natgillin/translations-raw huggingface dataset:
Adverse reactions reported for 88 patients with metastatic MCC and for 1,650 patients in a phase I study in solid tumours are presented in Table 2. 
Nuspojave zabilježene u 88 bolesnika s metastatskim karcinomom Merkelovih stanica i u 1650 bolesnika sa solidnim tumorima u ispitivanju faze I prikazane su u tablici 2. U oba se ispitivanja avelumab primjenjivao u dozi od 10 mg/kg svaka 2 tjedna.
Avelumab was discontinued in 0.2% (1/489) of patients due to Type 1 diabetes mellitus. 
Primjena avelumaba prekinuta je zbog šećerne bolesti tipa 1 u 0,2 % (1/489) bolesnika.
N=77b 
N=77b pozitivan (n=46)
Bavencio 20 mg/mL concentrate for solution for infusion 
Bavencio 20 mg/ml koncentrat za otopinu za infuziju
The median time to onset of immune-related pneumonitis was 2.5 months (range: 3 days to 11 months). 
Medijan vremena do nastupa imunološki posredovanog pneumonitisa iznosio je 2,5 mjeseci (raspon: od 3 dana do 11 mjeseci).
• inflammation of your intestines (colitis), diarrhoea (watery, loose or soft stools) or more bowel movements than usual; 
• upala crijeva (kolitis), proljev (vodenaste, rijetke ili mekane stolice) ili učestalija stolica nego obično • upala gušterače (pankreatitis)
Immune-related nephritis did not lead to discontinuation of avelumab in any patient. 
Imunološki posredovan nefritis nije doveo do prekida primjene avelumaba ni u jednog bolesnika.
Uncommon (may affect up to 1 in 100 people) 
Manje često (mogu se javiti u najviše 1 na 100 osoba)
The median duration was 6 weeks (range: 1 day to more than 14 months). 
Medijan trajanja iznosio je 6 tjedana (raspon: od 1 dana do više od 14 mjeseci).
Corticosteroids should be administered (1 to 2 mg/kg/day prednisone intravenously or oral equivalent) for Grade ≥ 3 adrenal insufficiency followed by a taper until a dose of less than or equal to 10 mg/day has been reached. 
(1 do 2 mg/kg na dan prednizona intravenski ili peroralni ekvivalent) i potom postupno snižavati dozu sve dok se ne dosegne doza od 10 mg/dan ili niža.
No dose adjustment is needed for patients with mild or moderate renal impairment (see section 5.2). 
U bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega nije potrebna prilagodba doze (vidjeti dio 5.2).
No dose adjustment is needed for patients with mild hepatic impairment (see section 5.2). 
U bolesnika s blagim oštećenjem funkcije jetre nije potrebna prilagodba doze (vidjeti dio 5.2).
Immune-related nephritis and renal dysfunction Avelumab can cause immune-related nephritis (see section 4.8). 
Avelumab može uzrokovati imunološki posredovan nefritis (vidjeti dio 4.8).
In patients treated with avelumab as monotherapy, 1.2% (21/1,738) of patients developed immune-related pneumonitis. 
U bolesnika liječenih avelumabom kao monoterapijom, 1,2 % (21/1738) bolesnika razvilo je imunološki posredovan pneumonitis.
Avelumab should be withheld for Grade 2 hepatotoxicity until resolution and permanently discontinued for Grade 3 or Grade 4 hepatotoxicity. 
Primjenu avelumaba kod hepatotoksičnosti 2. stupnja treba privremeno obustaviti do njezina povlačenja te trajno prekinuti kod hepatotoksičnosti 3. i 4. stupnja.
Two fatal cases have been reported in patients receiving avelumab in combination with axitinib (see section 4.8). 
U bolesnika koji su primali avelumab u kombinaciji s aksitinibom zabilježena su dva smrtna slučaja (vidjeti dio 4.8).
