natgillin/translations-raw huggingface dataset:
The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR), as determined by a blinded independent review committee (BIRC). 
Glavni merili učinkovitosti izida sta bila celokupni delež odziva (ORR - overall response rate) in trajanje odziva (DOR - duration of response), ki ju je opredelil neodvisni odbor za pregled, katerega člani niso imeli vpogleda v druge podatke bolnikov vključenih v raziskavo (BIRC - blinded independent review committee).
- parahydroxybenzoate: it may cause allergic reactions (possibly delayed). 
- parahidroksibenzoat: lahko povzroči alergijske reakcije (lahko zapoznele).
After the inhibitor has been discontinued for 3 to 5 elimination half-lives, VITRAKVI should be resumed at the dose taken prior to initiating the CYP3A4 inhibitor (see section 4.5). 
Potem ko je bil uporaba zaviralca prekinjena za 3 do 5 razpolovnih časov izločanja, je treba nadaljevati z odmerkom zdravila VITRAKVI, ki ga je bolnik jemal pred uvedbo zaviralca CYP3A4 (glejte poglavje 4.5).
Tumour types included in efficacy analysis n 
Vrste tumorjev, vključene v analizo učinkovitosti n študija 1
In order to further confirm the histology-independent efficacy of larotrectinib and to investigate the primary and secondary resistance mechanisms, the MAH should submit a pooled analysis for the increased sample size including the final report of study LOXO-TRK-15002 (NAVIGATE). 
Za dodatno potrditev učinkovitosti larotrektiniba neodvisno od histologije in zato, da bi raziskali mehanizme primarne in sekundarne odpornosti, mora imetnik dovoljenja za promet predložiti združene analize za povečano velikost vzorca, vključno s končnim poročilom študije LOXO-TRK-15002 (NAVIGATE)
Each mL of oral solution contains 295 mg sucrose, 22 mg sorbitol, 1.6 mg propylene glycol and 0.2 mg methyl parahydroxybenzoate. 
1 ml peroralne raztopine vsebuje 295 mg saharoze, 22 mg sorbitola, 1,6 mg propilenglikola in 0,2 mg metil parahidroksibenzoata.
In patients whose cancer is due to an altered NTRK gene, the change in the gene causes the body to make an abnormal protein called TRK fusion protein, which can lead to uncontrolled cell growth and cancer. 
Pri bolnikih z rakom zaradi spremenjenega gena NTRK, spremembe gena povzročijo, da telo proizvaja protein, ki se imenuje fuzijski protein TRK, kar lahko privede do nenadzorovane rasti celic in raka.
If a dose is missed, the patient should not take two doses at the same time to make up for a missed dose. 
Če bolnik pozabi vzeti odmerek, ne sme hkrati vzeti dveh odmerkov, da bi nadomestil pozabljeni odmerek.
The majority of adverse reactions were Grade 1 or 2 in severity (see Table 3) and were resolved without VITRAKVI dose modification or discontinuation. 
Večina neželenih učinkov je bilo 1. ali 2. stopnje (glejte preglednico 3) in so izzveneli ne da bi bil spremenjen odmerek ali bi bilo prekinjeno zdravljenje z zdravilom VITRAKVI.
The median change in tumour size in the pooled primary analysis set was a decrease of 66%. 
V združeni primarni analizi je bila mediana spremembe velikosti tumorja 66 % zmanjšanje.
In the overall safety database (n=125), the maximum grade transaminase elevation observed was Grade 4 ALT increase in 1 patient (<1%). 
V celotni podatkovni zbirki o varnosti (n = 125) je bila najvišja stopnja zvišane vrednosti ALT, ki so jo opazili, 4. stopnje pri 1 bolniku (< 1 %).
The efficacy and safety of VITRAKVI were studied in three multicentre, open-label, single-arm clinical studies in adult and paediatric cancer patients (Table 4). 
Učinkovitost in varnost zdravila VITRAKVI so preučevali v treh multicentričnih, odprtih kliničnih študijah z enim krakom pri odraslih in pediatričnih bolnikih z rakom (preglednica 4).
In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines: - medicines used to treat fungal or bacterial infections called itraconazole, voriconazole, 
Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete katero od naslednjih zdravil: - zdravila za zdravljenje glivičnih ali bakterijskih okužb, ki se imenujejo itrakonazol,
VITRAKVI is for oral use. 
