FrancophonIA/ELRC3.0 huggingface dataset:
English: • Check that the needle is locked to the Luer connector before moving out of the vertical plane.
Danish: • Tjek at kanylen er fastlåst til luer-fatningen, før den flyttes ud af lodret stilling.
English: All patients had received prior systemic therapy and most patients in each treatment arm had received a previous chemotherapy regimen for their primary diagnosis.
Danish: Alle patienter havde tidligere fået systemisk behandling, og de fleste patienter i begge behandlingsarme var tidligere behandlet med kemoterapi for den primære diagnose.
English: Clinical studies in postmenopausal women with primary breast cancer have shown that fulvestrant significantly downregulates ER protein in ER positive tumours compared with placebo.
Danish: Kliniske studier hos postmenopausale kvinder med primær brystkræft har vist, at fulvestrant nedregulerer ER-protein signifikant i ER positive tumorer i forhold til placebo.
English: These studies compared the safety and efficacy of monthly administration of Faslodex 250 mg versus the daily administration of 1 mg anastrozole (aromatase inhibitor).
Danish: Disse studier sammenlignede sikkerhed og virkning ved administration af Faslodex 250 mg månedligt versus daglig administration af 1 mg anastrozol (aromatase-hæmmer).
English: In Table 1, the following frequency categories for adverse drug reactions (ADRs) were calculated based on the Faslodex 500 mg treatment group in pooled safety analyses of studies that compared Faslodex 500 mg with Faslodex 250 mg [CONFIRM (Study D6997C00002), FINDER 1 (Study D6997C00004), FINDER 2 (Study D6997C00006), and NEWEST (Study D6997C00003) studies], or from FALCON (Study D699BC00001) alone that compared Faslodex 500 mg with anastrozole 1 mg. Where frequencies differ between the pooled safety analysis and FALCON, the highest frequency is presented.
Danish: I nedenstående tabel 1 er frekvenskategorier for bivirkninger baseret på en Faslodex 500 mg behandlingsgruppe i kombinerede sikkerhedsanalyser af studier, hvor Faslodex 500 mg blev sammenlignet med Faslodex 250 mg [CONFIRM (studie D6997C00002), FINDER 1 (studie D6997C00004), FINDER 2 (studie D6997C00006) og NEWEST (studie D6997C00003)] eller fra FALCON (Studie D699BC00001) alene, hvor Faslodex 500 mg blev sammenlignet med anastrozol 1 mg. Hvor frekvenserne adskiller sig mellem de kombinerede sikkerhedsanalyser og FALCON, er den højeste frekvens præsenteret.
English: Talk to your doctor or pharmacist or nurse before using Faslodex if any of these apply to you: - kidney or liver problems - low numbers of platelets (which help blood clotting) or bleeding disorders
Danish: Kontakt lægen eller apotekspersonalet eller sundhedspersonalet, før du bruger Faslodex, hvis nogle af følgende punkter gælder for dig: - nyre- eller leverproblemer - lavt blodpladetal (som fremmer dannelse af blodpropper) eller blødningsforstyrrelse - tidligere problemer med blodpropper
English: The majority of patients (87.0%) had metastatic disease at baseline.
Danish: Størstedelen af patienterne (87,0 %) havde metastatisk sygdom ved studiets udgangspunkt.
English: Fulvestrant blocks the trophic actions of estrogens without any partial agonist (estrogen-like) activity.
Danish: Fulvestrant blokerer de trofiske østrogenvirkninger uden at have nogen partiel agonistaktivitet (østrogenlignende).
English: Fulvestrant is excreted in milk in lactating rats.
Danish: Fulvestrant udskilles i mælken hos diende rotter.
English: Randomisation was stratified by disease setting (locally advanced or metastatic), prior chemotherapy for advanced disease, and measurable disease.
Danish: Randomiseringen blev stratificeret efter sygdomsomstændigheder (lokalt fremskreden eller metastatisk), tidligere kemoterapi mod fremskreden sygdom og målbar sygdom.
