FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg for the treatment of advanced/metastatic RCC was evaluated in a phase 3, randomised, open-label study (CA209214).
Danish: Sikkerheden og virkningen af nivolumab 3 mg/kg i kombination med ipilimumab 1 mg/kg til behandling af fremskredent/metastatisk RCC blev undersøgt i et randomiseret, åbent fase 3-studie (CA209214).
English: Nephritis and Renal Dysfunction
Danish: Nefritis og nedsat nyrefunktion
English: Blood and lymphatic system disorders Common eosinophilia
Danish: Ikke kendt aseptisk meningitish Blod og lymfesystem Almindelig eosinofili
English: Nivolumab as monotherapy (see section 4.2)
Danish: Nivolumab som monoterapi (se pkt.
English: For symptomatic Grade 2 adrenal insufficiency, nivolumab or nivolumab in combination with ipilimumab should be withheld, and physiologic corticosteroid replacement should be initiated as needed.
Danish: Ved symptomatisk grad 2 binyrebarkinsufficiens bør nivolumab eller nivolumab i kombination med ipilimumab udsættes og fysiologisk kortikosteroidsubstitution initieres efter behov.
English: Upon improvement, nivolumab or nivolumab in combination with ipilimumab may be resumed after corticosteroid taper, if needed.
Danish: Når der indtræder bedring, kan nivolumab eller nivolumab i kombination med ipilimumab genoptages efter nedtrapning af eventuelt kortikosteroid.
English: CA209205 Cohort Ba
Danish: CA209205 kohorte Ba
English: Baseline ECOG performance status was 0 (31%) or 1 (69%).
Danish: ECOG-performance-score ved baseline var 0 (31 %) eller 1 (69 %).
English: In the pooled dataset of nivolumab 3 mg/kg as monotherapy across tumour types (n = 2578) with minimum follow-up ranging from 2.3 to 28 months, the most frequent adverse reactions (≥ 10%) were fatigue (30%), rash (17%), pruritus (13%), diarrhoea (13%), and nausea (12%).
Danish: De hyppigste bivirkninger (≥ 10 %) i det puljede datasæt for nivolumab 3 mg/kg som monoterapi på tværs af tumortyper (n = 2.578) med en opfølgningperiode, som minimum spændte fra 2,3 til 28 måneder, var træthed (30 %), udslæt (17 %), pruritus (13 %), diarre (13 %) og kvalme (12 %).
English: or after diluting according to the following instructions: the final infusion concentration should range between 1 and 10 mg/mL.
Danish: ufortyndet efter overførsel til en infusionsbeholder ved brug af en passende steril sprøjte; eller efter fortynding ifølge disse instruktioner: den færdige koncentration i infusionsvæsken bør være fra 1 til 10 mg/ml.
English: Among the patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in CA209214, 169/547 (31%) had the first onset of Grade 3 or 4 adverse reactions during the initial combination phase.
Danish: Blandt de patienter, der blev behandlet med nivolumab 3 mg/kg i kombination med ipilimumab 1 mg/kg i CA209214 opstod grad 3 eller 4 bivirkninger i den indledende kombinationsfase for 169/547 (31 %).
English: With a minimum of 62.6 months follow-up, OS benefit remains consistently demonstrated across subgroups.
Danish: OS-fordelen forblev konsistent på tværs af forskellige undergrupper efter en opfølgningsperiode på mindst 24,2 måneder.
English: The first tumour assessments were conducted 8 weeks after randomisation and continued every 8 weeks thereafter for the first year and then every 12 weeks until progression or treatment discontinuation, whichever occurred later.
Danish: Den første tumorvurdering blev udført 8 uger efter randomisering, blev derefter foretaget hver 8. uge i det første år og herefter hver 12. uge indtil progression eller seponering, alt efter, hvad der indtraf sidst.
English: Common oedema (including peripheral oedema), pain oedema (including peripheral oedema), pain, chest pain, chills
Danish: Almindelig ødem (herunder perifert ødem), smerter ødem (herunder perifert ødem), smerter, brystsmerter, kulderystelser
English: Data from SCCHN, adjuvant melanoma and first-line RCC patients 75 years of age or older are too limited to draw conclusions on this population (see sections 4.8 and 5.1).
Danish: Data fra SCCHN-, adjuverende melanom- og førstelinje-RCC-patienter ≥75 år er for begrænsede til at kunne drage konklusioner for denne population (se pkt.
