FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean (standard deviation [SD]) estimated terminal half-life of daratumumab following the first 16 mg/kg dose was 9 (4.3) days.
Croatian: Srednja procijenjena vrijednost (standardno odstupanje [engl. standard deviation, SD]) terminalnog poluvijeka daratumumaba nakon prve doze od 16 mg/kg iznosila je 9 (4,3) dana.
English: Before and after each infusion of DARZALEX, you will be given medicines which help to lower the chance of infusion-related reactions (see “Medicines given during treatment with DARZALEX” in section 3).
Croatian: Prije i nakon svake infuzije lijeka DARZALEX primit ćete lijekove koji će pomoći smanjiti vjerojatnost razvoja reakcija na infuziju (pogledajte odlomak „Lijekovi koji se primjenjuju tijekom liječenja lijekom DARZALEX” u dijelu 3.).
English: The most frequent adverse reactions (≥ 20%) were infusion reactions, fatigue, nausea, diarrhoea, constipation, pyrexia, dyspnoea, cough, neutropenia, thrombocytopenia, anaemia, oedema peripheral, asthenia, peripheral sensory neuropathy and upper respiratory tract infection.
Croatian: Najčešće nuspojave (≥ 20%) bile su reakcije na infuziju, umor, mučnina, proljev, konstipacija, pireksija, dispneja, kašalj, neutropenija, trombocitopenija, anemija, periferni edem, astenija, periferna senzorna neuropatija i infekcija gornjih dišnih putova.
English: When DARZALEX dosing was interrupted in the setting of ASCT (Study MMY3006) for a median of 3.75 (range: 2.4; 6.9) months, upon re-initiation of DARZALEX the incidence of IRRs was 11% at first infusion following ASCT.
Croatian: Kada je primjena lijeka DARZALEX bila prekinuta radi ASCT-a (ispitivanje MMY3006) tijekom medijana od 3,75 mjeseci (raspon: 2,4; 6,9), incidencija reakcija na infuziju nakon ponovnog uvođenja lijeka DARZALEX iznosila je 11% kod prve infuzije nakon ASCT-a.
English: Analysis 2 included 694 patients (n=326 for lenalidomide-dexamethasone; n=246 for bortezomib-dexamethasone; n=99 for pomalidomidedexamethasone; n=11 for bortezomib-melphalan-prednisone; and n=12 for bortezomib-thalidomidedexamethasone), Analysis 3 included 352 patients (bortezomib-melphalan-prednisone) and Analysis 4 included 355 patients (lenalidomide-dexamethasone).
Croatian: 2. analiza uključila je 694 bolesnika (n=326 za lenalidomid-deksametazon; n=246 za bortezomib-deksametazon; n=99 za pomalidomid-deksametazon; n=11 za bortezomib-melfalan-prednizon; i n=12 za bortezomibtalidomid-deksametazon), 3. analiza uključila je 352 bolesnika (bortezomib-melfalan-prednizon), a 4. analiza uključila je 355 bolesnika (lenalidomid-deksametazon).
English: Decreases in absolute counts and percentages of total NK cells (CD16+CD56+) and activated (CD16+CD56
Croatian: Kod liječenja daratumumabom primijećeno je smanjenje apsolutnog broja i postotka ukupnog broja NK stanica (CD16+CD56+) i aktiviranih (CD16+CD56
English: • Do not store any unused portion of the infusion solution for reuse.
Croatian: • Preostala neupotrijebljena otopina za infuziju ne smije se čuvati za kasniju ponovnu uporabu.
English: The baseline demographic and disease characteristics were similar between the two treatment groups.
Croatian: Početne demografske značajke i karakteristike bolesti bile su slične u obje liječene skupine.
English: If you get any of the infusion-related reactions above, tell your doctor or nurse straight away.
Croatian: Ako se pojavi bilo koja od gore navedenih reakcija na infuziju, odmah o tome obavijestite svog liječnika ili medicinsku sestru.
English: No animal studies have been performed to evaluate the potential effects of daratumumab on reproduction or development.
Croatian: Nisu provedena ispitivanja na životinjama kojima bi se ocijenili mogući učinci daratumumaba na reprodukciju ili razvoj.
English: A total of 498 patients were randomised; 251 to the DVd arm and 247 to the Vd arm.
