natgillin/translations-raw huggingface dataset:
I to studier hos patienter med klassisk HL, som gennemgik allogen HSCT efter seponering af monoterapi med nivolumab, blev der blandt 49 evaluerede patienter rapporteret akut GVHD af grad 3 eller 4 hos 13 (26,5 %).
In 49 evaluated patients from two cHL studies who underwent allogeneic HSCT after discontinuing nivolumab monotherapy, Grade 3 or 4 acute GVHD was reported in 13/49 patients (26.5%).
Tabel 21: Effektresultater hos patienter med recidiverende/refraktært klassisk Hodgkins lymfom
Table 21: Efficacy results in patients with relapsed/refractory classical Hodgkin lymphoma
Figur 2: Progressionsfri overlevelse (CA209067)
Figure 2: Progression-free survival (CA209067)
Immunsystemet Almindelig infusionsrelateret reaktion, overfølsomhed infusionsrelateret reaktion, overfølsomhed
Immune system disorders Common infusion related reaction, hypersensitivity infusion-related reaction, hypersensitivity
64 % af patienterne var mænd, og 98 % var kaukasiere.
Sixty-four percent of patients were men and 98% were white.
Øvrige indholdsstoffer: Natriumcitratdihydrat, natriumchlorid (se afsnit 2 ”OPDIVO indeholder natrium”), mannitol (E421), diethylentriaminpentaeddikesyre, polysorbat 80, natriumhydroxid, saltsyre og vand til injektionsvæsker.
The other ingredients are sodium citrate dihydrate, sodium chloride (see section 2 "OPDIVO contains sodium"), mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injections.
Af de 1.008 behandlede patienter havde 103 (10 %) okulært/uvealt melanom, 66 (7 %) havde en ECOG-performance-score på 2, 165 (16 %) havde asymptomatiske behandlede og ubehandlede CNS-metastaser, 13 (1,3 %) havde behandlede leptomeningeale metastaser, 25 (2 %) havde autoimmun sygdom, og 84 (8 %) havde grad 3-4 immunrelaterede bivirkninger med tidligere anti-CTLA-4-behandling.
Of the 1008 treated patients, 103 (10%) had ocular/uveal melanoma, 66 (7%) had an ECOG performance score of 2, 165 (16%) had asymptomatic treated and untreated CNS metastases, 13 (1.3%) had treated leptomeningeal metastases, 25 (2%) had autoimmune disease, and 84 (8%) had Grade 3-4 immune-related AEs with prior anti-CTLA-4 therapy.
Studiet inkluderede voksne patienter, hvis sygdom havde progredieret under eller efter behandling med ipilimumab, og som, hvis positiv for BRAF-V600-mutation, også havde progredieret under eller efter behandling med BRAF-kinasehæmmer.
The study included adult patients who had progressed on or after ipilimumab and if BRAF V600 mutation positive had also progressed on or after BRAF kinase inhibitor therapy.
Kasser hætteglasset, hvis koncentratet er grumset, misfarvet eller indeholder andre partikler end nogle få delvist gennemsigtige eller hvidlige partikler.
Discard the vial if the solution is cloudy, is discoloured, or contains particulate matter other than a few translucentto-white particles.
Patienter, som ikke tidligere havde fået systemisk cancerbehandling for inoperabelt eller metastatisk melanom, blev indrulleret i studiet.
Patients who had not received prior systemic anticancer therapy for unresectable or metastatic melanoma were enrolled.
Grad 2 binyrebarkinsufficiens Grad 3 diabetes
Grade 2 adrenal insufficiency Grade 3 diabetes
Brug ikke OPDIVO efter den udløbsdato, der står på æsken og etiketten på hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use OPDIVO after the expiry date which is stated on the carton and on the vial label after EXP.
32 % af patienterne havde BRAF-mutationpositivt melanom; 26,5 % af patienterne havde PD-L1 ≥ 5 % tumorcellemembranekspression.
Thirty-two percent of patients had BRAF mutation-positive melanoma; 26.5% of patients had PD-L1 ≥ 5% tumour cell membrane expression.
PFS HR for nivolumab vs. kemoterapi var 1,03 (95 % CI: 0,78, 1,36).
The PFS HR for nivolumab vs. chemotherapy was 1.03 (95% CI: 0.78, 1.36).
Behandling blev fortsat så længe der blev obsereret kliniske fordele eller indtil behandlingen ikke længere kunne tolereres.
Treatment was continued as long as clinical benefit was observed or until treatment was no longer tolerated.
22 % af patienterne havde tidligere fået adjuverende behandling.
