FrancophonIA/ELRC3.0 huggingface dataset:
English: Study CA209069 was a randomised, Phase 2, double-blind study comparing the combination of nivolumab and ipilimumab with ipilimumab alone in 142 patients with advanced (unresectable or metastatic) melanoma with similar inclusion criteria to study CA209067 and the primary analysis in patients with BRAF wild-type melanoma (77% of patients).
Croatian: Ispitivanje CA209069 bilo je randomizirano, dvostruko slijepo ispitivanje faze 2 u kojem se kombinacija nivolumaba i ipilimumaba uspoređivala s monoterapijom ipilimumabom u 142 bolesnika s uznapredovalim (neresektabilnim ili metastatskim) melanomom.
English: Figure 3: Progression-free survival by PD-L1 expression: 5% cut off (CA209067)
Croatian: Preživljenje bez progresije bolesti prema ekspresiji PD-L1: granična vrijednost od 5% (CA209067)
English: Figure 4: Progression-free survival by PD-L1 expression: 1% cut off (CA209067)
Croatian: Preživljenje bez progresije bolesti prema ekspresiji PD-L1: granična vrijednost od 1% (CA209067)
English: Efficacy results are shown in Table 16.
Croatian: Rezultati za djelotvornost prikazani su u Tablici 16.
English: * nivolumab in combination with ipilimumab for the first 4 doses then followed by nivolumab monotherapy in melanoma.
Croatian: * Kod melanoma, nivolumab u kombinaciji s ipilimumabom kod prve 4 doze, a nakon toga monoterapija nivolumabom.
English: Baseline ECOG performance status was 0 (54%) or 1 (46%).
Croatian: Funkcionalni ECOG status na početku ispitivanja iznosio je 0 (54%) ili 1 (46%).
English: The median age was 62 years (range: 18-88) with 40% ≥ 65 years of age and 9% ≥ 75 years of age.
Croatian: Medijan dobi iznosio je 62 godine (raspon: 18-88), uz 40% bolesnika u dobi od ≥ 65 godina i 9% u dobi od ≥ 75 godina.
English: There was a dosedependent increase in foetal losses and increased neonatal mortality beginning in the third trimester.
Croatian: Od trećeg je tromjesečja primijećeno o dozi ovisno povećanje gubitka plodova te povećana neonatalna smrtnost.
English: The majority of cases were Grade 1 or 2 in severity reported in 4.2% (107/2578) and 5.4% (139/2578) of patients, respectively.
Croatian: Većina slučajeva bila je 1. ili 2. stupnja težine, a prijavljeni su u 4,2% (107/2578) odnosno 5,4% (139/2578) bolesnika.
English: Median time to onset was 3.6 months (range: 0.2-19.6).
Croatian: Medijan vremena do nastupa iznosio je 3,6 mjeseci (raspon: 0,2-19,6).
English: Data from SCCHN and adjuvant melanoma patients 75 years of age or older are too limited to draw conclusions on this population (see section 5.1).
Croatian: Podaci o primjeni u bolesnika s SCCHN-om te adjuvantno liječenih bolesnika s melanomom u dobi od 75 ili više godina preoskudni su da bi se na temelju njih donijeli zaključci o primjeni u toj populaciji (vidjeti dio 5.1).
English: Median time to onset was 1.5 months (range: 0.0-30.1).
Croatian: Medijan vremena do nastupa iznosio je 1,5 mjeseci (raspon: 0,0-30,1).
English: Grade 2 and Grade 3 thyroid disorders were reported in 15.7% (86/547) and 1.3% (7/547) of patients, respectively.
Croatian: Poremećaji štitnjače 2. stupnja prijavljeni su u 15,7% (86/547) bolesnika, a poremećaji štitnjače 3. stupnja u 1,3% (7/547) bolesnika.
English: Median time to onset was 0.5 months (range: 0.0-19.4).
Croatian: Medijan vremena do nastupa iznosio je 0,5 mjeseci (raspon: 0,0-19,4).
English: One vial of 4 mL contains 40 mg of nivolumab.
