FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients had received prior systemic therapy and most patients in each treatment arm had received a previous chemotherapy regimen for their primary diagnosis.
Slovenian: Vse bolnice so prejele predhodno sistemsko zdravljenje in večina bolnic v vsaki zdravljeni skupini je prejela predhodno kemoterapijo za svojo primarno diagnozo.
English: Do not take IBRANCE:
Slovenian: Ne jemljite zdravila IBRANCE:
English: However, in a follow-up study with fresh tumour samples, no relation between RB1 expression and tumour response was observed.
Slovenian: Vendar pa v nadaljevalni študiji s svežimi vzorci tumorja niso opazili povezave med ekspresijo RB1 in odzivom tumorja.
English: N=number of patients; CI=confidence interval; OR=objective response based on confirmed and unconfirmed responses according to RECIST 1.1; TTR=time to first tumour response.
Slovenian: n = število bolnic; IZ = interval zaupanja; OR = objektivni odziv na podlagi potrjenih in nepotrjenih odzivov v skladu z merili RECIST 1.1; TTR = čas do prvega odziva tumorja.
English: • Grade ≤2 (if not considered a safety risk for the patient) Resume at the next lower dose.
Slovenian: • stopnje ≤ 2 (če ne predstavlja varnostnega tveganja za bolnika).
English: * letrozole or fulvestrant
Slovenian: * letrozol ali fulvestrant
English: The median duration of palbociclib treatment across the pooled dataset at the time of the final overall survival (OS) analysis was 14.8 months.
Slovenian: Mediani čas trajanja zdravljenja s palbociklibom za združene podatke v času končne analize celokupnega preživetja (OS - Overall Survival) je bil 14,8 mesecev.
English: a Preferred Terms (PTs) are listed according to MedDRA 17.1. b Infections includes all PTs that are part of the System Organ Class Infections and infestations.
Slovenian: a. Priporočeni izrazi (PT - Preferred Terms) so navedeni v skladu z MedDRA 17.1. b. Okužbe vključujejo vse PT, ki so del organskega sistema “Infekcijske in parazitske bolezni”.
English: Updated analysis (23 October 2015 cutoff) IBRANCE plus fulvestrant (N=347)
Slovenian: Posodobljena analiza (datum zaključka 23. oktober 2015) Zdravilo IBRANCE in fulvestrant (n = 347)
English: IBRANCE capsules should be swallowed whole (should not be chewed, crushed, or opened prior to swallowing).
Slovenian: Kapsule zdravila IBRANCE je treba pogoltniti cele (pred zaužitjem jih ne smemo žvečiti, zdrobiti ali odpreti).
English: The results from the investigator-assessed PFS and final OS data from PALOMA-3 study are presented in Table 8.
Slovenian: Rezultati PFS po oceni raziskovalca in končni podatki o OS iz preskušanja PALOMA-3 so predstavljeni v preglednici 8.
English: The following medicines may reduce the effectiveness of IBRANCE:
Slovenian: Naslednja zdravila lahko zmanjšajo učinkovitost zdravila IBRANCE:
English: If you take more IBRANCE than you should
Slovenian: Če ste vzeli večji odmerek zdravila IBRANCE, kot bi smeli
English: With repeated once daily administration, palbociclib accumulates with a median accumulation ratio of 2.4 (range 1.5-4.2).
Slovenian: Pri ponavljajočem se odmerjanju enkrat na dan se palbociklib akumulira z medianim akumulacijskim razmerjem 2,4 (razpon 1,5-4,2).
English: Interstitial lung disease/pneumonitis
Slovenian: Intersticijska bolezen pljuč/pnevmonitis
English: If Grade 4 on Day 22, see Grade 4 dose modification guidelines below.
Slovenian: V primeru nevtropenije stopnje 4 na 22. dan glejte spodnje smernice za prilagajanje odmerka pri stopnji 4.
English: Women of childbearing potential who are receiving this medicinal product, or their male partners should use adequate contraceptive methods (e.g., double-barrier contraception such as condom and diaphragm).
Slovenian: Ženske v rodni dobi, ki prejemajo to zdravilo, ali njihovi moški partnerji morajo uporabljati ustrezno kontracepcijsko metodo (npr. dvojna mehanska kontracepcija, kot je kondom in diafragma).
English: Through inhibition of CDK4/6, palbociclib reduced cellular proliferation by blocking progression of the cell from G1 into S phase of the cell cycle.
Slovenian: Z zaviranjem CDK4/6 je palbociklib zmanjšal proliferacijo celic tako, da je blokiral napredovanje celice iz faze G1 v fazo S celičnega cikla.
English: The pharmacokinetics of palbociclib were characterised in patients with solid tumours including advanced breast cancer and in healthy volunteers.
