FrancophonIA/ELRC3.0 huggingface dataset:
English: Gastrointestinal disorders Very common nausea, vomiting, diarrhoear nausea, diarrhoear, constipation, vomiting
Danish: Mave-tarm-kanalen Meget almindelig Kvalme, opkastning, diarrér
English: The median duration was 2.1 months (range 0 day to 22.0+ months; + denotes a censored value).
Danish: Medianvarighed var 2,1 måneder (interval: 0 dage til 22,0+ måneder; + angiver en censureret værdi).
English: Nab-paclitaxel and carboplatin are administered until completion of 4-6 cycles, or progressive disease or unacceptable toxicity whichever occurs first
Danish: Nab-paclitaxel administeres på dag 1, 8 og 15 af hver serie c Nab-paclitaxel og carboplatin administeres indtil 4 - 6 serier er afsluttede, eller progressiv sygdom eller uacceptabel toksicitet, hvad end der forekommer først
English: Investigator-assessed Overall Best Response3* (RECIST 1.1)
Danish: 6-månder samlet overlevelse(%) 12-måneder samlet overlevelse (%) Investigatorvurderet overordnet bedste respons3* (RECIST 1.1)
English: Tel: + 372 - 6 177 380
Danish: Roche Eesti OÜ Tel: + 372 - 6 177 380
English: Kaplan-Meier curves for OS and PFS are presented in Figures 12 and 13.
Danish: Kaplan-Meierkurver for samlet overlevelse og progressionsfri overlevelse vises i figur 12 og 13.
English: ǂStratified by PD-L1 expression in tumour infiltrating immune cells, the number of prior chemotherapy regimens, and histology ** Based on the stratified log-rank test *** Based on Kaplan-Meier estimates
Danish: ** Baseret på den stratificerede log-rank-test *** Baseret på Kaplan-Meier estimater
English: During the induction phase, the recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion, followed by nab-paclitaxel and carboplatin every three weeks for four or six cycles.
Danish: Tecentriq i kombination med nab-paclitaxel og carboplatin I induktionsfasen er den anbefalede dosis 1.200 mg Tecentriq administreret som intravenøs infusion efterfulgt af nab-paclitaxel og carboplatin hver 3. uge i fire eller seks serier.
English: What Tecentriq is and what it is used for What you need to know before you are given Tecentriq How Tecentriq is given
Danish: Det skal du vide, før du begynder at bruge Tecentriq Sådan skal du bruge Tecentriq Bivirkninger
English: Hepatitis occurred in 2.0% (62/3,178) of patients who received atezolizumab monotherapy.
Danish: Der er konstateret hepatitis hos 2,0% (62/3.178) af de patienter, der har fået atezolizumab enkeltstofbehandling.
English: Treatment with atezolizumab must be permanently discontinued for Grade 3 or 4 nephritis.
Danish: Behandling med atezolizumab skal seponeres permanent ved grad 3 eller 4 nefritis.
English: The confirmed ORR per investigator-assessed mRECIST was 29.0% (95% CI: 20.4, 38.9) in patients with PD-L1 expression ≥ 5%, 23.7% (95% CI: 18.1, 30.1) in patients with PD-L1 expression ≥ 1%, and 19.7% (95% CI: 15.4, 24.6) in all comers.
Danish: Bekræftet objektiv responsrate var ifølge investigatorvurderet mRECIST 29,0% (95% konfidensinterval: 20,4; 38,9) hos patienter med PD-L1-ekspression ≥5%, 23,7% (95% konfidensinterval: 18,1; 30,1) hos patienter med PD-L1ekspression ≥1% og 19,7% (95% konfidensinterval: 15,4; 24,6) i ITT-populationen.
English: • flu-like illness
Danish: Influenzalignende sygdom,
English: Secondary Endpoints Investigator-assessed PFS (RECIST v1.1)*
Danish: Sekundære endepunkter Investigatorvurderet progressionsfri overlevelse (RECIST v1.1)*
English: IMpower150 (GO29436): Randomised phase III trial in chemotherapy-naïve patients with metastatic non-squamous NSCLC, in combination with paclitaxel and carboplatin with or without bevacizumab
Danish: IMpower150 (GO29436): Randomiseret, fase III-studie i kombination med paclitaxel og carboplatin, med eller uden bevacizumab, hos kemoterapinaive patienter med metastatisk ikke-planocellulær ikkesmåcellet lungekræft.
