natgillin/translations-raw huggingface dataset:
The incentives offered by the SME Regulation apply to the human and veterinary sectors, and include: 
Spodbude, ki jih ureja uredba o MSP, so namenjene sektorjema proizvodnje zdravil za uporabo v humani medicini in veterinarski medicini.
To maintain its SME status, the company should submit a completed declaration annually, based on its latest approved accounts. 
Prosilec bo prejel številko EMA-MSP, ko bo status MSP odobren.Podjetje mora na podlagi zadnjih revidiranih računovodskih izkazov vsako leto znova predložiti izpolnjeno izjavo, da obdrži status MSP.
Horizon 2020 
marec 2017
Administrative services6 
Upravne storitve
Application for marketing authorisation 
Vloga za izdajo dovoljenja za promet z zdravilom
Inspection (post-authorisation) 
Inšpekcijski pregled (po izdaji dovoljenja za promet z zdravilom)
4In the event of a negative outcome, where EMA scientific advice has been sought and followed 5Maximum Residue Limits 
V primeru negativnega izida, če podjetje zaprosi za znanstveno mnenje agencije in ga upošteva.
Fee exemption for micro-sized enterprises 
Izjeme glede pristojbin za mikro podjetja 40-odstotno znižanje pristojbine za mala in srednje velika podjetja
1According to Commission Regulation (EC) No 2049/2005 2See European Commission/Growth/Publications 3See SME Office area at www.ema.europa.eu 
V skladu z Uredbo Komisije (ES) št. 2049/2005.
90% fee reduction for non-orphan products 
Spodbuda v zvezi s pristojbinami 100-odstotno znižanje pristojbine za zdravila sirote
Activity/application Fee incentives 
Spodbuda v zvezi s pristojbinami
8See fees area at www.ema.europa.eu 
Glejte razdelek urada za MSP na spletišču ema.europa.eu.
The applicant will receive an EMA-SME number once the SME status has been assigned. 
Kako zaprositi za status MSP?
Take only one tablet per day. 
Vzemite samo eno tableto na dan.
See also section 2, “Warnings and precautions”. 
Glejte tudi poglavje 2, »Opozorila in previdnostni ukrepi«.
Study 101 
Študija 101
Thereafter, monitoring should be performed periodically. 
Nato je treba redno izvajati spremljanje.
See also the beginning of section 4. 
Glejte tudi začetek poglavja 4.
CI‡ 
IZ‡
• sensitivity to sunlight 
• občutljivost na sončno svetlobo
Version 4.0 (NCI CTCAE v4). 
Različica 4.0 (NCI CTCAE v4).
12-month survival probability (%) 
Verjetnost preživetja 12 mesecev (%)
The recommended dose is 
Priporočen odmerek je
Treatment should continue as long as clinical benefit is observed. 
Zdravljenje se mora nadaljevati, dokler je opazna klinična korist.
Your doctor may adjust your dose according to your needs and this may require use of a 30 mg tablet to achieve the new recommended dose. 
Vaš zdravnik lahko prilagodi vaš odmerek glede na vaše potrebe in to lahko zahteva uporabo 30 mg tablete za doseganje novega priporočenega odmerka.
Take your next dose at your regular time. 
Naslednji odmerek vzemite obrednem času.
There are no available data on patients over 85 years of age. 
Podatki za bolnike, starejše od 85 let, niso na voljo.
Available data cannot exclude potential excretion in human milk. 
Razpoložljivi podatki ne morejo izključiti morebitnega izločanja v materino mleko.
95% CI 
95% IZ
Dosing interruption and/or dose reduction may be required based on individual safety and tolerability. 
Prekinitev in/ali zmanjšanje odmerka bosta morda potrebna na podlagi individualne ocene varnosti in prenašanja.
The median duration of follow-up was 22.9 months. 
Povprečno trajanje sledenja zdravljenja je bilo 22,9 meseca.
Frequency categories are very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100). 
Kategorije pogostnosti so zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10) in občasni (≥1/1.000 do <1/100).
• Take Alunbrig once daily at the same time each day. 
• Vzemite zdravilo Alunbrig enkrat na dan, vsak dan ob istem času.
Symptoms may be similar to symptoms from lung cancer. 
Znaki so lahko podobni znakom pljučnega raka.
