FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of nephritis or renal dysfunction was 8.8% (48/547).
Croatian: U bolesnika s RCC-om liječenih nivolumabom u dozi od 3 mg/kg u kombinaciji s ipilimumabom u dozi od 1 mg/kg, incidencija nefritisa ili bubrežne disfunkcije iznosila je 8,8% (48/547).
English: The Kaplan-Meier curves for OS are shown in Figure 10.
Croatian: Kaplan-Meierove krivulje za OS prikazane su na Slici 10.
English: The prescribed dose for the patient is 240 mg or 480 mg given regardless of body weight depending on indication.
Croatian: Nivolumab u monoterapiji: Propisana doza za bolesnika ovisi o indikaciji, a iznosi 240 mg ili 480 mg, neovisno o tjelesnoj težini.
English: Median time to onset was 1.4 months (range: 0.027.9).
Croatian: Medijan vremena do nastupa iznosio je 1,4 mjeseca (raspon: 0,0-27,9).
English: or after diluting according to the following instructions: the final infusion concentration should range between 1 and 10 mg/mL.
Croatian: Konačna koncentracija infuzije mora biti u rasponu od 1 do 10 mg/ml.
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the proportion of patients who experienced a worsening from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 2.8% for anaemia (all Grade 3), 1.2% for thrombocytopaenia, 0.5% for leucopoenia, 6.7% for lymphopaenia, 0.7% for neutropaenia, 4.3% for increased alkaline phosphatase, 12.4% for increased AST, 15.3% for increased ALT, 1.2% for increased total bilirubin, 2.4% for increased creatinine, 5.3% for hyperglycaemia, 8.7% for increased amylase, 19.5% for increased lipase, 1.2% for hypocalcaemia, 0.2% each for hypernatraemia and hypercalcaemia, 0.5% for hyperkalemia, 0.3% for hypermagnesaemia, 4.8% for hypokalaemia, and 9.5% for hyponatraemia.
Croatian: U bolesnika s melanomom liječenih nivolumabom u dozi od 1 mg/kg u kombinaciji s ipilimumabom u dozi od 3 mg/kg, udio bolesnika kod kojih je došlo do pogoršanja početnih laboratorijskih vrijednosti do 3. ili 4. stupnja bio je sljedeći: 2,8% za anemiju (svi slučajevi bili su 3. stupnja), 1,2% za trombocitopeniju, 0,5% za leukopeniju, 6,7% za limfopeniju, 0,7% za neutropeniju, 4,3% za povišene razine alkalne fosfataze, 12,4% za povišene razine AST-a, 15,3% za povišene razine ALT-a, 1,2% za povišene razine ukupnog bilirubina, 2,4% za povišene razine kreatinina, 5,3% za hiperglikemiju, 8,7% za povišene razine amilaze, 19,5% za povišene razine lipaze, 1,2% za hipokalcijemiju, 0,2% za hipernatrijemiju i hiperkalcijemiju, 0,5% za hiperkalijemiju, 0,3% za hipermagnezijemiju, 4,8% za hipokalijemiju i 9,5% za hiponatrijemiju.
English: Renal Cell Carcinoma
Croatian: Karcinom bubrežnih stanica
English: Symptomatic Grade 2 or 3 hypothyroidism, hyperthyroidism, hypophysitis,
Croatian: Simptomatska hipotireoza, hipertireoza, hipofizitis 2. ili 3. stupnja Insuficijencija nadbubrežne žlijezde 2. stupnja
English: Confirmed objective response (95% CI) Odds ratio (95% CI) p-value
Croatian: Potvrđen objektivan odgovor (95% CI) Omjer izgleda (95% CI) p-vrijednost
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of patients with completely resected melanoma were evaluated in a phase 3, randomised, double-blind study (CA209238).
Croatian: Sigurnost i djelotvornost monoterapije nivolumabom u dozi od 3 mg/kg za liječenje bolesnika nakon potpune resekcije melanoma ispitivane su u randomiziranom, dvostruko slijepom ispitivanju faze 3 (CA209238).
