FrancophonIA/ELRC3.0 huggingface dataset:
English: Rydapt should not be used in children and adolescents because it is not known whether it is safe and effective in this age group.
Slovenian: Pri otrocih in mladostnikih se zdravila Rydapt ne sme uporabljati, ker ni znano, ali je uporaba zdravila v tej starostni skupini varna in učinkovita.
English: Finally, the long-term data from patients were analysed using a population pharmacokinetic approach.
Slovenian: Nazadnje so dolgoročne podatke pri bolnikih analizirali z metodami populacijske farmakokinetike.
English: The dimensions of the capsule are approximately 25.4 x 9.2 mm.
Slovenian: Kapsula je velika približno 25,4 x 9,2 mm.
English: The median time to response was 0.3 months (range: 0.1 to 3.7 months).
Slovenian: Mediani čas do odziva je bil 0,3 meseca (od 0,1 do 3,7 meseca).
English: Patients with symptomatic congestive heart failure were excluded from clinical studies.
Slovenian: Bolniki s simptomatskim kongestivnim popuščanjem srca so bili izključeni iz kliničnih študij.
English: Hypokalaemia*
Slovenian: hipokaliemija*
English: One blister contains 4 soft capsules.
Slovenian: En pretisni omot vsebuje 4 mehke kapsule.
English: Of the 116 patients enrolled, 89 were considered eligible for response assessment and constituted the primary efficacy population.
Slovenian: Od 116 vključenih bolnikov jih je bilo 89 ocenjenih kot primernih za presojo odziva in ti bolniki so predstavljali populacijo za primarno oceno učinkovitosti.
English: Your doctor will discuss with you the most suitable method of contraception for you to use.
Slovenian: Z zdravnikom se pogovorite, katera metoda kontracepcija bi bila za vas najbolj primerna.
English: Do not take Rydapt: - if you are allergic to midostaurin or to any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Rydapt: - če ste alergični na midostavrin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The capsules should be swallowed whole with a glass of water.
Slovenian: Kapsule je treba zaužiti cele skupaj s kozarcem vode.
English: Response to Rydapt was determined using a computational algorithm applied without any adjudication.
Slovenian: Odziv na zdravilo Rydapt je bil določen s pomočjo komputacijskega algoritma, ki je bil uporabljen brez presoje vrednosti.
English: The KIT D816V mutation was detected in 82% of patients.
Slovenian: Mutacijo KIT D816V so odkrili pri 82 % bolnikov.
English: Median overall survival was 40.0 months (patients were only followed up for one year after treatment discontinuation for survival).
Slovenian: Mediano celokupno preživetje je bilo 40,0 meseca (preživetje bolnikov so spremljali samo eno leto po zaključku zdravljenja).
English: Pregnant women should be advised of the potential risk to the foetus.
Slovenian: Nosečnice je treba opozoriti na možno tveganje za plod.
English: Environmental risk assessment studies have shown that midostaurin has the potential to be persistent, bioaccumulative and toxic to the environment.
Slovenian: Študije za oceno tveganja za okolje kažejo, da je midostavrin potencialno lahko obstojen, bioakumulativen in toksičen za okolje.
English: For trial sites in North America, all grades were collected for 13 pre-specified adverse events.
Slovenian: V študijskih centrih po Severni Ameriki so zbirali podatke o vseh stopnjah za 13 vnaprej opredeljenih neželenih učinkov.
English: Rydapt may harm your unborn baby and is not recommended during pregnancy.
Slovenian: Zdravilo Rydapt lahko škoduje nerojenemu otroku in ni priporočeno v času nosečnosti.
English: The primary endpoint was overall response rate (ORR).
Slovenian: Primarni cilj opazovanja je bila celokupna stopnja odziva (ORR - overall response rate).
English: Response rates were assessed based on the modified Valent and Cheson criteria and responses were adjudicated by a study steering committee.
Slovenian: Stopnjo odziva so ocenjevali na osnovi modificiranih kriterijev po Valentu in Chesonu, odzive pa so obravnavali člani nadzornega odbora študije.
English: It belongs to a class of medicines called protein kinase inhibitors.
