FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy by BRAF status: After18 months of follow-up, BRAF[V600] mutation-positive and BRAF wild-type patients randomised to nivolumab in combination with ipilimumab had a median PFS of 15.5 months (95% CI: 8.0, NA) and 11.3 months (95% CI: 8.3, 22.2), while those in the nivolumab monotherapy arm had a median PFS of 5.6 months (95% CI: 2.8, 9.3) and 7.1 months (95% CI: 4.9, 14.3), respectively.
Danish: Effekt i forhold til BRAF-status: Efter en opfølgningsperiode på 18 måneder havde BRAF[V600]mutationspositive patienter og patienter med BRAF-vildtype, som blev randomiseret til nivolumab i kombination med ipilimumab, en median-PFS på henholdsvis 15,5 måneder (95 % CI: 8,0; N.A.) og 11,3 måneder (95 % CI: 8,3; 22,2), mens de patienter, der blev randomiseret til nivolumabmonoterapi, havde en median-PFS på henholdsvis 5,6 måneder (95 % CI: 2,8; 9,3) og 7,1 måneder (95 % CI: 4,9; 14,3).
English: Nivolumab+ipilimumab (events: 139/314), median and 95% CI: N.A. (38.18, N.A.) OS rate and 95% CI at 12 months: 73% (68, 78), 24 months: 64% (59, 69), and 36 months: 58% (52, 63) ──Δ─── Nivolumab (events: 158/316), median and 95% CI: 37.59 months (29.08, N.A.) OS rate and 95% CI at 12 months: 74% (69, 79), 24 months: 59% (53, 64), and 36 months: 52% (46, 57) Ipilimumab (events: 206/315), median and 95% CI: 19.94 months (16.85, 24.61) OS rate and 95% CI at 12 months: 67% (61, 72), 24 months: 45% (39, 50), and 36 months: 34% (29, 39)
Danish: Nivolumab+ipilimumab (hændelser: 139/314), median og 95 % CI: N.A. (38,18; N.A.) OS rate og 95 % CI ved 12 måneder: 73 % (68; 78), 24 måneder: 64 % (59 ; 69), og 36 måneder: 58 % (52; 63) ──Δ─── Nivolumab (hændelser: 158/316), median og 95 % CI: 37,59 måneder (29,08; N.A.) OS rate og 95 % CI ved 12 måneder: 74 % (69; 79), 24 måneder: 59 % (53; 64), og 36 måneder: 52 % (46; 57) Ipilimumab (hændelser: 206/315), median og 95 % CI: 19,94 måneder (16,85; 24,61) OS rate og 95 % CI ved 12 måneder: 67 % (61; 72), 24 måneder: 45 % (39; 50), og 36 måneder: 34 % (29; 39)
English: The majority of cases were Grade 1 in severity reported in 20.1% (518/2578) of patients.
Danish: Størstedelen af tilfældene var grad 1 i sværhedsgrad og blev rapporteret hos 20,1 % (518/2.578) af patienterne.
English: With appropriate medical therapy, immune-related adverse reactions resolved in most cases.
Danish: I de fleste tilfælde forsvandt de immunrelaterede bivirkninger med passende medicinsk behandling.
English: Table 8: Efficacy Results (CA209066)
Danish: Tabel 8: Effektresultater (CA209066)
English: OPDIVO as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.
Danish: OPDIVO som monoterapi er indiceret til behandling af lokalt fremskredent inoperabelt eller metastatisk urothelialt karcinom hos voksne efter svigt af tidligere platinbaseret behandling.
English: Figure 3: Progression-free survival by PD-L1 expression: 5% cut off (CA209067)
Danish: Figur 3: Progressionsfri overlevelse i forhold til PD-L1-ekspression: 5 % cut-off (CA209067)
English: The median age was 61 years (range: 18 to 90 years), 65% of patients were men, and 97% were white.
Danish: Medianalderen var 61 år (18-90 år), 65 % af patienterne var mænd, og 97 % var kaukasiere.
English: Nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency.
Danish: Nivolumab eller nivolumab i kombination med ipilimumab skal seponeres permanent i tilfælde af svær (grad 3) eller livstruende (grad 4) binyrebarkinsufficiens.
