FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from SCCHN and adjuvant melanoma patients 75 years of age or older are too limited to draw conclusions on this population (see section 5.1).
Danish: Data fra SCCHN- og adjuverende melanom-patienter ≥ 75 år er for begrænsede til at kunne drage konklusioner for denne population (se pkt.
English: Severe hepatitis has been observed with nivolumab monotherapy or nivolumab in combination with ipilimumab (see section 4.8).
Danish: Svær hepatitis er observeret med nivolumab-monoterapi eller nivolumab i kombination med ipilimumab (se pkt.
English: Monotherapy phase
Danish: Monoterapifase
English: Skin colour change in patches (vitiligo), dry skin, redness of the skin, unusual hair loss or thinning, hives (itchy rash)
Danish: Pletvise farveændringer af huden (vitiligo), tør hud, hudrødme, unormalt hårtab eller udtynding af håret, nældefeber (kløende udslæt)
English: Inflammation of the nerves (causing numbness, weakness, tingling or burning pain of the arms and legs), headache, dizziness
Danish: Betændelseslignende reaktion i nerverne (som medfører følelsesløshed, svaghed, snurrende fornemmelse eller brændende smerter i arme og ben), hovedpine, svimmelhed Forhøjet blodtryk (hypertension)
English: Infections and infestations Common upper respiratory tract infection Uncommon pneumoniaa, bronchitis Not known aseptic meningitish
Danish: Infektioner og parasitære sygdomme Almindelig infektion i øvre luftveje Ikke almindelig pneumonia, bronkitis
English: Grade 3 and 4 cases were reported in 0.4% (11/2578) and <0.1% (1/2578) of patients, respectively.
Danish: Grad 3 og 4 tilfælde blev rapporteret hos henholdsvis 0,4 % (11/2.578) og <0,1 % (1/2.578) af patienterne.
English: Nivolumab+Ipilimumab (events: 111/210), median and 95% CI: 11.10 (7.98, 22.18) ──Δ─── Nivolumab (events: 125/208), median and 95% CI: 5.32 (2.83, 7.06) Ipilimumab (events: 159/202), median and 95% CI: 2.83 (2.76, 3.09)
Danish: Nivolumab+ipilimumab (hændelser: 111/210), median og 95 % CI: 11,10 (7,98; 22,18) ──Δ─── Nivolumab (hændelser: 125/208), median og 95 % CI: 5,32 (2,83; 7,06) Ipilimumab (hændelser: 159/202), median og 95 % CI: 2,83 (2,76; 3,09)
English: Randomised phase 3 study vs. chemotherapy (CA209037)
Danish: Randomiseret fase 3-studie versus kemoterapi (CA209037)
English: Stable disease, n (%) Duration of response in all responders (months)c
Danish: Stabil sygdom, n (%)
English: Nivolumab monotherapy should be withheld for Grade 3 diarrhoea or colitis, and corticosteroids initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Danish: Nivolumab-monoterapi skal udsættes ved grad 3 diarre eller colitis, og kortikosteroid initieres med en dosis ækvivalent med 1-2 mg/kg/dag methylprednisolon.
English: Overall survival Events
Danish: Samlet overlevelsea Hændelser
English: Squamous Cell Cancer of the Head and Neck (SCCHN) OPDIVO as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy (see section 5.1).
Danish: OPDIVO som monoterapi er indiceret til behandling af recidiverende eller metastatisk planocellulær hoved-halscancer hos voksne med sygdomsprogression under eller efter platinbaseret behandling (se pkt.
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of thyroid disorders was 25.2% (113/448).
Danish: Hos melanom-patienter, der blev behandlet med nivolumab 1 mg/kg i kombination med ipilimumab 3 mg/kg, var hyppigheden af thyroidearelaterede bivirkninger 25,2 % (113/448).
English: Figure 8: Kaplan-Meier curves of OS (CA209017)
Danish: Figur 8: Kaplan-Meier kurver for OS (CA209017)
English: Median time to onset was 2.6 months (range: 0.2520.6).
