FrancophonIA/ELRC3.0 huggingface dataset:
English: A statistically significant improvement in PFS as retrospectively assessed by a blinded Independent Radiology Committee (IRC) was demonstrated for CABOMETYX compared to sunitinib (Figure 3 and Table 5).
Croatian: Independent Radiology Committee, IRC) pokazalo se statistički značajno poboljšanje PFS-a uz CABOMETYX u odnosu na sunitinib (slika 3 i tablica 5).
English: Administration of the strong CYP3A4 inhibitor ketoconazole (400 mg daily for 27 days) to healthy volunteers decreased cabozantinib clearance (by 29%) and increased single-dose plasma cabozantinib exposure (AUC) by 38%.
Croatian: Primjena jakog inhibitora CYP3A4 ketokonazola (400 mg dnevno tijekom 27 dana) u zdravih dobrovoljaca izazvala je smanjenje klirensa kabozantiniba (za 29 %) te povećanje plazmatske izloženosti kabozantinibu (AUC) nakon primjene jedne doze za 38 %.
English: There is a possibility your fertility could be affected by treatment with CABOMETYX.
Croatian: Postoji mogućnost da će liječenje CABOMETYXOM utjecati na Vašu plodnost.
English: Cardiac electrophysiology An increase from baseline in corrected QT interval by Fridericia (QTcF) of 10 - 15 ms on Day 29 (but not on Day 1) following initiation of cabozantinib treatment (at a dose of 140 mg qd) was observed in a controlled clinical study in medullary thyroid cancer patients.
Croatian: U kontroliranom kliničkom ispitivanju u bolesnika s medularnim rakom štitnjače zabilježeno je povećanje u odnosu na početne vrijednosti QT intervala korigiranog po Fridericia formuli (QTcF) od 10 - 15 ms na 29. dan (ali ne na 1. dan) nakon početka liječenja kabozantinibom (pri dozi od 140 mg jednom dnevno).
English: Median time to onset was 10.0 weeks.
Croatian: Medijan vremena do pojave bio je 10,0 tjedana.
English: Blood pressure should be well-controlled prior to initiating cabozantinib.
Croatian: Prije uvođenja kabozantiniba krvni tlak treba biti dobro kontroliran.
English: Chronic co-administration of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing St. John's Wort [Hypericum perforatum]) with cabozantinib should therefore be avoided.
Croatian: Stoga se istodobna kronična primjena jakih induktora CYP3A4 (npr. fenitoina, karbamazepina, rifampicina, fenobarbitala ili biljnih pripravaka koji sadrže gospinu travu [Hypericum perforatum]) s kabozantinibom mora izbjegavati.
English: CABOMETYX is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.
Croatian: Hepatocelularni karcinom (engl. hepatocellular carcinoma, HCC) CABOMETYX je indiciran kao monoterapija za liječenje hepatocelularnog karcinoma (HCC) u odraslih koji su prethodno liječeni sorafenibom.
English: Re-initiate at a reduced dose.
Croatian: Ponovo uvedite liječenje sa smanjenom dozom.
English: How CABOMETYX works
Croatian: Kako CABOMETYX djeluje
English: CYP3A4 inhibitors and inducers
Croatian: Inhibitori i induktori CYP3A4
English: Concurrent administration of cabozantinib with the strong CYP3A4 inhibitor ketoconazole resulted in an increase in cabozantinib plasma exposure.
Croatian: Istodobna primjena kabozantiniba s jakim inhibitorom CYP3A4 ketokonazolom dovela je do porasta plazmatske izloženosti kabozantinibu.
English: Avoid becoming pregnant while being treated with CABOMETYX.
Croatian: Za vrijeme liječenja CABOMETYXOM izbjegavajte trudnoću.
English: The primary efficacy endpoint was overall survival (OS).
Croatian: Primarni je ishod djelotvornosti bilo ukupno preživljenje (engl.
English: Tablet content Microcrystalline cellulose Anhydrous lactose Hydroxypropyl cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Croatian: Sadržaj tablete mikrokristalična celuloza bezvodna laktoza hidroksipropilceluloza umrežena karmelozanatrij bezvodni, koloidni silicijev dioksid magnezijev stearat
English: Subjects should be cautioned regarding taking a P-gp substrate (e.g., fexofenadine, aliskiren, ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan) while receiving cabozantinib (see section 4.5).