English: Do not use this medicine after the expiry date which is stated on the carton or syringe labels after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen eller sprøjtens etiket efter forkortelsen EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Median duration of exposure to fulvestrant was 11.2 months in the fulvestrant + palbociclib arm and 4.9 months in the fulvestrant + placebo arm.
Danish: Medianvarigheden af eksponering for fulvestrant var 11,2 måneder i fulvestrant + palbociclib-armen og 4,9 måneder i fulvestrant + placebo-armen.
English: Benzyl alcohol Faslodex contains benzyl alcohol as an excipient which may cause allergic reactions.
Danish: Benzylalkohol Faslodex indeholder benzylalkohol som hjælpestof, hvilket kan medføre allergiske reaktioner.
English: Preclinical data do not suggest a stimulatory effect of fulvestrant on the postmenopausal endometrium (see section 5.3).
Danish: De prækliniske data tyder ikke på en stimulerende virkning af fulvestrant på det postmenopausale endometrium (se pkt.
English: -AI subgroup (n=313) Variable
Danish: -AI-undergruppe (n=313) Variabel
English: Studies using human liver preparations and recombinant human enzymes indicate that CYP3A4 is the only P450 isoenzyme involved in the oxidation of fulvestrant; however, non-P450 routes appear to be more predominant in vivo.
Danish: Studier, hvor der er anvendt humant levermateriale og rekombinante humane enzymer, indikerer, at CYP3A4 er det eneste P-450 isoenzym, der er involveret i oxidation af fulvestrant, hvor veje, der ikke involverer P-450, dog synes mere fremtrædende in vivo.
English: Patients of childbearing potential should use effective contraception during treatment with Faslodex and for 2 years after the last dose.
Danish: Patienter, der potentielt kan blive gravide, skal bruge effektiv prævention under behandlingen med Faslodex og i 2 år efter sidste dosis.
English: The objective response rate for Faslodex 250 mg was 19.2% compared with 16.5% for anastrozole.
Danish: Den objektive responsrate for Faslodex 250 mg var 19,2% i forhold til 16,5% for anastrozol.
English: • Remove the cap (A) in a straight upward direction.
Danish: • Fjern låget (A) med en lodret bevægelse.
English: • Thromboembolism (increased risk of blood clots)*
Danish: • Blodprop (øget risiko)*
English: • Remove glass syringe barrel from tray and check that it is not damaged.
Danish: • Tag glassprøjten ud af bakken og undersøg, om den er uskadt.
English: Secondary end points* OR [% (95% CI)] OR (measurable disease) [% (95% CI)]
Danish: Sekundære endepunkter* OR [% (95 % CI)] OR (målbar sygdom) [% (95 % CI)]
English: To be taken into account in high-risk groups such as patients with liver disease, or epilepsy.
Danish: Tag hensyn ved behandling af højrisikogrupper så som patienter med leversygdomme eller epilepsi.
English: Due to the structural similarity of fulvestrant and estradiol, fulvestrant may interfere with antibody based-estradiol assays and may result in falsely increased levels of estradiol.
Danish: På grund af strukturligheden mellem fulvestrant og estradiol kan fulvestrant interferere med antistofbaserede estradiol analyser og udvise falsk forhøjede estradiol niveauer.
English: Prior to the start of treatment with the combination of Faslodex plus palbociclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice.
Danish: Inden påbegyndelse af behandling med en kombination af Faslodex og palbociclib, samt under hele behandlingens varighed, skal præ- og perimenopausale kvinder behandles med LHRH-agonister ifølge lokal klinisk praksis.
English: It has also been shown that fulvestrant 500 mg downregulates ER and the proliferation marker Ki67, to a greater degree than fulvestrant 250 mg in breast tumours in postmenopausal neoadjuvant setting.
Danish: Det er også påvist, at fulvestrant 500 mg nedregulerer ER og proliferationsmarkøren Ki67 i højere grad end fulvestrant 250 mg ved brysttumorer i et postmenopausalt neoadjuverende regi.
English: Key secondary efficacy endpoints included overall survival (OS) and objective response rate (ORR).
Danish: Vigtige sekundære effektmål omfattede samlet overlevelse (OS) og objektiv responsrate (ORR).