IRC assessment 
Ocena IRC
Transporter substrates 
Transportni substrati
It is unknown if brigatinib passes into breast milk and could potentially harm the baby. 
Ni znano, če brigatinib prehaja v materino mleko in bi lahko potencialno škodoval otroku.
Investigator assessment 
Ocena preiskovalca
The blood-to-plasma concentration ratio is 0.69. 
Razmerje koncentracije v plazmi in krvi je 0,69.
Time to response 
Čas za odziv
Age, body weight, and albumin concentrations 
Starost, telesna masa in koncentracije albumina
A patient alert card 
Opozorilna kartica za bolnika
Tell your doctor or pharmacist right away if you have taken more tablets than recommended. 
Takoj obvestite svojega zdravnika ali farmacevta, če ste vzeli več tablet kot je priporočeno.
Additionally, patients with central nervous system (CNS) metastases were included, provided they were neurologically stable and did not require an increasing dose of corticosteroids. 
Poleg tega so bili vključeni bolniki z metastazami centralnega živčnega sistema (CNS), če so bili nevrološko stabilni in niso potrebovali povečanega odmerka kortikosteroidov.
The tablets should be swallowed whole and with water. 
Tablete je treba pogoltniti cele in z vodo.
Hypertension should be treated according to standard guidelines to control blood pressure. 
Hipertenzijo je treba zdraviti v skladu s standardnimi smernicami za nadzor krvnega tlaka.
See the package leaflet for further information. 
Glejte priložena navodila za več informacij.
• increased blood clotting time shown by test of activated partial thromboplastin time 
• podaljšan čas strjevanja krvi opažen pri preiskavah aktiviranega delnega tromboplastinskega časa
• Swallow the tablets whole, with a glass of water. 
• Tablete pogoltnite cele s kozarcem vode.
Alunbrig blocks the action of this protein and thus slows down the growth and spread of the cancer. 
Alunbrig blokira delovanje tega proteina in tako upočasni rast in širjenje raka.
The following medicines can affect or be affected by Alunbrig: 
Naslednja zdravila lahko vplivajo na ali nanje vpliva zdravilo Alunbrig:
• The tablets can be taken with or without food. 
• Tablete lahko jemljete s hrano ali brez nje.
Within each frequency grouping, undesirable effects are presented in order of frequency. 
V vsaki skupini pogostnosti so neželeni učinki razvrščeni glede na pogostnost pojavljanja.
• difficulty sleeping (insomnia) 
• težave s spancem (nespečnost)
Table 4: Efficacy results in ALTA (ITT population) Efficacy parameter 
Preglednica 4: Rezultati učinkovitosti v ALTA (populacija ITT) Parameter učinkovitosti
The major outcome measure was confirmed objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1) as evaluated by investigator. 
Glavni dejavnik izida je bila potrjena objektivna stopnja odziva (ORR-objective response rate) v skladu s kriteriji ocenjevanja odziva pri solidnih tumorjih (RECIST v1.1), kot jih je ocenil raziskovalec.
Testicular toxicity was observed in repeat-dose animal studies. 
Toksičnost je bila opažena pri študijah ponavljajočih se odmerkov na živalih.
(3.7, NE) 
(3,7; NO)
Avoid any grapefruit products during treatment as they may change the amount of brigatinib in your body. 
Med zdravljenjem se izogibajte izdelkom iz grenivk, ker lahko spremenijo količino brigatiniba v telesu.
Modest accumulation was observed upon repeated dosing (geometric mean accumulation ratio: 1.9 to 2.4). 
Manjše kopičenje je bilo opaženo pri ponavljajočem odmerjanju (geometrično povprečno razmerje kopičenja: 1,9 do 2,4).
The clinical relevance of these findings to human fertility is unknown. 
Klinični pomen teh ugotovitev na plodnost pri ljudeh ni znan.
Grade 3 hyperglycemia occurred in 7.3% of patients. 
Hiperglikemija stopnja 3 se je pojavila pri 7,3% bolnikov.
90 mg once daily (first 7 days) 
90 mg enkrat na dan (prvih 7 dni)
Most pulmonary adverse reactions were observed within the first 7 days of treatment. 
Večina neželenih učinkov na pljuča je bila opažena v prvih 7 dneh zdravljenja.
