FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of systemic corticosteroids or immunosuppressants before starting pembrolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of pembrolizumab.
Croatian: Treba izbjegavati primjenu sistemskih kortikosteroida ili imunosupresiva prije uvođenja pembrolizumaba jer ti lijekovi mogu utjecati na farmakodinamičku aktivnost i djelotvornost pembrolizumaba.
English: For signs or symptoms of SJS or TEN, pembrolizumab should be withheld and the patient should be referred to a specialised unit for assessment and treatment.
Croatian: U slučaju pojave znakova ili simptoma SJS-a ili TEN-a potrebno je odgoditi primjenu pembrolizumaba te bolesnika uputiti u specijaliziranu jedinicu radi ocjene stanja i liječenja.
English: Table 18: Efficacy results in KEYNOTE-087 and KEYNOTE-013
Croatian: Tablica 18: Rezultati za djelotvornost u ispitivanjima KEYNOTE-087 i KEYNOTE-013
English: If you have any questions about these medicines, ask your doctor.
Croatian: Ako imate bilo kakvih pitanja o tim lijekovima, obratite se svom liječniku.
English: % with duration ≥ 6 months
Croatian: % s trajanjem ≥ 6 mjeseci
English: Among patients who were evaluable for PD-L1 expression (98%), 82% were PD-L1 positive and 18% were PD-L1 negative.
Croatian: Među bolesnicima u kojih se mogla odrediti ekspresija PD-L1 (98%), njih 82% bilo je PD-L1 pozitivno, a njih 18% PD-L1 negativno.
English: Patients should be monitored for suspected severe skin reactions and other causes should be excluded.
Croatian: Bolesnike je potrebno nadzirati zbog mogućih sumnji na teške kožne reakcije te treba isključiti njihove druge moguće uzroke.
English: Treatment with pembrolizumab may increase the risk of rejection in solid organ transplant recipients.
Croatian: Liječenje pembrolizumabom može povećati rizik od odbacivanja solidnih organa kod bolesnika kojima je transplantiran.
English: Among patients who were evaluable for PD-L1 expression (79%), 69% (n=294) were PD-L1 positive and 31% (n=134) were PD-L1 negative.
Croatian: Među bolesnicima u kojih se mogla odrediti ekspresija PD-L1 (79%), njih 69% (n=294) bilo je PD-L1 pozitivno, a njih 31% (n=134) PD-L1 negativno.
English: The frequencies are based on all reported adverse drug reactions, regardless of the investigator assessment of causality.
Croatian: Učestalosti se temelje na svim prijavljenim nuspojavama lijeka, neovisno o ispitivačevoj ocjeni uzročne povezanosti.
English: Dose delay or discontinuation (see also section 4.4)
Croatian: Odgoda primjene doze ili prekid liječenja (vidjeti i dio 4.4)
English: In the Hodgkin lymphoma population, the ORR was 50.0%, 2 patients (11.1%) had a complete response and 7 patients (38.9%) had a partial response.
Croatian: U populaciji bolesnika s Hodgkinovim limfomom ORR je iznosio 50,0%, 2 bolesnika (11,1%) ostvarila su potpuni odgovor, a 7 bolesnika (38,9%) imalo je djelomičan odgovor.
English: Thirty-one percent had an ECOG Performance Status of 1, 69% had ECOG Performance Status of 0 and 32% had elevated LDH.
Croatian: 31% je imalo funkcionalni ECOG status 1, 69% je imalo funkcionalni ECOG status 0 i 32% je imalo povišeni LDH.
English: When used in combination with pembrolizumab, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer (see section 5.1).
Croatian: Kod primjene u kombinaciji s pembrolizumabom može se razmotriti povećavanje doze aksitiniba iznad početne doze od 5 mg u intervalima od šest tjedana ili dulje (vidjeti dio 5.1).
English: Response: Best objective response as confirmed complete response or partial response Based on Miettinen and Nurminen method stratified by ECOG (0 vs. 1), HPV status (positive vs. negative) and PD-L1 status (strongly positive vs. not strongly positive)
Croatian: Odgovor: Najbolji objektivan odgovor kao potvrđen potpun odgovor ili djelomičan odgovor Na temelju Miettinenove i Nurminenove metode stratificirane prema ECOG statusu (0 ili 1), HPV statusu (pozitivan ili negativan) i PD-L1 statusu (izrazito pozitivan ili nije izrazito pozitivan)
English: Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed.