Croatian: Jedna bočica od 4 ml sadrži 40 mg nivolumaba.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each mL of concentrate contains 10 mg of nivolumab.
Croatian: 2. NAVOĐENJE DJELATNE(IH) TVARI Jedan ml koncentrata sadrži 10 mg nivolumaba.
English: In the pooled dataset of nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma (n = 448) with minimum follow-up ranging from 6 to 28 months, the most frequent adverse reactions (≥ 10%) were rash (52%), fatigue (46%), diarrhoea (43%), pruritus (36%), nausea (26%), pyrexia (19%), decreased appetite (16%), hypothyroidism (16%), colitis (15%), vomiting (14%), arthralgia (13%), abdominal pain (13%), headache (11%), and dyspnoea (10%).
Croatian: U objedinjenom skupu podataka iz ispitivanja nivolumaba u dozi od 1 mg/kg u kombinaciji s ipilimumabom u dozi od 3 mg/kg kod melanoma (n = 448), uz minimalno praćenje u rasponu od 6 do 28 mjeseci, najčešće nuspojave (≥ 10%) bile su osip (52%), umor (46%), proljev (43%), svrbež (36%), mučnina (26%), pireksija (19%), smanjen tek (16%), hipotireoza (16%), kolitis (15%), povraćanje (14%), artralgija (13%), bol u abdomenu (13%), glavobolja (11%) i dispneja (10%).
English: Median time to response Months (range)
Croatian: Medijan vremena do odgovora Mjeseci (raspon)
English: Patients with any history of or concurrent brain metastases, prior treatment with an mammalian target of rapamycin (mTOR) inhibitor, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the study.
Croatian: U ispitivanje nisu bili uključeni bolesnici s prethodnim ili postojećim metastazama u mozgu, bolesnici koji su prethodno bili liječeni inhibitorom ciljne molekule rapamicina u sisavaca (engl. mammalian target of rapamycin, mTOR) ni bolesnici s aktivnom autoimunom bolešću ili medicinskim stanjima koja zahtijevaju liječenje sistemskim imunosupresivima.
English: In the dataset of nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC (n = 547), with a minimum follow-up of 17.5 months, the most frequent adverse reactions (≥ 10%) were fatigue (48%), rash (34%), pruritus (28%), diarrhoea (27%), nausea (20%), hypothyroidism (16%), musculoskeletal pain (15%), arthralgia (14%), decreased appetite (14%), pyrexia (14%), vomiting (11%), hyperthyroidism (11%).
Croatian: U skupu podataka iz ispitivanja nivolumaba u dozi od 3 mg/kg u kombinaciji s ipilimumabom u dozi od 1 mg/kg kod RCC-a (n = 547), uz minimalno praćenje od 17,5 mjeseci, najčešće nuspojave (≥ 10%) bile su umor (48%), osip (34%), svrbež (28%), proljev (27%), mučnina (20%), hipotireoza (16%), mišićno-koštana bol (15%), artralgija (14%), smanjen tek (14%), pireksija (14%), povraćanje (11%) i hipertireoza (11%).
English: Randomised phase 3 study of nivolumab in combination with ipilimumab or nivolumab as monotherapy vs. ipilimumab as monotherapy (CA209067)
Croatian: Randomizirano ispitivanje faze 3 nivolumaba u kombinaciji s ipilimumabom ili nivolumaba u monoterapiji naspram monoterapije ipilimumabom (CA209067)
English: Grade 2, Grade 3, and Grade 4 cases were reported in 4.4% (24/547), 0.7% (4/547), and 0.5% (3/547) of patients, respectively.
Croatian: Slučajevi 2. stupnja prijavljeni su u 4,4% (24/547) bolesnika, slučajevi 3. stupnja u 0,7% (4/547) bolesnika, a slučajevi 4. stupnja u 0,5% (3/547) bolesnika.
English: This is then followed by a second phase in which nivolumab monotherapy is administered intravenously at either 240 mg every 2 weeks or at 480 mg every 4 weeks, as presented in Table 2.