Croatian: Ispitanike je potrebno upozoriti u vezi uzimanja supstrata P-gp-a (npr. feksofenadina, aliskirena, ambrisentana, dabigatraneteksilata, digoksina, kolhicina, maraviroka, posakonazola, ranolazina, saksagliptina, sitagliptina, talinolola, tolvaptana) za vrijeme primjene kabozantiniba (vidjeti dio 4.5).
English: In the HCC study (CELESTIAL), diarrhoea was reported in 54% of cabozantinib-treated patients (251/467);Grade 3- 4 events in 9.9%.
Croatian: U ispitivanju HCC-a (CELESTIAL), proljev je zabilježen u 54 % bolesnika liječenih kabozantinibom (251/467); događaji od 3. do 4. stupnja u 9,9 %.
English: Objective Response Rate n (%) by Investigator Complete responses
Croatian: Stopa objektivnog odgovora n (%) prema ispitivaču
English: The most common serious adverse drug reactions in the HCC population (≥1% incidence) are hepatic encephalopathy, palmar-plantar erythrodysaesthesia syndrome, asthenia and diarrhoea.
Croatian: Najčešće ozbiljne nuspojave na lijek u populaciji bolesnika s karcinomom bubrežnih stanica (incidencija ≥1 %) su hepatična encefalopatija, sindrom palmarno-plantarne eritrodizestezije, astenija i proljev.
English: The most common serious adverse drug reactions in the RCC population (≥1% incidence) are diarrhoea, hypertension, dehydration, hyponatraemia, nausea, decreased appetite, embolism, fatigue, hypomagnesaemia, palmar-plantar erythrodysaesthesia syndrome (PPES).
Croatian: Najčešće ozbiljne nuspojave lijeka u populaciji bolesnika s karcinomom bubrežnih stanica (incidencija ≥1 %) bile su proljev, hipertenzija, dehidracija, hiponatrijemija, mučnina, smanjen apetit, embolija, umor, hipomagnezijemija, sindrom palmarno-plantarne eritrodizestezije (PPES).
English: In the HCC study (CELESTIAL), GI perforations were reported in 0.9% of cabozantinib-treated patients (4/467).
Croatian: U ispitivanju HCC-a (CELESTIAL), GI perforacije zabilježene su u 0,9 % bolesnika liječenih kabozantinibom (4/467).
English: Dose interruption or reduction, or permanent discontinuation of cabozantinib should be considered in case of persistent or recurrent significant GI adverse reactions (see Table 1).
Croatian: Potrebno je razmotriti privremeni prekid doziranja ili smanjenje doze ili pak trajni prekid doziranja kabozantiniba u slučaju perzistentnih ili rekurentnih značajnih gastrointestinalnih nuspojava (vidjeti Tablicu 1).
English: Median time to onset was 9.1 weeks.
Croatian: Medijan vremena do pojave bio je 9,1 tjedan.
English: Overall Survival Median OS (95% CI), months HR (95% CI)1,2 p-value1
Croatian: Ukupno preživljenje Medijan OS (95 % CI), mjeseci HR (95 % CI)1,2 p-vrijednost1
English: Based on the populationpharmacokinetic (PK) model, the volume of distribution of the central compartment (Vc/F) was estimated to be 212 L. Protein binding was not altered in subjects with mild or moderately impaired renal or hepatic function.
Croatian: Na osnovi populacijskofarmakokinetičkog (PK) modela, volumen distribucije središnjeg dijela (Vc/F) procijenjen je na 212 litara.
