FrancophonIA/ELRC3.0 huggingface dataset:
English: The PFS HR for nivolumab vs. chemotherapy was 1.03 (95% CI: 0.78, 1.36).
Danish: PFS HR for nivolumab vs. kemoterapi var 1,03 (95 % CI: 0,78, 1,36).
English: Treatment was continued as long as clinical benefit was observed or until treatment was no longer tolerated.
Danish: Behandling blev fortsat så længe der blev obsereret kliniske fordele eller indtil behandlingen ikke længere kunne tolereres.
English: Twenty-two percent of patients had received prior adjuvant therapy.
Danish: 22 % af patienterne havde tidligere fået adjuverende behandling.
English: Grade 1, Grade 2, Grade 3, and Grade 4 diabetes mellitus and Grade 4 diabetic ketoacidosis were each reported in 0.2% (1/448) of patients.
Danish: Grad 1, grad 2, grad 3 og grad 4 diabetes mellitus og grad 4 diabetisk ketoacidose blev hver især rapporteret hos 0,2 % (1/448) af patienterne.
English: * nivolumab in combination with ipilimumab for the first 4 doses then followed by nivolumab monotherapy in melanoma.
Danish: * nivolumab i kombination med ipilimumab for de første 4 doser, derefter efterfulgt af nivolumab som monoterapi ved melanom.
English: Nivolumab in combination with ipilimumab should be discontinued for life-threatening or recurrent severe cardiac and pulmonary adverse reactions (see section 4.2).
Danish: Nivolumab i kombination med ipilimumab bør seponeres ved livstruende eller tilbagevendende alvorlige kardielle og pulmonale bivirkninger (se pkt.
English: What you need to know before you use OPDIVO
Danish: Det skal du vide, før du begynder at bruge OPDIVO
English: OS benefit was observed regardless of HPV status (HPV-positive: HR = 0.63; 95% CI: 0.38, 1.04, HPV-negative: HR = 0.64; 95% CI: 0.40, 1.03, and HPV-unknown: HR = 0.78; 95% CI: 0.55, 1.10).
Danish: OS-fordel blev observeret uanset HPV-status (HPV-positiv: HR = 0,63; 95 % CI: 0,38; 1,04, HPV-negativ: HR = 0,64; 95 % CI: 0,40; 1,03 og HPV-ukendt: HR = 0,78; 95 % CI: 0,55; 1,10).
English: When nivolumab is administered in combination with ipilimumab, refer to the Summary of Product Characteristics for ipilimumab prior to initiation of treatment.
Danish: Når nivolumab administreres i kombination med ipilimumab bør produktresuméet for ipilimumab læses, inden behandlingen indledes.
English: Patients in the nivolumab monotherapy arm received nivolumab 3 mg/kg every 2 weeks.
Danish: Patienterne i nivolumab-monoterapi-armen fik nivolumab 3 mg/kg hver 2. uge.
English: Six patients (4%) randomised to docetaxel crossed over at any time to receive nivolumab treatment.
Danish: 6 patienter (4 %) randomiseret til docetaxel krydsede på et eller andet tidspunktover til nivolumab.
English: Immune-related adverse reactions have occurred at higher frequencies when nivolumab was administered in combination with ipilimumab compared with nivolumab as monotherapy.
Danish: Immunrelaterede bivirkninger forekom med større hyppighed, når nivolumab blev administreret i kombination med ipilimumab sammenlignet med nivolumab som monoterapi.
English: The median duration of treatment was 7.9 months (range: 1 day- 21.4+ months) in nivolumab with ipilimumab- treated patients and was 7.8 months (range: 1 days- 20.2+ months) in sunitinib treated patients.
Danish: Den mediane behandlingsvarighed var 7,9 måneder (1 dag-21,4+ måneder) hos nivolumab med ipilimumabbehandlede patienter og 7,8 måneder (1 dag-20,2+ måneder) hos sunitinib-behandlede patienter.
English: OS was not mature at the time of this analysis.
Danish: OS-data var ikke modnede nok endnu ved analysetidspunktet.
English: Among patients with quantifiable tumour PD-L1 expression, the distribution of patients was balanced across the three treatment groups.
Danish: Fordelingen af patienter med kvantificerbar PD-L1-tumorekspression var velbalanceret på tværs af de tre behandlingsgrupper.
English: In intermediate/poor-risk patients, OS benefit was observed in the nivolumab in combination with ipilimumab arm vs. sunitinib regardless of tumour PD-L1 expression.