Other immune-related adverse reactions (including myositis, hypopituitarism, uveitis, Guillain-Barré syndrome) 
hipopituitarizam, uveitis, Guillain-Barréov sindrom)
Avelumab should be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for Grade 4 immune-related adverse reaction (see section 4.2). 
Primjenu avelumaba potrebno je trajno prekinuti kod svake imunološki posredovane nuspojave 3. stupnja koja se ponavlja te kod imunološki posredovane nuspojave 4. stupnja (vidjeti dio 4.2).
Myocarditis* 
Rijetko miokarditis*
In patients treated with avelumab as monotherapy, 0.5% (8/1,738) of patients developed immune-related adrenal insufficiency. 
U bolesnika liječenih avelumabom kao monoterapijom, 0,5 % (8/1738) bolesnika razvilo je imunološki posredovanu adrenalnu insuficijenciju.
• Cough, shortness of breath 
• kašalj, nedostatak zraka
The median time to onset of immune-related hepatitis was 3.2 months (range: 1 week to 15 months). 
Medijan vremena do nastupa imunološki posredovanog hepatitisa iznosio je 3,2 mjeseca (raspon: od 1 tjedna do 15 mjeseci).
The median time to onset of immune-related hepatitis was 2.3 months (range: 2.1 weeks to 14.5 months). 
Medijan vremena do nastupa imunološki posredovanog hepatitisa iznosio je 2,3 mjeseca (raspon: od 2,1 tjedna do 14,5 mjeseci).
In patients treated with avelumab in combination with axitinib, 6.3% (31/489) of patients developed immune-related hepatitis. 
U bolesnika liječenih avelumabom u kombinaciji s aksitinibom, 6,3 % (31/489) bolesnika razvilo je imunološki posredovan hepatitis.
Treatment-related adverse reaction 
Nuspojava povezana s liječenjem
Two fatal cases have been reported in patients receiving avelumab (see section 4.8). 
U bolesnika koji su primali avelumab zabilježena su dva smrtna slučaja (vidjeti dio 4.8).
All 26 patients with immune-related colitis were treated with corticosteroids and 15 (58%) of the 26 patients received high-dose corticosteroids for a median of 19 days (range: 1 day to 2.3 months). 
Svih 26 bolesnika s imunološki posredovanim kolitisom bilo je liječeno kortikosteroidima, a 15 (58 %) od tih 26 bolesnika primalo je visoke doze kortikosteroida tijekom medijana od 19 dana (raspon: od 1 dana do 2,3 mjeseca).
• Skin rash, itching 
• kožni osip, svrbež
Patients should be monitored for signs and symptoms of immune-related colitis and causes other than immune-related colitis should be ruled out. 
Bolesnike je potrebno pratiti zbog mogućih znakova i simptoma imunološki posredovanog kolitisa te je potrebno isključiti druge uzroke osim imunološki posredovanog kolitisa.
All 21 patients with immune-related pneumonitis were treated with corticosteroids and 17 (81%) of the 21 patients were treated with high-dose corticosteroids for a median of 8 days (range: 1 day to 
Svi bolesnici s imunološki posredovanim pneumonitisom, njih ukupno 21, bili su liječeni kortikosteroidima, a 17 (81 %) bolesnika od tih 21 bilo je liječeno visokom dozom kortikosteroida tijekom medijana od 8 dana (raspon: od 1 dana do 2,3 mjeseca).
Infusion-related reactions, which might be severe, have been reported in patients receiving avelumab (see section 4.8). 
U bolesnika koji primaju avelumab zabilježene su reakcije povezane s infuzijom, koje mogu biti teške (vidjeti dio 4.8).
Avelumab should be withheld for Grade 2 immune-related hepatitis until resolution and permanently discontinued for Grade 3 or Grade 4 immune-related hepatitis (see section 4.2). 