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of nephritis or renal dysfunction was 5.1% (23/448).
Croatian: U bolesnika s melanomom liječenih nivolumabom u dozi od 1 mg/kg u kombinaciji s ipilimumabom u dozi od 3 mg/kg, incidencija nefritisa ili bubrežne disfunkcije iznosila je 5,1% (23/448).
English: Progression-free survival Rate (95% CI) at 60 months
Croatian: Preživljenje bez progresije bolesti Stopa (95% CI) nakon 60 mjeseci
English: Median time to onset was 2.1 months (range: 0.0-16.1).
Croatian: Medijan vremena do nastupa iznosio je 2,1 mjesec (raspon: 0,0-16,1).
English: At the time of this analysis, the hazard ratio was 0.66; (99.8% CI 0.48-0.91) with 166/425 events in the combination arm and 209/422 events in the sunitinib arm. At 18 months, the OS rate was 74.3 (95% CI 69.8-78.2) for nivolumab in combination with ipilimumab and 59.9 (95% CI 54.9-64.5) for sunitinib.
Croatian: U trenutku provedbe te analize omjer hazarda iznosio je 0,66 (99,8% CI: 0,48-0,91), uz 166/425 događaja u skupini liječenoj kombiniranom terapijom i 209/422 događaja u skupini liječenoj sunitinibom.
English: 8.7,22.2%), a median OS of 8.21 months (95% CI: 6.05,10.9), and a median PFS of 1.87 months (95% CI 1.77,3.15).
Croatian: Nivolumab u dozi od 3 mg/kg ostvario je stopu ukupnog odgovora (engl. overall response rate, ORR) od 14,5% (95% CI: 8,7-22,2%), medijan OS-a od 8,21 mjeseca (95% CI: 6,05-10,9) i medijan PFS-a od 1,87 mjeseci (95% CI: 1,77-3,15).
English: Median time to onset was 1.2 months (range: 0.0-24.7).
Croatian: Medijan vremena do nastupa iznosio je 1,2 mjeseca (raspon: 0,0-24,7).
English: Signs and symptoms may include muscle pain, stiffness, weakness, chest pain, or severe fatigue.
Croatian: Znakovi i simptomi mogu uključivati bol, ukočenost i slabost mišića, bol u prsnom košu ili jak umor. odbacivanje presađenog solidnog organa (unutarnjeg organa čvrste građe). reakcija presatka protiv primatelja
English: Median (95% CI) months Rate (95% CI) at 12 months
Croatian: Medijan (95% CI) (mjeseci) Stopa (95% CI) nakon 12 mjeseci
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of thyroid disorders was 25.2% (113/448).
Croatian: U bolesnika s melanomom liječenih nivolumabom u dozi od 1 mg/kg u kombinaciji s ipilimumabom u dozi od 3 mg/kg, incidencija poremećaja štitnjače iznosila je 25,2% (113/448).
English: For Grade 2 or 3 serum creatinine elevation, nivolumab or nivolumab in combination with ipilimumab should be withheld, and corticosteroids should be initiated at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju povišenja razine kreatinina 2. ili 3. stupnja, potrebno je odgoditi primjenu nivolumaba ili nivolumaba u kombinaciji s ipilimumabom i uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 0,5 do 1 mg/kg/dan metilprednizolona.
English: Grade 2 diarrhoea or colitis
Croatian: Proljev ili kolitis 2. stupnja
English: Nivolumab 3 mg/kg in Combination with Ipilimumab 1 mg/kg
Croatian: Nivolumab u dozi od 3 mg/kg u kombinaciji s ipilimumabom u dozi od 1 mg/kg
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, open-label study (CA209037).
Croatian: Sigurnost i djelotvornost nivolumaba u dozi od 3 mg/kg za liječenje uznapredovalog (neresektabilnog ili metastatskog) melanoma ispitivane su u randomiziranom, otvorenom ispitivanju faze 3 (CA209037).
