FrancophonIA/ELRC3.0 huggingface dataset:
English: Severe skin reactions led to discontinuation of pembrolizumab in 9 (0.2%) patients.
Croatian: Teške kožne reakcije dovele su do prekida liječenja pembrolizumabom u 9 (0,2%) bolesnika.
English: No clinically important differences in the clearance of pembrolizumab were found between patients with mild hepatic impairment and normal hepatic function.
Croatian: Nisu primijećene klinički značajne razlike u klirensu pembrolizumaba između bolesnika s blagim oštećenjem funkcije jetre i onih s normalnom jetrenom funkcijom.
English: Blockade of PD-L1 signaling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to result in an increase in foetal loss.
Croatian: U modelima skotnosti miševa i štakora pokazalo se da blokada PD-L1 signalizacije smanjuje toleranciju na plod i dovodi do povećane stope gubitka ploda.
English: Efficacy results for OS were consistent regardless of the age of tumour specimen (new vs. archival) based on an intergroup comparison.
Croatian: Usporedba između skupina pokazala je da su rezultati za djelotvornost s obzirom na OS bili dosljedni neovisno o starosti tumorskog uzorka (novi uzorak u odnosu na pohranjeni uzorak).
English: Pembrolizumab Axitinib n=432
Croatian: Pembrolizumab Aksitinib n=432
English: Table 17: Response to pembrolizumab 2 or 10 mg/kg every 3 weeks in previously treated patients with NSCLC in KEYNOTE-010
Croatian: Tablica 17: Odgovor na pembrolizumab u dozi od 2 mg/kg ili 10 mg/kg svaka 3 tjedna u prethodno liječenih bolesnika s NSCLC-om u ispitivanju KEYNOTE-010
English: Table 8 summarises efficacy results by PD-L1 expression.
Croatian: Tablica 8 sažeto prikazuje rezultate za djelotvornost prema ekspresiji PD-L1.
English: Patients were randomised (1:1) to receive either KEYTRUDA 200 mg every 3 weeks (n=270) or investigator's choice of any of the following chemotherapy regimens all given intravenously every 3 weeks (n=272): paclitaxel 175 mg/m
Croatian: Bolesnici su bili randomizirani (1:1) za primanje lijeka KEYTRUDA u dozi od 200 mg svaka 3 tjedna (n=270) ili bilo kojeg od sljedećih kemoterapijskih protokola prema izboru ispitivača, koji su se svi primjenjivali intravenski svaka 3 tjedna (n=272): paklitaksel 175 mg/m (n=84), docetaksel 75 mg/m
English: KEYNOTE-040: Controlled trial in HNSCC patients previously treated with platinum-containing chemotherapy
Croatian: KEYNOTE-040: Kontrolirano ispitivanje u bolesnika s HNSCC-om prethodno liječenih kemoterapijom koja sadrži platinu
English: Discard any unused portion left in the vial.
Croatian: Bacite sav lijek koji je preostao u bočici.
English: Uncommon pericardial effusion, pericarditis pericardial effusion myocarditis
Croatian: Manje često perikardijalni izljev, perikarditis perikardijalni izljev miokarditis
English: Median in months (95% CI) Objective Response Rate ORR
Croatian: Medijan u mjesecima (95% CI) Stopa objektivnog odgovora ORR
English: The median time to onset of hyperthyroidism was 1.4 months (range 1 day to 22.5 months).
Croatian: Medijan vremena do nastupa hipertireoze iznosio je 1,4 mjeseca (raspon: 1 dan do 22,5 mjeseci).
English: Patients were randomised (1:1) to one of the following treatment arms via intravenous infusion:
Croatian: Bolesnici su bili randomizirani (1:1) za primanje jednog od sljedećih protokola putem intravenske infuzije:
English: Table 9 summarizes efficacy results by PD-L1 expression.
Croatian: Tablica 9 sažeto prikazuje rezultate za djelotvornost prema ekspresiji PD-L1.
English: • Prior to reconstitution, the vial of lyophilised powder can be out of refrigeration (temperatures at or below 25°C) for up to 24 hours.
Croatian: • Bočica liofiliziranog praška se prije rekonstitucije može čuvati izvan hladnjaka (na temperaturi ispod ili na 25°C) tijekom najviše 24 sata.
