natgillin/translations-raw huggingface dataset:
Når det overvejes at anvende TAGRISSO som behandling til lokalt fremskreden eller metastatisk NSCLC, er det vigtigt at bestemme EGFR-mutationspositiv status. 
When considering the use of TAGRISSO as a treatment for locally advanced or metastatic NSCLC, it is important that the EGFR mutation positive status is determined.
Baseret på virkningsmekanismen og prækliniske data kan osimertinib forårsage fosterskader, hvis det gives til en gravid kvinde. 
Based on its mechanism of action and preclinical data, osimertinib may cause foetal harm when administered to a pregnant woman.
Dosisjustering er ikke nødvendig på grund af patientens alder, vægt, køn, etnicitet eller rygestatus (se pkt. 
No dosage adjustment is required due to patient age, body weight, gender, ethnicity and smoking status (see section 5.2).
Blandet model for gentagne målinger (MMRM) - hovedsymptomer på lungecancermiddelændring fra baseline hos TAGRISSO-patienter sammenlignet med kemoterapi 
Mixed Model Repeated Measures - Key lung cancer symptoms - mean change from baseline in TAGRISSO patients compared with chemotherapy
Det resulterende volumen på 30 ml væske skal administreres i henhold til vejledningen fra fremstilleren af den nasogastriske sonde med passende efterskylninger. 
The resulting 30 mL of liquid should be administered as per the naso-gastric tube manufacturer's instructions with appropriate water flushes.
I FLAURA og AURA3 (N=1.142) var 43 % af patienterne ≥ 65 år, og 13 % var ≥ 75 år. 
In FLAURA and AURA3 (N=1142), 43% of patients were 65 years of age and older, and 13% were 75 years of age and older.
På baggrund af in vitro-studier er 2 farmakologisk aktive metabolitter (AZ7550 og AZ5104) efterfølgende blevet identificeret i plasma fra arter fra prækliniske studier og hos mennesker efter oral dosering med osimertinib; AZ7550 viste en tilsvarende farmakologisk profil som TAGRISSO, mens AZ5104 er mere potent over for både muteret EGFR og vildtype-EGFR. 
Based on in vitro studies, 2 pharmacologically active metabolites (AZ7550 and AZ5104) have subsequently been identified in the plasma of preclinical species and in humans after oral dosing with osimertinib; AZ7550 showed a similar pharmacological profile to TAGRISSO while AZ5104 showed greater potency across both mutant and wild-type EGFR.
Patientrapporterede symptomer og helbredsrelateret livskvalitet (HRQL) blev indsamlet elektronisk under anvendelse af EORTC QLQ-C30 og dets lungecancermodul (EORTC QLQ-LC13). 
Patient-reported symptoms and health-related quality of life (HRQL) were electronically collected using the EORTC QLQ-C30 and its lung cancer module (EORTC QLQ-LC13).
De kliniske studier, der blev udført, udelukkede patienter med ASAT eller ALAT >2,5x øvre normalgrænse (ULN) eller, hvis det skyldtes underliggende malignitet, >5,0 x ULN eller med total-bilirubin >1,5 x ULN. 
Clinical studies that were conducted excluded patients with AST or ALT >2.5x upper limit of normal (ULN), or if due to underlying malignancy, >5.0x ULN or with total bilirubin >1.5x ULN.
Det er en irreversibel hæmmer af epidermal vækstfaktor-receptorer (EGFR'er) med sensibiliseringsmutationer (EGFRm) og TKI-resistensmutation T790M. 
It is an irreversible inhibitor of Epidermal Growth Factor Receptors (EGFRs) harboring sensitising-mutations (EGFRm) and TKI-resistance mutation T790M.
Der blev observeret en CNS-ORR på 54 % (27/50 patienter; 95 % CI: 39,368,2), og 12 % af disse responser var komplette responser. 
A CNS ORR of 54% (27/50 patients; 95% CI: 39.3, 68.2) was observed with 12% of these responses being complete responses.
Keratitis blev rapporteret hos 0,7 % (n=8) af de 1.142 patienter, der blev behandlet med TAGRISSO i FLAURA- og AURA-studierne. 
Keratitis was reported in 0.7% (n=8) of the 1142 patients treated with TAGRISSO in the FLAURA and AURA studies.
Når det overvejes at anvende TAGRISSO bør EGFR-mutationsstatus i tumor eller plasmaprøver bestemmes under anvendelse af en valideret testmetode (se pkt. 
