natgillin/translations-raw huggingface dataset:
OR (measurable disease) [% (95% CI)] CBR [% (95% CI)]
OR (merljiva bolezen) [% (95 % IZ)] CBR [% (95 % IZ)]
Despite these male reproductive organ findings, there were no effects on mating or fertility in male rats at projected exposure levels 13 times human clinical exposure based on AUC.
Kljub tem ugotovitvam glede reprodukcijskih organov samcev, ni bilo nobenih učinkov na parjenje ali plodnost pri samcih podgan pri načrtovanih ravneh izpostavljenosti, ki so ustrezale 13-kratniku klinične izpostavljenosti pri ljudeh na osnovi vrednosti AUC.
When the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor (see section 4.5).
Po ukinitvi močnega zaviralca odmerek zdravila IBRANCE (po 3-5 razpolovnih časih zaviralca) povečajte na odmerek, ki ste ga uporabljali pred uvedbo močnega zaviralca CYP3A (glejte poglavje 4.5).
The overall safety profile of IBRANCE is based on pooled data from 872 patients who received palbociclib in combination with endocrine therapy (N=527 in combination with letrozole and N=345 in combination with fulvestrant) in randomised clinical studies in HR-positive, HER2-negative advanced or metastatic breast cancer.
Celoten varnostni profil zdravila IBRANCE temelji na združenih podatkih 872 bolnikov, ki so prejemali palbociklib v kombinaciji z endokrinim zdravljenjem (n = 527 v kombinaciji z letrozolom in n = 345 v kombinaciji s fulvestrantom) v randomiziranih kliničnih preskušanjih HR-pozitivnega, HER2-negativnega napredovalega ali metastatskega raka dojk.
Available clinical data are reported in the clinical efficacy and safety section (see section
Razpoložljivi klinični podatki so prikazani v poglavju o klinični učinkovitosti in varnosti (glejte poglavje 5.1).
Pharmacokinetics of palbociclib has not been evaluated in patients <18 years of age.
Pediatrična populacija Farmakokinetike palbocikliba niso ovrednotili pri bolnikih, starih < 18 let.
• difficulty breathing, dry cough or chest pain which could be a sign of inflammation of the lungs.
• oteženo dihanje, suh kašelj ali bolečina v prsnem košu, ki so lahko znak vnetja pljuč.
Compared to palbociclib given under overnight fasted conditions, the AUCinf and Cmax of palbociclib increased by 21% and 38% when given with high-fat food, by 12% and 27% when given with low-fat food, and by 13% and 24% when moderate-fat food was given 1 hour before and 2 hours after palbociclib dosing.
V primerjavi s palbociklibom, danim na tešče preko noči, sta se AUCinf in cmax palbocikliba povečali za 21 % in 38 %, ko so ga dali s hrano z veliko vsebnostjo maščob, za 12 % in 27 %, ko so ga dali s hrano z majhno vsebnostjo maščob, ter za 13 % in 24 %, ko so 1 uro pred in 2 uri po odmerjanju palbocikliba dali hrano z zmerno vsebnostjo maščob.
Table 6 shows the efficacy results based on the primary and the updated analyses from the PALOMA-2 study, as assessed by the investigator and by the independent review.
Preglednica 6 prikazuje rezultate učinkovitosti na podlagi ocene raziskovalca in neodvisnega pregleda, ki temeljijo na primarni in posodobljeni analizi iz preskušanja PALOMA-2.
ALT=alanine aminotransferase; AST=aspartate aminotransferase; ILD=interstitial lung disease; N/n=number of patients; N/A=not applicable.
ALT = alanin-aminotransferaza; AST = aspartat-aminotransferaza; ILD = intersticijska bolezen pljuč; n = število bolnikov; N/V = ni na voljo
If you forget to take IBRANCE
Če ste pozabili vzeti zdravilo IBRANCE
Secondary endpoints included OR, CBR, overall survival (OS), safety, and time-to-deterioration (TTD) in pain endpoint.
Sekundarni opazovani dogodki so vključevali OR, CBR, celokupno preživetje (OS - Overall Survival), varnost in opazovani dogodek čas do poslabšanja (TTD - Time To Deterioration) bolečine.
A series of prespecified subgroup PFS analyses was performed based on prognostic factors and baseline characteristics to investigate the internal consistency of treatment effect.
