FrancophonIA/ELRC3.0 huggingface dataset:
English: • inflammation or problems of the muscles: symptoms may include muscle pain, or weakness or rapid fatigue of the muscles;
Croatian: • upalu ili probleme s mišićima: simptomi mogu uključivati bol u mišićima, ili slabost ili brzo umaranje mišića
English: Patients with suspected pneumonitis should be evaluated with radiographic imaging and managed as recommended in section 4.2.
Croatian: Bolesnike kod kojih se sumnja na pneumonitis treba procijeniti radiološkim oslikavanjem i liječiti u skladu s preporukama navedenima u dijelu 4.2.
English: • hoarse voice (dysphonia)
Croatian: • promuklost (disfonija)
English: The storage details are as follows:
Croatian: Informacije o čuvanju lijeka su sljedeće:
English: • type 1 diabetes: symptoms may include high blood sugar, feeling more hungry or thirsty than usual, passing urine more often than usual;
Croatian: • šećernu bolest tipa 1: simptomi mogu uključivati visoke razine šećera u krvi, jači osjećaj gladi ili žeđi nego inače, učestalije mokrenje
English: • inflammation of the kidneys (nephritis) that can decrease the amount of your urine
Croatian: • upala bubrega (nefritis), koja može smanjiti količinu mokraće
English: • inflammation of the liver that can cause nausea or feeling less hungry
Croatian: • upala jetre koja može uzrokovati mučninu ili smanjen osjećaj gladi
English: • inflammation of glands (especially the thyroid, adrenal, pituitary and pancreas): symptoms may include fast heart rate, extreme tiredness, weight gain or weight loss, dizziness or fainting, hair loss, feeling cold, constipation, headaches that will not go away or unusual headaches;
Croatian: • upalu žlijezda (osobito štitnjače, nadbubrežnih žlijezda, hipofize i gušterače): simptomi mogu uključivati ubrzane otkucaje srca, izražen umor, porast ili gubitak tjelesne težine, omaglicu ili nesvjesticu, opadanje kose, osjećaj hladnoće, zatvor, glavobolje koje ne prolaze ili neobične glavobolje
English: Resolution occurred for 27 patients in the IMFINZI treated group vs 6 in placebo.
Croatian: Nuspojava se povukla kod 27 bolesnika liječenih lijekom IMFINZI i 6 bolesnika koji su primali placebo.
English: Grade 2 with serum creatinine > 1.5-3 x (ULN or baseline)
Croatian: 2. stupanj, uz serumski kreatinin > 1,5 - 3 x (GGN ili početna vrijednost)
English: (95% CI) HR (95% CI) p-value p < 0.0001
Croatian: (95% CI) HR (95% CI) p-vrijednost p < 0,0001
English: HR (95% CI) p-value p < 0.0001
Croatian: HR (95% CI) p-vrijednost p < 0,0001
English: Table 2 lists the incidence of adverse reactions in patients with locally advanced, unresectable NSCLC in the PACIFIC Study, based on the frequency of that adverse reaction type regardless of investigator assessed causality.
Croatian: U Tablici 2 navodi se incidencija određene nuspojave u bolesnika s lokalno uznapredovalim, neresektabilnim NSCLC-om u ispitivanju PACIFIC na temelju učestalosti te vrste nuspojava neovisno o uzročnoj povezanosti prema ocjeni ispitivača.
English: Initiate thyroid hormone replacement as clinically indicated
Croatian: Uvesti nadomjesno liječenje hormonima štitnjače sukladno kliničkoj indikaciji
English: No formal pharmacokinetic (PK) drug-drug interaction studies have been conducted with durvalumab.
Croatian: Nisu provedena formalna farmakokinetička ispitivanja interakcija između durvalumaba i drugih lijekova.
English: • Tell your doctor if you are breast-feeding.
Croatian: • Recite liječniku ako dojite.
English: 10 mL of concentrate in a Type 1 glass vial with an elastomeric stopper and a white flip-off aluminium seal containing 500 mg durvalumab.
Croatian: 10 ml koncentrata u staklenoj bočici (staklo tipa 1) s elastomernim čepom i bijelim flip-off aluminijskim zaštitnim zatvaračem, koja sadrži 500 mg durvalumaba.
English: Immune-mediated pneumonitis/interstitial lung disease
Croatian: Imunološki uzrokovan pneumonitis/intersticijska bolest pluća
English: • you have liver problems.