English: Table 2 Adverse reactions based on PALOMA3 Study (N=517)
Danish: Bivirkninger baseret på PALOMA3 studiet (N=517)
English: What you need to know before you use Faslodex
Danish: Det skal du vide, før du begynder at bruge Faslodex
English: Adverse reactions listed below are classified according to frequency and System Organ Class (SOC).
Danish: Bivirkningerne, der er opremset herunder, er klassificeret i henhold til frekvens og systemorganklasse.
English: Thromboembolic events are commonly observed in women with advanced breast cancer and have been observed in clinical studies with Faslodex (see section 4.8).
Danish: Thromboemboliske tilfælde ses ofte hos kvinder med fremskreden brystkræft og er observeret i kliniske studier med Faslodex (se pkt.
English: • Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat
Danish: • Allergiske reaktioner, herunder hævelser af ansigt, læber, tunge og/eller hals
English: Faslodex should be administered as two consecutive 5 ml injections by slow intramuscular injection (1-2 minutes/injection), one in each buttock (gluteal area).
Danish: Faslodex skal indgives som to på hinanden følgende 5 ml injektioner ved langsom intramuskulær injektion (1-2 minutter/injektion), én i hver balde (glutealområdet).
English: • Increase of gamma-GT, a liver enzyme seen in a blood test
Danish: • Forhøjet gamma-GT (et leverenzym, der kan påvises i blodprøver)
English: Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance <30 ml/min), and, therefore, caution is recommended in these patients (see section 4.4).
Danish: Sikkerhed og virkning er ikke undersøgt hos patienter med svært nedsat nyrefunktion (kreatinin clearance < 30 ml/min), og derfor anbefales forsigtighed ved behandling af disse patienter (se pkt.
English: In dog studies following oral and intravenous administration, effects on the cardiovascular system (slight elevations of the S-T segment of the ECG [oral], and sinus arrest in one dog [intravenous]) were seen.
Danish: I forsøg med hunde efter oral og intravenøs administration, sås påvirkninger af det cardiovaskulære system (svage stigninger af S-T segmentet i EKG [ved oral indgift], og hjertestop hos en hund [ved intravenøs indgift].
English: To maintain sterility do not touch the syringe tip (B) (see Figure 2).
Danish: For at bevare steriliteten, må kanylens spids (B) ikke berøres (se figur 2).
English: There is no evidence of adverse endometrial effects in the breast cancer patients studied.
Danish: Der var ingen tegn på utilsigtede virkninger i endometriet hos brystkræftpatienterne i forsøget.
English: The overall safety profile of fulvestrant when used in combination with palbociclib is based on data from 517 patients with HR-positive, HER2-negative advanced or metastatic breast cancer in the randomised PALOMA3 study (see section 5.1).
Danish: Den samlede sikkerhedsprofil for fulvestrant, når det anvendes i kombination med palbociclib, er baseret på data fra 517 patienter med HR-positiv, HER2-negativ fremskreden eller metastatisk brystkræft i det randomiserede PALOMA3-studie (se pkt.
English: In two short-term studies (1 and 12 weeks) in premenopausal patients with benign gynaecologic disease, no significant differences in endometrial thickness were observed by ultrasound measurement between fulvestrant and placebo groups.
Danish: I to korttidsforsøg (1 og 12 uger) med præmenopausale patienter med godartet gynækologisk sygdom, blev der ved ultralydsmålingerne ikke observeret nogen signifikante forskelle i endometriets tykkelse mellem fulvestrant og placebo grupperne.
English: N=number of patients; CI=confidence interval; OR=objective response; CBR=clinical benefit response
Danish: N=antal patienter; CI=konfidensinterval; OR=objektivt respons; CBR=klinisk gevinstrate
English: Faslodex has no or negligible influence on the ability to drive or use machines.
Danish: Faslodex påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: • Administer intramuscularly slowly (1-2 minutes/injection) into the buttock (gluteal area).
Danish: • Injicér langsomt (1-2 minutter/injektion) intramuskulært i balden (glutealområdet).
English: In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.
