FrancophonIA/ELRC3.0 huggingface dataset:
English: Ogivri must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients.
Slovenian: Zdravila Ogivri ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) trastuzumab, mišje beljakovine ali na katero koli drugo sestavino zdravila.
English: Ogivri can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila Ogivri je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: It is also used in combination with other cancer medicines: with paclitaxel or docetaxel, or with another type of medicine called an aromatase inhibitor;
Slovenian: Uporablja se tudi v kombinaciji z drugimi zdravili za zdravljenje raka: s paklitakselom ali docetakselom ali drugo vrsto zdravil, imenovano zaviralci aromataze;
English: Patients received Ogivri or the reference medicine Herceptin, together with other cancer medicines (paclitaxel or docetaxel).
Slovenian: Bolniki so prejemali zdravilo Ogivri ali referenčno zdravilo Herceptin skupaj z drugimi zdravili za zdravljenje raka (paklitaksel ali docetaksel).
English: • early breast cancer (when the cancer has spread within the breast or to the lymph nodes (‘glands') under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable.
Slovenian: • zgodnjega raka dojke (kadar se je rak razširil znotraj dojke ali v podpazdušne žleze, ne pa na druge dele telesa) po kirurškem posegu, kemoterapiji (z zdravili za zdravljenje raka) in radioterapiji (zdravljenju z obsevanjem), če je smiselno.
English: In addition, one study involving 500 patients with metastatic breast cancer that overexpressed HER2 showed that Ogivri was effective in treating the condition.
Slovenian: Poleg tega je ena študija, v katero je bilo vključenih 500 bolnikov z metastatskim rakom dojke, ki je čezmerno izražal beljakovino HER2, pokazala, da je zdravilo Ogivri učinkovito pri zdravljenju te bolezni.
English: For cancers that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Ogivri is used before surgery in combination with chemotherapy and then again after surgery on its own;
Slovenian: Pri lokalno napredovalih rakih (vključno z vnetnimi tumorji) ali rakih, širših od 2 cm, se zdravilo Ogivri pred kirurškim posegom uporablja v kombinaciji s kemoterapijo, po posegu pa samostojno;
English: What are the risks associated with Ogivri?
Slovenian: Kakšna tveganja so povezana z zdravilom Ogivri?
English: The active substance in Ogivri, trastuzumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to the HER2 protein.
Slovenian: Učinkovina v zdravilu Ogivri, trastuzumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna beljakovino HER2 in se veže nanjo.
English: Because Ogivri is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Ogivri.
Slovenian: Zdravilo Ogivri je podobno biološko zdravilo, zato študij o učinkovitosti in varnosti trastuzumaba, izvedenih z zdravilom Herceptin, z zdravilom Ogivri ni treba ponavljati.
English: The reference medicine for Ogivri is Herceptin.
Slovenian: Referenčno zdravilo za zdravilo Ogivri je zdravilo Herceptin.
English: The safety of Ogivri has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Herceptin.
Slovenian: Varnost zdravila Ogivri je bila ocenjena in na podlagi vseh izvedenih študij so bili neželeni učinki zdravila ocenjeni kot primerljivi z neželenimi učinki referenčnega zdravila Herceptin.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Ogivri has a highly similar structure, purity and biological activity to Herceptin and is distributed in the body in the same way.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Ogivri po zgradbi, čistosti in biološkem delovanju primerljivo zdravilu Herceptin in da se po telesu enako prenaša.
English: Therefore, the Agency's view was that, as for Herceptin, the benefit of Ogivri outweighs the identified risks and it can be authorised for use in the EU.
Slovenian: Agencija je zato menila, da koristi zdravila Ogivri enako kot pri zdravilu Herceptin odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
English: Ogivri is a ‘biosimilar medicine'.
Slovenian: Zdravilo Ogivri je „podobno biološko zdravilo“.
English: In the light of all the data provided the difference was not assessed to be relevant and it was concluded that Ogivri would behave in the same way as Herceptin in its approved indications.
Slovenian: Na podlagi vseh predloženih podatkov razlike niso ocenili kot pomembne in so zaključili, da se bo zdravilo Ogivri pri odobrenih indikacijah vedlo enako kot zdravilo Herceptin.
English: Other information about Ogivri
Slovenian: Druge informacije o zdravilu Ogivri:
English: Studies have also shown that giving Ogivri infusion produces similar levels of the active substance in the body to giving an infusion of Herceptin.
Slovenian: Študije so pokazale tudi, da zdravilo Ogivri vzpostavi podobne ravni učinkovine v telesu kot zdravilo Herceptin.