English: Based on the stratified Cox proportional hazard model Based on stratified log-rank test
Croatian: Na temelju stratificiranog Coxovog modela proporcionalnih hazarda Na temelju stratificiranog log-rang testa
English: Uncommon neutropaenia, leukopaenia, eosinophilia lymphopaenia, eosinophilia
Croatian: Manje često neutropenija, leukopenija, eozinofilija limfopenija, eozinofilija
English: KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy (see section 5.1).
Croatian: KEYTRUDA kao monoterapija je indicirana za liječenje lokalno uznapredovalog ili metastatskog urotelnog karcinoma u odraslih bolesnika prethodno liječenih kemoterapijom koja je sadržavala platinu (vidjeti dio 5.1).
English: • If ALT or AST ≥ 10 times ULN or > 3 times ULN with concurrent total bilirubin ≥ 2 times ULN, both KEYTRUDA and axitinib should be permanently discontinued and corticosteroid therapy may be considered.
Croatian: • ako su ALT ili AST ≥10 puta iznad GGN-a ili >3 puta iznad GGN-a uz istodobnu vrijednost ukupnog bilirubina ≥2 puta iznad GGN-a, potrebno je trajno prekinuti i primjenu lijeka KEYTRUDA i primjenu aksitiniba, a može se razmotriti liječenje kortikosteroidima.
English: p-Value Median in months (95% CI) Rate (%) at 6 months (95% CI) Overall response rate ORR% (95% CI) p-Value Complete response Partial response Stable disease Response duration Median in months (range)
Croatian: p-vrijednost Medijan u mjesecima (95% CI) Stopa (%) u 6. mjesecu (95% CI) Stopa ukupnog odgovora ORR% (95% CI) p-vrijednost Potpun odgovor Djelomičan odgovor Stabilna bolest
English: KEYTRUDA 25 mg/mL concentrate for solution for infusion pembrolizumab
Croatian: KEYTRUDA 25 mg/ml koncentrat za otopinu za infuziju pembrolizumab
English: feeling tired, or chest pain; inflammation of the covering of the heart - hair colour changes; dry, itchy skin; small skin bumps, lumps or sores
Croatian: umor ili bol u prsnom košu; upala ovojnice srca - promjene boje kose; suha koža koja svrbi; malene kvržice, izrasline ili ranice na koži
English: Table 15: Efficacy Results in KEYNOTE-407
Croatian: Tablica 15: Rezultati za djelotvornost u ispitivanju KEYNOTE-407
English: The 18-month OS rate was 81.0% (95% CI 76.7, 84.6) for pembrolizumab in combination with axitinib and 70.7% (95% CI 65.8, 75.1) for sunitinib.
Croatian: Stopa OS-a u 18. mjesecu iznosila je 81,0% (95% CI 76,7; 84,6) za pembrolizumab u kombinaciji s aksitinibom, odnosno 70,7% (95% CI 65,8; 75,1) za sunitinib.
English: , influenza like illness, chills
Croatian: , bolest nalik gripi,
English: Assessment of tumour status was performed every 6 weeks through Week 18, every 9 weeks through Week 45 and every 12 weeks thereafter.
Croatian: Ocjena statusa tumora provodila se svakih 6 tjedana do 18. tjedna, svakih 9 tjedana do 45. tjedna, a zatim svakih 12 tjedana.
English: Data from pembrolizumab monotherapy in patients with resected Stage III melanoma, from pembrolizumab in combination with axitinib in patients with advanced RCC, from chemotherapy combination in patients with metastatic NSCLC, and from pembrolizumab (with or without chemotherapy) in patients receiving first-line treatment for metastatic or unresectable recurrent HNSCC ≥ 75 years are limited (see sections 4.4 and
Croatian: Podaci o primjeni pembrolizumaba u monoterapiji u bolesnika s reseciranim melanomom stadija III, primjeni pembrolizumaba u kombinaciji s aksitinibom u bolesnika s uznapredovalim RCC-om, odnosno u kombinaciji s kemoterapijom u bolesnika s metastatskim NSCLC-om te primjeni pembrolizumaba (u kombinaciji s kemoterapijom ili bez nje) u bolesnika koji primaju prvu liniju liječenja za metastatski ili neresektabilni rekurentni HNSCC u dobi od ≥ 75 godina su ograničeni (vidjeti dijelove 4.4 i 5.1).
English: The study excluded patients with EGFR or ALK genomic tumour aberrations; autoimmune disease that required systemic therapy within 2 years of treatment; a medical condition that required immunosuppression; or who had received more than 30 Gy of thoracic radiation within the prior 26 weeks.
