natgillin/translations-raw huggingface dataset:
Hos patienter behandlet med avelumab i kombination med axitinib blev der rapporteret grad 3 og grad 4 forhøjet ALAT og forhøjet ASAT hos hhv. 9 % og 7 % af patienterne. 
In patients treated with avelumab in combination with axitinib, Grades 3 and Grade 4 increased ALT and increased AST were reported in 9% and 7% of patients, respectively.
• Forhøjet eller nedsat blodtryk 
• Increases or decreases in blood pressure
E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE VILKÅR 
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Afbryd, indtil bivirkningerne bedres til grad 0-1, genoptag infusionen med 50 % langsommere hastighed 
Withhold until adverse reactions recover to Grade 0-1; restart infusion with a 50% slower rate
Patienterne skal overvåges for tegn og symptomer på binyreinsufficiens under og efter behandlingen. 
Patients should be monitored for signs and symptoms of adrenal insufficiency during and after treatment.
Responsrate, CR+PR** n (%) (95 % CI) 
Response rate, CR+PR** n (%) (95% CI)
Dette er ikke almindeligt. 
This is uncommon.
Den præspecificerede interimanalyse for del B omfattede 39 patienter, som fik mindst én dosis af avelumab og 29 patienter med en minumumsopfølgning på 13 uger på tidspunktet for dataafskæringen (cut-off-dato 24. marts 2017). 
The prespecified interim analysis for Part B included 39 patients who received at least one dose of avelumab and 29 patients with a minimum 13 weeks of follow-up at the time of the data cut-off (cut-off date 24 March 2017).
Den største gennemsnitlige maksimale reduktion (% variationskoefficient [coefficient of variation, CV %]) fra værdien ved baseline med forskellige tumortyper var ca. 32,1 % (CV 36,2 %). 
In the supplemental analysis, avelumab CL was found to decrease over time: the largest mean maximal reduction (% coefficient of variation [CV%]) from baseline value with different tumour types was approximately 32.1% (CV 36.2%).
Bavencio er en klar, farveløs til let gullig opløsning. 
Bavencio is a clear, colourless to slightly yellow solution.
Baseret på bivirkningens sværhedsgrad, skal avelumab afbrydes, og der skal administreres kortikosteroider. 
Based on the severity of the adverse reaction, avelumab should be withheld and corticosteroids to be administered.
Avelumab er et humant, monoklonalt IgG1-antistof rettet mod det immunmodulerende ligandprotein på celleoverfladen, PD-L1.Det fremstilles i ovariecellerne fra kinesiske hamstere ved hjælp af rekombinant dna-teknologi. 
Avelumab is a human monoclonal IgG1 antibody directed against the immunomodulatory cell surface ligand protein PD-L1 and produced in Chinese hamster ovary cells by recombinant DNA technology.
Dette er meget almindeligt. 
This is very common.
Grad 3 eller grad 4 pneumonitis eller tilbagevendende grad 2 pneumonitis 
Grade 3 or Grade 4 pneumonitis or recurrent Grade 2 pneumonitis
Hvis opløsningen er uklar, misfarvet eller hvis den indeholder partikler, må hætteglasset ikke anvendes. 
If the solution is cloudy, discoloured, or contains particulate matters, the vial should be discarded.
Detaljerede retningslinjer for behandling af immunrelaterede bivirkninger beskrives i pkt. 
Detailed guidelines for the management of immune-related adverse reactions are described in section 4.4.
Bivirkninger rapporteret for 489 patienter med fremskredent RCC behandlet i 2 kliniske studier med avelumab i kombination med axitinib vises i tabel 3. 
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.
De følgende bivirkninger er blevet indberettet i de kliniske studier med avelumab alene: Nogle bivirkninger har måske ikke symptomer, og kan kun opdages ved blodprøver. 
Some side effects may not have symptoms and may only be discovered through blood tests.
Bekræftet objektiv responsrate (ORR) 
Confirmed objective response rate (ORR)
Dette er almindeligt. 
This is common.