English: All these data were considered sufficient to conclude that Ogivri will behave in the same way as intravenous Herceptin in terms of effectiveness and safety in its authorised uses.
Slovenian: Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Ogivri pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Herceptin.
English: In addition, studies in metastatic breast cancer that overexpressed HER2 have shown that the effectiveness of Ogivri infusion is equivalent to that of Herceptin infusion.
Slovenian: Poleg tega so študije pri metastatskem raku dojk, ki je čezmerno izražal beljakovino HER2, pokazale, da je zdravilo Ogivri enako učinkovito kot zdravilo Herceptin.
English: Ogivri contains the active substance trastuzumab.
Slovenian: Zdravilo Ogivri vsebuje učinkovino trastuzumab.
English: How is Ogivri used?
Slovenian: Kako se zdravilo Ogivri uporablja?
English: Laboratory studies comparing Ogivri with Herceptin have shown that the active substance in Ogivri is highly similar to that in Herceptin in terms of structure, purity and biological activity.
Slovenian: Laboratorijske študije, v katerih so zdravilo Ogivri primerjali z zdravilom Herceptin, so pokazale, da je učinkovina zdravila Ogivri po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Herceptin.
English: Ogivri can only be used when the cancer ‘overexpresses HER2': this means that the cancer produces a protein called HER2 in large quantities on the cancer cells.
Slovenian: To pomeni, da na površini rakavih celic v velikih količinah nastaja beljakovina, imenovana HER2.
English: Other symptoms may occur as well.
Slovenian: Pojavijo pa se lahko tudi drugi simptomi.
English: Age < 65 years ≥ 65 years
Slovenian: Starost < 65 let ≥ 65 let
English: Patients should be monitored for the development of SPMs.
Slovenian: Bolnike je treba nadzirati glede razvoja SPN.
English: Amount of water for injections, required for reconstitution
Slovenian: Količina vode za injekcije, potrebna za rekonstitucijo
English: Overall survival (Months)
Slovenian: Celokupno preživetje (meseci)
English: Avoid vigorous agitation, DO NOT SHAKE.
Slovenian: Izogibajte se močnemu tresenju, NE STRESAJTE.
English: However, results should be taken with caution as assessment of consistency of effect within the different subgroups was hampered by the very limited number of patients included in the different subgroups.
Slovenian: Vendar pa je rezultate treba obravnavati previdno, saj je vrednotenje konsistence učinkovitosti v različnih podskupinah oviralo zelo majhno število bolnikov, vključenih v različne podskupine.
English: IRC assessment was performed post-hoc.
Slovenian: IRC je vrednotenje izvedel post-hoc.
English: Unopened vial 3 years.
Slovenian: Zaprte viale 3 leta
English: The final OS analysis met the protocol-specified boundary for statistical significance (p ≤ 0.046).
Slovenian: Končna analiza OS je izpolnjevala s protokolom določeno mejo za statistično značilen vpliv (p ≤ 0,046).
English: Efficacy results are presented in Table 8 and Figure 1.
Slovenian: Rezultati učinkovitosti so predstavljeni v tabeli 8 in na sliki 1.
English: All reports of infusion reaction were ≤ Grade 3.
Slovenian: Vsa poročila o infuzijskih reakcijah so bila ≤ stopnji 3.
English: The minimum follow-up was 70.6 months.
Slovenian: Najkrajši čas spremljanja je znašal 70,6 mesecev.
English: Overall survival (OS) was a key secondary study endpoint.
Slovenian: Celokupno preživetje (OS) je bil ključni sekundarni opazovani dogodek študije.
English: Do not try to treat your symptoms with other medicines.
Slovenian: Simptomov ne poskušajte zdraviti sami z drugimi zdravili.
English: * Continue this rate until infusion is completed.
Slovenian: * Nadaljujte s to hitrostjo do konca infundiranja.
English: See Table 8 and Figure 2.
Slovenian: Glejte tabelo 8 in sliko 2.
English: PFS results per the investigator and IRC are summarised in Table 10 (minimum follow-up of 9.1 months).
Slovenian: Rezultati PFS po oceni raziskovalca in IRC so povzeti v tabeli 10 (najmanjše obdobje spremljana 9,1 meseca).
English: Eleven (9.4%) patients had high-risk myeloma.
Slovenian: Enajst (9,4 %) bolnikov je imelo visoko rizičen mielom.
English: Pharmacokinetic interaction studies have not been conducted.
Slovenian: Študij farmakokinetičnih interakcij niso izvedli.
English: Paracetamol (650-1000 mg orally).
Slovenian: Paracetamol (od 650 do 1.000 mg peroralno).