Slovenian: Farmakokinetiko palbocikliba so ugotavljali pri bolnikih s čvrstimi tumorji, vključno z napredovalim rakom dojk, ter pri zdravih prostovoljcih.
English: The mean Cmax of palbociclib is generally observed between 6 to 12 hours following oral administration.
Slovenian: Povprečno vrednost cmax palbocikliba so na splošno opažali med 6 do 12 urami po peroralnem dajanju.
English: The relevant Kaplan-Meier plots are shown in Figures 2 and 3, respectively.
Slovenian: Ustrezni Kaplan-Meierjevi grafi so predstavljeni na sliki 2 oziroma 3.
English: Palbociclib was assessed for carcinogenicity in a 6-month transgenic mouse study and in a 2-year rat study.
Slovenian: Kancerogenost palbocikliba so ocenjevali v 6-mesečni študiji na transgenih miših in v 2-letni študiji na podganah.
English: Management of some adverse reactions may require temporary dose interruptions/delays, and/or dose reductions, or permanent discontinuation as per dose reduction schedules provided in Tables 1, 2, and 3 (see sections 4.4 and 4.8).
Slovenian: Obvladovanje nekaterih neželenih učinkov lahko zahteva začasno prekinitev/odložitev odmerkov in/ali zmanjšanje odmerkov ali trajno prekinitev zdravljenja skladno s shemami zmanjševanja odmerkov, navedenimi v preglednicah 1, 2 in 3 (glejte poglavji 4.4 in 4.8).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Slovenian: Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu.O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. Stem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Patient-reported symptoms were assessed using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 and its Breast Cancer Module (EORTC QLQ-BR23).
Slovenian: Simptome, o katerih so poročale bolnice, so ocenili z uporabo vprašalnika o kakovosti življenja (QLQ)-C30 Evropske organizacije za raziskave in zdravljenje raka (EORTC - European Organisation for Research and Treatment of Cancer) in njegovega modula za raka dojk (EORTC QLQ-BR23).
English: It should be taken with food, preferably a meal to ensure consistent palbociclib exposure (see section 5.2).
Slovenian: Jemati ga je treba s hrano, priporočljivo z obrokom, da zagotovimo konsistentno izpostavljenost palbociklibu (glejte poglavje 5.2).
English: PALOMA-2 (intent-to-treat population) - Efficacy results based on primary and updated cutoff dates
Slovenian: PALOMA-2 (populacija z namenom zdravljenja (Intent-To-Treat [ITT] population)) - Rezultati učinkovitosti, ki temeljijo na primarnem in posodobljenem datumu zaključka zajema podatkov
English: What IBRANCE is and what it is used for
Slovenian: Kaj je zdravilo IBRANCE in za kaj ga uporabljamo
English: Each carton contains 21 hard capsules (3 blister strips per pack) or 63 hard capsules (9 blister strips per pack).
Slovenian: Ena škatla vsebuje 21 trdih kapsul (3 pretisni omoti na pakiranje) ali 63 trdih kapsul (9 pretisnih omotov na pakiranje).
English: CBR=clinical benefit response; CI=confidence interval; N=number of patients; OR=objective response.
Slovenian: CBR = odziv klinične koristi; IZ = interval zaupanja; n = število bolnic; OR = objektivni odziv.
English: The majority of patients (97.4%) had metastatic disease at baseline, 23.6% of patients had bone-only disease, and 49.2% of patients had visceral disease.
Slovenian: Ob izhodišču je imela večina bolnic (97,4 %) metastatsko bolezen; 23,6 % bolnic je imelo bolezen samo v kosteh in 49,2 % jih je je imelo visceralno bolezen.
English: In the placebo plus fulvestrant arm, 15.5% of randomised patients received palbociclib and other CDK inhibitors as post progression subsequent treatments.
Slovenian: V skupini s placebom in fulvestrantom je 15,5 % randomiziranih bolnikov prejelo palbociklib in druge zaviralce CDK kot nadaljnje zdravljenje po napredovanju bolezni.
English: The efficacy and safety of palbociclib have not been studied in patients with critical visceral disease (see section 5.1).
Slovenian: Varnosti in učinkovitosti palbocikliba pri bolnikih s kritično visceralno boleznijo niso preučevali (glejte poglavje 5.1).
English: Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.4% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3, and no Grade 4 or fatal cases were reported.
Slovenian: V kliničnih preskušanjih (PALOMA-1, PALOMA-2, PALOMA-3) je imelo ILD/pnevmonitis katerekoli stopnje 1,4 % bolnikov, ki so se zdravili z zdravilom IBRANCE, ILD/pnevmonitis stopnje 3 je imelo 0,1 % bolnikov, o stopnji 4 ali smrtnih primerih pa niso poročali.
