natgillin/translations-raw huggingface dataset:
Der er ingen data tilgængelige for patienter med svært nedsat leverfunktion (se pkt. 
There are no data available on patients with severe hepatic impairment (see section 4.2).
Ved en dosis på 80 mg forudsagde en farmakokinetisk/farmakodynamisk analyse en lægemiddelrelateret forlængelse af QTc-intervallet på 14 msek med en øvre grænse på 16 msek (90 % KI). 
A pharmacokinetic/pharmacodynamic analysis predicted a drug-related QTc interval prolongation at 80 mg of 14 msec with an upper bound of 16 msec (90% CI).
Effektdata for CNS-metastaser i AURA3-studiet 
CNS metastases efficacy data in AURA3 study
Baseret på in vitro-data hæmmer osimertinib BCRP og P-gp (se pkt. 
Based on in vitro data, osimertinib is an inhibitor of BCRP and P-gp (see section 4.5).
Af de 1.142 patienter i FLAURA- og AURA-studierne behandlet med TAGRISSO 80 mg havde 0,9 % (n=10) QTc længere end 500 msek, og 3,6 % (n=41) havde en stigning i forhold til baseline-QTc på mere end 60 msek. 
Of the 1142 patients in FLAURA and AURA studies treated with TAGRISSO 80 mg, 0.9% of patients (n=10) were found to have a QTc greater than 500 msec, and 3.6% of patients (n=41) had an increase from baseline QTc greater than 60 msec. A pharmacokinetic/pharmacodynamic analysis with TAGRISSO predicted a concentration-dependent increase in QTc interval prolongation.
Hos raske forsøgspersoner, der fik en 80 mg tablet, og hvor ventriklens pH blev hævet ved administration af omeprazol i 5 dage, blev osimertinibeksponeringen ikke påvirket (AUC og Cmax stiger med henholdsvis 7 % og 2 %) med 90 % KI for eksponeringsforholdet inden for 80-125 % grænserne. 
In healthy volunteers administered an 80 mg tablet where gastric pH was elevated by dosing of omeprazole for 5 days, osimertinib exposure was not affected (AUC and Cmax increase by 7% and 2%, respectively) with the 90% CI for exposure ratio contained within the 80-125% limit.
Nedsat antal neutrofilocytter 
Neutrophils decreased
Virkning af syrenedsættende substanser på osimertinib I et klinisk farmakokinetisk studie resulterede samtidig administration af omeprazol ikke i klinisk relevante ændringer i osimertinibeksponeringen. 
Effect of gastric acid reducing active substances on osimertinib In a clinical pharmacokinetic study, co-administration of omeprazole did not result in clinically relevant changes in osimertinib exposures.
• TAGRISSO kan påvirke, hvor godt svangerskabsforebyggende tabletter (f.eks. p-piller) virker. 
• TAGRISSO may interfere with how well oral hormonal contraceptives work.
Virkning og sikkerhed med TAGRISSO til behandling af patienter med EGFR-mutationspositiv lokalt fremskreden NSCLC, der ikke er egnet til kurativ kirurgi eller strålebehandling, eller metastatisk NSCLC, som ikke tidligere havde fået systemisk behandling for fremskreden sygdom, blev påvist i et randomiseret, dobbeltblindet, aktiv-kontrolleret studie (FLAURA). 
Previously untreated EGFR mutation positive locally advanced or metastatic NSCLC - FLAURA The efficacy and safety of TAGRISSO for the treatment of patients with EGFR mutation positive locally advanced, not amenable to curative surgery or radiotherapy, or metastatic NSCLC, who had not received previous systemic treatment for advanced disease, was demonstrated in a randomised, double-blind, active-controlled study (FLAURA).