English: What you need to know before you use Empliciti 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Empliciti 3.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from available data).
Slovenian: Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: These side effects mostly occur during or after the infusion of the first dose.
Slovenian: Ti neželeni učinki se večinoma pojavijo med ali po infundiranju prvega odmerka zdravila.
English: Assessment of tumour response was conducted every 4 weeks.
Slovenian: Odziv tumorja so vrednotili na vsake 4 tedne.
English: This 8-hour period should be inclusive of the product administration period.
Slovenian: Teh 8 ur vključuje tudi samo obdobje aplikacije zdravila.
English: Rate (incidence rate/100 patient years)
Slovenian: Delež (delež pojavnosti/100 bolnik-let)
English: The effects of Empliciti in pregnant women or its possible harm to an unborn baby are unknown.
Slovenian: Učinki zdravila Empliciti pri nosečnicah ali njegovi možni škodljivi vplivi na nerojenega otroka niso znani.
English: Days 1-21
Slovenian: 1. do 21. dan
English: This results in damage to the bones and kidneys.
Slovenian: Posledično pride do poškodbe kosti in ledvic.
English: b modified International Myeloma Working Group (IMWG) criteria.
Slovenian: b modificirani kriteriji mednarodne delovne skupine za mielom (IMWG, International Myeloma Working Group).
English: Frequency overall
Slovenian: Celokupna pogostnost
English: Standard risk Cytogenetic category Presence of del17p
Slovenian: Dejavniki tveganja Visoko tveganje Standardno tveganje Citogenetska kategorija Prisotnost del17p
English: Empliciti is available in packs containing 1 vial.
Slovenian: Zdravilo Empliciti je na voljo v pakiranjih, ki vsebujejo 1 vialo.
English: After the remaining solids are completely dissolved, allow the reconstituted solution to stand for 5 to 10 minutes.
Slovenian: Ko se vsa trdna snov popolnoma raztopi, pustite rekonstituirano raztopino stati od 5 do 10 minut.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom preden prejmete to zdravilo.
English: What Empliciti is and what it is used for 2.
Slovenian: Kaj je zdravilo Empliciti in za kaj ga uporabljamo 2.
English: In these 19 patients, anti-product antibodies occurred within the first 2 months of the initiation of Empliciti treatment.
Slovenian: Pri teh 19 bolnikih so se protitelesa proti zdravilu pojavila v prvih 2 mesecih po uvedbi zdravljenja z zdravilom Empliciti.
English: Women of childbearing potential should use effective contraception.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo.
English: The lyophilised powder should dissolve in less than 10 minutes.
Slovenian: Liofiliziran prašek se mora raztopiti prej kot v 10 minutah.
English: It is not known, whether elotuzumab passes into breast milk or if there is any risk to the breast-fed infant.
Slovenian: Ni znano, če se elotuzumab izloča v materino mleko, ali če obstaja kakršno koli tveganje za dojenega otroka.
English: European Group for Blood and Marrow Transplantation (EBMT) criteria.
Slovenian: Kriteriji Evropske skupine za presajanje kostnega mozga in krvotvornih matičnih celic (EBMT).
English: Dose 2 and all subsequent doses
Slovenian: 2. odmerek in vsi kasnejši odmerki
English: Lenalidomide and pomalidomide are expected to be harmful for an unborn baby.
Slovenian: Za lenalidomid in pomalidomid se pričakuje, da bosta škodovala nerojenemu otroku.
English: Number of subjects at risk
Slovenian: Število ogroženih oseb
English: Then invert the vial a few times in order to dissolve any powder that may be present on top of the vial or the stopper.
Slovenian: Nato vialo nekajkrat obrnite, da se raztopi tudi ves prašek, ki bi lahko bil prisoten na vrhu viale ali zamašku.
English: Neutralizing antibodies were detected in 19 of 299 patients in CA204004.
Slovenian: Nevtralizirajoča protitelesa so odkrili pri 19 od 299 bolnikov v študiji CA204004.
English: The most serious adverse reaction that may occur during elotuzumab treatment is pneumonia.
Slovenian: Najbolj resen neželeni učinek, ki se lahko pojavi med zdravljenjem z elotuzumabom, je pljučnica.
English: After dilution, the infusion must be completed within 24 hours of preparation.
Slovenian: Po redčenju je treba infundiranje dokončati v 24 urah po pripravi.
English: Patients with Grade 2 or higher peripheral neuropathy were excluded from the clinical studies with E-Pd.
Slovenian: Bolnike s periferno nevropatijo stopnje 2 ali višjo, so iz kliničnih študij E-Pd izključili.
