FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were randomised (1:1:1) to receive pembrolizumab at a dose of 2 (n=180) or 10 mg/kg (n=181) every 3 weeks or chemotherapy (n=179; including dacarbazine, temozolomide, carboplatin, paclitaxel, or carboplatin+paclitaxel).
Croatian: Bolesnici su bili randomizirani (1:1:1) za primanje pembrolizumaba u dozi od 2 (n=180) ili 10 mg/kg (n=181) svaka 3 tjedna ili kemoterapije (n=179; uključujući dakarbazin, temozolomid, karboplatin, paklitaksel ili karboplatin+paklitaksel).
English: The following side effects have been reported in clinical trials with pembrolizumab in combination with chemotherapy:
Croatian: Sljedeće su nuspojave prijavljene u kliničkim ispitivanjima u kojima se pembrolizumab primjenjivao u kombinaciji s kemoterapijom:
English: Table 13: Efficacy results in KEYNOTE-189
Croatian: Tablica 13: Rezultati za djelotvornost u ispitivanju KEYNOTE-189
English: 5347 JN Oss The Netherlands
Croatian: N.V. Organon Veersemeer 4 5347 JN Oss Nizozemska
English: Eighty-two percent had M1c stage, 73% had at least two and 32% of patients had three or more prior systemic therapies for advanced melanoma.
Croatian: 82% bolesnika imalo je stadij M1c, 73% bolesnika je prethodno primalo najmanje dvije, a njih 32% tri ili više sistemskih terapija za
English: The median area under the concentration time curve at steady state over 3 weeks (AUC0-3weeks) was 794 mcg∙day/mL at a dose of 2 mg/kg every 3 weeks and 1,053 mcg∙day/mL at a dose of 200 mg every 3 weeks.
Croatian: Medijan područja ispod krivulje koncentracija-vrijeme u stanju dinamičke ravnoteže tijekom 3 tjedna (AUC0-3tjedna) iznosio je 794 µg∙dan/ml kod primjene doze od 2 mg/kg svaka 3 tjedna te 1053 µg∙dan/ml kod primjene doze od 200 mg svaka 3 tjedna.
English: Eightyfive percent of patients had visceral metastases, including 21% with liver metastases.
Croatian: Osamdeset i pet posto (85%) bolesnika imalo je visceralne metastaze, uključujući 21% njih s jetrenim metastazama.
English: Among the 495 patients in KEYNOTE-040, 129 (26%) had tumours that expressed PD-L1 with a TPS ≥ 50% based on the PD-L1 IHC 22C3 pharmDx
Croatian: Od 495 bolesnika uključenih u ispitivanje KEYNOTE-040, 129 (26%) bolesnika imalo je tumore koji eksprimiraju PD-L1 uz TPS ≥50% na temelju PD-L1 IHC 22C3 pharmDx
English: KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the firstline treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations.
Croatian: KEYTRUDA je u kombinaciji s pemetreksedom i kemoterapijom koja sadrži platinu indicirana za prvu liniju liječenja metastatskog neskvamoznog NSCLC-a u odraslih čiji tumori nisu pozitivni na mutacije gena EGFR ili ALK.
English: Chemotherapy n=272
Croatian: Kemoterapija n=272
English: The study excluded patients with nasopharyngeal carcinoma, active autoimmune disease that required systemic therapy within 2 years of treatment, a medical condition that required immunosuppression, or who were previously treated with 3 or more systemic regimens for recurrent and/or metastatic HNSCC.
Croatian: U ispitivanje se nisu uključivali bolesnici s nazofaringealnim karcinomom, aktivnom autoimunom bolešću kojima je bila potrebna sistemska terapija unutar 2 godine prije liječenja, bolesnici s medicinskim stanjem koje je zahtijevalo imunosupresiju te oni bolesnici koji su već liječeni sa 3 ili više sistemskih režima za rekurentni i/ili metastatski HNSCC.