Brigatinib was moderately bound (91%) to human plasma proteins and binding was not concentration-dependent. 
Brigatinib je bil zmerno vezan (91%) na proteine humane plazme in vezava ni odvisna od koncentracije.
Carcinogenicity studies have not been performed with brigatinib. 
Študije kancerogenosti z brigatinibom niso bile izvedene.
Women of childbearing potential/Contraception in males and females 
Ženske v rodni dobi/Kontracepcija za moške in ženske
Antihyperglycaemic treatment should be initiated or optimised as needed. 
Po potrebi je treba začeti ali optimizirati antihiperglikemično zdravljenje.
Randomisation was stratified by brain metastases (present, absent) and best prior response to crizotinib therapy (complete or partial response, any other response/unknown). 
Randomizacija je bila stratificirana z metastazami v možganih (prisotno, odsotno) in najboljšim predhodnim odzivom na terapijo s krizotinibom (popolni ali delni odziv, kateri koli drugi odziv/neznano).
Heart rate and blood pressure should be monitored regularly. 
Redno je treba spremljati srčni utrip in krvni tlak.
Liver function, including AST, ALT and total bilirubin should be assessed prior to the initiation of Alunbrig and then every 2 weeks during the first 3 months of treatment. 
Delovanje jeter, vključno z AST, ALT in celotnim bilirubinom, je treba oceniti pred začetkom zdravljenja z zdravilom Alunbrig in nato vsaka 2 tedna v prvih 3 mesecih zdravljenja.
Additional outcome measures included confirmed ORR as evaluated by an Independent Review Committee (IRC); time to response; progression free survival (PFS); duration of response (DOR); overall survival; and intracranial ORR and intracranial DOR as evaluated by an IRC. 
Dodatni ukrepi so vključevali potrjen ORR, ki ga je ocenil neodvisni revizijski odbor (IRC- Independent Review Committee); čas za odziv; preživetje brez napredovanja bolezni (PFSprogression free survival); trajanje odziva (DOR- duration of response); celokupno preživetje; in intrakranialni ORR in intrakranialni DOR, kot jih oceni IRC.
• inflammation of pancreas which may cause severe and persistent stomach pain, with or without nausea and vomiting (pancreatitis) 
• vnetje trebušne slinavke, ki lahko povzroči hude in trajne bolečine v želodcu, z ali brez siljenja na bruhanje bruhanja (pankreatitis)
Objective response rate 
Objektivna stopnja odziva
Bradycardia with life-threatening consequences, urgent intervention indicated 
Bradikardija z življenjsko ogrožajočimi posledicami, potrebno je bilo nujno posredovanje
If you are pregnant or think you may be pregnant or are planning to have a baby, talk to your doctor to discuss the risks of taking Alunbrig during pregnancy. 
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, da se pogovorite o tveganjih povezanih z jemanjem zdravila Alunbrig med nosečnostjo.
Eligibility criteria permitted enrolment of patients with a documented ALK rearrangement based on a validated test, ECOG Performance Status of 0-2, and prior chemotherapy. 
Vključitveni kriteriji so dopuščali vključevanje bolnikov z dokumentirano preureditvijo ALK na podlagi validiranega testa, stanja zmogljivost ECOG 0-2 in predhodne kemoterapije.
Grade 4 hypertension (life threatening consequences, urgent intervention indicated) 
Hipertenzija stopnje 4 (z življenjsko ogrožajočimi posledicami, potrebno je bilo nujno posredovanje)
The median time to onset for CPK elevations was 27 days. 
Mediani čas za pojav zvišanja CPK je bil 27 dni.
Alunbrig has not been studied in children or adolescents. 
Zdravilo Alunbrig ni bilo raziskano pri otrocih ali mladostnikih.
Treatment with Alunbrig is not recommended in persons under 18 years of age. 
Zdravljenje z zdravilom Alunbrig ni priporočljivo pri osebah, mlajših od 18 let.
Alunbrig has minor influence on the ability to drive and use machines. 
Zdravilo Alunbrig ima blag vpliv na sposobnost vožnje in upravljanja strojev.
• reduced number of red blood cells (anaemia) 
• zmanjšano število rdečih krvnih celic (anemija)
In the event of an overdose, monitor the patient for adverse reactions (see section 4.8) and provide appropriate supportive care. 