Croatian: • ako imate jetrenih tegoba
English: Probability of PFS
Croatian: Vjerojatnost PFS-a
English: • you have lung problems or breathing problems;
Croatian: • ako imate plućnih tegoba ili dišnih tegoba
English: Permanently discontinue a
Croatian: Trajno prekinuti liječenje a
English: No dose adjustment of IMFINZI is recommended in patients with mild or moderate renal impairment.
Croatian: Ne preporučuje se prilagođavati dozu kod bolesnika s blagim ili umjerenim oštećenjem bubrežne funkcije.
English: Each vial contains either 500 mg of durvalumab in 10 mL of concentrate or 120 mg of durvalumab in 2.4 mL of concentrate.
Croatian: Jedna bočica sadrži ili 500 mg durvalumaba u 10 ml koncentrata ili 120 mg durvalumaba u 2,4 ml koncentrata.
English: Driving and using machines IMFINZI is not likely to affect you being able to drive and use machines.
Croatian: Nije vjerojatno da će IMFINZI utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: The study excluded patients who had progressed following chemoradiation therapy, patients with prior exposure to any anti-PD-1 or anti-PD-L1 antibody, patients with active or prior documented autoimmune disease within 2 years of initiation of the study; a history of immunodeficiency; a history of severe immune-mediated adverse reactions; medical conditions that required systemic immunosuppression, except physiological dose of systemic corticosteroids; active tuberculosis or hepatitis B or C or HIV infection or patients receiving live attenuated vaccine within 30 days before or after the start of IMFINZI.
Croatian: U ispitivanje nisu bili uključeni bolesnici kojima je bolest uznapredovala nakon kemoradioterapije, bolesnici koji su prethodno bili izloženi bilo kojem protutijelu na PD-1 ili PD-L1, bolesnici koji su imali aktivnu ili prethodno dokumentiranu autoimunu bolest unutar 2 godine prije početka ispitivanja, imunodeficijenciju u anamnezi, teške imunološki uzrokovane nuspojave u anamnezi, medicinska stanja koja su zahtijevala sistemsku imunosupresiju, uz izuzetak fiziološke doze sistemskih kortikosteroida, aktivnu tuberkulozu, hepatitis B ili C ili HIV infekciju, kao ni bolesnici koji su primili živo atenuirano cjepivo unutar 30 dana prije ili nakon početka liječenja lijekom IMFINZI.
English: Hazard ratio (95% CI):
Croatian: Omjer hazarda (95% CI):
English: Resolution occurred in 18 patients.
Croatian: Nuspojave su se povukle kod 18 bolesnika.
English: • Administer the infusion solution intravenously over 60 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
Croatian: • Otopinu za infuziju primijenite intravenski tijekom 60 minuta kroz intravensku liniju koja ima ugrađen (engl. in-line) sterilni filtar veličine pora od 0,2 ili 0,22 mikrona i male sposobnosti vezanja proteina.
English: Immune-mediated myositis/polymyositis
Croatian: Imunološki uzrokovan miozitis/polimiozitis
English: The other ingredients are: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 80, water for injections.
Croatian: Drugi sastojci su: histidin, histidinklorid hidrat, trehaloza dihidrat, polisorbat 80, voda za injekcije.
English: This 1 patient received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day) and IMFINZI was not discontinued.
Croatian: Taj je jedan bolesnik primao visoke doze kortikosteroida (najmanje 40 mg prednizona ili ekvivalent na dan), ali primjena lijeka IMFINZI nije obustavljena.
English: The median time to onset was 85 days (range: 9-378 days).
Croatian: Medijan vremena do nastupa iznosio je 85 dana (raspon: 9 - 378 dana).
English: The median time to onset was 95 days (range: 28-239 days).
Croatian: Medijan vremena do nastupa iznosio je 95 dana (raspon: 28 - 239 dana).
English: Mild hepatic impairment (bilirubin ≤ ULN and AST > ULN or bilirubin > 1.0 to 1.5 × ULN and any AST) had no clinically significant effect on the PK of durvalumab.
Croatian: Blago oštećenje jetrene funkcije (bilirubin ≤ GGN i AST > GGN ili bilirubin > 1,0 - 1,5 × GGN i bilo koja vrijednost AST-a) nije klinički značajno utjecalo na farmakokinetiku durvalumaba.
English: Adverse drug reactions are listed according to system organ class in MedDRA.
Croatian: Nuspojave se navode prema MedDRA klasifikaciji organskih sustava.