Croatian: Randomizirano je ukupno 498 bolesnika; 251 u skupinu DVd i 247 u Vd skupinu.
English: Alternatively, genotyping may also be considered; o In case of urgent need for transfusion, non-cross matched ABO/RhD compatible RBC units can be administered as per local bank practices; o In the event of a planned transfusion, the HCPs should notify blood transfusion centres about the interference with indirect antiglobulin tests; o Reference to the need to consult the Summary of Product Characteristics (SmPC); o Reference to the need of giving the Patient Alert Card to the patients and to advise them to consult the Package Leaflet (PL).
Croatian: S druge strane, može se u obzir također uzeti genotipizacija; o Ako je potrebna hitna transfuzija, mogu se primijeniti ABO/RhD-kompatibilni eritrociti za koje nije provedena križna proba, u skladu s praksom lokalne banke krvi; o U slučaju planirane transfuzije, potrebno je obavijestiti centre za transfuziju krvi o toj interferenciji s nalazima indirektnog antiglobulinskog testa; o Napomena da je potrebno pročitati sažetak opisa svojstava lijeka (SmPC); o Napomena da je bolesnicima potrebno dati Karticu s upozorenjima za bolesnika i savjetovati ih da pročitaju uputu o lijeku (engl.
English: For patients that experience any Grade IRRs, continue monitoring post-infusion until symptoms resolve.
Croatian: Bolesnike kod kojih se pojave reakcije na infuziju, bilo kojeg stupnja, nastavite pratiti nakon infuzije dok se simptomi ne povuku.
English: Prior therapies included bortezomib (99%), lenalidomide (99%), pomalidomide (63%) and carfilzomib (50%).
Croatian: Prethodne terapije uključivale su bortezomib (99%), lenalidomid (99%), pomalidomid (63%) i karfilzomib (50%).
English: For patients with Grade 1, 2, or 3 IRRs, the infusion rate should be reduced when re-starting the infusion.
Croatian: Za bolesnike s reakcijama na infuziju 1., 2. ili 3. stupnja, potrebno je smanjiti brzinu infuzije pri njenom ponovnom uvođenju.
English: Daratumumab is a human monoclonal IgG1κ antibody against CD38 antigen, produced in a mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology.
Croatian: Daratumumab je humano monoklonsko IgG1κ protutijelo protiv CD38 antigena proizvedeno u staničnoj liniji sisavaca (jajnik kineskog hrčka [engl. chinese hamster ovary, CHO]) tehnologijom rekombinantne DNK.
English: At baseline, 27% of patients were refractory to the last line of treatment.
Croatian: Na početku, 27% bolesnika bilo je refrakterno na posljednju liniju liječenja.
English: In some cases you may have a severe allergic reaction which may include a swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing or an itchy rash (hives).
Croatian: U nekim slučajevima možete doživjeti tešku alergijsku reakciju koja može uključivati otečeno lice, usne, usta, jezik ili grlo, poteškoće s gutanjem ili disanjem ili osip koji svrbi (koprivnjača).
English: Infusion rate/dilution volume used upon re-initiation was that used for the last DARZALEX infusion prior to interruption due to ASCT.
Croatian: Brzina infuzije / volumen razrijeđene otopine nakon ponovnog uvođenja liječenja odgovarali su onima kod posljednje infuzije lijeka DARZALEX prije prekida njegove primjene radi ASCT-a.
English: Option 2 (Split dose infusion) Week 1 Day 1 (8 mg/kg)
Croatian: 2. opcija (Infuzija s podijeljenom dozom) 1. tjedan, 1. dan (8 mg/kg)
English: The clinical efficacy and safety of DARZALEX monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who had demonstrated disease progression on the last therapy, was demonstrated in two open-label studies.
Croatian: Klinička djelotvornost i sigurnost lijeka DARZALEX u monoterapiji u liječenju odraslih bolesnika s relapsnim i refrakternim multiplim mijelomom čija je prethodna terapija uključivala inhibitor proteasoma i imunomodulator i kod kojih je dokazana progresija bolesti pri zadnjoj terapiji, dokazane su u dva otvorena ispitivanja.
English: Due to the high affinity to a unique epitope on CD38, daratumumab is not anticipated to alter drug-metabolising enzymes.
Croatian: Zbog velikog afiniteta vezanja za jedinstven epitop na proteinu CD38, ne očekuje se da će daratumumab izmijeniti enzime koji metaboliziraju lijekove.