When considering the use of TAGRISSO, EGFR mutation status in tumour or plasma specimens should be determined using a validated test method (see section 4.4).
Resultater fra dyrestudier har vist, at osimertinib har indvirkning på kønsorganer hos hanner og hunner og kan forringe fertiliteten (se pkt. 
Results from animal studies have shown that osimertinib has effects on male and female reproductive organs and could impair fertility (see section 5.3).
Studier hos EGFR-mutationspositive NSCLC-patienter De nedenfor beskrevne data viser eksponering for TAGRISSO hos 1.142 patienter med EGFR-mutationspositiv ikke-småcellet lungecancer. 
Studies in EGFR mutation-positive NSCLC patients The data described below reflect exposure to TAGRISSO in 1142 patients with EGFR mutationpositive non-small cell lung cancer.
Hos patienter med kardielle risikofaktorer eller sygdomme, der kan påvirke LVEF, bør kardiel monitorering, herunder vurdering af LVEF ved baseline og under behandlingen, overvejes. 
In patients with cardiac risk factors and those with conditions that can affect LVEF, cardiac monitoring, including an assessment of LVEF at baseline and during treatment, should be considered.
• Bosentan - bruges mod forhøjet blodtryk i lungerne 
• Bosentan - used for high blood pressure in the lungs.
Patienterne blev randomiseret 1:1 til enten at få TAGRISSO (n=279, 80 mg oralt en gang daglig) eller EGFR TKI-komparator (n=277; gefitinib 250 mg oralt en gang daglig eller erlotinib 150 mg oralt en gang daglig). 
Patients were randomised 1:1 to receive either TAGRISSO (n=279, 80 mg orally once daily) or EGFR TKI comparator (n=277; gefitinib 250 mg orally once daily or erlotinib 150 mg orally once daily).
• Hvis din partner bliver gravid, mens du tager dette lægemiddel, skal du straks fortælle det til din læge. 
• If your partner becomes pregnant while you are taking this medicine, tell your doctor straight away.
Aktive substanser, der kan øge plasmakoncentrationen af osimertinib In vitro-studier har vist, at fase I-metaboliseringen af osimertinib hovedsageligt sker via CYP3A4 og CYP3A5. 
Active substances that may increase osimertinib plasma concentrations In vitro studies have demonstrated that the Phase I metabolism of osimertinib is predominantly via CYP3A4 and CYP3A5.
Effektresultater fra FLAURA efter investigators vurdering 
Efficacy results from FLAURA by investigator assessment
Osimertinib og dets metabolitter blev imidlertid påvist hos det diende afkom, og der var negativ indvirkning på afkommets vækst og overlevelse (se pkt. 
However, osimertinib and its metabolites were detected in the suckling pups and there were adverse effects on pup growth and survival (see section 5.3).
ORR i henhold til BICR i AURAex var 62 % (95 % CI: 55; 68) og 70 % (95 % CI: 63; 77) i AURA2. 
The ORR by BICR in AURAex was 62% (95% CI: 55, 68) and 70% (95% CI: 63, 77) in AURA2.
Patienter med CNS-metastaser, der ikke krævede steroider, og med stabil neurologisk status i mindst to uger efter afsluttet definitiv og steroid-behandling, var kvalificerede til at blive randomiseret til FLAURA-studiet. 
Patients with CNS metastases not requiring steroids and with stable neurologic status for at least two weeks after completion of the definitive therapy and steroids were eligible to be randomised in the FLAURA study.
Baseret på en farmakokinetisk analyse af 134 patienter med let nedsat leverfunktion, 8 patienter med moderat nedsat leverfunktion og 1.216 patienter med normal leverfunktion var eksponeringerne for osimertinib sammenlignelige. 
Based on a pharmacokinetic analysis of 134 patients with mild hepatic impairment, 8 patients with moderate hepatic impairment and 1216 patients with normal hepatic function osimertinib exposures were similar.
Hvis du har glemt at tage TAGRISSO 
If you forget to take TAGRISSO
• førstelinjebehandling af voksne patienter med lokalt fremskreden eller metastatisk ikkesmåcellet lungecancer (NSCLC) med aktiverende epidermal vækstfaktorreceptor (EGFR)-mutationer. 
