FrancophonIA/ELRC3.0 huggingface dataset:
English: For Grade 3 or Grade 4 infusion-related reactions, the infusion should be stopped and avelumab should be permanently discontinued (see section 4.2).
Croatian: U slučaju reakcija 3. ili 4. stupnja povezanih s infuzijom, potrebno je zaustaviti infuziju i trajno prekinuti primjenu avelumaba (vidjeti dio 4.2).
English: • Recurrent Grade 3 immune-related adverse reaction
Croatian: • Rekurentna imunološki posredovana nuspojava 3. stupnja
English: The median duration was 2.6 months (range: 3.3 weeks to more than 7.9 months).
Croatian: Medijan trajanja iznosio je 2,6 mjeseci (raspon: od 3,3 tjedna do više od 7,9 mjeseci).
English: The median duration was 2.1 weeks (range: 2 days to 8.9 months).
Croatian: Medijan trajanja iznosio je 2,1 tjedan (raspon: od 2 dana do 8,9 mjeseci).
English: The required volume of Bavencio should be withdrawn from the vial(s) and be transferred to the infusion bag.
Croatian: Iz bočice (bočica) treba izvući potreban volumen lijeka Bavencio i dodati ga u infuzijsku vrećicu.
English: Liver function test increased
Croatian: Manje često povišeni rezultati testova jetrene funkcije
English: Table 6 summarises the subsequent interim analysis of efficacy endpoints including an estimate of the 6-month rates by Kaplan-Meier for DOR and PFS, in patients receiving avelumab at the recommended dose for study EMR100070-003, Part B.
Croatian: Tablica 6 sažeto prikazuje kasniju interim analizu mjera ishoda djelotvornosti uključujući procjenu 6-mjesečnih stopa za trajanje odgovora i PFS primjenom Kaplan-Meierove analize u bolesnika koji su primali avelumab u preporučenoj dozi u ispitivanju EMR100070-003, dio B.
English: All 3 patients with immune-related pneumonitis were treated with high-dose corticosteroids for a median of 3.3 months (range: 3 weeks to 22.3 months).
Croatian: Sva 3 bolesnika s imunološki posredovanim pneumonitisom bila su liječena visokom dozom kortikosteroida tijekom medijana od 3,3 mjeseca (raspon: od 3 tjedna do 22,3 mjeseca).
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Bavencio Lijek čuvajte izvan pogleda i dohvata djece.
English: All 2 patients with immune-related nephritis were treated with high-dose corticosteroids for a median of 1.1 weeks (range: 3 days to 1.9 weeks).
Croatian: Oba bolesnika s imunološki posredovanim nefritisom liječena su visokom dozom kortikosteroida tijekom medijana od 1,1 tjedna (raspon: od 3 dana do 1,9 tjedana).
English: Immune-related pneumonitis
Croatian: Imunološki posredovan pneumonitis
English: Immune-related hepatitis
Croatian: Imunološki posredovan hepatitis
English: • Signs of inflammation of the heart (myocarditis) may include trouble breathing, dizziness or fainting, fever, chest pain and chest tightness or flu like symptoms.
Croatian: • Znakovi upale srčanog mišića (miokarditisa) mogu uključivati otežano disanje, omaglicu ili nesvjesticu, vrućicu, bol u prsnom košu ili stezanje u prsnom košu ili simptome slične gripi.
English: The study population characteristics were: median age of 61 years (range: 27.0 to 88.0), 38% of patients were 65 years or older, 75% were male, 75% were White, and the ECOG performance score was 0 (63%) or 1 (37%).
Croatian: Značajke ispitivane populacije bile su: medijan dobi od 61 godine (raspon: 27,0-88,0), 38% bolesnika bilo je u dobi od 65 godina ili starije, 75% su bili muškarci, 75% bijelci, a funkcionalni status prema ECOG-u bio je 0 (63%) ili 1 (37%).
English: Steady-state concentrations of avelumab were reached after approximately 4 to 6 weeks (2 to 3 cycles) of repeated dosing at 10 mg/kg every 2 weeks, and systemic accumulation was approximately 1.25-fold.
Croatian: do 3 ciklusa) ponavljane primjene doze od 10 mg/kg svaka 2 tjedna, a sistemsko nakupljanje bilo je približno 1,25 puta.
English: The median duration was 2.8 months (range: 3 days to more than 15.5 months).
Croatian: Medijan trajanja iznosio je 2,8 mjeseci (raspon: od 3 dana do više od 15,5 mjeseci).