English: Grade 3 ANCb (<1000 to 500/mm3) + Fever ≥38.5 ºC and/or infection
Slovenian: ANC stopnje 3 (< 1.000 do 500/mm + vročina ≥ 38,5 ºC in/ali okužba
English: Food intake increased the palbociclib exposure in this small subset of the population, but did not alter palbociclib exposure in the rest of the population to a clinically relevant extent.
Slovenian: Vnos hrane je pri tem majhnem delu populacije povečal izpostavljenost palbociklibu, vendar pa izpostavljenosti palbociklibu ni klinično pomembno spremenil pri preostali populaciji.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze-galaktoze tega zdravila ne smejo jemati.
English: No capsule should be ingested if it is broken, cracked, or otherwise not intact.
Slovenian: Če je kapsula zlomljena, zdrobljena ali kakorkoli drugače poškodovana, se je ne sme zaužiti.
English: Concomitant treatment with inhibitors or inducers of CYP3A4
Slovenian: Sočasno zdravljenje z zaviralci ali induktorji CYP3A4
English: However, IBRANCE may cause fatigue and patients should exercise caution when driving or using machines.
Slovenian: Zdravilo IBRANCE lahko povzroči utrujenost, zato morajo biti bolniki pri vožnji in upravljanju strojev previdni.
English: • Nefazodone used to treat depression.
Slovenian: • nefazodon, ki se uporablja za zdravljenje depresije.
English: IBRANCE is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila IBRANCE ne uporabljajte pri nosečnicah in ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: Other medicines and IBRANCE
Slovenian: Druga zdravila in zdravilo IBRANCE
English: Strong inhibitors of CYP3A4 may lead to increased toxicity (see section 4.5).
Slovenian: Močni zaviralci CYP3A4 lahko povečajo toksičnost (glejte poglavje 4.5).
English: Women of childbearing potential or their male partners must use a highly effective method of contraception while taking IBRANCE (see section 4.6).
Slovenian: Ženske v rodni dobi ali njihovi moški partnerji morajo med jemanjem zdravila IBRANCE uporabljati visoko učinkovito kontracepcijsko metodo (glejte poglavje 4.6).
English: For patients who experience a maximum of Grade 1 or 2 neutropenia in the first 6 cycles, complete blood counts for subsequent cycles should be monitored every 3 months, prior to the beginning of a cycle and as clinically indicated.
Slovenian: Pri bolnikih, pri katerih se v prvih 6 ciklih razvije nevtropenija stopnje največ 1 ali 2, je treba celotno krvno sliko v naslednjih ciklih spremljati vsake 3 mesece, pred začetkom cikla ter kot je klinično indicirano.
English: IBRANCE may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death.
Slovenian: Zdravilo IBRANCE lahko med zdravljenjem povzroči hudo ali življenjsko ogrožajoče vnetje pljuč, ki lahko privede do smrti.
English: A total of 405 PFS events were observed; 245 events (55.2%) in the palbociclib plus letrozole arm and 160 (72.1%) in the comparator arm respectively.
Slovenian: Opazili so skupno 405 dogodkov PFS; 245 dogodkov (55,2 %) v skupini s palbociklibom in letrozolom ter 160 (72,1 %) v primerjalni skupini.
English: Similarly, no relation was observed when studying the response to palbociclib in in vivo models with patient-derived xenografts (PDX models).
Slovenian: Podobno niso opazili povezave ob preučevanju odziva na palbociklib v modelih in vivo, v katerih so uporabili heterologen presadek, pridobljen od bolnikov (modeli PDX).
English: However, this finding was not reproduced consistently in subsequent studies in Japanese or Asian breast cancer patients after multiple dosing.
Slovenian: Vendar pa v kasnejših študijah pri japonskih ali azijskih bolnikih z rakom dojk te ugotovitve po večkratnem odmerjanju niso dosledno ponovili.
English: It is not known if IBRANCE is excreted in breast milk.
Slovenian: Ni znano, ali se zdravilo IBRANCE izloča v materino mleko.
English: Pregnancy and breast-feeding and fertility
Slovenian: Nosečnost, dojenje in plodnost
English: • Alfentanil used for anaesthesia in surgery; fentanyl used in pre-procedures as a pain reliever as well as an anaesthetic.
Slovenian: • alfentanil, ki se uporablja za anestezijo in kirurške posege; fentanil, ki se uporablja v postopkih pred posegi kot zdravilo za blaženje bolečin in anestetik,
English: For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg once daily on Schedule 3/1 (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih s hudo okvaro jeter (razred C po klasifikaciji Child-Pugh) je priporočeni odmerek zdravila IBRANCE 75 mg enkrat na dan po shemi 3/1 (glejte poglavji 4.4 in 5.2).
English: • fever, chills, weakness, shortness of breath, bleeding, or easy bruising which could be a sign of a serious blood disorder.