Danish: Mediantid til indtræden var 2,6 måneder (0,25-20,6).
English: The majority of cases were Grade 1 or 2 in severity reported in 1.6% (41/2578) and 0.7% (18/2578) of patients respectively.
Danish: Størstedelen af tilfældene var grad 1 eller 2 i sværhedsgrad og blev rapporteret hos henholdsvis 1,6 % (41/2.578) og 0,7 % (18/2.578) af patienterne.
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of liver function test abnormalities was 29.5% (132/448).
Danish: Hos melanom-patienter, der blev behandlet med nivolumab 1 mg/kg i kombination med ipilimumab 3 mg/kg, var hyppigheden af abnorme leverfunktionstests 29,5 % (132/448).
English: The median age was 66 years (range: 38 to 90) with 55% ≥65 years of age and 14% ≥75 years of age.
Danish: Medianalderen var 66 år (38 til 90 ) med 55 % >65 år og 14 % >75 år.
English: Sjogren's syndrome, myopathy, myositis (including polymyositis)a,f,
Danish: Sjælden Sjögrens syndrom, myopati, myositis (inklusive polymyositis)a,f, rabdomyolysea,f Nyrer og urinveje
English: Mouth ulcers and cold sores (stomatitis), inflammation of the pancreas (pancreatitis), constipation, dry mouth
Danish: Mundsår og forkølelsessår (stomatitis), betændelseslignende reaktion i bugspytkirtlen (pankreatitis), forstoppelse, mundtørhed
English: The Kaplan-Meier curves for OS are shown in Figure 9.
Danish: Kaplan-Meier kurverne for OS er vist i figur 9.
English: Median time to onset was 1.8 months (range: 0.0-26.6).
Danish: Mediantid til indtræden var 1,8 måneder (0,0-26,6).
English: Grade 2, Grade 3, and Grade 4 adrenal insufficiency (including secondary adrenocortical insufficiency) occurred in 1.6% (7/448), 1.3% (6/448) and 0.2% (1/448) of patients, respectively.
Danish: Grad 2, grad 3 og grad 4 binyrebarkinsufficiens (inklusive sekundær binyrebarkinsufficiens) forekom hos henholdsvis 1,6 % (7/448), 1,3 % (6/448) og 0,2 % (1/448) af patienterne.
English: The median age was 62 years (range: 21 to 85) with 34% ≥65 years of age and 7% ≥75 years of age.
Danish: Medianalderen var 62 år (21 til 85) med 34 % ≥65 år og 7 % ≥75 år.
English: Median time to onset was 1.2 months (range: 0.0-24.7).
Danish: Mediantid til indtræden var 1,2 måneder (0,0-24,7).
English: Although the clearance of nivolumab was increased by 20% when anti-nivolumab-antibodies were present, there was no evidence of loss of efficacy or altered toxicity profile in the presence of nivolumab antibodies based on the pharmacokinetic and exposure-response analyses for both monotherapy and combination.
Danish: Vurderet ud fra analyser af farmakokinetik og eksponeringsrespons for både monoterapi og kombinationsbehandlingen viste tilstedeværelse af antistoffer mod nivolumab ikke tegn på nedsat virkning eller ændret toksicitetsprofil, selvom clearance af nivolumab blev øget med 20 % ved tilstedeværelse af anti-nivolumab-antistoffer.
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of rash was 48.8% (267/547).
Danish: Hos RCC-patienter, der blev behandlet med nivolumab 3 mg/kg i kombination med ipilimumab 1 mg/kg, var hyppigheden af udslæt 48,8 % (267/547).
English: Not known tumour lysis syndromei Hepatobiliary disorders Common hepatitisc hepatitisc
Danish: Ikke kendt tumorlysesyndromi Lever og galdeveje Almindelig hepatitisc hepatitisc
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of thyroid disorders was 27.2% (149/547).