Inkluderer tilfælde rapporteret inden for termgruppen: Neglelejesygdom, neglelejeinflammation, neglelejeinfektion, neglemisfarvning, neglepigmentering, neglesygdom, negletoksicitet, negledystrofi, negleinfektion, negleriller, neglesmerter, onykoklase, onykolyse, onykomadose, onykomalacia, paronychion. 
Includes cases reported within the clustered terms: Nail bed disorder, nail bed inflammation, nail bed infection, nail discolouration, nail pigmentation, nail disorder, nail toxicity, nail dystrophy, nail infection, nail ridging, onychalgia, onychoclasis, onycholysis, onychomadesis, onychomalacia, paronychia.
Meget almindelig (68 %) 1,5 % 
Very common (68%) 1.5%
Nedsat antal leukocytter 
Leucocytes decreased
Alle patienter skulle have EGFR T790M-mutationspositiv NSCLC identificeret med cobas EGFR-mutationstest udført i et centralt laboratorium inden behandling. 
All patients were required to have EGFR T790M mutation-positive NSCLC identified by the cobas EGFR mutation test performed in a central laboratory prior to treatment.
BICR hos patienter med CNS-metastaser ved en baseline-hjernescanning i AURA3 
CNS efficacy by BICR in patients with CNS metastases on a baseline brain scan in AURA3
Meget almindelig (20 %) 0,2 % 
Very common (20%) 0.2%
Samlet PFS efter investigators vurdering efter status for CNS-metastaser ved studiets start, Kaplan-Meier-plot (fuldt analysesæt) i FLAURA 
Overall PFS by investigator assessment by CNS metastases status at study entry, Kaplan-Meier plot (full analysis set) in FLAURA
Meget almindelig (49 %) 1,2 % 
Very common (49%) 1.2%
TAGRISSOs sikkerhed og virkning er ikke klarlagt hos patienter med svært nedsat leverfunktion. 
The safety and efficacy of this medicinal product has not been established in patients with severe hepatic impairment.
Det primære virknings-endepunkt var progressionsfri overlevelse (PFS) vurderet af investigator. 
The primary efficacy end-point was progression-free survival (PFS) as assessed by investigator.
Tidligere behandlede T790M-positive NSCLC-patienter - AURAex og AURA2 Der blev udført to åbne, enkeltarmede kliniske studier, AURAex (fase 2-forlængelses kohorte (n=201)) og AURA2 (n=210) med patienter med EGFR T790M-mutationspositiv lungecancer, som havde progredieret på en eller flere tidligere systemiske behandlinger, herunder en EGFR TKI. 
Two single-arm, open-label clinical studies, AURAex (Phase 2 Extension cohort, (n=201)) and AURA2 (n=210) were conducted in patients with EGFR T790M mutation-positive lung cancer who have progressed on one or more prior systemic therapies, including an EGFR TKI.
Patienter med klinisk betydningsfulde anormaliteter i rytme og ledning målt ved hvilende elektrokardiogram (EKG) (fx QTc-interval over 470 ms) blev udelukket fra disse studier (se pkt. 
Patients with clinically important abnormalities in rhythm and conduction as measured by resting electrocardiogram (ECG) (e.g. QTc interval greater than 470 ms) were excluded from these studies (see section 4.8).
Fortæl det straks til lægen, hvis du bemærker denne alvorlige bivirkning: 
Serious side effects Tell your doctor straight away if you notice the following serious side effects:
I et klinisk farmakokinetisk studie reducerede samtidig administration af TAGRISSO og simvastatin (sensitivt CYP3A4-substrat) AUC og Cmax af simvastatin med henholdsvis 9 % og 23 %. 
In a clinical PK study, co-administration of TAGRISSO with simvastatin (sensitive CYP3A4 substrate) decreased the AUC and Cmax of simvastatin by 9% and 23% respectively.