English: How to use OPDIVO
Danish: Sådan skal du bruge OPDIVO
English: Skin rash sometimes with blisters, itching
Danish: Hududslæt, undertiden med blærer, kløe
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma was evaluated in a phase 2, multicentre, openlabel, single-arm study (CA209275).
Danish: Sikkerheden og virkningen af nivolumab 3 mg/kg som et enkelt stof til behandling af patienter med lokalt fremskredent eller metastatisk urothelialt karcinom blev vurderet i et fase 2, ikke-blindet, enkelt-arms multicenterstudie (CA209275).
English: The first tumour assessments were conducted 12 weeks after randomisation and continued every 6 weeks thereafter for the first year and then every 12 weeks until progression or treatment discontinuation, whichever occurred later.
Danish: Den første tumorvurdering blev udført 12 uger efter randomisering, blev derefter foretaget hver 6. uge i det første år og herefter hver 12. uge indtil progression eller seponering, alt efter, hvad der indtraf sidst.
English: Median time to onset was 2.6 months (range: 0.5-21.8).
Danish: Mediantid til indtræden var 2,6 måneder (0,5-21,8).
English: The OS HRs for nivolumab vs. chemotherapy were 1.32 (95% CI: 0.75, 2.32) for BRAF mutation-positive patients and 0.83 (95% CI: 0.62, 1.11) for BRAF wild-type patients.
Danish: OS HR for nivolumab vs. kemoterapi var 1,32 (95 % CI: 0,75, 2,32) hos BRAF-mutationpositive patienter og 0,83 (95 % CI: 0,62, 1,11) hos patienter med BRAF-vildtype.
English: In the pooled dataset of nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma (n = 448) with minimum follow-up ranging from 6 to 28 months, the most frequent adverse reactions (≥ 10%) were rash (52%), fatigue (46%), diarrhoea (43%), pruritus (36%), nausea (26%), pyrexia (19%), decreased appetite (16%), hypothyroidism (16%), colitis (15%), vomiting (14%), arthralgia (13%), abdominal pain (13%), headache (11%), and dyspnoea (10%).
Danish: De hyppigste bivirkninger (≥ 10 %) i det puljede datasæt for nivolumab 1 mg/kg i kombination med ipilimumab 3 mg/kg ved melanom (n = 448) med en opfølgningperiode, som minimum spændte fra 6 til 28 måneder, var udslæt (52 %), træthed (46 %), diarre (43 %), pruritus (36 %), kvalme (26 %), pyreksi (19 %), appetitløshed (16 %), hypotyroidisme (16 %), colitis (15 %), opkastning (14 %), artralgi (13 %), abdominalsmerter (13 %), hovedpine (11 %) og dyspnø (10 %).
English: The study included patients (18 years or older) who have experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen which may have included maintenance therapy and who had an ECOG performance status score of 0 or 1.
Danish: Studiet inkluderede patienter (18 år eller ældre), som havde oplevet sygdomsprogression under eller efter et tidligere platinbaseret dublet-kemoterapiregime med eventuel vedligeholdelsesbehandling, og som havde en ECOG-performance-score på 0 eller 1.
English: Table 14: Efficacy results (CA209017)
Danish: Tabel 14: Effektresultater (CA209017)
English: Median time to onset was 2.3 months (range: 0.0-18.2).
Danish: Mediantid til indtræden var 2,3 måneder (0,0-18,2).
English: Thereafter, the recommended dose of OPDIVO is 240 mg given every 2 weeks or 480 mg given every 4 weeks (single-agent phase).
Danish: Herefter er den anbefalede dosis OPDIVO 240 mg hver 2. uge eller 480 mg hver 4. uge (enkeltstoffasen).
English: The median age was 62 years (range: 18-88) with 40% ≥ 65 years of age and 9% ≥ 75 years of age.
Danish: Medianalderen var 62 år (18-88) med 40 % ≥ 65 år og 9 % ≥ 75 år.
English: In the dataset of nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC (n = 547), with a minimum follow-up of 17.5 months, the most frequent adverse reactions (≥ 10%) were fatigue (48%), rash (34%), pruritus (28%), diarrhoea (27%), nausea (20%), hypothyroidism (16%), musculoskeletal pain (15%), arthralgia (14%), decreased appetite (14%), pyrexia (14%), vomiting (11%), hyperthyroidism (11%).