English: In the majority of patients, immunogenicity occurred early in treatment and was transient resolving by 2 to 4 months.
Slovenian: Pri večini bolnikov se je imunogenost pojavljala na začetku zdravljenja in je bila prehodna ter izzvenela v 2 do 4 mesecih.
English: Multiple myeloma is a cancer of a type of white blood cell called plasma cells.
Slovenian: Multipli mielom je rak vrste belih krvnih celic, imenovanih plazmatke.
English: [95% CI]
Slovenian: [95 % IZ]
English: Kaplan-Meier curve for PFS per the investigator is provided in Figure 3.
Slovenian: Kaplan-Meierjeva krivulja preživetja PFS po oceni raziskovalca je prikazana na sliki 3.
English: The reconstituted solution is colourless to slightly yellow and clear to very opalescent.
Slovenian: Rekonstituirana raztopina je brezbarvna do rahlo rumena in bistra do zelo opalescentna.
English: The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of the paediatric population in treatment of multiple myeloma (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij za vse podskupine pediatrične populacije pri zdravljenju multiplega mieloma (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: Grade 3/4
Slovenian: vse stopnje stopnja 3/4
English: In case of detection of additional peaks on serum immunofixation, the possibility of a biclonal gammopathy should be excluded.
Slovenian: V primeru odkritja dodatnih vrhov pri imunofiksaciji seruma je treba izključiti možnost biklonske gamopatije.
English: Thus, the effect of elotuzumab on male and female fertility is unknown.
Slovenian: Učinek elotuzumaba na plodnost pri moških in ženskah ni znan.
English: Anti-product antibodies resolved by 2 to 3 months in 18 (95%) of these 19 patients.
Slovenian: Protitelesa proti zdravilu so izzvenela v 2 do 3 mesecih pri 18 (95 %) od 19 bolnikov.
English: Grade 3 infusion reactions occurred in 1% of patients.
Slovenian: Infuzijske reakcije stopnje 3 so se pojavile pri 1 % bolnikov.
English: Neutralizing antibodies were detected in 2 of 53 patients.
Slovenian: Nevtralizirajoča protitelesa so odkrili pri 2 od 53 bolnikov.
English: How to use Empliciti 4.
Slovenian: Kako uporabljati zdravilo Empliciti 4.
English: All patients had documented progression following their most recent therapy.
Slovenian: Pri vseh bolnikih je bilo dokumentirano napredovanje bolezni po zadnjem zdravljenju.
English: Vital signs should be monitored every 30 minutes for 2 hours after the end of the Empliciti infusion.
Slovenian: Vitalne znake je treba nadzirati vsakih 30 minut 2 uri po koncu infundiranja zdravila Empliciti.
English: Absorption Elotuzumab is dosed via intravenous route and therefore is immediately and completely bioavailable.
Slovenian: Absorpcija Elotuzumab se uporablja intravensko, zato je njegova biološka uporabnost takojšnja in popolna.
English: Because elotuzumab does not recognize non-human forms of SLAMF7 protein, in vivo safety data from animal studies are irrelevant.
Slovenian: Ker elotuzumab ne prepozna nečloveških oblik proteina SLAMF7, in vivo pridobljeni podatki o varnosti pri živalih niso relevantni.
English: As with all therapeutic proteins, there is a potential for immunogenicity to Empliciti.
Slovenian: Kot pri drugih terapevtskih beljakovinah tudi pri uporabi zdravila Empliciti obstaja možnost pojava imunogenosti.
English: The patient had no symptoms, did not require any treatment for the overdose, and was able to continue on elotuzumab therapy.
Slovenian: Bolnik ni imel nobenih simptomov, zdravljenje zaradi prevelikega odmerjanja ni bilo potrebno, zdravljenje z elotuzumabom pa se je lahko nadaljevalo.
English: The presence of elotuzumab in patient's serum may cause a small peak in the early gamma region on SPEP that is IgGƙ on serum immunofixation.
Slovenian: Elotuzumab v serumu bolnika lahko povzroči majhen vrh v začetni regiji gama pri SPEP, ki je IgGƙ pri imunofiksaciji seruma.
English: If there is no recurrence of the infusion reaction, the escalation can be resumed (see Tables 3 and 4).
Slovenian: Če se infuzijska reakcija ne ponovi, se s povečevanjem hitrosti lahko nadaljuje (glejte tabeli 3 in 4).
English: You will receive Empliciti under the supervision of an experienced healthcare professional.
Slovenian: Zdravilo Empliciti boste prejeli pod nadzorom zdravstvenega delavca z ustreznimi izkušnjami.
English: In study CA204125, all of the reported infusion reactions occurred during the first treatment cycle and were ≤ Grade 2.