Danish: Hos RCC-patienter, der blev behandlet med nivolumab 3 mg/kg i kombination med ipilimumab 1 mg/kg, var hyppigheden af thyroidearelaterede bivirkninger 27,2 % (149/547).
English: Patients with a baseline performance score ≥ 2, active brain metastases or leptomeningeal metastases, autoimmune disease, and patients who had been receiving systemic immunosuppressants prior to study entry were excluded from the pivotal clinical trials of nivolumab or nivolumab in combination with ipilimumab (see sections 4.5 and 5.1).
Danish: Patienter med en performance-score ved baseline ≥ 2, aktive hjernemetastaser eller leptomeningeale metastaser, autoimmun sygdom og patienter, som havde fået systemiske immunsuppressiva før studieinklusion, blev ikke inkluderet i de pivotale kliniske studier med nivolumab eller nivolumab i kombination med ipilimumab (se pkt.
English: The safety and efficacy of nivolumab 3 mg/kg for the treatment of advanced (unresectable or metastatic) melanoma were evaluated in a phase 3, randomised, open-label study (CA209037).
Danish: Sikkerheden og virkningen af nivolumab 3 mg/kg til behandling af fremskredent (inoperabelt eller metastatisk) melanom blev undersøgt i et randomiseret, åbent fase 3-studie (CA209037).
English: For symptomatic hypothyroidism, nivolumab or nivolumab in combination with ipilimumab should be withheld, and thyroid hormone replacement should be initiated as needed.
Danish: Ved symptomatisk hypotyroidisme bør nivolumab eller nivolumab i kombination med ipilimumab udsættes og substitutionsbehandling med thyroideahormon initieres efter behov.
English: The majority of cases were Grade 1 or 2 in severity reported in 3.5% (91/2578) and 1.2% (32/2578) of patients respectively.
Danish: Størstedelen af tilfældene var grad 1 eller 2 i sværhedsgrad og blev rapporteret hos henholdsvis 3,5 % (91/2.578) og 1,2 % (32/2.578) af patienterne.
English: Patients with a baseline performance score ≥ 2, active brain metastases or autoimmune disease, symptomatic interstitial lung disease, and patients who had been receiving systemic immunosuppressants prior to study entry were excluded from the pivotal clinical trials of NSCLC (see sections 4.5 and 5.1).
Danish: Patienter med en performance-score ≥ 2 ved baseline, aktive hjernemetastaser, autoimmun sygdom eller symptomatisk interstitiel lungesygdom og patienter, som havde fået systemiske immunsuppressiva før studieinklusion, blev udelukket fra de pivotale kliniske NSCLC-studier (se pkt.
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the proportion of patients who experienced a worsening from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 2.8% for anaemia (all Grade 3), 1.2% for thrombocytopaenia, 0.5% for leucopoenia, 6.7% for lymphopaenia, 0.7% for neutropaenia, 4.3% for increased alkaline phosphatase, 12.4% for increased AST, 15.3% for increased ALT, 1.2% for increased total bilirubin, 2.4% for increased creatinine, 5.3% for hyperglycaemia, 8.7% for increased amylase, 19.5% for increased lipase, 1.2% for hypocalcaemia, 0.2% each for hypernatraemia and hypercalcaemia, 0.5% for hyperkalemia, 0.3% for hypermagnesaemia, 4.8% for hypokalaemia, and 9.5% for hyponatraemia.
Danish: Hos melanom-patienter, der blev behandlet med nivolumab 1 mg/kg i kombination med ipilimumab 3 mg/kg, var andelen af patienter, som oplevede en forværring fra baseline til en grad 3 eller 4 abnorm laboratorietest, følgende: 2,8 % med anæmi (alle grad 3), 1,2 % med trombocytopeni, 0,5 % med leukopeni, 6,7 % med lymfopeni, 0,7 % med neutropeni, 4,3 % med forhøjet alkalisk phosphatase, 12,4 % med forhøjet ASAT, 15,3 % med forhøjet ALAT, 1,2 % med forhøjet total-bilirubin, 2,4 % med forhøjet kreatinin, 5,3 % med hyperglykæmi, 8,7 % med forhøjet amylase, 19,5 % med forhøjet lipase, 1,2 % med hypocalcæmi, 0,2 % med hypernatriæmi og hypercalcæmi, 0,5 % med hyperkaliæmi, 0,3 % med hypermagnesiæmi, 4,8 % med hypokaliæmi og 9,5 % med hyponatriæmi.
