natgillin/translations-raw huggingface dataset:
Patienterne skal overvåges for tegn og symptomer på immunrelateret colitis, og andre årsager end immunrelateret colitis skal udelukkes. 
Patients should be monitored for signs and symptoms of immune-related colitis and causes other than immune-related colitis should be ruled out.
Immunrelateret colitis Der er blevet rapporteret immunrelateret colitis hos patienter, der fik avelumab (se pkt. 
Immune-related colitis Immune-related colitis has been reported in patients receiving avelumab (see section 4.8).
Avelumab bør afbrydes ved grad 2 eller grad 3 nefritis, indtil reaktionen er reduceret til ≤ grad 1, og permanent seponeres for grad 4 nefritis. 
Avelumab should be withheld for Grade 2 or Grade 3 nephritis until resolution to ≤ Grade 1 and permanently discontinued for Grade 4 nephritis.
Medianvarigheden var 1,3 uger (interval: over 4 dage til 1,3 uger). 
The median duration was 1.3 weeks (range: more than 4 days to 1.3 weeks).
Medianvarigheden kunne ikke estimeres (interval: 2 dage til over 6 måneder). 
The median duration was not estimable (range: 2 days to more than 6 months).
Avelumab blev seponeret hos 0,2 % (1/489) af patienterne, på grund af type 1 diabetes mellitus. 
Avelumab was discontinued in 0.2% (1/489) of patients due to Type 1 diabetes mellitus.
Dosisjustering er ikke nødvendig for patienter med let nedsat leverfunktion (se pkt. 
No dose adjustment is needed for patients with mild hepatic impairment (see section 5.2).
Medianvarigheden kunne ikke estimeres (interval: 1 dag til over 26 måneder). 
The median duration was not estimable (range: 1 day to more than 26 months).
Ved bedring bør det overvejes at genoptage behandlingen med Bavencio eller axitinib eller at genoptage kombinationsbehandlingen sekventielt med både Bavencio og axitinib. 
Rechallenge with Bavencio or axitinib or sequential rechallenge with both Bavencio and axitinib after recovery should be considered.
Mediantiden til immunrelateret binyreinsufficiens opstod var 5,5 måneder (interval: 3,6 uger til 8,7 måneder). 
The median time to onset of immune-related adrenal insufficiency was 5.5 months (range: 3.6 weeks to 8.7 months).
Tabel 5 opsummerer PD-L1-ekpression og MCV-status for patienter med metastatisk MCC i studie EMR100070-003 (del A). 
Table 5 summarises the PD-L1 expression and MCV status of patients with metastatic MCC in study EMR100070-003 (Part A).
Der opstod immunrelateret pneumonitis hos patienter, der blev behandlet med avelumab. 
Immune-related pneumonitis occurred in patients treated with avelumab.
Hovedpine, svimmelhed, perifer neuropati Ikke almindelig Guillain-Barrés syndrom* 
Headache, dizziness, neuropathy peripheral
Hos patienter behandlet med avelumab i kombination med axitinib opstod der immunrelateret nefritis hos 0,4 % (2/489) af patienterne. 
In patients treated with avelumab in combination with axitinib, immune-related nephritis occurred in 0.4% (2/489) of patients.
• Nedsat antal blodplader i blodet 
• Decrease in the number of platelets in the blood
Avelumab bør afbrydes ved grad 3 eller grad 4 endokrinopatier, indtil reaktionerne forsvinder (se pkt. 
Avelumab should be withheld for Grade 3 or Grade 4 endocrinopathies until resolution (see section 4.2).
Hos patienter behandlet med avelumab som monoterapi opstod der immunrelateret myokarditis hos mindre end 1 % (5/4.000) af patienterne i alle kliniske studier af flere tumortyper, og hos 0,6 % (3/489) af patienterne, der fik avelumab i kombination med axitinib, herunder hos 2 (0,4 %) af patienterne med dødelig udgang. 
In patients treated with avelumab as monotherapy, immune-related myocarditis occurred in less than 1% (5/4,000) 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.
Der opstod immunrelateret hepatitis hos patienter, der blev behandlet med avelumab. 