English: Patients with the following conditions were excluded from clinical trials: active central nervous system (CNS) metastasis; active or a history of autoimmune disease; a history of other malignancies within the last 5 years; organ transplant; conditions requiring therapeutic immune suppression or active infection with HIV, or hepatitis B or C.
Croatian: Bolesnici sa sljedećim stanjima bili su isključeni iz kliničkih ispitivanja: aktivne metastaze u središnjem živčanom sustavu (SŽS), aktivna autoimuna bolest ili autoimuna bolest u anamnezi, druge zloćudne bolesti u anamnezi u prethodnih 5 godina, transplantiran organ, stanja koja zahtijevaju terapijsku imunosupresiju, aktivna infekcija HIV-om te hepatitis B ili C.
English: Treatment with avelumab and axitinib continued until RECIST v1.1-defined progression of disease by Blinded Independent Central Review (BICR) assessment or unacceptable toxicity.
Croatian: Liječenje avelumabom i aksitinibom nastavljeno je do progresije bolesti definirane kriterijima RECIST v1.1 prema procjeni zaslijepljenog neovisnog središnjeg povjerenstva (engl.
English: Tumour response assessments were performed every 6 weeks, as assessed by an Independent Endpoint Review Committee (IERC) using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Croatian: Independent Endpoint Review Committee, IERC) prema Kriterijima za ocjenu odgovora kod solidnih tumora (engl.
English: Minimum, maximum (months) ≥ 6 months by K-M, (95% CI) ≥ 12 months by K-M, (95% CI) ≥ 24 months by K-M, (95% CI) ≥ 36 months by K-M, (95% CI)
Croatian: Minimum, maksimum (mjeseci) ≥ 6 mjeseci prema K-M, (95 % CI) ≥ 12 mjeseci prema K-M, (95 % CI) ≥ 24 mjeseca prema K-M, (95 % CI) ≥ 36 mjeseci prema K-M, (95 % CI)
English: • Headache, dizziness
Croatian: • glavobolja, omaglica
English: Rash pruritic*, erythema*, rash generalised*, psoriasis*, rash erythematous*, rash macular*, rash papular*, dermatitis exfoliative*, erythema multiforme*, pemphigoid*, pruritus generalised*, eczema, dermatitis
Croatian: Manje često pruritični osip*, eritem*, generalizirani osip*, psorijaza*, eritematozni osip*, makulozni osip*, papulozni osip*, eksfolijativni dermatitis*, multiformni eritem*, pemfigoid*, generalizirani svrbež*, ekcem, dermatitis
English: Immune-related colitis resolved in 18 (70%) of 26 patients at the time of data cut-off.
Croatian: Imunološki posredovan kolitis povukao se u 18 (70 %) od 26 bolesnika u vrijeme prestanka prikupljanja podataka.
English: Efficacy endpoints (Part A) (per RECIST v1.1, IERC)
Croatian: Mjere ishoda djelotvornosti (dio A) (prema RECIST verziji 1.1, IERC)
English: Patients should be monitored for changes in liver function and symptoms of immune-related hepatitis and causes other than immune-related hepatitis should be ruled out.
Croatian: Bolesnike je potrebno pratiti zbog mogućih promjena u funkciji jetre i simptoma imunološki posredovanog hepatitisa te je potrebno isključiti druge uzroke osim imunološki posredovanog hepatitisa.
English: • Decrease in the number of platelets in the blood
Croatian: • sniženje broja krvnih pločica u krvi
English: Treatment modification
Croatian: Prilagodba liječenja
English: Immune-related pneumonitis resolved in 2 (66.7%) of the 3 patients at the time of data cut-off.
Croatian: Imunološki posredovan pneumonitis povukao se u 2 (66,7 %) od 3 bolesnika u vrijeme prestanka prikupljanja podataka.
English: Hypersensitivity
Croatian: Često preosjetljivost
English: Figure 3: Kaplan-Meier estimates for progression-free survival based on BICR assessment in patients irrespective of PD-L1 expression
Croatian: Slika 3: Kaplan-Meierove procjene preživljenja bez progresije bolesti prema procjeni BICR-a u bolesnika neovisno o ekspresiji PD-L1
English: Clear, colourless to slightly yellow solution.
Croatian: Bistra, bezbojna do blago žuta otopina.
English: Patients should be monitored for signs and symptoms of immune-related myocarditis.
Croatian: Bolesnike je potrebno pratiti zbog mogućih znakova i simptoma imunološki posredovanog miokarditisa.