Samlet PFS efter investigators vurdering efter status for CNS-metastaser ved studiets start, Kaplan-Meier-plot (fuldt analysesæt) i AURA3 
Overall PFS by investigator assessment by CNS metastases status at study entry, Kaplan-Meier plot (full analysis set) in AURA3
Beige, 7,25 x 14,5 mm oval, bikonveks tablet, præget med “AZ” og “80” på den ene side og uden prægning på den anden side. 
Beige, 7.25 x 14.5 mm, oval, biconvex tablet, debossed with “AZ” and “80” on one side and plain on the reverse.
54 % af patienterne havde ekstra-torakale viscerale metastaser, herunder 34 % med CNS-metastaser (identificeret som CNS-læsion ved baseline, anamnese og/eller tidligere kirurgi og/eller tidligere strålebehandling for CNS-metastaser) og 23 % med levermetastaser. 
Fifty-four percent (54%) of patients had extra-thoracic visceral metastases, including 34% with CNS metastases (identified by CNS lesion site at baseline, medical history, and/or prior surgery, and/or prior radiotherapy to CNS metastases) and 23% with liver metastases.
En populationsfarmakokinetisk analyse indikerede, at legemsvægt var en signifikant kovariat med en forventet ændring på < 20 % i osimertinib-AUCss over et interval på henholdsvis 88 kg til 43 kg (95 % til 5 % fraktiler) i sammenligning med AUCss for den mediane legemsvægt på 61 kg. 
Population PK analysis indicated that body weight was a significant covariate with a less than 20% change in osimertinib AUCss expected across a body weight range of 88 kg to 43 kg respectively (95% to 5% quantiles) when compared to the AUCss for the median body weight of 61 kg.
Interstitiel lungesygdom (ILD) 
Interstitial lung disease (ILD)
Inkluderer tilfælde rapporteret inden for termgruppen: Keratitis, punktat keratitis, corneaerosion, defekt i corneaepitelet. 
Includes cases reported within the clustered terms: Keratitis, punctate keratitis, corneal erosion, corneal epithelium defect.
Meget almindelig (47 %) 0,9 % 
Very common (47%) 0.9%
Det var et krav, at alle patienter skulle have EGFR-T790M-mutationspositiv NSCLC, identificeret ved hjælp af cobas EGFR-mutationstest udført af et centralt laboratorium inden randomisering. 
All patients were required to have EGFR T790M mutation-positive NSCLC identified by the cobas EGFR mutation test performed in a central laboratory prior to randomisation.
59 % af patienterne havde ekstra-torakale viscerale metastaser, herunder 39 % med CNS-metastaser (defineret som CNS-læsion ved baseline, anamnese og/eller tidligere operation og/eller tidligere strålingsbehandling af CNS-metastaser) og 29 % med levermetastaser. 
Fifty-nine percent (59%) of patients had extra-thoracic visceral metastasis including 39% with CNS metastases (identified by CNS lesion site at baseline, medical history, and/or prior surgery and/or prior radiotherapy to CNS metastases) and 29% with liver metastases.
Antal døde (% modenhed) 
Number of Deaths (% maturity)
CNS-metastase-effektdata fra FLAURA-studiet 
CNS metastases efficacy data in FLAURA study
AstraZeneca AB Gärtunavägen SE-151 85 Södertälje Sverige 
Gärtunavägen SE-151 85 Södertälje Sweden
Appetitløshed 
Appetite Loss
Bivirkninger indberettet i FLAURA- og AURA-studierne 
Adverse reactions reported in FLAURA and AURA studies
TAGRISSO 80 mg leveres som beige, filmovertrukne, ovale og bikonvekse tabletter, præget med “AZ” og “80” på den ene side og uden prægning på den anden side. 
TAGRISSO 80 mg is supplied as beige, film-coated, oval and biconvex tablets, marked with “AZ” and “80” on one side, and plain on the other.
Meget almindelig (54 %) 1,6 % 
Very common (54%) 1.6%
Demografiske data og sygdomskarakteristika ved baseline i den samlede studiepopulation var: medianalder 62, ≥75 år (15 %), kvinder (64 %), hvide (32 %), asiatere (65 %), aldrig-rygere (68 %), WHO performance-status 0 eller 1 (100 %). 