Immune-related hepatitis occurred in patients treated with avelumab.
Alle 8 patienter med immunrelateret binyreinsufficiens blev behandlet med kortikosteroider, 4 (50 %) af de 8 patienter fik højdosis systemiske kortikosteroider (≥ 40 mg prednison eller tilsvarende) efterfulgt af en nedtrapning i en mediantid på 1 dag (interval: 1 dag til 24 dage). 
All 8 patients with immune-related adrenal insufficiency were treated with corticosteroids, 4 (50%) of the 8 patients received high-dose systemic corticosteroids (≥ 40 mg prednisone or equivalent) followed by a taper for a median of 1 day (range: 1 day to 24 days).
Efter administration af Bavencio skal slangen skylles med enten 9 mg/ml (0,9 %) natriumchlorid injektionsvæske, opløsning, eller med 4,5 mg/ml (0,45 %) natriumchlorid injektionsvæske, opløsning. 
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.
8 (88,9%) patienter med immunrelateret binyreinsufficiens blev behandlet med kortikosteroider og 2 (25 %) af de 8 patienter fik højdosis kortikosteroider (≥ 40 mg prednison eller tilsvarende) i en mediantid på 8 dage (interval: 5 dage til 11 dage). 
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).
Hos patienter behandlet med avelumab som monoterapi opstod der immunrelateret pankreatitis hos mindre end 1 % (1/4.000) af patienterne i alle kliniske studier af flere tumortyper, og hos 0,6 % (3/489) af patienterne, der fik avelumab i kombination med axitinib, herunder hos 2 (0,4 %) af patienterne med dødelig udgang. 
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.
Tyreoideasygdomme 
Thyroid disorders
Behandlingsrelateret bivirkning 
Treatment-related adverse reaction
såsom irritabilitet eller glemsomhed, kuldefølelse, meget lavt blodtryk (besvimelse, svimmelhed, træthed, kvalme), vægtændringer eller hovedpine. 
may include extreme tiredness, rapid heartbeat, increased sweating, changes in mood or behaviour, such as irritability or forgetfulness, feeling cold, very low blood pressure (fainting, dizziness, fatigue, nausea), weight change or headache.
Bavencio skal fortyndes med enten 9 mg/ml (0,9 %) natriumchlorid injektionsvæske, opløsning, eller med 4,5 mg/ml (0,45 %) natriumchlorid injektionsvæske, opløsning. 
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.
ULN eller totalt bilirubin ≥ 3 gange ULN, skal både Bavencio og axitinib seponeres permanent, og der bør overvejes kortikosteroidbehandling. 
If ALT or AST ≥ 5 times ULN or > 3 times ULN with concurrent total bilirubin ≥ 2 times ULN or total bilirubin ≥ 3 times ULN, both Bavencio and axitinib should be permanently discontinued and corticosteroid therapy should be considered.
Ud af de 39 patienter var 30 (77 %) mænd med en medianalder på 75 år (interval: 47 til 88 år), 33 (85 %) var kaukasere og 31 (79 %) og 8 (21 %) havde en ECOG performancestatus på hhv. 0 og 1. 
Of the 39 patients, 30 (77%) were male, the median age was 75 years (range: 47 to 88 years), 33 (85%) were Caucasian, and 31 (79%) and 8 (21%) had an ECOG performance status of 0 and 1 respectively.
Ud af disse patienter var der 9 (1,8 %) patienter med grad 3 immunrelateret colitis. 
Of these patients, there were 9 (1.8%) patients with Grade 3 immune-related colitis.
Avelumab bør tilbageholdes ved grad 2 hepatotoksicitet, indtil reaktionen går væk, og det skal seponeres permanent for grad 3 eller grad 4 hepatotoksicitet. 
Avelumab should be withheld for Grade 2 hepatotoxicity until resolution and permanently discontinued for Grade 3 or Grade 4 hepatotoxicity.
Mediantiden til tyreoideasygdomme opstod var 2,8 måneder (interval: 3,6 uger til 19,3 måneder). 
The median time to onset of thyroid disorders was 2.8 months (range: 3.6 weeks to 19.3 months).
