FrancophonIA/ELRC3.0 huggingface dataset:
English: KEYNOTE-010: Controlled trial of NSCLC patients previously treated with chemotherapy The safety and efficacy of pembrolizumab were investigated in KEYNOTE-010, a multicentre, openlabel, controlled study for the treatment of advanced NSCLC in patients previously treated with platinum-containing chemotherapy.
Croatian: KEYNOTE-010: Kontrolirano ispitivanje u bolesnika s NSCLC-om prethodno liječenih kemoterapijom Sigurnost i djelotvornost pembrolizumaba ispitivane su u ispitivanju KEYNOTE-010, multicentričnom, otvorenom, kontroliranom ispitivanju liječenja uznapredovalog NSCLC-a u bolesnika prethodno liječenih kemoterapijom koja je uključivala platinu.
English: Vascular disorders Very common hypertension
Croatian: Krvožilni poremećaji Vrlo često hipertenzija
English: Table 14: Efficacy results by PD-L1 Expression in KEYNOTE-189
Croatian: Tablica 14: Rezultati za djelotvornost prema ekspresiji PD-L1 u ispitivanju KEYNOTE-189
English: No clinically important differences in the clearance of pembrolizumab were found between patients with mild or moderate renal impairment and patients with normal renal function.
Croatian: Nisu primijećene klinički značajne razlike u klirensu pembrolizumaba između bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega i onih s normalnom bubrežnom funkcijom.
English: patches of skin that have lost colour - inflammation of the sheath that surrounds tendons - increased level of amylase, an enzyme that breaks down starch; increased bilirubin in the blood
Croatian: upala kože; gubitak boje na nekim dijelovima kože - upala ovojnice koja okružuje tetive - povišene vrijednosti amilaze, enzima koji razgrađuje škrob; povišene vrijednosti bilirubina u krvi
English: In patients with NSCLC, pneumonitis occurred in 107 (4.9%), including Grade 2, 3, 4 or 5 cases in 39 (1.8%), 30 (1.4%), 10 (0.5%) and 9 (0.4%), respectively.
Croatian: U bolesnika s NSCLC-om, pneumonitis se javio u njih 107 (4,9%), uključujući slučajeve 2. stupnja u 39 (1,8%) bolesnika, slučajeve 3. stupnja u 30 (1,4%) bolesnika, slučajeve 4. stupnja u 10 (0,5%) bolesnika i slučajeve 5. stupnja u 9 (0,4%) bolesnika.
English: Table 27: Efficacy of pembrolizumab 200 mg every 3 weeks in HNSCC patients with TPS ≥ 50% who were previously treated with platinum chemotherapy in KEYNOTE-040
Croatian: Tablica 27: Djelotvornost pembrolizumaba u dozi od 200 mg svaka 3 tjedna u bolesnika s HNSCC-om i TPS-om ≥ 50% prethodno liječenih kemoterapijom koja sadrži platinu u ispitivanju KEYNOTE-040
English: Pembrolizumab 2 mg/kg Pembrolizumab 10 mg/kg 36% Docetaxel
Croatian: Pembrolizumab 2 mg/kg Pembrolizumab 10 mg/kg Docetaksel
English: The median time to onset of hypophysitis was 5.9 months (range 1 day to 17.7 months).
Croatian: Medijan vremena do nastupa hipofizitisa iznosio je 5,9 mjeseci (raspon: 1 dan do 17,7 mjeseci).