Kod imunološki posredovanog hepatitisa 2. stupnja potrebno je privremeno obustaviti primjenu avelumaba do njegovog povlačenja, a trajno prekinuti kod imunološki posredovanog hepatitisa 3. ili 4. stupnja (vidjeti dio 4.2).
Lymphopenia, eosinophilia 
Manje često limfopenija, eozinofilija
Complete response (CR) n (%) Partial response (PR) n (%) 
stopa objektivnog odgovora (ORR) n (%) (95% CI) potpuni odgovor (CR) n (%) djelomični odgovor (PR) n (%)
All 16 patients with immune-related hepatitis treated with corticosteroids and 15 (94%) of the 16 patients received high-dose corticosteroids for a median of 14 days (range: 1 day to 2.5 months). 
Svih 16 bolesnika s imunološki posredovanim hepatitisom bilo je liječeno kortikosteroidima, a 15 (94 %) od tih 16 bolesnika primalo je visoke doze kortikosteroida tijekom medijana od 14 dana (raspon: od 1 dana do 2,5 mjeseci).
The following side effects have been reported in clinical trials with avelumab alone: 
U kliničkim ispitivanjima u kojima se avelumab primjenjivao sam zabilježene su sljedeće nuspojave:
• Increased liver enzymes in the blood 
• povišeni jetreni enzimi u krvi
Back pain, arthralgia 
Vrlo često bol u leđima, artralgija
Avelumab has also shown to induce natural killer (NK) cell-mediated direct tumour cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC). 
(engl. antibody-dependent cell-mediated cytotoxicity, ADCC).
In patients treated with avelumab in combination with axitinib, 1.8% (9/489) of patients developed immune-related adrenal insufficiency. 
U bolesnika liječenih avelumabom u kombinaciji s aksitinibom, 1,8 % (9/489) bolesnika razvilo je imunološki posredovanu adrenalnu insuficijenciju.
Administer the infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or addon filter. 
Primijenite infuziju kroz sterilni, nepirogeni filtar s niskom sposobnošću vezanja proteina, veličine pora 0,2 mikrometra koji je ugrađen ili pričvršćen na liniju.
Diarrhoea, nausea, constipation, vomiting, abdominal pain 
Poremećaji probavnog sustava Vrlo često proljev, mučnina, konstipacija, povraćanje, bol u abdomenu
Alanine aminotransferase (ALT) increased*, aspartate aminotransferase (AST) increased*, blood creatine phosphokinase increased*, transaminases increased* 
Često povišena gama-glutamil transferaza, povišena alkalna fosfataza u krvi, povišena amilaza, povišena lipaza, povišen kreatinin u krvi Manje često povišena alanin aminotransferaza (ALT)*, povišena aspartat aminotransferaza (AST)*, povišena kreatin fosfokinaza u krvi*, povišene transaminaze*
Of these patients, there was 1 (0.1%) patient with Grade 3 immune-related adrenal insufficiency. 
Među tim bolesnicima, u 1 (0,1 %) je bolesnika imunološki posredovana adrenalna insuficijencija bila 3. stupnja.
One fatal case has been reported in patients receiving avelumab (see section 4.8). 
U bolesnika koji su primali avelumab zabilježen je jedan smrtni slučaj (vidjeti dio 4.8).
In patients treated with avelumab in combination with axitinib, 2.7% (13/489) of patients developed immune-related colitis. 
U bolesnika liječenih avelumabom u kombinaciji s aksitinibom, 2,7 % (13/489) bolesnika razvilo je imunološki posredovan kolitis.
Avelumab was discontinued in 0.3% (6/1,738) of patients due to immune-related pneumonitis. 
Primjena avelumaba prekinuta je zbog imunološki posredovanog pneumonitisa u 0,3 % (6/1738) bolesnika.
Nephritis and renal dysfunction 
Nefritis i poremećaj funkcije bubrega
Avelumab should be permanently discontinued if immune-related myocarditis is confirmed (see section 4.2). 
Ako se imunološki posredovan miokarditis potvrdi, primjenu avelumaba potrebno je trajno prekinuti (vidjeti dio 4.2).