Behandlingsmodifikation 
Treatment modification
Reducer infusionshastigheden med 
Reduce infusion rate by
Hyppighederne defineres som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden 
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to
Meget almindelig Nedsat appetit Almindelig 
Decreased appetite
En dosisreduktion i henhold til produktinformation for axitinib bør overvejes, hvis axitinib genoptages. 
Dose reduction according to the axitinib product information should be considered if rechallenging with axitinib.
Kvinder i den fertile alder skal rådes til at undgå graviditet, mens de får avelumab, og de bør anvende sikker kontraception under behandlingen med avelumab og i mindst 1 måned efter den sidste dosis avelumab. 
Women of childbearing potential should be advised to avoid becoming pregnant while receiving avelumab and should use effective contraception during treatment with avelumab and for at least 1 month after the last dose of avelumab.
Uddannelsesprogrammet er beregnet til at øge kendskabet og give oplysninger om tegn og symptomer på visse vigtige identificerede risici ved avelumab, herunder immunrelateret pneumonitis, hepatitis, colitis, pankreatitis, myokarditis, tyreoideasygdomme, binyreinsufficiens, type 1 diabetes mellitus, nefritis og nyredysfunktion, myositis, hypopituitarisme, uveitis, Guillain-Barrés syndrom og infusionsrelaterede reaktioner, og hvordan de skal behandles. 
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.
Behandlingsmodifikationer 
Treatment modifications
Resultater (N = 88) 
Results (N=88)
(≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000). 
< 1/1,000); very rare (< 1/10,000).
Hos patienter med infusionsrelaterede reaktioner af grad 2 skal infusionen midlertidigt afbrydes, indtil reaktionen er af grad 1 eller er forsvundet, og så kan infusionen påbegyndes igen med en 50 % langsommere infusionshastighed (se pkt. 
For patients with Grade 2 infusion-related reactions, the infusion should be temporary discontinued until Grade 1 or resolved, then the infusion will restart with a 50% slower infusion rate (see section 4.2).
Ud af de 480 patienter med mindst et gyldigt ADA-resultat på et vilkårligt tidspunkt, behandlet med avelumab 10 mg/kg som en intravenøs infusion hver 2. uge i kombination med axitinib 5 mg to gange dagligt, kunne 453 evalueres for ADA, som opstod under behandlingen, og 66 (14,6 %) testede positivt. 
Of the 480 patients with at least one valid ADA result at any time point treated with avelumab 10 mg/kg as an intravenous infusion every 2 weeks in combination with axitinib 5 mg twice daily, 453 were evaluable for treatment-emergent ADA and 66 (14.6%) tested positive.
• Tegn på betændelse i musklerne (myositis) kan omfatte muskelsmerter eller svaghed. 
• Signs of inflammation of the muscles (myositis) may include muscle pain or weakness.
• Øjenbetændelse 
• Inflammation of the eye
I tilfælde af en overdosering, skal patienterne overvåges nøje for tegn og symptomer på bivirkninger. 
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions.
Tabel 4 opsummerer endepunkter for virkning hos patienter, der fik avelumab ved den anbefalede dosis for studie EMR100070-003, del A, med en minimumsopfølgning på 36 måneder. 
Table 4 summarises efficacy endpoints in patients receiving avelumab at the recommended dose for study EMR100070-003, Part A, with a minimum follow-up of 36 months.
Figur 1: Kaplan-Meier-estimater af progressionsfri overlevelse (PFS) pr. RECIST v1.1, IERC (del A, minimumsopfølgning på 36 måneder) 
Figure 1: Kaplan-Meier estimates of progression-free survival (PFS) per RECIST v1.1, IERC (Part A, minimum follow-up of 36 months)
Koncentreret eddikesyre Polysorbat 20 
Glacial acetic acid Polysorbate 20
Avelumabs sikkerhed i kombination med axitinib er blevet evalueret hos 489 patienter med fremskredent RCC, der fik 10 mg/kg avelumab hver 2. uge, og axitinib 5 mg oralt to gange dagligt i 2 kliniske studier. 
The safety of avelumab in combination with axitinib has been evaluated in 489 patients with advanced RCC receiving 10 mg/kg avelumab every 2 weeks and axitinib 5 mg orally twice daily in two clinical studies.
