FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: If you stop taking TAGRISSO
Danish: Hvis du holder op med at tage TAGRISSO
English: 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).
Danish: Patienterne blev randomiseret i forholdet 2:1 (TAGRISSO: platinbaseret dubletkemoterapi) til at få TAGRISSO (n=279) eller platinbaseret dubletkemoterapi (n=140).
English: 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).
Danish: 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).
English: • To make sure you have taken all of the medicine, rinse the glass thoroughly with another 50 mL of water and drink it.
Danish: • For at være sikker på, at du har fået al medicinen, skal du skylle glasset grundigt med yderligere
English: For patients receiving EGFR TKI comparator, post-progression crossover to open-label TAGRISSO was permitted provided tumour samples tested positive for the T790M mutation.
Danish: For patienter, der fik EGFR TKI-komparator, blev post-progressionsskifte til open-label TAGRISSO tilladt, forudsat at tumorprøver blev testet positive for T790M-mutationen.
English: Efficacy results from AURA3 by investigator assessment
Danish: Effektresultater fra AURA3 efter investigators vurdering
English: 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.
Danish: Alle patienter med akut opståen og/eller uforklarlig forværring af lungesymptomer (dyspnø, hoste, feber) skal undersøges nøje for at udelukke ILD.
English: AURA3 demonstrated a statistically significant improvement in PFS in the patients treated with TAGRISSO compared to chemotherapy.
Danish: AURA3 udviste en statistisk signifikant forbedring af PFS hos patienter, der fik TAGRISSO, sammenlignet med kemoterapi.
English: Osimertinib did not cause genetic damage in in vitro and in vivo assays.
Danish: Osimertinib forårsagede ikke nogen genetisk skade i in vitro- og in vivo-analyser.
English: Number of patients with second progression
Danish: Antal patienter med anden progression (%)
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving TAGRISSO.
Danish: Fertile kvinder skal informeres om at undgå at blive gravide under behandling med TAGRISSO.
English: Arms
Danish: Arme
English: A pharmacokinetic study in patients with renal impairment has not been conducted.
Danish: Der er ikke udført noget farmakokinetisk studie med patienter med nedsat nyrefunktion.
English: 0.45, 0.88; P = 0.0068), which did not reach formal statistical significance.
Danish: P=0,0068), som ikke nåede formel statistisk signifikans.
English: 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.
Danish: 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.
English: HR=Hazard Ratio; CI=Confidence Interval, NC=Not Calculable, NS=Not Statistically Significant All efficacy results based on RECIST investigator assessment
Danish: 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
English: Osimertinib is a Tyrosine Kinase Inhibitor (TKI).
Danish: Osimertinib er en tyrosinkinasehæmmer (TKI).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: At the time of the interim analysis of overall survival (25% maturity), a HR of 0.63 favoured TAGRISSO (95% CI:
Danish: På tidspunktet for interimanalysen af den samlede overlevelse (25 % modenhed), favoriserede HR på 0,63 TAGRISSO (95 % CI: 0,45, 0,88;
English: Gastrointestinal effects
Danish: Gastrointestinale bivirkninger
English: 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).
Danish: 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).
English: • Aliskiren-used for high blood pressure.
Danish: • Aliskiren - bruges mod forhøjet blodtryk
English: Chemotherapy (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin)
Danish: Kemoterapi (Pemetrexed/Cisplatin eller Pemetrexed/Carboplatin)
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Kaplan-Meier Curves of Progression-Free Survival as assessed by investigator in FLAURA
Danish: Kaplan-Meier-kurver over progressionsfri overlevelse vurderet af investigator i FLAURA
English: 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).
Danish: 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).
English: • Dabigatran - used to prevent blood clots.
Danish: • Dabigatran - bruges forebyggende mod blodpropper
English: 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.
Danish: 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.
English: Based on population PK analysis, there was no relationship between markers of hepatic function (ALT, AST, bilirubin) and osimertinib exposure.
Danish: På baggrund af en populationsfarmakokinetisk analyse var der ingen sammenhæng mellem markører for leverfunktion (ALAT, ASAT, bilirubin) og osimertinibeksponering.
English: 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).
Danish: 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).
English: EGFR TKI comparator (gefitinib or erlotinib) (N=277)
Danish: EGFR TKI-komparator (gefitinib eller erlotinib) (N=277)
English: 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.
Danish: Svær, livstruende eller dødelig interstitiel lungesygdom (ILD) eller ILD-lignende bivirkninger (fx pneumonitis) er observeret hos patienter behandlet med TAGRISSO i kliniske studier.
English: Therefore, CYP3A4 inhibitors are not likely to affect the exposure of osimertinib.