Slovenian: Sodi v skupino zdravil, ki jih imenujemo zaviralci protein kinaz.
English: Out of 116 patients, 113 had a C-finding as defined by IWG response criteria (excluding ascites as a C-finding).
Slovenian: Izmed 116 bolnikov jih je 113 imelo izvid C po opredelitvi s kriteriji odziva IWG (pri čemer ascites ni štel med izvide C).
English: Criteria
Slovenian: Kriterij
English: Although the study was designed to be assessed with the modified Valent and Cheson criteria, as a post-hoc exploratory analysis, efficacy was also assessed per the 2013 International Working Group - Myeloproliferative Neoplasms Research and Treatment - European Competence Network on Mastocytosis (IWG-MRT-ECNM) consensus criteria.
Slovenian: Čeprav je bila študija oblikovana za ocenjevanje po modificiranih kriterijih po Valentu in Chesonu, kot naknadna eksploratorna analiza, je bila učinkovitost ovrednotena tudi po dogovorejnih kriterijih mednarodne delovne skupine 2013 International Working Group - Myeloproliferative Neoplasms Research and Treatment - European Competence Network on Mastocytosis (IWG-MRT-ECNM).
English: Overall survival n/N (%)
Slovenian: celokupno preživetje n/N (%)
English: What you need to know before you take Rydapt
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Rydapt
English: All animal findings described below were observed at midostaurin exposure significantly lower than therapeutic levels.
Slovenian: Vse spodaj navedene ugotovitve pri živalih so opažali pri izpostavljenosti midostavrinu, ki je bila precej manjša od terapevtskih ravni.
English: Grade 3/4 nausea and/or vomiting despite optimal anti-emetic therapy
Slovenian: navzea in/ali bruhanje 3. oziroma 4. stopnje kljub optimalnemu antiemetičnemu zdravljenju
English: There are no data on the effect of Rydapt on human fertility.
Slovenian: O vplivu zdravila Rydapt na plodnost pri človeku ni na voljo nobenih podatkov.
English: - Take Rydapt with food.
Slovenian: - Zdravilo Rydapt jemljite skupaj s hrano.
English: White blood cell counts (WBCs) should be monitored regularly, especially at treatment initiation.
Slovenian: Belo krvno sliko je treba redno spremljati, zlasti na začetku zdravljenja.
English: The median duration of exposure to Rydapt was 11.4 months (range: 0 to 81 months).
Slovenian: Mediano trajanje izpostavljenosti zdravilu Rydapt je bilo 11,4 meseca (od 0 do 81 mesecev).
English: There is no known specific antidote for midostaurin.
Slovenian: Za midostavrin ni znan noben specifičen antidot.
English: The safety and efficacy of Rydapt in children and adolescents below 18 years have not been established (see section 5.1).
Slovenian: Varnost in učinkovitost zdravila Rydapt pri otrocih in mladostnikih, ki so stari manj kot 18 let, nista bili dokazani (glejte poglavje 5.1).
English: Rydapt has minor influence on the ability to drive and use machines.
Slovenian: Rydapt ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Safety pharmacology and single/repeat dose toxicity
Slovenian: Farmakološka varnost in toksičnost pri posameznih/ponavljajočih odmerkih
English: If you use a hormonal contraceptive, you must also use a barrier method, such as a condom or a diaphragm.
Slovenian: Če uporabljate hormonsko kontracepcijo, morate poleg tega uporabljati še katero od pregradnih kontracepcijskih metod, kot sta kondom ali diafragma.
English: Treatment with Rydapt should be initiated by a physician experienced in the use of anti-cancer therapies.
Slovenian: Zdravljenje z zdravilom Rydapt mora uvesti zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
English: Activity was observed regardless of number of prior therapies, and presence or absence of an AHN.
Slovenian: Aktivnost bolezni so opazovali ne glede na število predhodnih terapij in prisotnost oziroma odsotnost pridružene hematološke neoplazme.
English: Overall survival probability, %
Slovenian: verjetnost celokupnega preživetja, %
English: Probability of Survival (%)
Slovenian: verjetnost preživetja (%)
English: Renal elimination is a minor route of elimination for midostaurin.