• the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
I FLAURA- og AURA-studierne var forekomsten af ILD 10,4 % hos patienter af japansk etnicitet, 1,8 % hos patienter af ikke-japansk asiatisk etnicitet og 2,8 % hos ikke-asiatiske patienter. 
In the FLAURA and AURA studies, the incidence of ILD was 10.4% in patients of Japanese ethnicity, 1.8% in patients of non-Japanese Asian ethnicity and 2.8% in non-Asian patients.
Om muligt er bivirkningerne i tabel 2 blevet tillagt bivirkningsfrekvenserne på basis af hyppigheden i sammenlignelige bivirkningsrapporter i et puljet datasæt fra 1.142 EGFR-mutationspositive NSCLC-patienter, som fik TAGRISSO i en dosis på 80 mg dagligt i FLAURA, AURA3-, AURAex-, AURA2 og AURA1-studierne. 
Adverse reactions have been assigned to the frequency categories in Table 2 where possible based on the incidence of comparable adverse event reports in a pooled dataset from the 1142 EGFR mutation positive NSCLC patients who received TAGRISSO at a dose of 80 mg daily in the FLAURA, AURA3, AURAex, AURA 2 and AURA1 studies.
Hvis du holder op med at tage TAGRISSO 
If you stop taking TAGRISSO
Patienterne blev randomiseret i forholdet 2:1 (TAGRISSO: platinbaseret dubletkemoterapi) til at få TAGRISSO (n=279) eller platinbaseret dubletkemoterapi (n=140). 
Patients were randomised in a 2:1 (TAGRISSO: platinum-based doublet chemotherapy) ratio to receive TAGRISSO (n=279) or platinum-based doublet chemotherapy (n=140).
CNS-effekt ved RECIST v1.1 i FLAURA viste en nominel statistisk signifikant forbedring i CNS PFS (HR=0,48, 95 % CI: 0,26, 0,86; P=0,014). 
CNS efficacy by RECIST v1.1 in FLAURA demonstrated a nominal statistically significant improvement in CNS PFS (HR=0.48, 95% CI 0.26, 0.86; P=0.014).
• For at være sikker på, at du har fået al medicinen, skal du skylle glasset grundigt med yderligere 
• To make sure you have taken all of the medicine, rinse the glass thoroughly with another 50 mL of water and drink it.
For patienter, der fik EGFR TKI-komparator, blev post-progressionsskifte til open-label TAGRISSO tilladt, forudsat at tumorprøver blev testet positive for T790M-mutationen. 
For patients receiving EGFR TKI comparator, post-progression crossover to open-label TAGRISSO was permitted provided tumour samples tested positive for the T790M mutation.
Effektresultater fra AURA3 efter investigators vurdering 
Efficacy results from AURA3 by investigator assessment
Alle patienter med akut opståen og/eller uforklarlig forværring af lungesymptomer (dyspnø, hoste, feber) skal undersøges nøje for at udelukke ILD. 
Careful assessment of all patients with an acute onset and/or unexplained worsening of pulmonary symptoms (dyspnoea, cough, fever) should be performed to exclude ILD.
AURA3 udviste en statistisk signifikant forbedring af PFS hos patienter, der fik TAGRISSO, sammenlignet med kemoterapi. 
AURA3 demonstrated a statistically significant improvement in PFS in the patients treated with TAGRISSO compared to chemotherapy.
Osimertinib forårsagede ikke nogen genetisk skade i in vitro- og in vivo-analyser. 
Osimertinib did not cause genetic damage in in vitro and in vivo assays.
Antal patienter med anden progression (%) 
Number of patients with second progression
Fertile kvinder skal informeres om at undgå at blive gravide under behandling med TAGRISSO. 
Women of childbearing potential should be advised to avoid becoming pregnant while receiving TAGRISSO.
Arme 
Arms
Der er ikke udført noget farmakokinetisk studie med patienter med nedsat nyrefunktion. 
A pharmacokinetic study in patients with renal impairment has not been conducted.
P=0,0068), som ikke nåede formel statistisk signifikans. 
0.45, 0.88; P = 0.0068), which did not reach formal statistical significance.
En BICR-vurdering af CNS-effekt med RECIST v1.1 i undergruppen med 116/419 (28 %) patienter, som blev identificeret som havende CNS-metastaser på en baseline-hjernescanning, er sammenfattet i tabel 6. 
A BICR assessment of CNS efficacy by RECIST v1.1 in the subgroup of 116/419 (28%) patients identified to have CNS metastases on a baseline brain scan are summarised in Table 6.
