natgillin/translations-raw huggingface dataset:
Risici ved brug af kombinationsbehandlingen med de 4 lægemidler atezolizumab, bevacizumab, paclitaxel og carboplatin, bør nøje overvejes af lægen før behandlingen påbegyndes (se pkt.
Physicians should carefully consider the combined risks of the four-drug regimen of atezolizumab bevacizumab, paclitaxel, and carboplatin before initiating treatment (see section 4.8).
Medianalderen var 64 år (interval: 26 til 90 år), og 10% af patienterne var ≥75 år.
The median age was 64 years (range: 26 to 90 years) with 10% of patients ≥75 years of age.
Mediantid til hændelse var 7,7 måneder (interval: 5,0 til 8,8 måneder).
The median time to onset was 7.7 months (range: 5.0 to 8.8 months).
Atezolizumab bør seponeres permanent hos patienter med infusionsrelaterede reaktioner af grad 3 eller 4.
Atezolizumab should be permanently discontinued in patients with Grade 3 or 4 infusion-related reactions.
Inkluderer indberetninger om fald i antal hvide blodceller, leukopeni f
e Includes reports of white blood cell count decreased and leukopenia.
De mest almindelige bivirkninger (≥ 20%) var kvalme (37,4%), træthed (36,4%), neutropeni (33,7%), anæmi (33,2%), diarré (29,5%), udslæt (28,5%), forstoppelse (27,0%), perifer neuropati (26,8%), nedsat appetit (24,6%), trombocytopeni (21,2%) og hoste (20,1%).
The most common adverse reactions (≥ 20%) were nausea (37.4%), fatigue (36.4%), neutropenia (33.7%), anaemia (33.2%), diarrhoea (29.5%), rash (28.5%), constipation (27.0%), peripheral neuropathy (26.8%), decreased appetite (24.6%), thrombocytopenia (21.2%) and cough (20.1%).
· Gem indlægssedlen.
• Keep this leaflet.
· Opbevar hætteglasset i æsken for at beskytte mod lys.
• Keep the vial in the outer carton in order to protect from light.
Der blev observeret en statistisk signifikant forbedring i samlet overlevelse ved behandling med atezolizumab i kombination med carboplatin og eptoposid sammenlignet med kontrolarmen (Hazardratio: 0,70, 95 % konfidensinterval: 0,54; 0,91; median samlet overlevelse var 12,3 måneder vs. 10,3 måneder).
A statistically significant improvement in OS was observed with atezolizumab in combination with carboplatin and etoposide compared to the control arm (HR of 0.70, 95% CI: 0.54, 0.91; median OS of 12.3 months vs. 10.3 months).
Tabel 6: Opsummering af opdateret effekt i ITT-populationen (IMpower150) Effekt endepunkt
Table 6: Summary of updated efficacy in the ITT population (IMpower150) Efficacy endpoint
· Uddannelsesmateriale for sundhedspersonalet · Patientkort
• Guide for healthcare professionals
Type I-hætteglas med butylgummiprop og aluminiumsforsegling med en grå flip-off plastikhætte, indeholdende 14 ml koncentrat til infusionsvæske,opløsning.
Type I glass vial with a butyl rubber stopper and an aluminium seal with a plastic, grey flip-off cap containing 14 mL of concentrate for solution for infusion.
Randomiseringen blev stratificeret efter PD-L1-ekspressionsstatus i IC, efter antal tidligere kemoterapi-regimer samt histologi.
Randomisation was stratified by PD-L1 expression status on IC, by the number of prior chemotherapy regimens and by histology.
Medianvarighed var 16,8 måneder (interval: 0 dage til 16,8 måneder).
The median duration was 16.8 months (range: 0 day to 16.8 months).
I den præspecificerede hierarkiske test-rækkefølge, blev IC2/3-populationen testet først med en samlet overlevelse hazardratio på 0,87 (95% konfidensinterval: 0,63; 1,21; median samlet overlevelse på 11,1 versus 10,6 måneder for henholdsvis atezolizumab og kemoterapi).
Per the pre-specified hierarchical testing order, the IC2/3 population was tested first, with an OS HR of 0.87 (95% CI: 0.63, 1.21; median OS of 11.1 vs. 10.6 months for atezolizumab and chemotherapy respectively).