Slovenian: Izločanje skozi ledvice je manj pomembna pot izločanja midostavrina.
English: Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first, using the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Slovenian: V okviru posameznega organskega sistema so neželeni učinki navedeni po pogostnosti, pri čemer so najpogostejši navedeni najprej, v skladu z naslednjim dogovorom (CIOMS III): zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Rydapt should be taken orally twice daily at approximately 12-hour intervals.
Slovenian: Zdravilo Rydapt je treba jemati peroralno dvakrat na dan s približno 12-urnim presledkom.
English: AUCtau was decreased by 28% and 20% on day 7, respectively.
Slovenian: AUCtau je bila na 7. dan manjša za 28 % oziroma za 20 %.
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Slovenian: V vsaki kategoriji pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: Available animal data have shown that midostaurin and its active metabolites pass into the milk of lactating rats.
Slovenian: Razpoložljivi podatki iz raziskav na živalih kažejo, da midostavrin in njegovi aktivni metaboliti prehajajo v mleko doječih podgan.
English: ADRs that led to treatment discontinuation occurred in 9.2% of patients.
Slovenian: Neželeni učinki, zaradi katerih je bilo treba prekiniti zdravljenje, so se pojavili pri 9,2 % bolnikov.
English: The key secondary endpoint was event-free survival (EFS; an EFS event is defined as a failure to obtain a complete remission (CR) within 60 days of initiation of protocol therapy, or relapse, or death from any cause).
Slovenian: Ključni sekundarni cilj opazovanja je bilo preživetje brez dogodkov (EFS - event-free survival) pri čemer je bil dogodek opredeljen kot neuspeh pri doseganju popolne remisije v 60 dneh od začetka zdravljenja po protokolu ali recidiv ali smrt iz kateregakoli vzroka).
English: The median duration of follow-up was 43 months.
Slovenian: Mediano trajanje spremljanja bolnikov je bilo 43 mesecev.
English: Of the patients with race information reported, 88.1% were Caucasian.
Slovenian: Med bolniki z znanimi podatki o rasni pripadnosti je bilo 88,1 % belcev.
English: What Rydapt is and what it is used for
Slovenian: Kaj je zdravilo Rydapt in za kaj ga uporabljamo
English: The median age in the primary efficacy population was 64 years with approximately half of the patients ≥65 years.
Slovenian: Mediana starost v populaciji za primarno oceno učinkovitosti je bila 64 let, pri čemer je bila približno polovica bolnikov stara najmanj 65 let.
English: Rydapt may be held for as many cycles as necessary until QTc improves.
Slovenian: Odmerjanje zdravila Rydapt je mogoče odložiti za toliko ciklusov, kot je potrebno, dokler se interval QTc ne izboljša.
English: Depending on how you respond to Rydapt, your doctor may lower your dose or temporarily interrupt the treatment.
Slovenian: Glede na to, kako se boste odzvali na zdravljenje z zdravilom Rydapt, vam bo zdravnik morda znižal odmerek ali začasno prekinil zdravljenje.
English: If you take more capsules than you should, or if someone else takes your medicine, talk to a doctor or go to a hospital straight away, taking the pack with you, as medical treatment may be necessary.
Slovenian: Če ste vzeli večji odmerek zdravila Rydapt, kot bi smeli Če vzamete več kapsul, kot bi jih smeli, ali če kdo drug zaužije vaše zdravilo, se posvetujte z zdravnikom ali se takoj odpravite v bolnišnico in s seboj vzemite škatlo z zdravilom, saj boste morda potrebovali zdravniško pomoč.
English: - Swallow the capsules whole with a glass of water.
Slovenian: - Kapsule pogoltnite cele in jih vzemite s kozarcem vode.
English: In vitro evaluation of drug-drug interaction potential
Slovenian: In vitro vrednotenje možnosti za medsebojno delovanje med zdravili
English: Effect of Rydapt on other medicinal products
Slovenian: Vpliv zdravila Rydapt na druga zdravila
English: Most of the side effects are mild to moderate and will generally disappear after a few weeks of treatment.