English: Table 7: Efficacy results by BRAF mutation status in KEYNOTE-006
Croatian: Tablica 7: Rezultati za djelotvornost prema statusu mutacije u genu BRAF u ispitivanju KEYNOTE-006
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: Patients had PD-L1 expression with a  50% tumour proportion score (TPS) based on the PD-L1 IHC 22C3 pharmDx
Croatian: Bolesnici su imali ekspresiju PD-L1 uz udio tumorskih stanica s ekspresijom (TPS) ≥ 50%, određenim uz pomoć seta PD-L1 IHC 22C3 pharmDx
English: Placebo + Pemetrexed + Platinum Chemotherapy n=206
Croatian: Placebo + pemetreksed + kemoterapija temeljena na platini n=206
English: PD-L1 negative
Croatian: PD-L1 negativni bolesnici
English: Standard Treatment* n=125
Croatian: Standardno liječenje* n=125
English: Ipilimumab 3 mg/kg every 3 weeks n=278
Croatian: Ipilimumab 3 mg/kg svaka 3 tjedna n=278
English: Subgroup analyses by enrollment were performed in KEYNOTE-426 in patients with PD-L1 CPS ≥ 1 [pembrolizumab/axitinib combination: n=243 (56%) vs. sunitinib: n=254 (59%)]; CPS < 1 [pembrolizumab/axitinib combination: n=167 (39%) vs. sunitinib: n=158 (37%)], and in patients with IMDC risk categories of favourable [pembrolizumab/axitinib combination: n=138 (32%) vs. sunitinib: n=131 (31%)]; intermediate [pembrolizumab/axitinib combination: n=238 (55%) vs. sunitinib: n=246 (57%)]; and poor [pembrolizumab/axitinib combination: n=56 (13%) vs. sunitinib: n=52 (12%)].
Croatian: U ispitivanju KEYNOTE-426 provedene su analize podskupina prema statusu pri uključivanju u ispitivanje, tj. u bolesnika koji su imali CPS za PD-L1 ≥1 [kombinacija pembrolizumab/aksitinib: n=243 (56%) naspram sunitiniba: n=254 (59%)], u bolesnika koji su imali CPS za PD-L1 <1 [kombinacija pembrolizumab/aksitinib: n=167 (39%) naspram sunitiniba: n=158 (37%)] te u bolesnika koji su prema IMDC kriterijima bili svrstani u kategoriju niskog rizika [kombinacija pembrolizumab/aksitinib: n=138 (32%) naspram sunitiniba: n=131 (31%)], umjerenog rizika [kombinacija pembrolizumab/aksitinib: n=238 (55%) naspram sunitiniba: n=246 (57%)] ili visokog rizika [kombinacija pembrolizumab/aksitinib: n=56 (13%) naspram sunitiniba: n=52 (12%)].
English: Immune-related severe skin reactions occurred in 89 (1.5%) patients, including Grade 2, 3 or 5 cases in 10 (0.2%), 65 (1.1%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab.
Croatian: Imunološki uzrokovane teške kožne reakcije javile su se u 89 (1,5%) bolesnika liječenih pembrolizumabom, uključujući slučajeve 2. stupnja u 10 (0,2%) bolesnika, slučajeve 3. stupnja u 65 (1,1%) bolesnika i slučajeve 5. stupnja u 1 (< 0,1%) bolesnika.
English: An analysis was performed in KEYNOTE-045 in patients who had PD-L1 CPS < 10 [pembrolizumab: n=186 (69%) vs. chemotherapy: n= 176 (65%)] or ≥ 10 [pembrolizumab: n=74 (27%) vs. chemotherapy: n= 90 (33%)] in both pembrolizumab- and chemotherapy-treated arms (see Table 20).
Croatian: U ispitivanju KEYNOTE-045 provedena je analiza bolesnika koji su imali CPS za PD-L1 < 10 [pembrolizumab: n=186 (69%) naspram kemoterapije: n= 176 (65%)] ili ≥ 10 [pembrolizumab: n=74 (27%) naspram kemoterapije: n= 90 (33%)] i u skupini liječenoj pembrolizumabom i u onoj koja je primala kemoterapiju (vidjeti Tablicu 20).
English: 754 patients included: median age of 61 years (range: 20 to 94); 36% age 65 or older; 82% male; 74% White and 19% Asian; 61% ECOG performance status of 1; and 77% former/current smokers.