Croatian: Klinički stabilnim bolesnicima koji su pokazivali početne znakove progresije bolesti bilo je dopušteno nastaviti liječenje do potvrde progresije bolesti.
English: 2Q 2020 2Q 2019 4Q 2021 4Q 2024
Croatian: 2. tromjesečje 2020. 2. tromjesečje 2019. 4. tromjesečje 2021. 4. tromjesečje 2024.
English: NR 21.7 (17.1, NR)
Croatian: ND 21,7 (17,1; ND)
English: OS rate at 24 months
Croatian: Stopa OS-a nakon 24 mjeseca
English: There was no statistically significant difference between pembrolizumab and chemotherapy in the final OS analysis that was not adjusted for the potentially confounding effects of crossover.
Croatian: Nije bilo statistički značajne razlike između pembrolizumaba i kemoterapije u završnoj analizi OS-a, koja nije bila prilagođena za potencijalno ometajuće učinke prijelaza bolesnika u drugu skupinu.
English: Randomisation was stratified by tumour PD-L1 expression (TPS < 1% [negative] vs. TPS ≥ 1%), investigator's choice of paclitaxel or nabpaclitaxel, and geographic region (East Asia vs. non-East Asia).
Croatian: Randomizacija je bila stratificirana prema tumorskoj ekspresiji PD-L1 (TPS < 1% [negativna ekspresija] naspram TPS ≥ 1%), ispitivačevu odabiru paklitaksela ili nab-paklitaksela i geografskoj regiji (istočna Azija naspram ostalo).
English: For patients ≥ 75 years, pembrolizumab combination therapy should be used with caution after careful consideration of the potential benefit/risk on an individual basis (see section 5.1).
Croatian: U bolesnika u dobi od ≥75 godina, pembrolizumab u kombiniranoj terapiji treba primjenjivati uz oprez, nakon pažljivog razmatranja mogućeg omjera koristi i rizika za pojedinog bolesnika (vidjeti dio 5.1).
English: Corticosteroids can also be used as premedication, when pembrolizumab is used in combination with chemotherapy, as antiemetic prophylaxis and/or to alleviate chemotherapy-related adverse reactions.
Croatian: Kortikosteroidi se mogu primijeniti i kao premedikacija kada se pembrolizumab daje u kombinaciji s kemoterapijom, kao antiemetička profilaksa i/ili za ublažavanje nuspojava povezanih s kemoterapijom.
English: There are no data on the use of pembrolizumab in pregnant women.
Croatian: Nema podataka o primjeni pembrolizumaba u trudnica.
English: Safety data of pembrolizumab in the adjuvant melanoma setting in patients ≥ 75 years are limited.
Croatian: Podaci o sigurnosti pembrolizumaba kod adjuvantnog liječenja melanoma u bolesnika u dobi od ≥ 75 godina su ograničeni.
English: For subjects with relapsed or refractory classical Hodgkin lymphoma, clinical data for the use of pembrolizumab in patients ineligible to ASCT due to reasons other than failure to salvage chemotherapy are limited (see section 5.1).
Croatian: Za ispitanike s relapsirajućim ili refraktornim klasičnim Hodgkinovim limfomom klinički podaci o primjeni pembrolizumaba u bolesnika koji nisu pogodni za ASCT zbog drugih razloga osim neuspjeha kemoterapije spasa su ograničeni (vidjeti dio 5.1).
English: Efficacy was evaluated for 276 patients from two defined cohorts, one which included patients previously treated with ipilimumab (and if BRAF V600 mutation-positive, with a BRAF or MEK inhibitor) and the other which included patients naïve to treatment with ipilimumab.
Croatian: Djelotvornost se ocjenjivala u 276 bolesnika iz dviju definiranih kohorti, od kojih je jedna uključivala bolesnike prethodno liječene ipilimumabom (i BRAF ili MEK inhibitorom, ako su imali melanom pozitivan na mutaciju BRAF V600), a druga bolesnike koji prethodno nisu bili liječeni ipilimumabom.
English: AstraZeneca Pharmaceuticals LP, Frederick Manufacturing Center (FMC) 633 Research Court
Croatian: AstraZeneca Pharmaceuticals LP, Frederick Manufacturing Center (FMC) 633 Research Court Frederick, Maryland (MD) 21703 Sjedinjene Američke Države (SAD)
English: Patients with EGFR activation mutation or ALK translocation also had disease progression on approved therapy for these mutations prior to receiving pembrolizumab.