Slovenian: Večina neželenih učinkov je blagih do zmernih in praviloma izzvenijo po nekaj tednih zdravljenja.
English: Median Survival (months)
Slovenian: osebe dogodki mediana preživetja (meseci)
English: The protocol includes a comprehensive collection of baseline data (including biomarkers), post-study treatments, and evaluation of minimal residual disease (MRD).
Slovenian: Protokol študije vključuje obsežno zbiranje izhodiščnih podatkov (vključno z biomarkerji), zdravljenje po končanju študije in vrednotenje minimalnega preostanka bolezni (MRD - minimal residual disease).
English: In a subgroup analysis, no apparent OS benefit was observed in females, however, a treatment benefit was observed in females in all secondary efficacy endpoints (see Table 6).
Slovenian: Pri analizi podskupin pri ženskah ni bilo opaziti očitne prednosti glede celokupnega preživetja, so pa pri ženskah opažali koristi zdravljenja pri vseh sekundarnih ciljih opazovanja za oceno učinkovitosti (glejte preglednico 6).
English: 36.8 (5.5, NE)
Slovenian: 36,8 (5,5, NO)
English: Midostaurin is a compound with good absorption and poor solubility.
Slovenian: Midostavrin je učinkovina z dobro absorpcijo in slabo topnostjo.
English: Medicinal products or substances known to affect the activity of CYP3A4 may affect the plasma concentrations of midostaurin and therefore the safety and/or efficacy of Rydapt.
Slovenian: Zdravila oziroma snovi z znanim delovanjem na aktivnost encimov CYP3A4 lahko vplivajo na koncentracijo midostavrina v plazmi, s tem pa tudi na varnost in/ali učinkovitost zdravila Rydapt.
English: The primary endpoint was ORR evaluated by the Valent criteria during the first two cycles of treatment.
Slovenian: Primarni cilj opazovanja je bila celokupna stopnja odziva, ocenjena na osnovi kriterijev po Valentu v času prvih dveh ciklusov zdravljenja.
English: This is because Rydapt can affect the way some medicines work.
Slovenian: To je pomembno zato, ker zdravilo Rydapt lahko vpliva na delovanje nekaterih drugih zdravil, pa tudi nekatera druga zdravila lahko vplivajo na delovanje zdravila Rydapt.
English: Symptoms are caused when too many mast cells enter organs such as the liver, bone marrow or spleen, and release substances such as histamine into the blood.
Slovenian: Simptomi bolezni se pojavijo takrat, ko v organe, kot so jetra, kostni mozeg ali vranica, prispe preveč mastocitov in ti v kri sproščajo snovi, kot je histamin.
English: Do not open, crush or chew them to ensure proper dosing and avoid the unpleasant taste of the capsule content.
Slovenian: Kapsul ne odpirajte, ne drobite in ne žvečite, s čimer zagotovite vnos ustreznega odmerka in se izognete neprijetnemu okusu vsebine kapsule.
English: Neutropenia and infections
Slovenian: Nevtropenija in okužbe
English: Your doctor will ask you to take a pregnancy test before you start treatment with Rydapt to make sure you are not pregnant.
Slovenian: Zdravnik vam bo naročil, da pred začetkom zdravljenja z zdravilom Rydapt opravite nosečnostni test in se prepričate, da niste noseči.
English: The primary endpoint of the study was overall survival (OS), measured from the date of randomisation until death by any cause.
Slovenian: Primarni cilj opazovanja v študiji je bilo celokupno preživetje, merjeno kot čas od dneva randomizacije do smrti iz kateregakoli vzroka.
English: How long to take Rydapt - Continue taking Rydapt for as long as your doctor tells you.
Slovenian: Koliko časa je treba jemati zdravilo Rydapt - Zdravilo Rydapt jemljite tako dolgo, kot vam naroči zdravnik.
English: Rydapt could harm your baby.
Slovenian: Zdravilo Rydapt lahko škoduje otroku.
English: Patients should be monitored for signs and symptoms of infection, including any device-related infections, and if a diagnosis of infection is made appropriate treatment must be instituted promptly, including, as needed, the discontinuation of Rydapt.
