natgillin/translations-raw huggingface dataset:
Although a similar antiviral effect was observed between the abacavir and indinavir containing regimens in terms of proportion of patients with undetectable viral load (400 copies/ml; intention to treat analysis (ITT), 47% versus 49%; as treated analysis (AT), 86% versus 94% for abacavir and indinavir combinations respectively), results favoured the indinavir combination, particularly in the subset of patients with high viral load ( &gt; 100,000 copies/ml at baseline; ITT, 46% versus 55%; AT, 84% versus 93% for abacavir and indinavir respectively).
Iako je zabilježen sličan protuvirusni učinak u režimima s abakavirom, odnosno indinavirom, mjeren udjelom broja bolesnika s virusnim opterećenjem ispod razine detekcije (≤400 kopija/ml; 47% za kombinacije s abakavirom naspram 49% za kombinacije s indinavirom u analizi bolesnika s namjerom liječenja (ITT, engl. intention to treat); 86% za kombinacije s abakavirom naspram 94% za kombinacije s indinavirom u analizi liječenih bolesnika (AT, engl. as treated)), rezultati su pokazali da je kombinacija s indinavirom učinkovitija, osobito u podskupini bolesnika s visokim virusnim opterećenjem ( &gt; 100 000 kopija/ml na početku; 46% za abakavir naspram 55% za indinavir u analizi bolesnika s namjerom liječenja; 84% za abakavir naspram 93% za indinavir u analizi liječenih bolesnika).
Although COCs may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using low-dose COCs (containing  0.05 mg ethinylestradiol).
Iako kombinirani oralni kontraceptivi mogu utjecati na perifernu inzulinsku rezistenciju i toleranciju glukoze, nema dokaza da je potrebno mijenjati terapijski režim u žena sa šećernom bolešću koje koriste KOK u niskim dozama (koji sadrži &lt; 0,05 mg etinilestradiola).
Although data are limited, patients with bilirubin &gt; 1.5 x ULN also have a higher incidence of Grade 4 neutropenia and febrile neutropenia (see also sections 4.2 and 5.2).
Premda su podaci ograničeni, bolesnici s vrijednošću bilirubina &gt; 1,5 x GGN također imaju veću incidenciju neutropenije i febrilne neutropenije 4. stupnja (vidjeti također dio 4.2 i dio 5.2).
Although limited by the small number of female subjects in study GS-US-183-0145, subgroup analysis by gender showed that the rates of virologic success in female subjects at weeks 48 and 96 (HIV-1 RNA &lt; 50 copies/mL) were numerically lower in the elvitegravir treatment arm than in the raltegravir treatment arm.
Unatoč ograničenom broju ispitanica u ispitivanju GS-US-183-0145, analiza podskupine prema spolu pokazala je da su stope virološkog uspjeha u ispitanica u 48. i 96. tjednu (HIV-1 RNK &lt; 50 kopija/ml) brojčano niže u skupini liječenja elvitegravirom od skupine liječenja raltegravirom.
Although MabThera is not myelosuppressive in monotherapy, caution should be exercised when considering treatment of patients with neutrophils &lt; 1.5 x 109/L and/or platelet counts &lt; 75 x 109/L as clinical experience in this population is limited.
Iako MabThera primijenjena u monoterapiji nema mijelosupresivan učinak, potreban je oprez kada se razmatra liječenje bolesnika s brojem neutrofila &lt; 1,5 x 109/l i/ili brojem trombocita &lt; 75 x 109/l jer je kliničko iskustvo u liječenju takvih bolesnika ograničeno.
Although proteinuria ( &gt; 2 g/day) increased belimumab clearance and decreases in creatinine clearance decreased belimumab clearance, these effects were within the expected range of variability.
Iako je proteinurija ( &gt; 2 g/dan) povisila klirens belimumaba, a smanjenja klirensa kreatinina su smanjila klirens belimumaba, ovi učinci su bili unutar očekivanog raspona varijabilnosti.