English: Drug eruption, erythema multiforme, psoriasis
Croatian: Manje često izbijanje kožnih promjena uzrokovano lijekom, multiformni eritem, psorijaza
English: Grade 0-1
Croatian: ≥ 3. stupnja.
English: In patients with ALT ≥ 3 times ULN (Grades 2-4, n=82), ALT resolved to Grades 0-1 in 92%.
Croatian: U bolesnika s ALT-om ≥ 3 puta iznad GGN-a (2.-4. stupnja, n=82), vrijednost ALT-a snizila se na 0.-1. stupanj u 92 %.
English: • Decrease in the number of a type of white blood cells (lymphocytes)
Croatian: • smanjenje broja jedne vrste bijelih krvnih stanica (limfocita)
English: Merkel cell carcinoma
Croatian: Karcinom Merkelovih stanica
English: • Signs of inflammation of the pancreas (pancreatitis) may include abdominal pain, nausea and vomiting.
Croatian: • Znakovi upale gušterače (pankreatitisa) mogu uključivati bol u trbuhu, mučninu i povraćanje.
English: Suspected myocarditis
Croatian: Sumnja na miokarditis
English: Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).
Croatian: Bavencio je indiciran kao monoterapija za liječenje odraslih bolesnika s metastatskim karcinomom
English: Of these patients, there were 2 (0.1%) patients with a fatal outcome, and 11 (0.6%) patients with Grade 3 immune-related hepatitis.
Croatian: Među njima su bila 2 (0,1 %) bolesnika sa smrtnim ishodom, dok je 11 (0,6 %) bolesnika imalo imunološki posredovan hepatitis 3. stupnja.
English: Infusion related reaction
Croatian: Reakcije povezane s infuzijom
English: Merkel cell carcinoma (study EMR100070-003)
Croatian: Klinička djelotvornost i sigurnost Karcinom Merkelovih stanica (ispitivanje EMR100070-003)
English: In patients treated with avelumab as monotherapy, 6% (98/1,738) of patients developed immune-related thyroid disorders, including 90 (5%) patients with hypothyroidism, 7 (0.4%) with hyperthyroidism, and 4 (0.2%) with thyroiditis.
Croatian: U bolesnika liječenih avelumabom kao monoterapijom, 6 % (98/1738) bolesnika razvilo je imunološki posredovane poremećaje štitne žlijezde, što je uključivalo njih 90 (5 %) s hipotireozom, 7 (0,4 %) s hipertireozom i 4 (0,2 %) s tireoiditisom.
English: Administer the solution for infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or add-on filter as described in section 4.2.
Croatian: Primijenite otopinu za infuziju kroz sterilni, nepirogeni filtar s niskom sposobnošću vezanja proteina, veličine pora 0,2 mikrometra koji je ugrađen ili pričvršćen na liniju, kako je opisano u dijelu 4.2.
English: Serum creatinine more than 6 times ULN Permanently discontinue
Croatian: Kreatinin u serumu više od 6 puta iznad GGN-a
English: Of these patients, there were 18 (3.7%) patients with Grade 3 and 3 (0.6%) patients with Grade 4 immune-related hepatitis.
Croatian: Među njima je bilo 18 (3,7 %) bolesnika s imunološki posredovanim hepatitisom 3. stupnja i 3 (0,6 %) bolesnika s imunološki posredovanim hepatitisom 4. stupnja.
English: It is administered over 60 minutes as an intravenous infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or add-on filter.
Croatian: Primjenjuje se tijekom 60 minuta kao intravenska infuzija kroz sterilni, nepirogeni filtar s niskom sposobnošću vezanja proteina, veličine pora 0,2 mikrometra, koji je ugrađen ili pričvršćen na liniju.
English: How to use Bavencio
Croatian: Kako primjenjivati Bavencio
English: Immune-related pneumonitis resolved in 12 (57%) of the 21 patients at the time of data cut-off.
Croatian: Imunološki posredovan pneumonitis povukao se u 12 (57 %) od 21 bolesnika u vrijeme prestanka prikupljanja podataka.
English: Rash, pruritus
Croatian: Vrlo često osip, pruritus
English: Immune-related nephritis resolved in 1 (50%) of the 2 patients at the time of data cut-off.
Croatian: Imunološki posredovan nefritis povukao se u 1 (50 %) od 2 bolesnika u vrijeme prestanka prikupljanja podataka.
English: The median time to onset of immune-related pneumonitis was 3.7 months (range: 2.7 months to 8.6 months).
