FrancophonIA/ELRC3.0 huggingface dataset:
English: In a phase III, open label, multicentre, randomised clinical study (BO21223/GALLIUM), 1202 patients with previously untreated Grade 1-3a advanced (stage II bulky disease, stage III/IV) FL were evaluated.
Croatian: U otvorenom, multicentričnom, randomiziranom kliničkom ispitivanju faze III (BO21223/GALLIUM) ocijenjena su 1202 bolesnika s prethodno neliječenim uznapredovalim FL-om gradusa 1 - 3a (bolest stadija II s velikom tumorskom masom [engl. bulky disease], bolest stadija III/IV).
English: 1100 mg prednisone/prednisolone or 20 mg dexamethasone or 80 mg methylprednisolone.
Croatian: 1100 mg prednizona/prednizolona ili 20 mg deksametazona ili 80 mg metilprednizolona.
English: Oral analgesic/anti-pyretic2
Croatian: Oralni analgetik/antipiretik2
English: The incidence of IRRs was 66% with the infusion of the first 1,000 mg of Gazyvaro (20% of patients experiencing a Grade 3-4 IRR).
Croatian: Incidencija reakcija na infuziju iznosila je 66% tijekom infuzije prvih 1000 mg lijeka Gazyvaro (20% bolesnika imalo je reakciju na infuziju 3. - 4. stupnja).
English: A total of 781 patients were randomised 2:2:1 to receive Gazyvaro plus chlorambucil, rituximab plus chlorambucil or chlorambucil alone.
Croatian: Ukupno je 781 bolesnik randomiziran u omjeru 2:2:1 za primanje lijeka Gazyvaro i klorambucila, rituksimaba i klorambucila ili samo klorambucila.
English: With a median observation time of 24.1 months for FL patients, 48 patients (28.1%) in the B arm and 30 patients (18.3%) in the G+B arm had died.
Croatian: Tijekom medijana vremena promatranja bolesnika s FL-om od 24,1 mjeseca preminulo je 48 bolesnika (28,1%) u skupini koja je primala bendamustin (B) i 30 bolesnika (18,3%) u skupini koja je primala obinutuzumab + bendamustin (G+B).
English: Previously untreated follicular lymphoma (study BO21223/GALLIUM)
Croatian: Prethodno neliječen folikularni limfom (ispitivanje BO21223/GALLIUM)
English: Table 3 Follicular lymphoma: Dose of Gazyvaro to be administered during induction treatment, followed by maintenance treatment
Croatian: Tablica 3 Folikularni limfom: Doza lijeka Gazyvaro koju je potrebno primijeniti tijekom uvodnog liječenja, nakon kojeg slijedi terapija održavanja
English: In addition, exploratory subgroup analyses of PFS across chemotherapy regimens (bendamustine, CHOP and CVP) were consistent with the results seen in the Gazyvaro plus chemotherapy population.
Croatian: Uz to, rezultati eksploracijskih analiza PFS-a prema podskupinama kod svih kemoterapijskih protokola (bendamustin, CHOP i CVP) bili su sukladni rezultatima zabilježenima u populaciji liječenoj lijekom Gazyvaro plus kemoterapijom.
English: HR (95% CI)
Croatian: Omjer hazarda (95% CI)
English: Indolent Non-Hodgkin Lymphoma including Follicular Lymphoma
Croatian: Indolentni ne-Hodgkinov limfom, uključujući folikularni limfom
English: The B-cell counts returned to normal levels, and immunologic function was restored within 6 months post-partum.
Croatian: U mladunčadi se broj B stanica normalizirao, a imunološka funkcija ponovno je uspostavljena unutar 6 mjeseci nakon okota.
English: In addition, there were no apparent effects of bendamustine, FC, chlorambucil or CHOP on the pharmacokinetics of Gazyvaro.
Croatian: Osim toga, nije bilo primjetnih učinaka bendamustina, klorambucila ni protokola FC i CHOP na farmakokinetiku lijeka Gazyvaro.
English: Anti-histaminic medicine3
Croatian: Antihistaminik3
English: Kaplan-Meier curves for progression-free survival (PFS) are shown in Figure 5.
Croatian: Kaplan-Meierove krivulje preživljenja bez progresije bolesti (PFS) prikazane su na Slici 5.
English: In repeat-dose toxicity studies in cynomolgus monkeys obinutuzumab had no adverse effects on male and female reproductive organs.