V primeru prevelikega odmerka spremljajte bolnika zaradi neželenih učinkov (glejte poglavje 4.8) in zagotovite ustrezno podporno oskrbo.
The MAH shall ensure that in each Member State where Alunbrig is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use Alunbrig have access to/are provided with the following educational package: 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer je zdravilo Alunbrig na trgu, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo predpisovali oz. uporabljali zdravilo Alunbrig, imeli dostop/prejeli naslednje izobraževalno gradivo:
Efficacy results from ALTA analysis are summarised in Table 4. and the Kaplan-Meier (KM) curve for investigator-assessed PFS is shown in Figure 1. 
Rezultati učinkovitosti iz analize ALTA so povzeti v preglednici 4 in krivulja Kaplan Meier (KM) za preiskovano ocenjeno PFS je prikazana na sliki 1.
The limited data on the safety and efficacy of Alunbrig in patients aged 65 years and older suggest that a dose adjustment is not required in elderly patients (see section 4.8). 
Omejeni podatki o varnosti in učinkovitosti zdravila Alunbrig pri bolnikih, starih 65 let ali več, kažejo, da prilagoditev odmerka pri starejših bolnikih ni potrebna (glejte poglavje 4.8).
The incidence of Grade 3-4 elevations of CPK was 13.6%. 
Pojav zvišanja CPK na stopnjo 3-4 je bil 13,6%.
What Alunbrig is and what it is used for 
Kaj je zdravilo Alunbrig in za kaj ga uporabljamo
(27.7, NE) 
(27,7; NO)
Ask your doctor about the birth control methods that may be right for you. 
Posvetujte se s svojim zdravnikom o metodah kontracepcije, ki so za vas ustrezne.
The mechanism of micronucleus induction was abnormal chromosome segregation (aneugenicity) and not a clastogenic effect on chromosomes. 
Mehanizem indukcije mikronukleusov je bila nenormalna segregacija kromosoma (anevgenost) in ne klastogeni učinek na kromosome.
• pain in arms and legs 
• bolečine v rokah in nogah
Patients should be advised to report any visual symptoms. 
Bolnikom je treba svetovati, naj poročajo o kakršnih koli simptomih motenj vida.
Alunbrig with food and drink 
Zdravilo Alunbrig skupaj s hrano in pijačo
Increased age and shorter interval (less than 7 days) between the last dose of crizotinib and the first dose of Alunbrig were independently associated with an increased rate of these pulmonary adverse reactions. 
Višja starost in kratek interval (manj kot 7 dni) med zadnjim odmerkom krizotiniba in prvim odmerkom zdravila Alunbrig sta bila neodvisno povezana s povečano stopnjo teh neželenih učinkov na pljuča.
(peripheral neuropathy) 
(periferna nevropatija)
(18.2, NE) 
(18,2; NO)
The median duration of peripheral neuropathy adverse reactions was 4.5 months, with a maximum duration of 28.7 months. 
Mediano trajanje neželenih učinkov povezanih s periferno nevropatijo je bilo 4,5 meseca, največ 28,7 meseca.
Grade 3 hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg, medical intervention indicated, more than one anti-hypertensive medicinal product, or more intensive therapy than previously used indicated) 
Hipertenzija stopnje 3 (SBP ≥160 mmHg ali DBP ≥100 mmHg, potreben je bil medicinski poseg, več kot eno antihipertenzivno zdravilo ali bolj intenzivno zdravljenje, kot je bilo že ustaljeno)
The most common sites of extra-thoracic metastasis included 69% brain (of whom 62% had received prior radiation to the brain), 39% bone, and 26% liver. 
Najpogostejša mesta ekstratorakalnih metastaz so vključevala 69% možganov (od katerih jih je 62% predhono opravilo obsevanje možganov), 39% kosti in 26% jeter.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporaba tega zdravila posvetujte s svojim zdravnikom.
Do not crush or dissolve the tablets. 
Tablete ne smete zdrobiti ali raztopiti.
Alunbrig may also induce other enzymes and transporters (e.g., CYP2C, P-gp) via the same mechanisms responsible for induction of CYP3A (e.g., pregnane X receptor activation). 