Ambulant patients while driving vehicles or operating machinery should take into account that acute dizziness may uncommonly (≥1/1,000 to &lt; 1/100) occur (see section 4.8).
Ambulantni bolesnici moraju uzeti u obzir mogućnost da se manje često (≥1/1000 do &lt; 1/100) prilikom upravljanja vozilima ili rada sa strojevima može javiti akutna omaglica (vidjeti dio 4.8).
Amitraz degrades on the haircoat of the dog into N-methyl-N’-(2,4-xylyl) formamidine ( &lt; 5 % of amitraz concentrations).
Amitraz se na dlaci psa razgrađuje u N-metil-N’-(2,4-ksilil) formamidin ( &lt; 5 % koncentracija amitraza).
AML with &gt; 30% marrow blasts according to the WHO classification.
AML-a s &gt; 30 % blasta u koštanoj srži prema klasifikaciji SZO-a.
Among 480 patients with &gt; 2 log viral reduction but detectable virus at week 12, altogether 188 patients continued therapy.
Od 480 bolesnika sa virusnim smanjenjem za &gt; 2 log, ali mjerljivim virusom u 12. tjednu, ukupno ih je 188 nastavilo liječenje.
Among 49 patients who received at least one dose of Eviplera, 100% of patients remained suppressed (HIV-1 RNA &lt; 50 copies/mL) at week 12 and week 24.
Od 49 pacijenata koji su primili barem jednu dozu lijeka Eviplera, 100% pacijenata ostalo je suprimirano (HIV-1 RNK &lt; 50 kopija/ml) u 12. i 24. tjednu.
Among 9 boys with left ventricular mass (LVMI) indexed to height2.7 within the normal range for children ( &lt; 39 g/m2.7 in boys) at baseline, LVMI remained stable at levels below the left ventricular hypertrophy (LVH) threshold throughout the 6.5 years of treatment.
Od 9 dječaka s masom lijevih ventrikula (engl. left ventricular mass, LVMI) indeksiranom na visinu2,7 unutar raspona normalnih vrijednosti za djecu ( &lt; 39 g/m2,7 u dječaka) na početku ispitivanja, LVMI je ostao stabilan na razinama ispod praga hipertrofije lijevog ventrikula (engl. left ventricular hypertrophy, LVH) tijekom 6,5 godina liječenja.
Among HBeAg-negative patients, differences in therapeutic response (78% vs 66%) and key secondary endpoints (mean log10 HBV DNA reduction: -5.00 vs -4.17, and HBV DNA undetectability: 82% vs 57%; p &lt; 0.0001) were higher for telbivudine up to week 104.
Među HBeAg-negativnim bolesnicima, razlike u terapijskom odgovoru (78% u odnosu na 66%) i ključnim sekundarnim mjerama ishoda (srednje smanjenje log10 HBV DNK: -5,00 u odnosu na -4,17, te negativan PCR: 82% u odnosu na 57%; p &lt; 0,0001) su bile veće za telbivudin do 104. tjedna.
Among HBeAg-positive patients, therapeutic response (63% vs 48%; p &lt; 0.0001) and key secondary endpoints (mean log10 HBV DNA reduction: -5.74 vs -4.42; p &lt; 0.0001, HBV DNA undetectability: 56% vs 39%; p &lt; 0.0001 and ALT normalisation of 70% vs 62%) demonstrated a widening difference at week 104 between telbivudine and lamivudine, respectively.
Među HBeAg-pozitivnim bolesnicima, terapijski odgovor (63% u odnosu na 48%; p &lt; 0,0001) i ključni sekundarni pokazatelji ishoda (srednje smanjenje log10 HBV DNK: -5,74 u odnosu na -4,42; p &lt; 0,0001, negativan PCR: 56% u odnosu na 39%; p &lt; 0,0001 i normalizacija ALT-a u 70% u odnosu na 62%) pokazali su proširenje razlike između telbivudina odnosno lamivudina u 104. tjednu.