English: Pregnancy - You must not use KEYTRUDA if you are pregnant unless your doctor specifically recommends it. - If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor.
Croatian: - Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obavijestite o tome svog liječnika.
English: KEYTRUDA in combination with axitinib in RCC For RCC patients treated with KEYTRUDA in combination with axitinib, see the Summary of Product Characteristics (SmPC) regarding dosing of axitinib.
Croatian: KEYTRUDA u kombinaciji s aksitinibom kod RCC-a Za bolesnike s RCC-om koji se liječe lijekom KEYTRUDA u kombinaciji s aksitinibom, za informacije o doziranju aksitiniba vidjeti njegov sažetak opisa svojstava lijeka.
English: PD L1 negative
Croatian: PD L1 negativni bolesnici
English: Rare toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema nodosum hair colour changes, lichenoid keratosis, papule
Croatian: Stevens-Johnsonov sindrom, nodozni eritem promjene boje kose, lihenoidna keratoza, papule
English: The efficacy of pembrolizumab in combination with pemetrexed and platinum chemotherapy was investigated in a multicentre, randomised, active-controlled, double-blind trial, KEYNOTE-189.
Croatian: Djelotvornost pembrolizumaba u kombinaciji s pemetreksedom i kemoterapijom temeljenom na platini ispitivana je u multicentričnom, randomiziranom, aktivnim lijekom kontroliranom, dvostruko slijepom ispitivanju KEYNOTE-189.
English: The study excluded patients with autoimmune disease or those receiving immunosuppression; further exclusion criteria were a history of severe or life-threatening immunerelated adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent dose) for greater than 12 weeks; ongoing adverse reactions ≥ Grade 2 from previous treatment with ipilimumab; previous severe hypersensitivity to other monoclonal antibodies; a history of pneumonitis or interstitial lung disease; HIV, hepatitis B or hepatitis C infection and ECOG Performance Status ≥ 2.
Croatian: U ispitivanje nisu bili uključeni bolesnici s autoimunom bolešću ni oni koji su primali imunosupresivnu terapiju; dodatni isključni kriteriji bili su prethodne teške ili po život opasne imunološki uzrokovane nuspojave tijekom liječenja ipilimumabom, definirane kao bilo koja toksičnost 4. stupnja ili toksičnost 3. stupnja koja je zahtijevala liječenje kortikosteroidima (>10 mg/dan prednizona ili ekvivalenta) dulje od 12 tjedana; nuspojave ≥2. stupnja koje su nastupile tijekom prethodnog liječenja ipilimumabom i koje su bile u tijeku; prethodna teška preosjetljivost na druga monoklonska protutijela; pneumonitis ili intersticijska bolest pluća u anamnezi; infekcija HIV-om, hepatitisom B ili hepatitisom C te funkcionalni ECOG status od ≥2.
English: Key eligibility criteria were metastatic non-squamous NSCLC, no prior systemic treatment for metastatic NSCLC, and no EGFR or ALK genomic tumour aberrations.
Croatian: Glavni kriteriji za uključivanje u ispitivanje bili su metastatski neskvamozni NSCLC, izostanak prethodnog sistemskog liječenja za metastatski NSCLC te nepostojanje tumorskih aberacija gena EGFR ili ALK.
English: Pembrolizumab should be withheld for Grade ≥ 3 until recovery to Grade ≤ 1 hyperthyroidism.
Croatian: Potrebno je odgoditi primjenu pembrolizumaba u slučaju hipertireoze ≥3. stupnja do poboljšanja do ≤1. stupnja.
English: 6-month PFS rate 9-month PFS rate 12-month PFS rate OS
Croatian: 6-mjesečna stopa PFS-a 9-mjesečna stopa PFS-a 12-mjesečna stopa PFS-a OS
English: The safety of pembrolizumab as monotherapy has been evaluated in 5,884 patients with advanced melanoma, resected Stage III melanoma (adjuvant therapy), NSCLC, cHL, urothelial carcinoma, or HNSCC across four doses (2 mg/kg every 3 weeks, 200 mg every 3 weeks, or 10 mg/kg every 2 or 3 weeks) in clinical studies.