HR=Hazard ratio; CI=Konfidensinterval, NC=Ikke muligt at beregne, NS=Ikke statistisk signifikant Alle effektresultater er baseret på RECIST-investigatorvurdering Baseret på ikke bekræftede responser 
HR=Hazard Ratio; CI=Confidence Interval, NC=Not Calculable, NS=Not Statistically Significant All efficacy results based on RECIST investigator assessment
Osimertinib er en tyrosinkinasehæmmer (TKI). 
Osimertinib is a Tyrosine Kinase Inhibitor (TKI).
I toksicitetsstudier med gentagne doser blev der set en øget incidens af manglende brunst, degenerering af corpora lutea i ovarierne og epitelial udtynding i uterus og vagina hos rotter, der var eksponeret for klinisk relevante osimertinib- plasmakoncentrationer i ≥1 måned. 
In repeat dose toxicity studies, an increased incidence of anoestrus, corpora lutea degeneration in the ovaries and epithelial thinning in the uterus and vagina were seen in rats exposed to osimertinib for ≥1 month at clinically relevant plasma concentrations.
Der blev fundet mindst 12 metabolitter i de puljede urin- og fæcesprøver fra mennesker, hvor 5 metabolitter udgjorde >1 % af dosis, hvoraf uomdannet osimertinib, AZ5104 og AZ7550 redegjorde for ca. 1,9, 6,6 og 2,7 % af dosis, mens et cysteinylprodukt (M21) og en ukendt metabolit (M25) udgjorde henholdsvis 1,5 % og 1,9 % af dosis. 
At least 12 components were observed in the pooled urine and faecal samples in humans with 5 components accounting for >1% of the dose of which unchanged osimertinib, AZ5104 and AZ7550, accounted for approximately 1.9, 6.6 and 2.7% of the dose while a cysteinyl adduct (M21) and an unknown metabolite (M25) accounted for 1.5% and 1.9% of the dose, respectively.
Interstitiel lungesygdom (ILD) eller ILD-lignende bivirkninger (f.eks. pneumonitis) blev rapporteret hos 3,9 % og var dødelig hos 0,4 % af de 1.142 patienter, som fik TAGRISSO i FLAURA- og AURA-studierne. 
Interstitial Lung Disease (ILD) or ILD-like adverse reactions (e.g. pneumonitis) were reported in 3.9% and were fatal in 0.4% of the 1142 patients who received TAGRISSO in FLAURA and AURA studies.
På tidspunktet for interimanalysen af den samlede overlevelse (25 % modenhed), favoriserede HR på 0,63 TAGRISSO (95 % CI: 0,45, 0,88; 
At the time of the interim analysis of overall survival (25% maturity), a HR of 0.63 favoured TAGRISSO (95% CI:
Gastrointestinale bivirkninger 
Gastrointestinal effects
I en populationsbaseret farmakokinetisk analyse (n=1.367) blev der ikke identificeret klinisk signifikant sammenhæng mellem forventet steady state-eksponering (AUCss) og patientens alder (interval 25-91 år), køn (65 % kvinder), etnicitet (herunder hvide, asiatiske, japanske, kinesiske og ikke-asiatiske-ikke-hvide patienter), behandlingslinje og rygestatus (n=34 nuværende rygere, n=419 tidligere rygere). 
In a population based pharmacokinetic analyses (n=1367), no clinically significant relationships were identified between predicted steady-state exposure (AUCss) and patient's age (range: 25 to 91 years), gender (65% female), ethnicity (including White, Asian, Japanese, Chinese and non-Asian-non-White patients), line of therapy and smoking status (n=34 current smokers, n=419 former smokers).
• Aliskiren - bruges mod forhøjet blodtryk 
• Aliskiren-used for high blood pressure.
Kemoterapi (Pemetrexed/Cisplatin eller Pemetrexed/Carboplatin) 
Chemotherapy (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin)
In vitro-studier har vist, at osimertinib er højpotent og har hæmmende aktivitet mod EGFR i en række klinisk relevante cellelinjer med ikke-småcellet lungecancer (NSCLC) med EGFR-sensibiliseringsmutation og T790M-mutation (tilsyneladende IC50'er fra 6 nM til 54 nM over for phospho-EGFR). 