Croatian: Medijan vremena do nastupa imunološki posredovanog pneumonitisa iznosio je 3,7 mjeseci (raspon: od 2,7 mjeseci do 8,6 mjeseci).
English: Immune-related thyroid disorders, immune-related adrenal insufficiency, and Type 1 diabetes mellitus have been reported in patients receiving avelumab (see section 4.8).
Croatian: U bolesnika koji primaju avelumab zabilježeni su imunološki posredovani poremećaji štitne žlijezde, imunološki posredovana adrenalna insuficijencija i šećerna bolest tipa 1 (vidjeti dio 4.8).
English: For Part A, the major efficacy outcome measure was confirmed best overall response (BOR); secondary efficacy outcome measures included duration of response (DOR), and progression-free survival (PFS).
Croatian: Response Evaluation Criteria in Solid Tumors, RECIST) v1.1. U dijelu A, glavna mjera ishoda djelotvornosti bila je potvrđen najbolji ukupni odgovor; sekundarne mjere ishoda djelotvornosti uključivale su trajanje odgovora i preživljenje bez progresije bolesti (engl. progression-free survival, PFS).
English: Renal cell carcinoma
Croatian: International Metastatic Renal Cell Carcinoma Database
English: • An infusion bag of appropriate size (preferably 250 mL) containing either sodium chloride 9 mg/mL (0.9%) solution for injection or with sodium chloride 4.5 mg/mL (0.45%) solution for injection should be used.
Croatian: • Potrebno je upotrijebiti infuzijsku vrećicu odgovarajuće veličine (najbolje od 250 ml) koja sadrži otopinu za injekciju natrijevog klorida od 9 mg/ml (0,9 %) ili otopinu za injekciju natrijevog klorida od 4,5 mg/ml (0,45 %).
English: A new ADA method with improved sensitivity and drug tolerance was used in the RCC population.
Croatian: (ADA) poboljšane osjetljivosti i tolerancije na lijek.
English: • Signs of inflammation of the intestines (colitis) may include diarrhoea (loose stools) or more bowel movements than usual, blood in your stools or dark, tarry, sticky stools, or severe stomach (abdomen) pain or tenderness.
Croatian: • Znakovi upale crijeva (kolitisa) mogu uključivati proljev (mekane stolice) ili učestalije stolice nego obično, krv u stolici ili tamne, katranaste, ljepljive stolice ili jaku bol ili osjetljivost u trbuhu (abdomenu).
English: Bavencio has to be diluted with either sodium chloride 9 mg/mL (0.9%) solution for injection or with sodium chloride 4.5 mg/mL (0.45%) solution for injection.
Croatian: Bavencio se mora razrijediti otopinom za injekciju natrijevog klorida od 9 mg/ml (0,9 %) ili otopinom za injekciju natrijevog klorida od 4,5 mg/ml (0,45 %).
English: • Hoarseness, cough, shortness of breath
Croatian: • promuklost, kašalj, nedostatak zraka
English: Thyroid disorders resolved in 7 (7%) of the 98 patients at the time of data cut-off.
Croatian: Poremećaji štitne žlijezde povukli su se u 7 (7 %) od 98 bolesnika u vrijeme prestanka prikupljanja podataka.
English: The median duration was 2.5 months (range: 1 day to more than 7.4 months).
Croatian: Medijan trajanja iznosio je 2,5 mjeseci (raspon: od 1 dana do više od 7,4 mjeseci).
English: Avelumab should be withheld for Grade 3 or Grade 4 symptomatic adrenal insufficiency (see section 4.2).
Croatian: Primjenu avelumaba treba privremeno obustaviti kod simptomatske adrenalne insuficijencije 3. ili 4. stupnja (vidjeti dio 4.2).
English: • Redness in the skin
Croatian: • crvenilo kože
English: Immune-related endocrinopathies
Croatian: Imunološki posredovane endokrinopatije
English: Immune-related adrenal insufficiency did not lead to discontinuation of avelumab in any patient.
Croatian: Imunološki posredovana adrenalna insuficijencija nije dovela do prekida primjene avelumaba ni u jednog bolesnika.
English: This is uncommon.
Croatian: Ovo je manje često.
English: Endocrine disorders
Croatian: I Endokrini poremećaji
English: Autoimmune hepatitis*, acute hepatic failure*, hepatic failure*, hepatitis*
Croatian: Manje često autoimuni hepatitis*, akutno zatajenje jetre*, zatajenje jetre*, hepatitis*
English: Twenty-eight (90.3%) of the 31 patients received high dose corticosteroids for a median of 2.4 weeks (range: 1 day to 10.2 months).