Danish: De hyppigste bivirkninger (≥ 10 %) i datasættet for nivolumab 3 mg/kg i kombination med ipilimumab 1 mg/kg ved RCC (n = 547) med en minimum opfølgningperiode på 17,5 måneder var træthed (48 %), udslæt (34 %), pruritus (28 %), diarre (27 %), kvalme (20 %), hypotyroidisme (16 %), muskuloskeletale smerter (15 %), artralgi (14 %), appetitløshed (14 %), pyreksi (14 %), opkastning (11 %) og hypertyroidisme (11 %).
English: Nivolumab+Ipilimumab (events: 29/68), median and 95% CI: N.A. (9.72, N.A.) ──Δ─── Nivolumab (events: 38/80), median and 95% CI: 21.95 (8.90, N.A.) Ipilimumab (events: 57/75), median and 95% CI: 3.94 (2.79, 4.21)
Danish: Nivolumab+ipilimumab (hændelser: 29/68), median og 95 % CI: N.A. (9,72; N.A.) ──Δ─── Nivolumab (hændelser: 38/80), median og 95 % CI: 21,95 (8,90; N.A.) Ipilimumab (hændelser: 57/75), median og 95 % CI: 3,94 (2,79; 4,21)
English: The majority of cases were Grade 1 or 2 in severity reported in 4.2% (107/2578) and 5.4% (139/2578) of patients, respectively.
Danish: Størstedelen af tilfældene var grad 1 eller 2 i sværhedsgrad og blev rapporteret hos henholdsvis 4,2 % (107/2.578) og 5,4 % (139/2.578) af patienterne.
English: 240 mg every 2 weeks over 30 minutes *As per monotherapy indication in section 4.1.
Danish: Urothelialt karcinom240 mg hver 2. uge over 30 minutter *Efter monoterapiindikationerne i pkt.
English: Disease-specific precautions
Danish: Sygdomsspecifikke forsigtighedsregler
English: Median duration of follow-up Months (range)
Danish: Medianvarighed af opfølgningsperiode Måneder (interval)
English: 8.7,22.2%), a median OS of 8.21 months (95% CI: 6.05,10.9), and a median PFS of 1.87 months (95% CI 1.77,3.15).
Danish: Nivolumab 3 mg/kg viste en ORR på 14,5 % (95 % CI: 8,7-22,2 %), en median-OS på 8,21 måneder (95 % CI: 6,05-10,9 måneder) og en median-PFS på 1,87 måneder (95 % CI: 1,77-3,15 måneder).
English: Efficacy results are shown in Table 16.
Danish: Effektresultater er vist i tabel 16.
English: One vial of 4 mL contains 40 mg of nivolumab.
Danish: Et 4 ml hætteglas indeholder 40 mg nivolumab.
English: Grade 2, Grade 3, and Grade 4 cases were reported in 0.5% (3/547), 2.4% (13/547), and 0.4% (2/547) of patients, respectively.
Danish: Grad 2, grad 3 og grad 4 blev rapporteret hos henholdsvis 0,5 % (3/547), 2,4 % (13/547) og 0,4 % (2/547) af patienterne.
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of diarrhoea or colitis was 28.2% (154/547).
Danish: Hos RCC-patienter, der blev behandlet med nivolumab 3 mg/kg i kombination med ipilimumab 1 mg/kg, var hyppigheden af diarre eller colitis, 28,2 % (154/547).
English: PD-L1 expression < 1%
Danish: PD-L1-ekspression < 1 %
English: Severe diarrhoea or colitis has been observed with nivolumab monotherapy or nivolumab in combination with ipilimumab (see section 4.8).
Danish: Svær diarre eller colitis er observeret med nivolumab-monoterapi eller nivolumab i kombination med ipilimumab (se pkt.
English: Table 11: Summary of overall survival by PD-L1 expression: 5% cut off - CA209067 - Minimum follow-up of 36 months
Danish: Overblik over samlet overlevelse ved PD-L1-ekspression: 5 % cut offCA209067 - Opfølgningsperiode på minimum 36 måneder
English: Median time to onset of these endocrinopathies was 1.9 months (range: 0.0-22.3).
Danish: Mediantid til indtræden af disse endokrinopatier var 1,9 måneder (0,0-22,3).
English: Median time to onset was 2.0 months (range: 0.4-26.8).
Danish: Mediantid til indtræden var 2,0 måneder (0,4-26,8).
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of advanced RCC with a clear cell component was evaluated in a Phase 3, randomised, open-label study (CA209025).