The baseline demographic and disease characteristics of the overall study population were: median age 62, ≥75 years old (15%), female (64%), white (32%), Asian (65%), never smoker (68%), WHO performance status 0 or 1 (100%).
Der blev ikke rapporteret tilfælde af arytmi i FLAURA- eller AURA-studierne (se pkt. 
No arrhythmic events were reported in FLAURA or AURA studies (see section 4.8).
Justeret middelværdi Estimeret forskel (95 %CI) p-værdi p <0,001 
Difference (95%CI) p-value p <0.001
Antal hændelser (% modenhed) 
Number of Events (% maturity)
Seponering af TAGRISSO (se pkt. 
Discontinue TAGRISSO (see Section 4.4)
MedDRA SOC MedDRA-term CIOMS-beskrivelse/ samlet frekvens (alle 
CIOMS descriptor/ overall frequency (all CTCAE grades)
Paronychion 
Paronychia
Meget almindelig (35 %) 4,1 % 
Very common (35%) 4.1%
Tidlige reduktioner i medianlaborietorietællinger af leukocytter, lymfocytter, neutrofilocytter og blodplader er observeret hos patienter behandlet med TAGRISSO. 
Early reductions in the median laboratory counts of leukocytes, lymphocytes, neutrophils and platelets have been observed in patients treated with TAGRISSO, which stabilised over time and then remained above the lower limit of normal.
BICR hos patienter med CNS-metastaser ved en baselinehjernescanning i FLAURA 
CNS efficacy by BICR in patients with CNS metastases on a baseline brain scan in FLAURA
Antal med respons (n), responsrate (95 % CI) 
Number of responses (n), Response Rate (95% CI)
Hæmatologiske tilfælde 
Haematological events
Antal med respons, responsrate (95 % CI) 
Number of responses, Response Rate (95% CI)
• Modafinil - bruges mod overdreven søvntrang (narkolepsi) 
• Modafinil -used for sleep disorders.
Den geometriske middelværdi (90% CI) for osimertinib AUC og Cmax var 63,3% (47,3; 84,5) og 51,4% (36,6; 72,3) hos patienter med let nedsat leverfunktionog 68,4% (49,6; 94,2) og 60,7% (41,6; 88,6) hos patienter med moderat nedsat leverfunktion. 
The geometric mean ratio (90% CI) of osimertinib AUC and Cmax was 63.3% (47.3, 84.5) and 51.4% (36.6, 72.3) in patients with mild hepatic impairment and 68.4% (49.6, 94.2) and 60.7% (41.6, 88.6) in patients with moderate hepatic impairment; for the metabolite AZ5104 the AUC and Cmax were 66.5% (43.4, 101.9) and 66.3% (45.3, 96.9) in patients with mild hepatic impairment and 50.9% (31.7, 81.6) and 44.0% (28.9, 67.1) in patients with moderate hepatic impairment, compared to the exposure in patients with normal hepatic function.
Samtidig anvendelse af perikon er kontraindiceret (se pkt. 
Concomitant use of St. John's Wort is contraindicated (see section 4.3).
Hver 40 mg filmovertrukket tablet indeholder 40 mg osimertinib. 
Each 40mg film-coated tablet contains 40mg of osimertinib.
Hver 80 mg filmovertrukket tablet indeholder 80 mg osimertinib. 
Each 80 mg film-coated tablet contains 80 mg of osimertinib.
Beige, 9 mm rund, bikonveks tablet, præget med “AZ” og “40” på den ene side og uden prægning på den anden side. 
Beige, 9 mm, round, biconvex tablet, debossed with “AZ” and “40” on one side and plain on the reverse.