• Dryness in the mouth 
• suhoća usta
Package leaflet: Information for the patient Bavencio 20 mg/mL concentrate for solution for infusion avelumab This medicine is subject to additional monitoring. 
Uputa o lijeku: Informacije za bolesnika Bavencio 20 mg/ml koncentrat za otopinu za infuziju avelumab
Pneumonitis* 
Često pneumonitis*
There was no evidence to suggest a clinically relevant change of avelumab clearance over time in patients with advanced RCC. 
U bolesnika s uznapredovalim karcinomom bubrežnih stanica nije bilo dokaza koji bi ukazivali na klinički važnu promjenu klirensa avelumaba tijekom vremena.
• Inflammation of the eye 
• začepljenje crijeva
In patients treated with avelumab in combination with axitinib, 0.6% (3/489) of patients developed immune-related pneumonitis. 
U bolesnika liječenih avelumabom u kombinaciji s aksitinibom, 0,6 % (3/489) bolesnika razvilo je imunološki posredovan pneumonitis.
The median time to onset of immune-related colitis was 5.1 months (range: 2.3 weeks to 14 months). 
Medijan vremena do nastupa imunološki posredovanog kolitisa iznosio je 5,1 mjesec (raspon: od 2,3 tjedna do 14 mjeseci).
The other ingredients are mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injections (see section 2 “Bavencio has a low sodium content”). 
Drugi sastojci su manitol, ledena acetatna kiselina, polisorbat 20, natrijev hidroksid, voda za injekcije
Avelumab should be permanently discontinued if immune-related pancreatitis is confirmed (see section 4.2). 
Ako se imunološki posredovan pankreatitis potvrdi, primjenu avelumaba potrebno je trajno prekinuti (vidjeti dio 4.2).
Improvement of PFS was observed across pre-specified subgroups. 
U unaprijed definiranim podskupinama opaženo je poboljšanje preživljenja bez progresije bolesti.
Of these patients, there were 7 (0.4%) patients with Grade 3 immune-related colitis. 
Među tim bolesnicima, njih 7 (0,4 %) imalo je imunološki posredovan kolitis 3. stupnja.
Rash pruritic, rash maculo-papular, pruritus generalized, dermatitis acneiform, erythema, rash macular, rash papular, rash erythematous, dermatitis, eczema, rash generalized 
Često pruritični osip, makulopapulozni osip, generalizirani pruritus, akneiformni dermatitis, eritem, makulozni osip, papulozni osip, eritematozni osip, dermatitis, ekcem, generalizirani osip
Hyperthyroidism, adrenal insufficiency, thyroiditis 
Često hipertireoza, adrenalna insuficijencija, tiroiditis Manje često autoimuni tiroiditis, hipofizitis
Blood and lymphatic system disorders 
Poremećaji krvi i limfnog sustava Vrlo često anemija
The median time to onset of immune-related colitis was 2.1 months (range: 2 days to 11 months). 
Medijan vremena do nastupa imunološki posredovanog kolitisa iznosio je 2,1 mjesec (raspon: od 2 dana do 11 mjeseci).
In patients treated with avelumab as monotherapy, 0.9% (16/1,738) of patients developed immune-related hepatitis. 
Imunološki posredovan hepatitis U bolesnika liječenih avelumabom kao monoterapijom, 0,9 % (16/1738) bolesnika razvilo je imunološki posredovan hepatitis.
• problems with your hormone producing glands (the thyroid, adrenal and pituitary glands) that may affect how these glands work; 
• problemi sa žlijezdama koje stvaraju hormone (štitna žlijezda, nadbubrežna žlijezda i hipofiza)
Avelumab should be withheld for Grade 3 or Grade 4 thyroid disorders (see section 4.2). 
Primjenu avelumaba treba privremeno obustaviti kod poremećaja štitne žlijezde 3. ili 4. stupnja (vidjeti dio 4.2).