Danish: Hos mellem- eller højrisikopatienter blev OS-fordel observeret i nivolumab i kombination med ipilimumab-armen versus sunitinib uanset PD-L1-tumorekspressionsniveau.
English: You should not be given OPDIVO if you are allergic to nivolumab or any of the other ingredients of this medicine (listed in section 6 "Contents of the pack and other information").
Danish: Du må ikke få OPDIVO: hvis du er allergisk over for nivolumab eller et af de øvrige indholdsstoffer i OPDIVO (angivet i afsnit 6).
English: Severe endocrinopathies, including hypothyroidism, hyperthyroidism, adrenal insufficiency (including secondary adrenocortical insufficiency), hypophysitis (including hypopituitarism), diabetes mellitus, and diabetic ketoacidosis have been observed with nivolumab monotherapy or nivolumab in combination with ipilimumab (see section 4.8).
Danish: Svære endokrinopatier, herunder hypotyroidisme, hypertyroidisme, binyrebarkinsufficiens (inklusive sekundær binyrebarkinsufficiens), hypofysitis (inklusive hypopituitarisme), diabetes mellitus og diabetisk ketoacidose, er observeret med nivolumab-monoterapi eller nivolumab i kombination med ipilimumab (se pkt.
English: In murine syngeneic tumour models, dual blockade of PD-1 and CTLA-4 resulted in synergistic anti-tumour activity.
Danish: I modeller med syngene tumorer hos mus resulterede dobbelt blokering af PD-1 og CTLA-4 i synergistisk anti-tumoraktivitet.
English: In head and neck cancer, a higher number of deaths within 3 months was observed in nivolumab compared to docetaxel.
Danish: Ved hoved-halscancer blev der observeret flere dødsfald inden for 3 måneder med nivolumab sammenlignet med docetaxel.
English: Figure 7: Recurrence-free Survival (CA209238)
Danish: Figur 7: Overlevelse uden tilbagefald (CA209238)
English: OPDIVO must be administered with caution in patients with moderate (total bilirubin > 1.5 × to 3 × the upper limit of normal [ULN] and any AST) or severe (total bilirubin > 3 × ULN and any AST) hepatic impairment.
Danish: OPDIVO skal administreres med forsigtighed til patienter med moderat nedsat leverfunktion (total-bilirubin > 1,5-3 × den øvre grænse for normalområdet [ULN] og en hvilken som helst ASAT) eller svært nedsat leverfunktion (total-bilirubin > 3 × ULN og en hvilken som helst ASAT).
English: In patients treated with nivolumab monotherapy, the incidence of hypersensitivity/infusion reactions was 4.7% (121/2578), including 6 Grade 3 and 2 Grade 4 cases.
Danish: Hos patienter, som blev behandlet med nivolumab-monoterapi, var hyppigheden af overfølsomhed/infusionsreaktioner 4,7 % (121/2.578), herunder 6 grad 3 og 2 grad 4 tilfælde.
English: Seventy-four percent of patients had cutaneous melanoma, and 11% had mucosal melanoma; 35% of patients had PD-L1 positive melanoma (≥ 5% tumour cell membrane expression).
Danish: 74 % af patienterne havde kutant melanom, og 11 % havde mukosalt melanom; 35 % af patienterne havde PD-L1-positivt melanom (≥5 % tumorcellemembranekspression).
English: Inflammation of the muscles such as myocarditis (inflammation of the heart muscle), myositis (inflammation of the muscles) and rhabdomyolysis (stiffness in muscles and joints, muscle spasm).
Danish: Betændelseslignende reaktion i musklerne såsom myocarditis (inflammation i hjertemusklen), myositis (inflammation i musklerne) og rabdomyolyse (stivhed i muskler og led, muskelkramper).
English: Progression Free Survival (Months)
Danish: Progressionsfri overlevelse (måneder)
English: Table 12: Objective response (CA209067)
Danish: Tabel 12: Objektivt respons (CA209067)
English: Signs and symptoms may include muscle pain, stiffness, weakness, chest pain, or severe fatigue.
Danish: Tegn og symptomer kan være muskelsmerter, muskelstivhed, muskelsvaghed, brystsmerter eller voldsom træthed.
English: Time to resolution ranged from 0.4 to 130.3+ weeks.
Danish: Tid til resolution var fra 0,4 til 130,3+ uger.
English: Time to resolution ranged from 0.4 to 144.1+ weeks.
