostat se uporablja v kombinaciji z bortezomibom in deksametazonom, kot je navedeno v preglednicah 1 in 2.
Due to the potential risk of death or malformation to the foetus, you should use the following methods of contraception while taking Farydak: 
Zaradi tveganja za smrt zarodka ali prirojene nepravilnosti pri otroku morate v času jemanja zdravila Farydak uporabljati naslednje kontracepcijske metode:
Based on non-clinical findings, male fertility may be compromised by treatment with Farydak (see section 5.3). 
Kot kažejo neklinične ugotovitve, lahko zdravljenje z zdravilom Farydak zmanjšuje plodnost pri moških (glejte poglavje 5.3).
In the event of long QT interval prior to initiation of panobinostat (QTcF ≥480 msec at baseline), the start of treatment should be delayed until pre-dose average QTcF has returned to <480 msec. 
Če je interval QT podaljšan že pred začetkom zdravljenja s panobinostatom (QTcF ≥480 milisekund ob izhodišču), je treba začetek zdravljenja odložiti, dokler ne znaša povprečje trajanja intervala QTcF pred odmerjanjem spet manj kot 480 milisekund.
• The patient compliance card shall contain instructions on the following key messages: o How to become familiar with the compliance card: this section provides a general overview of the compliance card and its purpose. 
Izobraževalni komplet za bolnike naj vsebuje: o Navodilo za uporabo o kartica za redno jemanje zdravil • Kartica za redno jemanje zdravil mora vsebovati navodila, ki zadevajo naslednja ključna sporočila: o kako se seznaniti s kartico za redno jemanje zdravil: v tem delu je podan splošen pregled kartice za redno jemanje zdravil in njen namen;
Multiple myeloma is a disorder of plasma cells (a type of blood cell) that grow out of control in the bone marrow. 
Diseminirani plazmocitom je bolezen plazmatk (vrste krvnih celic), ki se v kostnem mozgu prekomerno razmnožujejo.
≤1.0 x ULN >ULN Reduce panobinostat dose to 15 mg in the first treatment cycle. 
≤1,0 x ZMN >ZMN Znižajte odmerek panobinostata na 15 mg v prvem ciklusu.
The effect of hepatic impairment on the pharmacokinetics of panobinostat was evaluated in a phase I study, in 24 patients with solid tumours and with varying degrees of hepatic impairment. 
Vpliv okvare jeter na farmakokinetiko panobinostata so ocenjevali v študiji faze I pri 24 bolnikih s solidnimi tumorji in različnimi stopnjami okvare jeter.
These could be signs of a low level of red blood cells. 
To so lahko znaki zmanjšanega števila eritrocitov.
Co-administration of a single 20 mg panobinostat dose with ketoconazole, a strong CYP3A inhibitor, increased the Cmax and AUC of panobinostat by 1.6- and 1.8-fold, respectively, compared to when panobinostat was given alone. 
Sočasno odmerjanje enkratnega odmerka 20 mg panobinostata skupaj s ketokonazolom, ki je močan zaviralec CYP3A, je povzročilo 1,6-kratno zvišanje Cmax in 1,8-kratno povečanje AUC panobinostata v primerjavi z odmerjanjem samo panobinostata.
Therefore a complete blood count must be performed before initiating therapy with panobinostat, with frequent monitoring during treatment (in particular before each injection of bortezomib as per bortezomib SmPC). 
Bolnikom je zato treba pred začetkom zdravljenja s panobinostatom določiti celotno krvno sliko in jo nato pogosto kontrolirati tekom zdravljenja (zlasti pred vsako injekcijo bortezomiba, kot je navedeno v povzetku glavnih značilnosti zdravila za bortezomib).
Given panobinostat's cytostatic/cytotoxic mode of action, the potential risk to the foetus is high. 
Glede na citostatičen/citotoksičen način delovanja panobinostata je potencialno tveganje za plod veliko.
Farydak is an anti-cancer medicine that contains the active substance panobinostat, which belongs to a group of medicines called pan-deacetylase inhibitors. 
Zdravilo Farydak je zdravilo proti raku, ki vsebuje zdravilno učinkovino panobinostat, ta pa sodi v skupino učinkovin, ki jih imenujemo univerzalni zaviralci deacetilaz.
Progression-free survival Median, months [95% CI] Hazard ratio [95% CI]1 
preživetje brez napredovanja bolezni mediana, meseci [95% IZ]
For patients >75 years of age, depending on the patient's general condition and concomitant diseases, an adjustment of the starting doses or schedule of the components of the combination regimen may be considered (see section 4.2). 
Pri bolnikih, ki so stari več kot 75 let, je glede na njihovo splošno stanje in sočasne bolezni smiselno razmisliti o prilagoditvi začetnega odmerka oziroma razporeda odmerjanja posameznih učinkovin kombinirane sheme zdravljenja (glejte poglavje 4.2).
Given its cytostatic/cytotoxic mode of action, breast-feeding is contraindicated during Farydak treatment (see section 4.3). 
Zaradi citostatičnega/citotoksičnega načina delovanja je v času zdravljenja z zdravilom Farydak dojenje kontraindicirano (glejte poglavje 4.3).