Croatian: U istraživanjima toksičnosti ponovljenih doza na makaki majmunima obinutuzumab nije štetno utjecao na reproduktivne organe mužjaka ni ženki.
English: To ensure differentiation of the two infusion bags for the initial 1,000 mg dose, it is recommended to utilise bags of different sizes to distinguish between the 100 mg dose for Cycle 1 Day 1 and the 900 mg dose for Cycle 1 Day 1 (continued) or Day 2.
Croatian: Kako bi se mogle razlikovati dvije infuzijske vrećice kojima se primjenjuje prva doza od 1000 mg, preporučuje se upotrijebiti vrećice različitih veličina kako bi se doza od 100 mg namijenjena za primjenu 1. dan 1. ciklusa mogla razlikovati od doze od 900 mg namijenjene za primjenu 1. dan 1.
English: In clinical studies with Gazyvaro, doses ranging from 50 mg up to and including 2,000 mg per infusion have been administered.
Croatian: Gazyvaro primjenjivane su doze u rasponu od 50 mg do, i uključujući, 2000 mg po infuziji.
English: In the non-FL population the HR for IRC-assessed PFS was 0.94 [95% CI: 0.49, 1.90].
Croatian: U populaciji bolesnika s nefolikularnim limfomom, HR za PFS prema ocjeni neovisnog ocjenjivačkog povjerenstva iznosio je 0,94 (95% CI: 0,49; 1,90).
English: Patients were randomised 1:1 to receive either bendamustine (B) alone (n = 202) or Gazyvaro in combination with bendamustine (G+B) (n = 194) for 6 cycles, each of 28 days duration.
Croatian: Bolesnici su bili randomizirani u omjeru 1:1 za primanje samo bendamustina (B) (n = 202) ili lijeka Gazyvaro u kombinaciji s bendamustinom (G+B) (n = 194) tijekom 6 ciklusa, od kojih je svaki trajao 28 dana.
English: · Continue to use effective contraception for 18 months after stopping treatment with Gazyvaro.
Croatian: · Nastavite koristiti učinkovitu zaštitu od trudnoće još 18 mjeseci nakon prestanka liječenja lijekom Gazyvaro.
English: Cycle 1 - this will include three doses of Gazyvaro in the 28 days: · Day 1 - part of your first dose (100 mg) · Day 2 or Day 1 (continued) - remainder of first dose 900 mg · Day 8 - full dose (1,000 mg) · Day 15 - full dose (1,000 mg)
Croatian: Prvi ciklus - uključuje tri doze lijeka Gazyvaro u razdoblju od 28 dana: · 1. dan - dio prve doze (100 mg) · 2. dan ili 1. dan (nastavak) - ostatak prve doze (900 mg) · 8. dan - puna doza (1000 mg) · 15. dan - puna doza (1000 mg)
English: · If you had any of these symptoms before treatment with Gazyvaro, tell your doctor straight away if you notice any changes in them.
Croatian: · Ako ste bilo koji od tih simptoma imali i prije liječenja lijekom Gazyvaro, odmah obavijestite svog liječnika ako primijetite da su se oni promijenili.
English: Cycles 2, 3, 4, 5 and 6 this will be just one dose of Gazyvaro in the 28 days: · Day 1 - full dose (1,000 mg).
Croatian: 2., 3., 4., 5. i 6. ciklus - primjenjuje se samo jedna doza lijeka Gazyvaro u razdoblju od 28 dana: · 1. dan - puna doza (1000 mg)
English: In patients treated with Gazyvaro 8 out of 140 patients in the randomised phase and 2 out of 6 in the run in phase tested positive for ATA at 12 months of follow up.
Croatian: 8 od 140 bolesnika u randomiziranoj fazi i 2 od 6 bolesnika u uvodnoj fazi imalo je pozitivan nalaz testa na protutijela na lijek nakon 12 mjeseci praćenja.
English: 4.If a corticosteroid-containing chemotherapy regimen is administered on the same day as Gazyvaro, the corticosteroid can be administered as an oral medicinal product if given at least 60 minutes prior to Gazyvaro, in which case additional IV corticosteroid as premedication is not required.
Croatian: 4Ako se kemoterapijski protokol koji sadrži kortikosteroid primjenjuje istog dana kad i Gazyvaro, kortikosteroid se može primijeniti kao oralni lijek ako se daje najmanje 60 minuta prije lijeka Gazyvaro i u tom slučaju nije potrebno primijeniti dodatni intravenski kortikosteroid kao premedikaciju.