Hypothyroidisme:
Hypothyroidism:
Ved baseline havde 14,7% af patienterne levermetastaser, og de fleste patienter var aktive eller tidligere rygere (90%).
Fourteen point seven percent of patients had liver metastases at baseline, and most patients were current or previous smokers (90%).
Behandling med atezolizumab skal afbrydes ved grad 2 eller 3 diarré (≥4 gange så mange afføringer/dag i forhold til baseline) eller colitis (symptomatisk).
Treatment with atezolizumab should be withheld for Grade 2 or 3 diarrhoea (increase of ≥ 4 stools/day over baseline) or colitis (symptomatic).
Antal med komplet respons (%)
No. of complete response (%)
To patienter havde behov for kortikosteroidbehandling.
Two patients required the use of corticosteroids.
Der er gennemført et fase II, internationalt, enkeltarmet multicenterstudie med 2 kohorter (IMvigor210) med patienter med lokalt fremskredent eller metastatisk urotelialt carcinom (også kaldet blærekræft).
A phase II, multi-centre, international, two-cohort, single-arm clinical trial, IMvigor210, was conducted in patients with locally advanced or metastatic UC (also known as urothelial bladder cancer).
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1200 mg/20 ml
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1,200 mg/20 mL
Immunrelateret myositis
Immune-related myositis
Begge patienter havde behov for kortikosteroidbehandling.
Both patients required the use of corticosteroids.
Inkluderer indberetninger om hypofysitis, forstyrrelser i temperaturreguleringen.
Incudes reports of hypophysitis and temperature regulation disorder.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 840 mg/14 ml
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 840 mg/14 mL
I den farmakokinetiske populationsanalyse fandtes ingen klinisk betydelige forskelle i clearance af atezolizumab hos patienter med let nedsat leverfunktion (bilirubin £øvre referencegrænse og ASAT >øvre referencegrænse eller bilirubin >1,0 til 1,5 gange øvre referencegrænse og enhver ASAT, n= 71) i forhold patienter med normal leverfunktion (bilirubin og ASAT £øvre referencegrænse, n= 401).
In the population pharmacokinetic analysis, there were no clinically important differences in the clearance of atezolizumab between patients with mild hepatic impairment (bilirubin ≤ ULN and AST > ULN or bilirubin > 1.0 × to 1.5 × ULN and any AST, n= 71) and normal hepatic function (bilirubin and AST ≤
Figur 5: Kaplan-Meier-kurve for samlet overlevelse hos patienter med PD-L1-ekspression ≥ 1% (IMpassion130)
Figure 5: Kaplan-Meier Curve for Overall Survival in patients with PD-L1 expression ≥ 1% (IMpassion130)
Induktionsfasen efterfølges af en vedligeholdelsesfase uden kemoterapi, hvor 1.200 mg Tecentriq administreres som intravenøs infusion hver 3. uge.
The induction phase is followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq is administered by intravenous infusion every three weeks.
Sundhedspersonalet vil bortskaffe eventuelle medicinrester.
Your healthcare professional will throw away any medicines that are no longer being used.
Behandling med atezolizumab bør afbrydes permanent ved grad 4 pancreatitis eller enhver grad af recidiverende pancreatitis.
Treatment with atezolizumab should be permanently discontinued for Grade 4, or any grade of recurrent pancreatitis.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1200 mg/20 ml
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,200 mg/20 mL
Kort introduktion af atezolizumab (indikation og formålet med kortet) Information om, at atezolizumab kan forårsage alvorlige bivirkninger under og efter behandling, som skal behandles omgående
• Information that atezolizumab can cause serious side effects during or after treatment, that need to be treated right away
Inkluderer indberetninger om cytokinfrigivelsessyndrom, hypersensitivitet, anafylaksi g
Includes reports of cytokine release syndrome, hypersensitivity, anaphylaxis.
u Inkluderer indberetninger om autoimmun pankreatitis, pankreatitis, akut pankreatitis, forøget lipase, amylase.
u Includes reports of autoimmune pancreatitis, pancreatitis, pancreatitis acute, lipase increased, amylase increased.
Patienterne bør monitoreres omhyggeligt for symptomer tydende på akut pancreatitis.
Patients should be closely monitored for signs and symptoms that are suggestive of acute pancreatitis.
Ved symptomatisk hyperthyroidisme bør behandling med atezolizumab afbrydes og antityroide midler initieres efter behov.