In vitro studies have demonstrated that osimertinib has high potency and inhibitory activity against EGFR across a range of all clinically relevant EGFR sensitising-mutant and T790M mutant non-small cell lung cancer (NSCLC) cell lines (apparent IC50s from 6 nM to 54 nM against phospho-EGFR).
De væsentligste fund, der blev observeret i toksicitetsstudier med gentagne doser hos rotter og hunde, omfattede atrofiske, inflammatoriske og/eller degenerative forandringer, der påvirker epitelet i cornea (ledsaget af nedsat gennemsigtighed og uklarhed af cornea hos hunde ved oftalmologisk undersøgelse), mave-tarm-kanalen (herunder også tungen), huden og de hanlige og hunlige kønsorganer med sekundære forandringer i milten. 
The main findings observed in repeat dose toxicity studies in rats and dogs comprised atrophic, inflammatory and/or degenerative changes affecting the epithelia of the cornea (accompanied by corneal translucencies and opacities in dogs at ophthalmology examination), GI tract (including tongue), skin, and male and female reproductive tracts with secondary changes in spleen.
Behandlingen bør afbrydes hos patienter, som udvikler QTc-interval over 500 msek målt på mindst 2 forskellige EKG, indtil QTc-intervallet er under 481 msek eller tilbage til baseline-niveau, hvis QTc-intervallet er over eller lig med 481 msek; genstart TAGRISSObehandlingen med en reduceret dosis som beskrevet i Tabel 1. 
Treatment should be withheld in patients who develop a QTc interval greater than 500 msec on at least 2 separate ECGs until the QTc interval is less than 481 msec or recovery to baseline if the QTc interval is greater than or equal to 481 msec, then resume TAGRISSO at a reduced dose as described in Table 1.
Kaplan-Meier-kurver over progressionsfri overlevelse vurderet af investigator i FLAURA 
Kaplan-Meier Curves of Progression-Free Survival as assessed by investigator in FLAURA
Aktive substanser, der kan nedsætte plasmakoncentrationen af osimertinib I et klinisk farmakokinetisk studie med patienter blev steady state-AUC af osimertinib reduceret med 78 % ved samtidig administration af rifampicin (600 mg dagligt i 21 dage). 
Active substances that may decrease osimertinib plasma concentrations In a clinical pharmacokinetic study in patients, the steady-state AUC of osimertinib was reduced by 78% when co-administered with rifampicin (600 mg daily for 21 days).
• Dabigatran - bruges forebyggende mod blodpropper 
• Dabigatran - used to prevent blood clots.
TAGRISSOs sikkerhed og virkning er ikke klarlagt hos patienter med nyresygdom i slutstadiet [kreatininclearance (CLcr) < 15 ml/min., beregnet efter Cockcrofts og Gaults formel], og hos patienter i dialyse. 
The safety and efficacy of this medicinal product has not been established in patients with end-stage renal disease [creatinine clearance (CLcr) <15 mL/min, calculated by the Cockcroft and Gault equation], or on dialysis.
På baggrund af en populationsfarmakokinetisk analyse var der ingen sammenhæng mellem markører for leverfunktion (ALAT, ASAT, bilirubin) og osimertinibeksponering. 
Based on population PK analysis, there was no relationship between markers of hepatic function (ALT, AST, bilirubin) and osimertinib exposure.
Patienter med lav legemsvægt (<50 kg), som fik TAGRISSO 80 mg, rapporterede højere frekvens af grad ≥3 bivirkninger (52 % versus 35 %) og QTc-forlængelse (14 % versus 4 %) end patienter med højere legemsvægt (≥50 kg). 
Patients receiving TAGRISSO 80 mg with low body weight (<50 kg) reported higher frequencies of Grade ≥3 adverse events (52% versus 35%) and QTc prolongation (14% versus 4%) than patients with higher body weight (≥50 kg).
EGFR TKI-komparator (gefitinib eller erlotinib) (N=277) 
EGFR TKI comparator (gefitinib or erlotinib) (N=277)
Svær, livstruende eller dødelig interstitiel lungesygdom (ILD) eller ILD-lignende bivirkninger (fx pneumonitis) er observeret hos patienter behandlet med TAGRISSO i kliniske studier. 
Severe, life-threatening or fatal Interstitial Lung Disease (ILD) or ILD-like adverse reactions (e.g. pneumonitis) have been observed in patients treated with TAGRISSO in clinical studies.