English: Glycoengineering of the Fc part of obinutuzumab results in higher affinity for FcɣRIII receptors on immune effector cells such as natural killer (NK) cells, macrophages and monocytes as compared to non-glycoengineered antibodies.
Croatian: Fc dijela obinutuzumaba je veći afinitet za FcɣRIII receptore na efektorskim stanicama imunološkog sustava, poput stanica “prirodnih ubojica” (NK), makrofaga i monocita, u usporedbi s protutijelima koja nisu modificirana glikoinženjeringom.
English: Efficacy results for patients with previously untreated FL are summarised in Table 8.
Croatian: Rezultati za djelotvornost u bolesnika s prethodno neliječenim FL-om sažeto su prikazani u Tablici 8.
English: Patients with known hypersensitivity to obinutuzumab must not be treated (see section 4.3).
Croatian: Bolesnici s poznatom preosjetljivošću na obinutuzumab ne smiju primiti ovaj lijek (vidjeti dio 4.3).
English: · Tell your doctor or nurse if you are pregnant, think you might be pregnant or are planning to have a baby.
Croatian: · Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obavijestite svog liječnika ili medicinsku sestru.
English: The population pharmacokinetic analysis of obinutuzumab showed that age did not affect the pharmacokinetics of obinutuzumab.
Croatian: Populacijska farmakokinetička analiza obinutuzumaba pokazala je da dob ne utječe na farmakokinetiku obinutuzumaba.
English: Day of treatment cycle
Croatian: Dan u ciklusu liječenja
English: 11.6% of the patients had marginal zone lymphoma (MZL) and 7.1% had small lymphocytic lymphoma (SLL).
Croatian: Rezultati za djelotvornost u populaciji s FL-om prikazani su u Tablici 9. Limfom marginalne zone (engl. marginal zone lymphoma, MZL) imalo je 11,6% bolesnika, dok je njih 7,1% imalo limfom malih limfocita (engl. small lymphocytic lymphoma, SLL).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Pripremljeni lijek ne bi se smio čuvati dulje od 24 sata na temperaturi od 2°C-8°C, osim ako je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: During the initial treatment, the non-linear time-varying clearance pathway is dominant and is consequently the major clearance pathway.
Croatian: Tijekom početnog liječenja dominantan je nelinearni klirens koji se mijenja s vremenom i stoga on predstavlja glavni put klirensa.
English: For CLL cycles 2 - 6 and all FL cycles
Croatian: 2. - 6. ciklus kod KLL-a te svi ciklusi kod FL-a
English: At baseline, 22% of patients had Binet Stage A, 42% had Binet Stage B and 36% had Binet Stage C.
Croatian: Na početku liječenja je 22% bolesnika imalo bolest stadija A prema Binetovoj klasifikaciji, njih 42% imalo je bolest stadija B, a njih 36% bolest stadija C.
English: What Gazyvaro is
Croatian: Što je Gazyvaro
English: The overall incidence of haemorrhagic events was similar in the Gazyvaro treated arm and in the rituximab treated arm.
Croatian: Ukupna incidencija događaja krvarenja bila je slična u skupini liječenoj lijekom Gazyvaro i u skupini liječenoj rituksimabom.
English: Gazyvaro is not likely to affect your ability to drive, cycle or use any tools or machines.
Croatian: Nije vjerojatno da bi Gazyvaro mogao utjecati na sposobnost upravljanja vozilima, vožnje bicikla te rada s alatima ili strojevima.
English: A Phase III international, multicentre, open label, randomised, two-stage, three-arm clinical study (BO21004/CLL11) investigating the efficacy and safety of Gazyvaro plus chlorambucil (GClb) compared to rituximab plus chlorambucil (RClb) or chlorambucil (Clb) alone was conducted in patients with previously untreated CLL with comorbidities.
Croatian: Provedeno je međunarodno, multicentrično, otvoreno, randomizirano kliničko ispitivanje faze III, s dva stadija i tri skupine (BO21004/CLL), u kojem su ispitivane djelotvornost i sigurnost lijeka Gazyvaro u kombinaciji s klorambucilom (GClb) u usporedbi s rituksimabom i klorambucilom (RClb) ili samo klorambucilom (Clb) u bolesnika s prethodno neliječenim KLL-om i komorbiditetima.
English: The incidence of infection was 81% in the Gazyvaro plus chemotherapy arm (with Grade 3-5 events reported in 22% of patients and fatal events reported in 3% of patients).