Mediantiden til immunrelateret hepatitis opstod var 3,2 måneder (interval: 1 uge til 15 måneder). 
The median time to onset of immune-related hepatitis was 3.2 months (range: 1 week to 15 months).
Hypotyroidisme* 
Hypothyroidism*
Mediantiden til immunrelateret pneumonitis opstod, var 2,5 måneder (interval: 3 dage til 11 måneder). 
The median time to onset of immune-related pneumonitis was 2.5 months (range: 3 days to 11 months).
Tabel 4: Respons på avelumab 10 mg/kg hver 2. uge hos patienter med metastatisk MCC i studie EMR100070-003 (del A)* 
Table 4: Response to avelumab 10 mg/kg every 2 weeks in patients with metastatic MCC in study EMR100070-003 (Part A)*
Mediantiden til immunrelateret colitis opstod var 5,1 måneder (interval: 2,3 uger til 14 måneder). 
The median time to onset of immune-related colitis was 5.1 months (range: 2.3 weeks to 14 months).
Bavencio 20 mg/ml koncentrat til infusionsvæske, opløsning avelumab 
Bavencio 20 mg/mL concentrate for solution for infusion avelumab
Alle 13 patienter med immunrelateret colitis blev behandlet med kortikosteroider og 12 (92,3 %) ud af 13 patienter fik højdosis kortikosteroider i en median periode på 2,3 uger (interval: 5 dage til 4,6 måneder). 
All 13 patients with immune-related colitis were treated with corticosteroids and 12 (92.3%) of the 13 patients received high-dose corticosteroids for a median of 2.3 weeks (range: 5 days to 4.6 months).
Præmedicin 
Premedication
Meget almindelig Diarré, kvalme, forstoppelse, opkastning, abdominalsmerter Almindelig 
Diarrhoea, nausea, constipation, vomiting, abdominal pain
Tabel 5: Objektive responsrater efter PD-L1-ekspression og MCV-tumorstatus hos patienter med metastatisk MCC i studie EMR100070-003 (del A) 
Table 5: Objective response rates by PD-L1 expression and MCV tumour status in patients with metastatic MCC in study EMR100070-003 (Part A)
Der skal administreres kortikosteroider (1-2 mg/kg/dag prednison, givet intravenøst eller som tilsvarende oral mængde) ved grad ≥ 3 binyreinsufficiens, efterfulgt af nedtrapning til dosisniveau på ≤ 10 mg/dag er nået. 
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.
Avelumab bør tilbageholdes ved grad 2 immunrelateret pneumonitis, indtil reaktionen går væk, og skal seponeres permanent for grad 3, grad 4 eller tilbagevendende grad 2 immunrelateret pneumonitis (se pkt. 
Avelumab should be withheld for Grade 2 immune-related pneumonitis until resolution, and permanently discontinued for Grade 3, Grade 4 or recurrent Grade 2 immune-related pneumonitis (see section 4.2).
Administrer infusionsvæsken, opløsningen, med et sterilt, ikke-pyrogent, lavproteinbindende 0,2 mikrometer in-line- eller add-on-filter, som beskrevet i pkt. 
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.
(AIDS), 
(HCV);
Medianvarigheden var 1,6 uger (interval: 1 dag til over 9 måneder). 
The median duration was 1.6 weeks (range: 1 day to more than 9 months).
Bavencio 20 mg/ml koncentrat til infusionsvæske, opløsning 
Bavencio 20 mg/mL concentrate for solution for infusion
Immunrelateret pneumonitis førte ikke til seponering af avelumab hos nogen patienter. 
Immune-related pneumonitis did not lead to discontinuation of avelumab in any patient.
Mediantiden til immunrelateret colitis opstod var 2,1 måneder (interval: 2 dage til 11 måneder). 
The median time to onset of immune-related colitis was 2.1 months (range: 2 days to 11 months).
Forhøjede leverfunktionsprøver 
Liver function test increased
• Røde, kløende, skællende pletter på huden, aknelignende udslæt 
• Red, itchy, scaly patches on the skin, acne-like rash
• Forhøjet niveau af muskelenzymer i blodet 
• Increased muscle enzyme in the blood
Immunrelateret nefritis førte ikke til seponering af avelumab hos nogen patienter. 