Danish: Derfor er det sandsynligt, at CYP3A4-hæmmere ikke påvirker eksponeringen af osimertinib.
English: 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.
Danish: 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.
English: 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%).
Danish: 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 %).
English: 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).
Danish: 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).
English: Kaplan-Meier curves of Progression-Free Survival as assessed by investigator in AURA3
Danish: Kaplan-Meier-kurver for progressionsfri overlevelse vurderet af investigator i AURA3
English: Number of patients who had first subsequent treatment or died (%)
Danish: Antal patienter, der fik første efterfølgende behandling eller afgik ved døden (%)
English: 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.
Danish: 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.
English: 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”.
Danish: 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.
English: 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.
Danish: En valideret test skal udføres under anvendelse af enten tumor-DNA fra en vævsprøve eller cirkulerende tumor-DNA (ctDNA) fra en plasmaprøve.
English: 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).
Danish: 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).
English: Chemotherapy (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) (N=140)
Danish: Kemoterapi (Pemetrexed/Cisplatin eller Pemetrexed/Carboplatin) (N=140)
English: Until additional data become available, use in patients with severe hepatic impairment is not recommended (see section 5.2).
Danish: Indtil flere data bliver tilgængelige, frarådes anvendelse til patienter med svært nedsat leverfunktion (se pkt.
English: 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%).
Danish: 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 %).
English: In vitro studies have shown that osimertinib is not a substrate of OATP1B1 and OATP1B3.
Danish: In vitro-studier har vist, at osimertinib ikke er substrat for OATP1B1 og OATP1B3.
English: A HR< 1 favours TAGRISSO, an Odds ratio of >1 favours TAGRISSO Based on an interim analysis with 25% maturity a P-value < 0.0015 was required to achieve statistical significance ORR results by Blinded Independent Central Review (BICR) were consistent with those reported via investigator assessment; ORR by BICR assessment was 78% (95% CI:73, 83) on TAGRISSO and 70% (95% CI:65, 76) on EGFR TKI
Danish: En HR< 1 favoriserer TAGRISSO, en oddsratio på >1 favoriserer TAGRISSO Baseret på en interimanalyse med 25 % modenhed krævedes en P-værdi <0,0015 for at opnå statistisk signifikans ORR-resultater fra Blinded Independent Central Review (BICR) var i overstenstemmelse med det, der blev rapporteret via investigatorvurdering; ORR ved BICR-vurdering var 78 % (95 % CI: 73, 83) for TAGRISSO og 70 % (95 % CI: 65, 76) for EGFR TKI-komparator.
English: AURA3 demonstrated a statistically significant improvement in PFS for patients receiving TAGRISSO compared to those receiving chemotherapy irrespective of CNS metastases status at study entry.
Danish: AURA3 viste en statistisk signifikant forbedring i PFS for patienter, der fik TAGRISSO, sammenlignet med patienter, som fik kemoterapi, uanset deres status for CNS-metastaser ved studiets start.
English: In a female fertility study in rats, administration of osimertinib at 20 mg/kg/day (approximately equal to the recommended daily clinical dose of 80 mg) had no effects on oestrus cycling or the number of females becoming pregnant, but caused early embryonic deaths.
Danish: I et fertilitetsstudie med hunrotter havde administration af osimertinib i en dosis på 20 mg/kg pr. dag (svarende omtrent til den anbefalede daglige kliniske dosis på 80 mg) ingen indvirkning på brunstcyklussen eller på antallet af hunrotter, som blev drægtige, men det medførte tidlig embryodød.
English: See also Section 2.
Danish: Se også punkt 2.
English: • St. John's Wort (Hypericum perforatum) - an herbal medicine used for depression.
Danish: • Perikon (Hypericum perforatum) - et naturlægemiddel, der bruges mod depression.
English: A pre-specified PFS subgroup analysis based on CNS metastases status at study entry was performed in AURA3 and is shown in Figure 4.
Danish: PFS for en præspecificeret undergruppeanalyse, baseret på status for CNS-metastaser ved studiets start, blev udført i AURA3 og er vist i figur 4.
English: In a clinical trial, patients with different types of advanced solid tumours and with mild hepatic impairment (Child Pugh A, mean score = 5.3, n=7) or moderate hepatic impairment (Child Pugh B, mean score = 8.2, n=5) had no increase in exposure compared to patients with normal hepatic function (n=10) after a single 80 mg dose of TAGRISSO.
Danish: I et klinisk forsøg har patienter med forskellige typer af fremskredne solide tumorer og med let nedsat leverfunktion (Child Pugh A, gennemsnitlig score = 5,3, n = 7) eller moderat nedsat leverfunktion (Child Pugh B, gennemsnitlig score = 8,2, n = 5) sås ingen stigning i eksponering sammenlignet med patienter med normal leverfunktion (n = 10) efter en enkelt 80 mg dosis TAGRISSO.