Among lamivudine-refractory patients with baseline HBV DNA &lt; 107 log10 copies/ml, 64% (9/14) achieved HBV DNA &lt; 300 copies/ml at Week 48.
Od bolesnika s bolešću refrakternom na lamivudin i početnom HBV DNK &lt; 107 log10 kopija/ml, 64% (9/14) je postiglo HBV DNK &lt; 300 kopija/ml u 48. tjednu.
Among patients in the SBR arm who maintained their baseline regimen for 24 weeks and then switched to FTC/RPV/TDF, 92% (140/152) of patients had HIV-1 RNA &lt; 50 copies/mL after 24 weeks of FTC/RPV/TDF, consistent with the Week 24 results for patients who switched to FTC/RPV/TDF at baseline.
Od pacijenata u SBR skupini liječenoj koji su zadržali svoj početni režim 24 tjedna i potom su se prebacili na FTC/RPV/TDF, 92% (140/152) pacijenata imalo je HIV-1 RNA &lt; 50 kopija/ml nakon 24 tjedna FTC/RPV/TDF, dosljedno rezultatima iz 24. tjedna za pacijente koji su se na početku prebacili na FTC/RPV/TDF.
Among the 669 subjects randomized in this study (from 12 months to ≤17 years old), the abacavir/lamivudine once daily dosing group was demonstrated to be non-inferior to the twice daily group according to the pre-specified non-inferiority margin of -12%, for the primary endpoint of &lt; 80 c/mL at Week 48 as well as at Week 96 (secondary endpoint) and all other thresholds tested ( &lt; 200c/mL, &lt; 400c/mL, &lt; 1000c/mL), which all fell well within this non-inferiority margin.
Od 669 ispitanika randomiziranih u tom ispitivanju (u dobi od 12 mjeseci do ≤ 17 godina), skupina koja je primala abakavir/lamivudin jedanput na dan bila je neinferiorna skupini koja je primala te lijekove dvaput na dan, prema unaprijed određenoj granici neinferiornosti od -12% za primarnu mjeru ishoda od &lt; 80 kopija/ml u 48. tjednu, kao i u 96. tjednu (sekundarna mjera ishoda), i za sve ostale ispitivane granične vrijednosti ( &lt; 200 kopija/ml, &lt; 400 kopija/ml, &lt; 1000 kopija/ml), koje su se sve nalazile značajno unutar spomenute granice neinferiornosti.
Among these children, the vaccine-related adverse reactions, summarised in section b, were observed in individuals following vaccination with M-M-RVAXPRO (excluding isolated reports with frequency &lt; 0.2%).
U neke su djece nakon cijepljenja cjepivom M-M-RVAXPRO bile primijećene sljedeće nuspojave povezane s cjepivom, sažete u dijelu b (isključujući izolirane prijave čija je učestalost bila &lt; 0,2%).
Among these, two cases of platelets &lt; 50 x 109/L were reported and attributed to the leukapheresis procedure.
Među njima su bila zabilježena dva slučaja s brojem trombocita &lt; 50 x 109/l koja su pripisana postupku leukafereze.
Among these, two cases of platelets &lt; 50 x 109/l were reported and attributed to the leukapheresis procedure.
Među njima su i dva slučaja s tromobocitima &lt; 50 x 109/l, što je pripisano postupku leukafereze.
Amylase levels &gt; 3 times baseline occurred in 2% of patients, lipase levels &gt; 3 times baseline in 18% and platelets &lt; 50,000/mm3 in &lt; 1%.
Razine amilaze &gt; 3 puta iznad početne vrijednosti javile su se u 2% bolesnika, razine lipaze &gt; 3 puta iznad početne vrijednosti u 18% i trombociti &lt; 50 000/mm3 u &lt; 1% bolesnika.