Croatian: Bolesnici koji su imali aktivirajuću mutaciju gena EGFR ili translokaciju gena ALK također su doživjeli progresiju bolesti tijekom liječenja odobrenom terapijom za te mutacije prije primanja pembrolizumaba.
English: Pituitary function and hormone levels should be monitored to ensure appropriate hormone replacement.
Croatian: Treba nadzirati funkciju štitnjače i vrijednosti hormona kako bi se osigurao odgovarajući nadomjestak hormona.
English: Uncommon sarcoidosis Not known solid organ transplant rejection
Croatian: Nepoznato odbacivanje transplantiranog solidnog organa
English: Use of pembrolizumab for adjuvant treatment of patients with melanoma A trend toward increased frequency of severe and serious adverse reactions in patients ≥ 75 years was observed.
Croatian: Primjena pembrolizumaba za adjuvantno liječenje bolesnika s melanomom Opažen je trend povećanja učestalosti teških i ozbiljnih nuspojava u bolesnika u dobi od ≥ 75 godina.
English: Corticosteroids may also be given to you before receiving KEYTRUDA in combination with chemotherapy to prevent and/or treat nausea, vomiting, and other side effects caused by chemotherapy.
Croatian: Kortikosteroide ćete možda dobiti i prije nego što primite lijek KEYTRUDA u kombinaciji s kemoterapijom radi sprječavanja i/ili ublažavanja mučnine, povraćanja i drugih nuspojava koje uzrokuje kemoterapija.
English: Disease characteristics were: 21% HPV positive and 95% had Stage IV disease (Stage IVa 21%, Stage IVb 6%, and Stage IVc 69%).
Croatian: Značajke bolesti bile su sljedeće: 21% bolesnika bilo je pozitivno na HPV, a 95% bolesnika imalo je bolest stadija IV (21% bolest stadija IVa, 6% bolest stadija IVb, a 69% bolest stadija IVc).
English: No clinical data are available on the possible effects of pembrolizumab on fertility.
Croatian: Nisu dostupni klinički podaci o mogućim učincima pembrolizumaba na plodnost.
English: Patients should be monitored for signs and symptoms of adrenal insufficiency and hypophysitis (including hypopituitarism) and other causes excluded.
Croatian: Potrebno je nadzirati bolesnike zbog moguće pojave znakova i simptoma insuficijencije nadbubrežnih žlijezda i hipofizitisa (uključujući hipopituitarizam) te isključiti druge uzroke.
English: • Aseptically add 2.3 mL of water for injections to yield a 25 mg/mL (pH 5.2-5.8) solution of KEYTRUDA.
Croatian: • U aseptičkim uvjetima dodajte 2,3 ml vode za injekcije kako biste dobili otopinu lijeka KEYTRUDA koncentracije 25 mg/ml (pH 5,2-5,8).
English: The initial analysis resulted in a HR for OS of 0.82 (95% CI: 0.67, 1.01) with a one-sided p-value of 0.0316.
Croatian: Inicijalna analiza rezultirala je omjerom hazarda za OS od 0,82 (95% CI: 0,67; 1,01) s jednostranom pvrijednošću od 0,0316.
English: PD-L1 Expression Pembrolizumab
Croatian: Ekspresija PD-L1 Pembrolizumab
English: The diluted solution may be stored for up to 96 hours in a refrigerator (2°C - 8°C).
Croatian: Razrijeđena otopina može se čuvati najviše 96 sati u hladnjaku (2°C - 8°C).
English: In this patient population, the median observation time was 7.3 months (range: 1 day to 31 months) and the most frequent adverse reactions with pembrolizumab were fatigue (32%), nausea (20%), and diarrhoea (20%).
Croatian: U toj je populaciji bolesnika medijan vremena promatranja iznosio 7,3 mjeseca (raspon: 1 dan do 31 mjesec), a najčešće nuspojave kod primjene pembrolizumaba bile su umor (32%), mučnina (20%) i dijareja (20%).
English: Table 17 summarises key efficacy measures for the entire population (TPS  1%) and for the patients with TPS  50%, and Figure 11 shows the Kaplan-Meier curve for OS (TPS  1%), based on a final analysis with median follow up of 42.6 months.