English: Hypophysitis Hypophysitis occurred in < 0.1% (2/3,178) of patients who received atezolizumab monotherapy.
Danish: Der er set hypofysitis hos <0,1% (2/3.178) af patienterne behandlet med atezolizumab enkeltstofbehandling.
English: This study excluded patients who had a history of autoimmune disease, active or corticosteroid-dependent brain metastases, administration of a live, attenuated vaccine within 28 days prior to enrolment, administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medicinal product within 2 weeks prior to enrolment.
Danish: I dette studie ekskluderedes patienter med autoimmun sygdom i anamnesen, aktive eller kortikosteroidafhængige hjernemetastaser, administration af levende, svækket vaccine inden for 28 dage inden inklusion, administration af systemiske immunstimulerende midler inden for 4 uger eller systemisk immunsupprimerende lægemiddel inden for 2 uger inden inklusion.
English: Investigator-assessed PFS (RECIST v1.1) - Updated exploratory analysis4
Danish: 12-måneders progressionsfri overlevelse (%) Investigatorvurderet progressionsfri overlevelse (RECIST v1.1) - opdateret eksploratorisk analyse4
English: No. of partial response (%) 95% CI
Danish: Antal med delvist respons (%) 95% konfidensinterval
English: During the induction phase, the recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion followed by carboplatin, and then etoposide administered by intravenous infusion on day 1.
Danish: Førstelinjebehandling af småcellet lungekræft i udvidet sygdomsstadie Tecentriq i kombination med carboplatin og etoposid I induktionsfasen er den anbefalede dosis 1.200 mg Tecentriq administreret som intravenøs infusion efterfulgt af carboplatin og derefter etoposid administreret som intravenøs infusion på dag 1.
English: Figure 6: Kaplan-Meier curves for overall survival (IMpower130)
Danish: Figur 6: Kaplan-Meier-kurver for samlet overlevelse (IMpower130)
English: For the recommended dose of 1680 mg: twenty-eight mL of Tecentriq concentrate should be withdrawn from two vials of Tecentriq 840 mg and diluted into a 250 mL polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP) infusion bag containing sodium chloride
Danish: Til den anbefalede dosis på 1680 mg: Træk 28 ml Tecentriq koncentrat fra to Tecentriq 840 mg hætteglas, som fortyndes i en 250 ml polyvinylchlorid (PVC), polyolefin (PO), polyethylen (PE) eller eller polypropylen (PP) infusionspose indeholdende natriumchlorid 9 mg/ml (0,9%) injektionsvæske, opløsning.
English: • 1,680 milligrams (mg) every four weeks.
Danish: Den anbefalede dosis er enten: · 840 milligram (mg) hver 2. uge, eller · 1680 milligram (mg) hver 4. uge.
English: Grenzacherstrasse 124
Danish: F. Hoffmann-La Roche AG Grenzacherstrasse 124 4070 Basel
English: Tecentriq is used in combination with anticancer medicine (chemotherapy called nab-paclitaxel): if your doctor tested your cancer and found high levels of a specific protein in your body called program death ligand (PD-L1) when the cancer has spread to other parts of the body and has not been treated with anticancer medicines (chemotherapy) or else when the cancer has come back in the breast after previous treatment.
Danish: Tecentriq anvendes sammen med kemoterapi, kaldet nab-paclitaxel: hvis din læge tester din kræft og finder høje niveauer af et bestemt protein, kaldet programmeret døds-ligand 1 (PD-L1), i din krop.
English: 95% CI Stratifiedǂ hazard ratio (95% CI)
Danish: Stratificeretǂ hazardratio (95%
English: Blood and lymphatic system disorders Very common anaemia, thrombocytopeniac, neutropeniad, leukopeniae
Danish: Anæmi, trombocytopenic, neutropenid, leukopenie
English: No. of complete response (%) 95% CI
Danish: Antal med fuldstændigt respons (%) 95% konfidensinterval
English: ECOG performance status > 0 and haemoglobin < 10 g/dL.
Danish: Prognostiske risikofaktorer inkluderede tid siden tidligere kemobehandling <3 måneder, ECOG-performancestatus >0 og hæmoglobin <10 g/dl.
English: Hepatitis requiring the use of corticosteroids occurred in 0.6% (18/3,178) of patients receiving atezolizumab monotherapy.
Danish: Hepatitis med behov for brug af kortikosteroider sås hos 0,6% (18/3.178) af de patienter, der fik atezolizumab enkeltstofbehandling.