An agency of the European Union to be effective in reducing behavioural problems in dogs associated with separation anxiety and was more effective than behavioural therapy alone on the basis of a broad spectrum of behavioural signs of anxiety including signs of high attachment to the owner.
U terenskim ispitivanjima provedenima u SAD-u i Europi, Clomical se, u primjeni uz bihevioralnu terapiju, pokazao učinkovitim u smanjenju bihevioralnih problema u pasa koji se povezuju s anksioznosti zbog razdvajanja te učinkovitijim od same bihevioralne terapije na temelju širokog spektra bihevioralnih znakova anksioznosti, uključujući znakove velike privrženosti vlasniku.
An analysis of safety data in patients ≥ 60 years of age treated with capecitabine monotherapy and an analysis of patients treated with capecitabine plus docetaxel combination therapy showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions and treatment-related serious adverse reactions compared to patients &lt; 60 years of age.
Analiza podataka o sigurnosti primjene kod bolesnika u dobi od 60 i više godina liječenih monoterapijom kapecitabinom i analiza bolesnika liječenih kombinacijom kapecitabina i docetaksela pokazala je povećanje incidencije nuspojava 3. i 4. stupnja povezanih s terapijom i ozbiljnih nuspojava povezanih s terapijom, u usporedbi s bolesnicima mlađim od 60 godina.
An analysis of safety data in patients ≥ 60 years of age treated with capecitabine monotherapy and an analysis of patients treated with capecitabine plus docetaxel combination therapy showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions and treatment-related serious adverse reactions compared to patients &lt; 60 years of age.
Analiza podataka o sigurnosti primjene u bolesnika u dobi od 60 i više godina liječenih monoterapijom kapecitabinom i analiza bolesnika liječenih kombinacijom kapecitabina i docetaksela, pokazala je povećanje incidencije nuspojava 3. i 4. stupnja povezanih s liječenjem i ozbiljnih nuspojava povezanih s liječenjem, u usporedbi s bolesnicima mlađim od 60 godina.
An analysis of safety data in patients ≥60 years of age treated with capecitabine monotherapy and an analysis of patients treated with capecitabine plus docetaxel combination therapy showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions and treatment-related serious adverse reactions compared to patients &lt; 60 years of age.
Analiza podataka o sigurnosti primjene kod bolesnika starih 60 i više godina liječenih monoterapijom kapecitabina i analiza bolesnika liječenih kombinacijom kapecitabina i docetaksela, pokazala je povećanje incidencije nuspojava 3. i 4. stupnja povezanih s terapijom i ozbiljnih nuspojava povezanih s terapijom, u usporedbi s bolesnicima mlađim od 60 godina.
An analysis of safety data in patients ≥60 years of age treated with capecitabine monotherapy and an analysis of patients treated with capecitabine plus docetaxel combination therapy showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions and treatment-related serious adverse reactions compared to patients &lt; 60 years of age.
Analiza podataka o sigurnosti primjene kod bolesnika starih 60 i više godina liječenih monoterapijom kapecitabinom i analiza bolesnika liječenih kombinacijom kapecitabina i docetaksela, pokazala je povećanje incidencije nuspojava 3. i 4. stupnja povezanih s terapijom i ozbiljnih nuspojava povezanih s terapijom, u usporedbi s bolesnicima mlađim od 60 godina.
An analysis of safety data in patients 60 years of age treated with capecitabine monotherapy and an analysis of patients treated with capecitabine plus docetaxel combination therapy showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions and treatment-related serious adverse reactions compared to patients &lt; 60 years of age.
Analiza podataka o sigurnosti primjene kod bolesnika starih 60 i više godina liječenih monoterapijom kapecitabinom i analiza bolesnika liječenih kombinacijom kapecitabina i docetaksela, pokazala je povećanje incidencije nuspojava 3. i 4. stupnja povezanih s terapijom i ozbiljnih nuspojava povezanih s terapijom, u usporedbi s bolesnicima mlađim od 60 godina.