Na osnovi prognostičnih dejavnikov in izhodiščnih značilnosti so opravili vrsto analiz PFS predhodno določenih podskupin za preučitev notranje konsistentnosti učinka zdravljenja.
In vitro, the uptake of palbociclib into human hepatocytes occurred mainly via passive diffusion.
Privzem palbocikliba v humane hepatocite se je in vitro zgodil predvsem preko pasivne difuzije.
Tiredness is a very common side effect.
Utrujenost je zelo pogost neželeni učinek.
• Sulfasalazine used to treat rheumatoid arthritis.
• sulfasalazin, ki se uporablja za zdravljenje revmatoidnega artritisa,
Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported (see section 4.8).
V obdobju trženja zdravila so opazili dodatne primere ILD/pnevmonitisa, pri čemer so poročali tudi o smrtnih primerih (glejte poglavje 4.8).
Pre/perimenopausal women
Ženske v pred- in perimenopavzi
Additional efficacy measures (OR and time to response [TTR]) assessed in the sub-groups of patients with or without visceral disease based on the 31-May-2017 updated cutoff date are displayed in Table 7.
Dodatna merila učinkovitosti (OR in čas do odziva [TTR - Time To Response]) so ocenili pri podskupinah bolnic z visceralno boleznijo ali brez nje, rezultati, ki temeljijo na posodobljenem datumu zaključka zajema podatkov, 31. maju 2017, pa so prikazani v preglednici 7.
Patients receiving palbociclib should not breast feed.
Bolnice, ki prejemajo palbociklib, ne smejo dojiti.
Withhold IBRANCE, until recovery to Grade ≤2, and repeat complete blood count monitoring within 1 week.
Prekinite zdravljenje z zdravilom IBRANCE do izboljšanja na stopnjo ≤ 2 in v 1 tednu ponovite spremljanje celotne krvne slike.
If you miss a dose or vomit, take your next dose as scheduled.
Če pozabite vzeti odmerek ali bruhate, vzemite naslednji odmerek ob običajnem času.
A more mature update of efficacy data is reported in Table 8.
Preglednica 8 navaja posodobljene podatke o učinkovitosti.
The effect of palbociclib on the QT interval corrected for heart rate (QTc) interval was evaluated using time matched electrocardiogram (ECG) evaluating the change from baseline and corresponding pharmacokinetic data in 77 patients with advanced breast cancer.
Učinek palbocikliba na za srčni utrip korigiran interval QT (QTc) so ovrednotili s pomočjo ocene sprememb od izhodišča v časovno usklajenih elektrokardiogramih (EKG) in ustreznih farmakokinetičnih podatkov pri 77 bolnikih z napredovalim rakom dojk.
Pre/perimenopausal women received the LHRH agonist goserelin.
Ženske v pred-/perimenopavzi so prejemale goserelin, agonist LHRH.
Overall, neutropenia of any grade was reported in 716 (82.1%) patients receiving IBRANCE regardless of the combination, with Grade 3 neutropenia being reported in 500 (57.3%) patients, and Grade 4 neutropenia being reported in 97 (11.1 %) patients (see Table 4).
Na splošno so o nevtropeniji katerekoli stopnje poročali pri 716 (82,1 %) bolnikih, ki so prejemali zdravilo IBRANCE, ne glede na kombinacijo; od tega so o nevtropeniji stopnje 3 poročali pri 500 (57,3 %) bolnikih in o nevtropeniji stopnje 4 pri 97 (11,1 %) bolnikih (glejte preglednico 4).
Effect of CYP3A inducers
Učinek induktorjev CYP3A
Palbociclib is a highly selective, reversible inhibitor of cyclin-dependent kinases (CDK) 4 and 6.
Palbociklib je visoko selektiven, reverzibilen zaviralec od ciklina odvisnih kinaz (CDK - CyclinDependent Kinase) 4 in 6.
• Enzalutamide to treat prostate cancer.
• enzalutamid, ki se uporablja za zdravljenje raka prostate,
Based on in vitro data, palbociclib may inhibit the uptake transporter organic cationic transporter OCT1 and then may increase the exposure of medical product substrates of this transporter (e.g., metformin).
Podatki in vitro kažejo, da palbociklib lahko zavira privzemni prenašalec organskih kationov OCT1 in nato lahko poveča izpostavljenost zdravilom, ki so substrati tega prenašalca (npr. metformin).