Spørg lægen eller sundhedspersonalet, før du får Bavencio, hvis: 
Check with your doctor or nurse before you receive Bavencio if:
Endokrinopatier (hypotyroidisme, hypertyroidisme, adrenal insufficiens, hyperglykæmi) 
Endocrinopathies (hypothyroidism, hyperthyroidism, adrenal insufficiency, hyperglycaemia)
Avelumab bør tilbageholdes i tilfælde af formodet immunrelateret pankreatitis. 
Avelumab should be withheld in the event of suspected immune-related pancreatitis.
Anbefaling om dosisjustering for axitinib, når det anvendes sammen med Bavencio Når Bavencio administreres i kombination med axitinib henvises til produktinformationen for axitinib for anbefalinger om dosisjusteringer for axitinib. 
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.
Negativ (n = 31) 
Negative (n=31)
Grad 3 eller grad 4 infusionsrelateret reaktion 
Grade 3 or Grade 4 infusion-related reaction
Der er ikke tilstrækkelige data for patienter med svært nedsat nyrefunktion til doseringsanbefalinger. 
There are insufficient data in patients with severe renal impairment for dosing recommendations.
Hvis kortikosteroiderne anvendes til at behandle en bivirkning, skal behandlingen med kortikosteroider nedtrappes over mindst 1 måned, efter forbedring er observeret. 
If corticosteroids are used to treat an adverse reaction, a taper of at least 1 month duration should be initiated upon improvement.
Patienter med tidligere systemisk behandling rettet mod fremskredent eller metastatisk RCC; tidligere systemisk immunterapeutisk behandling med IL-2-, IFN-α-, anti-PD-1-, anti-PD-L1- eller anti-CTLA-4-antistoffer eller aktive hjernemetastaser, aktiv autoimmunsygdom, der kan forværres, når der fås immunstimulerende midler, andre tidligere maligniteter i anamnesen inden for de sidste 5 år, organtransplantation, var ikke egnede. 
Patients with prior systemic therapy directed at advanced or metastatic RCC; prior systemic immunotherapy treatment with IL-2, IFN-α, anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or active brain metastasis; active autoimmune disease that might deteriorate when receiving an immunostimulatory agents; a history of other malignancies within the last 5 years; organ transplant were ineligible.
• Influenzalignende sygdom (herunder feberfornemmelser, muskelsmerter) 
• Flu-like illness (includes feeling of fever, muscle aches)
Forhøjet kreatinin i blodet, forhøjet amylase, forhøjet lipase, forhøjet gamma-glutamyltransferase, forhøjet basisk phosphatase i blodet, forhøjet kreatinphosphokinase i blodet, nedsat tyroideastimulerende hormon i blodet, forhøjede transaminaser 
Blood creatinine increased, amylase increased, lipase increased, gamma-glutamyltransferase increased, blood alkaline phosphatase increased, blood creatine phosphokinase increased, blood thyroid stimulating hormone decreased, transaminases increased
12-måneders PFS-rate ved K-M, (95 % CI)** 52,4% (47,4; 57,2) 18-måneders PFS-rate ved K-M, (95 % CI)** 43,9% (38,8; 49,0) 
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)
Mediantiden til type 1 diabetes mellitus opstod var 1,9 måneder (interval: 1,1 måneder til 7,3 måneder). 
The median time to onset of Type 1 diabetes mellitus was 1.9 months (range: 1.1 months to 7.3 months).
ASAT eller ALAT over 5 gange ULN eller totalt bilirubin over 3 gange ULN 
AST or ALT greater than 5 times ULN or total bilirubin greater than 3 times ULN
Objektiv responsrate (ORR) 
Objective response rate (ORR)
For at bekræfte virkningen hos kemoterapi-naive patienter, der behandles, skal indehaveren af markedsføringstilladelsen indsende de endelige resultater af studiet EMR100070-003 - del B. 
In order to confirm the efficacy for chemotherapy-naïve treated patients, the MAH should submit the final results of study EMR 100070-003 - Part B.