For symptomatic hyperthyroidism, atezolizumab should be withheld and an anti-thyroid medicinal product should be initiated as needed.
I den farmakokinetiske populationsanalyse fandtes ingen klinisk betydelige forskelle i clearance af atezolizumab hos patienter med let (eGFR 60-89 ml/min/1,73 m2; n=208) eller moderat svær (eGFR 30-59 ml/min/1,73 m2; n=116) nedsat nyrefunktion i forhold til patienter med normal nyrefunktion (eGFR ≥ 90 ml/min/1,73 m2; n=140).
In the population pharmacokinetic analysis, no clinically important differences in the clearance of atezolizumab were found in patients with mild (estimated glomerular filtration rate [eGFR] 60 to 89 mL/min/1.73 m2; n=208) or, moderate (eGFR 30 to 59 mL/min/1.73 m2; n=116) renal impairment compared to patients with normal (eGFR greater than or equal to 90 mL/min/1.73 m2; n=140) renal function.
PD-L1 test for patienter med urotelialt carcinom
PD-L1 testing for patients with UC
Opbevar hætteglasset i æsken for at beskytte mod lys.
Keep the vial in the outer carton in order to protect from light.
Tidligere ubehandlede patienter med urotelialt carcinom, skal udvælges til behandling baseret på tumor ekspression af PD-L1, som skal bekræftes ved en valideret test (se pkt.
Patients with previously untreated UC should be selected for treatment based on the tumour expression of PD-L1 confirmed by a validated test (see section 5.1).
Det vides ikke om atezolizumab udskilles i modermælk.
It is unknown whether atezolizumab is excreted in human milk.
Patienter bør monitoreres for tegn og symptomer på myositis.
Patients should be monitored for signs and symptoms of myositis.
Type I-hætteglas med butylgummiprop og aluminiumsforsegling med en blå flip-off plastikhætte indeholdende 20 ml koncentrat til infusionsvæske, opløsning.
Type I glass vial with a butyl rubber stopper and an aluminium seal with a plastic aqua flip-off cap containing 20 mL of concentrate solution for infusion.
Tabel 5: Opsummering af effekt i den primære analysepopulation (alle grupper)* (OAK)
Table 5: Summary of efficacy in the primary analysis population (all comers)* (OAK)
Resultaterne for progressionsfri overlevelse, objektiv responsrate og varighed af respons fra den primære analyse, samt resultaterne fra den endelige eksploratoriske analyse af samlet overlevelse er opsummeret i tabel 12.
The PFS, ORR and DOR results from the primary analysis as well as the exploratory OS final analysis results are summarized in Table 12.
Det primære effekt-endepunkt for kohorte 1 var bekræftet objektiv responsrate vurderet af et uafhængigt bedømmelsespanel ved hjælp af RECIST v1.1.
The primary efficacy endpoint for Cohort 1 was confirmed objective response rate (ORR) as assessed by an independent review facility (IRF) using RECIST v1.1.
Sjælden: Kan påvirke op til 1 ud af 1000 patienter · hjertemuskelbetændelse · myasthenia gravis, en sygdom, der kan give muskelsvaghed · inflammation af hypofysen, som sidder i hjernen · nyrebetændelse
Rare: may affect up to 1 in 1,000 people • inflammation of the heart muscle
Mediantid til hændelse var 3,4 måneder (interval: 3 dage til 24,8 måneder).
The median time to onset was 3.4 months (range 3 days to 24.8 months).
4.2 og 4.8).
24.8 months).
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 840 mg/14 ml
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 840 mg/14 mL
IMvigor 130 (WO30070): Randomiseret, placebo-kontrolleret, fase III multicenter-studie med atezolizumab som monoterapi og i kombination med platinholdig kemoterapi hos patienter med ubehandlet lokalt fremskredent eller metastatisk urotelialt carcinom
IMvigor130 (WO30070): Phase III multi-center, randomized, placebo-controlled study of atezolizumab as monotherapy and in combination with platinum-based chemotherapy in patients with untreated locally advanced or metastatic urothelial carcinoma
Tecentriq er i kombination med carboplatin og etoposid indiceret til førstelinjebehandling af voksne patienter med småcellet lungekræft i udvidet sygdomsstadie (se pkt.
Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (see section 5.1).
Mediantid til hændelse var 4,9 måneder (interval: 0 dage til 31,3 måneder).