Croatian: 754 bolesnika uključivale su sljedeće: medijan dobi iznosio je 61 godinu (raspon: 20 - 94), a 36% bolesnika bilo je u dobi od 65 ili više godina; 82% muškaraca; 74% bijelaca i 19% azijata; 61% bolesnika s funkcionalnim ECOG statusom 1 te 77% bivših/aktivnih pušača.
English: Patient-reported outcomes (PROs) were assessed using EORTC QLQ-C30.
Croatian: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30, EORTC QLQ-C30).
English: KEYTRUDA 25 mg/mL concentrate for solution for infusion.
Croatian: KEYTRUDA 25 mg/ml koncentrat za otopinu za infuziju.
English: KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection (see section 5.1).
Croatian: KEYTRUDA kao monoterapija je indicirana za adjuvantno liječenje melanoma stadija III u odraslih kod kojih je bolest zahvatila limfne čvorove i koji su podvrgnuti potpunoj resekciji (vidjeti dio 5.1).
English: Table 16: Efficacy results by PD-L1 Expression in KEYNOTE-407
Croatian: Tablica 16: Rezultati za djelotvornost prema ekspresiji PD-L1 u ispitivanju KEYNOTE-407
English: Pembrolizumab 2 mg/kg every 3 weeks Pembrolizumab 10 mg/kg every 3 weeks Chemotherapy
Croatian: Pembrolizumab 2 mg/kg svaka 3 tjedna Pembrolizumab 10 mg/kg svaka 3 tjedna Kemoterapija
English: The median time to onset of adrenal insufficiency was 5.4 months (range 1 day to 17.7 months).
Croatian: Medijan vremena do nastupa insuficijencije nadbubrežnih žlijezda iznosio je 5,4 mjeseca (raspon: 1 dan do 17,7 mjeseci).
English: Table 8: Efficacy results by PD-L1 expression in KEYNOTE-002
Croatian: Tablica 8: Rezultati za djelotvornost prema ekspresiji PD-L1 u ispitivanju KEYNOTE-002
English: Based on the severity of the adverse reaction, pembrolizumab should be withheld or permanently discontinued, and corticosteroids should be administered (see section 4.2).
Croatian: Ovisno o težini nuspojave potrebno je odgoditi ili trajno prekinuti primjenu pembrolizumaba te primijeniti kortikosteroide (vidjeti dio 4.2).
English: Pembrolizumab Monotherapy n=124
Croatian: Monoterapija pembrolizumabom n=124
English: Standard Treatment* n=235
Croatian: Standardno liječenje* n=235
English: Patients with nasopharyngeal carcinoma, active autoimmune disease that required systemic therapy within two years of treatment or a medical condition that required immunosuppression were ineligible for the study.
Croatian: U ispitivanju nisu mogli sudjelovati bolesnici s nazofaringealnim karcinomom, bolesnici s aktivnom autoimunom bolešću kojima je bila potrebna sistemska terapija unutar 2 godine prije liječenja ni bolesnici s medicinskim stanjem koje je zahtijevalo imunosupresiju.
English: Patients were randomized 1:1:1 to one of the following treatment arms:
Croatian: Bolesnici su bili randomizirani u omjeru 1:1:1 u jednu od sljedećih terapijskih skupina:
English: Table 6: Efficacy results by BRAF mutation status in KEYNOTE-002
Croatian: Tablica 6: Rezultati za djelotvornost prema statusu mutacije u genu BRAF u ispitivanju KEYNOTE-002
English: #) of patients with duration ≥ 12 months
Croatian: #) bolesnika s trajanjem odgovora ≥ 12 mjeseci
English: From a microbiological point of view, the reconstituted or diluted solution should be used immediately.
Croatian: S mikrobiološkog stajališta, rekonstituiranu ili razrijeđenu otopinu potrebno je odmah primijeniti.
English: §% (95% CI) Complete response Partial response p-Value Response duration Median in months (range)
Croatian: §% (95% CI) Potpun odgovor Djelomičan odgovor p-vrijednost Trajanje odgovora Medijan u mjesecima (raspon)
English: Eighty-six percent had a primary tumour in the lower tract and 14% had a primary tumour in the upper tract.