Zdravilo VITRAKVI je za peroralno uporabo.
In the paediatric sub-population (n=28), the ORR was 82%. 
V pediatrični podpopulaciji (n = 28) je bil celokupni delež odziva 82 %.
These patients were required to have received prior standard therapy appropriate for their tumour type and stage of disease or who, in the opinion of the investigator, would have had to undergo radical surgery (such as limb amputation, facial resection, or paralysis causing procedure), or were unlikely to tolerate, or derive clinically meaningful benefit from available standard of care therapies in the advanced disease setting. 
Pri teh bolnikih je bilo potrebno predhodno standardno zdravljenje glede na vrsto tumorja in stadij bolezni ali pa bi jim bilo treba po mnenju raziskovalca opraviti radikalen kirurški poseg (na primer amputacijo uda, resekcijo obraza ali poseg, ki povzroča paralizo) ali pa pri napredovali bolezni verjetno ne bi prenašali standardnih vrst zdravljenja, ki so na voljo, oziroma od njih verjetno ne bi imeli klinično pomembne koristi.
100 mg once daily 
100 mg enkrat na dan
There was not enough data to investigate the potential influence of race on the systemic exposure of larotrectinib. 
Za oceno možnega vpliva rase na sistemsko izpostavljenost larotrektinibu ni dovolj podatkov.
VITRAKVI as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, - who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and - who have no satisfactory treatment options (see sections 4.4 and 5.1). 
Zdravilo VITRAKVI kot monoterapija je indicirano za zdravljenje odraslih in pediatričnih bolnikov s solidnimi tumorji s prisotno fuzijo gena nevrotropne receptorske tirozin kinaze (NTRK - Neurotrophic Tyrosine Receptor Kinase), - ki imajo bolezen, ki je lokalno napredovala, bolezen z metastazami ali kjer bi kirurška resekcija verjetno povzročila hudo obolevnost, in - pri katerih ni zadovoljivih možnosti zdravljenja (glejte poglavji 4.4 in 5.1).
< 18 years of age, and 3 patients ≥ 18 years, and 8 patients white and 5 patients male; and ECOG PS 0-1 (8 patients), or 2 (1 patient). 
< 18 let, in 3 bolniki ≥ 18 let; 8 belcev in 5 moških; ECOG PS 0-1 (8 bolnikov) ali 2 (1 bolnik).
Co-administration with CYP3A4/P-gp inducers 
Sočasna uporaba z induktorji CYP3A4/P-gp
The measured impact of any concomitant genomic alterations on larotrectinib efficacy is provided below (see clinical efficacy). 
Izmerjeni vpliv katere koli sočasne spremembe genoma na učinkovitost larotrektiniba je navedena v nadaljevanju (glejte klinična učinkovitost).
No clinical studies have been performed to investigate interactions with OATP1B1 substrates. 
Kliničnih študij za ugotavljanje interakcij s substrati OATP1B1 niso izvedli.
reactions included two cases Neutrophil count decreased (Neutropenia) and one case of anaemia. 
Učinki 3. stopnje so vključevali dva primera zmanjšanja števila nevtrofilcev (neutropenija) in en primer anemije.
Women of childbearing potential should have a pregnancy test prior to starting treatment with VITRAKVI. 
Ženske v rodni dobi morajo pred začetkom zdravljenja z zdravilom VITRAKVI opraviti test nosečnosti.
The recommended dose in adults is 100 mg larotrectinib twice daily, until disease progression or until unacceptable toxicity occurs. 
Priporočeni odmerek zdravila pri odraslih je 100 mg larotrektiniba dvakrat na dan, dokler ne pride do napredovanja bolezni ali dokler se ne pojavi nesprejemljiva toksičnost.
Sucrose: may be harmful to the teeth. 
Saharoza: lahko škoduje zobem.
Tumour responses were assessed by the investigator using RANO or RECIST v1.1 criteria. 
Odzive tumorja so raziskovalci ocenili z uporabo kriterijev RANO ali RECIST v1.1.
The target for larotrectinib is the TRK family of proteins inclusive of TRKA, TRKB, and TRKC that are encoded by NTRK1, NTRK2 and NTRK3 genes, respectively. 
Tarča za larotrektinib je družina proteinov TRK, vključno s TRKA, TRKB in TRKC, ki jih kodirajo geni NTRK1, NTRK2 oziroma NTRK3.