English: b 25/100 (25%) of the patients in CA209205 Cohort C presented B-Symptoms at baseline.
Croatian: a18/80 (22,5%) bolesnika iz kohorte B u ispitivanju CA209205 pokazivalo je B-simptome na početku ispitivanja. b25/100 (25%) bolesnika iz kohorte C u ispitivanju CA209205 pokazivalo je B-simptome na početku ispitivanja.
English: The median age was 62 years (range: 21 to 85) with 34% ≥65 years of age and 7% ≥75 years of age.
Croatian: Medijan dobi iznosio je 62 godine (raspon: 21-85), uz 34% bolesnika u dobi od ≥ 65 godina i 7% u dobi od ≥ 75 godina.
English: Grade 3 and 4 cases were reported in 0.7% (19/2578) and <0.1% (1/2578) of patients respectively.
Croatian: Slučajevi 3. stupnja prijavljeni su u 0,7% (19/2578) bolesnika, a slučajevi 4. stupnja u < 0,1% (1/2578) bolesnika.
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of metastatic or recurrent SCCHN were evaluated in a phase 3, randomised, open-label study (CA209141).
Croatian: Sigurnost i djelotvornost nivolumaba u dozi od 3 mg/kg kao monoterapije za liječenje metastatskog ili relapsirajućeg SCCHN-a ocjenjivale su se u randomiziranom, otvorenom ispitivanju faze 3 (CA209141).
English: OPDIVO as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.
Croatian: OPDIVO je u monoterapiji indiciran za liječenje odraslih bolesnika s uznapredovalim karcinomom bubrežnih stanica (engl. renal cell carcinoma, RCC) nakon prethodne terapije.
English: Acid in the blood produced from diabetes (diabetic ketoacidosis) A temporary inflammation of the nerves that causes pain, weakness and paralysis in the extremities (Guillain-Barré syndrome); damage to nerves causing numbness and weakness (polyneuropathy); inflammation of the nerves; foot drop (peroneal nerve palsy); inflammation of the nerves caused by the body attacking itself, causing numbness, weakness, tingling or burning pain (autoimmune neuropathy); muscle weakness and tiredness without atrophy (myasthenia gravis)
Croatian: Manje česte (mogu se javiti u do 1 na 100 osoba) bronhitis privremena i reverzibilna nezarazna upala zaštitnih membrana koje okružuju mozak i kralježničnu moždinu (aseptički meningitis) kronične bolesti koje se povezuju s nakupljanjem upalnih stanica u različitim organima i tkivima, najčešće plućima (sarkoidoza) povišene razine kiseline u krvi kiselina u krvi kao posljedica šećerne bolesti (dijabetička ketoacidoza) privremena upala živaca koja uzrokuje bol, slabost i paralizu udova (Guillain-Barréov sindrom); oštećenje živaca koje uzrokuje utrnulost i slabost (polineuropatija); upala živaca; pad stopala (paraliza peronealnog živca); upala živaca koja nastaje zato što tijelo napada samo sebe, a uzrokuje utrnulost, slabost, trnce ili žareću bol (autoimuna neuropatija); mišićna slabost i umor bez atrofije (miastenija gravis) upala mozga promjene srčanog ritma ili brzine otkucaja srca, neuobičajen srčani ritam, upala srčanog mišića perforacija crijeva, upala želuca (gastritis), upala dvanaesnika kožna bolest koje uzrokuje zadebljale i crvene mrlje na koži, često prekrivene srebrnastim ljuskicama (psorijaza), teška kožna bolest koja uzrokuje crvene točkice često praćene svrbežom,
English: The primary efficacy outcome measures were OS, ORR and PFS as determined by a Blinded Independent Central Review (BICR) in intermediate/poor risk patients.
Croatian: Primarne mjere ishoda za djelotvornost bile su OS, ORR i PFS prema ocjeni zaslijepljenog neovisnog središnjeg povjerenstva (engl.