Danish: Til præ- eller perimenopausale kvinder skal kombinationsbehandlingen med palbociclib kombineres med en luteiniserende hormonfrigivende hormon (LHRH)-agonist.
English: Treatment --- Fulvestrant 500 mg (N=230) - - - - - - Anastrozole 1 mg (N=232)
Danish: Behandling --- Fulvestrant 500 mg (N=230) - - - - - - Anastrozol 1 mg (N=232)
English: Administration of Faslodex 500 mg regimen achieves exposure levels at, or close to, steady state within the first month of dosing (mean [CV]: AUC 475 [33.4%] ng.days/ml, Cmax 25.1 [35.3%] ng/ml, Cmin 16.3 [25.9%] ng/ml, respectively).
Danish: Administration af Faslodex 500 mg regime medfører eksponeringsniveauer ved, eller tæt ved, steady-state indenfor den første måned (gennemsnitlig [variationskoefficient]: AUC 475 [33,4%] ng. Dage/ml, Cmax 25,1 [35,3%] ng/ml, Cmin 16,3 [25,9%] ng/ml henholdsvis).
English: Uncommon Febrile neutropenia Metabolism and nutrition disorders Very common Decreased appetite Nervous system disorders Common Dysgeusia Eye disorders Common Lacrimation increased Vision blurred Dry eye Respiratory, thoracic and mediastinal disorders Common Epistaxis Gastrointestinal disorders Very common Nausea Stomatitis Diarrhoea Vomiting Skin and subcutaneous tissue disorders Very common Alopecia Rash Common Dry skin General disorders and administration site conditions Very common Fatigue Pyrexia Common Asthenia Investigations Common AST increased ALT increased
Danish: Thrombocytopeni Ikke almindelig Febril neutropeni Metabolisme og ernæring Meget almindelig Nedsat appetit Nervesystemet Almindelig Dysgeusi Øjne Almindelig Øget tåresekretion Sløret syn Tørre øjne Luftveje, thorax og mediastinum Almindelig Epistaxis Mave-tarm-kanalen Meget almindelig Kvalme Stomatitis Diarré Opkastning Hud og subkutane væv Meget almindelig Alopeci Udslæt Almindelig Tør hud Almene symptomer og reaktioner på administrationsstedet Meget almindelig Træthed Feber Almindelig Asteni Undersøgelser Almindelig Forhøjet ASAT Forhøjet ALAT
English: • Injection site reactions, such as pain and/or inflammation
Danish: • Irritation ved injektionsstedet som smerte og/eller betændelse (inflammation)
English: Although the data collected were limited, the steady-state trough concentrations of fulvestrant in children appear to be consistent with those in adults.
Danish: Selvom de indsamlede data var begrænsede, svarede steady-state-dalkoncentrationerne af fulvestrant hos børnene i denne undersøgelse til dem, som blev observeret hos voksne.
English: Neutropenia includes the following PTs: Neutropenia, Neutrophil count decreased.
Danish: Neutropeni inkluderer de følgende PTs: neutropeni, nedsat neutrofiltal.
English: Addition of palbociclib to Faslodex resulted in a symptom benefit by significantly delaying Time-to-Deterioration in pain symptom compared with Faslodex plus placebo (median 8.0 months versus 2.8 months; HR of 0.64 [95% CI: 0.49, 0.85]; p<0.001).
Danish: Tillæg af palbociclib til Faslodex gav en symptomfordel ved i betydelig grad at forsinke tiden indtil forværring i smertesymptomer sammenlignet med Faslodex plus placebo (median 8,0 måneder versus 2,8 måneder; HR på 0,64 [95 % CI: 0,49; 0,85]; p<0,001).
English: Clinical interaction studies with rifampicin (inducer of CYP3A4) and ketoconazole (inhibitor of CYP3A4) showed no clinically relevant change in fulvestrant clearance.
Danish: Kliniske interaktionsstudier med rifampicin (en CYP3A4 inducer) og ketoconazol (CYP3A4 hæmmer) viste ingen klinisk relevant ændring i fulvestrant clearance.
English: • Numbness, tingling and pain
Danish: • Følelsesløshed, snurren og smerter
English: A clinical interaction study with midazolam (substrate of CYP3A4) demonstrated that fulvestrant does not inhibit CYP3A4.