Immune-related nephritis did not lead to discontinuation of avelumab in any patient.
Hos patienter behandlet med avelumab som monoterapi opstod immunrelateret nefritis hos 0,1 % (1/1.738) af patienterne, der fik avelumab, hvilket førte til permanent seponering af avelumab. 
Immune-related nephritis and renal dysfunction In patients treated with avelumab as monotherapy, immune-related nephritis occurred in 0.1% (1/1,738) of patients receiving avelumab leading to permanent discontinuation of avelumab.
Sådan vil du få Bavencio 
How you will receive Bavencio
Sådan skal du bruge Bavencio 
How to use Bavencio
Meget almindelig Kvalme, diarré, forstoppelse, opkastning, abdominalsmerter Almindelig 
Nausea, diarrhoea, constipation, vomiting, abdominal pain
Hos patienter behandlet med avelumab som monoterapi udviklede 1,5 % (26/1.738) af patienterne immunrelateret colitis. 
In patients treated with avelumab as monotherapy, 1.5% (26/1,738) of patients developed immune-related colitis.
Der er blevet rapporteret immunrelateret pankreatitis hos patienter, der fik avelumab. 
Immune-related pancreatitis has been reported in patients receiving avelumab.
Mediantiden til immunrelateret binyreinsufficiens opstod var 2,5 måneder (interval: 1 dag til 8 måneder). 
The median time to onset of immune-related adrenal insufficiency was 2.5 months (range: 1 day to 8 months).
Hos patienter behandlet med avelumab i kombination med axitinib udviklede 2,7 % (13/489) af patienterne immunrelateret colitis. 
In patients treated with avelumab in combination with axitinib, 2.7% (13/489) of patients developed immune-related colitis.
• Kvalme, løse afføringer, forstoppelse, opkastning 
• Nausea, loose stools, constipation, vomiting
Mediantiden til tyreoideasygdomme opstod var 2,8 måneder (interval: 2 uger til 13 måneder). 
The median time to onset of thyroid disorders was 2.8 months (range: 2 weeks to 13 months).
To tilfælde med dødelig udgang er blevet rapporteret hos patienter, der fik avelumab (se pkt. 
Two fatal cases have been reported in patients receiving avelumab (see section 4.8).
Medianvarigheden var 6 uger (interval: 1 dag til over 14 måneder). 
The median duration was 6 weeks (range: 1 day to more than 14 months).
Avelumab blev seponeret hos 0,4% (2/489) af patienterne, på grund af immunrelateret colitis. 
Avelumab was discontinued in 0.4% (2/489) of patients due to immune-related colitis.
Immunerelateret binyreinsufficiens førte ikke til seponering af avelumab hos nogen patienter. 
Immune-related adrenal insufficiency did not lead to discontinuation of avelumab in any patient.
• Muskelsmerter 
• Muscle pain
Alle 21 patienter med immunrelateret pneumonitis blev behandlet med kortikosteroider, og 17 (81 %) af de 21 patienter blev behandlet med højdosis kortikosteroider i en mediantid på 8 dage (interval: 1 dag til 2,3 måneder). 
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
Alle 26 patienter med immunrelateret colitis blev behandlet med kortikosteroider og 15 (58 %) af de 26 patienter fik højdosis kortikosteroider i en mediantid på 19 dage (interval: 1 dag til 2,3 måneder). 
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).
• Løs afføring, kvalme, forstoppelse, opkastning 
• Loose stools, nausea, constipation, vomiting
Avelumab bør afbrydes ved grad 3 eller grad 4 symptomatisk binyreinsufficiens (se pkt. 
Avelumab should be withheld for Grade 3 or Grade 4 symptomatic adrenal insufficiency (see section 4.2).
Alle 16 patienter med immunrelateret hepatitis blev behandlet med kortikosteroider og 15 (94 %) af de 16 patienter fik højdosis kortikosteroider i en mediantid på 14 dage (interval: 1 dag til 2,5 måneder). 
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).
