natgillin/translations-raw huggingface dataset:
Tal med din læge, før du tager Nerlynx, hvis du ammer eller planlægger at amme, da små mængder af dette lægemiddel kan udskilles i modermælk. 
Talk to your doctor before taking Nerlynx if you are breast-feeding or plan to breast-feed because small amounts of this medicine may pass into your breast milk.
Indlægsseddel: Information til patienten Nerlynx 40 mg filmovertrukne tabletter neratinib Dette lægemiddel er underlagt supplerende overvågning. 
Package leaflet: Information for the patient Nerlynx 40 mg film-coated tablets neratinib This medicine is subject to additional monitoring.
Neratinibs binding til humane plasmaproteiner, herunder kovalent binding til humant serumalbumin (HSA), var over 98 % og uafhængig af koncentration. 
Distribution Binding of neratinib to human plasma proteins, including covalent binding to human serum albumin (HSA), was greater than 98% and independent of concentration.
I tilfælde af overdosering bør behandlingen tilbageholdes, og der skal gives almindelig understøttende behandling. 
In the event of an overdose, administration should be withheld and general supportive measures undertaken.
Et karcinogenicitetsstudie over 6 måneder hos Tg.rasH2-transgene mus og data fra et studie over 2 år med rotter viste ingen tegn på karcinogent potentiale. 
A 6-month carcinogenicity study in Tg.rasH2 transgenic mice and the rat 2-year data showed no signs of carcinogenic potential.
Inden Nerlynx lanceres i de enkelte medlemsstater, skal indehaveren af markedsføringstilladelsen indgå en aftale med den relevante nationale myndighed om indholdet og formatet af informationsmaterialet, herunder kommunikationsmedier, distributionsmåder og alle øvrige aspekter af programmet. 
Prior to launch of Nerlynx in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Venstre ventrikel dysfunktion er blevet forbundet med HER2-hæmning. 
Left ventricular dysfunction has been associated with HER2 inhibition.
• Relevante oplysninger om gastrointestinal toksicitet (diarré) (f.eks. detaljer om tegn og symptomer (alvorlighed, sværhedsgrad, hyppighed, tid til debut, varighed, risici og konsekvenser)) 
• Relevant information of Gastrointestinal toxicity (diarrhoea) (e.g. signs and symptoms to be detailed (seriousness, severity, frequency, time to onset, duration, risks and consequences))
Indvirkningen af neratinib på andre stoffer 
Effects of neratinib on other substances
Oval, rød filmovertrukket tablet med "W104" præget på den ene side. 
Oval, red film-coated tablet with ‘W104' debossed on one side.
Mannitol (E421) Mikrokrystallinsk cellulose Crospovidon 
Mannitol (E421) Microcrystalline cellulose Crospovidone Povidone
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne-Billancourt Frankrig 
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne-Billancourt France
En række andre situationer kan også medføre dosisjustering som klinisk indiceret (f.eks. uacceptable toksiciteter, vedvarende grad 2-bivirkninger osv.). 
Additional clinical situations may result in dose adjustments as clinically indicated (e.g. intolerable toxicities, persistent Grade 2 adverse reactions, etc.).
Karcinogenese, mutagenese Neratinib var hverken klastogent eller mutagent i et standardbatteri af genotoksiske studier. 
Carcinogenesis, mutagenesis Nerlynx was neither clastogenic nor mutagenic in the standard battery of genotoxicity studies.
Indehaveren af markedsføringstilladelsen skal i alle de medlemsstater, hvor Nerlynx markedsføres, sikre, at alle sundhedspersoner, som forventes at ordinere/administrere Nerlynx, samt alle patienter/omsorgspersoner, som forventes at anvende Nerlynx, har adgang til/får udleveret følgende informationpakke: 
The MAH shall ensure that in each Member State where Nerlynx is marketed, all healthcare professionals who are expected to prescribe/dispense Nerlynx, as well as all patients/carers who are expected to use Nerlynx, have access to/are provided with the following educational package:
1 Hændelsesfri frekvenser for alle endepunkter, undtagen CNS-recidiv, for hvilket den kumulative incidens er rapporteret. 