Zdravilo Alunbrig lahko inducira tudi druge encime in transporte (npr. CYP2C, P-gp) preko enakih mehanizmov, ki so odgovorni za indukcijo CYP3A (npr. aktivacija pregnanskega X receptorja).
Intracranial disease control rate 
Stopnja kontrole intrakranialne bolezni
Of these, three Grade 3 adverse reactions (2.7%) including macular oedema and cataract were reported. 
Od tega so poročali o neželenih učinkih stopnje 3 (2,7%), vključno z makularnim edemom in katarakto.
• The active substance is brigatinib. 
• Učinkovina je brigatinib.
Treatment with Alunbrig should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. 
Zdravljenje z zdravilom Alunbrig mora uvesti in nadzorovati zdravnik z izkušnjami pri uporabi zdravil za zdravljenje raka.
• change in sense of taste 
• sprememba okusa
• If you vomit after taking Alunbrig, do not take any more tablets until your next scheduled dose. 
• Če po zaužitju zdravila Alunbrig bruhate, ne vzemite dodatnih tablet do naslednjega načrtovanega odmerka.
reduce to 60 mg once daily permanently discontinue not applicable 
zmanjšanje na 60 mg enkrat na dan trajno prenehanje navedba smiselno ni potrebna
Adverse reactions reported in ALTA and Study 101 at the recommended dosing regimen are presented in Table 3 and are listed by system organ class, preferred term and frequency. 
Neželeni učinki, o katerih so poročali v študiji ALTA in študiji 101 pri priporočenem režimu odmerjanja, so predstavljeni v preglednici 3 in so navedeni glede na organske sisteme, prednostne izraze in pogostnost.
After a single dose and at steady state, systemic exposure was dose proportional over the dose range of 60-240 mg once daily. 
Po enkratnem odmerku in v stanju dinamičnega ravnovesja je bila sistemska izpostavljenost sorazmerna odmerku v razponu odmerkov 60-240 mg enkrat na dan.
Study 101: An open-label multicentre phase 1/2 dose escalation/expansion trial in patients with advanced malignancies. 
Študija 101: Multicentrično, odprto preskušanje stopnjevanja/razširjanja odmerka faze 1/2 pri bolnikih z napredovalimi malignimi boleznimi.
Studies in animals have shown reproductive toxicity (see section 5.3). 
Študije na živalih so pokazale toksičnost za sposobnost razmnoževanja (glejte poglavje 5.3).
Median (months) 95% CI 
Povprečno (mesecev) 95% IZ
Unchanged brigatinib was the major circulating radioactive component (92%) along with AP26123 (3.5%), the primary metabolite also observed in vitro. 
Nespremenjeni brigatinib je bil glavna krožeča radioaktivna komponenta (92%) skupaj z AP26123 (3,5%), primarnim presnovkom, ki je bil opažen tudi in vitro.
• symptoms such as numbness, tingling, prickling sensation, weakness or pain in hands or feet 
• simptomi, kot so odrevenelost, mravljinčenje, zbadanje, šibkost ali bolečina v rokah ali nogah
Macrogol Polyvinyl alcohol Titanium dioxide 
Obloga tablete smukec makrogol polivinilalkohol titanov dioksid
• reduced number of white blood cells, called neutrophils and lymphocytes, in blood tests 
• zmanjšano število belih krvnih celic, imenovanih nevtrofilci in limfociti, pri preiskavah krvi
Adverse reactions† all grades 
Neželeni učinki† vse stopnje
• carbamazepine: a medicine to treat epilepsy, euphoric/depressive episodes and certain pain conditions 
• karbamazepin: zdravilo za zdravljenje epilepsije, evforične/depresivne epizode in nekaterih bolečinskih stanj
Early pulmonary adverse reactions also occurred in a dose escalation study in patients (N = 137) (Study 101) including three fatal cases (hypoxia, acute respiratory distress syndrome and pneumonia). 
Zgodnji neželeni učinki na pljuča so se prav tako pojavili v študiji stopnjevanja odmerka pri bolnikih (N = 137) (študija 101), vključno s tremi smrtnimi primeri (hipoksija, sindrom akutne respiratorne stiske in pljučnica).
The effect of gemfibrozil on the pharmacokinetics of brigatinib is not clinically meaningful and the underlying mechanism for the decreased exposure of brigatinib is unknown. 