The median time to onset was 4.9 months (range: 0 day to 31.3 months).
Se også produktresuméet for kombinationsprodukterne (se pkt.
Please also refer to the full prescribing information for the combination products (see also section 5.1).
Resultater fra IMpassion130, målt ved den endelige analyse for progresisonsfri overlevelse, objektiv responsrate og varighed af respons hos patienter med PD-L1-ekspression ≥ 1% med en median overlevelsesopfølgning på 13 måneder er vist i tabel 6 og Kaplan-Meier-kurven for progressionsfri overlevelse er vist i figur 4.
PFS, ORR and DOR results of IMpassion130 for patients with PD-L1 expression ≥ 1% at the time of the final analysis for PFS with a median survival follow up of 13 months are summarized in Table 6 with Kaplan-Meier curves for PFS in Figure 4.
Efter fortynding, vil 1 ml opløsning indeholde ca. 4,4 mg Tecentriq (1200 mg/270 ml).
After dilution, one mL of solution should contain approximately 4.4 mg of Tecentriq (1,200 mg/270 mL).
Medianalder var 67 år (interval: 31 til 88), og 77,1% af patienterne var mænd.
The median age was 67 years (range: 31 to 88), and 77.1% of patients were male.
Patienter med infusionsrelaterede reaktioner af grad 1 eller 2 kan fortsætte behandling med atezolizumab under tæt overvågning.
Patients with Grade 1 or 2 infusion-related reactions may continue to receive atezolizumab with close monitoring; premedication with antipyretic and antihistamines may be considered.
Igangsættelse af systemisk kortikosteroid (i doser på 1 til 2 mg/kg/dag prednison eller ækvivalent produkt) bør overvejes.
Initiation of systemic corticosteroids (at a dose of 1 to 2 mg/kg/day of prednisone or equivalent) should be considered.
Forekomst af fuldstændigt respons, vurderet af et uafhængigt bedømmelsespanel ved hjælp af RECIST v1.1, var 6,1% (95% konfidensinterval: 3,7; 9,4) i ITT-populationen.
The rate of complete response per IRF-RECIST v1.1 in the all comer population was 6.1% (95% CI: 3.7, 9.4).
Det vides ikke om moderat eller svært nedsat leverfunktion (bilirubin >1,5 til 3 gange øvre referencegrænse, enhver ændring i ASAT eller bilirubin >3 gange øvre referencegrænse samt enhver ændring i ASAT) påvirker atezolizumabs farmakokinetik.
The effect of moderate or severe hepatic impairment (bilirubin > 1.5 × to 3 × ULN and any AST or bilirubin > 3 × ULN and any AST) on the pharmacokinetics of atezolizumab is unknown.
Mediantid til hændelse var 13,1 måneder (interval: 9,0 til 17,5 måneder).
The median time to onset was 13.1 months (range: 9.0 to 17.5 months).
Infektioner og parasitære sygdomme Meget almindelig Urinvejsinfektiona
Infections and infestations Very common urinary tract infectiona lung infectionb
Ved den endelige analyse af progressionsfri overlevelse havde patienterne en median opfølgningstid på 15,3 måneder.
At the time of the final analysis for PFS, patients had a median follow up time of 15.3 months.
Der kan opstå immunrelaterede bivirkninger med atezolizumab efter sidste dosis er givet.
Immune-related adverse reactions with atezolizumab may occur after the last dose of atezolizumab.
d Inkluderer indberetninger om neuropati, fald i neutrofiler, febril neutropeni, neutropenisk sepsis, granulocytopeni.
d Includes reports of neutropenia, neutrophil count decreased, febrile neutropenia, neutropenic sepsis, granulocytopenia.
Patienterne bør monitoreres for kliniske symptomer på meningitis og encefalitis.
Patients should be monitored for clinical signs and symptoms of meningitis or encephalitis.
Mediantid til hændelse var 3,6 måneder (interval: 3 dage til 9,9 måneder).
The median time to onset was 3.6 months (range 3 days to 9.9 months).
For triplenegativ brystkræft anbefales det, at patienterne behandles med Tecentriq indtil sygdomsprogression eller indtil der opstår toksicitet, der ikke kan behandles (se pkt.
For TNBC, it is recommended that patients are treated with Tecentriq until disease progression or unmanageable toxicity (see section 5.1).