In in vitro and in vivo tumour models, larotrectinib demonstrated anti-tumour activity in cells with constitutive activation of TRK proteins resulting from gene fusions, deletion of a protein regulatory domain, or in cells with TRK protein overexpression. 
V in vitro ter in vivo tumorskih modelih je larotrektinib pokazal protitumorsko delovanje v celicah s konstitutivno aktivacijo proteinov TRK, ki je posledica genskih fuzij, izbrisa regulatorne domene proteina, ali v celicah s prekomerno izraženim proteinom TRK.
Effect of CYP3A, P-gp and BCRP inhibitors on larotrectinib Larotrectinib is a substrate of cytochrome P450 (CYP) 3A, P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). 
Učinki zaviralcev CYP3A, P-gp BCRP na larotrektinib Larotrektinib je substrat citokroma P450 (CYP) 3A, P-glikoproteina (P-gp) in proteina odpornosti pri raku dojke (BCRP - breast cancer resistance protein).
Safety pharmacology 
Farmakologija glede varnosti
Larotrectinib was negative in the in vivo mouse micronucleus test at the maximum tolerated dose of 500 mg/kg. 
Larotrektinib je bil negativen v in vivo mikronukleus testu z največjim toleriranim odmerkom 500 mg/kg pri miših.
The oral solution can be taken with or without food but should not be taken with grapefruit or grapefruit juice. 
Peroralno raztopino se lahko uporablja s hrano ali brez nje, vendar se je ne sme jemati skupaj z grenivko ali sokom grenivke.
- Do not take the medicine if the bottle or bottle cap looks damaged or like it has leaked. 
- Ne uporabljajte tega zdravila, če opazite, da je steklenica ali zaporka steklenice poškodovana ali pušča.
Based on the mechanism of action, foetal harm cannot be excluded when administering larotrectinib to a pregnant woman. 
Glede na mehanizem delovanja, pri dajanju larotrektiniba nosečnicam ni mogoče izključiti poškodbe ploda.
If you are able to become pregnant, your doctor should do a pregnancy test before you start treatment. 
Če ste v rodni dobi, bo zdravnik pred začetkom zdravljenja pri vas opravil test nosečnosti.
The pooled primary analysis set consisted of 93 patients and did not include primary CNS tumours. 
Združeni rezultati primarnih analiz so bili pridobljeni pri 93 bolnikih in niso vključevali primarnih tumorjev osrednjega živčevja.
The half-life of larotrectinib in plasma of cancer patients given 100 mg twice daily of VITRAKVI was approximately 3 hours. 
Razpolovni čas larotrektiniba v plazmi bolnikov z rakom, ki so prejemali 100 mg zdravila VITRAKVI dvakrat na dan, je bila približno 3 ure.
The safety pharmacology of larotrectinib was evaluated in several in vitro and in vivo studies that assessed effects on the CV, CNS, respiratory, and GI systems in various species. 
Farmakologija glede varnosti larotrektiniba je bila ocenjena v več in vitro ter in vivo študijah, v katerih so ocenjevalei učinke na kardiovaskularni sistem, osrednje živčevje, dihala in prebavila pri različnih vrstah.
The pooled efficacy results for overall response rate, duration of response and time to first response, in the primary analysis population (n=93) and with post-hoc addition of primary CNS tumours (n=9) resulting in the pooled population (n=102), are presented in Table 5 and Table 6. 
Združeni rezultati učinkovitosti za celokupni delež odziva, trajanje odziva in čas do prvega odziva, v populaciji primarne analize (n = 93) in z ad-hoc dodajanimi primarnimi tumorji osrednjega živčevja (n = 9), kar se kaže kot združena populacija (n = 102), so predstavljeni v preglednici 5 in preglednici 6.
Avoid co-administration of strong or moderate CYP3A4/P-gp inducers with VITRAKVI due to a risk of decreased exposure (see section 4.5). 
Izogibajte se sočasni uporabi močnih ali zmernih induktorjev CYP3A4/P-gp z zdravilom VITRAKVI, ker obstaja tveganje za zmanjšano izpostavljenost (glejte poglavje 4.5).
The safety population characteristics were comprised of patients with a median age of 45 years (range: 0.1, 80) with 30% of patients being paediatric patients. 
V varnostni populaciji je bila mediana starost bolnikov 45 let (razpon: 0,1, 80), 30 % bolnikov je bilo pediatričnih bolnikov.