Učinek gemfibrozila na farmakokinetiko brigatiniba ni klinično pomemben in osnovni mehanizem za zmanjšano izpostavljenost brigatinibu ni znan.
Dose reduction levels First 
Ravni zmanjšanja odmerka prvič drugič tretjič
• abnormal electrical activity of the heart (prolonged electrocardiogram QT interval) 
• nenormalna električna aktivnost srca (podaljšan interval QT na elektrokardiogramu)
bpm = beats per minute; CPK = Creatine Phosphokinase; DBP = diastolic blood pressure; HR = heart rate; SBP = systolic blood pressure; ULN = upper limit of normal *Graded per National Cancer Institute Common Terminology Criteria for Adverse Events. 
CPK = kreatin fosfokinaza; DBP = diastolični krvni tlak; HR = srčni utrip; SBP = sistolični krvni tlak; ULN = zgornja meja normalne vrednosti *Razvrščeni po nacionalnem kriteriju nacionalnega inštituta za rak za neželene učinke.
This effect was observed at approximately five fold the human exposure at the 180 mg once daily dose. 
Ta učinek so opazili pri približno petkratni izpostavljenosti človeka pri odmerku 180 mg enkrat na dan.
Given that brigatinib exhibits high solubility and high permeability, inhibition of P-gp and BCRP is not expected to result in a clinically meaningful change in the systemic exposure of brigatinib. 
Glede na to da brigatinib izkazuje visoko topnost in visoko prepusnost, ne pričakujemo, da bi inhibicija P-gp in BCRP povzročila klinično pomembno spremembo sistemske izpostavljenosti brigatinibu.
The abnormal gene produces a protein known as a kinase that stimulates the growth of the cancer cells. 
Nenormalni gen proizvaja protein, ki se imenuje kinaza in spodbuja rast rakavih celic.
Baseline demographics and disease characteristics in ALTA were median age 54 years old (range 18 to 82; 23% 65 and over), 67% White and 31% Asian, 57% female, 36% ECOG PS 0 and 57% ECOG PS 1, 7% ECOG PS2, 60% never smoker, 35% former smoker, 5% current smoker, 98% Stage IV, 97% adenocarcinoma, and 74% prior chemotherapy. 
Osnovna demografija in značilnosti bolezni pri študiji ALTA so bile: mediana starost 54 let (razpon od 18 do 82, 23% 65 let in več), 67% belcev in 31% Azijcev, 57% žensk, 36% stanje zmogljivosti 0 po ECOG in 57% stanje zmogljivosti 1 po ECOG, 7% stanje zmogljivosti 2 po ECOG, 60% oseb, ki ni nikoli kadilo, 35% bivših kadilcev, 5% trenutnih kadilcev, 98% IV. stopnja, 97% adenokarcinom in 74% s predhodno izvedeno kemoterapijo.
Your doctor may need to adjust your treatment or stop Alunbrig temporarily or permanently. 
Vaš zdravnik bo morda moral prilagoditi zdravljenje, začasno prekiniti ali trajno ukiniti uporabo zdravila Alunbrig.
Alunbrig is not recommended during pregnancy unless the benefit outweighs the risk to the baby. 
Zdravila Alunbrig ni priporočeno jemati med nosečnostjo, razen če korist odtehta tveganje za dojenčka.
Adverse reactions seen in animals at exposure levels similar to clinical exposure levels with possible relevance to clinical use were as follows: gastrointestinal system, bone marrow, eyes, testes, liver, kidney, bone, and heart. 
Neželeni učinki, ki so jih opazili pri živalih, pri ravneh izpostavljenosti, podobnih stopnjam klinične izpostavljenosti, ki so lahko pomembni za klinično uporabo, so bili na: gastrointestinalni sistem, kostni mozeg, oči, moda, jetra, ledvice, kosti in srce.
Of these, 19 patients had an investigator-assessed confirmed objective response (76%; 95% CI: 55, 91) and the KM estimate median duration of response among the 19 responders was 26.1 months (95% CI: 7.9, 26.1). 
Od tega je za 19 bolnikov raziskovalec ocenil potrjen objektivni odziv (76%, 95% IZ: 55; 91) in KM oceno mediane trajanja odziva med 19 odzivi je bila 26,1 meseca (95% IZ: 7,9; 26,1).