Croatian: Tablica 17 sažeto prikazuje ključne mjere za djelotvornost za cijelu populaciju (TPS ≥ 1%) i za bolesnike koji su imali TPS ≥ 50%, dok Slika 11 prikazuje Kaplan-Meierovu krivulju za OS (TPS ≥ 1%) utemeljenu na rezultatima završne analize uz medijan praćenja od 42,6 mjeseci.
English: Over 15 weeks of follow-up, patients treated with pembrolizumab had stable global health status/QoL, while those treated with investigator's choice chemotherapy had a decline in global health status/QoL.
Croatian: Tijekom 15 tjedana praćenja bolesnici liječeni pembrolizumabom imali su stabilan opći zdravstveni status/kvalitetu života, dok su oni liječeni kemoterapijom po izboru ispitivača doživjeli pogoršanje općeg zdravstvenog statusa/kvalitete života.
English: Subjects whose tumours express PD-L1 CPS < 10 already enrolled into the pembrolizumab monotherapy arm can continue treatment.
Croatian: Ispitanici s tumorima koji eksprimiraju PD-L1 s CPS-om < 10, a koji su već uključeni u skupinu liječenu monoterapijom pembrolizumabom mogu nastaviti s liječenjem.
English: Based on patients with a confirmed response by independent review, starting from the date the response was first recorded; n=23 for patients previously treated with ipilimumab; n=18 for patients naïve to treatment with ipilimumab Based on Kaplan-Meier estimation
Croatian: Na temelju bolesnika s potvrđenim odgovorom prema neovisnoj ocjeni, počevši od datuma kada je odgovor prvi put zabilježen; n = 23 za bolesnike prethodno liječene ipilimumabom; n=18 za bolesnike koji prethodno nisu bili liječeni ipilimumabom
English: Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.
Croatian: Bolesnici pozitivni na tumorske mutacije gena EGFR ili ALK trebaju također primiti ciljanu terapiju prije nego što prime lijek KEYTRUDA.
English: Grade 3 or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
Croatian: 3. stupanj ili sumnja na Stevens-Johnsonov sindrom (SJS) ili toksičnu epidermalnu nekrolizu (TEN)
English: Based on patients with a best overall response as confirmed complete or partial response Based on Miettinen and Nurminen method stratified by PD-L1 status, platinum chemotherapy and smoking status
Croatian: Na temelju bolesnika s najboljim ukupnim odgovorom kao potvrđenim potpunim ili djelomičnim odgovorom Na temelju Miettinenove i Nurminenove metode stratificirane prema PD-L1 statusu, kemoterapiji temeljenoj na platini i pušačkom statusu
English: The following additional clinically significant, immune-related adverse reactions have been reported in clinical trials or in post-marketing experience: uveitis, arthritis, myositis, myocarditis, pancreatitis, Guillain-Barré syndrome, myasthenic syndrome, haemolytic anaemia, sarcoidosis and encephalitis (see sections 4.2 and 4.8).
Croatian: U kliničkim ispitivanjima ili u razdoblju nakon stavljanja lijeka u promet prijavljene su i ove dodatne klinički značajne imunološki uzrokovane nuspojave: uveitis, artritis, miozitis, miokarditis, pankreatitis, Guillain-Barréov sindrom, mijastenični sindrom, hemolitička anemija, sarkoidoza i encefalitis (vidjeti dijelove 4.2 i 4.8).
English: KEYTRUDA potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumours or other cells in the tumour microenvironment.
Croatian: KEYTRUDA pojačava odgovore T-stanica, uključujući odgovore protiv tumora, blokiranjem vezivanja PD-1 za PD-L1 i PD-L2 koji su eksprimirani na antigen prezentirajućim stanicama, a mogu ih eksprimirati tumorske ili druge stanice u tumorskom mikrookruženju.
English: 15.9 (13.2, NA)
Croatian: 15,9 (13,2; ND)
English: Complete response Partial response p-Value
Croatian: Djelomičan odgovor p-vrijednost
English: Common pain in extremity, myositis w, arthritis myositis w, pain in extremity, arthritis myositis w, arthritis x,
Croatian: Često bol u ekstremitetima, miozitis w, artritis miozitis w, bol u ekstremitetima, artritis miozitis w, artritis x,
English: The frequencies included below and in Table 2 are based on all reported adverse drug reactions, regardless of the investigator assessment of causality.
Croatian: Učestalosti navedene u nastavku i u Tablici 2 temelje se na svim prijavljenim nuspojavama lijeka, neovisno o ocjeni ispitivača o uzročnoj povezanosti.