English: If you miss a dose of OPDIVO
Danish: Hvis du har glemt at få OPDIVO
English: Number of Subjects at Risk Nivolumab 3 mg/kg
Danish: Samlet overlevelse (måneder) Antal forsøgspersoner i risikogruppe Nivolumab 3 mg/kg
English: The majority of cases were Grade 1 or 2 in severity reported in 0.8% (21/2578) and 1.7% (44/2578) of patients respectively.
Danish: Størstedelen af tilfældene var grad 1 eller 2 i sværhedsgrad og blev rapporteret hos henholdsvis 0,8 % (21/2.578) og 1,7 % (44/2.578) af patienterne.
English: For Grade 2 or 3 serum creatinine elevation, nivolumab or nivolumab in combination with ipilimumab should be withheld, and corticosteroids should be initiated at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 2 eller 3 stigning i serumkreatinin bør nivolumab eller nivolumab i kombination med ipilimumab udsættes og kortikosteroid initieres med en dosis ækvivalent med 0,5-1 mg/kg/dag methylprednisolon.
English: Nivolumab+Ipilimumab (events: 63/155), median and 95% CI: N.A. (39.06, N.A.) ──Δ─── Nivolumab (events: 71/171), median and 95% CI: N.A. (40.21, N.A.) Ipilimumab (events: 103/164), median and 95% CI: 21.49 months (16.85, 29.08)
Danish: Nivolumab+Ipilimumab (hændelser: 63/155), median og 95 % CI: N.A. (39,06; N.A.) ──Δ─── Nivolumab (hændelser: 71/171), median og 95 % CI: N.A. (40,21; N.A.) Ipilimumab (hændelser: 103/164), median og 95 % CI: 21,49 måneder (16,85; 29,08)
English: Median time to onset was 2.1 months (range: 0.0-16.1).
Danish: Mediantid til indtræden var 2,1 måneder (0,0-16,1).
English: Unless an alternate aetiology has been identified, signs or symptoms of endocrinopathies should be considered immune-related.
Danish: Tegn og symptomer på endokrinopatier skal anses for at være immunrelaterede, medmindre en anden ætiologi er identificeret.
English: Data from cHL patients 65 years of age or older are too limited to draw conclusions on this population (see section 5.1).
Danish: Data fra patienter med klassisk HL på 65 år og derover er for begrænsede til at kunne drage konklusioner for denne population (se pkt.
English: Median time to onset was 1.4 months (range: 0.027.9).
Danish: Mediantid til indtræden var 1,4 måneder (0,0-27,9).
English: Randomised phase 3 study vs. docetaxel (CA209057)
Danish: Randomiseret fase-3 studie versus docetaxel (CA209057)
English: Figure 9: Kaplan-Meier curves of OS (CA209057)
Danish: Figur 9: Kaplan-Meier kurver for OS (CA209057)
English: Nivolumab+Ipilimumab (events: 63/123), median and 95% CI: 11.24 (6.93, 23.03) ──Δ─── Nivolumab (events: 77/117), median and 95% CI: 2.83 (2.76, 5.13) Ipilimumab (events: 87/113), median and 95% CI: 2.79 (2.66, 2.96)
Danish: Nivolumab+ipilimumab (hændelser: 63/123), median og 95 % CI: 11,24 (6,93; 23,03) ──Δ─── Nivolumab (hændelser: 77/117), median og 95 % CI: 2,83 (2,76; 5,13) Ipilimumab (hændelser: 87/113), median og 95 % CI: 2,79 (2,66; 2,96)
English: Rash is a composite term which includes maculopapular rash, rash erythematous, rash pruritic, rash follicular, rash macular, rash morbilliform, rash papular, rash pustular, rash papulosquamous, rash vesicular, rash generalised, exfoliative rash, dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis atopic, dermatitis bullous, dermatitis exfoliative, dermatitis psoriasiform, drug eruption and pemphigoid.