Danish: Tid til resolution spændte fra 0,4 til 144,1+ uger.
English: To further investigate the value of biomarkers other than PD-L1 expression status at tumour cell membrane level by IHC (e.g., other genomic-based methods/ assays, and associated cut offs, that might prove more sensitive and specific in predicting response to treatment based on PD-L1, PD-L2, tumour infiltrating lymphocytes with measurement of CD8+T density, RNA signature, expression of components of antigen-presentation complexes and/or other inhibitory checkpoint receptors/ligands within tumour, etc.) as predictive of nivolumab + ipilimumab combination therapy efficacy in the context of melanoma studies CA209038, CA209067, or CA209069.
Danish: Yderligere at undersøge værdien af biomarkører andre end PD-L1ekspressionsstatus ved tumorcellemembran-niveau ved immunhistokemisk (IHC) analyse (f.eks. andre genombaserede metoder / analyser og relaterede cut-offs, som kan vise sig at være mere følsomme og specifikke til at forudse respons på behandlingen, baseret på PD-L1, PD-L2, tumorinfiltrerende lymfocytter med måling af CD8+T-densitet, RNA-signatur, ekspression af komponenter fra antigenpræsenterende komplekser og/eller andre hæmmende checkpoint receptorer/ligander i tumor etc.) som prædiktive for virkningen af nivolumab + ipilimumab kombinationsterapi i forbindelse med melanom-studierne CA209038, CA209067 eller CA209069.
English: Prespecified interim analysis Minimum follow-up: 13.2 months
Danish: Planlagt interimanalyse Minimum opfølgning: 13,2 måneder
English: It is available in packs containing either 1 vial of 4 mL, 1 vial of 10 mL or 1 vial of 24 mL.
Danish: Det fås i æsker med enten 1 hætteglas med 4 ml, 1 hætteglas med 10 ml eller 1 hætteglas med 24 ml.
English: Prior radiation therapy Prior ASCT
Danish: Forudgående strålebehandling Forudgående ASCT
English: Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Plaza 254
Danish: Indehaver af markedsføringstilladelsen Bristol-Myers Squibb Pharma EEIG Plaza 254
English: Patients with treated brain metastases were eligible if neurologically returned to baseline at least 2 weeks prior to enrolment, and either off corticosteroids, or on a stable or decreasing dose of < 10 mg daily prednisone equivalents.
Danish: Patienter med behandlede hjernemetastaser var egnede til at deltage, hvis de neurologisk var vendt tilbage til baseline mindst 2 uger før studieoptagelse og enten havde afsluttet kortikosteroid-behandling eller var på en stabil eller faldende dosis ækvivalent med < 10 mg prednison dagligt.
English: 56 (56%) M 44 (44%) F
Danish: 56 (56 %) M 44 (44 %) K
English: 10 (67%) M 5 (33%) F
Danish: 10 (67 %)M / 5 (33 %)K
English: Of the patients who were treated with nivolumab in combination with ipilimumab and evaluable for the presence of anti-nivolumab antibodies, the incidence of anti-nivolumab antibodies was 26.0% with nivolumab 3 mg/kg and ipilimumab 1 mg/kg every 3 weeks and 37.8% with nivolumab 1 mg/kg and ipilimumab 3 mg/kg every 3 weeks.
Danish: Af de patienter, som blev behandlet med nivolumab i kombination med ipilimumab, og som var evaluerbare for tilstedeværelse af anti-nivolumab-antistoffer, var forekomsten af anti-nivolumabantistoffer 26,0 % med 3 mg/kg nivolumab og 1 mg/kg ipilimumab hver 3. uge, og 37,8 % med 1 mg/kg nivolumab og 3 mg/kg ipilimumab hver 3. uge.
English: Study CA209063 was a single-arm, open-label study conducted in 117 patients with locally advanced or metastatic squamous NSCLC after two or more lines of therapy; otherwise similar inclusion criteria as study CA209017 were applied.
Danish: Studie CA209063 var et åbent enkeltarmsstudie med 117 patienter med lokalt fremskreden eller metastatisk planocellulær NSCLC efter to eller flere tidligere behandlingsforløb; derudover blev de samme inklusionskriterier som i studie CA209017 anvendt.
English: The prescribed dose for the patient is 240 mg or 480 mg given regardless of body weight depending on indication.
Danish: Den ordinerede dosis for patienten er 240 mg eller 480 mg uanset kropsvægt, alt afhængig af indikation.
English: Baseline characteristics were balanced across the three treatment groups.