An improvement of 20% was seen in 48% of the subjects receiving rotigotine and in 19% of the subjects receiving placebo (Difference 29%, CI95% 18%; 39%, p &lt; 0.0001).
Poboljšanje od 20% zabilježeno je u 48% ispitanika liječenih rotigotinom i u 19% ispitanika koji su primali placebo (razlika 29%, CI95%: 18%, 39%; p &lt; 0,0001).
An improvement of 20% was seen in 48% of the subjects receiving rotigotine and in 19% of the subjects receiving placebo (Difference 29%, CI95% 18%; 39%, p &lt; 0.0001).
Poboljšanje od 20% zabilježeno je u 48% ispitanika liječenih rotigotinom i u 19% ispitanika koji su primali placebo (razlika 29%, CI95%: 18%; 39%, p &lt; 0,0001).
An improvement of 20% was seen in 48% of the subjects receiving rotigotine and in 19% of the subjects receiving placebo (Difference 29%, CI95% 18%; 39%, p &lt; 0.0001).
Poboljšanje od 20% zabilježeno je u 48% ispitanika liječenih rotigotinom i u 19% koji su primali placebo (razlika 29%, CI95%: 18%, 39%; p &lt; 0,0001).
An increase in the concentration of enoxaparin sodium after using prophylactic doses (non-weight adjusted) has been observed in low-weight female patients ( &lt; 45 kg) and low-weight male patients ( &lt; 57 kg), which may lead to a higher risk of bleeding.
Primijećen je porast koncentracije enokaparin-natrija nakon primjene profilaktičkih doza (bez prilagodbe prema TT) u bolesnica niske tjelesne težine ( &lt; 45 kg) i muških bolesnika niske tjelesne težine ( &lt; 57 kg), koja bi mogla dovesti do povišenog rizika za nastanak krvarenja.
An increase in the concentration of enoxaparin sodium after using prophylactic doses (non-weight adjusted) has been observed in low-weight female patients ( &lt; 45 kg) and low-weight male patients ( &lt; 57 kg), which may lead to a higher risk of bleeding.
Primijećen je porast koncentracije enokaparin-natrija nakon primjene profilaktičkih doza (bez prilagodbe prema TT) u bolesnica niske tjelesne težine ( &gt; 45 kg) i muških bolesnika niske tjelesne težine ( &lt; 57 kg), koja bi mogla dovesti do povišenog rizika za nastanak krvarenja.
An increase in the concentration of enoxaparin sodium after using prophylactic doses (non-weight adjusted) has been observed in low-weight female patients ( &lt; 45 kg) and low-weight male patients ( &lt; 57 kg), which may lead to a higher risk of bleeding.
Primijećen je porast koncentracije enokaparinnatrija nakon primjene profilaktičkih doza (bez prilagodbe prema TT) u bolesnica niske tjelesne težine ( &lt; 45 kg) i muških bolesnika niske tjelesne težine ( &lt; 57 kg), koja bi mogla dovesti do povišenog rizika za nastanak krvarenja.
An increased dose was administered more frequently to patients aged 2 to &lt; 4 years and to patients with NOMID/CINCA symptoms compared with FCAS or MWS.
Povećana doza primjenjivala se učestalije kod bolesnika u dobi od 2 do &lt; 4 godine i kod bolesnika sa simptomima NOMID-a/CINCA-e u usporedbi sa FCAS-om ili MWS-om.
An increased incidence of congestive heart failure is associated with doxorubicin therapy at cumulative lifetime doses &gt; 450 mg/m2 or at lower doses for patients with cardiac risk factors.
Povećana incidencija kongestivnog zatajenja srca povezana je s liječenjem doksorubicinom u doživotnim kumulativnim dozama &gt; 450 mg/m2 ili pri nižim dozama u bolesnika s rizičnim čimbenicima za srčanu bolest.