Danish: Sikkerheden og virkningen af nivolumab 3 mg/kg som enkeltstof til behandling af fremskredent RCC med en clear cell-komponent blev undersøgt i et randomiseret, åbent fase 3-studie (CA209025).
English: Ipilimumab 1 mg/kg over 30 minutes
Danish: Ipilimumab 1 mg/kg over 30 minutter
English: Patients with active autoimmune disease, ocular melanoma, or active brain or leptomeningeal metastases were excluded from the study.
Danish: Patienter med aktiv autoimmun sygdom, okulært melanom eller aktive hjerne- eller leptomeningeale metastaser blev ekskluderet fra studiet.
English: Depending on your dose, the appropriate amount of OPDIVO will be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for injection before use.
Danish: Afhængigt af din dosis vil den ønskede mængde OPDIVO blive fortyndet med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske eller glucose 50 mg/ml (5 %) injektionsvæske før brug.
English: A total of 582 patients were randomised to receive either nivolumab 3 mg/kg administered intravenously over 60 minutes every 2 weeks (n = 292) or docetaxel 75 mg/m2 every 3 weeks
Danish: I alt 582 patienter blev randomiseret til at få enten nivolumab 3 mg/kg intravenøst over 60 minutter hver 2. uge (n = 292) eller docetaxel 75 mg/m2 hver 3. uge (n = 290).
English: Patients with active autoimmune disease, ocular/uveal melanoma, or active brain or leptomeningeal metastases were excluded from the study.
Danish: Patienter med aktiv autoimmun sygdom, okulært/uvealt melanom eller aktive hjerne- eller leptomeningeale metastaser blev ekskluderet fra studiet.
English: Resolution occurred in 31 patients (91.2%) with a median time to resolution of 6.1 weeks (range: 0.7-85.9+).
Danish: Resolution forekom hos 31 patienter (91,2 %) med en mediantid til resolution på 6,1 uger (0,7-85,9+).
English: The Kaplan-Meier curves for OS are shown in Figure 8.
Danish: Kaplan-Meier kurverne over OS er vist i figur 8.
English: Nivolumab 3 mg/kg in Combination with Ipilimumab 1 mg/kg
Danish: Nivolumab 3 mg/kg i kombination med ipilimumab 1 mg/kg
English: Grade 2 and Grade 3 cases were reported in 5.1% (131/2578) and 1.2% (31/2578) of patients respectively.
Danish: Grad 2 og grad 3 tilfælde blev rapporteret hos henholdsvis 5,1 % (131/2.578/2.227) og 1,2 % (31/2.578) af patienterne.
English: The total dose of OPDIVO required can be infused directly as a 10 mg/mL solution or can be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for injection (see section 6.6).
Danish: Den totale dosis OPDIVO kan indgives direkte som 10 mg/ml koncentrat eller kan fortyndes med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske eller glucose 50 mg/ml (5 %) injektionsvæske (se pkt.
English: Median (95% CI) months Rate (95% CI) at 6 months Overall survivalc
Danish: Median (95 % CI) måneder Rate (95 % CI) ved 6 måneder Samlet overlevelsec
English: Grade 4 rash
Danish: Grad 4 udslæt
English: Table 18: Efficacy results (CA209025)
Danish: Tabel 18: Effektresultater (CA209025)
English: Patients with active autoimmune disease, symptomatic interstitial lung disease, or active brain metastases were excluded from the study.
Danish: Patienter med aktiv autoimmun sygdom, symptomatisk interstitiel lungesygdom eller aktive hjernemetastaser blev ekskluderet fra studiet.
English: Median time to onset was 2.6 months (range: 0.7-12.6).
Danish: Mediantid til indtræden var 2,6 måneder (0,7-12,6).
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of pneumonitis including interstitial lung disease, was 7.8% (35/448).
Danish: Hos melanom-patienter, der blev behandlet med nivolumab 1 mg/kg i kombination med ipilimumab 3 mg/kg, var hyppigheden af pneumonitis, herunder interstitiel lungesygdom, 7,8 % (35/448).
English: For symptomatic hyperthyroidism, nivolumab or nivolumab in combination with ipilimumab should be withheld and antithyroid medication should be initiated as needed.
Danish: Ved symptomatisk hypertyroidisme bør nivolumab eller nivolumab i kombination med ipilimumab udsættes og antityroide lægemidler initieres efter behov.