Croatian: Sigurnost pembrolizumaba u monoterapiji ocijenjena je u 5884 bolesnika s uznapredovalim melanomom, reseciranim melanomom stadija III (adjuvantna terapija), NSCLC-om, kHL-om, urotelnim karcinomom ili HNSCC-om koji su u kliničkim ispitivanjima primali lijek u jednoj od četiri doze (2 mg/kg svaka 3 tjedna, 200 mg svaka 3 tjedna ili 10 mg/kg svaka 2 ili 3 tjedna).
English: Pembrolizumab has not been studied in patients with severe renal impairment.
Croatian: Pembrolizumab se nije ispitivao u bolesnika s teškim oštećenjem funkcije bubrega.
English: Patients should be treated with KEYTRUDA until disease progression or unacceptable toxicity.
Croatian: Bolesnike treba liječiti lijekom KEYTRUDA do progresije bolesti ili pojave neprihvatljive toksičnosti.
English: Patients were randomised (1:1:1) to receive pembrolizumab at a dose of 2 (n=344) or 10 mg/kg (n=346) every 3 weeks or docetaxel at a dose of 75 mg/m2 every 3 weeks (n=343) until disease progression or unacceptable toxicity.
Croatian: Bolesnici su bili randomizirani (1:1:1) za primanje pembrolizumaba u dozi od 2 mg/kg (n=344) ili 10 mg/kg (n=346) svaka 3 tjedna ili docetaksela u dozi od 75 mg/m2 svaka 3 tjedna (n=343) do progresije bolesti ili pojave neprihvatljive toksičnosti.
English: Patients with the following conditions were excluded from clinical trials: active CNS metastases; ECOG PS ≥ 2 (except for urothelial carcinoma and RCC); HIV, hepatitis B or hepatitis C infection; active systemic autoimmune disease; interstitial lung disease; prior pneumonitis requiring systemic corticosteroid therapy; a history of severe hypersensitivity to another monoclonal antibody; receiving immunosuppressive therapy and a history of severe immune-related adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent) for greater than 12 weeks.
Croatian: U klinička ispitivanja nisu bili uključeni bolesnici sa sljedećim stanjima: aktivnim metastazama u središnjem živčanom sustavu (SŽS); funkcionalnim ECOG statusom ≥2 (osim u ispitivanjima primjene kod urotelnog karcinoma i RCC-a); infekcijom HIV-om, hepatitisom B ili hepatitisom C; aktivnom sistemskom autoimunom bolešću; intersticijskom bolešću pluća; prethodnim pneumonitisom koji je zahtijevao sistemsku kortikosteroidnu terapiju; teškom preosjetljivošću na drugo monoklonsko protutijelo u povijesti bolesti; bolesnici koji primaju imunosupresivnu terapiju i oni koji su u anamnezi imali teške imunološki uzrokovane nuspojave tijekom liječenja ipilimumabom, definirane kao bilo koja toksičnost 4. stupnja ili toksičnost 3. stupnja koja je zahtijevala liječenje kortikosteroidima (>10 mg/dan prednizona ili ekvivalenta) dulje od 12 tjedana.
English: Chemotherapy n=179
Croatian: Kemoterapija n=179
English: The following side effects have been reported in clinical trials with pembrolizumab in combination with axitinib:
Croatian: Sljedeće su nuspojave prijavljene u kliničkim ispitivanjima u kojima se pembrolizumab primjenjivao u kombinaciji s aksitinibom:
English: In patients with HNSCC treated with pembrolizumab as monotherapy (n=909), the incidence of hypothyroidism was 16.1% (all Grades) with 0.3% Grade 3.