Tumorprøver blev undersøgt for PD-L1-ekspression på tumorceller og for Merkelcelle-polyomavirus (MCV) med en eksperimentel immunhistokemisk test (IHC). 
Tumour samples were evaluated for PD-L1 tumour cell expression, and for Merkel cell polyomavirus (MCV) using an investigational immunohistochemistry (IHC) assay.
Figur 4: Forest-afbildning af progressionsfri overlevelse baseret på BICR-vurdering hos patienter uanset ekspression af PD-L1 
Figure 4: Forest plot of progression-free survival based on BICR assessment in patients irrespective of PD-L1 expression
Hvis du holder op med at få Bavencio 
If you stop receiving Bavencio
De følgende bivirkninger er blevet indberettet i de kliniske studier med avelumab i kombination med axitinib: 
The following side effects have been reported in clinical trials with avelumab in combination with axitinib:
Der er ikke tilstrækkelige data for patienter med moderat eller svært nedsat leverfunktion til doseringsanbefalinger. 
There are insufficient data in patients with moderate or severe hepatic impairment for dosing recommendations.
Meget almindelig Vægttab, forhøjet alaninaminotransferase (ALAT), forhøjet aspartataminotransferase (ASAT) 
Weight decreased, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased
Objektiv responsrate (ORR) n (%) (95% CI) 
Objective response rate (ORR) n (%) (95% CI)
Type 1 diabetes mellitus Avelumab kan forårsage type 1 diabetes mellitus, herunder diabetisk ketoacidose (se pkt. 
Type 1 diabetes mellitus Avelumab can cause Type 1 diabetes mellitus, including diabetic ketoacidosis (see section 4.8).
• Nedsat antal røde blodlegemer 
• Decrease in the number of red blood cells
Brug af anden medicin sammen med Bavencio 
Other medicines and Bavencio
Andre klinisk vigtige immunrelaterede bivirkninger blev rapporteret hos under 1 % af patienterne: myositis, hypopituitarisme, uveitis, og Guillain-Barrés syndrom (se pkt. 
Other clinically important immune-related adverse reactions were reported in less than 1% of patients: myositis, hypopituitarism, uveitis, and Guillain-Barré syndrome (see section 4.8).
Behandling med insulin påbegyndes ved type 1 diabetes mellitus. 
Initiate treatment with insulin for Type 1 diabetes mellitus.
Hos denne patientpopulation var de mest almindelige bivirkninger diarré (62,8 %), hypertension (49,3 %), træthed (42,9 %), kvalme (33,5 %), dysfoni (32,7 %), nedsat appetit (26,0 %), hypotyroidisme (25,2 %), hoste (23,7 %), hovedpine (21,3 %), dyspnø (20,9 %) og artralgi (20,9 %). 
In this patient population, the most common adverse reactions were diarrhoea (62.8%), hypertension (49.3%), fatigue (42.9%), nausea (33.5%), dysphonia (32.7%), decreased appetite (26.0%), hypothyroidism (25.2%), cough (23.7%), headache (21.3%), dyspnoea (20.9%), and arthralgia
Klar, farveløs til let gullig opløsning. 
Clear, colourless to slightly yellow solution.
Ældre Dosisjustering er ikke nødvendig for ældre patienter (≥ 65 år) (se pkt. 
Elderly No dose adjustment is needed for elderly patients (≥ 65 years) (see sections 5.1 and 5.2).
28 (90,3 %) ud af 31 patienter fik højdosis kortikosteroider i en median periode på 2,4 uger (interval: 1 dag til 10,2 måneder). 
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).
Infusionsrelaterede reaktioner, som kan være svære, er blevet rapporteret hos patienter, der fik avelumab (se pkt. 
Infusion-related reactions, which might be severe, have been reported in patients receiving avelumab (see section 4.8).
Avelumab er et humant immunoglobulin G1 (IgG1) monoklonalt antistof rettet mod liganden for programmeret celledød 1 (PD-L1). 
Avelumab is a human immunoglobulin G1 (IgG1) monoclonal antibody directed against programmed death ligand 1 (PD-L1).