Slovenian: Bolnike je treba opazovati glede pojavljanja znakov in simptomov okužbe, kar vključuje tudi katerokoli okužbo zaradi medicinskega pripomočka, in v primeru ugotovitve prisotnosti okužbe takoj začeti z ustreznim zdravljenjem, vključno z ukinitvijo zdravila Rydapt, če je to potrebno.
English: No dose adjustment is required in patients aged over 65 years (see section 5.2).
Slovenian: Pri bolnikih, ki so stari več kot 65 let, ni potrebno prilagajati odmerjanja (glejte poglavje 5.2).
English: Each soft capsule contains approximately 83 mg ethanol anhydrous and 415 mg macrogolglycerol hydroxystearate.
Slovenian: Ena mehka kapsula vsebuje približno 83 mg brezvodnega etanola in 415 mg makrogolglicerol hidroksistearata.
English: Acute myeloid leukaemia is a form of cancer of certain white blood cells (called myeloid cells) in which the body over-produces an abnormal type of these cells.
Slovenian: Akutna mieloična levkemija je oblika raka določenih belih krvnih celic (ki jih imenujemo mieloične celice), pri kateri v telesu nastaja preveč nenormalnih celic te vrste.
English: You should discuss this with your doctor before starting treatment.
Slovenian: Pred začetkom zdravljenja se morate o tem pogovoriti z zdravnikom.
English: Excipients with known effect
Slovenian: Pomožni snovi z znanim učinkom
English: any time during induction (%)
Slovenian: kadarkoli v času indukcijskega zdravljenja (%)
English: Dose modifications (interruption or adjustment) due to ADRs occurred in 31% of patients.
Slovenian: Do prilagajanja odmerjanja (prekinitve ali spremembe odmerjanja) zaradi neželenih učinkov je prišlo pri 31 % bolnikov.
English: Your doctor will tell you exactly how many capsules to take.
Slovenian: Koliko zdravila Rydapt je treba jemati Zdravnik vam bo natančno povedal, koliko kapsul morate jemati.
English: Caution is warranted in patients at risk of QTc prolongation (e.g. due to concomitant medicinal products and/or electrolyte disturbances).
Slovenian: Previdnost je potrebna pri bolnikih s povečanim tveganjem za podaljšanje intervala QTc (na primer zaradi sočasno uporabljanih zdravil in/ali neravnovesja elektrolitov).
English: Strong CYP3A4 inhibitors may increase midostaurin blood concentrations.
Slovenian: Močni zaviralci CYP3A4 lahko zvišajo koncentracijo midostavrina v krvi.
English: QTc interval >500 msecs
Slovenian: dolžina intervala QTc >500 milisekund
English: In patients who develop unexplained severe neutropenia, treatment with Rydapt should be interrupted until ANC is ≥1.0 x 10
Slovenian: Pri bolnikih, pri katerih pride do nepojasnjene hude nevtropenije, je treba zdravljenje z zdravilom Rydapt prekiniti, dokler AŠN ne doseže ≥1,0 x 10
English: Do not stop taking your medicine unless your doctor tells you to do so.
Slovenian: Ne prenehajte jemati zdravila, če vam tega ni naročil zdravnik.
English: If you become pregnant or think you are pregnant, tell your doctor right away.
Slovenian: Če zanosite ali posumite, da ste zanosili, takoj obvestite zdravnika.
English: Stopping your treatment with Rydapt may cause your condition to become worse.
Slovenian: Če prekinete zdravljenje z zdravilom Rydapt, se vaša bolezen lahko poslabša.
English: In vitro data showed midostaurin is more than 98% bound to plasma proteins, such as albumin, α1-acid glycoprotein (AGP) and lipoprotein.
Slovenian: Po podatkih in vitro se midostavrin v več kot 98 % veže na plazemske beljakovine, kot so albumini, α1-kisli glikoprotein (AGP) in lipoproteini.
English: In addition, in patients who achieved complete remission during induction, the cumulative incidence of relapse at 12 months was 26% in the midostaurin arm versus 41% in the placebo arm.