English: Treatment beyond initial investigator-assessed RECIST, version 1.1-defined progression was permitted if the patient had a clinical benefit and was tolerating study drug as determined by the investigator.
Croatian: Liječenje nakon početne progresije koju je utvrdio ispitivač sukladno verziji 1.1 RECIST kriterija bilo je dopušteno ako je bolesnik ostvarivao kliničku korist i ako je dobro podnosio ispitivani lijek, prema ocjeni ispitivača.
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.55 (0.40, 0.75) Nivolumab vs. Ipilimumab - hazard ratio: 0.54 (0.40, 0.73) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 1.02 (0.73, 1.43)
Croatian: Nivolumab + ipilimumab naspram ipilimumaba - omjer hazarda: 0,55 (0,40; 0,75) Nivolumab naspram ipilimumaba - omjer hazarda: 0,54 (0,40; 0,73) Nivolumab + ipilimumab naspram nivolumaba - omjer hazarda: 1,02 (0,73; 1,43)
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of advanced RCC with a clear cell component was evaluated in a Phase 3, randomised, open-label study (CA209025).
Croatian: Sigurnost i djelotvornost nivolumaba u dozi od 3 mg/kg kao monoterapije za liječenje uznapredovalog RCC-a sa svjetlostaničnom komponentom ispitivane su u randomiziranom, otvorenom ispitivanju faze 3 (CA209025).
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.59 (0.42, 0.82) Nivolumab vs. Ipilimumab - hazard ratio: 0.84 (0.61, 1.16) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.70 (0.49, 0.99)
Croatian: Nivolumab + ipilimumab naspram ipilimumaba - omjer hazarda: 0,59 (0,42; 0,82) Nivolumab naspram ipilimumaba - omjer hazarda: 0,84 (0,61; 1,16) Nivolumab + ipilimumab naspram nivolumaba - omjer hazarda: 0,70 (0,49; 0,99)
English: Median time to onset was 2.1 months (range: 0.0-27.6).
Croatian: Medijan vremena do nastupa iznosio je 2,1 mjesec (raspon: 0,0-27,6).
English: Rate (95% CI) at 12 months
Croatian: Stopa (95% CI) nakon 12 mjeseci
English: Grade 2, Grade 3, and Grade 4 cases were reported in 13.6% (61/448), 15.8% (71/448), and 0.4% (2/448) of patients, respectively.
Croatian: Slučajevi 2. stupnja prijavljeni su u 13,6% (61/448) bolesnika, slučajevi 3. stupnja u 15,8% (71/448) bolesnika, a slučajevi 4. stupnja u 0,4% (2/448) bolesnika.
English: Rate (95% CI) At 6 months At 12 months
Croatian: Stopa (95% CI) nakon 6 mjeseci nakon 12 mjeseci
English: Uncommon adrenal insufficiency, hypopituitarism, hypophysitis, thyroiditis, diabetes mellitus Rare diabetic ketoacidosis
Croatian: Manje često insuficijencija nadbubrežne žlijezde, hipopituitarizam, hipofizitis, tireoiditis, dijabetes
English: Headache
Croatian: Težina
English: Median (95% CI) Rate (95% CI) At 6 months At 12 months
Croatian: Medijan (95% CI) Stopa (95% CI) Nakon 6 mjeseci Nakon 12 mjeseci
English: Grade 2, Grade 3, and Grade 4 cases were reported in 4.7% (21/448), 1.1% (5/448), and 0.2% (1/448) of patients, respectively.
Croatian: Slučajevi 2. stupnja prijavljeni su u 4,7% (21/448) bolesnika, slučajevi 3. stupnja u 1,1% (5/448) bolesnika, a slučajevi 4. stupnja u 0,2% (1/448) bolesnika.