English: Musculoskeletal and connective tissue disorders pain in extremity muscle spasms, arthralgia osteonecrosis of the jaw
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva bol u ekstremitetima spazam mišića, artralgija osteonekroza čeljusti
English: Blood and lymphatic disorders anaemia thrombocytopenia, neutropenia lymphopenia
Croatian: Poremećaji krvi i limfnog sustava anemija trombocitopenija, neutropenija limfopenija
English: Median PFS (95% CI), months HR (95% CI), p-value1
Croatian: Medijan PFS-a (95 % CI), mjeseci HR (95 % CI), p-vrijednost1
English: and rifampicin - Allergy medicines such as fexofenadine and ranolazine - Medicines used to treat epilepsy or fits such as phenytoin, carbamazepine, and phenobarbital - Herbal preparations containing St. John's Wort (Hypericum perforatum), sometimes used for treating depression or depression-related conditions such as anxiety - Medicines used to thin the blood, such as warfarin - Medicines to treat high blood pressure or other heart conditions, such as aliskiren,
Croatian: - Lijekovi za liječenje gljivičnih infekcija, kao što su itrakonazol, ketokonazol i posakonazol - Lijekovi za liječenje bakterijskih infekcija (antibiotici), kao što su eritromicin, klaritromicin i rifampicin - Lijekovi za alergije, kao što su feksofenadin i ranolazin - Lijekovi za liječenje epilepsije ili napadaja, kao što su fenitoin, karbamazepin i fenobarbital - Biljni pripravci koji sadrže gospinu travu (Hypericum perforatum) i ponekad se koriste za liječenje depresije i poremećaja povezanih s depresijom kao što je tjeskoba - Lijekovi za razrjeđivanje krvi, kao što je varfarin - Lijekovi za liječenje visokog krvnog tlaka ili drugih bolesti srca, kao što su aliskiren, ambrisentan,
English: ambrisentan, dabigatran etexilate, digoxin, talinolol, and tolvaptan - Medicines for diabetes, such as saxagliptin and sitagliptin - Medicines used to treat gout, such as colchicine - Medicines used to treat HIV or AIDS, such as efavirenz, ritonavir, maraviroc and emtricitabine - Medicines used to prevent transplant rejection (ciclosporin) and ciclosporin-based regimens in rheumatoid arthritis and psoriasis
Croatian: dabigatraneteksilat, digoksin, talinolol i tolvaptan - Lijekovi za dijabetes, kao što su saksagliptin i sitagliptin - Lijekovi za liječenje gihta, kao što je kolhicin - Lijekovi za liječenje HIV-a ili SIDA-e, kao što su efavirenz, ritonavir, maravirok i emtricitabin
English: The most frequent adverse reactions of any grade (experienced by at least 25% of patients) in the RCC population included diarrhoea, hypertension, fatigue, AST increased, ALT increased, nausea, decreased appetite, PPES, dysgeusia, platelet count decreased, stomatitis, anaemia, vomiting, weight decreased, dyspepsia, and constipation.
Croatian: Najčešće nuspojave bilo kojeg stupnja (pojavile su se u najmanje 25 % bolesnika) u populaciji bolesnika s karcinomom bubrežnih stanica uključivale su proljev, hipertenziju, umor, povišeni AST, povišeni ALT, mučninu, smanjeni apetit, PPES, disgeuziju, sniženi broj trombocita, stomatitis, anemiju, povraćanje, smanjenje tjelesne težine, dispepsiju i i konstipaciju.
English: In renal cell carcinoma following prior vascular endothelial growth factor (VEGF)-targeted therapy, dose reductions and dose interruptions due to an AE occurred in 59.8% and 70%, respectively, of cabozantinib-treated patients in the pivotal clinical trial (METEOR).
Croatian: U liječenju karcinoma bubrežnih stanica nakon prethodne terapije usmjerene na vaskularni endotelni faktor rasta (VEGF), doza je zbog štetnih događaja bila smanjena u 59,8 %, a doziranje prekinuto u 70 % bolesnika liječenih kabozantinibom u pivotalnom kliničkom ispitivanju (METEOR).
English: Table 1: Recommended CABOMETYX dose modifications for adverse reactions Adverse reaction and severity
Croatian: Tablica 1: Preporučene prilagodbe doza CABOMETYXA u slučaju nuspojava
English: • Stomach upset, including diarrhoea, nausea, vomiting, constipation, indigestion, abdominal pain,
Croatian: • Nadražen želudac, uključujući proljev, mučninu, povraćanje, zatvor, probavne tegobe,bolove u trbuhu
English: Therefore, cabozantinib may have the potential to increase plasma concentrations of co-administered substrates of P-gp.
Croatian: Prema tome, moguće je da kabozantinib može povećati plazmatske koncentracije supstrata P-gp-a koji se primjenjuju istodobno s kabozantinibom.
English: Respiratory, thoracic, and mediastinal disorders dysphonia, dyspnoea, cough pulmonary embolism
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja disfonija, dispneja, kašalj plućna embolija
English: Median time to onset was 5.9 weeks.
Croatian: Medijan vremena do pojave bio je 5,9 tjedana.
English: In the treatment-naïve RCC study (CABOSUN), GI perforations were reported in 2.6% (2/78) of cabozantinib-treated patients.