English: • inflammation of the heart
Croatian: • upala srca
English: Recommended treatment modifications for IMFINZI and management recommendations
Croatian: Preporučene prilagodbe liječenja lijekom IMFINZI i preporuke za zbrinjavanje nuspojava
English: Consider increasing dose of corticosteroids and/or using additional systemic immunosuppressants if there is worsening or no improvement.
Croatian: Ako dođe do pogoršanja ili izostane poboljšanje, treba razmotriti povećanje doze kortikosteroida i/ili primjenu dodatnih sistemskih imunosupresiva.
English: Infusion related reactions should be managed as recommended in section 4.2
Croatian: Reakcije na infuziju treba liječiti prema preporukama navedenima u dijelu 4.2.
English: Rare (may affect up to 1 in 1000 people)
Croatian: Rijetke (mogu se javiti u do 1 na 1000 osoba)
English: In patients treated with durvalumab in the PACIFIC Study, the proportion of patients who experienced a laboratory abnormality worsening from baseline was as follows: 38.5% (all Grades), 2.3% (Grades 3-4) for alanine aminotransferase increased, 36.0% (all Grades), 2.8% (Grade 3-4) for aspartate aminotransferase increased, 16.3% (all Grades) for creatinine increased, 26.5% (all Grades) for TSH elevated > ULN and above baseline, 31.9% (all Grades) for TSH decreased < LLN and below baseline.
Croatian: Kod bolesnika liječenih durvalumabom u ispitivanju PACIFIC, udio bolesnika kod kojih je došlo do pogoršanja odstupanja u laboratorijskim nalazima u odnosu na početne vrijednosti iznosio je: 38,5% (svi stupnjevi) odnosno 2,3% (3. - 4. stupanj) za povišene vrijednosti alanin aminotransferaze, 36,0% (svi stupnjevi) odnosno 2,8% (3. - 4. stupanj) za povišene vrijednosti aspartat aminotransferaze, 16,3% (svi stupnjevi) za povišene vrijednosti kreatinina, 26,5% (svi stupnjevi) za vrijednosti TSH-a iznad GGN-a i početne vrijednosti te 31,9% (svi stupnjevi) za vrijednosti TSH-a ispod donje granice normale (DGN) i početne vrijednosti.
English: In the PACIFIC Study, in patients who had completed treatment with at least 2 cycles of concurrent chemoradiation within 1 to 42 days prior to initiation of the trial, pneumonitis or radiation pneumonitis occurred in 161 (33.9%) patients in the IMFINZI-treated group and 58 (24.8%) in the placebo group, including Grade 3 (3.4% vs 3.0%) and Grade 5 (1.1% vs 1.7%) (see section 4.8).
Croatian: Među bolesnicima u ispitivanju PACIFIC koji su dovršili liječenje najmanje dvama ciklusima kemoradioterapije unutar 1 - 42 dana prije početka ispitivanja, pneumonitis ili radijacijski pneumonitis javili su se kod 161 (33,9%) bolesnika u skupini liječenoj lijekom IMFINZI te 58 (24,8%) onih koji su primali placebo, uključujući događaje 3. stupnja (3,4% naspram 3,0%) i događaje 5. stupnja (1,1% naspram 1,7%) (vidjeti dio 4.8).
English: In the placebo group, 11 of the 16 patients received systemic corticosteroids, including 9 patients who received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Croatian: U skupini koja je primala placebo, 11 od 16 bolesnika liječilo se sistemskim kortikosteroidima, uključujući 9 bolesnika koji su primali visoke doze kortikosteroida (najmanje 40 mg prednizona ili ekvivalent na dan).
English: Immune-mediated rash or dermatitis
Croatian: Imunološki uzrokovan osip ili dermatitis
English: Patients with the following were excluded from the PACIFIC Study: a baseline ECOG performance score ≥ 2; active or prior documented autoimmune disease within 2 years of initiation of the study; a history of immunodeficiency; a history of severe immune-mediated adverse reactions; medical conditions that required systemic immunosuppression, except physiological dose of systemic corticosteroids (≤ 10 mg/day prednisone or equivalent); active tuberculosis or hepatitis B or C or HIV infection or patients receiving live attenuated vaccine within 30 days before or after the start of IMFINZI.