Slovenian: Poleg tega je bila med bolniki, ki so v času indukcijskega zdravljenja dosegli popolno remisijo, kumulativna pogostnost recidiva po 12. mesecih 26 % v skupini z midostavrinom v primerjavi z 41 % v skupini s placebom.
English: In the event of an overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic and supportive treatment initiated.
Slovenian: V primeru prevelikega odmerjanja je treba bolnike skrbno spremljati in biti pozoren na znake oziroma simptome neželenih učinkov ter uvesti ustrezne ukrepe simptomatskega in podpornega zdravljenja.
English: Investigations Hyperglycaemia (non-fasting)*
Slovenian: Preiskave hiperglikemija (ne na tešče)*
English: Frequency category
Slovenian: kategorija pogostnosti katerekoli stopnje
English: Race/ethnicity
Slovenian: Rasna in etnična pripadnost
English: If you forget to take Rydapt
Slovenian: Če ste pozabili vzeti zdravilo Rydapt
English: Persistent Grade 1/2 toxicity Persistent Grade 1 or 2 toxicity that patients deem unacceptable may prompt an interruption for as many as 28 days.
Slovenian: Vztrajni toksični učinki 1. ali 2. stopnje, ki so za bolnika nesprejemljivi, so lahko razlog za prekinitev odmerjanja, ki traja tudi do 28 dni.
English: The mean AUClast of CGP52421 decreased by 60%.
Slovenian: Povprečna AUClast metabolita CGP52421 se je zmanjšala za 60 %.
English: HR (95% CI) - SCT HR (95% CI) - no SCT
Slovenian: HR (95% IZ) - PKMC HR (95%IZ) - brez PKMC
English: Due to the limited pharmacokinetic data in paediatric patients, no comparison with midostaurin pharmacokinetics in adults can be made.
Slovenian: Ker je farmakokinetičnih podatkov pri pediatričnih bolnikih malo, jih ni mogoče primerjati s farmakokinetičnimi podatki midostavrina pri odraslih.
English: Patients were stratified by FLT3 mutation status: TKD, ITD with allelic ratio <0.7, and ITD with allelic ratio ≥0.7.
Slovenian: Bolnike so stratificirali glede na status mutacije FLT3: TKD, ITD z razmerjem med aleli <0,7 in ITD z razmerjem med aleli ≥0,7.
English: Based on population pharmacokinetic model analyses of the effect of gender on clearance of midostaurin and its active metabolites, there was no statistically significant finding and the anticipated changes in exposure (<20%) were not deemed to be clinically relevant.
Slovenian: V analizah modela populacijske farmakokinetike glede vpliva spola na očistek midostavrina in njegovih aktivnih metabolitov niso prišli do statistično značilnih rezultatov in ocenjujejo, da predvidene razlike v izpostavljenosti (<20 %) niso klinično pomembne.
English: You should also tell your doctor if you are already taking Rydapt and you are prescribed a new medicine that you have not previously taken during treatment with Rydapt.
Slovenian: Zdravnika morate obvestiti tudi v primeru, da jemljete zdravilo Rydapt in vam dodatno predpišejo novo zdravilo, ki ga še niste jemali sočasno z zdravilom Rydapt.
English: In a toxicity study in juvenile rats, midostaurin was administered from days 7 to 70 postpartum.
Slovenian: V študiji toksičnosti so mladičem podgan dajali midostavrin od 7. do 70. dne po rojstvu.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE39
Slovenian: Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe, zaviralci protein-kinaze, oznaka ATC: L01XE39
English: Midostaurin has a tissue distribution of geometric mean of 95.2 l (Vz/F).
Slovenian: Midostavrin se porazdeli po tkivih z geometričnim povprečjem navideznega volumna porazdelitve 95,2 l (Vz/F).
English: The most frequent serious ADR in both arms was febrile neutropenia (16%).
Slovenian: Najbolj pogost resen neželeni učinek je bila v obeh skupinah febrilna nevtropenija (16 %).
English: The most frequent (incidence ≥1%) were febrile neutropenia, nausea, vomiting and pleural effusion.
Slovenian: Najbolj pogosti (s pogostnostjo ≥1 %) so bili febrilna nevtropenija, navzea, bruhanje in plevralni izliv.