Croatian: U ispitivanju prethodno neliječenog RCC-a (CABOSUN), GI perforacije zabilježene su u 2,6 % (2/78) bolesnika liječenih kabozantinibom.
English: • Increase in cholesterol levels in the blood
Croatian: • Povišene razine kolesterola u krvi
English: In hepatocellular carcinoma following prior systemic therapy, dose reductions and dose interruptions occurred in 62% and 84%, respectively, of cabozantinib-treated patients in the clinical trial (CELESTIAL).
Croatian: U liječenju hepatocelularnog karcinoma nakon prethodne sistemske terapije, doza je bila smanjena u 62 %, a doziranje prekinuto u 84 % bolesnika liječenih kabozantinibom u kliničkom ispitivanju (CELESTIAL).
English: • Symptoms including pain in the abdomen, nausea (feeling sick), vomiting, constipation, or fever.
Croatian: • Simptomi koji uključuju bol u trbuhu, mučninu, povraćanje, zatvor ili vrućicu.
English: Subjects should be cautioned regarding taking a P-gp substrate (e.g., fexofenadine, aliskiren, ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan) while receiving cabozantinib.
Croatian: Ispitanike je potrebno upozoriti u vezi uzimanja supstrata P-gp-a (npr. feksofenadina, aliskirena, ambrisentana, dabigatraneteksilata, digoksina, kolhicina, maraviroka, posakonazola, ranolazina, saksagliptina, sitagliptina, talinolola, tolvaptana) za vrijeme primjene kabozantiniba.
English: • Decrease in bile flow from the liver
Croatian: • Smanjeno istjecanje žuči iz jetre
English: Concurrent administration of cabozantinib with the strong CYP3A4 inducer rifampicin resulted in a decrease in cabozantinib plasma exposure.
Croatian: Istodobna primjena kabozantiniba s jakim induktorom CYP3A4 rifampicinom dovela je do smanjenja plazmatske izloženosti kabozantinibu.
English: Clinical data in renal cell carcinoma following prior vascular endothelial growth factor (VEGF)targeted therapy
Croatian: Klinički podaci za karcinom bubrežnih stanica nakon prethodne terapije usmjerene na vaskularni endotelni faktor rasta (VEGF)
English: Stable disease Progressive Disease
Croatian: Stabilna bolest
English: In the HCC study (CELESTIAL), the incidence of severe haemorrhagic events (Grade ≥ 3) was 7.3% in cabozantinib-treated patients (34/467).
Croatian: U ispitivanju HCC-a (CELESTIAL), incidencija teških događaja krvarenja (stupnja ≥ 3) bila je 7,3 % u bolesnika liječenih kabozantinibom (34/467).
English: Events of venous thromboembolism, including pulmonary embolism, and arterial thromboembolism, sometimes fatal, have been observed with cabozantinib.
Croatian: Prilikom primjene kabozantiniba zabilježeni su, ponekad smrtonosni, događaji venske tromboembolije, uključujući plućnu emboliju, te arterijsku tromboemboliju.
English: • Blisters, pain of the hands or soles of the feet, rash or redness of the skin
Croatian: • Mjehuri, bolne šake ili tabani, osip ili crvenilo na koži
English: Palmar-plantar erythrodysaesthesia syndrome (PPES) has been observed with cabozantinib.
Croatian: Prilikom primjene kabozantiniba zabilježen je sindrom palmarno-plantarne eritrodizestezije (PPES).
English: Probability of Progression-Free Survival
Croatian: Vjerojatnost preživljenja bez progresije bolesti
English: The most frequent adverse reactions of any grade (experienced by at least 25% of patients) in the HCC population included diarrhoea, palmar-plantar erythrodysaesthesia syndrome, fatigue, decreased appetite hypertension and nausea.
Croatian: Najčešće nuspojave bilo kojeg stupnja (pojavile su se u najmanje 25 % bolesnika) u populaciji bolesnika s karcinomom bubrežnih stanica uključivale su proljev, sindrom palmarno-plantarne eritrodizestezije, umor, smanjen apetit, hipertenziju i mučninu.
English: Median time to onset was 4.9 weeks.
Croatian: Medijan vremena do pojave bio je 4,9 tjedana.
English: In the study in RCC following prior VEGF-targeted therapy (METEOR), fistulas were reported in 1.2% (4/331) of cabozantinib-treated patients and included anal fistulas in 0.6% (2/331) cabozantinibtreated patients.