Croatian: Visoku dozu kortikosteroida primalo je 28 (90,3 %) od 31 bolesnika tijekom medijana od 2,4 tjedna (raspon: od 1 dana do 10,2 mjeseca).
English: Rechallenge with Bavencio or axitinib or sequential rechallenge with both Bavencio and axitinib after recovery should be considered.
Croatian: Nakon oporavka je potrebno razmotriti ponovno uvođenje (rechallenge) lijeka Bavencio ili aksitiniba, ili ponovno uvođenje i lijeka Bavencio i aksitiniba sekvencijski.
English: Patients should be monitored for signs and symptoms of immune-related pneumonitis and causes other than immune-related pneumonitis should be ruled out.
Croatian: Bolesnike je potrebno pratiti zbog mogućih znakova i simptoma imunološki posredovanog pneumonitisa te je potrebno isključiti druge uzroke osim imunološki posredovanog pneumonitisa.
English: The educational programme is aimed at increasing awareness and providing information concerning the signs and symptoms of certain important identified risks of avelumab, including immune-related pneumonitis, hepatitis, colitis, pancreatitis, myocarditis, thyroid disorders, adrenal insufficiency, type 1 diabetes mellitus, nephritis and renal dysfunction, myositis, hypopituitarism, uveitis, GuillainBarre syndrome and infusion related reactions, and how to manage them.
Croatian: hepatitis, kolitis, pankreatitis, miokarditis, poremećaje štitne žlijezde, adrenalnu insuficijenciju, šećernu bolest tipa 1, nefritis i poremećaj funkcije bubrega, miozitis, hipopituitarizam, uveitis, Guillain-Barreov sindrom i reakcije povezane s infuzijom, te kako ih zbrinuti.
English: Initiate treatment with insulin for Type 1 diabetes mellitus.
Croatian: Kod šećerne bolesti tipa 1 započnite liječenje inzulinom.
English: Figure 4: Forest plot of progression-free survival based on BICR assessment in patients irrespective of PD-L1 expression
Croatian: Slika 4: Grafikon raspona pouzdanosti za preživljenja bez progresije bolesti prema procjeni BICR-a u bolesnika neovisno o ekspresiji PD-L1
English: Efficacy endpoints (Part B) (per RECIST v1.1, IERC)
Croatian: Mjere ishoda djelotvornosti (dio B) (prema RECIST verziji 1.1, IERC)
English: Immune-related colitis resolved in 10 (76.9%) of 13 patients at the time of data cut-off.
Croatian: Imunološki posredovan kolitis povukao se u 10 (76,9 %) od 13 bolesnika u vrijeme prestanka prikupljanja podataka.
English: Patients with active or a history of central nervous system (CNS) metastasis; active or a history of autoimmune disease; a history of other malignancies within the last 5 years; organ transplant; conditions requiring therapeutic immune suppression or active infection with HIV, or hepatitis B or C were excluded.
Croatian: Isključeni su bili bolesnici s aktivnim metastazama ili anamnezom metastaza u središnjem živčanom sustavu (SŽS); aktivnom autoimunom bolešću ili autoimunom bolešću u anamnezi; anamnezom drugih zloćudnih bolesti u prethodnih 5 godina; transplantiranim organom; stanjima koja zahtijevaju imunosupresiju, aktivnom infekcijom HIV-om ili hepatitisom B ili C.
English: After administration of Bavencio, the line should be flushed with either sodium chloride 9 mg/mL (0.9%) solution for injection or with sodium chloride 4.5 mg/mL (0.45%) solution for injection.
Croatian: Nakon primjene lijeka Bavencio, liniju treba isprati otopinom za injekciju natrijevog klorida od 9 mg/ml (0,9 %) ili otopinom za injekciju natrijevog klorida od 4,5 mg/ml (0,45 %).
English: In patients treated with avelumab as monotherapy, immune-related pancreatitis occurred in less than 1% (1/4,000) of patients across clinical trials in multiple tumour types and in 0.6% (3/489) of patients receiving avelumab in combination with axitinib including 2 (0.4%) patients with fatal outcome.
Croatian: U bolesnika liječenih avelumabom kao monoterapijom, imunološki posredovan pankreatitis pojavio se u manje od 1 % (1/4000) bolesnika u kliničkim ispitivanjima više vrsta tumora i u 0,6 % (3/489) bolesnika koji su primali avelumab u kombinaciji s aksitinibom, uključujući i 2 (0,4 %) bolesnika sa smrtnim ishodom.