Tabel 10: Opsummering af effekt i den primære analysepopulation (alle grupper)* (OAK)
Table 10: Summary of efficacy in the primary analysis population (all comers)* (OAK)
Figur 4: Kaplan-Meier-kurve for progressionsfri overvelse hos patienter med PD-L1-ekspression ≥ 1% (IMpassion130)
Figure 4: Kaplan-Meier Curve for Progression Free Survival in patients with PD-L1 expression ≥ 1% (IMpassion130)
IMvigor210 (GO29293): Enkeltarmet studie med patienter med tidligere ubehandlet urotelialt carcinom, hvor behandling med cisplatin ikke er egnet samt med urotelialt carcinom-patienter tidligere behandlet med kemoterapi
IMvigor210 (GO29293): Single-arm trial in previously untreated urothelial carcinoma patients who are ineligible for cisplatin therapy and in urothelial carcinoma patients previously treated with chemotherapy
Figur 1: Kaplan-Meier-kurve for samlet overlevelse (IMvigor211)
Figure 1: Kaplan-Meier curve for overall survival (IMvigor211)
y Inkluderer indberetninger om myositis, rabdomyolyse, polymyalgia rheumatica, dermatomyositis, muskelbyld, myoglobin i urinen.
y Includes reports of myositis, rhabdomyolysis, polymyalgia rheumatica, dermatomyositis, muscle abscess, myoglobin urine present.
Indehaveren af markedsføringstilladelse skal aftale med de nationale myndigheder om indholdet og formatet af uddannelsesmaterialet, herunder kommunikationsmedier, distributionsmetoder og alle andre aspekter for materialet, før lancering af Tecentriq i hvert medlemsland.
Prior to launch of Tecentriq in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media,
De mest almindelige bivirkninger (>10%) var træthed (35,9%), nedsat appetit (25,5%), kvalme (23,5%), hoste (20,8%), dyspnø (20,5%), pyreksi (20,1%), diarré (19,7%), udslæt (19,5%), rygsmerter (15,3%), opkastning (15,0%), asteni (14,5%), arthralgi (13,9%), smerter i bevægeapparatet (13,0%), pruritus (12,6%) og urinvejsinfektion (11,6%).
(25.5%), nausea (23.5%), cough (20.8%), dyspnoea (20.5%), pyrexia (20.1%), diarrhoea (19.7%), rash (19.5%), back pain (15.3%), vomiting (15.0%), asthenia (14.5%), arthralgia (13.9%), musculoskeletal pain (13.0%), pruritus (12.6%) and urinary tract infection (11.6%).
Patienter med EGFR-mutationer havde dog ikke forbedret samlet overlevelse med atezolizumab sammenlignet med docetaxel (hazardratio 1,24; 95% konfidensinterval: 0,71; 2,18; median samlet overlevelse på 10,5 versus 16,2 måneder for henholdsvis atezolizumab og docetaxel).
However, patients with EGFR mutations did not show improved OS with atezolizumab compared to docetaxel (HR of 1.24, 95% CI: 0.71, 2.18; median OS of 10.5 vs. 16.2 months for atezolizumab and docetaxel, respectively).
Guillain-Barré-syndrom og demyeliserende polyneuropati sås hos 0,2% (5/3.178) af patienterne behandlet med atezolizumab enkeltstofbehandling.
Guillain-Barré syndrome and demyelinating polyneuropathy occurred in 0.2% (5/3,178) of patients who received atezolizumab monotherapy.
Der er ikke gennemført formelle interaktionsstudier med atezolizumab.
No formal pharmacokinetic drug interaction studies have been conducted with atezolizumab.
Kemoterapi (n=464)
Chemotherapy (n = 464)
310 patienter blev behandlet med atezolizumab 1200 mg ved intravenøs infusion hver 3. uge og indtil der ikke længere var klinisk effekt.
There were 310 patients treated with atezolizumab 1,200 mg by intravenous infusion every 3 weeks until loss of clinical benefit.
Behandling med atezolizumab kan genoptages, når symptomerne er under kontrol og thyroideafunktionen i bedring.
Treatment with atezolizumab may be resumed when symptoms are controlled and thyroid function is improving.
Atezolizumab blev administreret i en fast dosis på 1200 mg ved intravenøs infusion hver 3. uge.
Atezolizumab was administered as a fixed dose of 1,200 mg by intravenous infusion every 3 weeks.