When avelumab 10 mg/kg was administered in combination with axitinib 5 mg, the respective exposures of avelumab and axitinib were unchanged compared to the single agents. 
Kad se avelumab u dozi od 10 mg/kg primjenjivao u kombinaciji s aksitinibom u dozi od 5 mg,
Median PFS, months (95% CI) 3-month PFS rate by K-M, (95% CI) 6-month PFS rate by K-M, (95% CI) 12-month PFS rate by K-M, (95% CI) CI: Confidence interval; RECIST: Response Evaluation Criteria in Solid Tumours; IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier * Efficacy data with a minimum follow-up of 7 months (cut-off date 14 September 2018) ** CR or PR was confirmed at a subsequent tumour assessment a Based on number of patients with confirmed response (CR or PR) 
Medijan PFS-a, mjeseci (95 % CI) 3-mjesečna stopa PFS-a prema K-M, (95 % CI) 6-mjesečna stopa PFS-a prema K-M, (95 % CI) 12-mjesečna stopa PFS-a prema K-M, (95 % CI) CI: interval pouzdanosti; RECIST: Kriteriji za ocjenu odgovora kod solidnih tumora (engl.
Avelumab should be withheld for Grade 2 or Grade 3 immune-related colitis until resolution, and permanently discontinued for Grade 4 or recurrent Grade 3 immune-related colitis (see section 4.2). 
Kod imunološki posredovanog kolitisa 2. ili 3. stupnja potrebno je privremeno obustaviti primjenu avelumaba do njegova povlačenja, a trajno prekinuti kod imunološki posredovanog kolitisa 4. stupnja ili rekurentnog imunološki posredovanog kolitisa 3. stupnja (vidjeti dio 4.2).
Hyperglycaemia 
Često hiperglikemija
Other immune-related adverse reactions 
Druge imunološki posredovane nuspojave
Table 2: Adverse reactions in patients treated with avelumab as monotherapy in clinical study EMR100070-003 and adverse reactions from a phase I study (EMR100070-001) in solid tumours 
EMR100070-003 i nuspojave u ispitivanju faze I (EMR100070-001) kod solidnih tumora
Median PFS, months (95% CI) 6-month PFS rate by K-M, (95% CI) 12-month PFS rate by K-M, (95% CI) 24-month PFS rate by K-M, (95% CI) 36-month PFS rate by K-M, (95% CI) CI: Confidence interval; RECIST: Response Evaluation Criteria in Solid Tumours; IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier; +denotes a censored value * Efficacy data with a minimum follow-up of 36 months (cut-off date 14 September 2018) ** CR or PR was confirmed at a subsequent tumour assessment a Based on number of patients with confirmed response (CR or PR) 
6-mjesečna stopa PFS-a prema K-M, (95 % CI) 12-mjesečna stopa PFS-a prema K-M, (95 % CI) 24-mjesečna stopa PFS-a prema K-M, (95 % CI) 36-mjesečna stopa PFS-a prema K-M, (95 % CI) CI: interval pouzdanosti; RECIST: Kriteriji za ocjenu odgovora kod solidnih tumora (engl.
Avelumab should be withheld for Grade 3 or Grade 4 endocrinopathies until resolution (see section 4.2). 
Kod endokrinopatija 3. ili 4. stupnja potrebno je privremeno obustaviti primjenu avelumaba do njihovog povlačenja (vidjeti dio 4.2).
Of these patients, there were 2 (0.4%) patients with Grade 3 immune-related adrenal insufficiency. 
Od tih je bolesnika njih 2 (0,4 %) imalo imunološki posredovanu adrenalnu insuficijenciju 3. stupnja.
In patients treated with avelumab as monotherapy, 1.5% (26/1,738) of patients developed immune-related colitis. 
Imunološki posredovan kolitis U bolesnika liječenih avelumabom kao monoterapijom, 1,5 % (26/1738) bolesnika razvilo je imunološki posredovan kolitis.