1 Event-free rates for all endpoints, except for CNS recurrence for which cumulative incidence is reported.
Nerlynx kan forårsage ændringer i leverfunktionen, som kan ses i blodprøver. 
Nerlynx can cause changes in liver function - these are shown in blood tests.
Samtidig behandling med stoffer, der øger den gastriske pH, bør undgås, da opløseligheden og absorptionen af neratinib kan falde. 
Concomitant treatment with substances that increase gastric pH should be avoided, as neratinib solubility and absorption may decrease.
Den mediane kumulative varighed af diarré, uanset grad, var 59 dage, og den mediane kumulative varighed af grad 3-diarré var 5 dage. 
The median cumulative duration of any grade diarrhoea was 59 days and the median cumulative duration of Grade 3 diarrhoea was 5 days.
• Grad 4-diarré [livstruende konsekvenser, akut intervention indiceret] 
• Grade 4 diarrhoea [life-threatening consequences; urgent intervention indicated]
• carbamazepin, phenobarbital, phenytoin (antiepileptika) 
• carbamazepine, phenobarbital, phenytoin (antiepileptics)
En risiko for ammede nyfødte/spædbørn kan ikke udelukkes. 
A risk to the breast-fed infant cannot be excluded.
Hormonreceptor-positive patienter, sygdomsfri overlevelse pr. patientundergruppe 
Hormone receptor positive patients, disease-free survival by patient subgroup
• ikke opnår bedring til grad 0-1 af behandlingsrelateret toksicitet 
• Fail to recover to Grade 0 to 1 from treatment-related toxicity,
Glemte doser bør ikke erstattes, idet behandlingen bør fortsætte med den næste planlagte daglige dosis (se pkt. 
Missed doses should not be replaced and treatment should resume with the next scheduled daily dose (see Section 4.9).
Nerlynx virker ved at blokere HER2-receptorerne på kræftcellerne. 
Nerlynx works by blocking the HER2 receptors on the cancer cells.
Det vides ikke på nuværende tidspunkt, om neratinib kan mindske virkningen af systemisk virkende hormonelle præventionsmidler, og derfor skal kvinder, der benytter systemisk virkende hormonel prævention, også bruge en barrieremetode. 
It is currently unknown whether neratinib may reduce the effectiveness of systemically acting hormonal contraceptives, and therefore women using systemically acting hormonal contraceptives should add a barrier method.
Tabletovertræk Polyvinylalkohol Titandioxid (E171) Macrogol 
Tablet coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol
2 Ikke-stratificeret Cox-proportional hazard-model 3 Ikke-stratificeret tosidet log rank-test for alle endepunkter, undtagen CNS-recidiv, for hvilket Grays metode blev anvendt. 
2 Unstratified Cox proportional hazards model 3 Unstratified 2-sided log-rank test for all endpoints, except for CNS recurrence for which Gray's method was used.
• Der bør sørges for indtagelse af ~ 2 l væske for at undgå dehydrering 
• Fluid intake of ~2 L should be maintained to avoid dehydration
Dette lægemiddel kan give følgende bivirkninger: 
The following side effects may happen with this medicine:
Kontakt lægen eller apotekspersonalet, før du tager Nerlynx. 
Talk to your doctor or pharmacist before taking Nerlynx.
Ca. 10 % af patienterne havde stadie 1-tumorer, ca. 40 % havde stadie 2-tumorer, og ca. 30 % havde stadie 3-tumorer. 
Approximately 10% of patients had Stage I tumours, approximately 40% had Stage II tumours and approximately 30% had Stage III tumours.
Diarréen kan være svær og forbundet med dehydrering. 
The diarrhoea may be severe and associated with dehydration.
* I henhold til CTCAE v4.0 † Komplikationer omfatter dehydrering, feber, hypotension, nyresvigt eller neutropeni af grad 3-4 ‡ På trods af optimal medicinsk behandling 
* Per CTCAE v4.0 † Complicated features include dehydration, fever, hypotension, renal failure, or Grade 3 or 4 neutropenia ‡ Despite being treated with optimal medical therapy
Der sås ingen grad 3- eller grad 4-tilfælde af forhøjet bilirubin i blodet. 
There was no Grade 3 or 4 adverse reactions of blood bilirubin increased.