Produktgrænse overlevelsesestimat (N = 116) 
Product-Limit Survival Estimate (N=116)
Hjælpestoffer: Mannitol, koncentreret eddikesyre, polysorbat 20, natriumhydroxid, vand til injektionsvæsker. 
Excipients: Mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injections.
Ikke almindelig Colitis*, autoimmun colitis*, enterocolitis*, ileus Sjælden 
Colitis*, autoimmune colitis*, enterocolitis*, ileus
• tarmbetændelse (colitis), diarré (vandig, løs eller blød afføring) eller flere afføringer end normalt, 
• inflammation of your intestines (colitis), diarrhoea (watery, loose or soft stools) or more bowel movements than usual;
Binyreinsufficiens gik væk hos 1 patient efter kortikoidbehandling på tidspunktet for data cut-off. 
Adrenal insufficiency resolved in 1 patient with corticoid treatment at the time of data cut-off.
Hepatitis, hepatotoksicitet, immunmedieret hepatitis, leversygdom 
Hepatitis, hepatotoxicity, immune-mediated hepatitis, liver disorder
Retningslinjerne for behandling af disse bivirkninger er beskrevet i pkt. 
The management guidelines for these adverse reactions are described in section 4.4.
• Tilbagevendende grad 3 immunrelateret bivirkning 
• Recurrent Grade 3 immune-related adverse reaction
Forberedelse og administration Anvend aseptisk teknik for at forberede infusionsvæsken, opløsningen. 
Preparation and administration An aseptic technique for the preparation of the solution for infusion should be used.
Komplet respons (complete response, CR)** n (%) Partielt respons (partial response, PR)** n (%) 
Complete response (CR)** n (%) Partial response (PR)** n (%)
• Tegn på type 1 diabetes kan omfatte en større sult- eller tørstfølelse end normalt, et hyppigere vandladningsbehov, vægttab og træthedsfølelse. 
• Signs of type 1 diabetes may include feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired.
Der opstod hepatotoksicitet hos patienter i behandling med avelumab i kombination med axitinib med højere end forventede hyppigheder af grad 3 og grad 4 ALAT- og ASAT-forhøjelser, sammenlignet med avelumab alene (se pkt. 
Hepatotoxicity occurred in patients treated with avelumab in combination with axitinib with higher than expected frequencies of Grade 3 and Grade 4 ALT and AST elevation compared to avelumab alone (see section 4.8).
Farmakokinetikken for avelumab blev vurderet ved brug af en population til at undersøge farmakokinetikken for avelumab som monoterapi, og avelumab i kombination med axitinib. 
Avelumab pharmacokinetics (PK) was assessed using a population PK approach for avelumab as monotherapy and avelumab in combination with axitinib.
Positiv (n = 19) Negativ (n = 55) 
Positive (n=19) Negative (n=55)
Hvis du ammer, skal du fortælle det til lægen. 
If you are breast-feeding, tell your doctor.
Positiv (n = 58) Negativ (n = 16) 
Positive (n=58) Negative (n=16)
Der blev ikke fundet nogen klinisk vigtige forskelle i clearance af avelumab mellem patienter med let nedsat leverfunktion (bilirubin ≤ ULN og ASAT > ULN eller bilirubin fra 1 til 1,5 gange ULN, n = 217) og normal leverfunktion (bilirubin og ASAT ≤ ULN, n = 1.388) i en populationsfarmakokinetisk analyse. 
No clinically important differences in the clearance of avelumab were found between patients with mild hepatic impairment (bilirubin ≤ ULN and AST > ULN or bilirubin between 1 and 1.5 times ULN, n=217) and normal hepatic function (bilirubin and AST ≤ ULN, n=1,388) in a population PK analysis.
Avelumab bør tilbageholdes i tilfælde af formodet immunrelateret myokarditis. 
Avelumab should be withheld in the event of suspected immune-related myocarditis.
Der er ikke udført interaktionsstudier med avelumab. 
No interaction studies have been conducted with avelumab.
I murine(mus) drægtighedsmodeller har blokeringen af PD-L1-signalering vist forstyrrelse i tolerancen over for fosteret, og medført et øget fostertab (se pkt. 