Croatian: Iz ispitivanja su bili isključeni bolesnici s tumorskim aberacijama gena EGFR ili ALK, bolesnici s autoimunom bolešću koja je zahtijevala sistemsku terapiju unutar 2 godine prije liječenja, bolesnici s medicinskim stanjem koje je zahtijevalo imunosupresiju ni bolesnici koji su primili više od 30 Gy radioterapije prsišta unutar prethodnih 26 tjedana.
English: No dose adjustment is needed for patients with mild or moderate renal impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega.
English: ORR difference, % (95% CI)
Croatian: Razlika ORR-a, % (95% CI)
English: KEYNOTE-361 is an ongoing Phase III, randomised, controlled, open-label clinical trial of pembrolizumab with or without platinum-based combination chemotherapy versus chemotherapy as first-line treatment in subjects with advanced or metastatic urothelial carcinoma.
Croatian: U tijeku je randomizirano, kontrolirano, otvoreno kliničko ispitivanje faze III pod nazivom KEYNOTE-361 u kojem se ispituje pembrolizumab s kemoterapijom na temelju platine ili bez nje naspram kemoterapije kao prve linije liječenja u ispitanika s uznapredovalim ili metastatskim urotelnim karcinomom.
English: Guillain-Barré syndrome g,
Croatian: Rijetko Guillain-Barréov sindrom g, mijastenični sindrom h, meningitis (aseptični)
English: The median time to onset of hypothyroidism was 3.5 months (range 1 day to 19.6 months).
Croatian: Medijan vremena do nastupa hipotireoze iznosio je 3,5 mjeseci (raspon: 1 dan do 19,6 mjeseci).
English: Grades 3 or 4, or recurrent Grade 2 Permanently discontinue
Croatian: 3. ili 4. stupanj, ili rekurentan 2. stupanj
English: Uncommon hepatitis hepatitis
Croatian: Manje često hepatitis hepatitis
English: No dose adjustment is needed for patients with mild hepatic impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim oštećenjem funkcije jetre.
English: 12-month OS rate, % (95% CI)
Croatian: Stopa 12-mjesečnog OS-a, % (95% CI)
English: KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (see section 5.1).
Croatian: KEYTRUDA kao monoterapija je indicirana za liječenje lokalno uznapredovalog ili metastatskog urotelnog karcinoma u odraslih bolesnika koji nisu pogodni za kemoterapiju koja sadrži cisplatin i u kojih tumori eksprimiraju PD-L1 s kombiniranim pozitivnim rezultatom (engl. combined positive score, CPS) ≥ 10 (vidjeti dio 5.1).
English: A total of 65 NSCLC patients aged ≥ 75 years were enrolled in study KEYNOTE-407 (34 in the pembrolizumab combination and 31 in the control).
Croatian: U ispitivanje KEYNOTE-047 bilo je uključeno ukupno 65 bolesnika s NSCLC-om u dobi od ≥ 75 godina (34 u skupinu koja je primala pembrolizumab u kombiniranoj terapiji i 31 u kontrolnu skupinu).
English: Median in months (95% CI)
Croatian: Medijan u mjesecima (95% CI)
English: Based on Kaplan-Meier estimates; includes 43 patients with responses of 6 months or longer
Croatian: Na temelju procjena prema Kaplan-Meieru; uključuje 43 bolesnika s odgovorom od 6 ili više mjeseci
English: Secondary outcome measures were ORR (as assessed by BICR using RECIST v1.1) and duration of response.
Croatian: Sekundarne mjere ishoda bile su ORR (prema ocjeni zaslijepljenog neovisnog središnjeg povjerenstva na temelju verzije 1.1 kriterija RECIST) i trajanje odgovora.
English: The study excluded patients with autoimmune disease, a medical condition that required immunosuppression and patients with more than 2 prior lines of systemic chemotherapy for metastatic urothelial cancer.
Croatian: U ispitivanje nisu bili uključeni bolesnici s autoimunom bolešću, bolesnici s medicinskim stanjem koje je zahtijevalo imunosupresiju ni bolesnici koji su prethodno primili više od 2 linije sistemske kemoterapije za metastatski urotelni karcinom.
English: KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
Croatian: KEYTRUDA kao monoterapija je indicirana za prvu liniju liječenja metastatskog karcinoma pluća nemalih stanica (engl. non-small cell lung carcinoma, NSCLC) u odraslih čiji tumori eksprimiraju PD-L1 uz udio tumorskih stanica s ekspresijom (engl. tumour proportion score, TPS) ≥ 50% i koji nisu pozitivni na tumorske mutacije gena EGFR ili ALK.