Meget almindelig (17 %) 0,1 % 
Very common (17%) 0.1%
Meget almindelig (31 %) 0,3 % 
Very common (31%) 0.3%
Sådan skal du tage TAGRISSO 
How to take TAGRISSO
• Orale (taget gennem munden) hormonelle svangerskabsforebyggende tabletter (f.eks. P-piller). 
• Oral hormonal contraceptive pill- used to prevent pregnancy.
Inkluderer tilfælde rapporteret inden for termgruppen udslæt: Udslæt, generaliseret udslæt, erytematøst udslæt, makuløst udslæt, makulopapuløst udslæt, papuløst udslæt, pustuløst udslæt, pruritisk udslæt, vesikulært udslæt, follikulært udslæt, erytem, folliculitis, akne, dermatitis, acneiform dermatitis, medikamentelt udslæt, huderosion. 
Includes cases reported within the clustered terms for rash AEs: Rash, rash generalised, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pustular, rash pruritic, rash vesicular, rash follicular, erythema, folliculitis, acne, dermatitis, dermatitis acneiform, drug eruption, skin erosion.
TAGRISSO 40 mg tabletter Hver tablet indeholder 40 mg osimertinib (som mesylat). 
TAGRISSO 40 mg tablets Each tablet contains 40 mg osimertinib (as mesylate).
TAGRISSO 40 mg tabletter 
TAGRISSO 40 mg tablets
Efter oral administration af TAGRISSO blev peak plasma-koncentration af osimertinib nået med en median tmax på 6 (min.-maks. 
Following oral administration of TAGRISSO, peak plasma concentrations of osimertinib were achieved with a median (min-max) tmax of 6 (3-24) hours, with several peaks observed over the first 24 hours in some patients.
Patientrapporterede resultater 
Patient Reported Outcomes
TAGRISSO 80 mg tabletter Hver tablet indeholder 80 mg osimertinib (som mesylat). 
TAGRISSO 80 mg tablets Each tablet contains 80 mg osimertinib (as mesylate).
TAGRISSO indeholder: 
What TAGRISSO contains
Meget almindelig (33 %) 0,1 % 
Very common (33%) 0.1%
TAGRISSO 80 mg tabletter 
TAGRISSO 80 mg tablets
Odds ratio (95 % CI); p-værdi 
Odds ratio (95% CI); P-value
CNS-responsvarighed 
CNS Duration of Response
CNS-progressionsfri overlevelse bestemt ved RECIST v1.1 af CNS-BICR i ITT-populationen (fuldt analysesæt) (målbare og ikke-målbare CNS-læsioner ved baseline i henhold til BICR), n=75 for TAGRISSO og n=41 for kemoterapi 
CNS Objective Response Rate and Duration of Response determined by RECIST v1.1 by CNS BICR in the evaluable for response population (CNS measurable lesions at baseline by BICR) n=30 for TAGRISSO and n=16 for Chemotherapy
Hver tablet indeholder 40 mg osimertinib (som mesylat). 
Each tablet contains 40 mg osimertinib (as mesylate).
HR=Hazard ratio; CI=Konfidensinterval, NC=Ikke muligt at beregne En HR< 1 favoriserer TAGRISSO, en oddsratio på >1 favoriserer TAGRISSO CNS PFS bestemt ved RECIST v1.1 af CNS BICR (målbare og ikke målbare CNS-læsioner ved baseline ved BICR) n=61 for TAGRISSO og n=67 for EGFR TKI-komparator; ubekræftede responser 
CNS PFS determined by RECIST v1.1by CNS BICR (CNS measurable and non-measurable lesions at baseline by BICR) n=61 for TAGRISSO and n=67 for EGFR TKI comparator; responses are unconfirmed Nominally statistically significant
Median OS i måneder (95 % CI) 
Median OS in months (95% CI)
TAGRISSO 40 mg leveres som beige, filmovertrukne, runde og bikonvekse tabletter, præget med “AZ” og “40” på den ene side og uden prægning på den anden side. 