Danish: Baseline-karakteristika var velbalancerede mellem de tre behandlingsgrupper.
English: Sixteen patients (6%) randomised to docetaxel crossed over at any time to receive nivolumab treatment.
Danish: 16 patienter (6 %) randomiseret til docetaxel krydsede på et eller andet tidspunkt over til nivolumab.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 10 mg of nivolumab.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml koncentrat indeholder 10 mg nivolumab.
English: Tumour assessments were conducted according to the RECIST version 1.1.
Danish: Tumor blev vurderet ifølge RECIST version 1.1.
English: Study CA209069 was a randomised, Phase 2, double-blind study comparing the combination of nivolumab and ipilimumab with ipilimumab alone in 142 patients with advanced (unresectable or metastatic) melanoma with similar inclusion criteria to study CA209067 and the primary analysis in patients with BRAF wild-type melanoma (77% of patients).
Danish: Studie CA209069 var et randomiseret, dobbeltblindt fase 2-studie, som sammenlignede kombinationen af nivolumab og ipilimumab med ipilimumab alene hos 142 patienter med fremskredent (inoperabelt eller metastatisk) melanom med lignende inklusionskriterier som i studie CA209067 og den primære analyse hos patienter med BRAF-vildtype-melanom (77 % af patienterne).
English: General disorders and administration site conditions Very common fatigue, pyrexia fatigue, pyrexia
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig træthed, pyreksi træthed, pyreksi
English: When OPDIVO is given in combination with ipilimumab for the treatment of skin cancer, the recommended dose of OPDIVO is 1 mg of nivolumab per kilogram of your body weight for the first 4 doses (combination phase).
Danish: Hvis OPDIVO gives sammen med ipilimumab til behandling af hudkræft, er den anbefalede dosis OPDIVO 1 mg nivolumab pr. kilogram kropsvægt for de første 4 doser (kombinationsfasen).
English: The geometric mean clearance (CL), terminal half-life, and average exposure at steady state at 3 mg/kg every 2 weeks of nivolumab were 7.9 mL/h, 25.0 days, and 86.6 μg/mL, respectively, based on a population PK analysis.
Danish: Baseret på en farmakokinetisk populationsanalyse var nivolumabs gennemsnitlige geometriske clearance (CL), terminale halveringstid og gennemsnitlige eksponering ved steady state med 3 mg/kg hver 2. uge henholdsvis 7,9 ml/t, 25,0 dage og 86,6 μg/ml.
English: Patients in the comparator arm received ipilimumab 3 mg/kg and nivolumab-matched placebo intravenously every 3 weeks for 4 doses followed by placebo every 2 weeks.
Danish: Patienterne i sammenligningsarmen fik ipilimumab 3 mg/kg og nivolumab-matchet placebo intravenøst hver 3. uge givet 4 gange og efterfulgt af placebo hver 2. uge.
English: Tumour PD-L1 expression level
Danish: PD-L1-tumorekspressionsniveau
English: Patients in Cohort C (n = 33) who have received brentuximab vedotin only prior to ASCT had ORR of 70% (95% CI: 51, 84), CR of 15% (95% CI: 5, 32), PR of 55% (95% CI: 36, 72).
Danish: Patienter i kohorte C (n = 33), som kun fik brentuximab vedotin før ASCT havde ORR på 70 % (95 % CI: 51; 84), CR på 15 % (95 % CI: 5; 32), PR på 55 % (95 % CI: 36; 72).
English: Nivolumab + ipilimumab (events: 166/425), median and 95.0% CI: NA (32.49, NA)
Danish: Nivolumab + ipilimumab (hændelser: 166/425), median og 95,0 % CI: NA (32,49; NA)
English: Randomisation was stratified by tumour PD-L1 expression (≥ 5% vs. < 5%/indeterminate), and stage of disease per the AJCC staging system.
Danish: Randomisering blev stratificeret efter PD-L1-tumorekspression (≥ 5 % versus < 5 %/ubestemmelig), og sygdomsstadie ifølge AJCC-stadieklassificeringen.
English: Diarrhoea (watery, loose or soft stools) or any symptoms of inflammation of the intestines (colitis), such as stomach pain and mucus or blood in stool.
Danish: Diarre (vandig, løs eller blød afføring) eller symptomer på en betændelseslignende reaktion i tarmene (colitis), som f.eks. mavesmerter og slim eller blod i afføringen.