Croatian: Nakon toga slijedi druga faza, u kojoj se nivolumab u monoterapiji primjenjuje intravenski u dozi od 240 mg svaka 2 tjedna ili u dozi od 480 mg svaka 4 tjedna, kako je navedeno u Tablici 2.
English: For ease of preparation, the concentrate can be transferred directly into a pre-filled bag containing the appropriate volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection.
Croatian: Za lakšu pripremu, koncentrat može biti direktno prenesen u vreću prethodno napunjenu prikladnim volumenom otopine natrijevog klorida za injekciju od 9 mg/ml (0,9%) ili otopine glukoze za injekciju od 50 mg/mL
English: NR (32.72, NR) NR (39.06, NR)
Croatian: NP (32,72; NP) NP (39,06; NP)
English: If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 1 to 2 mg/kg/day methylprednisolone equivalents, and nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued.
Croatian: Ako unatoč uvođenju kortikosteroida nastupi pogoršanje ili izostane poboljšanje, dozu kortikosteroida treba povećati na dozu ekvivalentnu 1 do 2 mg/kg/dan metilprednizolona, a liječenje nivolumabom ili nivolumabom u kombinaciji s ipilimumabom mora se trajno prekinuti.
English: Median PFSa (months)
Croatian: Medijan OS-aa (mjeseci) Medijan PFS-aa (mjeseci)
English: PD-L1 expression ≥ 5%
Croatian: Ekspresija PD-L1 ≥ 5%
English: Table 16: Efficacy results (CA209057)
Croatian: Tablica 16: Rezultati za djelotvornost (CA209057)
English: Table 18: Efficacy results (CA209025)
Croatian: Tablica 18: Rezultati za djelotvornost (CA209025)
English: 0.5% with nivolumab 3 mg/kg and ipilimumab 1 mg/kg every 3 weeks and 4.6% with nivolumab 1 mg/kg and ipilimumab 3 mg/kg every 3 weeks.
Croatian: Incidencija neutralizirajućih protutijela na nivolumab iznosila je 0,5% uz nivolumab u dozi od 3 mg/kg i ipilimumab u dozi od 1 mg/kg svaka 3 tjedna te 4,6% uz nivolumab u dozi od 1 mg/kg i ipilimumab u dozi od 3 mg/kg svaka 3 tjedna.
English: Median time to onset was 2.6 months (range: 0.5-21.8).
Croatian: Medijan vremena do nastupa iznosio je 2,6 mjeseci (raspon: 0,5-21,8).
English: Preparation and administration of OPDIVO
Croatian: Priprema i primjena lijeka OPDIVO
English: If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 2 to 4 mg/kg/day methylprednisolone equivalents and nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued.
Croatian: Ako unatoč uvođenju kortikosteroida nastupi pogoršanje ili izostane poboljšanje, dozu kortikosteroida treba povećati na dozu ekvivalentnu 2 do 4 mg/kg/dan metilprednizolona, a liječenje nivolumabom ili nivolumabom u kombinaciji s ipilimumabom mora se trajno prekinuti.
English: Bristol-Myers Squibb GmbH & Co. KGaA Tel: 0800 0752002 (+49 (0)89 121 42-350)
Croatian: KGaA Tel: 0800 0752002 (+49 (0)89 121 42-350)
English: with Stage IIIB/C or Stage IV American Joint Committee on Cancer (AJCC), 7th edition, histologically confirmed melanoma that is completely surgically resected.
Croatian: U ispitivanje su bili uključeni odrasli bolesnici koji su imali funkcionalni ECOG status 0 ili 1 i histološki potvrđen melanom stadija IIIB/C ili stadija IV prema 7. izdanju klasifikacije Američkog udruženja za rak (AJCC), koji je bio potpuno reseciran.
English: Withhold dose(s) until symptoms resolve and management with corticosteroids, if needed, is complete
Croatian: Odgoditi primjenu doze(a) dok se simptomi ne povuku i dok se ne dovrši liječenje kortikosteroidima, ako je ono potrebno
English: Median time to onset was 2.0 months (range: 0.4-26.8).