What TAGRISSO looks like and contents of the pack TAGRISSO 40 mg is supplied as beige, film-coated, round and biconvex tablets, marked with “AZ” and “40” on one side, and plain on the other.
CNS objektiv responsrate og responsvarighed bestemt ved RECIST v1.1 af CNS-BICR i den population, der var evaluerbar for respons (målbare CNS-læsioner ved baseline i henhold til BICR), n=30 for TAGRISSO og n=16 for kemoterapi Baseret kun på patienter med respons; DoR defineret som tiden fra datoen for første dokumenterede respons (komplet respons eller delvist respons) indtil progression eller død; DCR defineret som andelen af patienter med respons (komplet respons eller delvist respons) eller stabil sygdom ≥ 6 uger 
Based on patients with response only; DoR defined as the time from the date of first documented response (complete response or partial response) until progression or death event; DCR definedas the proportion of patients with response (complete response or partial response), or stable disease ≥ 6 weeks CNS Progression Free Survival determined by RECIST v1.1 by CNS BICR in the full analysis set population (CNS measurable and non-measurable lesions at baseline by BICR) n=75 for TAGRISSO and n=41 for Chemotherapy
Sikkerhedsfund i de enkeltarmede fase 2-studier (AURAex og AURA2) var generelt i overensstemmelse med dem, der blev observeret i TAGRISSO-armen i AURA3. 
Safety findings in the single-arm Phase 2 AURAex and AURA2 studies were generally consistent with those observed in the AURA3 TAGRISSO arm. No additional or unexpected toxicity has been observed and adverse events have been aligned in type, severity and frequency.
Der blev ikke indberettet tilfælde af QTc-relateret arytmi i FLAURA- eller AURA-studierne (se pkt. 
No QTcrelated arrhythmias were reported in the FLAURA or AURA studies (see sections 4.4 and 5.1).
Hver tablet indeholder 80 mg osimertinib (som mesylat). 
Each tablet contains 80 mg osimertinib (as mesylate).
• du tidligere har haft en betændelseslignende sygdom (inflammation) i dine lunger (en sygdom, 
• you have suffered from inflammation of your lungs (a condition called ‘interstitial lung disease').
Median PFS2, måneder (95 % CI) 
Median PFS2, months (95% CI)
lægemiddelinduceret ILD, steroidkrævende strålingspneumonitis eller anden evidens for klinisk aktiv ILD blev udelukket fra de kliniske studier (se pkt. 
Patients with a past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD were excluded from clinical studies (see section 4.8).
TAGRISSO 40 mg filmovertrukne tabletter TAGRISSO 80 mg filmovertrukne tabletter 
TAGRISSO 40 mg film-coated tablets TAGRISSO 80 mg film-coated tablets
Det er vist, at serumalbumin, der også er en markør for nedsat leverfunktion, påvirker osimertinibs farmakokinetik. 
The hepatic impairment marker serum albumin showed an effect on the PK of osimertinib.
Brug af anden medicin sammen med TAGRISSO Fortæl lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig. 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
EGFR TKI-komparator (gefitinib eller erlotinib) 
EGFR TKI comparator (gefitinib or erlotinib) N=67
Nedsat antal lymfocytter l Meget almindelig (67 %) 7,2 % 
Very common (67%) 7.2%
BICR-vurdering var 64,9 % [95 % CI: 59,0; 70,5] ved osimertinib og 34,3 % [95 % CI: 26,5; 42,8] ved kemoterapi; DoR iht. 
ORR and DoR results by investigator assessment were consistent with those reported via Blinded Independent Central Review (BICR); ORR by BICR assessment was 64.9% [95% CI: 59.0, 70.5] on osimertinib and 34.3 % [95% CI: 26.5, 42.8] on chemotherapy; DoR by BICR assessment was 11.2 months (95% CI: 8.3, NC) on osimertinib and 3.1 months (95% CI: 2.9, 4.3) on chemotherapy.