English: Each vial contains an excess fill of 0.25 ml (total content per vial 4.25 ml) to ensure the recovery of 4 ml of concentrate.
Croatian: Svaka bočica sadrži višak punjenja od 0,25 ml (jedna bočica sadrži ukupno 4,25 ml) kako bi se osiguralo izvlačenje 4 ml koncentrata.
English: If you stop receiving KEYTRUDA
Croatian: Ako prestanete primati lijek KEYTRUDA
English: Patients should be monitored for changes in liver function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and symptoms of hepatitis, and other causes excluded.
Croatian: Potrebno je nadzirati bolesnike zbog mogućih promjena u funkciji jetre (na početku liječenja, periodički tijekom liječenja i prema potrebi na temelju kliničke procjene) i pojave simptoma hepatitisa te isključiti druge uzroke.
English: BRAF mutations were reported in 20 (39%) patients.
Croatian: Mutacije u genu BRAF prijavljene su u 20 (39%) bolesnika.
English: Administer the infusion solution intravenously over 30 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 to 5 µm in-line or add-on filter.
Croatian: Primijenite otopinu za infuziju intravenski tijekom 30 minuta koristeći sterilan, nepirogen, ugrađeni (in-line) ili pričvrsni (add-on) filtar veličine 0,2-5 µm male sposobnosti vezanja proteina.
English: See Table 28 for p-Value for inferential test of PFS based on the pre-specified interim analysis, where statistical significance has been reached.
Croatian: Vidjeti Tablicu 28 za p-vrijednost za inferencijalnu provjeru ukupnog preživljenja temeljenu na unaprijed određenoj interim analizi gdje je dosegnuta statistička značajnost.
English: Patients who experienced GVHD after their transplant procedure may be at an increased risk for GVHD after treatment with pembrolizumab.
Croatian: Bolesnici u kojih je nakon transplantacije nastupio GVHD mogu biti izloženi povećanom riziku od GVHD-a nakon liječenja pembrolizumabom.
English: Medical management guidelines for both medicines should be followed (see section 4.2 and refer to the SmPC for axitinib).
Croatian: Potrebno je pridržavati se pripadajućih smjernica za praćenje i zbrinjavanje kod svakog od ova dva lijeka (vidjeti dio 4.2 i pročitati sažetak opisa svojstava lijeka za aksitinib).
English: Overall, 20 cHL patients ≥ 65 years were treated with pembrolizumab in studies KEYNOTE-087 and KEYNOTE-013.
Croatian: Ukupno je 20 bolesnika s kHL-om u dobi od 65 ili više godina liječeno pembrolizumabom u ispitivanjima KEYNOTE-087 i KEYNOTE-013.
English: Common hypertension hypertension
Croatian: Često hipertenzija hipertenzija
English: The reconstituted vials and/or diluted intravenous bags may be stored for a cumulative time of up to 96 hours in a refrigerator (2°C - 8°C).
Croatian: Bočice s rekonstituiranim lijekom i/ili infuzijske vrećice s razrijeđenim lijekom mogu se čuvati tijekom ukupno 96 sati u hladnjaku (2°C - 8°C).
English: KEYTRUDA contains the active substance pembrolizumab, which is a monoclonal antibody.
Croatian: KEYTRUDA sadrži djelatnu tvar pembrolizumab, koji je monoklonsko protutijelo.
English: Continuation of pembrolizumab may be considered, after corticosteroid taper, if needed (see section 4.2).
Croatian: Može se razmotriti nastavak primjene pembrolizumaba, nakon postupnog snižavanja doze kortikosteroida, ukoliko je potrebno (vidjeti dio 4.2).
English: Patients received pembrolizumab at a dose of 200 mg every 3 weeks until unacceptable toxicity or disease progression.
Croatian: Bolesnici su primali pembrolizumab u dozi od 200 mg svaka 3 tjedna do pojave neprihvatljive toksičnosti ili progresije bolesti.
English: The key eligibility criteria for this study were metastatic squamous NSCLC, regardless of tumour PD-L1 expression status, and no prior systemic treatment for metastatic disease.
Croatian: Glavni kriteriji za uključivanje u ovo ispitivanje bili su metastatski skvamozni NSCLC, neovisno o statusu tumorske ekspresije PD-L1, i izostanak prethodnog sistemskog liječenja za metastatsku bolest.