English: Hypersensitivity/Infusion Reaction a at least 40 mg daily prednisone equivalents b frequency is based on the number of patients who experienced the immune-related adverse reaction
Croatian: Endokrinopatije Kožne reakcije Preosjetljivost/reakcija na infuziju a najmanje u dozi ekvivalentnoj 40 mg prednizona na dan b
English: Median duration of response Months (range)
Croatian: Medijan trajanja odgovora Mjeseci (raspon)
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Croatian: 6.1 Popis pomoćnih tvari natrijev citrat dihidrat natrijev klorid manitol (E421) pentetatna kiselina (dietilentriaminpentaacetatna kiselina) polisorbat 80 natrijev hidroksid (za podešavanje pH) kloridna kiselina (za podešavanje pH) voda za injekcije
English: Nivolumab+Ipilimumab (events: 77/155), median and 95% CI: 12.35 (8.74, N.A.) ──Δ─── Nivolumab (events: 86/171), median and 95% CI: 14.00 (7.03, N.A.) Ipilimumab (events: 129/164), median and 95% CI: 3.91 (2.83, 4.17)
Croatian: Nivolumab + ipilimumab (događaji: 77/155), medijan i 95% CI: 12,35 (8,74; N.D.) ──Δ─── Nivolumab (događaji: 86/171), medijan i 95% CI: 14,00 (7,03, N.D.)
English: Withhold dose(s) until symptoms resolve and management with corticosteroids is complete
Croatian: Odgoditi primjenu doze(a) dok se simptomi ne povuku i dok se ne dovrši liječenje kortikosteroidima
English: Figure 9: Kaplan-Meier curves of OS (CA209057)
Croatian: Kaplan-Meierove krivulje za OS (CA209057)
English: The majority of patients were male (75%) and white (88%), all Memorial Sloan Kettering Cancer Center (MSKCC) risk groups were represented, and 34% and 66% of patients had a baseline KPS of 70 to 80% and 90 to 100%, respectively.
Croatian: Memorial Sloan Kettering Cancer Center, MSKCC); 34% bolesnika imalo je početni KPS od 70 do 80%, dok je njih 66% imalo početni KPS od 90 do 100%.
English: Severe pneumonitis or interstitial lung disease, including fatal cases, has been observed with nivolumab monotherapy or nivolumab in combination with ipilimumab (see section 4.8).
Croatian: Kod liječenja nivolumabom u monoterapiji ili u kombinaciji s ipilimumabom primijećeni su teški pneumonitis ili intersticijska bolest pluća, uključujući slučajeve sa smrtnih ishodom (vidjeti dio 4.8).
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.42 (0.31, 0.55) Nivolumab vs. Ipilimumab - hazard ratio: 0.44 (0.34, 0.58) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.94 (0.69, 1.28)
Croatian: Nivolumab + ipilimumab naspram ipilimumaba - omjer hazarda: 0,42 (0,31; 0,55) Nivolumab naspram ipilimumaba - omjer hazarda: 0,44 (0,34; 0,58) Nivolumab + ipilimumab naspram nivolumaba - omjer hazarda: 0,94 (0,69; 1,28)
English: Nivolumab 3 mg/kg (events: 183/410), median and 95% CI: 25.00 (21.75, N.A.)
Croatian: Broj ispitanika pod rizikom Nivolumab Everolimus Nivolumab 3 mg/kg (događaji: 183/410), medijan i 95% CI: 25,00 (21,75; ND) Everolimus 10 mg (događaji: 215/411), medijan i 95% CI: 19,55 (17,64; 23,06)
English: Treatment beyond initial investigator-assessed RECIST version 1.1-defined progression was permitted in patients receiving nivolumab, if the patient had a clinical benefit and was tolerating study drug, as determined by the investigator.
Croatian: Liječenje nakon početne progresije koju je utvrdio ispitivač prema verziji 1.1 RECIST kriterija bilo je dopušteno ako je bolesnik ostvarivao kliničku korist i ako je dobro podnosio ispitivani lijek, prema ocjeni ispitivača.