Croatian: Incidencija infekcije iznosila je 81% u skupini koja je primala Gazyvaro plus kemoterapiju (događaji 3. - 5. stupnja prijavljeni su u 22% bolesnika, a smrtni slučajevi u 3% bolesnika).
English: · Full dose (1,000 mg) once every 2 months for up to 2 years as long as your disease does not progress.
Croatian: Terapija održavanja · Puna doza (1000 mg) jedanput svaka 2 mjeseca tijekom najviše 2 godine ili dok ne dođe do pogoršanja bolesti.
English: The safety and efficacy of Gazyvaro has not been established in patients with severe renal impairment (CrCl < 30 mL/min) (see sections 4.8 and 5.2).
Croatian: Sigurnost i djelotvornost lijeka Gazyvaro u bolesnika s teškim oštećenjem funkcije bubrega (CrCl < 30 ml/min) nisu ustanovljene (vidjeti dijelove 4.8 i 5.2).
English: For CLL patients receiving the Day 1 (Cycle 1) dose split over the two days, the Day 1 infusion rate may be increased back up to 25 mg/hr after 1 hour, but not increased further.
Croatian: U bolesnika s KLL-om koji prvu dozu (1. dan 1. ciklusa) primaju podijeljenu tijekom dva dana, brzinu infuzije primijenjene 1. dan moguće je nakon 1 sata ponovno povećati do 25 mg/h, ali ne više od toga.
English: Median observation time: 22 months
Croatian: Medijan vremena promatranja: 22 mjeseca
English: IRC: Independent Review Committee; PFS: progression-free survival; HR: Hazard Ratio; CI: Confidence Interval * Stratification factors were chemotherapy regimen, FLIPI risk group for follicular lymphoma, geographic region Significance level at this efficacy interim analysis: 0.012 ¶ Data Not Yet Mature.
Croatian: PFS: preživljenje bez progresije bolesti (engl. progression-free survival); HR: omjer hazarda (engl. hazard ratio); CI: interval pouzdanosti (engl. confidence interval); CR: potpun odgovor (engl. complete response); PR: djelomičan odgovor (engl. partial response) * Stratifikacijski čimbenici bili su kemoterapijski protokol, skupina rizika kod folikularnog limfoma prema FLIPI indeksu, geografska regija Razina značajnosti pri ovoj interim analizi djelotvornosti: 0,012 Podaci još nisu zreli.
English: Compared to Type I antibodies, obinutuzumab, a Type II antibody, is characterised by an enhanced direct cell death induction with a concomitant reduction in CDC at an equivalent dose.
Croatian: U usporedbi s protutijelima tipa I, obinutuzumab, koji je protutijelo tipa II, u ekvivalentnoj dozi jače inducira izravnu staničnu smrt, a istodobno smanjuje citotoksičnost ovisnu o komplementu.
English: During the follow-up phase, Grade 3-5 infections are observed more in patients who received Gazyvaro plus bendamustine in the induction phase.
Croatian: Tijekom faze praćenja, infekcije 3. - 5. stupnja češće su primijećene u bolesnika koji su tijekom faze uvodnog liječenja primali Gazyvaro plus bendamustin.
English: · Chronic lymphocytic leukaemia (also called “CLL”) Gazyvaro is used in patients who have not had any treatment for CLL before and who have other illnesses which make it unlikely that they would be able to tolerate a full dose of a different medicine used to treat CLL called fludarabine.
Croatian: · Kronične limfocitne leukemije (koja se još zove i 'KLL') - Gazyvaro se koristi u bolesnika koji još nisu primili nikakvo liječenje za KLL i koji imaju druge bolesti zbog kojih vjerojatno ne bi mogli podnijeti liječenje punom dozom jednog drugog lijeka za KLL, koji se zove fludarabin.
English: If you get any of the above, tell your doctor or nurse straight away.
Croatian: Ako se pojavi bilo koja od gore navedenih nuspojava, odmah obavijestite svog liječnika ili medicinsku sestru.
English: Due to the potential depletion of B-cells in infants of mothers who have been exposed to Gazyvaro during pregnancy, infants should be monitored for B-cell depletion and vaccinations with live virus vaccines should be postponed until the infant's B-cell count has recovered.
Croatian: Izloženost obinutuzumabu u maternici i cijepljenje dojenčadi živim virusnim cjepivima Zbog moguće deplecije B stanica u dojenčadi čije su majke bile izložene lijeku Gazyvaro tijekom trudnoće, dojenčad je potrebno nadzirati kako bi se uočili mogući znakovi deplecije B stanica, a cijepljenje živim virusnim cjepivima potrebno je odgoditi do oporavka broja B stanica u dojenčadi.