English: Secondary efficacy outcome measures were ORR and response duration.
Croatian: Sekundarne mjere ishoda za djelotvornost bile su ORR i trajanje odgovora.
English: Disease subtypes were 80% nodular sclerosis, 11% mixed cellularity, 4% lymphocyte-rich and 2% lymphocyte-depleted.
Croatian: Podtipovi bolesti bili su: 80% nodularna skleroza, 11% bolest mješovitih stanica, 4% pretežno limfocitna bolest i 2% bolest s gubitkom limfocita.
English: Response was assessed in KN087 and KN013 every 12 and 8 weeks, respectively, with the first planned post-baseline assessment at week 12.
Croatian: Odgovori su se procjenjivali svakih 12 tjedana u ispitivanju KN087 odnosno svakih 8 tjedana u ispitivanju KN013, a prva ocjena nakon početka ispitivanja bila je planirana u 12. tjednu.
English: Progression-Free Survival (%)
Croatian: Preživljenje bez progresije bolesti (%)
English: Table 29: Efficacy Results in KEYNOTE-426 by IMDC Risk Category
Croatian: Tablica 29: Rezultati za djelotvornost u ispitivanju KEYNOTE-426 prema kategorijama rizika na temelju IMDC kriterija
English: Seventy-four percent of patients had received Auto-SCT, 26% were transplant ineligible, and 45% of patients had prior radiation therapy.
Croatian: Sedamdeset i četiri posto bolesnika primilo je ASCT, 26% njih nije bilo pogodno za transplantaciju, a 45% bolesnika prethodno je primalo terapiju zračenjem.
English: Thirty-five percent had tumour PD-L1 expression TPS < 1% [negative]; 19% were East Asian; and 60% received paclitaxel.
Croatian: Trideset i pet posto (35%) bolesnika imalo je tumorsku ekspresiju PD-L1 uz TPS < 1% (negativna ekspresija), 19% bilo je iz istočne Azije, a 60% primalo je paklitaksel.
English: Rechallenge with a single medicine or sequential rechallenge with both medicines after recovery may be considered.
Croatian: Nakon oporavka, može se razmotriti ili ponovno uvođenje samo jednog od lijekova ili ponovno uvođenje obaju lijekova jednog za drugim.
English: The baseline and prognostic disease characteristics of the study population of KEYNOTE-052 included a proportion of patients eligible for a carboplatin-based combination, for whom the benefit is being assessed in a comparative study, and patients eligible for mono-chemotherapy, for whom no randomised data are available.
Croatian: Početne i prognostičke značajke bolesti u populaciji iz ispitivanja KEYNOTE-052 uključivale su udio bolesnika pogodnih za kombiniranu terapiju utemeljenu na karboplatinu u kojih se korist ocjenjuje u usporednom ispitivanju, i bolesnike pogodne za monokemoterapiju za koje nisu dostupni randomizirani podaci.
English: Long-term hormone replacement therapy may be necessary in cases of immune-related endocrinopathies.
Croatian: U slučaju imunološki uzrokovanih endokrinopatija možda će biti potrebna dugotrajna hormonska nadomjesna terapija.
English: 10.3 (6.7, NA)
Croatian: 10,3 (6,7; ND)
English: Common pneumonitis pneumonitis pneumonitis
Croatian: Često pneumonitis pneumonitis pneumonitis
English: KEYTRUDA, as monotherapy or as combination therapy, should be permanently discontinued for Grade 4 or recurrent Grade 3 immune-related adverse reactions, unless otherwise specified in Table 1.
Croatian: Liječenje lijekom KEYTRUDA u monoterapiji ili kombiniranoj terapiji potrebno je trajno prekinuti u slučaju imunološki uzrokovanih nuspojava 4. stupnja ili rekurentnih imunološki uzrokovanih nuspojava 3. stupnja, osim ako nije drugačije navedeno u Tablici 1.
English: At the time of this analysis, the hazard ratio in the overall population (95% CI) was 0.59 (0.45, 0.78) with 84/432 (19.4%) events in the combination arm and 122/429 (28.4%) events in the sunitinib arm.
Croatian: U trenutku analize, omjer hazarda u ukupnoj populaciji (95% CI) bio je 0,59 (0,45; 0,78) uz 84/432 (19,4%) događaja u skupini koja je primala kombinirano liječenje i 122/429 (28,4%) događaja u skupini koja je primala sunitinib.