English: Colitis requiring the use of corticosteroids occurred in 0.6% (19/3,178) of patients receiving atezolizumab monotherapy.
Danish: Colitis med behov for brug af kortikosteroider sås hos 0,6% (19/3.178) af de patienter, der fik atezolizumab enkeltstofbehandling.
English: Nephritis has been observed in clinical trials with atezolizumab (see section 4.8).
Danish: Der er observeret nefritis i kliniske studier med atezolizumab (se pkt.
English: Nephritis
Danish: Nefritisaa
English: GERMANY
Danish: Portugal
English: For the description of Tecentriq trials, refer to the Tecentriq 1,200 mg concentrate for solution for infusion Summary of Product Characteristics (SmPC) section 5.1.
Danish: Beskrivelse af kliniske forsøg med Tecentriq kan findes under punk 5.1 i produkresuméet for Tecentriq 1200 mg koncentrat til infusionsvæske, opløsning.
English: compared to 57.5%), Grade 5 events (6.1% compared to 2.5%), adverse events of special interest to atezolizumab (52.4% compared to 48.0%), as well as adverse events leading to withdrawal of any study treatment (33.8% compared to 13.3%).
Danish: I førstelinje studiet (IMpower150), blev der observeret en overordnet større hyppighed af bivirkninger ved brug af kombinationsbehandlingen med de 4 lægemidler atezolizumab, bevacizumab, paclitaxel og carboplatin sammenlignet med atezolizumab, paclitaxel og carboplatin, inklusive grad 3 og 4 tilfælde (63,6% sammenlignet med 57,5%), grad 5 tilfælde (6,1% sammenlignet med 2,5%), bivirkninger af særlig interesse for atezolizumab (52,4% sammenlignet med 48,0%), samt bivirkninger der ledte til udtrædelse af enhver forsøgsbehandling (33,8% sammenlignet med 13,3%).
English: IMpower130 (GO29537): Randomised phase III trial in chemotherapy-naïve patients with metastatic non-squamous NSCLC, in combination with nab-paclitaxel and carboplatin
Danish: IMpower130 (GO29537): Randomiseret fase III-studie i kombination med nab-paclitaxel og carboplatin hos patienter med metastatisk ikke-planocellulært ikke-småcellet lungekræft, der ikke tidligere er behandlet med kemoterapi
English: QLQ-LC13 was observed with atezolizumab compared to docetaxel (HR of 0.71, 95% CI: 0.49, 1.05;
Danish: Der sås forlænget tid til forværring i patientindberettede brystsmerter målt ved EORTC QLQ-LC13 med atezolizumab sammenlignet med docetaxel (hazardratio 0,71; 95% konfidensinterval: 0,49; 1,05; median blev ikke nået i nogen af behandlingsarmene).
English: Figure 11 summarises the results of OS in the ITT and PD-L1 subgroups, demonstrating OS benefit with atezolizumab in all subgroups, including those with PD-L1
Danish: I figur 3 vises resultaterne af den samlede overlevelse i ITTpopulationen samt i PD-L1-subgrupperne, der viser, at atezolizumab har en positiv betydning for den samlede overlevelse i alle subgrupper, inklusive gruppen med PD-L1-ekspression <1% i tumorceller (TC) og tumorinfiltrerende immunceller (IC).
English: *The primary analysis population consists of the first 850 randomised patients
Danish: *Den primære analysepopulation består af de første 850 randomiserede patienter ǂStratificeret efter PD-L1-ekspression i tumorinfiltrerende immunceller (IC), antal tidligere kemoterapi-regimer samt histologi.
English: Pancreatitis, including increases in serum amylase and lipase levels, has been observed in clinical trials with atezolizumab (see section 4.8).
Danish: Der er i kliniske forsøg med atezolizumab observeret pancreatitis, inklusiv stigninger i serum-amylase og -lipase (se pkt.
English: Myositis occurred in 0.4% (12/3178) of patients who received atezolizumab monotherapy.
Danish: Der er set myositis hos 0,4% (12/3.178) af patienterne, der fik atezolizumab enkeltstofbehandling.
English: For the description of studies with Tecentriq administered every 3 weeks at 1,200 mg, refer to the Tecentriq 1,200 mg concentrate for solution for infusion SmPC.
Danish: Se produktresuméet for Tecentriq 1200 mg koncentrat til infusionsvæske, opløsning for beskrivelse af studie med Tcentriq 1200 mg administreret hver 3. uge.