Hazard ratio (95 %-KI)2 
Hazard ratio (95% CI)2
Bivirkningerne ved Nerlynx (f.eks. dehydrering og svimmelhed som følge af diarré, udmattelse og besvimelsesanfald) kan indvirke på den måde, som opgaver, der kræver dømmekraft eller motoriske eller kognitive evner, udføres på. 
The side effects of Nerlynx (for example, dehydration and dizziness resulting from diarrhoea, fatigue, and fainting) may affect how tasks that require judgment, motor or cognitive skills are carried out.
Der blev ikke observeret signifikante ændringer i fertilitetsparametre hos han- og hunrotter ved doser på op til 12 mg/kg/dag (se pkt. 
No significant changes in fertility parameters in male and female rats were detected in dosing up to 12 mg/kg/day (see Section 5.3).
Nerlynx-dosis 
Nerlynx dose
Hvis neratinib anvendes under graviditet, eller hvis patienten bliver gravid under behandlingen med Nerlynx, bør patienten advares om den mulige risiko for fosteret. 
If neratinib is used during pregnancy, or if the patient becomes pregnant while taking Nerlynx, the patient should be informed of the potential hazard to the foetus.
Af de 1.660 patienter, der blev behandlet med Nerlynx-monoterapi uden forebyggende loperamid, oplevede 94,6 % mindst 1 tilfælde af diarré. 
Of the 1,660 patients treated with Nerlynx monotherapy without loperamide prophylaxis, 94.6% experienced at least 1 episode of diarrhoea.
Du kan muligvis få tegn eller symptomer på leverproblemer (f.eks. gulfarvning af huden og/eller øjnene, mørk urin eller lys afføring). 
You may or may not have signs or symptoms of liver problems (e.g., yellow skin and/or eyes, dark urine, or light-colour stools).
Behandling af diarré kræver korrekt brug af et lægemiddel mod diarré, kostændringer og passende dosisjustering af Nerlynx. 
Diarrhoea management requires the correct use of an anti-diarrhoeal medicinal product, dietary changes, and appropriate dose modifications of Nerlynx.
Ældre patienter (65 år og derover) har en højere risiko for nyresvigt og dehydrering, hvilket kan være en komplikation til diarré, og disse patienter bør overvåges nøje. 
Elderly patients (≥65 years of age) are at a higher risk of renal insufficiency and dehydration which may be a complication of diarrhoea and these patients should be carefully monitored.
Massebalancen efter administration af en enkelt oral dosis på 200 mg neratinib blev undersøgt hos seks raske forsøgspersoner. 
The mass balance after administration of a single oral dose of 200 mg of neratinib was studied in six healthy subjects.
P-værdi3 
P-value3
placebo blev fastholdt over fem år, kan der ikke laves et pålideligt estimat af effektstørrelsen. 
While the treatment benefit of Nerlynx over placebo was maintained at five years, the effect size cannot be reliably estimated.
Nerlynx anvendes til patienter, der har brystkræft i tidligt stadie, og: - som er såkaldt HER2-positive (human epidermal vækstfaktorreceptor 2-positive), og - som tidligere er blevet behandlet med et andet lægemiddel, der hedder trastuzumab. 
Nerlynx is used for patients who have early stage breast cancer which: - is human epidermal growth factor receptor 2-positive (HER2-positive) and - has previously been treated with another medicine called ‘trastuzumab'.
Diarré var også den hyppigste bivirkning, der medførte seponering, idet 14,4 % af de patienter, der blev behandlet med Nerlynx uden forebyggende loperamid, seponerede behandlingen på grund af diarré. 
Diarrhoea was also the most common adverse reaction leading to discontinuation, 14.4 % of patients treated with Nerlynx without loperamide prophylaxis discontinued treatment due to diarrhoea.
Diarré-tilfældene sås generelt i løbet af den første måned, idet 83,6 % af patienterne rapporterede om diarré i løbet af den første uge, 46,9 % i den anden uge, 40,2 % i den tredje uge og 43,2 % i den fjerde uge (den mediane tid til første forekomst var 2 dage). 
Diarrhoea generally occurred in the first month, with 83.6% of patients reporting this toxicity in the first week, 46.9% in the second week, 40.2% in the third week and 43.2% in the fourth week (median time to first onset was 2 days).