English: (43 nivolumab, 25 investigator's choice)
Danish: (43 nivolumab, 25 investigators valg)
English: Open-label phase 1/2 study (CA209032)
Danish: Fase 1/2 ikke-blindet studie (CA209032)
English: Table 6: Adverse reactions with nivolumab in combination with ipilimumab Nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg*
Danish: Tabel 6: Bivirkninger for nivolumab i kombination med ipilimumab Nivolumab 1 mg/kg i kombination med ipilimumab 3 mg/kg*
English: Nivolumab+ipilimumab vs ipilimumab (primary analysis) - HR (95% CI): 0.55 (0.45, 0.69); p-value: < 0.0001 Nivolumab vs ipilimumab (primary analysis) - HR (95% CI): 0.65 (0.53, 0.80); p-value: < 0.0001
Danish: Nivolumab+ipilimumab versus ipilimumab (primær analyse) - HR (95 % CI): 0,55 (0,45; 0,69); p-værdi: <0,0001 Nivolumab versus ipilimumab (primær analyse) - HR (95 % CI): 0,65 (0,53; 0,80); p-værdi: <0,0001
English: Uncommon uveitis
Danish: Ikke almindelig uveitis
English: Acid in the blood produced from diabetes (diabetic ketoacidosis) A temporary inflammation of the nerves that causes pain, weakness and paralysis in the extremities (Guillain-Barré syndrome); damage to nerves causing numbness and weakness (polyneuropathy); inflammation of the nerves; foot drop (peroneal nerve palsy); inflammation of the nerves caused by the body attacking itself, causing numbness, weakness, tingling or burning pain (autoimmune neuropathy); muscle weakness and tiredness without atrophy (myasthenia gravis)
Danish: Syrestoffer i blodet som følge af sukkersyge (diabetisk ketoacidose) Midlertidig betændelseslignende reaktion i nerverne, der medfører smerter, svaghed og lammelse af arme og ben (Guillain-Barré syndrom); nerveskade, som medfører følelsesløshed og svaghed (polyneuropati); betændelseslignende reaktion i nerverne; dropfod (peroneusparese); betændelseslignende reaktion i nerverne, som skyldes, at kroppen angriber sig selv, og som medfører følelsesløshed, svaghed og en stikkende eller brændende smerte (autoimmun neuropati), svaghed i muskulaturen og øget træthed uden svind af muskelvæv (myasthenia gravis)
English: Severe infusion reactions have been reported in clinical trials of nivolumab or nivolumab in combination with ipilimumab (see section 4.8).
Danish: Der er rapporteret om svære infusionsreaktioner i kliniske studier med nivolumab eller nivolumab i kombination med ipilimumab (se pkt.
English: Table 7: Immune-related adverse reactions leading to permanent discontinuation or requiring high-dose corticosteroids by dosing regimen Nivolumab 3 mg/kg monotherapy
Danish: Immunrelaterede bivirkninger, der førte til permanent seponering, eller der krævede behandling med højdosis-kortikosteroider ud fra dosisregime Nivolumab 3 mg/kg som monoterapi
English: ECOG PS 2 CNS Metastasis
Danish: ECOG-PS 2
English: For Grade 2 transaminase or total bilirubin elevation, nivolumab or nivolumab in combination with ipilimumab should be withheld.
Danish: Ved grad 2 forhøjelse af aminotransferase eller total-bilirubin udsættes nivolumab eller nivolumab i kombination med ipilimumab.
English: or stop your treatment with OPDIVO altogether.
Danish: udsætte den næste dosis OPDIVO, eller helt stoppe din behandling med OPDIVO.
English: ≥ 10% to < 50%a
Danish: ≥ 10 % til < 50 %a
English: Patients with active autoimmune disease, medical conditions requiring immunosuppression, recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, salivary gland or non-squamous histologies (e.g., mucosal melanoma), or active brain or leptomeningeal metastases were excluded from the study.
Danish: Patienter med aktiv autoimmun sygdom, sygdomstilstande der kræver immunsuppression, recidiverende eller metastatisk nasopharynxcancer, planocellulært karcinom af ukendt primær, spytkirtelhistologi eller ikke-planocellulær histologi (f.eks. slimhindemelanom) eller aktive hjerne- eller leptomeningeale metastaser blev udelukket fra studiet.
English: Median time to onset of these endocrinopathies was 2.8 months (range: 0.3-29.1).
Danish: Mediantid til indtræden af disse endokrinopatier var 2,8 måneder (0,3-29,1).
English: Efficacy results are presented in Table 9.
Danish: Effektresultater er vist i tabel 9.