The Patient Information brochure shall contain the following key messages: 
Brošura s informacijama za bolesnika sadržavat će sljedeće ključne poruke: • Kratak uvod u brošuru i njezinu svrhu
• Loose stools, nausea, constipation, vomiting 
• mekane stolice, mučnina, zatvor, povraćanje
Avelumab was discontinued in 0.4% (2/489) of patients due to immune-related colitis. 
Primjena avelumaba prekinuta je zbog imunološki posredovanog kolitisa u 0,4 % (2/489) bolesnika.
Immune-related colitis Immune-related colitis has been reported in patients receiving avelumab (see section 4.8). 
U bolesnika koji primaju avelumab zabilježen je imunološki posredovan kolitis (vidjeti dio 4.8).
• Muscle pain 
Memorial Sloan
In both studies, avelumab was administered at 10 mg/kg every 2 weeks. 
10 mg/kg avelumaba svaka 2 tjedna.
Avelumab was discontinued in 0.5% (9/1,738) of patients due to immune-related hepatitis. 
Primjena avelumaba prekinuta je zbog imunološki posredovanog hepatitisa u 0,5 % (9/1738) bolesnika.
12-month PFS rate by K-M, (95% CI)** 52.4% (47.4, 57.2) 18-month PFS rate by K-M, (95% CI)** 43.9% (38.8, 49.0) 
Sunitinib: (N=444, događaja=258, medijan=8,0 mjeseci, 95% CI (6,7; 9,8.))
Fatigue, pyrexia, oedema peripheral 
Opći poremećaji i reakcije na mjestu primjene Vrlo često umor, pireksija, periferni edem
An updated RMP should be submitted: 
MSKCC prognostički kriteriji:
Fatigue has been reported following administration of avelumab (see section 4.8). 
Nakon primjene avelumaba zabilježen je umor (vidjeti dio 4.8).
PD-L1 expression at cut-off of 1% 
Smatra se da je put PD-1/PD-L1
Immune-related pancreatitis has been reported in patients receiving avelumab. 
U bolesnika koji primaju avelumab zabilježen je imunološki posredovan pankreatitis.
Avelumab was discontinued in 0.1% (2/1,738) of patients due to immune-related adrenal insufficiency. 
Primjena avelumaba prekinuta je zbog imunološki posredovane adrenalne insuficijencije u 0,1 % (2/1738) bolesnika.
Objective response rate (ORR) n (%) (95% CI) 
Stopa odgovora CR+PR** n (%) (95 % CI)
Of these patients, there were 2 (0.4%) patients with Grade 3 immune-related nephritis. 
Od tih je bolesnika njih 2 (0,4 %) imalo imunološki posredovan nefritis 3. stupnja.
Hypotension, flushing 
Često hipotenzija, navale crvenila
Avelumab should be withheld and antihyperglycaemics in patients with Grade ≥ 3 hyperglycaemia should be administered. 
≥ 3. stupnja treba privremeno obustaviti primjenu avelumaba i primijeniti antihiperglikemike.
Immune-related myocarditis has been reported in patients receiving avelumab. 
U bolesnika koji primaju avelumab zabilježen je imunološki posredovan miokarditis.
• Signs of liver problems, including inflammation of the liver (hepatitis) may include yellowing of your skin (jaundice) or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea coloured), bleeding or bruising more easily than normal, feeling less hungry than usual, tiredness or abnormal liver function tests. 
• Znakovi problema s jetrom, uključujući upalu jetre (hepatitis), mogu uključivati žutu boju kože (žuticu) ili bjeloočnica, jaku mučninu ili povraćanje, bol na desnoj strani trbuha
The following side effects have been reported in clinical trials with avelumab in combination with axitinib: 
Sljedeće nuspojave zabilježene su u kliničkim ispitivanjima avelumaba u kombinaciji s aksitinibom: Vrlo često (mogu se javiti u više od 1 na 10 osoba)
Immune-related pneumonitis occurred in patients treated with avelumab. 