Croatian: Osamdeset i šest posto (86%) bolesnika imalo je primarni tumor u donjem dijelu mokraćnog sustava, a 14% njih u gornjem dijelu mokraćnog sustava.
English: • From a microbiological point of view, the reconstituted or diluted solution should be used immediately.
Croatian: • S mikrobiološkog stajališta, rekonstituiranu ili razrijeđenu otopinu potrebno je odmah primijeniti.
English: KEYTRUDA, or if corticosteroid dosing cannot be reduced to ≤ 10 mg prednisone or equivalent per day within 12 weeks, KEYTRUDA should be permanently discontinued.
Croatian: * Ako se toksičnost povezana s liječenjem ne poboljša do 0. ili 1. stupnja unutar 12 tjedana nakon primjene posljednje doze lijeka KEYTRUDA ili ako se doza kortikosteroida unutar 12 tjedana ne može smanjiti na ≤10 mg prednizona ili ekvivalenta na dan, liječenje lijekom KEYTRUDA potrebno je trajno prekinuti.
English: KEYTRUDA 50 mg powder for concentrate for solution for infusion pembrolizumab
Croatian: KEYTRUDA 50 mg prašak za koncentrat za otopinu za infuziju pembrolizumab
English: Chemotherapy
Croatian: Kemoterapija
English: Hepatitis led to discontinuation of pembrolizumab in 19 (0.3%) patients.
Croatian: Hepatitis je doveo do prekida liječenja pembrolizumabom u 19 (0,3%) bolesnika.
English: Table 3: Efficacy results in KEYNOTE-006
Croatian: Tablica 3: Rezultati za djelotvornost u ispitivanju KEYNOTE-006
English: Table 9: Efficacy results by PD-L1 expression in KEYNOTE-006
Croatian: Tablica 9: Rezultati za djelotvornost prema ekspresiji PD-L1 u ispitivanju KEYNOTE-006
English: Among the 542 randomised patients in KEYNOTE-045, baseline characteristics were: median age 66 years (range: 26 to 88), 58% age 65 or older; 74% male; 72% White and 23% Asian; 56% ECOG performance status of 1 and 1% ECOG performance status of 2; and 96% M1 disease and 4% M0 disease.
Croatian: Početne značajke među 542 bolesnika randomizirana u ispitivanju KEYNOTE-045 bile su sljedeće: medijan dobi 66 godina (raspon: 26 - 88), 58% bilo je u dobi od 65 ili više godina; 74% muškaraca; 72% bijelaca i 23% azijata; 56% bolesnika s funkcionalnim ECOG statusom 1 i 1% njih s funkcionalnim ECOG statusom 2; 96% bolesnika s bolešću stadija M1 te 4% njih s bolešću stadija M0.
English: Table 12: Efficacy results in KEYNOTE-024
Croatian: Tablica 12: Rezultati za djelotvornost u ispitivanju KEYNOTE-024
English: Use of pembrolizumab for first-line treatment of patients with NSCLC In general, the frequency of adverse reactions for pembrolizumab combination therapy is observed to be higher than for pembrolizumab monotherapy or chemotherapy alone, reflecting the contributions of each of these components (see sections 4.2 and 4.8).
Croatian: Primjena pembrolizumaba za prvu liniju liječenja bolesnika s NSCLC-om Učestalost nuspojava opažena kod primjene pembrolizumaba u kombiniranoj terapiji općenito je viša od učestalosti zabilježene kod monoterapije pembrolizumabom ili primjene samo kemoterapije, što odražava doprinos svake od tih sastavnica (vidjeti dijelove 4.2 i 4.8).
English: Use of pembrolizumab for first-line treatment of patients with HNSCC In general, the frequency of adverse reactions for pembrolizumab combination therapy is observed to be higher than for pembrolizumab monotherapy or chemotherapy alone, reflecting the contributions of each of these components (see section 4.8).