Derfor er det sandsynligt, at CYP3A4-hæmmere ikke påvirker eksponeringen af osimertinib. 
Therefore, CYP3A4 inhibitors are not likely to affect the exposure of osimertinib.
Baseret på in vitro-studier hæmmer osimertinib kompetitivt CYP 3A4/5, men ikke CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 og 2E1 ved klinisk relevante koncentrationer. 
Based on in vitro studies, osimertinib is a competitive inhibitor of CYP 3A4/5 but not CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 and 2E1 at clinically relevant concentrations.
Sammenlignet med yngre forsøgspersoner (<65) rapporterede flere af forsøgspersonerne ≥ 65 år bivirkninger, der medførte dosisjustering af studiemedicinen (doseringsafbrydelse eller nedsat dosis) (13,4 % versus 7,6 %). 
Compared with younger subjects (<65), more subjects ≥65 years old had reported adverse reactions that led to study drug dose modifications (interruptions or reductions) (13.4% versus 7.6%).
TAGRISSOs virkning og sikkerhed til behandling af patienter med lokalt avanceret eller metastatisk T790M-NSCLC, hvis sygdom var progredieret under eller efter EGFR-TKI-behandling, blev demonstreret i et randomiseret, åbent, aktivt kontrolleret fase 3-studie (AURA3). 
The efficacy and safety of TAGRISSO for the treatment of patients with locally advanced or metastatic T790M NSCLC whose disease has progressed on or after EGFR TKI therapy, was demonstrated in a randomised, open-label, active-controlled Phase 3 study (AURA3).
Kaplan-Meier-kurver for progressionsfri overlevelse vurderet af investigator i AURA3 
Kaplan-Meier curves of Progression-Free Survival as assessed by investigator in AURA3
Antal patienter, der fik første efterfølgende behandling eller afgik ved døden (%) 
Number of patients who had first subsequent treatment or died (%)
Baseret på in vitro-studier er osimertinib substrat for P-gp og BCRP, men det er ikke sandsynligt, at det resulterer i klinisk relevante lægemiddelinteraktioner med aktive substanser og osimertinib i kliniske doser. 
Based on in vitro studies, osimertinib is a substrate of P-gp and BCRP, but is unlikely to result in clinically relevant drug interactions with active substances by osimertinib at the clinical doses.
Information om andre indholdsstoffer i denne medicin Denne medicin indeholder mindre end 1 mmol (23 mg) natrium per 40 mg eller 80 mg tablet, dvs. den er i det væsentlige natriumfri. 
Information on other ingredients in this medicine This medicine contains less than 1 mmol sodium (23 mg) per 40 mg or 80 mg tablet, that is to say essentially “sodium-free”.
En valideret test skal udføres under anvendelse af enten tumor-DNA fra en vævsprøve eller cirkulerende tumor-DNA (ctDNA) fra en plasmaprøve. 
A validated test should be performed using either tumour DNA derived from a tissue sample or circulating tumour DNA (ctDNA) obtained from a plasma sample.
Indtil 9. måned var der ingen klinisk meningsfulde forskelle i patientrapporterede symptomer mellem TAGRISSO og EGFR TKI-komparatorgrupperne (vurderet som en forskel på ≥10 point). 
Up to month 9 there were no clinically meaningful differences in patient-reported symptoms between TAGRISSO and EGFR TKI comparator groups (as assessed by a difference of ≥ 10 points).
Kemoterapi (Pemetrexed/Cisplatin eller Pemetrexed/Carboplatin) (N=140) 
Chemotherapy (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) (N=140)
Indtil flere data bliver tilgængelige, frarådes anvendelse til patienter med svært nedsat leverfunktion (se pkt. 
Until additional data become available, use in patients with severe hepatic impairment is not recommended (see section 5.2).
Baseline-karakteristika for den samlede studiepopulation (AURAex og AURA2) var følgende: gennemsnitsalder 63 år, 13 % af patienterne var ≥75 år gamle, kvinder (68 %), hvide (36 %), asiater (60 %). 
Baseline characteristics of the overall study population (AURAex and AURA2) were as follows: median age 63 years, 13% of patients were ≥75 years old, female (68%), White (36%), Asian (60%).
In vitro-studier har vist, at osimertinib ikke er substrat for OATP1B1 og OATP1B3. 
In vitro studies have shown that osimertinib is not a substrate of OATP1B1 and OATP1B3.