56 capsules 
56 trdih kapsul
VITRAKVI is available as a capsule or oral solution with equivalent oral bioavailability and may be used interchangeably. 
Zdravilo VITRAKVI je na voljo v obliki kapsule ali peroralne raztopine z enakovredno biološko uporabnostjo pri peroralni uporabi in se ju sme uporabljati izmenično.
Larotrectinib was not mutagenic in bacterial reverse mutation (Ames) assays and in in vitro mammalian mutagenesis assays. 
Larotrektinib ni bil mutagen v preskusih bakterijske reverzne mutacije (Ames) in in vitro preskusih mutageneze pri sesalcih.
Larotrectinib had minimal activity in cell lines with point mutations in the TRKA kinase domain, including the clinically identified acquired resistance mutation, G595R. 
Larotrektinib je imel minimalno aktivnost v celičnih linijah, s točkovnimi mutacijami v domeni kinaze TRKA, vključno s klinično ugotovljeno mutacijo G595R, ki povzroča pridobljeno odpornost.
- Slowly depress the plunger, directing the liquid towards the inside cheek to allow for natural swallowing. 
- Bat počasi pritiskajte in tekočino usmerite proti notranjosti lica, da omogočite naravno požiranje.
Sodium: this medicine contains less than 1 mmol sodium (23 mg) per 5 mL, that is to say essentially ‘sodium-free'. 
Natrij: to zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 5 ml, kar v bistvu pomeni ‘brez natrija'.
The pooled primary analysis set of efficacy includes 93 patients with TRK fusion-positive cancer enrolled across the three studies that had measurable disease assessed by RECIST v1.1, a non-CNS primary tumour and received at least one dose of larotrectinib. 
V združeno analizo izsledkov učinkovitosti je bilo vključenih 93 bolnikov z rakom z dokazano fuzijo TRK, ki so sodelovali v treh študijah in so imeli bolezen opredeljeno po kriterijih RECIST v1.1, primarni tumor izven osrednjega živčevja in so prejeli najmanj en odmerek larotrektiniba.
Of 125 patients in the overall safety population who received VITRAKVI, 28 (22%) patients were 65 years or older and 8 (6%) patients were 75 years or older. 
Od 125 bolnikov v celotni varnostni populaciji, ki so prejemali zdravilo VITRAKVI, je bilo 28 (22 %) bolnikov starih 65 let ali več in 8 (6 %) bolnikov starih 75 let ali več.
Oral syringe - Use a suitable oral syringe with CE marking and bottle adapter (28 mm diameter) if applicable. 
- Uporabite primerno peroralno brizgo z oznako CE in nastavek za steklenico (premera 28 mm), če je potrebno.
b Investigator assessment using either RANO or RECIST v1.1 criteria for primary CNS tumours (9 patients). 
b Ocena raziskovalca z uporabo kriterijev RANO ali RECIST v1.1 za primarne tumorje osrednjega živčevja (9 bolnikov).
Contraception in female and male 
Kontracepcija pri ženskah in moških
In addition, 9 patients with primary CNS tumours and measurable disease at baseline were treated in Study 2 (“NAVIGATE”) and in Study 3 (“SCOUT”). 
Poleg tega je bilo 9 bolnikov s primarnimi tumorji osrednjega živčevja in merljivo boleznijo na izhodišču, zdravljenih v študiji 2 (»NAVIGATE«) in študiji 3 (»SCOUT«).
If you take more VITRAKVI than you should 
Če ste vzeli večji odmerek zdravila VITRAKVI, kot bi smeli
Table 6: Overall response rate and duration of response by tumour type Tumour type 
Preglednica 6: Celokupni delež in trajanje odziva glede na vrsto tumorja Vrsta tumorja
First 
prva
If you stop taking VITRAKVI 
Če ste prenehali jemati zdravilo VITRAKVI
In all cases, patients with evidence of anti-tumour activity who required a dose reduction were able to continue dosing at a reduced dose and/or schedule (see section 4.4). 
Bolniki z dokazanim protitumorskim delovanjem, pri katerih je bilo potrebno znižanje odmerka, so v vseh primerih lahko nadaljevali zdravljenje z jemanjem zmanjšanega odmerka in/ali po prilagojenem režimu zdravljenja (glejte poglavje 4.4).
In vitro studies indicate that larotrectinib is not a substrate for either OATP1B1 or OATP1B3. 