English: PD-L1 expression < 5%
Danish: PD-L1-ekspression < 5 %
English: In patients treated with nivolumab monotherapy, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 5.2% for anaemia (all Grade 3), 1.0% for thrombocytopaenia, 1.0% for leucopoenia, 10.0% for lymphopaenia, 1.1% for neutropaenia, 2.1% for increased alkaline phosphatase, 2.7% for increased AST, 2.2% for increased ALT, 1.2% for increased total bilirubin, 0.9% for increased creatinine, 3.8% for hyperglycaemia, 1.0% for hypoglycaemia, 3.5% for increased amylase, 7.9% for increased lipase, 6.4% for hyponatraemia, 1.8% for hyperkalaemia, 1.5% for hypokalaemia, 1.2% for hypercalcaemia, 0.7% for hypermagnesaemia, 0.5% for hypomagnesaemia, 0.7% for hypocalcaemia, and 0.1% for hypernatraemia.
Danish: Hos patienter, som blev behandlet med nivolumab-monoterapi, var andelen af patienter, som oplevede et skift fra baseline til en grad 3 eller 4 abnorm laboratorietest, følgende: 5,2 % med anæmi (alle grad 3), 1,0 % med trombocytopeni, 1,0 % for leukopeni, 10,0 % med lymfopeni, 1,1 % med neutropeni, 2,1 % med forhøjet alkalisk phosphatase, 2,7 % med forhøjet ASAT, 2,2 % med forhøjet ALAT, 1,2 % med forhøjet total-bilirubin, 0,9 % med forhøjet kreatinin, 3,8 % med hyperglykæmi, 1,0 % med hypoglykæmi, 3,5 % med forhøjet amylase, 7,9 % med forhøjet lipase, 6,4 % med hyponatriæmi, 1,8 % med hyperkaliæmi, 1,5 % med hypokaliæmi, 1,2 % med hypercalcæmi, 0,7 % med hypermagnesiæmi, 0,5 % med hypomagnesiæmi, 0,7 % med hypocalcæmi og 0,1 % med hypernatriæmi.
English: Progression Free Survival Events (%)
Danish: Måneder (interval) Mediantid til respons Måneder (interval) Progressionsfri overlevelse Hændelser (%)
English: Patients with Karnofsky performance status < 70% and patients with any history of or concurrent brain metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the study.
Danish: Patienter med KPS < 70 % og patienter med hjernemetastaser i anamnesen, aktiv autoimmun sygdom eller en sygdomstilstand, der krævede systemisk immunsuppression, blev udelukket fra studiet.
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of pneumonitis including interstitial lung disease was 6.2% (34/547).
Danish: Hos RCC-patienter, der blev behandlet med nivolumab 3 mg/kg i kombination med ipilimumab 1 mg/kg, var hyppigheden af pneumonitis, herunder interstitiel lungesygdom, 6,2 % (34/547).
English: Single-arm phase 2 study (CA209172)
Danish: Fase 2-enkeltarmsstudie (CA209172)
English: Table 16: Efficacy results (CA209057)
Danish: Tabel 16: Effektresultater (CA209057)
English: Resolution occurred in 21 patients (91.3%) with a median time to resolution of 2.1 weeks (range: 0.1- 125.1+).
Danish: Resolution forekom hos 21 patienter (91,3 %) med en mediantid til resolution på 2,1 uger (0,1-125,1+).
English: Based on the severity of myotoxicity, nivolumab or nivolumab in combination with ipilimumab should be withheld or discontinued (see section 4.2), and appropriate treatment instituted.
Danish: Afhængigt af sværhedsgraden af myotoksicitet skal behandlingen med nivolumab eller nivolumab i kombination med ipilimumab udsættes eller seponeres (se pkt.
English: Preparing the infusion
Danish: Klargøring af infusion
English: Rate (95% CI) at 12 months Rate (95% CI) at 18 months Rate (95% CI) at 24 months a
Danish: Hyppighed (95 % CI) ved 12 måneder Hyppighed (95 % CI) ved 18 måneder Hyppighed (95 % CI) ved 24 måneder a
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of liver function test abnormalities was 18.5% (101/547).
Danish: Hos RCC-patienter, der blev behandlet med nivolumab 3 mg/kg i kombination med ipilimumab 1 mg/kg, var hyppigheden af abnorme leverfunktionstests 18,5 % (101/547).