English: The observed PFS results at 18 months of follow-up and ORR and OS results at 28 months of follow-up were consistently demonstrated across subgroups of patients including baseline ECOG performance status, BRAF status, M stage, age, history of brain metastases, and baseline LDH level.
Danish: resultater ved 28 måneders opfølgningen blev vist konsistent på tværs af forskellige undergrupper afpatienter inklusive ECOG-performance-score ved baseline, BRAF-status, M-stadie, alder, hjernemetastaser i anamnesen og LDH-niveau ved baseline.
English: Figure 4: Progression-free survival by PD-L1 expression: 1% cut off (CA209067)
Danish: Figur 4: Progressionsfri overlevelse i forhold til PD-L1-ekspression: 1 % cut-off (CA209067)
English: In patients treated with nivolumab monotherapy, the incidence of nephritis or renal dysfunction was 2.8% (71/2578).
Danish: Hos patienter, som blev behandlet med nivolumab-monoterapi, var hyppigheden af nefritis eller nedsat nyrefunktion 2,8 % (71/2.578).
English: Severe pneumonitis or interstitial lung disease, including fatal cases, has been observed with nivolumab monotherapy or nivolumab in combination with ipilimumab (see section 4.8).
Danish: Svær pneumonitis eller interstitiel lungesygdom, herunder dødelige tilfælde, er set med nivolumabmonoterapi eller nivolumab i kombination med ipilimumab (se pkt.
English: Table 24: OS by tumour PD-L1 expression (CA209141)
Danish: Tabel 24: OS i forhold til PD-L1-tumorekspression (CA209141)
English: Nivolumab 3 mg/kg (events: 184/240), median and 95% CI: 7.72 (5.68,8.77) Investigator's choice (events: 105/121), median and 95% CI: 5.06 (4.04, 6.24)
Danish: Samlet overlevelse (måneder) Antal forsøgspersoner i risikogruppe Nivolumab Investigators valg Nivolumab 3 mg/kg (hændelse: 184/240), median og 95 % CI: 7,72 (5,68; 8,77) Investigators valg (hændelse: 105/121), median og 95 % CI: 5,06 (4,04; 6,24)
English: Grade 2 and Grade 3 thyroid disorders were reported in 14.5% (65/448) and 1.3% (6/448) of patients, respectively.
Danish: Grad 2 og grad 3 thyroidearelaterede bivirkninger blev rapporteret hos henholdsvis 14,5 % (65/448) og 1,3 % (6/448) af patienterne.
English: Figure 12: Kaplan-Meier curves of OS (CA209141)
Danish: Figur 12: Kaplan-Meier-kurver for OS (CA209141)
English: Treatment beyond initial investigator-assessed RECIST, version 1.1-defined progression was permitted if the patient had a clinical benefit, did not have rapid disease progression, and was tolerating study drug as determined by the investigator.
Danish: Behandling ud over den første investigatorvurderede RECIST, version 1.1-defineret progression var tilladt, hvis patienten havde en klinisk fordel, ikke havde hurtig sygdomsprogression og kunne tolerere studiemedicinen, hvilket blev vurderet af investigatoren.
English: Probability of Progression Free Survival
Danish: Sandsynlighed for progressionsfri overlevelse
English: Inflammation of the lungs (pneumonitis, characterised by coughing and difficulty breathing), fluid around the lungs, blood clots, cough
Danish: Betændelseslignende reaktion i lungerne (pneumonitis, med hoste og vejrtrækningsbesvær), væske omkring lungerne, blodpropper, hoste
English: Very common (may affect more than 1 in 10 people) Underactive thyroid gland (which can cause tiredness or weight gain),overactive thyroid gland (which can cause rapid heart rate, sweating and weight loss) Decreased appetite
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) Nedsat funktion af skjoldbruskkirtlen (som kan medføre træthed eller vægtstigning), øget funktion af skjoldbruskkirtlen (som kan medføre hurtig hjerterytme (puls), svedudbrud og vægttab)
English: (27 nivolumab, 10 investigator's choice)
Danish: (27 nivolumab, 10 investigators valg)
English: Because of the small sample size, no definitive conclusions can be drawn from these data.
Danish: På grund af den lille population kan der ikke drages nogen endelige konklusioner på baggrund af disse data.