Danish: Et klinisk interaktionsstudie med midazolam (substrat af CYP3A4) viste at fulvestrant ikke hæmmer CYP3A4.
English: Infections and infestations Very common Infections Blood and lymphatic system disorders Very common Neutropenia Leukopenia Anaemia Thrombocytopenia
Danish: Infektioner og parasitære sygdomme Meget almindelig Infektioner Blod og lymfesystem Meget almindelig Neutropeni Leukopeni Anæmi
English: The pharmacokinetics of fulvestrant has been evaluated in a single-dose clinical study conducted in women with mild to moderate hepatic impairment (Child-Pugh class A and B).
Danish: Farmakokinetikken for fulvestrant er blevet undersøgt i et klinisk enkeltdosis-studie, der blev gennemført hos kvinder som havde let til moderat nedsat leverfunktion, (Child-Pugh klasse A og B).
English: When Faslodex is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib.
Danish: Når Faslodex gives i kombination med palbociclib er det vigtigt, at du også læser indlægssedlen for palbociclib.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Faslodex in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Faslodex i alle undergrupper af den pædiatriske population med brystkræft (se pkt.
English: • Lower back pain irradiating to leg on one side (sciatica)
Danish: • Smerter i lænden, der stråler ned i det ene ben (iskias)
English: Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
Danish: Thrombocytopeni inkluderer de følgende PTs: thrombocytopeni, nedsat trombocyttal.
English: Fulvestrant has been shown to cross the placenta after single intramuscular doses in rat and rabbit.
Danish: Det er vist, at fulvestrant passerer placenta hos rotter og kaniner efter en enkelt intramuskulær dosis.
English: In patients receiving fulvestrant in combination with palbociclib, the median time to first episode of any grade neutropenia was 15 days (range: 13-317) and the median duration of Grade ≥3 neutropenia was 7 days.
Danish: Hos patienter, der fik fulvestrant i kombination med palbociclib, var mediantid til første tilfælde af enhver grad af neutropeni 15 dage (interval: 13-317), og medianvarigheden af grad ≥3-neutropeni var 7 dage.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements (see section 5.3).
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer (se pkt.
English: Breast-feeding must be discontinued during treatment with Faslodex.
Danish: Amning skal ophøre under behandling med Faslodex.
English: In a two-year mouse oncogenicity study (daily oral administration) there was an increased incidence of ovarian sex cord stromal tumours (both benign and malignant) at doses of 150 and 500 mg/kg/day.
Danish: I et toårigt onkogenicitetsstudie hos mus (med daglig oral administration) sås en øget forekomst af sex cordstromale tumorer (både benigne og maligne) i ovarierne ved doser på 150 og 500 mg/kg/dag.
English: • Decreased levels of platelets (thrombocytopenia)
Danish: • Nedsat antal blodplader (trombocytopeni)
English: In the FALCON study, the number of patients who reported an adverse reaction of joint and musculoskeletal pain was 65 (31.2%) and 48 (24.1%) for fulvestrant and anastrozole arms, respectively.
Danish: I FALCON-studiet var antallet af patienter, som rapporterede en bivirkning i form af smerter i led, muskler og knogler, henholdsvis 65 (31,2 %) og 48 (24,1 %) for fulvestrant-armen og anastrozol-armen.
English: There was up to about 2.5-fold increase in AUC in women with hepatic impairment compared to healthy subjects.
Danish: Hos kvinder med nedsat leverfunktion sås en stigning i AUC på op til 2,5 gange sammenlignet med raske forsøgspersoner.
English: Includes adverse drug reactions for which the exact contribution of Faslodex cannot be assessed due to the underlying disease.
Danish: Omfatter bivirkninger, hvor det nøjagtige omfang af Faslodexs bidrag ikke kan bedømmes på grund af den tilgrundliggende sygdom.
English: What Faslodex contains - The active substance is fulvestrant.
Danish: Faslodex indeholder: - Aktivt stof: fulvestrant.
English: You must not breast-feed while on treatment with Faslodex.