Croatian: U bolesnika s HNSCC-om liječenih pembrolizumabom u monoterapiji (n=909) incidencija hipotireoze iznosila je 16,1% (svi stupnjevi) s 0,3% slučajeva 3. stupnja.
English: Uncommon lichenoid keratosis u, psoriasis, dermatitis, papule, hair colour changes psoriasis, dermatitis acneiform, dermatitis, vitiligo t, eczema hair colour changes, lichenoid keratosis, papule, psoriasis, vitiligo
Croatian: Manje često lihenoidna keratoza u, psorijaza, dermatitis, papule, promjene boje kose psorijaza, akneiformni dermatitis, dermatitis, vitiligo t, ekcem promjene boje kose, lihenoidna keratoza, papule, psorijaza, vitiligo
English: The baseline characteristics of these
Croatian: Početne značajke tih
English: The median time to onset of pneumonitis was 3.3 months (range 2 days to 26.8 months).
Croatian: Medijan vremena do nastupa pneumonitisa iznosio je 3,3 mjeseca (raspon: 2 dana do 26,8 mjeseci).
English: % with duration ≥ 6 months % with duration ≥ 9 months
Croatian: % bolesnika s trajanjem ≥ 6 mjeseci % bolesnika s trajanjem ≥ 9 mjeseci
English: KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen.
Croatian: KEYTRUDA kao monoterapija je indicirana za liječenje lokalno uznapredovalog ili metastatskog NSCLC-a u odraslih čiji tumori eksprimiraju PD-L1 uz TPS ≥ 1% i koji su prethodno primili najmanje jedan kemoterapijski protokol.
English: Use of pembrolizumab in urothelial cancer for patients who are considered ineligible for cisplatincontaining chemotherapy and whose tumours express PD-L1 with CPS ≥ 10
Croatian: Primjena pembrolizumaba u bolesnika s urotelnim karcinomom koje se ne smatra pogodnima za liječenje kemoterapijom koja sadrži cisplatin i u kojih tumori eksprimiraju PD-L1 s CPS-om ≥ 10
English: Uncommon pancreatitis pancreatitis pancreatitis
Croatian: Manje često pankreatitis pankreatitis pankreatitis
English: However, once you are treated with KEYTRUDA, your doctor may give you corticosteroids to reduce the side-effects that you may have with KEYTRUDA.
Croatian: Vaš liječnik Vam može dati kortikosteroide kako bi se smanjile nuspojave koje možete imati uz lijek KEYTRUDA.
English: Table 11: Efficacy results by PD-L1 expression and BRAF mutation status in KEYNOTE-054
Croatian: Tablica 11: Rezultati za djelotvornost prema ekspresiji PD-L1 i statusu mutacije gena BRAF u ispitivanju KEYNOTE-054
English: The median duration was 3.3 months (range 3 days to 18.1+ months).
Croatian: Medijan trajanja iznosio je 3,3 mjeseca (raspon: 3 dana do 18,1+ mjesec).
English: All patients with BRAF mutant tumours were previously treated with a BRAF inhibitor.
Croatian: Svi bolesnici oboljeli od tumora s mutacijom u genu BRAF prethodno su bili liječeni BRAF inhibitorom.
English: Grade ≥ 3 with AST or ALT > 5 times ULN or total bilirubin > 3 times ULN
Croatian: ≥3. stupanj s vrijednostima AST-a ili ALT-a >5 puta iznad GGN-a ili ako je ukupni bilirubin >3 puta iznad GGN-a
English: Adrenal insufficiency resolved in 16 patients, 4 with sequelae.
Croatian: Insuficijencija nadbubrežnih žlijezda povukla se u 16 bolesnika, od kojih u 4 s posljedicama.
English: Patients must have undergone lymph node dissection, and if indicated, radiotherapy within 13 weeks prior to starting treatment.
Croatian: Kod bolesnika se unutar 13 tjedana prije početka liječenja morala provesti disekcija limfnog čvora te radioterapija, ako je bila indicirana.