• Lopinavir, indinavir, nelfinavir, ritonavir, telaprevir, and saquinavir used to treat HIV
• lopinavir, indinavir, nelfinavir, ritonavir, telaprevir in sakvinavir, ki se uporabljajo za zdravljenje okužb z virusom HIV/AIDS-a,
A 6.9-month difference in median OS in the palbociclib plus fulvestrant arm compared with the placebo plus fulvestrant arm was observed; this result was not statistically significant at the prespecified significance level of 0.0235 (1-sided).
V skupini s palbociklibom in fulvestrantom so v primerjavi s skupino s placebom in fulvestrantom opazili 6,9-mesečno razliko v medianem OS; ta rezultat pri vnaprej določeni stopnji pomembnosti 0,0235 (1-stranska) ni bil statistično pomemben.
Severe, life-threatening, or fatal ILD and/or pneumonitis can occur in patients treated with IBRANCE when taken in combination with endocrine therapy.
Pri bolnikih, ki se zdravijo z zdravilom IBRANCE, se lahko pojavita huda, življenjsko ogrožajoča ali smrtna ILD in/ali pnevmonitis, kadar zdravilo jemljejo v kombinaciji z endokrinim zdravljenjem.
In faeces, the sulfamic acid conjugate of palbociclib was the major drug-related component, accounting for 25.8% of the administered dose.
V blatu je bil konjugat palbocikliba s sulfamidno kislino pomembna z zdravilom povezana komponenta, in je znašal 25,8 % danega odmerka.
The recommended dose is 125 mg of palbociclib once daily for 21 consecutive days followed by 7 days off treatment (Schedule 3/1) to comprise a complete cycle of 28 days.
Priporočeni odmerek palbocikliba je 125 mg enkrat na dan 21 zaporednih dni, čemur sledi 7 dni brez zdravljenja (shema 3/1) tako, da celotni cikel traja 28 dni.
Based on these results, palbociclib should be taken with food (see section 4.2).
Ti rezultati kažejo, da je treba palbociklib jemati s hrano (glejte poglavje 4.2).
Additional efficacy measures (OR and TTR) assessed in the sub-groups of patients with or without visceral disease are displayed in Table 9.
Dodatna merila učinkovitosti (OR in TTR) so ocenili pri podskupinah bolnic z visceralno boleznijo ali brez nje, rezultati pa so prikazani v preglednici 9.
If you stop taking IBRANCE
Če ste prenehali jemati zdravilo IBRANCE
Time-to-Deterioration was prespecified as time between baseline and first occurrence of ≥10 points increase from baseline in pain symptom scores.
Čas do poslabšanja so vnaprej opredelili kot čas od izhodišča do prvega pojava povečanja rezultata simptomov bolečine za ≥ 10 točk od izhodiščne vrednosti.
• Cyclosporine, everolimus, tacrolimus, and sirolimus used in organ transplantation to prevent rejection.
• ciklosporin, everolimus, takrolimus in sirolimus, ki se uporabljajo za preprečevanje zavrnitve organov po presaditvi,
The relevance of the male rat neoplastic finding to humans is unknown.
Pomen pojava neoplastičnih sprememb pri samcih podgan za človeka ni znan.
Since IBRANCE has myelosuppressive properties, it may predispose patients to infections.
Ker ima zdravilo IBRANCE mielosupresivne lastnosti, lahko pri bolnikih poveča nagnjenost k okužbam.
Consider dose reduction in cases of prolonged (>1 week) recovery from Grade 3 neutropenia or recurrent Grade 3 neutropenia on Day 1 of subsequent cycles.
V primerih dolgotrajnega (> 1 teden) okrevanja od nevtropenije stopnje 3 ali ponovljene nevtropenije stopnje 3, v naslednjih ciklih razmislite o zmanjšanju odmerka na 1. dan cikla.
Febrile neutropenia has been reported in about 2% of patients exposed to IBRANCE across the overall clinical programme.
V celotnem kliničnem programu so o febrilni nevtropeniji poročali pri približno 2 % bolnikov, ki so bili izpostavljeni zdravilu IBRANCE.
In vitro evaluations indicate that palbociclib has low potential to inhibit the activities of organic anion transporter (OAT)1, OAT3, organic cation transporter (OCT)2, organic anion transporting polypeptide (OATP)1B1, OATP1B3, and bile salt export pump (BSEP) at clinically relevant concentrations.