Twenty-two percent of patients had received prior adjuvant therapy.
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.
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.
* nivolumab i kombination med ipilimumab for de første 4 doser, derefter efterfulgt af nivolumab som monoterapi ved melanom.
* nivolumab in combination with ipilimumab for the first 4 doses then followed by nivolumab monotherapy in melanoma.
Nivolumab i kombination med ipilimumab bør seponeres ved livstruende eller tilbagevendende alvorlige kardielle og pulmonale bivirkninger (se pkt.
Nivolumab in combination with ipilimumab should be discontinued for life-threatening or recurrent severe cardiac and pulmonary adverse reactions (see section 4.2).
Det skal du vide, før du begynder at bruge OPDIVO
What you need to know before you use OPDIVO
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).
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).
Når nivolumab administreres i kombination med ipilimumab bør produktresuméet for ipilimumab læses, inden behandlingen indledes.
When nivolumab is administered in combination with ipilimumab, refer to the Summary of Product Characteristics for ipilimumab prior to initiation of treatment.
Patienterne i nivolumab-monoterapi-armen fik nivolumab 3 mg/kg hver 2. uge.
Patients in the nivolumab monotherapy arm received nivolumab 3 mg/kg every 2 weeks.
6 patienter (4 %) randomiseret til docetaxel krydsede på et eller andet tidspunktover til nivolumab.
Six patients (4%) randomised to docetaxel crossed over at any time to receive nivolumab treatment.
Immunrelaterede bivirkninger forekom med større hyppighed, når nivolumab blev administreret i kombination med ipilimumab sammenlignet med nivolumab som monoterapi.
Immune-related adverse reactions have occurred at higher frequencies when nivolumab was administered in combination with ipilimumab compared with nivolumab as monotherapy.
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.
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.
OS-data var ikke modnede nok endnu ved analysetidspunktet.
OS was not mature at the time of this analysis.
Fordelingen af patienter med kvantificerbar PD-L1-tumorekspression var velbalanceret på tværs af de tre behandlingsgrupper.
Among patients with quantifiable tumour PD-L1 expression, the distribution of patients was balanced across the three treatment groups.
Hos mellem- eller højrisikopatienter blev OS-fordel observeret i nivolumab i kombination med ipilimumab-armen versus sunitinib uanset PD-L1-tumorekspressionsniveau.
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.
Du må ikke få OPDIVO: hvis du er allergisk over for nivolumab eller et af de øvrige indholdsstoffer i OPDIVO (angivet i afsnit 6).
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").
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.
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).
I modeller med syngene tumorer hos mus resulterede dobbelt blokering af PD-1 og CTLA-4 i synergistisk anti-tumoraktivitet.
In murine syngeneic tumour models, dual blockade of PD-1 and CTLA-4 resulted in synergistic anti-tumour activity.
Ved hoved-halscancer blev der observeret flere dødsfald inden for 3 måneder med nivolumab sammenlignet med docetaxel.
In head and neck cancer, a higher number of deaths within 3 months was observed in nivolumab compared to docetaxel.
Figur 7: Overlevelse uden tilbagefald (CA209238)
Figure 7: Recurrence-free Survival (CA209238)
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).
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.
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.
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.
74 % af patienterne havde kutant melanom, og 11 % havde mukosalt melanom; 35 % af patienterne havde PD-L1-positivt melanom (≥5 % tumorcellemembranekspression).
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).
Betændelseslignende reaktion i musklerne såsom myocarditis (inflammation i hjertemusklen), myositis (inflammation i musklerne) og rabdomyolyse (stivhed i muskler og led, muskelkramper).
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).
Progressionsfri overlevelse (måneder)
Progression Free Survival (Months)
Tabel 12: Objektivt respons (CA209067)
Table 12: Objective response (CA209067)
Tegn og symptomer kan være muskelsmerter, muskelstivhed, muskelsvaghed, brystsmerter eller voldsom træthed.
Signs and symptoms may include muscle pain, stiffness, weakness, chest pain, or severe fatigue.
Tid til resolution var fra 0,4 til 130,3+ uger.
Time to resolution ranged from 0.4 to 130.3+ weeks.
Tid til resolution spændte fra 0,4 til 144,1+ uger.
Time to resolution ranged from 0.4 to 144.1+ weeks.
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.
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.
Planlagt interimanalyse Minimum opfølgning: 13,2 måneder
Prespecified interim analysis Minimum follow-up: 13.2 months
Det fås i æsker med enten 1 hætteglas med 4 ml, 1 hætteglas med 10 ml eller 1 hætteglas med 24 ml.