An increased incidence of elevations of ALT or AST &gt; 5 times the ULN was reported in Zinbryta-treated patients compared to placebo (4% versus &lt; 1%) or interferon beta-1a (intramuscular) (6% versus 3%).
Povećana incidencija povišenja razine ALT ili AST &gt; 5 puta GGN prijavljena je u bolesnika liječenih Zinbrytom u usporedbi s placebom (4% naspram &lt; 1%) ili interferonom beta-1a (intramuskularno) (6% naspram 3%).
An increased incidence of infections and serious infections was not observed in patients with lymphocyte counts &lt; 0.8x109/l or
Povećana incidencija infekcija i ozbiljnih infekcija nije zabilježena u bolesnika s brojem limfocita &lt; 0,8x109/l ili &lt; 0,5x109/l.
An increased incidence of serious colitis ( &lt; 1%) was reported in patients treated with Zinbryta in clinical studies.
U kliničkim ispitivanjima zabilježena je povećana incidencija ozbiljnog kolitisa ( &lt; 1%) u bolesnika liječenih Zinbrytom.
An increased risk of cervical cancer in long-term users of COCs ( &gt; 5 years) has been reported in some epidemiological studies, but there continues to be controversy about the extent to which this finding is attributable to the confounding effects of sexual behaviour and other factors such as human papilloma virus (HPV).
U nekim je epidemiološkim ispitivanjima prijavljen povećan rizik od raka vrata maternice u dugotrajnih korisnica KOK-a ( &gt; 5 godina), no i dalje je sporno u kojoj se mjeri ovaj nalaz može pripisati istodobnim učincima spolnog ponašanja i drugih čimbenika poput humanog papiloma virusa (HPV).
An increased risk was observed in men with detectable HIV-1 RNA in plasma and CD4 counts &gt; 400 cells/mm3 (6.3 % versus 1.2 % for men with CD4 counts &lt; 400 cells/mm3).
Povećan rizik primijećen je u muškaraca s detektabilnom HIV-1 RNK u plazmi i brojem CD4 &gt; 400 stanica/mm3 (6,3% naspram 1,2% za muškarce s brojem CD4 &lt; 400 stanica/mm3).
An infusion time of &gt; 2 hours should be considered to help reduce symptoms of anxiety and irritability, and to avoid unduly high maximum concentrations of clofarabine (see section 5.2).
Kako bi se ublažili simptomi anksioznosti i razdražljivosti te izbjegle neopravdano visoke maksimalne koncentracije klofarabina, treba razmotriti primjenu infuzije u trajanju duljem od 2 sata (vidjeti dio 5.2).
An interim analysis showed there was a significant prolongation of the time to progression of disease in the 10 mg/kg group as compared with the placebo group (hazard ratio, 2.55; p &lt; 0.001).
Preliminarna analiza pokazala je značajno produljenje vremena do progresije bolesti u skupini koja je primala bevacizumab u dozi od 10 mg/kg u usporedbi sa skupinom koja je primala placebo (omjer rizika 2,55; p &lt; 0,001).
An interim analysis was conducted on 61 subjects who received sofosbuvir and ribavirin; the majority of subjects had HCV genotype 1, 44 subjects were CPT class A and 17 subjects were CPT class B. Of these 61 subjects, 44 subjects underwent liver transplantation following up to 48 weeks of treatment with sofosbuvir and ribavirin; 41 had HCV RNA &lt; LLOQ at the time of transplantation.
Privremena analiza bila je provedena na 61 ispitaniku koji je primao sofosbuvir i ribavirin; većina ispitanika imala je HCV-genotip 1, 44 ispitanika imalo CPT stadij A, a 17 ispitanika imalo je CPT stadij B. Od 61 ispitanika, u 44 ispitanika transplantacija jetre obavljena je nakon najviše 48 tjedana liječenja sofosbuvirom i ribavirinom; 41 je imao HCV RNK &lt; donje granice kvantifikacije u vrijeme transplantacije (LLOQ).