In vitro vrednotenja kažejo, da ima palbociklib v klinično pomembnih koncentracijah majhen potencial za zaviranje aktivnosti prenašalca organskih anionov (OAT)1, OAT3, prenašalca organskih kationov (OCT)2, polipeptidnega prenašalca organskih anionov (OATP)1B1, OATP1B3 in črpalke žolčnih soli (BSEP - Bile Salt Export Pump).
Females of childbearing potential who are receiving this medicinal product, or their male partners should use adequate contraceptive methods (e.g., double-barrier contraception) during therapy and for at least 3 weeks or 14 weeks after completing therapy for females and males, respectively (see section 4.5).
Ženske v rodni dobi, ki prejemajo to zdravilo, ali njihovi moški partnerji morajo med zdravljenjem in vsaj 3 tedne (ženske) oziroma 14 tednov (moški) po koncu zdravljenja uporabljati ustrezne kontracepcijske metode (npr. dvojna mehanska kontracepcija) (glejte poglavje 4.5).
Adverse reactions based on pooled dataset from 3 randomised studies (N=872)
Neželeni učinki, ki temeljijo na združeni zbirki podatkov iz 3 randomiziranih preskušanj (n = 872)
Withhold IBRANCE until recovery to Grade ≤2.
Prekinite zdravljenje z zdravilom IBRANCE do izboljšanja na stopnjo ≤ 2.
The mean absolute bioavailability of palbociclib after an oral 125 mg dose is 46%.
Povprečna absolutna biološka uporabnost palbocikliba po peroralnem odmerku 125 mg je 46 %.
Insufficient data are available in patients requiring haemodialysis to provide any dose adjustment recommendation in this patient population (see sections 4.4 and 5.2).
Pri bolnikih, ki potrebujejo hemodializo, ni na voljo dovolj podatkov za kakršnakoli priporočila glede prilagajanja odmerka pri tej skupini bolnikov (glejte poglavji 4.4 in 5.2).
• Rifampin used to treat tuberculosis (TB).
• rifampicin, ki se uporablja za zdravljenje tuberkuloze,
Palbociclib was not mutagenic in a bacterial reverse mutation (Ames) assay and did not induce structural chromosomal aberrations in the in vitro human lymphocyte chromosome aberration assay.
Palbociklib ni deloval mutageno pri preskusu reverzne mutacije pri bakterijah (Amesov test) in ni sprožil strukturnih kromosomskih aberacij pri in vitro preskusu kromosomskih aberacij na humanih limfocitih.
Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnoea).
Bolnike je treba spremljati glede pljučnih simptomov, ki kažejo na ILD/pnevmonitis (npr. hipoksija, kašelj, dispneja).
Palbociclib should not be taken with grapefruit or grapefruit juice (see section 4.5).
Palbocikliba ne smemo jemati z grenivko ali grenivkinim sokom (glejte poglavje 4.5).
Based on male reproductive organ findings (seminiferous tubule degeneration in testis, epididymal hypospermia, lower sperm motility and density, and decreased prostate secretion) in nonclinical safety studies, male fertility may be compromised by treatment with palbociclib (see section 5.3).
Ugotovitve glede moških reprodukcijskih organov (degeneracija semenskih kanalov v modih, hipospermija epididimisa, manjša gibljivost in gostota semenčic ter zmanjšano izločanje prostate) v predkliničnih študijah varnosti kažejo, da zdravljenje s palbociklibom lahko ogrozi plodnost pri moških (glejte poglavje 5.3).
Therefore, concomitant use of palbociclib with strong CYP3A4 inducers should be avoided.
Sočasni uporabi palbocikliba z močnimi induktorji CYP3A4 se je zato treba izogibati.
When coadministered with palbociclib, the recommended dose of fulvestrant is 500 mg administered intramuscularly on Days 1, 15, 29, and once monthly thereafter.
Pri sočasnem dajanju s palbociklibom je priporočeni odmerek fulvestranta 500 mg intramuskularno 1., 15. in 29. dan ter nato enkrat na mesec.
* Secondary endpoints results are based on confirmed and unconfirmed responses according to RECIST 1.1.
* Rezultati sekundarnih opazovanih dogodkov temeljijo na potrjenih in nepotrjenih odzivih v skladu z merili RECIST 1.1.
In the event of a palbociclib overdose, both gastrointestinal (e.g., nausea, vomiting) and haematological (e.g., neutropenia) toxicity may occur and general supportive care should be provided.