Slovenian: V študiji CA204125 so se vse infuzijske reakcije, o katerih so poročali, pojavile pri prvem ciklu zdravljenja in so bile ≤ stopnje 2.
English: The OS data from the exploratory analysis were not mature at the data cut-off (29 November 2018) with a minimum follow up of 18.3 months.
Slovenian: Podatki o celokupnem preživetju iz eksploratorne analize ob pridobitvi podatkov (29. november 2018) še niso bili zreli, najmanjše obdobje spremljanja pa je bilo 18,3 meseca.
English: Patients with cardiac amyloidosis or plasma cell leukemia were excluded from this study.
Slovenian: Bolnike s srčno amiloidozo ali plazmocitno levkemijo so izključili iz študije.
English: If you have any further questions, ask your doctor, or pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja, se posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
English: Patients should be monitored and infections should be managed with standard treatment.
Slovenian: Bolnike je treba nadzirati, v primeru okužb pa uvesti standardno zdravljenje.
English: The maximum infusion rate should not exceed 5 mL/min.
Slovenian: Največja hitrost infundiranja ne sme preseči 5 ml/min.
English: Investigator Assessed
Slovenian: Ocena raziskovalca
English: Studies to evaluate the effect of elotuzumab on fertility have not been performed.
Slovenian: Študij, ki bi ovrednotile vpliv elotuzumaba na plodnost, niso izvedli.
English: A pre-specified analysis for 3-year PFS rate was performed based on a minimum follow-up time of 33 months.
Slovenian: Vnaprej določena analiza deleža 3-letnega preživetja brez napredovanja bolezni (PFS) je bila izvedena na osnovi minimalnega časa spremljanja 33 mesecev.
English: Non-clinical safety information primarily consists of limited in vitro human cell/tissue studies where no safety findings were identified.
Slovenian: Nekliničnih podatkov o varnosti je malo, v glavnem pa so bili pridobljeni z in vitro študijami na človeških celicah/tkivih, kjer pa niso ugotovili vpliva na varnost.
English: The pre-planned final OS analysis was performed after 212 deaths in the E-Ld arm and 225 deaths in the Ld arm.
Slovenian: Vnaprej načrtovana končna analiza celokupnega preživetja je bila izvedena po 212 smrtnih primerih v skupini E-Ld in 225 smrtnih primerih v skupini Ld.
English: These cells divide out of control and collect in the bone marrow.
Slovenian: Te celice se nenadzorovano delijo in kopičijo v kostnem mozgu.
English: Cycle 1, Dose 3 and 4 and all subsequent Cycles
Slovenian: 1. cikel, 3. in 4. odmerek in vsi kasnejši cikli
English: Final volume of reconstituted Empliciti in the vial
Slovenian: Končni volumen rekonstituiranega zdravila Empliciti v viali
English: Depending on the seriousness of the infusion reactions, you may require additional treatment to prevent complications and reduce your symptoms, or your infusion of Empliciti may be interrupted.
Slovenian: Odvisno od resnosti infuzijskih reakcij boste morda potrebovali dodatno zdravljenje za preprečitev zapletov ali ublažitev simptomov, infundiranje zdravila Empliciti pa bo morda treba prekiniti.
English: Do not stop treatment unless you have discussed this with your doctor.
Slovenian: Zdravljenja ne prekinjajte, ne da bi se o tem prej posvetovali z zdravnikom.
English: Children and adolescents Empliciti is not recommended for use in children and adolescents aged under 18 years.
Slovenian: Otroci in mladostniki Pri otrocih in mladostnikih, mlajših od 18 let, uporaba zdravila Empliciti ni priporočljiva.
English: Absence of del17p Presence of t(4;14) Absence of t(4;14) ISS Stage I
Slovenian: Odsotnost del17p Prisotnost t(4;14) Odsotnost t(4;14)
English: Median OS was not reached for E-Pd treatment group.
Slovenian: Mediana celokupnega preživetja za skupino zdravljenja E-Pd ni bila dosežena.
English: What Empliciti is and what it is used for
Slovenian: Kaj je zdravilo Empliciti in za kaj ga uporabljamo
English: Thirty-five percent (35%) of patients were refractory (progression during or within 60 days of last therapy) and 65% were relapsed (progression after 60 days of last therapy).
Slovenian: Petintrideset odstotkov (35 %) bolnikov je bilo neodzivnih (napredovanje med ali v 60 dneh po zadnjem zdravljenju), pri 65 % bolnikov pa se je bolezen ponovila (napredovanje po 60 dneh po zadnjem zdravljenju).