Danish: Udslæt er en sammensat term, der omfatter makulopapuløst udslæt, erytematøst udslæt, kløende udslæt, follikulært udslæt, makuløst udslæt, morbilliformt udslæt, papuløst udslæt, pustuløst udslæt, papulosquamøst udslæt, vesikuløst udslæt, generaliseret udslæt, eksfoliativt udslæt, dermatitis, akneiform dermatitis, allergisk dermatitis, atopisk dermatitis, bulløs dermatitis, eksfoliativ dermatitis, psoriasiform dermatitis, lægemiddeludslæt og pemfigoid.
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of metastatic or recurrent SCCHN were evaluated in a phase 3, randomised, open-label study (CA209141).
Danish: Sikkerheden og virkningen af nivolumab 3 mg/kg som enkeltstof til behandling af metastatisk eller recidiverende SCCHN blev evalueret i et randomiseret, åbent fase 3-studie (CA209141).
English: Treatment beyond initial investigator-assessed RECIST, version 1.1-defined progression was permitted if the patient had a clinical benefit and was tolerating study drug as determined by the investigator.
Danish: Behandling efter initial investigatorvurderet RECIST, version 1.1-defineret progression var tilladt, hvis patienten efter investigators vurdering oplevede klinisk fordel og tolererede studiemedicinen.
English: Nivolumab+Ipilimumab (events: 77/155), median and 95% CI: 12.35 (8.74, N.A.) ──Δ─── Nivolumab (events: 86/171), median and 95% CI: 14.00 (7.03, N.A.) Ipilimumab (events: 129/164), median and 95% CI: 3.91 (2.83, 4.17)
Danish: Nivolumab+ipilimumab (hændelser: 77/155), median og 95 % CI: 12,35 (8,74; N.A.) ──Δ─── Nivolumab (hændelser: 86/171), median og 95 % CI: 14,00 (7,03; N.A.) Ipilimumab (hændelser: 129/164), median og 95 % CI: 3,91 (2,83; 4,17)
English: Grade 3 and 4 cases were reported in 0.7% (19/2578) and <0.1% (1/2578) of patients respectively.
Danish: Grad 3 og 4 tilfælde blev rapporteret hos henholdsvis 0,7 % (19/2.578) og <0,1 % (1/2.578) af patienterne.
English: Nivolumab+Ipilimumab (events: 59/123), median and 95% CI: N.A. (26.45, N.A.) ──Δ─── Nivolumab (events: 71/117), median and 95% CI: 23.46 months (13.01, 36.53) Ipilimumab (events: 77/113), median and 95% CI: 18.56 months (13.67, 23.20)
Danish: Nivolumab+Ipilimumab (hændelser: 59/123), median og 95 % CI: N.A. (26,45; N.A.) ──Δ─── Nivolumab (hændelser: 71/117), median og 95 % CI: 23,46 måneder (13,01; 36,53) Ipilimumab (hændelser: 77/113), median og 95 % CI: 18,56 måneder (13,67; 23,20)
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.39 (0.28, 0.54) Nivolumab vs. Ipilimumab - hazard ratio: 0.65 (0.48, 0.88) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.60 (0.43, 0.84)
Danish: Nivolumab+ipilimumab versus ipilimumab - hazard ratio: 0,39 (0,28; 0,54) Nivolumab versus ipilimumab - hazard ratio: 0,65 (0,48; 0,88) Nivolumab+ipilimumab versus nivolumab - hazard ratio: 0,60 (0,43; 0,84)
English: Patients with a baseline performance score ≥ 2, active brain or leptomeningeal metastases, active autoimmune disease, medical conditions requiring systemic immunosuppression, or carcinoma of the nasopharynx or salivary gland as the primary tumour sites were excluded from the SCCHN clinical trial (see sections 4.5 and 5.1).