An odds ratio (OR) &gt; 1 indicates an advantage for BR-CAP.
Omjer izgleda (OR) &gt; 1 ukazuje na prednost za BR-CAP.
An odds ratio (OR) &gt; 1 indicates an advantage for BzmbR-CAP.
OR &gt; 1 ukazuje na prednost za uvodno liječenje za BzmbR-CAP.
An odds ratio (OR) &gt; 1 indicates an advantage for BzR-CAP.
Omjera izgleda (OR) &gt; 1 ukazuje na prednost za BzR-CAP.
An odds ratio (OR) &gt; 1 indicates an advantage for VcR-CAP.
Omjera izgleda (OR) &gt; 1 ukazuje na prednost za VcR-CAP.
An open-label, parallel-group trial in non-iron deficient adult subjects with a pre-treatment haemoglobin of ≥ 10 to ≤ 13 g/dl who were scheduled for major orthopaedic hip or knee surgery compared epoetin alfa 300 IU/kg subcutaneously daily for 10 days prior to surgery, on the day of surgery and for four days after surgery to epoetin alfa 600 IU/kg subcutaneously once weekly for 3 weeks prior to surgery and on the day of surgery.
U otvorenom ispitivanju na usporedbnim skupinama odraslih ispitanika koji nemaju nedostatak željeza s razinom hemoglobina prije početka liječenja od &gt; 10 do ≤ 13 g/dl predviđenih za veliki elektivni ortopedski kirurški zahvat na kuku ili koljenu uspoređena je primjena 300 IU/kg epoetina alfa na dan supkutano tijekom 10 dana prije operacije, na dan operacije i još 4 dana nakon operacije s primjenom 600 IU/kg epoetina alfa supkutano jednom tjedno, 3 tjedna prije operacije i na dan operacije.
An open-label, parallel-group trial in non-iron deficient adult subjects with a pretreatment haemoglobin of ≥ 10 to ≤ 13 g/dl who were scheduled for major orthopaedic hip or knee surgery compared epoetin alfa 300 IU/kg subcutaneously daily for 10 days prior to surgery, on the day of surgery and for four days after surgery to epoetin alfa 600 IU/kg subcutaneously once weekly for 3 weeks prior to surgery and on the day of surgery.
U otvorenom ispitivanju na usporedbnim skupinama odraslih ispitanika koji nemaju nedostatak željeza s razinom hemoglobina prije početka liječenja od &gt; 10 do ≤ 13 g/dl predviđenih za veliki elektivni ortopedski kirurški zahvat na kuku ili koljenu uspoređena je primjena 300 IU/kg epoetina alfa na dan supkutano tijekom 10 dana prije operacije, na dan operacije i još 4 dana nakon operacije s primjenom 600 IU/kg epoetina alfa supkutano jednom tjedno, 3 tjedna prije operacije i na dan operacije.
An OS analysis of the study, carried out as planned at 72% (N = 574) of events, demonstrated a clinically meaningful and statistically significant survival benefit of Lonsurf plus BSC compared to placebo plus BSC (hazard ratio: 0.68; 95% confidence interval [CI] [0.58 to 0.81]; p &lt; 0.0001) and a median OS of 7.1 months vs 5.3 months, respectively; with 1-year survival rates of 26.6% and 17.6%, respectively.
Analiza ukupnog preživljenja (OS), provedena kako je planirana, za 72% (N=574) događaja, pokazala je klinički i statistički značajnu korist u smislu preživljenja kod primjene Lonsurfa uz BSC u usporedbi sa primjenom placeba uz BSC (omjer hazarda 0,68%, 95% interval pouzdanosti [CI] [0,58 do 0,81]; p &lt; 0,0001) te medijan OS iznosi 7,1 mjesec u usporedbi sa 5,3 mjeseca kod placeba; sa stopom jednogodišnjeg preživljenja od 26,6% u usporedbi sa 17,6% kod placeba.