Hyppigheden og sværhedsgraden af gastrointestinale lidelser (diarré, mavesmerter, kvalme og opkastning) syntes at være dosisrelateret. 
The frequency and severity of gastrointestinal disorders (diarrhoea, abdominal pain, nausea and vomiting) appeared to be dose-related.
Dosisjusteringer og behandling - generelle toksiciteter* Sværhedsgrad af toksicitet† 
Nerlynx dose modifications and management - general toxicities* Severity of toxicity†
Din læge vil sammen med dig drøfte fordele og risici ved at tage Nerlynx under amning. 
Your doctor will discuss with you the benefits and risks of taking Nerlynx during this time.
Informationsmaterialet til patienter bør omfatte: o Indlægsseddel o En behandlingsvejledning til patienter/omsorgspersoner o "Min behandlingsjournal" Vejledningen til patienter/omsorgspersoner skal indeholde følgende vigtige oplysninger (i lægmandssprog) 
The patient information pack should contain: o Patient information leaflet o A patient/carer treatment guide o “My Treatment Journal” The Patient/carer guide shall contain the following key messages (in lay language)
Denne præsystemiske interaktion af neratinib med digoxin kan være klinisk relevant for P-gp-substrater med et snævert terapeutisk vindue (f.eks. dabigatran, digoxin og fexofenadin). 
This pre-systemic interaction of neratinib with digoxin might be clinically relevant for P-gp substrates with a narrow therapeutic window (e.g. dabigatran, digoxin, and fexofenadine).
Hyppigheden af grad 3-tilfælde var omtrent den samme blandt asiatiske og kaukasiske patienter (1,6 % og 1,0 %). 
The frequency of Grade 3 events was similar between Asians and Caucasians (1.6% vs. 1.0%).
Der findes ingen specifik antidot, og en eventuel fordel ved hæmodialyse til behandling af overdosering af Nerlynx kendes ikke. 
There is no specific antidote, and the benefit of haemodialysis in the treatment of Nerlynx overdose is unknown.
Det vides på nuværende tidspunkt ikke, om Nerlynx reducerer virkningen af systemisk virkende hormonelle præventionsmidler. 
It is currently unknown whether Nerlynx reduces the effectiveness of systemically acting hormonal contraceptives.
Diarré forekommer generelt i løbet af den første eller anden uges behandling med Nerlynx og kan recidivere. 
Diarrhoea generally occurs early during the first or second week of treatment with Nerlynx and may be recurrent.
Ved baseline havde 57,4 % hormonreceptor-positiv sygdom (defineret som ER-positiv og/eller PgR-positiv), 23,6 % var knude-negative, 46,8 % havde 1-3 positive knuder, og 29,6 % havde fire eller flere positive knuder. 
At baseline, 57.4% had hormone receptor positive disease (defined as ER-positive and/or PgR-positive), 23.6% were node negative, 46.8% had one to three positive nodes and 29.6% had four or more positive nodes.
Foreløbig metabolit-profilering i humant plasma indikerer, at neratinib efter oral administration undergår oxidativ metabolisering gennem CYP3A4. 
Preliminary metabolite profiling in human plasma indicates that after oral administration, neratinib undergoes oxidative metabolism through CYP3A4.
Kvinder, der bruger systemisk virkende hormonelle præventionsmidler, bør derfor også bruge en barrieremetode (se pkt. 
Therefore, women using systemically acting hormonal contraceptives should add a barrier method (see Section 4.6).
- Lægen vil fortælle dig, hvordan du skal tage lægemidlet mod diarré. 
- Your doctor will tell you how to take the anti-diarrhoea medicine.
Seponér Nerlynx indtil bedring til grad ≤ 1 eller baseline-niveau inden for 3 uger efter seponering. 
Stop Nerlynx until recovery to Grade ≤1 or baseline within 3 weeks of stopping treatment.
• Grad 3-diarré, der varer mellem 2 dage og 3 uger‡ 
• Grade 3 diarrhoea lasting between 2 days and 3 weeks‡
Nerlynx påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner. 
Nerlynx has minor or moderate influence on the ability to drive and use machines.
Nerlynx kan medføre diarré tidligt i behandlingen. 
Nerlynx can cause diarrhoea early during treatment.