Croatian: Primjena pembrolizumaba za prvu liniju liječenja bolesnika s HNSCC-om Općenito je opažena viša učestalost nuspojava kod primjene pembrolizumaba u kombiniranoj terapiji u odnosu na onu zabilježenu kod monoterapije pembrolizumabom ili primjene samo kemoterapije, što odražava doprinos svake od tih sastavnica (vidjeti dio 4.8).
English: Hypothyroidism occurred in 645 (11.0%) patients, including Grade 2 or 3 cases in 475 (8.1%) and 8 (0.1%) patients, respectively, receiving pembrolizumab.
Croatian: Hipotireoza se javila u 645 (11,0%) bolesnika liječenih pembrolizumabom, uključujući slučajeve 2. stupnja u 475 (8,1%) bolesnika i slučajeve 3. stupnja u 8 (0,1%) bolesnika.
English: Treatment with pembrolizumab continued until RECIST 1.1-defined progression of disease as determined by the investigator, unacceptable toxicity, or a maximum of 24 months.
Croatian: Liječenje pembrolizumabom nastavilo se do progresije bolesti definirane verzijom 1.1 kriterija RECIST koju je utvrdio ispitivač, pojave neprihvatljive toksičnosti ili najviše 24 mjeseca.
English: The median time to onset of colitis was 4.3 months (range 7 days to 24.3 months).
Croatian: Medijan vremena do nastupa kolitisa iznosio je 4,3 mjeseca (raspon: 7 dana do 24,3 mjeseca).
English: Table 10: Efficacy results in KEYNOTE-054
Croatian: Tablica 10: Rezultati za djelotvornost u ispitivanju KEYNOTE-054
English: Standard Treatment* n=255
Croatian: Standardno liječenje* n=255
English: The median duration was 1.1 months (range 1 day to 20.9+ months).
Croatian: Medijan trajanja iznosio je 1,1 mjesec (raspon: 1 dan do 20,9+ mjeseci).
English: Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving pembrolizumab (see section 4.8).
Croatian: U bolesnika liječenih pembrolizumabom prijavljeni su slučajevi Stevens-Johnsonova sindroma (SJS) i toksične epidermalne nekrolize (TEN) (vidjeti dio 4.8).
English: Uncommon adrenal insufficiency hypophysitis d, thyroiditis hypophysitis d,
Croatian: Manje često insuficijencija nadbubrežnih žlijezda hipofizitis d, tireoiditis e,
English: Duration of Response Number of responders Median in months (range)
Croatian: Trajanje odgovora Broj bolesnika s odgovorom Medijan u mjesecima (raspon)
English: It is unknown whether pembrolizumab is secreted in human milk.
Croatian: Nije poznato izlučuje li se pembrolizumab u majčino mlijeko.
English: • a kind of head and neck cancer called head and neck squamous cell carcinoma
Croatian: • jedne vrste raka glave i vrata koji se zove karcinom skvamoznih stanica glave i vrata
English: Table 4: Efficacy results in KEYNOTE-002
Croatian: Tablica 4: Rezultati za djelotvornost u ispitivanju KEYNOTE-002
English: KEYNOTE-045: Controlled trial in urothelial carcinoma patients who have received prior platinumcontaining chemotherapy
Croatian: KEYNOTE-045: Kontrolirano ispitivanje u bolesnika s urotelnim karcinomom koji su prethodno primali kemoterapiju koja je sadržavala platinu
English: • Cetuximab 400 mg/m 2 load then 250 mg/m 2 once weekly, carboplatin AUC 5 mg/mL/min every 3 weeks or cisplatin 100 mg/m 2 every 3 weeks, and 5-FU 1,000 mg/m 2/d 4 days continuous every 3 weeks (maximum of 6 cycles of platinum and 5-FU)
Croatian: • KEYTRUDA 200 mg svaka 3 tjedna, karboplatin AUC 5 mg/ml/min svaka 3 tjedna ili cisplatin 100 mg/m2 svaka 3 tjedna te 5-FU 1000 mg/m2 na dan tijekom 4 uzastopna dana svaka 3 tjedna (najviše 6 ciklusa platine i 5-FU)
English: • Equilibrate the vial to room temperature (at or below 25°C).