Clinical efficacy in patients with relapsed and relapsed and refractory multiple myeloma (Study D2308 - Panorama 1) 
Klinična učinkovitost pri bolnikih z recidivom oziroma z recidivno in neodzivno obliko diseminiranega plazmocitoma (študija D2308 - Panorama 1)
The safety data of panobinostat have been assessed from a total of 451 patients with multiple myeloma treated with panobinostat in combination with bortezomib and dexamethasone and from a total of 278 patients treated with panobinostat as a single agent. 
Varnost uporabe panobinostata so ocenjevali iz podatkov skupno 451 bolnikov z diseminiranim plazmocitomom, ki so jih zdravili s panobinostatom v kombinaciji z bortezomibom in deksametazonom, ter skupno 278 bolnikov, ki so jih zdravili samo s panobinostatom.
Farydak is used to treat adult patients with a rare type of blood cancer called multiple myeloma. 
Za kaj uporabljamo zdravilo Farydak Zdravilo Farydak uporabljamo za zdravljenje odraslih bolnikov z redko vrsto krvnega raka, ki ga imenujemo diseminirani plazmocitom.
Due to the potential risk of death or malformation to the foetus, Farydak should not be taken during: 
Zaradi tveganja za smrt zarodka ali prirojene nepravilnosti pri otroku zdravila Farydak ne smete jemati:
Table 7 includes adverse drug reactions that occur due to the addition of panobinostat to the bortezomib and dexamethasone combination. 
Preglednica 7 vključuje neželene učinke do katerih je prišlo zaradi dodatka panobinostata h kombinaciji bortezomiba in deksametazona.
In patients with CTC grade 3 thrombocytopenia (platelet count <50 x 109/l with bleeding) panobinostat may need to be temporarily withheld and/or the subsequent dose may need to be reduced. 
Pri bolnikih s trombocitopenijo 3. stopnje po kriterijih CTC (s koncentracijo trombocitov <50 x 109/l s krvavitvijo) je morda treba začasno prekiniti z uporabo panobinostata in/ali zdravljenje nadaljevati z nižjim odmerkom.
>1.0 x ULN and ≤1.5 x ULN 
>1,0 x ZMN in ≤1,5 x ZMN
Table 6 Recommended starting dose modification for patients with hepatic impairment Grade of hepatic impairment* 
Preglednica 6: Priporočila za prilagajanje začetnih odmerkov pri bolnikih z okvaro jeter stopnja okvare jeter*
At the first sign of abdominal cramping, loose stools or onset of diarrhoea, it is recommended that the patient be treated with an anti-diarrhoeal medicinal product (e.g. loperamide). 
Pri prvih znakih trebušnih krčev, odvajanja redkega blata oziroma ob začetku diareje je priporočeno bolnika zdraviti z antidiaroiki (na primer z loperamidom).
After a single oral dose of [14C] panobinostat in patients, 29 to 51% of administered radioactivity is excreted in the urine and 44 to 77% in the faeces. 
Po enkratnem peroralnem odmerku s [14C] označenega panobinostata se je pri bolnikih 29 do 51 %
Blood electrolytes, especially potassium, magnesium and phosphorus, should be measured at baseline and monitored periodically as clinically indicated, especially in patients with diarrhoea. 
Koncentracije elektrolitov v krvi, zlasti kalija, magnezija in fosforja, je treba izmeriti pred začetkom zdravljenja, nato pa periodično spremljati v skladu s kliničnimi indikacijami, zlasti pri bolnikih z diarejo.
- For women taking Farydak 
- Za ženske, ki jemljejo zdravilo Farydak
It is recommended to monitor patients over 65 years of age more frequently, especially for thrombocytopenia and gastrointestinal toxicity (see section 4.8 and section 4.2). 
Pri bolnikih, ki so stari več kot 65 let, so priporočeni pogostejši pregledi, zlasti glede trombocitopenije in gastrointestinalne toksičnosti (glejte poglavje 4.8 in poglavje 4.2).
Likewise ischaemic heart disease (including myocardial infarction and ischaemia) were reported in 4.5% of patients with ST-T depression and 4.8% of patients with T wave change and 2.7% of patients with neither of these ECG abnormalities. 
Podobno so tudi o koronarni bolezni (vključno z miokardnim infarktom in ishemijo) poročali pri 4,5 % bolnikov z denivelacijo segmenta ST-T, pri 4,8 % bolnikov s spremembami vala T in pri 2,7 % bolnikov, ki na EKG posnetku niso imeli navedenih sprememb.
Please refer to Table 1 for cycles 1 to 8 and Table 2 for cycles 9-16. 
Za cikluse 1 do 8 glejte preglednico 1, za cikluse 9 do 16 pa preglednico 2.
Refractoriness to bortezomib was defined as disease progression on or within 60 days of the last bortezomib-containing line of therapy. 
Neodzivnost na bortezomib je bila opredeljena kot napredovanje bolezni v času prejemanja sheme zdravljenja, ki je vključevala bortezomib, ali v 60 dneh po zadnji tovrstni shemi zdravljenja.