Croatian: U ispitivanju RCC-a nakon prethodne terapije usmjerene na VEGF (METEOR) fistule su zabilježene u 1,2 % (4/331) bolesnika liječenih kabozantinibom i uključivale su analne fistule u 0,6 % (2/331) bolesnika liječenih kabozantinibom.
English: In the treatment-naïve RCC study (CABOSUN), diarrhoea was reported in 73% of cabozantinibtreated patients (57/78);Grade 3-4 events in 10%..
Croatian: U ispitivanju prethodno neliječenog RCC-a (CABOSUN), proljev je zabilježen u 73 % bolesnika liječenih kabozantinibom (57/78); događaji od 3. do 4. stupnja u 10 %.
English: How to take CABOMETYX
Croatian: Kako uzimati CABOMETYX
English: Cabozantinib should be discontinued in patients who develop an acute myocardial infarction or any other clinically significant thromboembolic complication.
Croatian: U bolesnika koji razviju akutni infarkt miokarda ili bilo koju drugu klinički značajnu tromboembolijsku komplikaciju, primjena kabozantiniba mora se prekinuti.
English: Figure 1: Kaplan Meier curve for progression-free survival by independent radiology review committee, in RCC subjects following prior vascular endothelial growth factor (VEGF)targeted therapy (first 375 subjects randomized) (METEOR)
Croatian: Slika 1: Kaplan-Meierova krivulja preživljenja bez progresije bolesti u ispitanika s RCC-om nakon prethodne terapije usmjerene na vaskularni endotelni faktor rasta (VEGF) prema odboru za neovisnu radiološku procjenu (prvih 375 randomiziranih ispitanika) (METEOR)
English: In the study in RCC following prior VEGF-targeted therapy (METEOR), diarrhoea was reported in 74% of cabozantinib-treated RCC patients (245/331); Grade 3-4 events in 11%.
Croatian: U ispitivanju RCC-a nakon prethodne terapije usmjerene na VEGF (METEOR), proljev je zabilježen u 74 % bolesnika s RCC-om liječenih kabozantinibom (245/331); događaji od 3. do 4. stupnja u 11 %.
English: Hepatic effects Abnormalities of liver function tests (increases in alanine aminotransferase [ALT], aspartate aminotransferase [AST] and bilirubin) have been frequently observed in patients treated with cabozantinib.
Croatian: U bolesnika liječenih kabozantinibom često su opažene abnormalnosti testova funkcije jetre (povećanja alanin aminotransferaze [ALT], aspartat aminotransferaze [AST] i bilirubina).
English: Ipsen NV Guldensporenpark 87
Croatian: België/Belgique/Belgien, Luxembourg/Luxemburg Italia Ipsen NV Guldensporenpark 87
English: • Increase in blood triglyceride levels in the blood
Croatian: • Povišenje razina triglicerida u krvi
English: Table 5: Efficacy results in treatment-naïve RCC subjects (ITT population, CABOSUN) CABOMETYX (N=79)
Croatian: Tablica 5: Rezultati djelotvornosti u prethodno neliječenih ispitanika s RCC-om (ITT populacija, ispitivanje CABOSUN)
English: 2D barcode carrying the unique identifier included.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom 18. JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC:
English: Cabozantinib should be discontinued if hypertension is severe and persistent despite anti-hypertensive therapy and dose reduction of cabozantinib.
Croatian: Ako je hipertenzija teška i perzistira unatoč primjeni antihipertenzivne terapije i smanjenju doze kabozantiniba, primjena kabozantiniba se mora prekinuti.
English: Figure 2: Kaplan-Meier curve of overall survival in RCC subjects following prior vascular endothelial growth factor (VEGF)-targeted therapy (METEOR)
Croatian: Slika 2: Kaplan-Meierova krivulja ukupnog preživljenja u ispitanika s RCC-om nakon prethodne terapije usmjerene na vaskularni endotelni faktor rasta (VEGF) (METEOR)
English: Al. Jana Pawła II 29 Selise 26-11,
Croatian: Selise 26-11,
English: Vascular disorders hypertension, haemorrhage venous thrombosis arterial thrombosis
Croatian: Krvožilni poremećaji hipertenzija, krvarenje venska tromboza, arterijska tromboza aneurizme i disekcije arterije
English: Serious gastrointestinal (GI) perforations and fistulas, sometimes fatal, have been observed with cabozantinib.