V primeru prevelikega odmerjanja palbocikliba se lahko pojavita gastrointestinalna (npr. navzea, bruhanje) in hematološka (npr. nevtropenija) toksičnost in zagotoviti je treba splošno podporno oskrbo.
Prior to the start of treatment with the combination of palbociclib plus fulvestrant, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice.
Pred začetkom zdravljenja s kombinacijo palbocikliba in fulvestranta in skozi celotno trajanje tega zdravljenja je treba ženske v pred-/perimenopavzi zdraviti z agonisti LHRH, skladno z lokalno klinično prakso.
In a pharmacokinetic study in healthy volunteers, palbociclib AUCinf and Cmax values were 30% and 35% higher, respectively, in Japanese subjects compared with non-Asian subjects after a single oral dose.
V farmakokinetični študiji pri zdravih prostovoljcih so bile vrednosti AUCinf in cmax palbocikliba pri japonskih preskušancih po enkratnem peroralnem odmerku 30 % oziroma 35 % večje v primerjavi z neazijskimi preskušanci.
CTCAE=Common Terminology Criteria for Adverse Events.
CTCAE = merila NCI za poenoteno terminologijo neželenih dogodkov (National Cancer Institute Common Terminology Criteria for Adverse Events).
Therefore, administration of palbociclib with medicinal products that are substrates of P-gp (e.g., digoxin, dabigatran, colchicine) or BCRP (e.g., pravastatin, rosuvastatin, sulfasalazine) may increase their therapeutic effect and adverse reactions.
Uporaba palbocikliba z zdravili, ki so substrati P-gp (npr. digoksin, dabigatran, kolhicin) ali BCRP (npr. pravastatin, rosuvastatin, sulfasalazin), zato lahko poveča njihov terapevtski učinek in neželene učinke.
Do not chew or crush the capsules.
Kapsul ne žvečite ali drobite.
When coadministered with palbociclib, the aromatase inhibitor should be administered according to the dose schedule reported in the Summary of Product Characteristics.
Pri sočasnem dajanju s palbociklibom je treba zaviralec aromataze dajati v skladu s shemo odmerjanja, ki je navedena v Povzetku glavnih značilnosti zdravila.
The capsule length is 21.7 ± 0.3 mm.
Kapsula je dolga 21,7 ± 0,3 mm.
Table 4 reports the adverse reactions from the pooled dataset of 3 randomised studies.
Preglednica 4 navaja neželene učinke iz združene zbirke podatkov 3 randomiziranih preskušanj.
The pharmacokinetics of palbociclib have not been studied in patients requiring haemodialysis.
Farmakokinetike palbocikliba niso preučevali pri bolnikih, ki so potrebovali hemodializo.
Recommended dose
Odmerek priporočeni odmerek
Grade 3: ANC 500 - <1000/mm3; Grade 4: ANC <500/mm3.
3; stopnja 2: ANC 1.000 - < 1.500/mm stopnja 3: ANC 500 - < 1.000/mm 3; stopnja 4: ANC < 500/mm
What you need to know before you take IBRANCE 3.
Kaj morate vedeti, preden boste vzeli zdravilo IBRANCE 3.Kako jemati zdravilo IBRANCE 4.
• Dihydroergotamine and ergotamine used to treat migraine.
• dihidroergotamin in ergotamin, ki se uporabljata za zdravljenje migrene,
Data from a DDI study in healthy male subjects indicated that palbociclib exposures were comparable when a single dose of palbociclib was coadministered with multiple doses of tamoxifen and when palbociclib was given alone.
Podatki iz študije DDI pri zdravih moških preskušancih so pokazali primerljive izpostavljenosti palbociklibu pri sočasni uporabi enkratnega odmerka palbocikliba skupaj z večkratnimi odmerki tamoksifena, v primerjavi s samostojno uporabo palbocikliba.
How to store IBRANCE 6.
Shranjevanje zdravila IBRANCE 6.
Randomised Phase 3 Study PALOMA-3: IBRANCE in combination with fulvestrant
Randomizirano preskušanje 3. faze PALOMA-3: zdravilo IBRANCE v kombinaciji s fulvestrantom
Table 5 reports the laboratory abnormalities observed in pooled datasets from 3 randomised studies.
Preglednica 5 navaja laboratorijske nenormalnosti, opažene v združeni zbirki podatkov 3 randomiziranih preskušanj.