English: Table 25: Efficacy by tumour cell and TAIC PD-L1 expression (CA209141)
Danish: Tabel 25: Virkning i forhold til tumorcelle- og tumor-associeret immuncell PD-L1-ekspression (CA209141)
English: Allergic reaction, reactions related to the infusion of the medicine Decreased secretion of hormones produced by adrenal glands (glands situated above the kidneys), underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain, swelling of the thyroid gland, diabetes Dehydration
Danish: Øget mængde af bestemte typer hvide blodlegemer Allergisk reaktion, reaktioner i forbindelse med infusion af medicinen Nedsat udskillelse af de hormoner, der dannes i binyrerne (kirtler placeret over nyrerne), nedsat funktion af hypofysen eller betændelseslignende reaktion (hypofysitis) i hypofysen (sidder nederst i hjernen), hævelse af skjoldbruskkirtlen, sukkersyge (diabetes) Dehydrering
English: OPDIVO concentrate may be diluted with either: sodium chloride 9 mg/mL (0.9%) solution for injection; or 50 mg/mL (5%) glucose solution for injection.
Danish: OPDIVO-koncentrat kan fortyndes med enten: natriumchlorid 9 mg/ml (0,9 %) injektionsvæske; eller glucose 50 mg/ml (5 %) injektionsvæske.
English: Grade 3 and 4 cases were reported in 1.6% (41/2578) and 0.3% (9/2578) of patients, respectively.
Danish: Grad 3 og 4 tilfælde blev rapporteret hos henholdsvis 1,6 % (41/2.578) og 0,3 % (9/2.578) af patienterne.
English: In the dataset of nivolumab 3 mg/kg as monotherapy for the adjuvant treatment of melanoma (n = 452), the most frequent adverse reactions (≥ 10%) were fatigue (46%), rash (29%), diarrhoea (24%), pruritus (23%), nausea (15%), arthralgia (13%), musculoskeletal pain (11%), and hypothyroidism (11%).
Danish: De hyppigste bivirkninger (≥ 10 %) i datasættet for nivolumab-monoterapi 3 mg/kg ved adjuverende behandling af melanom (n = 452) var træthed (46 %), udslæt (29 %), diarre (24 %), pruritus (23 %), kvalme (15 %), artralgi (13 %), smerter i skeletmuskulaturen (11 %) og hypothyroidisme (11 %).
English: A total of 418 patients were randomised to receive either nivolumab (n = 210) administered intravenously over 60 minutes at 3 mg/kg every 2 weeks or dacarbazine (n = 208) at 1000 mg/m2 every
Danish: I alt 418 patienter blev randomiseret til enten nivolumab (n = 210) 3 mg/kg hver 2. uge administreret intravenøst over 60 minutter eller dacarbazin (n = 208) 1000 mg/m2 hver 3. uge.
English: Median time to response Months (range)
Danish: Mediantid til respons Måneder (interval)
English: For Grade 2 (symptomatic) pneumonitis, nivolumab or nivolumab in combination with ipilimumab should be withheld and corticosteroids initiated at a dose of 1 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 2 (symptomatisk) pneumonitis bør nivolumab eller nivolumab i kombination med ipilimumab udsættes og kortikosteroid initieres med en dosis ækvivalent med 1 mg/kg/dag methylprednisolon.
English: The majority of cases were Grade 1 or 2 in severity reported in 8.5% (220/2578) and 3.0% (78/2578) of patients respectively.
Danish: Størstedelen af tilfældene var grad 1 eller 2 i sværhedsgrad og blev rapporteret hos henholdsvis 8,5 % (220/2.578) og 3,0 % (78/2.578) af patienterne.
English: Data from cHL patients 65 years of age or older are too limited to draw conclusions on this population.
Danish: Data fra patienter med klassisk HL ≥ 65 år er for begrænsede til at kunne drage konklusioner for denne population.
English: • Adverse Reaction Management Guide
Danish: • Behandlingsguide til bivirkninger
English: For ease of preparation, the concentrate can also be transferred directly into a pre-filled bag containing the appropriate volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection.
Danish: For lettere klargøring kan koncentratet også overføres direkte til en brugsklar pose, der indeholder den ønskede mængde natriumchlorid 9 mg/ml (0,9 %) injektionsvæske eller glucose 50 mg/ml (5 %) injektionsvæske.
English: The median age was 61 years (range: 21-85) with 38% ≥ 65 years of age and 8% ≥ 75 years of age.
Danish: Medianalderen var 61 år (21-85) med 38 % ≥ 65 år og 8 % ≥ 75 år.