English: Uncommon eosinophilia
Danish: Ikke almindelig eosinofili
English: Progression-free survival Events
Danish: Progressionsfri overlevelse Hændelser
English: What OPDIVO looks like and contents of the pack OPDIVO concentrate for solution for infusion (sterile concentrate) is a clear to opalescent, colourless to pale yellow liquid that may contain few light particles.
Danish: OPDIVO koncentrat til infusion, opløsning (sterilt koncentrat) er en klar til opaliserende, farveløs til lysegul væske, der kan indeholde få lyse partikler.
English: If you have any questions about ipilimumab, please ask your doctor.
Danish: Spørg lægen, hvis du har nogen spørgsmål om ipilimumab.
English: When administered in combination with ipilimumab, OPDIVO should be given first followed by ipilimumab on the same day.
Danish: Når OPDIVO administreres i kombination med ipilimumab, skal OPDIVO administreres først og efterfølges af ipilimumab den samme dag.
English: Median OS for tumour PD-L1 expression ≥ 1% was not reached for nivolumab in combination with ipilimumab, and was 19.61 months in the sunitinib arm (HR = 0.52; 95% CI: 0.34, 0.78).
Danish: Median-OS for PD-L1-tumorekspression ≥ 1 % blev ikke nået for nivolumab i kombination med ipilimumab, og var 19,61 måneder i sunitinib-armen (HR = 0,52; 95 % CI: 0,34; 0,78).
English: Table 17: ORR and OS by tumour PD-L1 expression (CA209057)
Danish: Tabel 17: ORR og OS i forhold til PD-L1-tumorekspression (CA209057)
English: Skin and subcutaneous tissue disorders Very common rashe, pruritus rashe, pruritus
Danish: Hud og subkutane væv Meget almindelig udslæte, pruritus udslæte, pruritus
English: Inflammatory disease of blood vessels
Danish: Betændelseslignende sygdom i blodkar
English: BRAF and tumour PD-L1 status and best response to prior ipilimumab.
Danish: Randomisering blev stratificeret i forhold til BRAF- og PD-L1-tumorstatus samt bedste respons på tidligere ipilimumab-behandling.
English: Adverse reactions reported in the pooled dataset for patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg (n = 448) and for patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg (n = 547) are presented in Table 6.
Danish: Bivirkninger, der blev rapporteret i det puljede datasæt for patienter behandlet med nivolumab 1 mg/kg i kombination med ipilimumab 3 mg/kg (n = 448) og for patienter behandlet med nivolumab 3 mg/kg i kombination med ipilimumab 1 mg/kg (n = 547) er vist i tabel 6.
English: Probability of Overall Survival
Danish: Sandsynlighed for samlet overlevelse
English: CA209039 is a Phase 1b open-label, multi-centre, dose-escalation, and multidose study of nivolumab in relapsed/refractory hematologic malignancies, including 23 patients with cHL treated with nivolumab 3 mg/kg monotherapy; amongst which, 15 patients received prior brentuximab vedotin treatment as a salvage therapy following ASCT, similar to Cohort B of study CA209205.
Danish: CA209039 er et åbent multicenter, multi-dosis fase 1b-dosiseskaleringsstudie af nivolumab ved recidiverende/refraktære hæmatologiske maligniteter, herunder 23 patienter med klassisk HL behandlet med nivolumab-monoterapi 3 mg/kg; blandt disse fik 15 patienter forudgående behandling med brentuximab vedotin som salvage-behandling efter ASCT, ligesom kohorte B i studie CA209205.
English: The study included adult patients (18 years or older) with confirmed, treatment-naive, Stage III or IV BRAF wild-type melanoma and an ECOG performance-status score of 0 or 1.
Danish: Studiet inkluderede voksne patienter (18 år eller ældre) med bekræftet, behandlingsnaiv, stadie III eller IV BRAF-vildtype-melanom og ECOG-performance-score på 0 eller 1.
English: Nivolumab showed numerically less effect on OS (HR 1.85; 95% CI: 0.76, 4.51), PFS (HR=1.76; 95%-CI: 0.77, 4.05) and ORR (9.1% vs. 16.7%).
Danish: Nivolumab viste numerisk mindre effekt på OS (HR=1,85; 95 % CI: 0,76; 4,51), PFS (HR=1,76; 95 % CI: 0,77; 4,05 ) og ORR (9,1 % versus 16,7 %).