Croatian: U ispitivanje PACIFIC nisu bili uključeni bolesnici koji su imali početni ECOG funkcionalni status ≥ 2, aktivnu ili prethodno dokumentiranu autoimunu bolest unutar 2 godine prije početka ispitivanja, imunodeficijenciju u anamnezi, teške imunološki uzrokovane nuspojave u anamnezi, medicinska stanja koja su zahtijevala sistemsku imunosupresiju, uz izuzetak fiziološke doze sistemskih kortikosteroida (≤ 10 mg prednizona na dan ili ekvivalent), aktivnu tuberkulozu ili hepatitis B ili C ili HIV infekciju, kao ni bolesnici koji su primili živo atenuirano cjepivo unutar 30 dana prije ili nakon početka liječenja lijekom IMFINZI.
English: • overactive thyroid gland that can cause fast heart rate or weight loss
Croatian: • prekomjerna aktivnost štitnjače, koja može uzrokovati ubrzane otkucaje srca ili gubitak tjelesne težine
English: Administer the infusion solution intravenously over 60 minutes using a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
Croatian: Otopinu za infuziju primijenite intravenski tijekom 60 minuta koristeći ugrađen (engl. in-line) sterilan filtar veličine pora od 0,2 ili 0,22 mikrona koji ima malu sposobnost vezanja proteina.
English: Patient reported outcomes
Croatian: Ishodi koje su prijavljivali bolesnici
English: Mild (creatinine clearance (CrCL) 60 to 89 mL/min) and moderate renal impairment (creatinine clearance (CrCL) 30 to 59 mL/min) had no clinically significant effect on the PK of durvalumab.The effect of severe renal impairment (CrCL 15 to 29 mL/min) on the PK of durvalumab is unknown.
Croatian: Blago (klirens kreatinina [CrCl]: 60 - 89 ml/min) i umjereno (CrCl: 30 - 59 ml/min) oštećenje bubrežne funkcije nije klinički značajno utjecalo na farmakokinetiku durvalumaba.
English: Concurrent ALT or AST > 3 x ULN and total bilirubin > 2 x ULN with no other cause
Croatian: Istodobna vrijednost ALT-a ili AST-a > 3 x GGN i ukupnog bilirubina > 2 x GGN bez drugog uzroka
English: IMFINZI is clear to opalescent, colourless to slightly yellow solution.
Croatian: IMFINZI je bistra do opalescentna, bezbojna do blijedožuta otopina.
English: If you have any questions about how IMFINZI works or why this medicine has been prescribed for you, ask your doctor or pharmacist.
Croatian: Ako imate pitanja o tome kako IMFINZI djeluje ili zašto
English: Immune-mediated pneumonitis
Croatian: Imunološki uzrokovan pneumonitis
English: 2.4 mL of concentrate in a Type 1 glass vial with an elastomeric stopper and a gray flip-off aluminium seal containing 120 mg durvalumab.
Croatian: 2,4 ml koncentrata u staklenoj bočici (staklo tipa 1) s elastomernim čepom i sivim flip-off aluminijskim zaštitnim zatvaračem, koja sadrži 120 mg durvalumaba.
English: Immune-mediated adrenal insufficiency or hypophysitis/hypopituitarism
Croatian: Imunološki uzrokovana insuficijencija nadbubrežnih žlijezda ili hipofizitis/hipopituitarizam2.
English: Resolution occurred in 42 patients.
Croatian: Nuspojave su se povukle kod 42 bolesnika.
English: Of the 137 patients, 134 patients received hormone replacement therapy and two patients received high-dose corticosteroids (at least 40 mg prednisone or equivalent per day) for hypothyroidism followed by hormone replacement.
Croatian: Od 137 bolesnika, njih 134 su primala hormonsku nadomjesnu terapiju, a dva su bolesnika za svoju hipotireozu najprije primala visoke doze kortikosteroida (najmanje 40 mg prednizona ili ekvivalent na dan), a zatim nadomjeske hormona.
English: Adverse drug reactions in patients with locally advanced unresectable NSCLC treated with IMFINZI at 10 mg/kg
Croatian: Tablica 2. Nuspojave kod bolesnika s lokalno uznapredovalim neresektabilnim NSCLC-om liječenih lijekom IMFINZI u dozi od 10 mg/kg Bilo koji stupanj (%)
English: Resolution occurred in 13 patients.
Croatian: Nuspojave su se povukle kod 13 bolesnika.
English: Excipients: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 80, water for injections.
Croatian: Pomoćne tvari: histidin, histidinklorid hidrat, trehaloza dihidrat, polisorbat 80, voda za injekcije.