English: KEYTRUDA 200 mg every 3 weeks n=514
Croatian: KEYTRUDA 200 mg svaka 3 tjedna n=514
English: Patients on chemotherapy who experienced independently-verified progression of disease were able to crossover and receive pembrolizumab.
Croatian: Bolesnici liječeni kemoterapijom u kojih je došlo do potvrđene progresije bolesti od strane neovisnog procjenitelja mogli su prijeći u drugu skupinu i primati pembrolizumab.
English: Rare immune thrombocytopenic purpura, haemolytic anaemia, pure red cell aplasia, haemophagocytic lymphohistiocytosis eosinophilia
Croatian: Rijetko imuna trombocitopenična purpura, hemolitička anemija, izolirana aplazija crvene krvne loze, hemofagocitna limfohistiocitoza eozinofilija
English: Chemotherapy:
Croatian: Kemoterapija:
English: powder for concentrate for solution for infusion 1 vial
Croatian: prašak za koncentrat za otopinu za infuziju 1 bočica
English: Pembrolizumab 2 mg/kg every 3 weeks in patients previously treated with ipilimumab n=89
Croatian: Pembrolizumab 2 mg/kg svaka 3 tjedna u bolesnika prethodno liječenih ipilimumabom n=89
English: Colitis resolved in 84 patients, 2 with sequelae.
Croatian: Kolitis se povukao u 84 bolesnika, od kojih u 2 s posljedicama.
English: Duration of Response Median in months (range) % with duration ≥6 months
Croatian: Trajanje odgovora Medijan u mjesecima (raspon) % bolesnika s trajanjem ≥ 6 mjeseci
English: The median trough concentrations (Cmin) at steady-state were approximately 22 mcg/mL at a dose of 2 mg/kg every 3 weeks and 29 mcg/mL at a dose of 200 mg every 3 weeks.
Croatian: Medijan najnižih koncentracija (Cmin) u stanju dinamičke ravnoteže iznosio je približno 22 µg/ml kod primjene doze od 2 mg/kg svaka 3 tjedna, te 29 µg/ml kod primjene doze od 200 mg svaka 3 tjedna.
English: A subgroup analysis was performed as part of the final analysis of KEYNOTE-002 in patients who were BRAF wild type (n=414; 77%) or BRAF mutant with prior BRAF treatment (n=126; 23%) as summarised in Table 6.
Croatian: U sklopu završne analize ispitivanja KEYNOTE-002 provedena je analiza podskupina u bolesnika koji su imali divlji tip gena BRAF (n=414; 77%) ili mutaciju u genu BRAF i koji su prethodno primali BRAF terapiju (n=126; 23%), kako je sažeto prikazano u Tablici 6.
English: The efficacy of pembrolizumab in combination with carboplatin and either paclitaxel or nabpaclitaxel was investigated in Study KEYNOTE-407, a randomised, double-blind, multicentre, placebo-controlled study.
Croatian: Djelotvornost pembrolizumaba u kombinaciji s karboplatinom i paklitakselom ili nab-paklitakselom ispitivana je u randomiziranom, dvostruko slijepom, multicentričnom, placebom kontroliranom ispitivanju KEYNOTE-407.
English: Table 28: Efficacy Results in KEYNOTE-426
Croatian: Tablica 28: Rezultati za djelotvornost u ispitivanju KEYNOTE-426
English: The median follow-up time was 12.8 months (range: 0.1 to 21.5 months).
Croatian: Medijan praćenja iznosio je 12,8 mjeseci (raspon: 0,1 do 21,5 mjeseci).
English: Randomisation was stratified by American Joint Committee on Cancer (AJCC) 7
Croatian: Randomizacija je bila stratificirana na temelju stadija bolesti prema 7. izdanju klasifikacije Američkog povjerenstva za rak (engl.
English: KEYTRUDA has not been studied in patients with moderate or severe hepatic impairment (see sections 4.4 and 5.2).