Invasiv sygdoms-fri overlevelse Sygdomsfri overlevelse, herunder duktalt carcinom in situ 
Invasive disease-free survival Disease-free survival including ductal carcinoma in situ
Kvinder bør undgå at blive gravide, mens de tager Nerlynx og i op til 1 måned efter behandlingens afslutning. 
Women should avoid becoming pregnant while taking Nerlynx and for up to 1 month after ending treatment.
Det skal du vide, før du begynder at tage Nerlynx 3. 
What you need to know before you take Nerlynx 3.
Den primære analyse af studiet 2 år efter randomisering viste, at Nerlynx reducerede risikoen for recidiverende invasiv sygdom eller død signifikant med 34 % (HR = 0,66 med 95 %-KI (0,49-0,90), tosidet p = 0,008) i ITT-populationen. 
The primary analysis of the study after 2 years post-randomisation demonstrated that Nerlynx significantly reduced the risk of invasive disease recurrence or death by 34% (HR=0.66 with 95% CI (0.49, 0.90), two-sided p = 0.008) in the ITT population.
Du bør tage et lægemiddel mod diarré, så diarréen ikke bliver alvorlig, og så du ikke bliver dehydreret under behandlingen med Nerlynx. 
You should take an anti-diarrhoea medicine so that your diarrhoea does not become severe, and to prevent you from getting dehydrated during treatment with Nerlynx.
Nogle lægemidler kan også påvirke den måde, Nerlynx virker på. 
Also some other medicines can affect the way Nerlynx works.
Neratinib medførte ingen hæmmende aktivitet over for uptaketransportørerne OATP1B1*1a, OATP1B3, OAT1, OAT3 og OCT2 med rapporterede IC50-værdier > 10 mikroM. 
Neratinib produced no inhibitory activity towards the uptake transporters, OATP1B1*1a, OATP1B3, OAT1, OAT3 and OCT2, with reported IC50 values were > 10µM.
Incidensen af grad 1- og grad 2-tilfælde var hhv. 6,2 % og 1,4 %. 
The incidence of Grade 1 and Grade 2 was 6.2% and 1.4% respectively.
Informationsmateriale til patienter: 
The patient educational material:
Hver beholder indeholder 180 filmovertrukne tabletter. 
Each bottle contains 180 film-coated tablets.
Hos kaniner blev der ikke observeret nogen effekt på parring eller dyrenes evne til at blive drægtige, men der blev observeret embryoføtal dødelighed og føtale morfologiske anomalier (f.eks. kuppelformet hoved, udvidelse af hjernens ventrikler og misdannede anteriore fontaneller og forstørrede anteriore og/eller posteriore fontaneller) ved doser, der kan anses for klinisk relevante. 
In rabbits, there were no effects on mating or the ability of animals to become pregnant, but embryofoetal lethality and foetal morphologic anomalies (e.g. domed head, dilation of brain ventricles and misshapen anterior fontanelles and enlarged anterior and/or posterior fontanelles) were observed at doses that may be considered to be clinically relevant.
Nerlynx kan nemlig påvirke den måde, visse andre lægemidler virker på. 
This is because Nerlynx can affect the way some other medicines work.
Hazard (95 %-KI)2 P-værdi3 
Hazard (95% CI)2 P-value3
* Se tabel 3 og 4 nedenfor mht. behandling af diarré og levertoksicitet † I henhold til CTCAE v4.0 
* Refer to Table 3 and Table 4 below for management of diarrhoea and hepatotoxicity † Per CTCAE v4.0
0,2 % af patienterne havde diarré af grad 4. 
0.2% of patients had diarrhoea classified as Grade 4.
Den anbefalede dosis Nerlynx er 6 tabletter én gang dagligt (i alt 240 mg). 
The recommended dose of Nerlynx is 6 tablets once a day (a total of 240 mg).
3 for yderligere oplysninger om den medicin mod diarré, som du skal tage samtidigt med Nerlynx. 
See Section 3 for more information about the anti-diarrhoea medicine you need to take at the same time as Nerlynx.
Indvirkningen af andre stoffer på neratinib 
Effects of other substances on neratinib
• Seponér Nerlynx permanent • Undersøg eventuelle andre årsager 
• Permanently discontinue Nerlynx • Evaluate alternative causes
Grapefrugtjuice bør undgås under behandling med Nerlynx (se pkt. 