English: Endocrinopathies Skin
Danish: Endokrinopatier
English: Common adrenal insufficiency, hypopituitarism, hypophysitis, hyperthyroidism, thyroiditis adrenal insufficiencyc, hypophysitisc, thyroiditis, diabetes mellitusc
Danish: Almindelig binyrebarkinsufficiens, hypopituitarisme, hypofysitis, hypertyroidisme, tyroiditis binyrebarkinsufficiensc, hypofysitisc, tyroiditis, diabetes mellitusc
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of relapsed or refractory cHL following ASCT was evaluated in two multi-centre, open-label, single-arm studies (CA209205 and CA209039).
Danish: Sikkerheden og virkningen af nivolumab 3 mg/kg som enkeltstof til behandling af recidiverende eller refraktært klassisk HL efter ASCT blev undersøgt i to åbne, enkelt-armede multicenterstudier (CA209205 og CA209039).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each mL of concentrate contains 10 mg of nivolumab.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml koncentrat indeholder 10 mg nivolumab.
English: Common vitiligo, dry skin, erythema, alopecia, urticaria dry skin, erythema, urticaria
Danish: Almindelig vitiligo, tør hud, erytem, alopeci, urticaria tør hud, erytem, urticaria
English: Resolution occurred in 192 patients (72.2%) with a median time to resolution of 11.6 weeks (range: 0.1-126.7+).
Danish: Resolution forekom hos 192 patienter (72,2 %) med en mediantid til resolution på 11,6 uger (0,1-126,7+).
English: The median age was 65 years (range: 18-87), 59% were men, and 99.5% were white.
Danish: Medianalderen var 65 år (18-87), 59 % var mænd, og 99,5 % var kaukasiere.
English: Patients with active autoimmune disease and symptomatic interstitial lung disease were excluded from clinical trials of cHL (see section 5.1).
Danish: Patienter med aktiv autoimmun sygdom og symptomatisk interstitiel lungesygdom blev udelukket fra de kliniske studier hos patienter med klassisk HL (se pkt.
English: Efficacy results are shown in Table 8.
Danish: Effektresultater er vist i tabel 8.
English: A total of 361 patients were randomised to receive either nivolumab 3 mg/kg (n = 240) administered intravenously over 60 minutes every 2 weeks or investigator's choice of either cetuximab (n = 15), 400 mg/m2 loading dose followed by 250 mg/m2 weekly or methotrexate (n = 52) 40 to 60 mg/m2 weekly, or docetaxel (n = 54) 30 to 40 mg/m2 weekly.
Danish: I alt 361 patienter blev randomiseret til at få enten nivolumab 3 mg/kg (n = 240) intravenøst over 60 minutter hver 2. uge eller behandling efter investigators valg i form af enten cetuximab (n = 15) 400 mg/m2 støddosis efterfulgt af 250 mg/m2 ugentligt eller methotrexat (n = 52) 40
English: Nivolumab 1 mg/kg over 30 minutes
Danish: Nivolumab 1 mg/kg over 30 minutter
English: A total of 1096 patients were randomised in the trial, of which 847 patients had intermediate/poor-risk RCC and received either nivolumab 3 mg/kg (n = 425) administered intravenously over 60 minutes in combination with ipilimumab 1 mg/kg administered intravenously over 30 minutes every 3 weeks for 4 doses followed by nivolumab monotherapy 3 mg/kg every 2 weeks or sunitinib (n = 422) 50 mg daily, administered orally for 4 weeks followed by 2 weeks off, every cycle.
Danish: Af dem havde 847 patienter mellem- eller højrisikoRCC, og fik enten nivolumab 3 mg/kg (n = 425) administreret intravenøst over 60 minutter i kombination med ipilimumab 1 mg/kg administreret intravenøst over 30 minutter hver 3. uge for 4 doser, efterfulgt af nivolumab-monoterapi 3 mg/kg hver 2. uge, eller sunitinib (n = 422) 50 mg dagligt, administreret oralt i 4 uger efterfulgt af 2 ugers pause, hver cyklus.
English: A total of 821 patients were randomised to receive either nivolumab 3 mg/kg (n = 410) administered intravenously over 60 minutes every 2 weeks or everolimus (n = 411) 10 mg daily, administered orally.
Danish: I alt 821 patienter blev randomiseret til at få enten nivolumab 3 mg/kg (n = 410) som intravenøs administration over 60 minutter hver 2. uge eller everolimus (n = 411) 10 mg dagligt oralt.