English: Sixty-nine percent (69%) of patients had received a prior PI (66% received bortezomib) and 76% of patients received an IMiD (42% received lenalidomide).
Croatian: Šezdeset i devet posto (69%) bolesnika prethodno je primilo inhibitor proteasoma (66% je primilo bortezomib) i 76% primilo je imunomodulator (42% je primilo lenalidomid).
English: These observations suggest CD38 may become saturated at higher doses, after which the impact of target binding clearance is minimised and the clearance of daratumumab approximates the linear clearance of endogenous IgG1.
Croatian: Navedena opažanja ukazuju na to da pri većim dozama možda dolazi do zasićenja CD38, nakon čega se minimizira utjecaj klirensa posredovanog vezivanjem za ciljno mjesto, a klirens daratumumaba približava se linearnom klirensu endogenog IgG1.
English: Excipients: glacial acetic acid, mannitol (E421), polysorbate 20, sodium acetate trihydrate, sodium chloride, water for injections.
Croatian: Pomoćne tvari: ledena acetatna kiselina, manitol (E421), polisorbat 20, natrijev acetat trihidrat, natrijev klorid, voda za injekcije.
English: An odds ratio > 1 indicates an advantage for D-VMP. p-value from Fisher's exact test.
Croatian: Omjer izgleda > 1 ukazuje na prednost za D-VMP. p-vrijednost iz Fisherovog egzaktnog testa.
English: Consider administering low-dose oral methylprednisolone (≤ 20 mg) or equivalent the day after the DARZALEX infusion.
Croatian: Razmotrite primjenu niske doze metilprednizolona peroralno (≤ 20 mg) ili ekvivalenta dan nakon infuzije lijeka DARZALEX.
English: After each infusion of DARZALEX you will be given medicines (such as corticosteroids) to lower the chance of infusion-related reactions.
Croatian: Nakon svake infuzije lijeka DARZALEX primit ćete lijekove (poput kortikosteroida) kako bi se smanjila vjerojatnost razvoja reakcija na infuziju.
English: DARZALEX is given as an infusion (drip) into a vein.
Croatian: DARZALEX se daje u obliku infuzije (ukapavanjem) u venu.
English: Additional background regimen specific corticosteroids (e.g. prednisone) should not be taken on DARZALEX infusion days when patients have received dexamethasone as a pre-medication.
Croatian: Dodatni specifični kortikosteroid osnovnog režima (npr. prednizon) ne smije se uzimati na dane primjene infuzije lijeka DARZALEX kada su bolesnici primili deksametazon kao premedikaciju.
English: Prior therapies included bortezomib (100%), lenalidomide (95%), pomalidomide (36%) and carfilzomib (19%).
Croatian: Prethodne terapije uključivale su bortezomib (100%), lenalidomid (95%), pomalidomid (36%) i karfilzomib (19%).
English: This is equivalent to 0.46% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 0,46% preporučenog maksimalnog dnevnog unosa natrija za odraslu osobu.
English: 200 mL/hour
Croatian: 200 ml/sat
English: The effect of daratumumab on the QTc interval was evaluated in an open-label study for 83 patients (Study GEN501) with relapsed and refractory multiple myeloma following daratumumab infusions (4 to 24 mg/kg).
Croatian: Učinak daratumumaba na QTc interval procijenjen je u otvorenom ispitivanju s 83 bolesnika (ispitivanje GEN501) s relapsnim i refrakternim multiplim mijelomom nakon infuzija daratumumaba (4 - 24 mg/kg).
English: The rates of engraftment and haematopoietic reconstitution was similar among the transplanted subjects in the D-VTd and VTd arms (D-VTd: 99.8%; VTd: 99.6%; as measured by the recovery of neutrophils > 0.5 x 10
Croatian: Stope usađivanja i ponovne uspostave hematopoeze bile su slične među ispitanicima podvrgnutima transplantaciji u skupini koja je primala D-VTd i onoj koja je primala VTd (D-VTd: 99,8%; VTd: 99,6%; utvrđeno na temelju oporavka broja neutrofila na vrijednost > 0,5 x 10
English: A total of 569 patients were randomised; 286 to the DRd arm and 283 to the Rd arm.
Croatian: Ukupno je randomizirano 569 bolesnika; 286 u DRd skupinu i 283 u Rd skupinu.