However, in murine models of pregnancy, blockade of PD-L1 signalling has been shown to disrupt tolerance to the foetus and to result in an increased foetal loss (see section 5.3).
Håndteringsanvisninger 
Handling instructions
Koncentrat til infusionsvæske, opløsning (koncentrat, sterilt). 
Concentrate for solution for infusion (sterile concentrate).
Tabel 6 opsummerer den efterfølgende interimanalyse af effektendepunkter, herunder et estimat af hyppighederne for DOR og PSF efter 6 måneder ved Kaplan-Meier, hos patienter, der fik avelumab ved den anbefalede dosis for studie EMR100070-003, del B. 
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.
Hos denne patientpopulation var de mest almindelige bivirkninger med avelumab træthed (32,4 %), kvalme (25,1 %), diarré (18,9 %), nedsat appetit (18,4 %), obstipation (18,4 %), infusionsrelaterede reaktioner (17,1 %), vægttab (16,6 %) og opkastning (16,2 %). 
In this patient population, the most common adverse reactions with avelumab were fatigue (32.4%), nausea (25.1%), diarrhoea (18.9%), decreased appetite (18.4%), constipation (18.4%), infusion-related reactions (17.1%), weight decreased (16.6%), and vomiting (16.2%).
Immunrelateret nefritis og nyredysfunktion Avelumab kan forårsage immunrelateret nefritis (se pkt. 
Immune-related nephritis and renal dysfunction Avelumab can cause immune-related nephritis (see section 4.8).
Der er ikke udført reproduktionsstudier hos dyr med avelumab. 
Animal reproduction studies have not been conducted with avelumab.
Immunrelateret hepatitis 
Immune-related hepatitis
Avelumab er ikke blevet undersøgt hos patienter med moderat nedsat leverfunktion (bilirubin fra 1,5 til 3 gange ULN) eller svært nedsat leverfunktion (bilirubin > 3 gange ULN). 
Avelumab has not been studied in patients with moderate hepatic impairment (bilirubin between 1.5 and 3 times ULN) or severe hepatic impairment (bilirubin > 3 times ULN).
efter fortynding 
After opening
Almindelig (kan forekomme hos op til 1 ud af 10 personer) 
Common (may affect up to 1 in 10 people)
Ved infusionsrelaterede reaktioner af grad 3 eller grad 4 skal infusionen stoppes, og avelumab skal seponeres permanent (se pkt. 
For Grade 3 or Grade 4 infusion-related reactions, the infusion should be stopped and avelumab should be permanently discontinued (see section 4.2).
Minimum, maksimum (måneder) ≥ 3 måneder ved K-M, (95 % CI) ≥ 6 måneder ved K-M, (95 % CI) ≥ 12 måneder ved K-M, (95 % CI) 
Minimum, maximum (months) ≥ 3 months by K-M, (95% CI) ≥ 6 months by K-M, (95% CI) ≥ 12 months by K-M, (95% CI)
Tyreoideasygdommene gik væk hos 15 (12,4 %) af de 121 patienter på tidspunktet for data cut-off. 
Thyroid disorders resolved in 15 (12.4%) of the 121 patients at the time of data cut-off.
• Anbefaling om at se indlægssedlen 
• Recommendation to consult the package leaflet
Figur 2: Kaplan-Meier-estimater for progressionsfri overlevelse (PFS) pr. RECIST v1.1, IERC (del B, N=116) 
Figure 2: Kaplan-Meier estimates of progression-free survival (PFS) per RECIST v1.1, IERC (Part B, N=116)
• Nedsat antal af en type af hvide blodlegemer (lymfocytter) 
• Decrease in the number of a type of white blood cells (lymphocytes)
Patienterne skal overvåges for kliniske tegn og symptomer på endokrinopatier. 
Patients should be monitored for clinical signs and symptoms of endocrinopathies.
Det rette volumen Bavencio skal trækkes up af hætteglasset/hætteglassene, og overføres til infusionsposen. 
The required volume of Bavencio should be withdrawn from the vial(s) and be transferred to the infusion bag.
Den fortyndede opløsning må ikke nedfryses eller omrystes. 
Do not freeze or shake the diluted solution.