Danish: Patienter med performance-score ≥ 2 ved baseline, aktive hjerne- eller leptomeningeale metastaser, aktiv autoimmun sygdom, sygdomstilstande, der krævede systemisk immunsuppression, eller cancer i nasopharynx eller spytkirtlen som de primære tumorsteder blev ekskluderet fra de kliniske SCCHNstudier (se pkt.
English: Figure 10: Kaplan-Meier curves of OS (CA209025)
Danish: Figur 10: Kaplan-Meier kurver for OS (CA209025)
English: Gastrointestinal disorders Very common diarrhoea, nausea Common colitisa, stomatitis, vomiting, abdominal pain, constipation, dry mouth Uncommon pancreatitis, gastritis Rare duodenal ulcer
Danish: Almindelig colitisa, stomatitis, opkastning, abdominalsmerter, obstipation, mundtørhed Ikke almindelig pancreatitis, gastritis Sjælden ulcus duodeni Hud og subkutane væv Meget almindelig udslæte, pruritus
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.42 (0.33, 0.54) Nivolumab vs. Ipilimumab - hazard ratio: 0.57 (0.45, 0.72) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.74 (0.58, 0.96)
Danish: Nivolumab+ipilimumab versus ipilimumab - hazard ratio: 0,42 (0,33; 0,54) Nivolumab versus ipilimumab - hazard ratio: 0,57 (0,45; 0,72) Nivolumab+ipilimumab versus nivolumab - hazard ratio: 0,74 (0,58; 0,96)
English: Each mL of concentrate contains 0.1 mmol (or 2.5 mg) sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på En ml koncentrat indeholder 0,1 mmol (eller 2,5 mg) natrium.
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of rash was 65.0% (291/448).
Danish: Hos melanom-patienter, der blev behandlet med nivolumab 1 mg/kg i kombination med ipilimumab 3 mg/kg, var hyppigheden af udslæt 65,0 % (291/448).
English: The Kaplan-Meier curves for OS are shown in Figure 10.
Danish: Kaplan-Meier kurverne for OS er vist i figur 10.
English: Nivolumab+ipilimumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.42 (0.32, 0.56); p-value: < 0.0001 Nivolumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.55 (0.42, 0.73); p-value: < 0.0001
Danish: Nivolumab versus ipilimumab (primær analyse) - HR (99,5 % CI): 0,55 (0,42; 0,73); p-værdi: <0,0001 Nivolumab+ipilimumab versus nivolumab (deskriptiv analyse) - HR (95 % CI): 0,76 (0,62; 0,95)
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of nephritis or renal dysfunction was 8.8% (48/547).
Danish: Hos RCC-patienter, der blev behandlet med nivolumab 3 mg/kg i kombination med ipilimumab 1 mg/kg, var hyppigheden af nefritis eller nedsat nyrefunktion 8,8 % (48/547).
English: The Kaplan-Meier curves for OS are shown in Figure 12.
Danish: Kaplan-Meier-kurverne for OS er vist i figur 12.
English: Manufacturer Bristol-Myers Squibb S.r.l.
Danish: BRISTOL-MYERS SQUIBB S.R.L.
English: PD-L1 < 1%, PD-L1+ TAIC rared
Danish: PD-L1 < 1 %, PD-L1+ TAIC sjældend
English: At the time of this analysis, the hazard ratio was 0.66; (99.8% CI 0.48-0.91) with 166/425 events in the combination arm and 209/422 events in the sunitinib arm. At 18 months, the OS rate was 74.3 (95% CI 69.8-78.2) for nivolumab in combination with ipilimumab and 59.9 (95% CI 54.9-64.5) for sunitinib.