English: Interference with Indirect Antiglobulin Test (Indirect Coombs Test) Daratumumab binds to CD38 on RBCs and interferes with compatibility testing, including antibody screening and cross matching (see section 4.4).
Croatian: Interferencija s indirektnim antiglobulinskim testom (indirektan Coombsov test) Daratumumab se veže za CD38 na eritrocitima i utječe na testove kompatibilnosti, uključujući probir na protutijela i križne probe (vidjeti dio 4.4).
English: Twenty-seven percent had International Staging System (ISS) Stage I, 43% had ISS Stage II and 29% had ISS Stage III disease.
Croatian: International Staging System), 43% imalo je ISS stadij II, a 29% ISS stadij III.
English: However, if a background regimen-specific corticosteroid (e.g. dexamethasone, prednisone) is administered the day after the DARZALEX infusion, additional post-infusion medications may not be needed (see section 5.1).
Croatian: Međutim, ako se specifični kortikosteroid (npr. deksametazon, prednizon) osnovnog režima primjenjuje dan nakon infuzije lijeka DARZALEX, možda neće biti potrebni dodatni lijekovi koji se primjenjuju nakon infuzije (vidjeti dio 5.1).
English: Fertility No animal studies have been performed to determine potential effects on fertility in males or females.
Croatian: Nisu provedena ispitivanja na životinjama kojima bi se utvrdili mogući učinci na plodnost mužjaka ili ženki.
English: Results of a PFS analysis by censoring patients who were randomized to daratumumab maintenance in the second randomization, at the date of the second randomization showed HR=0.50; 95% CI: 0.34, 0.75; p=0.0005.
Croatian: Rezultati PFS analize dobiveni cenzuriranjem bolesnika koji su bili randomizirani na terapiju održavanja daratumumabom u drugoj randomizaciji, u trenutku druge randomizacije bili su HR=0,50; 95% CI: 0,34; 0,75; p=0,0005.
English: No dose reduction of DARZALEX is recommended.
Croatian: Smanjenja doza lijeka DARZALEX se ne preporučuju.
English: The majority of patients (86%) received a prior PI, 55% of patients had received a prior IMiD, including 18% of patients who had received prior lenalidomide; and 44% of patients had received both a prior PI and IMiD.
Croatian: Većina bolesnika (86%) prethodno je primilo inhibitor proteasoma (IP), 55% bolesnika prethodno je primilo imunomodulator, uključujući 18% bolesnika koji su prethodno primili lenalidomid; i 44% bolesnika koji su prethodno primili i inhibitor proteasoma i imunomodulator.
English: DARZALEX is also supplied as an initiation pack containing 11 vials: (6 x 5 mL vials + 5 x 20 mL vials).
Croatian: DARZALEX također dolazi u pakiranju za početak liječenja koje sadrži 11 bočica: (6 x bočice od 5 ml + 5 x bočice od 20 ml).
English: In responders, the median time to response was 1.05 months (range: 0.2 to 12.1 months) in the DRd group and 1.05 months (range: 0.3 to 15.3 months) in the Rd group.
Croatian: Kod bolesnika koji su odgovorili na liječenje, medijan vremena do odgovora iznosio je 1,05 mjeseci (raspon: 0,2 do 12,1 mjesec) u DRd skupini i 1,05 mjeseci (raspon: 0,3 do 15,3 mjeseca) u Rd skupini.
English: Oedema peripheral Pyrexia
Croatian: periferni edem pireksija astenija zimica
English: When dexamethasone is the background-regimen specific corticosteroid, the dexamethasone treatment dose will instead serve as pre-medication on DARZALEX infusion days (see section 5.1).
Croatian: Kad se deksametazon primjenjuje kao specifični kortikosteroid osnovnog režima, terapijska doza deksametazona će umjesto toga poslužiti kao premedikacija na dane primjene infuzije lijeka DARZALEX (vidjeti dio 5.1).
English: IRRs occurring at re-initiation of DARZALEX following ASCT were consistent in terms of symptoms and severity (Grade 3/4: <1%) with those reported in previous studies at Week 2 or subsequent infusions.
Croatian: Reakcije na infuziju koje su se javile kod ponovnog uvođenja lijeka DARZALEX nakon ASCT-a po simptomima i težini (3/4. stupanj: <1%) odgovarale su onima prijavljenima u prethodnim ispitivanjima kod infuzije u 2. tjednu ili sljedećih infuzija.