U bolesnika liječenih avelumabom javljao se imunološki posredovan pneumonitis.
The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy. 
uključen u održavanje tolerancije na fetus tijekom trajanja trudnoće.
This is very common for thyroid gland, common for adrenal glands, and uncommon for pituitary gland. 
Ovo je vrlo često kod upale štitne žlijezde, često kod upale nadbubrežne žlijezde i manje često kod upale hipofize.
Product-Limit Survival Estimate (N=116) 
Procjena preživljenja Kaplan-Meierovom metodom (N=116)
Grade 2 or Grade 3 colitis or diarrhoea Withhold until adverse reactions recover to 
Kod nefritisa 2. ili 3. stupnja treba privremeno obustaviti primjenu avelumaba do njegovog povlačenja na
Avelumab was discontinued in 0.1% (2/1,738) of patients due to immune-related thyroid disorders. 
Primjena avelumaba prekinuta je zbog imunološki posredovanih poremećaja štitne žlijezde u 0,1 % (2/1738) bolesnika.
Corticosteroids should be administered for immune-related pancreatitis (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a corticosteroid taper). 
Kod imunološki posredovanog pankreatitisa potrebno je primijeniti kortikosteroide (početnu dozu prednizona od 1 do 2 mg/kg na dan ili ekvivalentni lijek te nakon toga postupno snižavati dozu kortikosteroida).
Positive (n=58) Negative (n=16) 
Ekspresija PD-L1 uz graničnu vrijednost od 1 % N=74a pozitivna (n=58) negativna (n=16)
The median time to onset of thyroid disorders was 2.8 months (range: 2 weeks to 13 months). 
Medijan vremena do nastupa poremećaja štitne žlijezde iznosio je 2,8 mjeseci (raspon: od 2 tjedna do
Immune-related hepatitis occurred in patients treated with avelumab. 
U bolesnika liječenih avelumabom javljao se imunološki posredovan hepatitis.
Colitis*, autoimmune colitis*, enterocolitis*, ileus 
Manje često kolitis*, autoimuni kolitis*, enterokolitis*, ileus Rijetko pankreatitis*
Avelumab was discontinued in 0.5% (9/1,738) of patients due to immune-related colitis. 
Primjena avelumaba prekinuta je zbog imunološki posredovanog kolitisa u 0,5 % (9/1738) bolesnika.
Infusion-related reactions Grade 1 infusion-related reaction 
Reakcija 1. stupnja povezana s infuzijom Smanjiti brzinu infuzije za
Common 
Independent
Adverse reactions Blood and lymphatic system disorders 
Poremećaji krvi i limfnog sustava Često anemija, trombocitopenija
Of these patients, there were 3 (0.2%) patients with Grade 3 immune-related thyroid disorders. 
Od tih je bolesnika njih 3 (0,2 %) imalo imunološki posredovane poremećaje štitne žlijezde 3. stupnja.
• Increased pancreatic enzymes in the blood 
• povišeni enzimi gušterače u krvi
bumpy rash or skin wheals, flushing, low blood pressure (dizziness, fatigue, nausea) fever, 
zimica ili drhtavica, izdignuti osip ili koprivnjača, navale crvenila, nizak krvni tlak (omaglica, umor, mučnina), vrućica, bol u leđima i bol u trbuhu.
Guillain-Barré Syndrome* 
uveitis i Guillain-Barreov sindrom o reakcije povezane s infuzijom
Avelumab should be withheld in the event of suspected immune-related pancreatitis. 
Kod sumnje na imunološki posredovan pankreatitis potrebno je privremeno obustaviti primjenu avelumaba.
Mannitol 
Bavencio.
Grade 3 or Grade 4 endocrinopathies Withhold until adverse reactions recover to 
Endokrinopatije 3. ili 4. stupnja