English: nivolumab + ipilimumab Median OS (95% CI)
Croatian: n nivolumab + ipilimumab Medijan OS-a (95% CI)
English: Table 5: Adverse reactions with nivolumab monotherapy Nivolumab monotherapy
Croatian: Tablica 5: Nuspojave kod primjene nivolumaba u monoterapiji
English: Median time to onset was 1.2 months (range: 0.0-22.6).
Croatian: Medijan vremena do nastupa iznosio je 1,2 mjeseca (raspon: 0,0-22,6).
English: NAME OF THE MEDICINAL PRODUCT OPDIVO 10 mg/mL concentrate for solution for infusion.
Croatian: OPDIVO 10 mg/ml koncentrat za otopinu za infuziju.
English: Patients with active autoimmune disease, ocular melanoma, or active brain or leptomeningeal metastases were excluded from the study.
Croatian: U ispitivanje nisu bili uključeni bolesnici s aktivnom autoimunom bolešću, očnim/uvealnim melanomom, aktivnim metastazama u mozgu ili leptomeningealnim metastazama.
English: The primary efficacy outcome measure was ORR as determined by BICR.
Croatian: Primarna mjera ishoda za djelotvornost bila je ORR prema ocjeni zaslijepljenog neovisnog središnjeg povjerenstva (BICR).
English: Figure 8: Kaplan-Meier curves of OS (CA209017)
Croatian: Kaplan-Meierove krivulje za OS (CA209017)
English: Grade 2, Grade 3, and Grade 4 cases were reported in 1.6% (7/448), 0.9% (4/448), and 0.7% (3/448) of patients, respectively.
Croatian: Slučajevi 2. stupnja prijavljeni su u 1,6% (7/448) bolesnika, slučajevi 3. stupnja u 0,9% (4/448) bolesnika, a slučajevi 4. stupnja u 0,7% (3/448) bolesnika.
English: CA209205 Cohort Ba
Croatian: Kohorta Ba iz ispitivanja CA209205
English: CA209205 Cohort Cb
Croatian: Kohorta Cb iz ispitivanja CA209205
English: Inflammation of the eye (which causes pain and redness), blurred vision Fast heart rate
Croatian: Poremećaji oka Često uveitis, zamagljen vid zamagljen vid
English: Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.
Croatian: Ako se podvrgnete alogenom presađivanju matičnih stanica, liječnik će Vas nadzirati zbog mogućih znakova komplikacija.
English: For Grade 2 diarrhoea or colitis, nivolumab or nivolumab in combination with ipilimumab should be withheld.
Croatian: U slučaju proljeva ili kolitisa 2. stupnja, potrebno je odgoditi primjenu nivolumaba ili nivolumaba u kombinaciji s ipilimumabom.
English: Grade 4 diarrhoea or colitis
Croatian: Proljev ili kolitis 4. stupnja
English: Events Hazard ratio 95% CI Rate (95% CI) at 60 months
Croatian: Omjer hazarda 95% CI Stopa (95% CI) nakon 60 mjeseci
English: Uncommon eosinophilia
Croatian: Manje često eozinofilija
English: Urothelial Carcinoma
Croatian: Karcinom urotela
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.35 (0.22, 0.55) Nivolumab vs. Ipilimumab - hazard ratio: 0.41 (0.27, 0.62) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.87 (0.54, 1.41)
Croatian: Nivolumab + ipilimumab naspram ipilimumaba - omjer hazarda: 0,35 (0,22; 0,55) Nivolumab naspram ipilimumaba - omjer hazarda: 0,41 (0,27; 0,62) Nivolumab + ipilimumab naspram nivolumaba - omjer hazarda: 0,87 (0,54; 1,41)
English: CA209205 Cohort Ca
Croatian: Kohorta Ca iz ispitivanja CA209205
English: CA209205 Cohort B and CA209039
Croatian: Kohorta B iz ispitivanja CA209205 i bolesnici iz ispitivanja CA209039
English: Patients with a baseline performance score ≥ 2, active brain or leptomeningeal metastases, active autoimmune disease, medical conditions requiring systemic immunosuppression, or carcinoma of the nasopharynx or salivary gland as the primary tumour sites were excluded from the SCCHN clinical trial (see sections 4.5 and 5.1).