English: · You will be given 6 or 8 treatment cycles of Gazyvaro in combination with other medicines for cancer - each cycle lasts 28 or 21 days depending on which other cancer medicines are given together with Gazyvaro.
Croatian: · Primit ćete 6 ili 8 ciklusa liječenja lijekom Gazyvaro u kombinaciji s drugim lijekovima za liječenje raka - svaki ciklus traje 28 dana ili 21 dan, ovisno o tome koji se drugi lijekovi za liječenje raka primjenjuju zajedno s lijekom Gazyvaro.
English: Tell your doctor or nurse straight away if you get any of the following symptoms during your infusion or up to 24 hours after having your infusion:
Croatian: Odmah obavijestite svog liječnika ili medicinsku sestru ako tijekom infuzije ili do 24 sata nakon infuzije primijetite neki od sljedećih simptoma:
English: In nonclinical studies, obinutuzumab induces direct cell death and mediates antibody dependent cellular cytotoxicity (ADCC) and antibody dependent cellular phagocytosis (ADCP) through recruitment of FcɣRIII positive immune effector cells.
Croatian: U nekliničkim ispitivanjima obinutuzumab potiče izravnu staničnu smrt te posreduje u staničnoj citotoksičnosti ovisnoj o protutijelima (engl. antibody dependent cellular cytotoxicity, ADCC) i staničnoj fagocitozi ovisnoj o protutijelima (engl. antibody dependent cellular phagocytosis, ADCP)
English: Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced FL (see section 5.1)
Croatian: Gazyvaro je u kombinaciji s kemoterapijom, nakon čega u bolesnika koji ostvare odgovor slijedi terapija održavanja lijekom Gazyvaro, indiciran za liječenje bolesnika s prethodno neliječenim uznapredovalim FL-om (vidjeti dio 5.1).
English: Completed at least 1 hour prior to Gazyvaro infusion
Croatian: Završiti primjenu najmanje 1 sat prije infuzije lijeka Gazyvaro
English: In Cycle 1, the overall incidence of IRRs was higher in patients receiving Gazyvaro plus chemotherapy compared to patients in the comparator arm.
Croatian: U 1. ciklusu je ukupna incidencija reakcija na infuziju bila veća u bolesnika koji su primali Gazyvaro plus kemoterapiju nego u bolesnika u usporednoj skupini.
English: · Follicular lymphoma (also called “FL”) Gazyvaro is used in patients who have not had any treatment for FL Gazyvaro is used in patients who have had at least one treatment with a medicine called rituximab before and whose FL has come back or got worse during or after this treatment.
Croatian: - Gazyvaro se koristi u bolesnika koji još nisu primili nikakvo liječenje za FL - Gazyvaro se koristi u bolesnika koji su prethodno primili najmanje jedno liječenje lijekom koji se zove rituksimab i kojima se FL vratio ili pogoršao tijekom ili nakon tog liječenja.
English: Results of subgroup analyses were in general consistent with the results seen in the FL population, supporting the robustness of the overall result.
Croatian: Rezultati analiza podskupina u načelu su bili sukladni rezultatima zabilježenima u populaciji s FL-om, što govori u prilog robusnosti cjelokupnog rezultata.
English: Motor symptoms with corticospinal tract findings (e.g. muscular weakness, paralysis and sensory disturbances), sensory abnormalities, cerebellar symptoms, and visual field defects are common.
Croatian: Česti su motorički simptomi koji se odnose na kortikospinalni put (npr. mišićna slabost, paraliza i osjetilne smetnje), osjetilni poremećaji, cerebelarni simptomi i ispadi vidnog polja.
English: If there are any modifications of the infusion rate or interruptions during the first 100 mg the second bag must be administered the following day.
Croatian: Ako je tijekom primjene prvih 100 mg lijeka potrebno prilagođavati brzinu infuzije ili prekinuti primjenu, druga vrećica mora se primijeniti sljedećeg dana.
English: · Grade 1-2 (mild to moderate): The infusion rate must be reduced and symptoms treated.
Croatian: · Reakcija 1. ili 2. stupnja (blaga do umjerena): brzina infuzije mora se smanjiti, a simptomi zbrinuti.