English: Efficacy endpoint
Danish: Effekt endepunkt
English: Pancreatitis requiring the use of corticosteroids occurred in 0.1% (4/3,178) of patients receiving atezolizumab monotherapy.
Danish: Pankreatitis med behov for kortikosteroidbehandling sås hos 0,1% (4/3.178) af patienterne behandlet med atezolizumab enkeltstofbehandling.
English: If symptoms improve to ≤ Grade 1, corticosteroids should be tapered over ≥ 1 month.
Danish: Hvis symptomerne forbedres til ≤grad 1, skal kortikosteroidbehandlingen nedtrappes over ≥1 måned.
English: Kaplan-Meier curves for OS in the ITT population are presented in Figure 2.
Danish: Kaplan-Meier-kurver for samlet overlevelse i ITT-populationen vises i figur 2.
English: 18.1, 30.1) in patients with PD-L1 expression ≥ 1%, and 19.7% (95% CI: 15.4, 24.6) in all comers.
Danish: ekspression ≥1% og 19,7% (95% konfidensinterval: 15,4; 24,6) i ITT-populationen.
English: Rare nephritisaa
Danish: Nedsat nyrefunktion
English: The majority of patients were white (70%).
Danish: Størstedelen af patienterne var af kaukasisk etnicitet (70%).
English: At the time of the updated OS analysis, an exploratory PFS analysis was performed as presented in Table 6.
Danish: I tabel 6 er vist en eksploratorisk analyse af progressionsfri overlevelse, som blev udført samtidigt med den opdaterede analyse af samlet overlevelse.
English: The Kaplan-Meier curve for OS in the ITT population is presented in Figure 2.
Danish: Kaplan-Meier-kurven for samlet overlevelse i ITT-populationen vises i figur 2.
English: Treatment with atezolizumab should be withheld for Grade 2 myocarditis, and treatment with systemic corticosteroids at a dose of 1 to 2mg/kg/day of prednisone or equivalent should be started.
Danish: Behandling med atezolizumab bør afbrydes for grad 2 myocarditis og behandling igangsættes med systemiske kortikosteroider med dosis 1 til 2 mg/kg /dag af prednison eller ækvivalent produkt.
English: Tumour assessments were conducted every 6 weeks for the first 48 weeks following Cycle 1, then every 9 weeks thereafter.
Danish: Tumoranalyser blev udført hver 6. uge i de første 48 uger efter 1. serie, og herefter hver 9. uge.
English: Patients had to be eligible for taxane monotherapy (i.e. absence of rapid clinical progression, life-threatening visceral metastases, or need for rapid symptom and/or disease control) and were excluded if they had received prior chemotherapy in the neoadjuvant or adjuvant setting within the last 12 months, a history of autoimmune disease; administration of a live, attenuated vaccine within 4 weeks prior to randomisation, administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medications within 2 weeks prior to randomisation; untreated, symptomatic or corticosteroid-dependent brain metastases.
Danish: Patienterne skulle være berettiget til taxan enkeltstofbehandling (dvs. fravær af hurtig klinisk progression, livstruende visceral metastaser eller behov for hurtig symptom og/eller sygdomskontrol) og blev ekskluderet, hvis de tidligere havde modtaget kemoterapi som neoadjuvant- eller adjuvantbehandling inden for de sidste 12 måneder.
English: Adrenal insufficiency led to discontinuation of atezolizumab in 1 (<0.1%) patient.
Danish: Myositis førte til seponering af atezolizumab hos 1 (< 0,1%) patient.
English: • inflammation of the thyroid, adrenal glands and the pituitary gland (hypothyroidism, hyperthyroidism, adrenal insufficiency or hypophysitis): symptoms may include tiredness, weight loss, weight gain, change in mood, hair loss, constipation, dizziness, headaches, increased thirst, increased urination and changes in vision.
Danish: Kontakt straks lægen, hvis du oplever følgende symptomer: · lungebetændelse (pneumonitis): symptomer kan omfatte ny eller forværret hoste, åndenød og brystsmerter · leverbetændelse (hepatitis): symptomer kan omfatte gulfarvning af hud eller øjne, kvalme, opkastning, blødning eller blå mærker, mørkfarvet urin og mavesmerter · tarmbetændelse (colitis): symptomer kan omfatte diarré (tynd, løs eller blød afføring), blod i afføringen og mavesmerter · inflammation i skjoldbruskkirtlen, binyrernes eller hypofysens funktion (for lidt aktiv skjoldbruskkirtel, for aktiv skjoldbruskkirtel, forringet binyrefunktion eller hypofysitis): symptomer kan omfatte træthed, vægttab, vægtøgning, humørsvingninger, hårtab, forstoppelse, svimmelhed, hovedpine, øget tørst, øget vandladningstrang og ændret syn
English: Treatment with atezolizumab should be withheld for Grade 2 or 3 myositis and corticosteroid therapy (1-2 mg/kg/day prednisone or equivalent) should be initiated.