Croatian: U kliničko ispitivanje kod SCCHN-a nisu bili uključeni bolesnici s početnom ocjenom funkcionalnog statusa ≥ 2, aktivnim metastazama u mozgu ili leptomeningealnim metastazama, aktivnom autoimunom bolešću, medicinskim stanjima koja su zahtijevala primjenu sistemskih imunosupresiva te karcinomom nazofarinksa ili žlijezda slinovnica kao primarnim sijelima tumora (vidjeti dijelove 4.5 i 5.1).
English: Common pyrexia, oedema (including peripheral oedema) Uncommon pain, chest pain Investigationsb
Croatian: Često pireksija, edem (uključujući periferni edem)
English: Tell your doctor if you are pregnant or think you might be, if you are planning to become pregnant, or if you are breast-feeding.
Croatian: Bolesnicima koji se liječe lijekom OPDIVO mora se dati Kartica s upozorenjima za bolesnika te ih se mora upozoriti na rizike liječenja lijekom OPDIVO (vidjeti i Uputu o lijeku).
English: Physicians should consider the delayed onset of nivolumab effect before initiating treatment in patients with poorer prognostic features and/or aggressive disease.
Croatian: Prije nego što započnu liječenje u bolesnika s lošijim prognostičkim značajkama i/ili agresivnom bolešću, liječnici trebaju uzeti u obzir odgođeni nastup učinka nivolumaba.
English: Nivolumab+ipilimumab vs ipilimumab (primary analysis) - HR (95% CI): 0.55 (0.45, 0.69); p-value: < 0.0001 Nivolumab vs ipilimumab (primary analysis) - HR (95% CI): 0.65 (0.53, 0.80); p-value: < 0.0001
Croatian: Nivolumab naspram ipilimumaba (primarna analiza) - omjer hazarda (95% CI): 0,65 (0,53; 0,80); p-vrijednost: <0,0001
English: For symptomatic hypothyroidism, nivolumab or nivolumab in combination with ipilimumab should be withheld, and thyroid hormone replacement should be initiated as needed.
Croatian: U slučaju simptomatske hipotireoze, potrebno je odgoditi primjenu nivolumaba ili nivolumaba u kombinaciji s ipilimumabom i po potrebi uvesti nadomjesnu terapiju hormonima štitnjače.
English: Renal impairment
Croatian: Rijetko kolestaza
English: Severe rash has been observed with nivolumab in combination with ipilimumab and, less commonly, with nivolumab as monotherapy (see section 4.8).
Croatian: Kod liječenja nivolumabom u kombinaciji s ipilimumabom, a manje često i kod primjene nivolumaba u monoterapiji, primijećen je težak osip (vidjeti dio 4.8).
English: High blood pressure (hypertension)
Croatian: Krvožilni poremećaji Često hipertenzija
English: Infections of the upper respiratory tract
Croatian: Infekcije i infestacije Često infekcija gornjih dišnih putova
English: Docetaxel ──Δ─── Nivolumab 3 mg/kg (events: 190/292), median and 95% CI: 12.19 (9.66, 14.98) - - -- - - Docetaxel (events: 223/290), median and 95% CI: 9.36 (8.05, 10.68) The trial demonstrated a statistically significant improvement in OS for patients randomised to nivolumab as compared with docetaxel at the prespecified interim analysis when 413 events were observed (93% of the planned number of events for final analysis).
Croatian: Docetaksel ──Δ─── Nivolumab 3 mg/kg (događaji: 190/292), medijan i 95% CI: 12,9 (9,66; 14,98) - - -- - - Docetaksel (događaji: 223/290), medijan i 95% CI: 9,36 (8,05; 10,68)