Danish: Du må ikke amme, mens du behandles med Faslodex.
English: Two syringes must be administered to receive the 500 mg recommended monthly dose.
Danish: Der skal administreres to injektionssprøjter for at give den anbefalede 500 mg månedlig dosis.
English: In patients receiving fulvestrant in combination with palbociclib in the PALOMA3 study, neutropenia of any grade was reported in 287 (83.2%) patients, with Grade 3 neutropenia being reported in 191 (55.4%) patients, and Grade 4 neutropenia being reported in 37 (10.7%) patients.
Danish: Hos patienter, der fik fulvestrant i kombination med palbociclib i PALOMA3-studiet, blev der rapporteret neutropeni af enhver grad hos 287 patienter (83,2 %), hvor der blev rapporteret grad 3neutropeni hos 191 patienter (55,4 %), og neutropeni i grad 4 blev rapporteret hos 37 patienter (10,7 %).
English: Updated Analysis (23 October 2015 cut-off) Faslodex plus palbociclib (N=347)
Danish: Opdateret analyse (skæringsdato 23. oktober 2015) Faslodex plus palbociclib (N=347)
English: The recommended dose is 500 mg fulvestrant (two 250 mg/5 ml injections) given once a month, with an additional 500 mg dose given 2 weeks after the initial dose.
Danish: Den anbefalede dosis er 500 mg fulvestrant (to 250 mg/5 ml-injektioner), der gives en gang om måneden, samt en ekstra 500 mg dosis givet 2 uger efter den første dosis.
English: After temperature excursions, the product should be returned immediately to the recommended storage conditions (store and transport in a refrigerator 2°C - 8°C).
Danish: Efter temperaturudsving skal produktet straks igen opbevares ved de anbefalede opbevaringsforhold (opbevares i køleskab og transporteres nedkølet ved 2 °C - 8 °C).
English: Table 6 Efficacy results in visceral and non-visceral disease from PALOMA3 study (intentto-treat population)
Danish: Effektresultater i visceral og ikke-visceral sygdom fra PALOMA-3-studiet (intent-to-treat-population)
English: For user convenience, the needle bevel-up position is oriented to the lever arm (see Figure 4).
Danish: For brugervenlighed vendes kanylens skråspids opad mod vippearmen (se figur 4).
English: • Transport filled syringe to point of administration.
Danish: • Flyt den fyldte injektionssprøjte til administrationsstedet.
English: A total of 335 patients in the Faslodex plus palbociclib arm and 166 patients in the Faslodex plus placebo arm completed the questionnaire at baseline and at least 1 post-baseline visit.
Danish: 166 patienter i Faslodex plus placebo-armen udfyldte spørgeskemaet ved baseline og ved mindst et besøg efterfølgende.
English: -AE subgroup (n=423)
Danish: -AE-undergruppe (n=423)
English: Faslodex has 2 pack presentations, either a pack containing 1 glass pre-filled syringe or a pack containing 2 glass pre-filled syringes.
Danish: Faslodex leveres i 2 forskellige pakninger, enten en pakning indeholdende 1 fyldt glasinjektionssprøjte eller en pakning med 2 fyldte glas-injektionssprøjter.
English: • Weakness, tiredness*
Danish: • Svaghedsfølelse, træthed*
English: The geometric mean (standard deviation) steady state trough concentration (Cmin,ss) and AUCss was 4.2 (0.9) ng/mL and 3680 (1020) ng*hr/mL, respectively.
Danish: Den geometriske, gennemsnitlige steady-state-(ss)dalkoncentration af fulvestrant (Cmin,ss) og AUCss var henholdsvis 4,2 (0,9) ng/ml og 3.680 (1.020) ng t/ml (standardafvigelse).
English: In the fulvestrant + placebo arm (n=172), neutropenia of any grade was reported in 7 (4.1%) patients, with Grade 3 neutropenia reported in 1 (0.6%) patient.
Danish: I fulvestrant + placebo-armen (n = 172) blev neutropeni af enhver grad rapporteret hos 7 patienter (4,1 %), og grad 3-neutropeni blev rapporteret hos 1 patient (0,6 %).