English: Negligible levels of durvalumab was found in milk of cynomolgous monkey on Day 28 after birth.
Croatian: U mlijeku ženki makaki majmuna izmjerene su zanemarive razine durvalumaba 28 dana nakon okota.
English: Do not use if this medicine is cloudy, discoloured or contains visible particles.
Croatian: Lijek se ne smije primijeniti ako je mutan, ako je promijenio boju ili ako sadrži vidljive čestice.
English: The median time to onset was 70 days (range: 15-312 days).
Croatian: Medijan vremena do nastupa iznosio je 70 dana (raspon: 15 - 312 dana).
English: The median time to onset was 141 days (range: 70-265 days).
Croatian: Medijan vremena do nastupa iznosio je 141 dan (raspon: 70 - 265 dana).
English: Mix diluted solution by gentle inversion.
Croatian: Promiješajte razrijeđenu otopinu nježno je okrećući.
English: Patients should be monitored for clinical signs and symptoms of type 1 diabetes mellitus.
Croatian: Bolesnike treba nadzirati zbog moguće pojave kliničkih znakova i simptoma šećerne bolesti tipa 1.
English: Immune-mediated hepatitis
Croatian: Imunološki uzrokovan hepatitis
English: In the IMFINZI-treated group, 44 of the 51 patients received systemic corticosteroids, including 28 patients who received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day), and 2 patients also received infliximab.
Croatian: U skupini liječenoj lijekom IMFINZI, 44 od 51 bolesnika primala su sistemske kortikosteroide, uključujući 28 bolesnika koji su primali visoke doze kortikosteroida (najmanje 40 mg prednizona ili ekvivalent na dan), a 2 su bolesnika primala i infliksimab.
English: • Infusion-related reactions: symptoms may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing dizziness, or fever.
Croatian: • reakcije na infuziju: simptomi mogu uključivati zimicu ili drhtanje, svrbež ili osip, navale crvenila, nedostatak zraka ili piskanje pri disanju, omaglicu ili vrućicu
English: Immune-mediated endocrinopathies
Croatian: Imunološki uzrokovane endokrinopatije
English: IMFINZI was discontinued in 26 patients.
Croatian: Primjena lijeka IMFINZI obustavljena je kod 26 bolesnika.
English: When you are given IMFINZI, you can have some serious side effects.
Croatian: Tijekom liječenja lijekom IMFINZI mogu se pojaviti neke ozbiljne nuspojave.
English: Immune-mediated hepatitis should be managed as recommended in section 4.2.
Croatian: Imunološki uzrokovan hepatitis treba liječiti u skladu s preporukama navedenima u dijelu 4.2.
English: Immune-mediated hypothyroidism and hyperthyroidism (including thyroiditis) occurred in patients receiving IMFINZI, and hypothyroidism may follow hyperthyroidism (see section 4.8).
Croatian: Kod bolesnika koji su primali IMFINZI javile su se imunološki uzrokovane hipotireoza i hipertireoza (uključujući tireoiditis); hipotireoza može nastupiti nakon hipertireoze (vidjeti dio 4.8).
English: Events of StevensJohnson Syndrome or toxic epidermal necrolysis have been reported in patients treated with PD-1 inhibitors.
Croatian: Kod bolesnika liječenih inhibitorima PD-L1 prijavljeni su događaji Stevens-Johnsonova sindroma ili toksične epidermalne nekrolize.
English: Immune-mediated type 1 diabetes mellitus
Croatian: Imunološki uzrokovana šećerna bolest tipa 1
English: IMFINZI was discontinued in 8 patients.
Croatian: Primjena lijeka IMFINZI obustavljena je kod 8 bolesnika.
English: Patients should be monitored for clinical signs and symptoms of hypophysitis or hypopituitarism.
Croatian: Bolesnike treba nadzirati zbog moguće pojave kliničkih znakova i simptoma hipofizitisa ili hipopituitarizma.
English: • Discard any unused portion left in the vial.
Croatian: • Bacite sav neupotrijebljen lijek koji je preostao u bočici.
English: • has responded or stabilised after initial treatment with chemotherapy and radiotherapy.