Behandlingen kan genoptages, når symptomerne er under kontrol med antityroide midler, og thyroideafunktionen er i bedring.
Treatment may be resumed when symptoms are controlled by antithyroid medicinal product and thyroid function is improving
Inkluderer indberetninger om orofaryngeale smerter, orofaryngealt ubehag, svælgirritation.
Includes reports of oropharyngeal pain, oropharyngeal discomfort, throat irritation.
Ved småcellet lungekræft i udvidet sygdomsstadie og førstelinjebehandling af ikke-småcellet lungekræft, der behandles med Tecentriq i kombination med carboplatin og nab-placlitaxel, anbefales det, at patienterne behandles med Tecentriq indtil sygdomsprogression eller indtil der opstår toksicitet, der ikke kan behandles.
For ES-SCLC and for first-line NSCLC, in patients given Tecentriq in combination with carboplatin and nab-paclitaxel, it is recommended that patients are treated with Tecentriq until disease progression or unmanageable toxicity.
Der er ikke gennemført udviklings- og reproduktionsstudier med atezolizumab.
No developmental and reproductive studies were conducted with atezolizumab.
Behandling med atezolizumab bør afbrydes hvis grad 2 hændelse (ALAT eller ASAT >3-5 gange øvre referencegrænse eller blod-bilirubin >1,5 til 3 gange øvre referencegrænse) vedvarer i mere end 5 til 7 dage og behandling med 1 til 2 mg/kg/dag prednison eller ækvivalent produkt skal igangsættes.
Treatment with atezolizumab should be withheld if Grade 2 event (ALT or AST > 3 to 5 x ULN or blood bilirubin > 1.5 to 3 x ULN) persists for more than 5 to 7 days, and 1 to 2 mg/kg/day of prednisone or equivalent should be started.
Patientkort
Patient alert card
Efter fortynding, vil 1 ml opløsning indeholde ca. 6,0 mg Tecentriq (1680 mg/278 ml).
After dilution, one mL of solution should contain approximately 6.0 mg of Tecentriq (1680 mg/278 mL).
Arm B (Placebo + carboplatin + etoposid)
Arm B (Placebo + carboplatin + etoposide)
· Øvrige indholdsstoffer er L-histidin; eddikesyre, koncentreret; saccharose; polysorbat 20 og vand til injektionsvæsker.
• The other ingredients are L-histidine, glacial acetic acid, sucrose, polysorbate 20 and water for injections.
I et 26-ugers toksicitetsstudie med gentagne doser påvirkede atezolizumab dog menstruationscyklus ved et estimeret AUC ca. 6 gange højere end det AUC, der ses hos patienter behandlet med den anbefalede dosis.
No reproductive and development toxicity studies have been conducted with atezolizumab; however, based on the 26-week repeat dose toxicity study, atezolizumab had an effect on menstrual cycles at an estimated AUC approximately 6 times the AUC in patients receiving the recommended dose and was reversible (see section 5.3).
hyperthyroidisme, binyrebarkinsufficiens og hypofysitis) - Immunrelaterede neuropatier (Guillain-Barre syndrom, myastenisk syndrom/myasthenia gravis) - Immunrelateret meningoencefalitis - Immunrelateret myocarditis - Immunrelateret nefritis - Immunrelateret myositis - Infusionsrelaterede reaktioner
Immune-Related Endocrinopathies (Type 1 Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Adrenal Insufficiency and Hypophysitis) Immune-Related Neuropathies (Guillain-Barre Syndrome, Myasthenic Syndrome / Myasthenia Gravis) Immune-Related Meningoencephalitis Immune-Related Myocarditis Immune-Related Nephritis Immune-Related Myositis Infusion-Related Reactions
Det anvendes til denne kræftform: hvis lungekræften har spredt sig til andre dele af kroppen (udvidet sygdomsstadie) hvis du ikke tidligere har fået kemoterapi for småcellet lungekræft i udvidet sygdomsstadie
It is used if: the lung cancer has spread to other parts of the body (extensive-stage) you have not received any prior chemotherapy for extensive-stage SCLC.
Tabel 9: Opsummering af effekt i den primære analyse af ITT-WT-populationen (IMpower130) Effekt-endepunkter
Table 9: Summary of efficacy from IMpower130 in the primary analysis (ITT-WT population) Efficacy endpoints