Croatian: KEYTRUDA se nije ispitivala u bolesnika s umjerenim ili teškim oštećenjem funkcije jetre (vidjeti dijelove 4.4 i 5.2).
English: BRAF mutant with prior BRAF treatment
Croatian: Mutacija u genu BRAF uz prethodnu BRAF terapiju
English: There were no notable effects in the male and female reproductive organs in monkeys based on 1-month and 6-month repeat dose toxicity studies (see section 5.3).
Croatian: U 1-mjesečnim i 6-mjesečnim ispitivanjima toksičnosti ponovljenih doza nisu zabilježeni primjetni učinci na reproduktivne organe mužjaka i ženki majmuna (vidjeti dio 5.3).
English: Of these patients, 55% had no recurrence of ALT > 3 times ULN, and of those patients with recurrence of ALT > 3 times ULN, all recovered.
Croatian: U 55% tih bolesnika nije došlo do ponovnog povišenja vrijednosti ALT-a na > 3 puta iznad GGN-a, a svi bolesnici u kojih je došlo do povišenja ALT-a na > 3 puta iznad GGN-a su se oporavili.
English: (n=99), or cetuximab 400 mg/m2 loading dose and then 250 mg/m2 once weekly (n=71).
Croatian: mg/m2 te dalje u dozi od 250 mg/m2 jednom tjedno (n=71).
English: Duration of Response Median duration of response in months (range) % with duration ≥ 6 months
Croatian: Trajanje odgovora Medijan trajanja odgovora u mjesecima (raspon) % bolesnika s trajanjem ≥ 6 mjeseci
English: Pembrolizumab must be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for any Grade 4 immune-related adverse reaction (see sections 4.2 and 4.8).
Croatian: Liječenje pembrolizumabom se mora trajno prekinuti u slučaju da se ponovno pojavi bilo koja imunološki uzrokovana nuspojava 3. stupnja i u slučaju bilo koje imunološki uzrokovane nuspojave 4. stupnja (vidjeti dijelove 4.2 i 4.8).
English: Use of pembrolizumab in urothelial carcinoma patients who have received prior platinum-containing chemotherapy
Croatian: Primjena pembrolizumaba u bolesnika s urotelnim karcinomom koji su prethodno primali kemoterapiju koja je sadržavala platinu
English: * Includes patients without measurable disease at baseline by independent radiology IRO = Integrated radiology and oncologist assessment using RECIST 1.1
Croatian: * Uključuje bolesnike bez mjerljive bolesti na početku ispitivanja, što je utvrđeno neovisnom radiološkom procjenom IRO = integrirana radiološka i onkološka procjena na temelju verzije 1.1 kriterija RECIST Na temelju stabilne bolesti ili boljeg ishoda kao najboljeg odgovora
English: The pembrolizumab monotherapy arm remains open only to patients whose tumours express PD-L1 with a CPS ≥ 10.
Croatian: U skupinu liječenu monoterapijom pembrolizumabom mogu se nastaviti uključivati samo bolesnici u kojih tumori eksprimiraju PD-L1 s CPS-om ≥ 10.
English: Patients were treated with pembrolizumab until unacceptable toxicity or disease progression.
Croatian: Bolesnici su bili liječeni pembrolizumabom do pojave neprihvatljive toksičnosti ili progresije bolesti.
English: The median time to onset of hepatitis was 3.6 months (range 8 days to 21.4 months).
Croatian: Medijan vremena do nastupa hepatitisa iznosio je 3,6 mjeseci (raspon: 8 dana do 21,4 mjeseca).
English: arthralgia musculoskeletal pain v,
Croatian: artralgija mišićno-koštana bol v,
English: Standard Treatment* n=133
Croatian: Standardno liječenje* n=133
English: The median time to onset of nephritis was 5.0 months (range 12 days to 21.4 months).
Croatian: Medijan vremena do nastupa nefritisa iznosio je 5,0 mjeseci (raspon: 12 dana do 21,4 mjeseca).