Critical visceral disease
Kritična visceralna bolezen
The most common (≥2%) Grade ≥3 adverse reactions of palbociclib were neutropenia, leukopenia, infections, anaemia, aspartate aminotransferase (AST) increased, fatigue, and alanine aminotransferase (ALT) increased.
Najpogostejši (≥ 2 %) neželeni učinki palbocikliba stopnje ≥ 3 so bili nevtropenija, levkopenija, okužbe, anemija, zvečane vrednosti aspartat-aminotransferaze (AST), utrujenost in zvečane vrednosti alanin-aminotransferaze (ALT).
Therefore, IBRANCE should be taken with food, preferably a meal (see sections 4.2 and 5.2).
Zdravilo IBRANCE je zato treba jemati s hrano, priporočljivo z obrokom (glejte poglavji 4.2 in 5.2).
In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.
Pri ženskah v pred- in perimenopavzi je treba endokrino zdravljenje kombinirati z agonistom gonadoliberina (LHRH - Luteinizing Hormone-Releasing Hormone).
The Kaplan-Meier curves for PFS based on the updated cutoff date of 31 May 2017 are displayed in Figure 1 below.
Na spodnji sliki 1 so prikazane Kaplan-Meierjeve krivulje za PFS, ki temeljijo na posodobljenem datumu zaključka zajema podatkov, 31. maju 2017.
Capsule shell: gelatin, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).
Ovojnica kapsule: želatina, rdeči železov oksid (E172), rumeni železov oksid (E172), titanov dioksid (E171).
Testing of palbociclib in a panel of molecularly profiled breast cancer cell lines revealed high activity against luminal breast cancers, particularly ER-positive breast cancers.
Preskušanje palbocikliba v naboru molekularno profiliranih celičnih linij raka dojk je pokazalo visoko aktivnost proti luminalnim tipom raka dojk, zlasti raku dojk, pozitivnem na estrogenske receptorje (ER).
In vitro studies with human hepatocytes, liver cytosolic and S9 fractions, and recombinant sulphotransferase (SULT) enzymes indicated that CYP3A and SULT2A1 are mainly involved in the metabolism of palbociclib.
Študije in vitro na humanih hepatocitih, jetrnih citosolskih in S9 frakcijah in rekombinantnih encimih iz skupine sulfotransferaz (SULT) so pokazale, da sta v presnovo palbocikliba vključena predvsem encima CYP3A in SULT2A1.
Secondary endpoint results are based on confirmed and unconfirmed responses according to RECIST 1.1.
Rezultati sekundarnih opazovanih dogodkov temeljijo na potrjenih in nepotrjenih odzivih v skladu z merili RECIST 1.1.
• Voriconazole, itraconazole, ketoconazole, and posaconazole used to treat fungal infections.
• vorikonazol, itrakonazol, ketokonazol in posakonazol, ki se uporabljajo za zdravljenje glivičnih okužb,
Treatment of pre/perimenopausal women with the combination of palbociclib plus an aromatase inhibitor should always be combined with an LHRH agonist (see section 4.4).
Zdravljenje žensk v pred- in perimenopavzi s kombinacijo palbocikliba in zaviralca aromataze je treba vedno kombinirati z agonistom LHRH (glejte poglavje 4.4).
The observed hazard ratio (HR) was 0.576 (95% confidence interval [CI]: 0.46, 0.72) in favour of palbociclib plus letrozole, with a stratified log-rank test 1-sided p-value of <0.000001.
Opaženo razmerje ogroženosti (HR - Hazard Ratio) je bilo 0,576 (95 % IZ: 0,46; 0,72) v korist palbociklibu in letrozolu, pri čemer je bila 1-stranska vrednost p stratificiranega log-rang testa < 0,000001.
In addition, based on a population pharmacokinetic analysis that included 183 patients with advanced cancer, where 73 patients had mild renal impairment and 29 patients had moderate renal impairment, mild and moderate renal impairment had no effect on the pharmacokinetics of palbociclib.
Poleg tega, na podlagi populacijske farmakokinetične analize podatkov 183 bolnikov z napredovalim rakom, od katerih je 73 bolnikov imelo blago okvaro ledvic, 29 bolnikov pa je imelo zmerno okvaro ledvic, blaga ali zmerna okvara ledvic ni imela nobenega učinka na farmakokinetiko palbocikliba.
Primary Analysis (26 February 2016 Cutoff)
Primarna analiza (datum zaključka 26. februar 2016)