English: The median duration was 1.8 months (range 4 days to 29.2+ months).
Croatian: Medijan trajanja iznosio je 1,8 mjeseci (raspon: 4 dana do 29,2+ mjeseca).
English: Uncommon type 1 diabetes mellitus type 1 diabetes mellitus type 1 diabetes mellitus
Croatian: šećerna bolest tipa 1
English: A subgroup analysis was performed as part of the final analysis of KEYNOTE-006 in patients who were BRAF wild type (n=525; 63%), BRAF mutant without prior BRAF treatment (n=163; 20%) and BRAF mutant with prior BRAF treatment (n=139; 17%) as summarised in Table 7.
Croatian: U sklopu završne analize ispitivanja KEYNOTE-006 provedena je analiza podskupina u bolesnika koji su imali divlji tip gena BRAF (n=525; 63%), bolesnika koji su imali mutaciju u genu BRAF, ali prethodno nisu primali BRAF terapiju (n=163; 20%) te bolesnika koji su imali mutaciju u genu BRAF i prethodno su primali BRAF terapiju (n=139; 17%), kako je sažeto prikazano u Tablici 7.
English: • The Patient Alert Card
Croatian: • Karticu s upozorenjima za bolesnika
English: The median duration was 0.9 months (range 1 day to 8.7+ months).
Croatian: Medijan trajanja iznosio je 0,9 mjeseci (raspon: 1 dan do 8,7+ mjeseci).
English: Median in months (95% CI) Objective Response Rate ORR % (95% CI) p-Value
Croatian: Medijan u mjesecima (95% CI) Stopa objektivnog odgovora ORR % (95% CI) p-vrijednost
English: tenosynovitis
Croatian: tenosinovitis
English: Based on Kaplan-Meier estimates; includes 16 patients with responses of 6 months or longer
Croatian: Na temelju procjena prema Kaplan-Meieru; uključuje 16 bolesnika s odgovorom od 6 ili više mjeseci
English: Very common dyspnoea, cough dyspnoea, cough dyspnoea, cough, dysphonia
Croatian: Vrlo često dispneja, kašalj dispneja, kašalj dispneja, kašalj, disfonija
English: • a kind of lung cancer called non-small cell lung cancer
Croatian: • jedne vrste raka pluća koji se zove rak pluća nemalih stanica
English: • If ALT or AST ≥ 3 times ULN but < 10 times ULN without concurrent total bilirubin ≥ 2 times ULN, both KEYTRUDA and axitinib should be withheld until these adverse reactions recover to Grades 0-1.
Croatian: • ako su ALT ili AST ≥3 puta, ali <10 puta iznad GGN-a bez istodobne vrijednosti ukupnog bilirubina ≥2 puta iznad GGN-a, potrebno je odgoditi i primjenu lijeka KEYTRUDA i primjenu aksitiniba dok se te nuspojave ne poboljšaju na 0. ili 1. stupanj.
English: KEYNOTE-189: Controlled trial of combination therapy in non-squamous NSCLC patients naïve to treatment
Croatian: KEYNOTE-189: Kontrolirano ispitivanje kombinirane terapije u prethodno neliječenih bolesnika s neskvamoznim NSCLC-om
English: Assessment of tumour status was performed at 9 weeks after the first dose, then every 6 weeks through the first year, followed by every 12 weeks thereafter.
Croatian: Procjena statusa tumora provedena je 9 tjedana nakon prve doze, zatim svakih 6 tjedana tijekom prvih godinu dana, a nakon toga svakih 12 tjedana.
English: The recommended dose of KEYTRUDA as monotherapy is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes.
Croatian: Preporučena doza lijeka KEYTRUDA u monoterapiji je 200 mg svaka 3 tjedna ili 400 mg svakih 6 tjedana, a primjenjuje se intravenskom infuzijom u trajanju od 30 minuta.
English: Eighty-one percent had a primary tumour in the lower tract, and 19% of patients had a primary tumour in the upper tract.
Croatian: Osamdeset i jedan posto (81%) bolesnika imalo je primarni tumor u donjem dijelu mokraćnog sustava, a 19% njih u gornjem dijelu mokraćnog sustava.