English: It should be recognised that daratumumab bound to RBCs may mask detection of antibodies to minor antigens in the patient's serum.
Croatian: Treba napomenuti da daratumumab vezan za eritrocite može otežati detekciju protutijela na manje značajne antigene u bolesnikovu serumu.
English: In Study MMY3006, the number of CD34+ cell yield was numerically lower in the D-VTd arm compared with the VTd arm (Median: D-VTd: 6.3 x 10
Croatian: U ispitivanju MMY3006 prinos CD34+ stanica bio je brojčano manji u skupini koja je primala D-VTd nego u onoj koja je primala VTd (medijan: D-VTd: 6,3 x 10
English: A total of 737 patients were randomized: 368 to the DRd arm and 369 to the Rd arm.
Croatian: Ukupno je randomizirano 737 bolesnika: 368 u DRd skupinu i 369 u Rd skupinu.
English: • low number of a type of blood cell called platelets which help to clot blood (thrombocytopenia)
Croatian: • nizak broj jedne vrste krvnih stanica zvanih krvne pločice (trombociti) koje pomažu pri zgrušavanju krvi (trombocitopenija)
English: In the Phase III study MMY3007, which compared treatment with D-VMP to treatment with VMP in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant, safety analysis of the subgroup of patients with an ECOG performance score of 2 (D-VMP: n=89, VMP: n=84), was consistent with the overall population (see section 5.1).
Croatian: U ispitivanju faze III MMY3007, koje je usporedilo D-VMP liječenje s VMP liječenjem u bolesnika s novodijagnosticiranim multiplim mijelomom kod kojih nije prikladna autologna transplantacija matičnih stanica, sigurnosna analiza podskupine bolesnika s ECOG funkcionalnim statusom 2 (DVMP: n=89, VMP: n=84), bila je u skladu s onom u ukupnoj populaciji (vidjeti dio 5.1).
English: Following the start of daratumumab treatment, none of the monotherapy patients and 2 of the 1051 combination therapy patients tested positive for anti-daratumumab antibodies; 1 of the combination therapy patients developed transient neutralising antibodies against daratumumab.
Croatian: Nakon početka liječenja daratumumabom, nijedan bolesnik na monoterapiji nije bio pozitivan na protutijela na daratumumab, a 2 od 1051 bolesnika na kombiniranoj terapiji su bila pozitivna na protutijela na daratumumab; 1 od bolesnika na kombiniranoj terapiji razvio je prolazno neutralizirajuća protutijela na daratumumab.
English: The baseline demographic and disease characteristics were similar between the DARZALEX and the control arm.
Croatian: Početne demografske vrijednosti i karakteristike bolesti bile su slične između skupine liječene lijekom DARZALEX i kontrolne skupine.
English: • Severe allergic reaction which may include a swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing or an itchy rash (hives).
Croatian: • teške alergijske reakcije koje mogu uključivati otečeno lice, usne, usta, jezik ili grlo, poteškoće s gutanjem ili disanjem ili osip koji svrbi (koprivnjača).
English: At baseline, 32% of patients were refractory to the last line of treatment.
Croatian: Na početku je 32% bolesnika bilo je refrakterno na posljednju liniju liječenja.
English: At a survival update with a median duration of follow-up of 15.2 months, median OS was not reached (95% CI: 19.9 months, not estimable), with 74% of subjects still alive.
Croatian: U trenutku ažuriranja podataka o preživljenju nakon medijana praćenja od 15,2 mjeseca, medijan OS-a nije bio dosegnut (95% CI: 19,9 mjeseci; ne može se procijeniti), a 74% bolesnika još je bilo živo.
English: Weeks 1 to 8
Croatian: 1. - 8. tjedan
English: First dose of the every-2-week dosing schedule is given at Week 9 First dose of the every-2-week dosing schedule is given at Week 1 upon re-initiation of treatment following ASCT
Croatian: Prva doza iz rasporeda primjene svaka 2 tjedna daje se u 9. tjednu Prva doza iz rasporeda primjene svaka 2 tjedna daje se u 1. tjednu nakon ponovnog uvođenja liječenja poslije ASCT-a
English: Daratumumab is an IgG1κ human monoclonal antibody (mAb) that binds to the CD38 protein expressed at a high level on the surface of multiple myeloma tumour cells, as well as other cell types and tissues at various levels.