Študije in vitro kažejo, da larotrektinib ni substrat za OATP1B1 niti za OATP1B3.
At the time of analysis, the median duration of response had not been reached, 75% patients had responses which were ongoing with an estimated 88% of responses lasting 6 months or longer and 75% of responses lasting 12 months or longer. 
Pri 75 % bolnikih je odziv še trajal; po ocenah je 88 % odzivov trajalo 6 mesecev ali dlje in 75 % odzivov 12 mesecev ali dlje.
In rats, larotrectinib accelerated intestinal transit and increased gastric secretion and acidity. 
Pri podganah je larotrektinib pospešil pasažo skozi črevesje in povečal sekrecijo in kislost v želodcu.
• Phase 2 multinational, open label, tumour “basket” study 
• mednarodna, odprta študija faze 2, tipa »košarica« pri tumorjih
Put the oral syringe in the adapter opening. 
Peroralno brizgo vstavite v odprtino nastavka.
It is unknown whether larotrectinib/metabolites are excreted in human milk. 
Ni znano, ali se larotrektinib/presnovki izločajo v materino mleko.
If you have any questions on how VITRAKVI works or why it has been prescribed for you, ask your doctor, pharmacist or nurse. 
Če imate vprašanja glede delovanja zdravila VITRAKVI ali zakaj vam je bilo predpisano, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
In the overall safety database (n=125), the maximum grade neurologic reaction observed was Grade 3 which was observed in three (2%) patients and included dizziness (one patient, <1%) and paraesthesia (two patients, 1.6%). 
V celotni podatkovni zbirki o varnosti (n = 125) je bila najvišja stopnja nevroloških učinkov, ki so jih opazili, 3. stopnja; opazili so jo pri treh (2 %) bolnikih, in je vključevala vrtoglavico (en bolnik; < 1 %) in parestezijo (2 bolnika, 1,6 %).
- less than 1 mmol (or 23 mg) of sodium per 5 mL, that is to say essentially ‘sodium free'. 
- manj kot 1 mmol (ali 23 mg) natrija na 5 ml, kar v bistvu pomeni »brez natrija«.
Effect of larotrectinib on CYP3A substrates 
Učinek larotrektiniba na substrate CYP3A
At the recommended dose of 100 mg taken twice daily, steady-state arithmetic mean (± standard deviation) Cmax and daily AUC in adults were 914 ± 445 ng/mL and 5410 ± 3813 ng*h/mL, respectively. 
Ob jemanju priporočenega odmerka 100 mg dvakrat na dan sta bili aritmetična srednja vrednost stanja dinamičnega ravnovesja (± standardni odklon) Cmax in dnevna vrednost AUC pri odraslih 914 ± 445 ng/ml oziroma 5410 ± 3813 ng*h/ml.
The adverse reactions of vomiting (35% versus 14% in adults), leucocyte count decrease (22% versus 9% in adults), neutrophil count decrease (30% versus 7% in adults), blood alkaline phosphatase increased (14% versus 2% in adults) and transaminase elevations (ALT 41% versus 27% in adults and AST 35% versus 26% in adults) were more frequent in paediatric patients compared to adults. 
Neželeni učinki bruhanje (35 % v primerjavi s 14 % pri odraslih), zmanjšano število levkocitov (22 % v primerjavi z 9 % pri odraslih), zmanjšano število nevtrofilcev (35 % v primerjavi s 7 % pri odraslih), zvišane vrednosti alkalne fosfataze v krvi (14 % v primerjavi z 2 % pri odraslih) in zvišane vrednosti transaminaz (41 % v primerjavi z 27 % pri odraslih za ALT in 35 % v primerjavi z 26 % pri odraslih za AST) so bili pogostejši pri pediatričnih bolnikih kot pri odraslih.
The fraction excreted as unchanged drug in urine was 29% following IV microtracer dose, indicating that direct renal excretion accounted for 29% of total clearance. 
mikrooznačevalca v urinu izločilo 29 % zdravila , kar kaže, da je neposredno izločanje skozi ledvice predstavljalo 29 % skupnega očistka.
Effect of larotrectinib on substrates of PXR regulated enzymes In vitro studies indicate that larotrectinib may induce PXR regulated enzymes (e.g. CYP2C family and UGT). 