English: Common hypercalcaemia, hypermagnesaemia, hypernatraemia, weight decreased hypermagnesaemia, hypernatraemia, weight decreased
Danish: Almindelig hypercalcæmi, hypermagnesiæmi, hypernatriæmi, vægttab hypermagnesiæmi, hypernatriæmi, vægttab
English: Resolution occurred in 191 patients (65.9%) with a median time to resolution of 11.4 weeks (range: 0.1-150.1+).
Danish: Resolution forekom hos 191 patienter (65,9 %) med en mediantid til resolution på 11,4 uger (0,1-150,1+).
English: Resolution occurred in 186 patients (89.4%) with a median time to resolution of 3.0 weeks (range: 0.1-159.4+).
Danish: Resolution forekom hos 186 patienter (89,4 %) med en mediantid til resolution på 3,0 uger (0,1-159,4+).
English: (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy) and who have experienced disease progression during or within 6 months of receiving platinum-based therapy regimen and had an ECOG performance status score of 0 or 1.
Danish: Studiet inkluderede patienter (≥18 år) med histologisk bekræftet recidiverende eller metastatisk SCCHN (mundhule, pharynx, larynx) i stadie III/IV, der ikke kunne behandles med lokal terapi med kurativ intention (operation eller strålebehandling med eller uden kemoterapi), og som havde oplevet sygdomsprogression under et platinbaseret behandlingsregime eller inden for 6 måneder derefter, og som havde en ECOG-performance-score på 0 eller 1.
English: Grade 2 and Grade 3 thyroid disorders were reported in 15.7% (86/547) and 1.3% (7/547) of patients, respectively.
Danish: Grad 2 og grad 3 thyroidearelaterede bivirkninger blev rapporteret hos henholdsvis 15,7 % (86/547) og 1,3 % (7/547) af patienterne.
English: Data from SCCHN and adjuvant melanoma patients 75 years of age or older are too limited to draw conclusions on this population.
Danish: Data fra SCCHN- og adjuverende melanompatienter ≥ 75 år er for begrænsede til at kunne drage konklusioner for denne population.
English: Nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued for life-threatening (Grade 4) hypophysitis.
Danish: Nivolumab eller nivolumab i kombination med ipilimumab skal seponeres permanent i tilfælde af livstruende (grad 4) hypofysitis.
English: Efficacy results are shown in Table 23.
Danish: Effektresultater er vist i tabel 23.
English: Grade 2 and Grade 3 hypopituitarism occurred in 0.4% (2/448) and 0.7% (3/448) of patients, respectively.
Danish: Grad 2 og grad 3 hypopituitarisme forekom hos henholdsvis 0,4 % (2/448) and 0.7 % (3/448) af patienterne.
English: Figure 6: Overall survival by PD-L1 expression: 1% cut off (CA209067) - Minimum follow-up of 36 months
Danish: Figur 6: Samlet overlevelse ved PD-L1-ekspression: 1 % cut off (CA209067)Opfølgningsperiode på minimum 36 måneder
English: If you have questions about this medicine, please ask your doctor.
Danish: Kontakt lægen, hvis du har spørgsmål til lægemidlet.
English: Inflammation of the pancreas (pancreatitis), inflammation of the stomach (gastritis) Severe condition of the skin that causes red, often itchy spots, similar to the rash of measles, which starts on the limbs and sometimes on the face and the rest of the body (erythema multiforme), skin disease with thickened patches of red skin, often with silvery scales (psoriasis), skin condition of the face where the nose and cheeks are unusually red (rosacea), hives (itchy, bumpy rash)
Danish: Alvorlig hudsygdom med røde, ofte kløende knopper, som ligner mæslingeudslæt, og som begynder på arme og ben, og nogle gange i ansigtet og på resten af kroppen (erythema multiforme), hudsygdom med fortykkede røde områder på huden, ofte med sølvagtige skæl (psoriasis), hudsygdom i ansigtet med usædvanlig rødme af næse og kinder (rosacea), nældefeber (kløende, hævet udslæt)
English: The safety and efficacy of nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg or nivolumab 3 mg/kg vs. ipilimumab 3 mg/kg monotherapy for the treatment of advanced (unresectable or metastatic) melanoma were evaluated in a phase 3, randomised, double-blind study (CA209067).
Danish: Sikkerheden og virkningen af nivolumab 1 mg/kg i kombination med ipilimumab 3 mg/kg eller nivolumab 3 mg/kg versus ipilimumab 3 mg/kg monoterapi til behandling af fremskredent (inoperabelt eller metastatisk) melanom blev undersøgt i et randomiseret, dobbeltblindt fase 3-studie (CA209067).