English: Pembrolizumab + Axitinib vs. Sunitinib
Croatian: Pembrolizumab + aksitinib: Sunitinib:
English: KEYNOTE-024: Controlled trial of NSCLC patients naïve to treatment The safety and efficacy of pembrolizumab were investigated in KEYNOTE-024, a multicentre, controlled study for the treatment of previously untreated metastatic NSCLC.
Croatian: KEYNOTE-024: Kontrolirano ispitivanje u prethodno neliječenih bolesnika s NSCLC-om Sigurnost i djelotvornost pembrolizumaba ispitivane su u ispitivanju KEYNOTE-024, multicentričnom, kontroliranom ispitivanju liječenja prethodno neliječenog metastatskog NSCLC-a.
English: PD L1 positive
Croatian: PD L1 pozitivni bolesnici
English: KEYTRUDA 50 mg powder for concentrate for solution for infusion.
Croatian: KEYTRUDA 50 mg prašak za koncentrat za otopinu za infuziju.
English: Among the 1,019 patients, the baseline characteristics were: median age of 54 years (25% age 65 or older); 62% male; and ECOG PS of 0 (94%) and 1 (6%).
Croatian: Početne značajke među 1019 bolesnika bile su sljedeće: medijan dobi 54 godine (25% u dobi od 65 ili više godina), 62% muškaraca te funkcionalni ECOG status 0 (94%) i 1 (6%).
English: Assessment of tumour status was performed at 12 weeks, then every 6 weeks through week 48, followed by every 12 weeks thereafter.
Croatian: Procjena statusa tumora provedena je nakon 12 tjedana, zatim svakih 6 tjedana do 48. tjedna, a nakon toga svakih 12 tjedana.
English: Number at Risk Pembrolizumab + Axitinib:
Croatian: Broj bolesnika pod rizikom Pembrolizumab + aksitinib:
English: Among the 616 patients in KEYNOTE-189, baseline characteristics were: median age of 64 years (49% age 65 or older); 59% male; 94% White and 3% Asian; 43% and 56% ECOG performance status of 0 or 1 respectively; 31% PD-L1 negative (TPS < 1%); and 18% with treated or untreated brain metastases at baseline.
Croatian: Početne značajke među 616 bolesnika u ispitivanju KEYNOTE-189 bile su sljedeće: medijan dobi 64 godine (49% bilo je u dobi od 65 ili više godina); 59% muškaraca; 94% bijelaca i 3% azijata; 43% bolesnika s funkcionalnim ECOG statusom 0 i 56% njih s funkcionalnim ECOG statusom 1; 31% PD-L1 negativnih bolesnika (TPS < 1%) i 18% bolesnika s liječenim ili neliječenim moždanim metastazama na početku ispitivanja.
English: KEYNOTE-052: Open label trial in urothelial carcinoma patients ineligible for cisplatin-containing chemotherapy
Croatian: KEYNOTE-052: Otvoreno ispitivanje u bolesnika s urotelnim karcinomom koji nisu bili pogodni za kemoterapiju koja sadrži cisplatin
English: The exposure multiple between the NOAEL and a human dose of 200 mg was 74.
Croatian: NOAEL je bio 74 puta viši od izloženosti koja se postiže u ljudi nakon primjene doze od 200 mg.
English: Gastrointestinal disorders Very common diarrhoea, abdominal pain m, nausea, vomiting, constipation diarrhoea, nausea, vomiting, constipation, abdominal pain diarrhoea, abdominal pain m, nausea, vomiting, constipation
Croatian: Poremećaji probavnog sustava Vrlo često dijareja, bol u abdomenu m, mučnina, povraćanje, konstipacija dijareja, mučnina, povraćanje, konstipacija, bol u abdomenu dijareja, bol u abdomenu m,
English: Pembrolizumab + Axitinib N = 432
Croatian: Pembrolizumab + aksitinib N = 432
English: The safety of pembrolizumab in combination with chemotherapy has been evaluated in 1,067 patients with NSCLC or HNSCC receiving 200 mg, 2 mg/kg or 10 mg/kg pembrolizumab every 3 weeks, in clinical studies.
Croatian: Sigurnost pembrolizumaba u kombinaciji s kemoterapijom ocijenjena je u 1067 bolesnika s NSCLC-om ili HNSCC-om koji su u kliničkim ispitivanjima primali pembrolizumab u dozi od 200 mg, 2 mg/kg ili 10 mg/kg svaka 3 tjedna.
English: KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic HNSCC in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinumcontaining chemotherapy (see section 5.1).