Učinek larotrektiniba na substrate encimov reguliranih s PXR Študije in vitro kažejo, da larotrektinib lahko inducira encime regulirane s PXR (npr. družino CYP2C
• Adult patients (≥ 18 years) with advanced solid tumours with an NTRK gene fusion 
• odrasli bolniki (≥ 18 let) z napredovalimi solidnimi tumorji s fuzijo genov NTRK
Based on population pharmacokinetic analyses exposure (Cmax and AUC) in paediatric patients (1 month to <3 months of age) at the recommended dose of 100 mg/m2 with a maximum of 100 mg BID was 3-fold higher than in adults (≥18 years of age) given the dose of 100 mg BID. 
Na podlagi farmakokinetičnih analiz populacije, izpostavljenost (Cmax in AUC) pri pediatričnih bolnikih (starih od 1 meseca do < 3 mesecev) pri priporočenem odmerku 100 mg/m2 z največ 100 mg dvakrat na dan je bila 3-krat večja kot pri odraslih (starih 18 let ali več), ki so jim dajali odmerek 100 mg dvakrat na dan.
Permanent discontinuation of VITRAKVI for treatment emergent adverse reactions, regardless of attribution occurred in 3% of patients (one case each of ALT increase, AST increase, intestinal perforation, jaundice, small intestinal obstruction). 
Do trajne ukinitve zdravljenja z zdravilom VITRAKVI zaradi neželenih učinkov, ki so se pojavili med zdravljenjem in so jih pripisali preskušanemu zdravilu, je prišlo pri 3 % bolnikov (po en primer zaradi zvišanja vrednosti ALT, zvišanja vrednosti AST, perforacije v črevesju, zlatenice, majhne obstrukcije v črevesju).
As a precautionary measure, it is preferable to avoid the use of VITRAKVI during pregnancy. 
Iz previdnosti se je med nosečnostjo uporabi zdravila VITRAKVI bolje izogibati.
Adolescents (n=8)c 
(n = 8)c
Of these, 77% had received prior systemic therapy with a median of 1 prior systemic treatment regimen. 
Predhodno sistemsko zdravljenje je prejelo 77 % od teh bolnikov, z mediano 1 predhodnega režima sistemskega zdravljenja.
The recommended dose modifications for VITRAKVI for adverse reactions are provided in Table 1. 
Priporočene spremembe odmerka zdravila VITRAKVI pri pojavu neželenih učinkov so navedene v Preglednici 1.
Gastrointestinal stromal tumoura Bone sarcomaa Cholangiocarcinomaa 
gastrointestinalni stromalni tumora kostni sarkoma holangiokarcinoma
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 
- saharozo: če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
The recommended dose in paediatric patients is 100 mg/m2 larotrectinib twice daily with a maximum of 100 mg per dose until disease progression or until unacceptable toxicity occurs. 
Priporočeni odmerek zdravila pri pediatričnih bolnikih je 100 mg/m2 larotrektiniba dvakrat na dan, z največ 100 mg na odmerek, dokler ne pride do napredovanja bolezni ali dokler se ne pojavi nesprejemljiva toksičnost.
Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, antineoplastic agents, protein kinase inhibitors, ATC code: L01XE53. 
Farmakoterapevtska skupina: antineoplastična sredstva in imunomodulatorji, antineoplastična sredstva, zaviralci proteinskih kinaz; oznaka ATC: L01XE53
Adult and paediatric patients with body surface area of at least 1.0 m2 
Sprememba odmerka Odrasli in pediatrični bolniki s telesno površino najmanj 1,0 m2
The safety of VITRAKVI was evaluated in 125 patients with TRK fusion-positive cancer in one of three clinical trials, Studies 1, 2 (“NAVIGATE”), and 3 (“SCOUT”). 
Povzetek varnostnega profila Varnost zdravila VITRAKVI je bila ocenjena pri 125 bolnikih z rakom z dokazano fuzijo TRK v enem od treh kliničnih preskušanj, tj. v študiji 1, 2 (»NAVIGATE«) in 3 (»SCOUT«).
The safety profile in the paediatric population (< 18 years) was consistent in types of reported adverse reactions to those observed in the adult population. 
Varnostni profil pri pediatrični populaciji (< 18 let) glede neželenih učinkov, o katerih so poročali, je bil skladen s tistimi, ki so jih opazili pri odrasli populaciji.
The ORR in the total population may not reflect the expected response in a specific tumour type. 
Rezultati za celotno populacijo se lahko razlikujejo od opaženega odziva pri posameznih vrstah tumorjev.