English: In the pivotal BO21004/CLL11 study, 46% (156 out of 336) of patients with CLL treated with Gazyvaro plus chlorambucil were 75 years or older (median age was 74 years).
Croatian: U ključnom ispitivanju BO21004/CLL11, 46% (156 od 336) bolesnika s KLL-om liječenih lijekom Gazyvaro i klorambucilom bilo je u dobi od 75 ili više godina (medijan dobi iznosio je 74 godine).
English: These patients experienced more serious adverse events and adverse events leading to death than patients with a CrCl ≥ 50 mL/min (see section 4.2, 4.4 and 5.2).
Croatian: U tih su se bolesnika ozbiljnije nuspojave i nuspojave sa smrtnim ishodom javljale češće nego u bolesnika koji su imali CrCl ≥ 50 ml/min (vidjeti dijelove 4.2, 4.4 i 5.2).
English: Serious bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of Gazyvaro therapy.
Croatian: Tijekom terapije lijekom Gazyvaro i po njezinu završetku mogu se razviti ozbiljne bakterijske i gljivične infekcije, a mogu se pojaviti i nove ili reaktivirati postojeće virusne infekcije.
English: Pruritus, night sweats
Croatian: · noćno znojenje
English: Table 8 Summary of efficacy in patients with previously untreated FL from BO21223/ GALLIUM study
Croatian: Tablica 8 Sažetak rezultata za djelotvornost u bolesnika s prethodno neliječenim FL-om iz ispitivanja BO21223/GALLIUM
English: Gazyvaro is a concentrate for solution for infusion and is a colourless to slightly brown liquid.
Croatian: Gazyvaro je koncentrat za otopinu za infuziju te bezbojna do smećkasta tekućina.
English: However, in patients with FL the addition of Gazyvaro to bendamustine delayed the time to worsening of health-related quality of life as measured by the FACT-Lym TOI score by 2.2 months (median 5.6 versus 7.8 months for B and G+B respectively HR = 0.83; 95% CI: 0.60, 1.13).
Croatian: Gazyvaro bendamustinu produljilo vrijeme do pogoršanja kvalitete života vezane uz zdravlje, mjerene indeksom ishoda ispitivanja (TOI) iz upitnika FACT-Lym, za 2,2 mjeseca (medijan: 5,6 mjeseci uz bendamustin naspram 7,8 mjeseci uz G+B; HR = 0,83; 95% CI: 0,60; 1,13).
English: Oral analgesic/anti-pyretic2 Anti-histaminic medicine3
Croatian: Oralni analgetik/antipiretik2 Antihistaminik3
English: The incidence of prolonged neutropenia and late onset neutropenia was 3% and 7%, respectively.
Croatian: Incidencija dugotrajne neutropenije iznosila je 3%, a incidencija odgođene neutropenije 7%.
English: (INV-assessed, CT) Responders (%) (CR, PR) Difference in response rate (%) [95% CI] p-value (Cochran-Mantel-Haenszel test) Complete Response (CR) Partial Response (PR)
Croatian: Bolesnici s odgovorom (%) (CR, PR) Razlika u stopi odgovora (%) [95% CI] p-vrijednost (Cochran-Mantel-Haenszelov test) Potpun odgovor (CR)
English: Median observation time: 20 months
Croatian: Medijan vremena promatranja: 20 mjeseci
English: For instructions on dilution of Gazyvaro before administration, see below.
Croatian: Za upute o razrjeđivanju lijeka Gazyvaro prije primjene, vidjeti u nastavku.
English: In patients with FLIPI score 0-1 (low risk), no difference between Gazyvaro plus chemotherapy and rituximab plus chemotherapy was observed (INV-assessed PFS HR 1.17 (95%CI 0.63;2.19, 40 PFS events).
Croatian: indeks iznosio 0 - 1 (nizak rizik) nije opažena razlika između primjene lijeka Gazyvaro plus kemoterapije i rituksimaba plus kemoterapije (HR za PFS prema ocjeni ispitivača: 1,17 [95% CI: 0,63;
English: The observed improvement in OS seen with G+B was supported by a stratified HR for OS of 0.62 (95% CI: 0.39, 0.98) in this post hoc analysis.
Croatian: Primijećeno poboljšanje OS-a kod primjene kombinacije G+B u toj je post-hoc analizi podupirao i stratificirani HR za OS od 0,62 (95% CI: 0,39; 0,98).
English: low levels of lymphocytes (a type of white blood cells)
Croatian: - niske razine limfocita (jedne vrste bijelih krvnih stanica)