English: How much OPDIVO is given
Danish: Så meget OPDIVO skal du have
English: In case of a severe or life-threatening infusion reaction, the nivolumab or nivolumab in combination with ipilimumab infusion must be discontinued and appropriate medical therapy administered.
Danish: I tilfælde af en svær eller livstruende infusionsreaktion skal infusionen med nivolumab eller nivolumab i kombination med ipilimumab afbrydes og passende behandling gives.
English: If melanoma or RCC patients need to be switched from the 240 mg every 2 weeks schedule to the 480 mg every 4 weeks schedule, the first 480 mg dose should be administered two weeks after the last
Danish: Hvis melanom- eller RCC-patienter skal skifte fra 240 mg hver 2. uge til 480 mg hver 4. uge, bør den første dosis med 480 mg administreres to uger efter den sidste dosis med 240 mg.
English: Tell your doctor if you are on a low-sodium (low-salt) diet before you are given OPDIVO.
Danish: Fortæl det til lægen, inden du får OPDIVO, hvis du er på en diæt med lavt natriumindhold (lavt saltindhold).
English: The majority of patients were white (92%) and male (55%).
Danish: Størstedelen af patienterne var kaukasiere (92 %) og mænd (55 %).
English: h p-value is compared to alpha 0.009 in order to achieve statistical significance.
Danish: h p-værdi blev sammenlignet med en alfa-værdi på 0,009 for at opnå statistisk signifikans.
English: Uncommon Guillain-Barré syndrome, polyneuropathy, neuritis, peroneal nerve palsy, autoimmune neuropathy (including facial and abducens nerve paresis), encephalitisc polyneuropathy, autoimmune neuropathy (including facial and abducens nerve paresis), myasthenia gravisc
Danish: Ikke almindelig Guillain Barré syndrom, polyneuropati, neuritis, peroneusparese, autoimmun neuropati (herunder facial og nervus abducens parese), encephalitisc polyneuropati, autoimmun neuropati (herunder facial og nervus abducens parese), myasthenia gravisc
English: Immune-related nephritis and renal dysfunction
Danish: Immunrelateret nefritis og nedsat nyrefunktion
English: Squamous NSCLC
Danish: Planocellulær NSCLC
English: CA209032 was a Phase 1/2 open-label multi-cohort study which included a cohort of 78 patients (including 18 subjects who received planned crossover treatment with nivolumab 3 mg/kg plus ipilimumab 1 mg/kg combination) with similar inclusion criteria to study CA209275 treated with nivolumab monotherapy 3 mg/kg for urothelial carcinoma.
Danish: CA209032 var et fase 1/2 ikke-blindet multikohorte studie, som omfattede en kohorte på 78 patienter (herunder 18 patienter, som overgik i følge studieprotokollen til behandling med en kombination af nivolumab 3 mg/kg plus ipilimumab 1 mg/kg) med tilsvarende inklusionskriterier som studie CA209275 behandlet med nivolumab-monoterapi 3 mg/kg for urothelialt karcinom.
English: Nivolumab 3 mg/kg (events: 183/410), median and 95% CI: 25.00 (21.75, N.A.)
Danish: Nivolumab 3 mg/kg (hændelser: 183/410), median-OS og 95 % CI: 25,00 (21,75; N.A.)
English: Tumour PD-L1 expression levels were balanced between the two treatment groups (nivolumab vs. investigator's choice) at each of the predefined tumour PD-L1 expression levels of ≥ 1% (55% vs. 62%), ≥ 5% (34% vs. 43%), or ≥ 10% (27% vs.
Danish: Niveauerne af PD-L1-tumorekspression var velbalancerede mellem de to behandlingsgrupper (nivolumab vs. investigators valg) ved hvert af de prædefinerede PD-L1-tumorekspressionsniveauer på ≥ 1 % (55 % vs. 62 %), ≥ 5 % (34 % vs. 43 %), og ≥ 10 % (27 % vs. 34 %).
English: Grade 2 hypopituitarism occurred in 0.4% (2/547) of patients.
Danish: Grad 2 hypopituitarisme forekom hos 0,4 % (2/547) af patienterne.
English: Randomised phase 3 study of nivolumab vs ipilimumab 10 mg/kg (CA209238)
Danish: Randomiseret fase 3-studie med nivolumab versus ipilimumab 10 mg/kg (CA209238)
English: Table 20: Baseline patient characteristics in CA209205 Cohort B, Cohort C and CA209039
Danish: Tabel 20: Patientkarakteristika ved baseline i CA209205 kohorte B, kohorte C og CA209039