Danish: Behandling med atezolizumab bør afbrydes for grad 2 eller grad 3 myositis, og der bør initieres behandling med kortikosteroider (1 til 2 mg/kg/dag prednison eller ækvivalent produkt).
English: An updated OS analysis was performed with a median follow up of 18 months, OS results are presented in Table 6 and Kaplan-Meier curves in Figure 5.
Danish: Resultaterne for samlet overlevelse er vist i tabel 6 og i Kaplan-Meier-kurven i figur 5.
English: Upon improvement to Grade ≤ 1, corticosteroid should be tapered over ≥ 1 month.
Danish: Når bivirkningen forbedres til grad ≤1, skal kortikosteroidbehandlingen nedtrappes over ≥1 måned.
English: • low levels of adrenal hormones
Danish: Nedsat antal lymfocytter
English: PFS improvements were also shown in patients with EGFR mutations or ALK rearrangements (HR of 0.55, 95% CI: 0.35, 0.87; median PFS
Danish: Forbedringer i progressionsfri overlevelse blev også vist hos patienter med EGFR-mutationer eller ALK-rearrangement (hazardratio: 0,55 (95% konfidensinterval: 0,35; 0,87) median progressionsfri overlevelse 10,0 versus 6,1 måneder) og levermetastaser (hazardratio: 0,41 (95% konfidensinterval: 0,26; 0,62) median progressionfri overlevelse 8,2 versus 5,4 måneder).
English: Myocarditis has been observed in clinical trials with atezolizumab (see section 4.8).
Danish: Der er i kliniske forsøg med atezolizumab observeret myocarditis (se pkt.
English: • you are allergic to atezolizumab or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal du vide, før du begynder at bruge Tecentriq Brug ikke Tecentriq: · hvis du er allergisk over for atezolizumab eller et af de øvrige indholdsstoffer (angivet i afsnit
English: Figure 4: Kaplan-Meier curve for PFS in the ITT population (IMpower150)
Danish: Figur 4: Kaplan-Meier-kurve for progressionsfri overlevelse i ITT-populationen (IMpower150)
English: Grade 3 or 4: (ALT or AST > 5 x ULN
Danish: Grade 3 eller 4: (ALAT eller ASAT >5 gange øvre referencegrænse eller blod-bilirubin >3 gange øvre referencegrænse)
English: Investigator-assessed ORR (RECIST v1.1)
Danish: Investigatorvurderet objektiv responsrate (RECIST v1.1)
English: Treatment with atezolizumab should be withheld for Grade 2 nephritis, and treatment with systemic corticosteroids at a dose of 1 to 2mg/kg/day of prednisone or equivalent should be started.
Danish: Behandling med atezolizumab bør afbrydes for grad 2 nefritis og behandling igangsættes med systemiske kortikosteroider med dosis på 1 til 2 mg/kg /dag af prednison eller ækvivalent produkt.
English: musculoskeletal painx arthralgia, musculoskeletal painx, back pain
Danish: Artralgi, smerter i bevægeapparatetx, rygsmerter
English: • Give you other medicines to prevent complications and reduce symptoms.
Danish: Lægen vil måske: · give dig anden medicin for at forhindre komplikationer og mindske symptomerne · udskyde næste dosis Tecentriq · stoppe din behandling med Tecentriq.
English: Stratified by sex and PD-L1 expression on TC and IC ^ Confirmed ORR and DoR are exploratory endpoints
Danish: ‡ Stratificeret efter køn og PD-L1-ekspression i TC og IC ^ Konfirmeret objektiv responsrate og varighed af respons er eksploratoriske endepunkter RECIST=Response Evaluation Criteria in Solid Tumors v1.1
English: 95% CI Stratified hazard ratio‡ (95% CI)
Danish: Stratificeret hazard ratio‡ (95% konfidensinterval)
English: Patients with ECOG performance status ≥ 2 were excluded from the clinical trials in NSCLC, TNBC
Danish: ECOG-performancestatus (Eastern Cooperative Oncology Group) ≥2 Patienter med en ECOG-performancestatus ≥2 blev ekskluderet i kliniske studier af ikke-småcellet lungekræft, triplenegativ brystkræft og 2. linje urotelialt carcinom (se pkt.