Croatian: Medijan vremena do nastupa iznosio je 2,0 mjeseci (raspon: 0,4-26,8).
English: The safety and efficacy of nivolumab 3 mg/kg for the treatment of advanced (unresectable or metastatic) melanoma were evaluated in a phase 3, randomised, double-blind study (CA209066).
Croatian: Sigurnost i djelotvornost nivolumaba u dozi od 3 mg/kg za liječenje uznapredovalog (neresektabilnog ili metastatskog) melanoma ispitivane su u randomiziranom, dvostruko slijepom ispitivanju faze 3 (CA209066).
English: Resolution occurred in 132 patients (76.7%) with a median time to resolution of 5.9 weeks (range: 0.1-82.6+).
Croatian: Nuspojave su se povukle u 132 bolesnika (76,7%), a medijan vremena do njihova povlačenja iznosio je 5,9 tjedana (raspon: 0,1-82,6+).
English: The Kaplan-Meier curves for OS are shown in Figure 8.
Croatian: Kaplan-Meierove krivulje za OS prikazane su na Slici 8.
English: Baseline ECOG performance status was 0 (31%) or 1 (69%).
Croatian: Početni funkcionalni ECOG status iznosio je 0 (31%) ili 1 (69%).
English: The OS HRs for nivolumab vs. chemotherapy were 1.32 (95% CI: 0.75, 2.32) for BRAF mutation-positive patients and 0.83 (95% CI: 0.62, 1.11) for BRAF wild-type patients.
Croatian: Omjer hazarda za OS uz nivolumab u odnosu na kemoterapiju iznosio je 1,32 (95% CI: 0,75; 2,32) u bolesnika pozitivnih na mutaciju gena BRAF te 0,83 (95% CI: 0,62; 1,11) u bolesnika s divljim tipom gena BRAF.
English: Diabetes mellitus including Type 1 diabetes mellitus (3 Grade 2, 2 Grade 3, and 3
Croatian: Prijavljen je dijabetes mellitus, uključujući dijabetes tipa 1 (3 slučaja 2. stupnja, 2 slučaja 3. stupnja i 3 slučaja 4. stupnja), kao i dijabetička ketoacidoza (1 slučaj 4. stupnja).
English: After 28 months of follow-up, median durations of response for patients with tumour PD-L1 expression level ≥5% were not reached (range: 0+-31.6+) in the combination arm, not reached (range: 2.8-30.6+) in the nivolumab monotherapy arm and not reached (range: 1.4-30.6+) in the ipilimumab arm. At tumour PD-L1 expression <5%, median durations of response were not reached (range: 0+-33.3+) in the combination arm, not reached (range: 0+-32.3+) in the nivolumab monotherapy arm and 18.2 months (range: 0.0+-31.5+) in the ipilimumab monotherapy arm.
Croatian: Nakon 28 mjeseci praćenja, medijan trajanja odgovora u bolesnika s razinom tumorske ekspresije PD-L1 ≥ 5% nije postignut u skupini liječenoj kombiniranom terapijom (raspon: 0+-31,6+), kao ni u skupini liječenoj monoterapijom nivolumabom (raspon: 2,8-30,6+) te skupini liječenoj monoterapijom ipilimumabom (raspon: 1,4-30,6+).
English: Tumour assessments, according to the RECIST, version 1.1, were conducted 9 weeks after randomisation and continued every 6 weeks thereafter.
Croatian: Procjene tumora prema verziji 1.1 RECIST kriterija provodile su se 9 tjedana nakon randomizacije te svakih 6 tjedana nakon toga.
English: Median time to onset was 2.3 months (range: 0.0-18.2).
Croatian: Medijan vremena do nastupa iznosio je 2,3 mjeseca (raspon: 0,0-18,2).