English: Severe endocrinopathies, including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, diabetic ketoacidosis, hypothyroidism, and hyperthyroidism have been observed with pembrolizumab treatment.
Croatian: Tijekom liječenja pembrolizumabom zapažene su teške endokrinopatije, uključujući insuficijenciju nadbubrežnih žlijezda, hipofizitis, šećernu bolest tipa 1, dijabetičku ketoacidozu, hipotireozu i hipertireozu.
English: The median duration was not reached (range 3 days to 26.2+ months).
Croatian: Medijan trajanja nije dosegnut (raspon: 3 dana do 26,2+ mjeseca).
English: The median follow-up time was 7.8 months (range: 0.1 to 19.1 months).
Croatian: Medijan praćenja iznosio je 7,8 mjeseci (raspon: 0,1 - 19,1 mjesec).
English: BRAF wild type
Croatian: Divlji tip gena BRAF
English: The safety and efficacy of pembrolizumab were evaluated in KEYNOTE-045, a multicentre, randomised (1:1), controlled study for the treatment of locally advanced or metastatic urothelial carcinoma in patients with disease progression on or after platinum-containing chemotherapy.
Croatian: Sigurnost i djelotvornost pembrolizumaba ocjenjivane su u ispitivanju KEYNOTE-045, multicentričnom, randomiziranom (1:1), kontroliranom ispitivanju liječenja lokalno uznapredovalog ili metastatskog urotelnog karcinoma u bolesnika kojima je bolest progredirala tijekom ili nakon kemoterapije koja je sadržavala platinu.
English: • Placebo with pemetrexed 500 mg/m 2 and investigator's choice of cisplatin 75 mg/m or carboplatin AUC 5 mg/mL/min intravenously every 3 weeks for 4 cycles followed by placebo and pemetrexed 500 mg/m intravenously every 3 weeks (n=206)
Croatian: • placebo u kombinaciji s pemetreksedom 500 mg/m 2 i kemoterapijom po izboru ispitivača, koja je mogla biti ili cisplatin 75 mg/m2 ili karboplatin AUC 5 mg/ml/min, primijenjenima intravenski svaka 3 tjedna tijekom 4 ciklusa, nakon čega su se primjenjivali placebo i pemetreksed 500 mg/m2 intravenski svaka 3 tjedna (n=206)
English: Table 4 summarises key efficacy measures at the final analysis in patients previously treated with ipilimumab, and the KaplanMeier curve for PFS is shown in Figure 3.
Croatian: U Tablici 4 sažeto su prikazane ključne mjere ishoda za djelotvornost u trenutku završne analize u bolesnika prethodno liječenih ipilimumabom, dok je Kaplan-Meierova krivulja za PFS prikazana na Slici
English: In patients with NSCLC, pneumonitis occurred in 8.1% with a history of prior thoracic radiation.
Croatian: Pneumonitis se javio u 8,1% bolesnika s NSCLC-om koji su prethodno primali radioterapiju prsišta.
English: Allogeneic HSCT prior to treatment with pembrolizumab In patients with a history of allogeneic HSCT, acute GVHD, including fatal GVHD, has been reported after treatment with pembrolizumab.
Croatian: U bolesnika s alogenim HSCT-om u anamnezi su nakon liječenja pembrolizumabom prijavljeni slučajevi akutnog GVHD-a, uključujući GVHD sa smrtnim ishodom.
English: Patients were randomised (1:1:1) to receive pembrolizumab 10 mg/kg every 2 (n=279) or 3 weeks (n=277) or ipilimumab 3 mg/kg every 3 weeks (n=278).
Croatian: Bolesnici su bili randomizirani (1:1:1) za primanje pembrolizumaba u dozi od 10 mg/kg svaka 2 (n=279) ili 3 tjedna (n=277) ili za liječenje ipilimumabom u dozi od 3 mg/kg svaka 3 tjedna (n=278).