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg//kg, the incidence of hypersensitivity/infusion reactions was 4.0% (22/547); all were Grade 1 or 2 in severity.
Danish: Hos patienter, der blev behandlet med nivolumab 3 mg/kg i kombination med ipilimumab 1 mg/kg, var hyppigheden af overfølsomheds-/infusionsreaktioner 4,0 % (22/547); de var alle grad 1 eller 2 i sværhedsgrad.
English: Single-arm phase 2 study (CA209063)
Danish: Fase 2-enkeltarmsstudie (CA209063)
English: This study included patients regardless of their tumour PD-L1 status.
Danish: Studiet inkluderede patienter uagtet deres PD-L1-tumorstatus.
English: Objective response (95% CI) Odds ratio (95% CI) p-value
Danish: Objektivt respons (95 % CI) Oddsratio (95 % CI) p-værdi
English: Grade 2 and Grade 3 cases were reported in 13.7% (75/547) and 3.7% (20/547) of patients, respectively.
Danish: Grad 2 og grad 3 tilfælde blev rapporteret hos henholdsvis 13,7 % (75/547) og 3,7 % (20/547) af patienterne.
English: Grade 2, Grade 3, and Grade 4 cases were reported in 4.8% (26/547), 6.6% (36/547), and 1.6% (9/547) of patients, respectively.
Danish: Grad 2, grad 3 og grad 4 tilfælde blev rapporteret hos henholdsvis 4,8 % (26/547), 6,6 % (36/547) og 1,6 % (9/547) af patienterne.
English: Grade 2 and Grade 3 cases were reported in 10.4% (57/547) and 4.9% (27/547) of patients, respectively.
Danish: Grad 2 og grad 3 tilfælde blev rapporteret hos henholdsvis 10,4 % (57/547) og 4,9 % (27/547) af patienterne.
English: Tumour assessments, according to the RECIST, version 1.1, were conducted 9 weeks after randomisation and continued every 6 weeks thereafter.
Danish: Tumorvurdering ifølge RECIST, version 1.1, blev udført 9 uger efter randomisering og derefter hver 6. uge.
English: Changes in the rhythm or rate of the heartbeat, abnormal heart rhythm, inflammation of the heart muscle
Danish: Ændret hjerterytme eller hjertefrekvens, unormal hjerterytme, en betændelseslignende reaktion (inflammation) i hjertemusklen
English: Grade 2 and Grade 3 cases were reported in 3.1% (17/547) and 1.1% (6/547), of patients, respectively.
Danish: Grad 2 og grad 3 tilfælde blev rapporteret hos henholdsvis 3,1 % (17/547) og 1,1 % (6/547) af patienterne.
English: Progression- free survival Rate (95% CI) at 12 months Rate (95% CI) at 18 months Overall survival
Danish: Progressionsfri overlevelse Rate (95 % CI) ved 12 måneder Rate (95 % CI) ved 18 måneder
English: Randomised phase 3 study of nivolumab in combination with ipilimumab or nivolumab as monotherapy vs. ipilimumab as monotherapy (CA209067)
Danish: Randomiseret fase 3-studie med nivolumab i kombination med ipilimumab eller nivolumab som monoterapi versus ipilimumab som monoterapi (CA209067)
English: Resolution occurred in 86 patients (85.1%) with a median time to resolution of 6.1 weeks (range: 0.1+-82.9+).
Danish: Resolution forekom hos 86 patienter (85,1 %) med en mediantid til resolution på 6,1 uger (0,1+-82,9+).
English: Nervous system disorders Very common headache Common peripheral neuropathy, dizziness headache, peripheral neuropathy, dizziness
Danish: Almindelig perifer neuropati, svimmelhed hovedpine, perifer neuropati, svimmelhed
English: Efficacy results are shown in Table 14.
Danish: Effektresultater er vist i tabel 14.
English: One vial of 24 mL contains 240 mg of nivolumab.
Danish: Et 24 ml hætteglas indeholder 240 mg nivolumab.
English: Patients with active brain metastases or leptomeningeal metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the study.
Danish: Patienter med aktive hjernemetastaser eller leptomeningeale metastaser, aktiv autoimmunsygdom eller sygdomstilstande, der krævede systemisk immunsuppressionblev ekskluderet fra studiet.