Croatian: • Pričekajte da se bočica ugrije na sobnu temperaturu (25°C ili manje).
English: Consider the benefit of treatment with pembrolizumab versus the risk of possible GVHD in patients with a history of allogeneic HSCT.
Croatian: U bolesnika s alogenim HSCT-om u anamnezi treba razmotriti koristi liječenja pembrolizumabom naspram rizika od mogućeg GVHD-a.
English: An analysis was performed in KEYNOTE-407 in patients who had PD-L1 TPS < 1% [pembrolizumab plus chemotherapy arm: n=95 (34%) vs. placebo plus chemotherapy arm: n=99 (35%)], TPS 1% to 49% [pembrolizumab plus chemotherapy arm: n=103 (37%) vs. placebo plus chemotherapy arm: n=104 (37%)] or TPS ≥ 50% [pembrolizumab plus chemotherapy arm: n=73 (26%) vs. placebo plus chemotherapy arm: n=73 (26%)] (see Table 16).
Croatian: U ispitivanju KEYNOTE-407 provedena je analiza u bolesnika koji su imali PD-L1 TPS < 1% (skupina koja je primala pembrolizumab plus kemoterapiju: n=95 [34%] naspram skupine koja je primala placebo plus kemoterapiju: n=99 [35%]), TPS 1% - 49% (skupina koja je primala pembrolizumab plus kemoterapiju: n=103 [37%] naspram skupine koja je primala placebo plus kemoterapiju: n=104 [37%]) ili TPS ≥ 50% (skupina koja je primala pembrolizumab plus kemoterapiju: n=73 [26%] naspram skupine koja je primala placebo plus kemoterapiju: n=73 [26%]) (vidjeti Tablicu 16).
English: Colitis led to discontinuation of pembrolizumab in 29 (0.5%) patients.
Croatian: Kolitis je doveo do prekida liječenja pembrolizumabom u 29 (0,5%) bolesnika.
English: Table 21: Response to pembrolizumab 200 mg every 3 weeks in patients with urothelial carcinoma ineligible for cisplatin-containing chemotherapy in KEYNOTE-052
Croatian: Tablica 21: Odgovor na pembrolizumab u dozi od 200 mg svaka 3 tjedna u bolesnika s urotelnim karcinomom koji nisu bili pogodni za kemoterapiju koja sadrži cisplatin u ispitivanju KEYNOTE-052
English: Assessment of tumour status was performed at Week 6 and Week 12, followed by every 9 weeks thereafter.
Croatian: Ocjena statusa tumora provedena je u 6. tjednu i 12. tjednu, a zatim se provodila svakih 9 tjedana.
English: Hyperthyroidism occurred in 244 (4.1%) patients, including Grade 2 or 3 cases in 64 (1.1%) and 7 (0.1%) patients, respectively, receiving pembrolizumab.
Croatian: Hipertireoza se javila u 244 (4,1%) bolesnika liječena pembrolizumabom, uključujući slučajeve 2. stupnja u 64 (1,1%) bolesnika i slučajeve 3. stupnja u 7 (0,1%) bolesnika.
English: Table 5: Efficacy results in KEYNOTE-001
Croatian: Tablica 5: Rezultati za djelotvornost u ispitivanju KEYNOTE-001
English: 129 patients included: median age 62 years (40% age 65 or older); 81% male; 78% White, 11% Asian, and 2% Black; 23% and 77% with an ECOG performance status 0 or 1, respectively; and 19% with HPV positive tumours.
Croatian: 129 bolesnika bile su sljedeće: medijan dobi 62 godine (40% bilo je u dobi od 65 ili više godina); 81% muškaraca; 78% bijelaca, 11% azijata te 2% bolesnika crne rase; 23% s funkcionalnim ECOG statusom 0, odnosno 77% s funkcionalnim ECOG statusom 1; te 19% s HPV pozitivnim tumorima.