Croatian: Daratumumab je IgG1κ humano monoklonsko protutijelo koje se veže za protein CD38, koji se u velikoj mjeri eksprimira na površini tumorskih stanica multiplog mijeloma, a u različitoj mjeri i na drugim vrstama stanica i tkiva.
English: B. PACKAGE LEAFLET
Croatian: Package Leaflet PL).
English: What DARZALEX contains
Croatian: Što DARZALEX sadrži
English: The median age was 58 (range: 22 to 65) years.
Croatian: Medijan dobi iznosio je 58 godina (raspon: 22 - 65).
English: The median time to onset of a reaction was 1.5 hours (range: 0 to 72.8 hours).
Croatian: Medijan vremena do nastupa reakcije iznosio je 1,5 sati (raspon: 0 do 72,8 sati).
English: o A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient is using DARZALEX (daratumumab), and that this treatment is associated with the Important Identified Risk of Interference for blood typing (minor antigen) (Positive Indirect Coombs' test), which might persist for up to 6 months after the last product's infusion, and a clear reference that the patient should continue to carry this card until 6 months after the treatment has ended; o Contact details of the DARZALEX (daratumumab) prescriber; o Reference to the need to consult the Package Leaflet (PL).
Croatian: o Poruku upozorenja za zdravstvene radnike koji liječe bolesnika u bilo koje vrijeme, uključujući i hitna stanja, da bolesnik uzima lijek DARZALEX (daratumumab), i da je to liječenje povezano s važnim identificiranim rizikom od interferencije kod tipiziranja krvi (manje značajan antigen) (pozitivan indirektan Coombsov test), koje može potrajati i do 6 mjeseci nakon posljednje infuzije lijeka, te jasnu napomenu da bolesnik treba nastaviti nositi ovu karticu do 6 mjeseci nakon završetka liječenja; o Kontakt podatke propisivača lijeka DARZALEX (daratumumab); o Napomenu da je potrebno pročitati uputu o lijeku (engl.
English: With an overall median follow-up of 13.5 months, the hazard ratio for OS was 0.64 (95% CI: 0.40, 1.01; p=0.0534).
Croatian: S ukupnim medijanom praćenja od 13,5 mjeseci, omjer hazarda za ukupno preživljenje bio je 0,64 (95% CI: 0,40; 1,01; p=0,0534).
English: A Chi-Squared estimate of the common odds ratio is used.
Croatian: Koristi se Hi-kvadrat procjena običnog omjera izgleda (common odds ratio, OR).
English: Bortezomib is given twice weekly at Weeks 1, 2, 4 and 5 for the first 6-week cycle, followed by once weekly at Weeks 1, 2, 4 and 5 for eight more 6-week cycles.
Croatian: Bortezomib se daje dva puta tjedno u 1., 2., 4. i 5. tjednu tijekom prvog 6-tjednog ciklusa, nakon čega slijedi primjena jedanput tjedno u 1., 2., 4. i 5. tjednu još osam 6-tjednih ciklusa.
English: DARZALEX is for intravenous use.
Croatian: DARZALEX se primjenjuje intravenski.
English: DARZALEX 20 mg/mL concentrate for solution for infusion.
Croatian: DARZALEX 20 mg/ml koncentrat za otopinu za infuziju
English: Results of an updated PFS analysis approximately 9 months after the original clinical cutoff, continued to show an improvement in PFS for patients in the DRd arm compared with the Rd arm.
Croatian: Rezultati ažurirane analize PFS-a približno 9 mjeseci nakon izvornog prekida prikupljanja kliničkih podataka (engl. cutoff), nastavili su pokazivati poboljšanje PFS-a za bolesnike u DRd skupini u usporedbi s Rd skupinom.
English: Toxicology data have been derived from studies with daratumumab in chimpanzees and with a surrogate anti-CD38 antibody in cynomolgus monkeys.
Croatian: Toksikološki podaci dobiveni su iz ispitivanja daratumumaba na čimpanzama te ispitivanja zamjenskog anti-CD38 protutijela na makaki majmunima.
English: Subsequent (Week 3 onwards, 16 mg/kg) infusions
Croatian: Sljedeće (3. tjedan i nadalje, 16 mg/kg) infuzije