It is available in packs containing either 1 vial of 4 mL, 1 vial of 10 mL or 1 vial of 24 mL.
Forudgående strålebehandling Forudgående ASCT
Prior radiation therapy Prior ASCT
Indehaver af markedsføringstilladelsen Bristol-Myers Squibb Pharma EEIG Plaza 254
Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Plaza 254
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.
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.
56 (56 %) M 44 (44 %) K
56 (56%) M 44 (44%) F
10 (67 %)M / 5 (33 %)K
10 (67%) M 5 (33%) F
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.
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.
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.
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.
Den ordinerede dosis for patienten er 240 mg eller 480 mg uanset kropsvægt, alt afhængig af indikation.
The prescribed dose for the patient is 240 mg or 480 mg given regardless of body weight depending on indication.
Baseline-karakteristika var velbalancerede mellem de tre behandlingsgrupper.
Baseline characteristics were balanced across the three treatment groups.
16 patienter (6 %) randomiseret til docetaxel krydsede på et eller andet tidspunkt over til nivolumab.
Sixteen patients (6%) randomised to docetaxel crossed over at any time to receive nivolumab treatment.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml koncentrat indeholder 10 mg nivolumab.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 10 mg of nivolumab.
Tumor blev vurderet ifølge RECIST version 1.1.
Tumour assessments were conducted according to the RECIST version 1.1.
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).
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).
Almene symptomer og reaktioner på administrationsstedet Meget almindelig træthed, pyreksi træthed, pyreksi
General disorders and administration site conditions Very common fatigue, pyrexia fatigue, pyrexia
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).
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).
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.
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.
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.
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.
PD-L1-tumorekspressionsniveau
Tumour PD-L1 expression level
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).
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).
Nivolumab + ipilimumab (hændelser: 166/425), median og 95,0 % CI: NA (32,49; NA)
Nivolumab + ipilimumab (events: 166/425), median and 95.0% CI: NA (32.49, NA)
Randomisering blev stratificeret efter PD-L1-tumorekspression (≥ 5 % versus < 5 %/ubestemmelig), og sygdomsstadie ifølge AJCC-stadieklassificeringen.
Randomisation was stratified by tumour PD-L1 expression (≥ 5% vs. < 5%/indeterminate), and stage of disease per the AJCC staging system.
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.
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.
Ikke almindelig eosinofili
Uncommon eosinophilia
Progressionsfri overlevelse Hændelser
Progression-free survival Events
OPDIVO koncentrat til infusion, opløsning (sterilt koncentrat) er en klar til opaliserende, farveløs til lysegul væske, der kan indeholde få lyse partikler.
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.
Spørg lægen, hvis du har nogen spørgsmål om ipilimumab.
If you have any questions about ipilimumab, please ask your doctor.
Når OPDIVO administreres i kombination med ipilimumab, skal OPDIVO administreres først og efterfølges af ipilimumab den samme dag.
When administered in combination with ipilimumab, OPDIVO should be given first followed by ipilimumab on the same day.
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).
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).
Tabel 17: ORR og OS i forhold til PD-L1-tumorekspression (CA209057)
Table 17: ORR and OS by tumour PD-L1 expression (CA209057)
Hud og subkutane væv Meget almindelig udslæte, pruritus udslæte, pruritus
Skin and subcutaneous tissue disorders Very common rashe, pruritus rashe, pruritus
Betændelseslignende sygdom i blodkar
Inflammatory disease of blood vessels
Randomisering blev stratificeret i forhold til BRAF- og PD-L1-tumorstatus samt bedste respons på tidligere ipilimumab-behandling.
BRAF and tumour PD-L1 status and best response to prior ipilimumab.
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.
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.
Sandsynlighed for samlet overlevelse
Probability of Overall Survival
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.
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.
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.
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.
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 %).
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%).
Så meget OPDIVO skal du have
How much OPDIVO is given
I tilfælde af en svær eller livstruende infusionsreaktion skal infusionen med nivolumab eller nivolumab i kombination med ipilimumab afbrydes og passende behandling gives.
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.
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.
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
Fortæl det til lægen, inden du får OPDIVO, hvis du er på en diæt med lavt natriumindhold (lavt saltindhold).
Tell your doctor if you are on a low-sodium (low-salt) diet before you are given OPDIVO.
Størstedelen af patienterne var kaukasiere (92 %) og mænd (55 %).
The majority of patients were white (92%) and male (55%).
h p-værdi blev sammenlignet med en alfa-værdi på 0,009 for at opnå statistisk signifikans.
h p-value is compared to alpha 0.009 in order to achieve statistical significance.