English: Pembrolizumab 2mg/kg every 3 weeks (n=44)
Croatian: Pembrolizumab 2 mg/kg svaka 3 tjedna (n=44)
English: An HR=0.96 [95% CI 0.37,2.52] in OS, an HR=0.60 [95% CI 0.29,1.21] in PFS, and an ORR of 47% and 42% for pembrolizumab combination vs chemotherapy was reported within this study subgroup.
Croatian: 2,52) za OS, omjer hazarda=0,60 (95% CI 0,29; 1,21) za PFS te ORR od 47% i 42% za pembrolizumab u kombiniranoj terapiji naspramodnosno kemoterapije.
English: Use of pembrolizumab in combination with axitinib for first-line treatment of patients with RCC When pembrolizumab is given with axitinib, higher than expected frequencies of Grades 3 and 4 ALT and AST elevations have been reported in patients with advanced RCC (see section 4.8).
Croatian: Primjena pembrolizumaba u kombinaciji s aksitinibom za prvu liniju liječenja bolesnika s RCC-om Kad se pembrolizumab primjenjivao u kombinaciji s aksitinibom, prijavljena učestalost povišenja vrijednosti ALT-a i AST-a 3. i 4. stupnja u bolesnika s RCC-om bila je viša od očekivane (vidjeti dio 4.8).
English: PFS HR (95% CI)
Croatian: HR za PFS (95% CI)
English: In patients treated with pembrolizumab monotherapy, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 10.9% for lymphocytes decreased, 8.2% for sodium decreased, 6.3% for haemoglobin decreased, 5.2% for phosphate decreased, 4.8% for glucose increased, 2.8% for AST increased, 2.7% for alkaline phosphatase increased, 2.7% for ALT increased, 2.2% for potassium decreased, 1.8% for calcium increased, 1.8% for neutrophils decreased, 1.8% for potassium increased, 1.7% for bilirubin increased, 1.7% for platelets decreased, 1.6% for albumin decreased, 1.5% for calcium decreased, 1.3% for creatinine increased, 0.8% for leucocytes decreased, 0.7% for magnesium increased, 0.6% for glucose decreased, 0.2% for magnesium decreased, and 0.2% for sodium increased.
Croatian: Udio bolesnika liječenih monoterapijom pembrolizumabom u kojih je zabilježeno odstupanje vrijednosti laboratorijskih parametara 3. ili 4. stupnja u odnosu na početnu vrijednost bio je sljedeći: 10,9% za smanjen broj limfocita, 8,2% za snižene vrijednosti natrija, 6,3% za snižene vrijednosti hemoglobina, 5,2% za snižene vrijednosti fosfata, 4,8% za povišene vrijednosti glukoze, 2,8% za povišene vrijednosti AST-a, 2,7% za povišene vrijednosti alkalne fosfataze, 2,7% za povišene vrijednosti ALT-a, 2,2% za snižene vrijednosti kalija, 1,8% za povišene vrijednosti kalcija, 1,8% za smanjen broj neutrofila, 1,8% za povišene vrijednosti kalija, 1,7% za povišene vrijednosti bilirubina, 1,7% za smanjen broj trombocita, 1,6% za snižene vrijednosti albumina, 1,5% za snižene vrijednosti kalcija, 1,3% za povišene vrijednosti kreatinina, 0,8% za smanjen broj leukocita, 0,7% za povišene vrijednosti magnezija, 0,6% za snižene vrijednosti glukoze, 0,2% za snižene vrijednosti magnezija te 0,2% za povišene vrijednosti natrija.
English: These reactions are presented by system organ class and by frequency.
Croatian: Te se nuspojave navode prema klasifikaciji organskih sustava i učestalosti.
English: Treatment could continue beyond disease progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator.
Croatian: Liječenje se moglo nastaviti i nakon progresije bolesti ako je bolesnik bio klinički stabilan i ako je prema ocjeni ispitivača ostvarivao kliničku korist.
English: Endpoint n=370
Croatian: Mjera ishoda n=370