Croatian: Prilikom primjene kabozantiniba zabilježene su ozbiljne, u nekim slučajevima i smrtonosne, gastrointestinalne (GI) perforacije i fistule.
English: Cabozantinib should not be administered to patients that have or are at risk for severe haemorrhage.
Croatian: Kabozantinib se ne smije primjenjivati u bolesnika s teškim krvarenjem ili s rizikom od teškog krvarenja.
English: In the HCC study (CELESTIAL), fatal haemorrhagic events were reported at a higher incidence with cabozantinib than placebo.
Croatian: U ispitivanju HCC-a (CELESTIAL), smrtonosno krvarenje prijavljeno je u višoj incidenciji u skupini koja je primala kabozantinib nego u skupini koja je primala placebo.
English: In treatment-naïve renal cell carcinoma, dose reductions and dose interruptions occurred in 46% and 73%, respectively, of cabozantinib-treated patients in the clinical trial (CABOSUN).
Croatian: U prethodno neliječenih bolesnika s karcinomom bubrežnih stanica, doza je bila smanjena u 46 %, a doziranje prekinuto u 73 % bolesnika liječenih kabozantinibom u kliničkom ispitivanju (CABOSUN).
English: In the study in RCC following prior VEGF-targeted therapy (METEOR), GI perforations were reported in 0.9% (3/331) of cabozantinib-treated RCC patients.
Croatian: U ispitivanju RCC-a nakon prethodne terapije usmjerene na VEGF (METEOR), GI perforacije zabilježene su u 0,9 % (3/331) bolesnika s RCC-om liječenih kabozantinibom.
English: CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets cabozantinib
Croatian: CABOMETYX 20 mg filmom obložene tablete CABOMETYX 40 mg filmom obložene tablete CABOMETYX 60 mg filmom obložene tablete kabozantinib
English: Each film-coated tablet contains 46.61 mg lactose For the full list of excipients, see section 6.1.
Croatian: Jedna filmom obložena tableta sadrži 46,61 mg laktoze.
English: Danmark, Norge, Suomi/Finland, Sverige, Ísland
Croatian: Danmark, Norge, Suomi/Finland, Sverige, Ísland Magyarország Institut Produits Synthèse (IPSEN) AB Kista Science Tower
English: Skin and subcutaneous tissue disorders palmar-plantar erythrodysaesthesia syndrome, rash pruritus, alopecia, dry skin, dermatitis acneiform, hair colour change
Croatian: pruritus, alopecija, suha koža, akneiformni dermatitis, promjena boje kose
English: In the study in RCC following prior VEGF-targeted therapy (METEOR), the incidence of severe haemorrhagic events (Grade ≥ 3) was 2.1% (7/331) in cabozantinib-treated RCC patients.
Croatian: U ispitivanju RCC-a nakon prethodne terapije usmjerene na VEGF (METEOR), incidencija teških hemoragijskih događaja (≥ 3. stupanj) bila je 2,1 % (7/331) u bolesnika s RCC-om liječenih kabozantinibom.
English: Median time to onset of all events was 4.1 weeks.
Croatian: Medijan vremena do pojave bio je 4,1 tjedan.
English: Secondary efficacy endpoints were progression-free survival (PFS) and objective response rate (ORR), as assessed by the Investigator using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
Croatian: Objective Response Rate, ORR), koje procjenjuje ispitivač prema kriteriju RECIST (engl.
English: What CABOMETYX is
Croatian: Što CABOMETYX sadrži
English: Patients with cardiac impairment
Croatian: Bolesnici s oštećenjem funkcije srca
English: No cases of hepatic encephalopathy were reported in the RCC studies (METEOR and CABOSUN).
Croatian: U ispitivanjima RCC-a (METEOR i CABOSUN) nisu prijavljeni slučajevi hepatične encefalopatije.
English: • Changes in blood tests used to monitor general health and function of your organs (including the liver, and kidney), low levels of electrolytes (like magnesium, or potassium)
Croatian: (uključujući jetru i bubrege), niske razine elektrolita (kao što su magnezij ili kalij)
English: CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets
Croatian: CABOMETYX 20 mg filmom obložene tablete CABOMETYX 40 mg filmom obložene tablete CABOMETYX 60 mg filmom obložene tablete
English: Clinical data in treatment-naïve renal cell carcinoma
Croatian: Klinički podaci za prethodno neliječeni karcinom bubrežnih stanica