English: Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2
Danish: ‡ Stratificeret efter køn og ECOG-performancestatus
English: Other endpoints Investigator-assessed ORR (RECIST v1.1)^
Danish: Investigatorvurderet objektiv responsrate (RECIST v1.1)^
English: Adrenal insufficiency requiring the use of corticosteroids occurred in 0.3% (9/3,178) of patients receiving atezolizumab monotherapy.
Danish: Binyrerbarkinsufficiens med behov for kortikosteroid sås hos 0,3% (9/3.178) af patienterne behandlet med atezolizumab enkeltstofbehandling.
English: The confirmed ORR per investigator-assessed mRECIST was 29.0% (95% CI: 20.4, 38.9) in patients with PD-L1 expression ≥ 5%, 23.7% (95% CI:
Danish: Bekræftet objektiv responsrate var ifølge investigatorvurderet mRECIST 29,0% (95% konfidensinterval: 20,4; 38,9) hos patienter med PD-L1-ekspression ≥5%, 23,7% (95% konfidensinterval: 18,1; 30,1) hos patienter med PD-L1
English: PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumors v1.1.
Danish: IC=tumorinfiltrerende immunceller; NE=kan ikke estimeres; RECIST=Response Evaluation Criteria in Solid Tumours v1.1.
English: PFS = progression-free survival; RECIST = Response Evaluation Criteria in Solid Tumours v1.1.
Danish: RECIST=Response Evaluation Criteria in Solid Tumours v1.1.
English: Induction (Four 21-Day Cycles)
Danish: Induktion (fire 21-dages serier)
English: Myasthenia Gravis) - Immune-Related Meningoencephalitis - Immune-Related Myocarditis - Immune-Related Nephritis - Immune-Related Myositis - Infusion-Related Reactions
Danish: - Immunrelateret hepatitis - Immunrelateret pneumonitis - Immunrelateret colitis - Immunrelateret pancreatitis - Immunrelatere endokrinopatier (type 1diabetes mellitus, hypothyroidisme,
English: Cases of diarrhoea or colitis have been observed in clinical trials with atezolizumab (see section 4.8).
Danish: Der er i kliniske forsøg med atezolizumab observeret tilfælde af diarré og colitis (se pkt.
English: The primary efficacy endpoint was OS.
Danish: Det primære effekt-endepunkt var samlet overlevelse.
English: • dizziness
Danish: atezolizumab
English: Treatment may be resumed when the symptoms improve to Grade 0 or Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day and patient is stable on replacement therapy
Danish: Behandlingen kan genoptages hvis bivirkningen forbedres til ≤grad 1 inden for 12 uger og kortikosteroiddosis er reduceret til ≤10 mg/dag prednison, eller ækvivalent produkt, og patienten er stabil på substitutionsbehandling (hvis dette er nødvendigt).
English: (15 mg/kg)
Danish: (100 mg/m2)b,c
English: Stratifiedǂ hazard ratio (95% CI) 12-month OS (%)**
Danish: Primært effekt-endepunkt Samlet overlevelse Antal dødsfald (%) Mediantid til hændelser (måneder) 95% konfidensinterval Stratificeretǂ hazardratio (95% konfidensinterval) p-værdi** Samlet overlevelse ved 12 måneder
English: Musculoskeletal and connective tissue disorders Very common arthralgia, back pain,
Danish: Knogler, led, muskler og bindevæv Meget almindelig Artralgi, rygsmerter, smerter i bevægeapparatetx
English: If the event improves to ≤ Grade 1, corticosteroids should be tapered over ≥ 1 month.
Danish: Hvis bivirkningen forbedres til ≤grad 1, skal behandlingen med kortikosteroid nedtrappes over ≥1 måned.
English: Investigator-assessed PFS (RECIST v1.1)*
Danish: Investigatorvurderet progressionsfri overlevelse (RECIST v1.1)*
English: Further details on serious adverse reactions are provided in Section 4.4 Warnings & Precautions.
Danish: Yderligere oplysninger om alvorlige bivirkninger findes i pkt.
English: However, it may be stopped if the side effects become too much of a problem.
Danish: Hvis du får for mange bivirkninger, kan behandlingen dog blive stoppet.