English: In vivo oral administration of osimertinib lead to tumour shrinkage in both EGFRm and T790M NSCLC xenograft and transgenic mouse lung tumour models.
Danish: In vivo oral administration af osimertinib medførte tumorskrumpning i både EGFRm- og T790M-NSCLC i xenograft-lungecancermodeller og lungecancermodeller med transgene mus.
English: In vitro studies indicate that osimertinib is metabolised predominantly by CYP3A4, and CYP3A5.
Danish: In vitro-studier indikerer, at osimertinib hovedsageligt metaboliseres af CYP3A4 og CYP3A5.
English: TAGRISSO demonstrated a clinically meaningful and statistically significant improvement in PFS compared to EGFR TKI comparator (median 18.9 months and 10.2 months, respectively, HR=0.46, 95% CI: 0.37, 0.57; P<0.0001).
Danish: TAGRISSO viste en klinisk betydningsfuld og statistisk signifikant forbedring i PFS sammenlignet med EGFR TKI-komparator (henholdsvis median 18,9 måneder og 10,2 måneder, HR=0,46, 95 % CI: 0,37, 0,57; P<0,0001).
English: Up to month 9, there were no clinically meaningful differences between the TAGRISSO and EGFR TKI comparator groups in functioning or HRQL.
Danish: Frem til 9. måned var der ingen klinisk meningsfulde forskelle mellem TAGRISSO og EGFR TKIkomparatorgrupperne i funktionsevne eller HRQL.
English: Older patients reported more Grade 3 or higher adverse reactions compared to younger patients (13.4% versus 9.3%).
Danish: Typen af rapporterede bivirkninger var ens uanset alder. Ældre patienter rapporterede flere bivirkninger af grad 3 eller højere i sammenligning med yngre patienter (13,4 % versus 9,3 %).
English: At baseline, no differences in patient reported symptoms, function or HRQL were observed between TAGRISSO and EGFR TKI comparator (gefitinib or erlotinib) arms.
Danish: Ved baseline blev der ikke observeret forskelle i patientrapporterede symptomer, funktion eller HRQL mellem TAGRISSO og EGFR TKI-komparatorarme (gefitinib eller erlotinib).
English: In the subset of patients without CNS lesions at baseline, there were a lower number of new CNS lesions in the TAGRISSO arm compared to the EGFR TKI comparator arm (7/226 [3.1%] vs. 15/214 [7.0%], respectively).
Danish: I delmængden af patienter uden CNS-læsioner ved baseline var der et lavere antal nye CNS-læsioner i TAGRISSO-armen sammenlignet med EGFR TKIkomparatorarmen (henholdsvis 7/226 [3,1 %] versus 15/214 [7,0 %]).
English: CNS Progression-free survival
Danish: CNS-progressionsfri overlevelse
English: The PFS benefit of TAGRISSO compared to EGFR TKI comparator was consistent across all predefined subgroups analysed, including ethnicity, age, gender, smoking history, CNS metastases status at study entry and EGFR mutation type (Exon 19 deletion or L858R).
Danish: PFS-fordelen ved TAGRISSO sammenlignet med EGFR TKI-komparator var konsistent på tværs af alle foruddefinerede undergrupper, der blev analyseret, herunder etnicitet, alder, køn, rygehistorik, CNS-metastasestatus ved indtrædelse i studiet og EGFR-mutationstype (Exon 19-deletion eller L858R).
English: • Phenytoin, carbamazepine or phenobarbital -used for seizures or fits.
Danish: • Phenytoin, carbamazepin og phenobarbital - bruges mod krampeanfald.
English: Across clinical trials, Left Ventricular Ejection Fraction (LVEF) decreases greater than or equal to 10% and a drop to less than 50% occurred in 3.9% (35/908) of patients treated with TAGRISSO who had baseline and at least one follow-up LVEF assessment.
Danish: I kliniske studier forekom der fald i venstre ventrikels ejektionsfraktion (LVEF) ≥ 10 %, og et fald til under 50 % optrådte hos 3,9 % (35/908) af de patienter, der blev behandlet med TAGRISSO, og hvor der forelå baseline-LVEF og mindst én opfølgende vurdering.
English: This medicine contains < 1 mmol sodium (23 mg) per 40 mg or 80 mg tablet, that is to say essentially “sodium-free”.
Danish: Denne medicin indeholder <1 mmol natrium (23 mg) per 40 mg eller 80 mg tablet, dvs. den er i det væsentlige "natriumfri".
English: Permanently discontinue TAGRISSO
Danish: Permanent seponering af TAGRISSO