Median, måneder (95 % CI) 
Median, Months (95% CI)
Median TFST, måneder (95 % CI) 
Median TFST, months (95% CI)
HR (95 % CI); P-værdi 
HR (95% CI); P-value
HR (95 % CI); p-værdi 
HR (95% CI) ; P-value
TAGRISSO 80 mg tabletter osimertinib 
TAGRISSO 80 mg tablets osimertinib
TAGRISSO 40 mg tabletter osimertinib 
TAGRISSO 40 mg tablets osimertinib
Median TSST, måneder (95 % CI) 
Median TSST, months (95% CI)
TAGRISSO 40 mg filmovertrukne tabletter TAGRISSO 80 mg filmovertrukne tabletter osimertinib 
TAGRISSO 40 mg film-coated tablets TAGRISSO 80 mg film-coated tablets osimertinib
Median OS, måneder (95 % CI) 
Median OS, Months (95% CI)
Du skal bruge effektiv prævention under behandlingen. 
Contraception - information for women and men You must use effective contraception during treatment.
Spørg lægen, apotekspersonalet eller sundhedspersonalet, før du tager TAGRISSO, hvis du er i tvivl. 
If you are not sure, talk to your doctor, pharmacist or nurse before taking TAGRISSO.
Det skal du vide, før du begynder at tage TAGRISSO Sådan skal du tage TAGRISSO Bivirkninger 
What you need to know before you take TAGRISSO 3.
TAGRISSO 80 mg filmovertrukne tabletter osimertinib 
TAGRISSO 80 mg film-coated tablets osimertinib
TAGRISSO 40 mg filmovertrukne tabletter osimertinib 
TAGRISSO 40 mg film-coated tablets osimertinib
Analyse af HRQL og af forbedring af fysiske funktioner Patienter, der fik TAGRISSO, havde signifikant større chancer for at opnå klinisk betydende forbedringer større end eller lig med 10 point i den generelle helbredsstatus og fysiske funktioner på EORTC-C30-spørgeskemaet i studieperioden, sammenlignet med kemoterapi. 
HRQL and physical functioning improvement analysis Patients on TAGRISSO had significantly greater chances of achieving a clinically meaningful improvement of greater than or equal to 10 points on the global health status and physical functioning of the EORTC-C30 questionnaire compared with chemotherapy during the study period Odds Ratio (OR) global health status: 2.11, (95% CI 1.24, 3.67, p=0.007); OR physical functioning 2.79 (95% CI 1.50, 5.46, p=0.002).
HR=hazard ratio; CI=konfidensinterval; NC=kan ikke beregnes Alle effektresultater er baseret på RECIST, investigators vurdering Den første analyse af OS blev udført ca. 4 måneder efter den primære analyse af PFS. OS-analysen blev ikke justeret for de potentielt konfunderende effekter af overkrydsning (94 [67 %] patienter i kemoterapiarmen fik efterfølgende behandling med osimertinib). 
The OS analysis was not adjusted for the potentially confounding effects of crossover (94 [67%] patients on the chemotherapy arm received subsequent osimertinib treatment).
Hos 4,3 % af patienterne blev behandlingen seponeret på grund af bivirkninger. 
Discontinuation due to adverse reactions was 4.3%.
Lunge 
Diarrhoea
Ikke almindelig (0,7 %) 0,1 % 
Uncommon (0.7%)
der hedder "interstitiel lungesygdom") 
Interstitial lung disease
Sådan virker TAGRISSO 
How TAGRISSOworks
Lusduna gives én gang om dagen på samme tidspunkt hver dag. 
Lusduna is used once a day at the same time each day.
Den fuldstændige EPAR for Lusduna findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Lusduna can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Lusduna. 
This is a summary of the European public assessment report (EPAR) for Lusduna.