Grapefruit juice should be avoided during treatment with Nerlynx (see Section 4.5).
Hos patienter med kendte risikofaktorer relateret til hjertet bør der foretages overvågning af hjertefunktionen, herunder vurdering af LVEF som klinisk indiceret. 
In patients with known cardiac risk factors, conduct cardiac monitoring, including assessment of LVEF, as clinically indicated.
Patienterne skal have at vide, at de skal påbegynde forebyggende behandling med et middel mod diarré sammen med den første Nerlynx-dosis og fastholde regelmæssig dosering af midlet mod diarré i de første 1-2 måneder af Nerlynx-behandlingen med titrering til 1-2 afføringer pr. dag. 
Patients should be instructed to initiate prophylactic treatment with an anti-diarrhoeal medicinal product with the first dose of Nerlynx, and maintain regular dosing of the anti-diarrhoeal medicinal product during the first 1-2 months of Nerlynx treatment, titrating to 1-2 bowel movements per day.
Leverfunktionstest, herunder alaninaminotransferase (ALAT), aspartataminotransferase (ASAT) og total bilirubin, bør monitoreres efter 1 uge og derefter en gang månedligt i de første 3 måneder og derefter hver 6. uge, så længe behandlingen fortsætter, eller det er klinisk indiceret (se pkt. 
Liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin should be monitored at 1 week, then monthly for the first 3 months and every 6 weeks thereafter while on treatment or as clinically indicated (see Section 4.2).
Meget almindelig Muskelspasmer 
Very Common Muscle spasms
Genoptag derefter Nerlynxbehandling på det næste, lavere dosisniveau. 
Then resume Nerlynx at the next lower dose level.
Efter oral administration af 240 mg neratinib var absorptionen langsom, og peak plasmakoncentrationer af neratinib sås ca. 7 timer efter indgivelse. 
Following oral administration of 240 mg neratinib, absorption was slow and peak plasma concentrations of neratinib occurred around 7 hours after administration.
Hvis du holder op med at tage Nerlynx 
If you stop taking Nerlynx
Dosis blev reduceret hos 24,7 % af de Nerlynx-behandlede patienter. 
Dose reductions occurred in 24.7% of Nerlynx-treated patients.
Det skal du vide, før du begynder at tage Nerlynx Tag ikke Nerlynx 
What you need to know before you take Nerlynx Do not take Nerlynx
Hos patienter, der var hormonreceptor-negative, uanset tid fra trastuzumab-behandling, var hazard ratio for iDFS efter 2 år 0,93 (95 %-KI: 0,60-1,43). 
In patients that were hormone receptor negative, regardless of time from trastuzumab therapy, the hazard ratio for iDFS at 2 years was 0.93, with 95% CI (0.60, 1.43).
Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, andre antineoplastiske stoffer, proteinkinasehæmmere; ATC-kode: L01XE45 
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors, ATC code: L01XE45
• Afbryd Nerlynx-behandlingen 
• Interrupt Nerlynx treatment
Oversigten nedenfor opstiller de bivirkninger, der er observeret ved neratinib under gennemgangen af de puljede data for 1.710 patienter. 
The table below lists adverse reactions observed with neratinib based on the assessment of pooled data from 1,710 patients.
Hver beholder indeholder 180 tabletter. 
Each bottle contains 180 tablets.
Hvis du er gravid, vil lægen vurdere den mulige fordel for dig og risikoen for fostret, før du får dette lægemiddel. 
If you are pregnant, the doctor will assess the potential benefit to you and risk to the foetus before giving this medicine to you.
Seponér behandlingen med Nerlynx hos patienter, som: 
Discontinue Nerlynx for patients who:
Puljede sikkerhedsdata for 1.710 patienter, der blev behandlet med Nerlynx alene, viste en højere forekomst af dermatologisk toksicitet hos asiatiske patienter (57,1 %) end hos kaukasiske patienter (34,6 %). 
Pooled safety data of 1710 patients treated with Nerlynx monotherapy showed a higher incidence of dermatologic toxicities in Asian patients (57.1%) versus Caucasian patients (34.6%).