English: Single-arm phase 2 study (CA209171)
Croatian: Ispitivanje faze 2 sa samo jednom skupinom (CA209171)
English: Nivolumab+Ipilimumab (events: 111/210), median and 95% CI: 11.10 (7.98, 22.18) ──Δ─── Nivolumab (events: 125/208), median and 95% CI: 5.32 (2.83, 7.06) Ipilimumab (events: 159/202), median and 95% CI: 2.83 (2.76, 3.09)
Croatian: Nivolumab + ipilimumab (događaji: 111/210), medijan i 95% CI: 11,10 (7,98; 22,18) ──Δ─── Nivolumab (događaji: 125/208), medijan i 95% CI: 5,32 (2,83; 7,06) Ipilimumab (događaji: 159/202), medijan i 95% CI: 2,83 (2,76; 3,09)
English: Post-marketing event (also see section 4.4)
Croatian: h Događaj zabilježen nakon stavljanja lijeka u promet (vidjeti i dio 4.4). i
English: The recommended dose is 1 mg/kg nivolumab in combination with 3 mg/kg ipilimumab administered intravenously every 3 weeks for the first 4 doses.
Croatian: Preporučena doza nivolumaba iznosi 1 mg/kg u kombinaciji s ipilimumabom u dozi od 3 mg/kg, a primjenjuje se intravenski svaka 3 tjedna kod prve 4 doze.
English: Grade 2 and Grade 3 cases were reported in 5.1% (131/2578) and 1.2% (31/2578) of patients respectively.
Croatian: Slučajevi 2. stupnja prijavljeni su u 5,1% (131/2578) bolesnika, a slučajevi 3. stupnja u 1,2% (31/2578) bolesnika.
English: PD-L1 expression ≥ 1%
Croatian: Ekspresija PD-L1 ≥ 1%
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of diarrhoea or colitis was 46.7% (209/448).
Croatian: U bolesnika s melanomom liječenih nivolumabom u dozi od 1 mg/kg u kombinaciji s ipilimumabom u dozi od 3 mg/kg, incidencija proljeva ili kolitisa iznosila je 46,7% (209/448).
English: Grade 3 diarrhoea or colitis observed with nivolumab in combination with ipilimumab requires permanent discontinuation of treatment and initiation of corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Croatian: Proljev ili kolitis 3. stupnja primijećeni kod liječenja nivolumabom u kombinaciji s ipilimumabom zahtijeva trajan prekid liječenja i uvođenje kortikosteroida u dozi ekvivalentnoj 1 do 2 mg/kg/dan metilprednizolona.
English: In intermediate/poor-risk patients, OS benefit was observed in the nivolumab in combination with ipilimumab arm vs. sunitinib regardless of tumour PD-L1 expression.
Croatian: U bolesnika s umjerenim/visokim rizikom su kod primjene nivolumaba u kombinaciji s ipilimumabom u odnosu na sunitinib opaženi korisni učinci na OS neovisno o razini tumorske ekspresije PD-L1.
English: A total of 582 patients were randomised to receive either nivolumab 3 mg/kg administered intravenously over 60 minutes every 2 weeks (n = 292) or docetaxel 75 mg/m2 every 3 weeks
Croatian: Ukupno su 582 bolesnika bila randomizirana za primanje ili nivolumaba u dozi od 3 mg/kg primijenjenog intravenski tijekom 60 minuta svaka 2 tjedna (n = 292) ili docetaksela u dozi od 75 mg/m2 svaka 3 tjedna (n = 290).
English: Secondary efficacy assessments included investigator-assessed ORR and PFS.
Croatian: Sekundarne mjere ishoda za djelotvornost uključivale su ORR i PFS prema ocjeni ispitivača.
English: A total of 272 patients were randomised to receive either nivolumab 3 mg/kg (n = 135) administered intravenously over 60 minutes every 2 weeks or docetaxel (n = 137) 75 mg/m2 every 3 weeks.
Croatian: Ukupno su 272 bolesnika bila randomizirana u skupine koje su primale ili nivolumab u dozi od 3 mg/kg (n = 135), primijenjen intravenski tijekom 60 minuta svaka 2 tjedna, ili docetaksel (n = 137) u dozi od 75 mg/m2 svaka 3 tjedna.