Croatian: • kada je NSCLC odgovorio na početno liječenje kemoterapijom i radioterapijom i postao stabilan
English: How you are given IMFINZI
Croatian: Kako ćete primiti IMFINZI
English: Initiate 1 to 2 mg/kg/day prednisone or equivalent followed by a taper and hormone replacement as clinically indicated
Croatian: Uvesti prednizon u dozi od 1 - 2 mg/kg na dan ili ekvivalent, koja se zatim postupno smanjuje, te hormonsko nadomjesno liječenje sukladno kliničkoj indikaciji
English: • inflammation of the skin: symptoms may include rash, itching, skin blistering or ulcers in the mouth or on other moist surfaces;
Croatian: • upalu kože: simptomi mogu uključivati osip, svrbež, pojavu mjehurića na koži ili vrijedove u ustima ili na drugim vlažnim površinama
English: IMFINZI was not discontinued in any patient due to hyperthyroidism.
Croatian: Primjena lijeka IMFINZI nije obustavljena ni u jednog bolesnika zbog hipertireoze.
English: Grade 4
Croatian: - 4. stupanj
English: Patients should be monitored for signs and symptoms of infusion related reactions.
Croatian: Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma reakcija na infuziju.
English: (95% CI) p-value
Croatian: (95% CI) p-vrijednost
English: If any of the above apply to you (or you are not sure), talk to your doctor before you are given IMFINZI.
Croatian: Ako se bilo što od gore navedenoga odnosi na Vas (ili niste sigurni), obratite se svom liječniku prije nego što primite IMFINZI.
English: Median PFS (95% CI)
Croatian: Medijan PFS-a (95% CI)
English: The median time to onset was 41 days (range: 14-195 days).
Croatian: Medijan vremena do nastupa iznosio je 41 dan (raspon: 14 - 195 dana).
English: In the combined safety database with IMFINZI monotherapy, (n = 1889 multiple tumour types), immune-mediated pneumonitis occurred in 79 (4.2%) patients, including Grade 3 in 12 (0.6%) patients, Grade 4 in 1 (< 0.1%) patient, and Grade 5 in 5 (0.3%) patients.
Croatian: U bazi objedinjenih podataka o sigurnosti monoterapije lijekom IMFINZI (n = 1889, više vrsta tumora), imunološki uzrokovan pneumonitis javio se kod 79 (4,2%) bolesnika, uključujući događaje 3. stupnja kod 12 (0,6%) bolesnika, događaj 4. stupnja kod 1 (< 0,1%) bolesnika i događaje 5. stupnja kod 5 (0,3%) bolesnika.
English: It is unknown whether durvalumab is secreted in human breast milk.
Croatian: Nije poznato izlučuje li se durvalumab u majčino mlijeko kod ljudi.
English: In the PACIFIC Study, (n = 475 in the IMFINZI arm, and n = 234 in the placebo arm) immune-mediated pneumonitis occurred in 51 (10.7%) patients in the IMFINZI-treated group and 16 (6.8%) patients in the placebo group, including Grade 3 in 8 (1.7%) patients on IMFINZI vs. 6 (2.6%) patients on placebo and Grade 5 (fatal) in 4 (0.8%) patients on IMFINZI vs. 3 (1.3%) patients on placebo.
Croatian: U ispitivanju PACIFIC (n = 475 u skupini liječenoj lijekom IMFINZI te n = 234 u skupini koja je primala placebo), imunološki uzrokovan pneumonitis javio se kod 51 (10,7%) bolesnika liječenog lijekom IMFINZI te 16 (6,8%) bolesnika koji su primali placebo, uključujući događaje 3. stupnja kod 8 (1,7%) bolesnika liječenih lijekom IMFINZI naspram 6 (2,6%) bolesnika koji su primali placebo te događaje 5. stupnja (sa smrtnim ishodom) kod 4 (0,8%) bolesnika liječenih lijekom IMFINZI naspram 3 (1,3%) bolesnika koja su primala placebo.
English: If you miss an appointment to get IMFINZI
Croatian: Ako propustite primiti lijek IMFINZI
English: • inflammation of the liver: symptoms may include nausea or vomiting, feeling less hungry, pain on the right side of your stomach, yellowing of skin or whites of eyes, drowsiness, dark urine or bleeding or bruising more easily than normal;
Croatian: • upalu jetre: simptomi mogu uključivati mučninu ili povraćanje, smanjen osjećaj gladi, bol u desnoj strani trbuha, žutu boju kože ili bjeloočnica, omamljenost, tamnu mokraću te povećanu sklonost krvarenju ili nastanku modrica
English: Kaplan-Meier curve of OS for PD-L1 TC ≥ 1%
Croatian: Slika 3. Kaplan-Meierove krivulje OS-a za PD-L1 TC ≥ 1%