Croatian: KEYTRUDA kao monoterapija je indicirana za liječenje rekurentnog ili metastatskog HNSCC-a u odraslih bolesnika čiji tumori eksprimiraju PD-L1 uz TPS ≥ 50% i čija bolest progredira tijekom ili nakon kemoterapije koja sadrži platinu (vidjeti dio 5.1).
English: Patients were treated with pembrolizumab until disease progression or unacceptable toxicity.
Croatian: Bolesnici su bili liječeni pembrolizumabom do progresije bolesti ili do pojave neprihvatljive toksičnosti.
English: Figure 11: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-010 (patients with PD-L1 expression tumour proportion score  1%, intent to treat population)
Croatian: Slika 11: Kaplan-Meierova krivulja za ukupno preživljenje prema liječenoj skupini u ispitivanju KEYNOTE-010 (bolesnici s udjelom tumorskih stanica s ekspresijom PD-L1  1%, populacija koju se namjeravalo liječiti)
English: A direct comparison of pembrolizumab when used in combination with chemotherapy to pembrolizumab monotherapy is not available.
Croatian: Nije dostupna izravna usporedba pembrolizumaba kod njegove primjene u kombinaciji s kemoterapijom u odnosu na primjenu u monoterapiji.
English: Figure 10: Kaplan-Meier Curve for Progression-Free Survival in KEYNOTE-407
Croatian: Slika 10: Kaplan-Meierova krivulja za preživljenje bez progresije bolesti u ispitivanju KEYNOTE-407
English: Uncommon amylase increased blood bilirubin increased, amylase increased amylase increased
Croatian: Manje često povišene vrijednosti amilaze povišene vrijednosti bilirubina u krvi, povišene vrijednosti amilaze povišene vrijednosti amilaze
English: The safety and efficacy of pembrolizumab were investigated in KEYNOTE-052, a multicentre, openlabel study for the treatment of locally advanced or metastatic urothelial carcinoma in patients who were not eligible for cisplatin-containing chemotherapy.
Croatian: Sigurnost i djelotvornost pembrolizumaba ispitivane su u ispitivanju KEYNOTE-052, multicentričnom, otvorenom ispitivanju liječenja lokalno uznapredovalog ili metastatskog urotelnog karcinoma u bolesnika koji nisu bili pogodni za kemoterapiju koja sadrži cisplatin.
English: Data for the following immune-related adverse reactions are based on patients who received pembrolizumab across four doses (2 mg/kg every 3 weeks, 10 mg/kg every 2 or 3 weeks, or 200 mg every 3 weeks) in clinical studies (see section 5.1).
Croatian: Podaci o sljedećim imunološki uzrokovanim nuspojavama temeljeni su na kliničkim ispitivanjima u bolesnika koji su primali pembrolizumab u jednoj od četiri doze (2 mg/kg svaka 3 tjedna, 10 mg/kg svaka 2 ili 3 tjedna, ili 200 mg svaka 3 tjedna) (vidjeti dio 5.1).
English: IIIC ≥ 4 positive lymph nodes) and geographic region (North America, European countries, Australia and other countries as designated).
Croatian: American Joint Committee on Cancer, AJCC) (IIIA, IIIB, IIIC uz 1-3 pozitivna limfna čvora ili IIIC uz ≥ 4 pozitivna limfna čvora) te geografske regije (Sjeverna Amerika, europske zemlje, Australija i ostale zemlje).
English: Number of events (%) Median in months (95% CI)
Croatian: Broj događaja (%) Medijan u mjesecima (95% CI)
English: The median time to onset of ALT increased was 2.3 months (range: 7 days to 19.8 months).
Croatian: Medijan vremena do nastupa povišenih vrijednosti ALT-a iznosio je 2,3 mjeseca (raspon od 7 dana do 19,8 mjeseci).
English: Sixty-three percent had M1c stage and 2% of patients had a history of brain metastases.
Croatian: 63% bolesnika imalo je melanom stadija M1c, dok je 2% bolesnika imalo metastaze u mozgu u anamnezi.
English: Standard Treatment* n=122
Croatian: Standardno liječenje* n=122
English: vomiting (26%), headache (22%), abdominal pain (21%), anaemia (21%) and constipation (20%).
Croatian: Najčešće nuspojave (prijavljene u najmanje 20% pedijatrijskih bolesnika) bile su pireksija (31%), povraćanje (26%), glavobolja (22%), bol u abdomenu (21%), anemija (21%) i konstipacija (20%).