English: • Decreases in blood pressure
Croatian: • sniženja krvnog tlaka
English: Hypothyroidism*
Croatian: Često hipotireoza*
English: The median duration was not estimable (range: 1 day to more than 26 months).
Croatian: Medijan trajanja nije se mogao procijeniti (raspon: od 1 dana do više od 26 mjeseci).
English: Animal reproduction studies have not been conducted with avelumab.
Croatian: Nisu provedena reproduktivna ispitivanja avelumaba na životinjama.
English: The median time to onset of immune-related adrenal insufficiency was 5.5 months (range: 3.6 weeks to 8.7 months).
Croatian: Medijan vremena do nastupa imunološki posredovane adrenalne insuficijencije iznosio je 5,5 mjeseci (raspon: od 3,6 tjedana do 8,7 mjeseci).
English: Dose modification advice for axitinib when used with Bavencio When Bavencio is administered in combination with axitinib, please refer to the axitinib product information for recommended dose modifications for axitinib.
Croatian: Kad se Bavencio primjenjuje u kombinaciji s aksitinibom, o preporukama vezanim uz prilagodbu doze za aksitinib potrebno je pročitati u informacijama o lijeku za aksitinib.
English: The median duration was 1.3 weeks (range: more than 4 days to 1.3 weeks).
Croatian: Medijan trajanja iznosio je 1,3 tjedna (raspon: od više od 4 dana do 1,3 tjedna).
English: • Decreased kidney function
Croatian: • smanjena bubrežna funkcija
English: The median duration was not estimable (range: 2 days to more than 6 months).
Croatian: Medijan trajanja nije se mogao procijeniti (raspon: od 2 dana do više od 6 mjeseci).
English: Of 1,738 patients treated with avelumab 10 mg/kg as an intravenous infusion every 2 weeks, 1,627 were evaluable for treatment-emergent anti-drug antibodies (ADA) and 96 (5.9%) tested positive.
Croatian: Imunogeničnost Prisutnost protutijela na lijek nastalih tijekom liječenja mogla se procijeniti u 1627 od 1738 bolesnika liječenih avelumabom u dozi od 10 mg/kg koji se primjenjivao kao intravenska infuzija svaka 2 tjedna, a test je bio pozitivan u njih 96 (5,9 %).
English: Patients should be monitored for signs and symptoms of immune-related pancreatitis.
Croatian: Bolesnike je potrebno pratiti zbog mogućih znakova i simptoma imunološki posredovanog pankreatitisa.
English: In patients treated with avelumab as monotherapy, Type 1 diabetes mellitus without an alternative aetiology occurred in 0.1% (2/1,738) of patients including two Grade 3 reactions that led to permanent discontinuation of avelumab.
Croatian: Šećerna bolest tipa 1 U bolesnika liječenih avelumabom kao monoterapijom, šećerna bolest tipa 1 koja nije imala drugi uzrok nastala je u 0,1 % (2/1738) bolesnika uključujući dvije reakcije 3. stupnja koje su dovele do trajnog prestanka primjene avelumaba.
English: • Signs of type 1 diabetes may include feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired.
Croatian: • Znakovi šećerne bolesti tipa 1 mogu uključivati jači osjećaj gladi ili žeđi nego obično,
English: Adverse reactions reported for 489 patients with advanced RCC treated in two clinical studies with avelumab in combination with axitinib are presented in Table 3.
Croatian: Tablični popis nuspojava Nuspojave zabilježene u 489 bolesnika s uznapredovalim karcinomom bubrežnih stanica liječenih avelumabom u kombinaciji s aksitinibom u dva klinička ispitivanja prikazane su u tablici
English: Eight (88.9%) patients with immune-related adrenal insufficiency were treated with corticosteroids and 2 (25%) of the 8 patients received high-dose corticosteroids (≥ 40 mg prednisone or equivalent) for a median of 8 days (range: 5 days to 11 days).
Croatian: Osam (88,9 %) bolesnika s imunološki posredovanom adrenalnom insuficijencijom liječeno je kortikosteroidima, a 2 (25 %) od tih 8 bolesnika primalo je visoke doze kortikosteroida (≥ 40 mg prednizona ili ekvivalentnog lijeka) tijekom medijana od 8 dana (raspon: od 5 dana do 11 dana).