English: Median time to onset of these endocrinopathies was 1.9 months (range: 0.0-22.3).
Croatian: Medijan vremena do nastupa tih endokrinopatija iznosio je 1,9 mjeseci (raspon: 0,0-22,3).
English: Randomised phase 3 study vs. docetaxel (CA209057)
Croatian: Randomizirano ispitivanje faze 3 naspram docetaksela (CA209057)
English: Grade 2, Grade 3, and Grade 4 cases were reported in 0.5% (3/547), 2.4% (13/547), and 0.4% (2/547) of patients, respectively.
Croatian: Slučajevi 2. stupnja prijavljeni su u 0,5% (3/547) bolesnika, slučajevi 3. stupnja u 2,4% (13/547) bolesnika, a slučajevi 4. stupnja u 0,4% (2/547) bolesnika.
English: The recommended dose is 3 mg/kg nivolumab in combination with 1 mg/kg ipilimumab administered intravenously every 3 weeks for the first 4 doses.
Croatian: Preporučena doza nivolumaba iznosi 3 mg/kg u kombinaciji s ipilimumabom u dozi od 1 mg/kg, a primjenjuje se intravenski svaka 3 tjedna kod prve 4 doze.
English: Common hypothyroidism, hyperthyroidism
Croatian: Endokrini poremećaji Često hipotireoza, hipertireoza
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of pneumonitis including interstitial lung disease, was 7.8% (35/448).
Croatian: U bolesnika s melanomom liječenih nivolumabom u dozi od 1 mg/kg u kombinaciji s ipilimumabom u dozi od 3 mg/kg, incidencija pneumonitisa, uključujući intersticijsku bolest pluća, iznosila je 7,8% (35/448).
English: Grade 5 cases were reported in < 0.1% (2/2578) of patients in these studies.
Croatian: U tim su ispitivanjima slučajevi 5. stupnja prijavljeni u < 0,1% (2/2578) bolesnika.
English: Hazard ratio 98.52% CI p-value
Croatian: Ukupno preživljenje Događaji Omjer hazarda 98,52% CI p-vrijednost
English: The safety and efficacy of nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg for the treatment of advanced/metastatic RCC was evaluated in a phase 3, randomised, open-label study (CA209214).
Croatian: Sigurnost i djelotvornost nivolumaba u dozi od 3 mg/kg u kombinaciji s ipilimumabom u dozi od 1 mg/kg za liječenje uznapredovalog/metastatskog RCC-a ispitivane su u randomiziranom, otvorenom ispitivanju faze 3 (CA209214).
English: Progression-free survival Median (95% CI) months Rate (95% CI) at 6 months
Croatian: Preživljenje bez progresije bolesti Medijan (95% CI) (mjeseci) Stopa (95% CI) nakon 6 mjeseci
English: OPDIVO concentrate may be diluted with either: sodium chloride 9 mg/mL (0.9%) solution for injection; or 50 mg/mL (5%) glucose solution for injection.
Croatian: Koncentrat lijeka OPDIVO može se razrijediti: otopinom natrijeva klorida za injekciju od 9 mg/ml (0,9%); ili otopinom glukoze za injekciju od 50 mg/ml (5%)
English: Single-arm phase 2 study (CA209063)
Croatian: Ispitivanje faze 2 sa samo jednom skupinom (CA209063)
English: OS may be confounded by dropout, imbalance of subsequent therapies and differences in baseline factors.
Croatian: Ometajući faktori kod analize OS-a mogu biti slučajevi koji su ispali iz liječenja, (engl. dropout), neusklađenost kasnijih terapija i razlike u početnim značajkama.
English: Among patients with quantifiable tumour PD-L1 expression, the distribution of patients was balanced across the treatment groups.
Croatian: Bolesnici s mjerljivom tumorskom ekspresijom PD-L1 bili su ravnomjerno raspodijeljeni u obje liječene skupine.
English: The median age was 66 years (range: 38 to 90) with 55% ≥65 years of age and 14% ≥75 years of age.