• Oplysninger om, at avelumab kan forårsage alvorlige bivirkninger under og efter behandlingen, 
• Information that avelumab can cause serious side effects during or after treatment, that need to be treated right away and warning message on the importance of being aware of signs and symptoms while receiving avelumab treatment
Nyrer og urinveje 
Rash, pruritus
Ud af disse patienter var der 7 (0,4 %) patienter med grad 3 immunrelateret colitis. 
Of these patients, there were 7 (0.4%) patients with Grade 3 immune-related colitis.
Avelumab bør tilbageholdes ved grad 2 eller grad 3 immunrelateret colitis, indtil reaktionen går væk, og skal seponeres permanent for grad 4 eller tilbagevendende grad 3 immunrelateret colitis (se pkt. 
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).
Avelumab blev seponeret hos 0,3 % (6/1.738) af patienterne, på grund af immunrelateret pneumonitis. 
Avelumab was discontinued in 0.3% (6/1,738) of patients due to immune-related pneumonitis.
Kløende udslæt, makulopapuløst udslæt, generaliseret pruritus, dermatitis acneiform, erytem, makuløst udslæt, papulært udslæt, erytematøst udslæt, dermatitis, eksem, generaliseret udslæt 
Rash pruritic, rash maculo-papular, pruritus generalized, dermatitis acneiform, erythema, rash macular, rash papular, rash erythematous, dermatitis, eczema, rash generalized
• problemer med dine hormonproducerende kirtler (skjoldbruskkirtlen, binyrerne og hypofysen), 
• problems with your hormone producing glands (the thyroid, adrenal and pituitary glands) that may affect how these glands work;
Avelumab bør afbrydes ved grad 3 eller grad 4 tyreoideasygdomme (se pkt. 
Avelumab should be withheld for Grade 3 or Grade 4 thyroid disorders (see section 4.2).
Andre immunrelaterede bivirkninger 
Other immune-related adverse reactions
• Ledsmerter, rygsmerter, mavesmerter, muskelsmerter 
• Joint pain, back pain, belly pain, muscle pain
Avelumab skal seponeres permanent ved alle grad 3 immunrelaterede bivirkninger, der vender tilbage, og ved grad 4 immunrelaterede bivirkninger (se pkt. 
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).
Avelumab blev seponeret hos 0,5 % (9/1.738) af patienterne, på grund af immunrelateret hepatitis. 
Avelumab was discontinued in 0.5% (9/1,738) of patients due to immune-related hepatitis.
Hos patienter behandlet med avelumab som monoterapi udviklede 1,2 % (21/1.738) af patienterne immunrelateret pneumonitis. 
In patients treated with avelumab as monotherapy, 1.2% (21/1,738) of patients developed immune-related pneumonitis.
Et tilfælde med dødelig udgang er blevet rapporteret hos patienter, der fik avelumab (se pkt. 
One fatal case has been reported in patients receiving avelumab (see section 4.8).
Forhøjet gamma-glutamyltransferase, forhøjet basisk phosphatase i blodet, forhøjet amylase, forhøjet lipase, forhøjet kreatinin i blodet Ikke almindelig Forhøjet alaninaminotransferase (ALAT)*, forhøjet aspartataminotransferase (ASAT)*, forhøjet kreatinphosphokinase i blodet*, forhøjede transaminer* 
Alanine aminotransferase (ALT) increased*, aspartate aminotransferase (AST) increased*, blood creatine phosphokinase increased*, transaminases increased*
• Hæshed, hoste, stakåndethed 
• Hoarseness, cough, shortness of breath
Hos patienter behandlet med avelumab i kombination med axitinib udviklede 6,3 % (31/489) af patienterne immunrelateret hepatitis. 
In patients treated with avelumab in combination with axitinib, 6.3% (31/489) of patients developed immune-related hepatitis.
Akut nyreskade 
Acute kidney injury
Formodet myokarditis 
Suspected myocarditis
• Hovedpine, svimmelhed 
• Headache, dizziness
Hos patienter behandlet med avelumab i kombination med axitinib udviklede 0,6 % (3/489) af patienterne immunrelateret pneumonitis. 