Danish: Hazard ratio var ved analysetidspunktet 0,66; (99,8 % CI 0,48-0,91) med 166/425 hændelser i kombinationsarmen, og 209/422 hændelser i sunitinib-armen.
English: Rare toxic epidermal necrolysisa,f, StevensJohnson syndromef Musculoskeletal and connective tissue disorders Very common arthralgia musculoskeletal paing, arthralgia
Danish: Sjælden toksisk epidermal nekrolysea,f, StevensJohnsons syndromf
English: Per the AJCC 8th edition, this corresponds to patients with lymph node involvement or metastases.
Danish: Dette er tilsvarende patienter med lymfeknudeinvolvering eller metastaser, per AJCC 8. udgave.
English: Grade 2, Grade 3, and Grade 4 cases were reported in 6.7% (30/448), 15.4% (69/448), and 1.8% (8/448) of patients, respectively.
Danish: Grad 2, grad 3 og grad 4 tilfælde blev rapporteret hos henholdsvis 6,7 % (30/448), 15,4 % (69/448) og 1,8 % (8/448) af patienterne.
English: Table 7: Immune-related adverse reactions leading to permanent discontinuation or requiring high-dose corticosteroids by dosing regimen
Danish: Immunrelaterede bivirkninger, der førte til permanent seponering, eller der krævede behandling med højdosis-kortikosteroider ud fra dosisregime Immunrelateret bivirkning, der førte til permanent seponering
English: If applicable, dilute with the required volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection.
Danish: Hvis det er relevant, udføres fortynding med det påkrævede volumen natriumchlorid 9 mg/ml (0,9 %) injektionsvæske eller glucose 50 mg/ml (5 %) injektionsvæske.
English: PD-L1 ≥ 1%, PD-L1+ TAIC rared
Danish: PD-L1 ≥ 1 %, PD-L1+ TAIC sjældend
English: Uncommon vasculitis Respiratory, thoracic and mediastinal disorders Common pneumonitisa,c, dyspnoeaa, cough Uncommon pleural effusion Rare lung infiltration
Danish: Almindelig pneumonitisa,c, dyspnøa, hoste Ikke almindelig pleuraeffusion
English: Grade 2, Grade 3, and Grade 4 cases were reported in 4.7% (21/448), 1.1% (5/448), and 0.2% (1/448) of patients, respectively.
Danish: Grad 2, grad 3 og grad 4 tilfælde blev rapporteret hos henholdsvis 4,7 % (21/448), 1,1 % (5/448) og 0,2 % (1/448) af patienterne.
English: For symptomatic diabetes, nivolumab or nivolumab in combination with ipilimumab should be withheld, and insulin replacement should be initiated as needed.
Danish: Ved symptomatisk diabetes bør nivolumab eller nivolumab i kombination med ipilimumab udsættes og insulinbehandling initieres efter behov.
English: Grade 2, Grade 3, and Grade 4 cases were reported in 13.6% (61/448), 15.8% (71/448), and 0.4% (2/448) of patients, respectively.
Danish: Grad 2, grad 3 og grad 4 tilfælde blev rapporteret hos henholdsvis 13,6 % (61/448), 15,8 % (71/448) og 0,4 % (2/448) af patienterne.
English: Median time to onset was 1.2 months (range: 0.0-22.6).
Danish: Mediantid til indtræden var 1,2 måneder (0,0-22,6).
English: Nervous system disorders Common peripheral neuropathy, headache, dizziness
Danish: Almindelig perifer neuropati, hovedpine, svimmelhed Ikke almindelig
English: Patients were enrolled regardless of their tumour PD-L1 status.
Danish: Patienterne blev indrulleret i studiet uanset deres PD-L1-tumorstatus.
English: Median (95% CI) months Rate (95% CI) at 12 months
Danish: Median (95 % CI) måneder Rate (95 % CI) ved 12 måneder