Croatian: Medijan dobi iznosio je 66 godina (raspon: 38 - 90), uz 55% bolesnika u dobi od ≥ 65 godina i 14% u dobi od ≥ 75 godina.
English: The PFS HRs for nivolumab vs. chemotherapy were 1.58 (95% CI: 0.87, 2.87) for BRAF mutationpositive patients and 0.82 (95% CI: 0.60, 1.12) for BRAF wild-type patients.
Croatian: Omjer hazarda za PFS uz nivolumab u odnosu na kemoterapiju iznosio je 1,58 (95% CI: 0,87; 2,87) u bolesnika pozitivnih na mutaciju gena BRAF te 0,82 (95% CI: 0,60; 1,12) u bolesnika s divljim tipom gena BRAF.
English: Grade 3 rash
Croatian: Osip 3. stupnja
English: Nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued for life-threatening diabetes.
Croatian: Liječenje nivolumabom ili nivolumabom u kombinaciji s ipilimumabom mora se trajno prekinuti u slučaju po život opasnog dijabetesa.
English: Allergic reaction, reactions related to the infusion of the medicine Underactive thyroid gland (which can cause tiredness or weight gain), overactive thyroid gland (which can cause rapid heart rate, sweating and weight loss) Decreased appetite
Croatian: Česte (mogu se javiti u do 1 na 10 osoba) infekcije gornjih dišnih putova alergijska reakcija, reakcije povezane s infuzijom lijeka smanjena aktivnost štitnjače (koja može izazvati umor ili povećanje tjelesne težine), pojačana aktivnost štitnjače (koja može uzrokovati ubrzani puls, znojenje i gubitak tjelesne težine)
English: For symptomatic Grade 2 or 3 hypophysitis, nivolumab or nivolumab in combination with ipilimumab should be withheld, and hormone replacement should be initiated as needed.
Croatian: U slučaju simptomatskog hipofizitisa 2. ili 3. stupnja, potrebno je odgoditi primjenu nivolumaba ili nivolumaba u kombinaciji s ipilimumabom i po potrebi uvesti hormonsku nadomjesnu terapiju.
English: Severe infusion reactions have been reported in clinical trials of nivolumab or nivolumab in combination with ipilimumab (see section 4.8).
Croatian: U kliničkim ispitivanjima nivolumaba ili nivolumaba u kombinaciji s ipilimumabom prijavljene su teške reakcije na infuziju (vidjeti dio 4.8).
English: Hazard ratioa 99.1% CI p-valueb,h Median (95% CI)
Croatian: Ukupno preživljenje Događaji Omjer hazardaa 99,8% CI p-vrijednostb, c Medijan (95% CI)
English: Head and Neck Cancer
Croatian: Rak glave i vrata
English: OS benefit was observed regardless of HPV status (HPV-positive: HR = 0.63; 95% CI: 0.38, 1.04, HPV-negative: HR = 0.64; 95% CI: 0.40, 1.03, and HPV-unknown: HR = 0.78; 95% CI: 0.55, 1.10).
Croatian: HR = 0,64; 95% CI: 0,40; 1,03; i HPV status nepoznat: HR = 0,78; 95% CI: 0,55; 1,10).
English: Nivolumab+ipilimumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.42 (0.32, 0.56); p-value: < 0.0001 Nivolumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.55 (0.42, 0.73); p-value: < 0.0001
Croatian: Nivolumab naspram ipilimumaba (primarna analiza) - HR (99,5% CI): 0,55 (0,42; 0,73); p-vrijednost: < 0,0001 Nivolumab + ipilimumab naspram nivolumaba (opisna analiza) - HR (95% CI): 0,76 (0,62; 0,95)
English: The majority of cases were Grade 1 or 2 in severity reported in 8.5% (220/2578) and 3.0% (78/2578) of patients respectively.
Croatian: Većina slučajeva bila je 1. ili 2. stupnja težine, a prijavljeni su u 8,5% (220/2578) odnosno 3,0% (78/2578) bolesnika.