In patients treated with avelumab in combination with axitinib, 0.6% (3/489) of patients developed immune-related pneumonitis.
Mediantiden til immunrelateret pneumonitis opstod var 2,3 måneder (interval: 2,1 uger til 14,5 måneder). 
The median time to onset of immune-related hepatitis was 2.3 months (range: 2.1 weeks to 14.5 months).
Avelumab bør afbrydes ved grad 2 immunrelateret hepatitis, indtil reaktionen går væk, og skal seponeres permanent for grad 3 eller grad 4 immunrelateret hepatitis (se pkt. 
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).
Kontakt derimod din læge som kan 
Your doctor may
Hos patienter behandlet med avelumab som monoterapi udviklede 0,9 % (16/1.738) af patienterne immunrelateret hepatitis. 
In patients treated with avelumab as monotherapy, 0.9% (16/1,738) of patients developed immune-related hepatitis.
Binyreinsufficiens 
Adrenal insufficiency
Hos patienter behandlet med avelumab i kombination med axitinib udviklede 1,8 % (9/489) af patienterne immunrelateret binyreinsufficiens. 
In patients treated with avelumab in combination with axitinib, 1.8% (9/489) of patients developed immune-related adrenal insufficiency.
Ud af disse patienter var der 1 (0,1 %) patient med grad 3 immunrelateret binyreinsufficiens. 
Of these patients, there was 1 (0.1%) patient with Grade 3 immune-related adrenal insufficiency.
Avelumab blev seponeret hos 0,2% (1/489) af patienterne, på grund af immunrelaterede tyreoideasygdomme. 
Avelumab was discontinued in 0.2% (1/489) of patients due to immune-related thyroid disorders.
Pustuløst udslæt 
Hepatic impairment
Der bør administreres kortikosteroider (indledende dosis på 1-2 mg/kg/dag prednison eller tilsvarende, efterfulgt af en nedtrapning af kortikosteroider) til nefritis grad ≥ 2. 
Corticosteroids (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a corticosteroid taper) should be administered for Grade ≥ 2 nephritis.
Hypertension, hypotension Ikke almindelig Rødme 
Hypertension, hypotension
• Hoste, stakåndethed 
Headache, dizziness
Grad 1 infusionsrelateret reaktion 
Infusion-related reactions Grade 1 infusion-related reaction
Medianalderen var 74 år (interval 41 til 93 år), 75 (65 %) var kaukasere og 72 (62 %) og 44 (38 %) havde en ECOG performancestatus på hhv. 0 og 1. 
Of the 116 patients, 81 (70%) were male, the median age was 74 years (range: 41 to 93 years), 75 (65%) were Caucasian, and 72 (62%) and 44 (38%) had an ECOG performance status of 0 and 1, respectively.
Hos patienter behandlet med avelumab som monoterapi udviklede 0,5 % (8/1.738) af patienterne immunrelateret binyreinsufficiens. 
In patients treated with avelumab as monotherapy, 0.5% (8/1,738) of patients developed immune-related adrenal insufficiency.
Avelumab blev seponeret hos 0,5 % (9/1.738) af patienterne, på grund af immunrelateret colitis. 
Avelumab was discontinued in 0.5% (9/1,738) of patients due to immune-related colitis.
kulderystelser eller rysten, ujævnt udslæt eller hudvabler, rødmen, lavt blodtryk 
bumpy rash or skin wheals, flushing, low blood pressure (dizziness, fatigue, nausea) fever,
• Forhøjet niveau af enzymer fra bugspytkirtlen i blodet 
• Increased pancreatic enzymes in the blood
Afbryd 
Withhold
men < 3 gange ULN, skal både Bavencio og axitinib afbrydes, indtil disse bivirkninger bedres til grad 0-1. 
Treatment modifications when Bavencio is used in combination with axitinib If ALT or AST ≥ 3 times ULN but < 5 times ULN or total bilirubin ≥ 1.5 times ULN but < 3 times ULN, both Bavencio and axitinib should be withheld until these adverse reactions recover to Grades 0-1.
Meget almindelig Dysfoni, hoste, dyspnø Almindelig 
Dysphonia, cough, dyspnoea