Slovenian: • vročina, mrzlica, oslabelost, kratka sapa, krvavitev ali modrice, ki so lahko znaki resne bolezni krvi,
English: Febrile neutropenia has been reported in 0.9% of patients receiving IBRANCE in combination with fulvestrant and in 1.7% of patients receiving palbociclib in combination with letrozole.
Slovenian: O febrilni nevtropeniji so poročali pri 0,9 % bolnikov, ki so prejemali zdravilo IBRANCE v kombinaciji s fulvestrantom, in pri 1,7 % bolnikov, ki so prejemali palbociklib v kombinaciji z letrozolom.
English: Tell your healthcare provider right away if you have any new or worsening symptoms including:
Slovenian: Nemudoma obvestite zdravnika, če se pri vas pojavijo novi simptomi ali se vam simptomi poslabšajo, vključno z naslednjimi:
English: Effect of acid reducing agents
Slovenian: Učinek zdravil za zmanjševanje kisline
English: What you need to know before you take IBRANCE
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo IBRANCE
English: In vivo, palbociclib is a weak, time-dependent inhibitor of CYP3A.
Slovenian: In vivo je palbociklib šibek, časovno odvisen zaviralec CYP3A.
English: In the dosing range of 25 mg to 225 mg, the area under the curve (AUC) and Cmax increase proportionally with dose in general.
Slovenian: Pri razponu odmerjanja od 25 mg do 225 mg vrednosti površine pod krivuljo (AUC) in cmax na splošno naraščata sorazmerno z odmerkom.
English: If coadministration with a strong CYP3A inhibitor is unavoidable, reduce the IBRANCE dose to 75 mg once daily.
Slovenian: Če se sočasni uporabi z močnim zaviralcem CYP3A4 ni mogoče izogniti, zmanjšajte odmerek zdravila IBRANCE na 75 mg enkrat na dan.
English: † 1-sided p-value from the log-rank test stratified by the presence of visceral metastases and sensitivity to prior endocrine therapy per randomisation.
Slovenian: 1-stranska vrednost p log-rang testa, ki so ga stratificirali glede na prisotnost visceralnih metastaz in občutljivost na predhodno endokrino zdravljenje v skladu z randomizacijo.
English: Efficacy results - PALOMA-3 study (investigator assessment, intent-to-treat population)
Slovenian: Rezultati učinkovitosti - preskušanje PALOMA-3 (ocena raziskovalca, populacija z namenom zdravljenja)
English: More than half (62%) had an ECOG PS of 0, 60% had visceral metastases, and 60% had received more than 1 prior hormonal regimen for their primary diagnosis.
Slovenian: Več kot polovica (62 %) je imela stanje zmogljivosti (PS - Performance Status) po lestvici ECOG (Eastern Cooperative Oncology Group) 0, 60 % jih je imelo visceralne metastaze in 60 % jih je predhodno prejelo več kot 1 shemo hormonskega zdravljenja za svojo primarno diagnozo.
English: In vitro, palbociclib is not an inhibitor of CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, and 2D6, and is not an inducer of CYP1A2, 2B6, 2C8, and 3A4 at clinically relevant concentrations.
Slovenian: In vitro, palbociklib v klinično pomembnih koncentracijah ni zaviralec CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19 in 2D6, kot tudi ni induktor CYP1A2, 2B6, 2C8 in 3A4.
English: Palbociclib absorption and exposure were very low in approximately 13% of the population under the fasted condition.
Slovenian: Na tešče sta bili absorpcija palbocikliba in izpostavljenost palbociklibu zelo majhni pri približno 13 % populacije.
English: There are no or limited amount of data from the use of palbociclib in pregnant women.
Slovenian: Podatkov o uporabi palbocikliba pri nosečnicah ni oziroma so omejeni.
English: IBRANCE has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo IBRANCE ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: N/A
Slovenian: N/V
English: The recommended dose is 125 mg of IBRANCE taken once a day for 3 weeks followed by 1 week without taking IBRANCE.
Slovenian: Priporočeni odmerek je 125 mg zdravila IBRANCE enkrat na dan 3 tedne, čemur sledi 1 teden brez jemanja tega zdravila.
English: Patients should be monitored for signs and symptoms of infection and treated as medically appropriate (see section 4.2).
Slovenian: Bolnike je treba spremljati glede znakov in simptomov okužbe ter jih ustrezno zdraviti (glejte poglavje 4.2).
English: The exposure of animals at the no observed effect level for aneugenicity was approximately 7 times human clinical exposure based on AUC.
Slovenian: Izpostavljenost živali pri vrednosti koncentracije brez opaznega učinka za anevgenost je bila približno 7-krat večja od klinične izpostavljenosti pri ljudeh na osnovi vrednosti AUC.
English: IBRANCE is for oral use.
Slovenian: Zdravilo IBRANCE je za peroralno uporabo.
English: In patients who have new or worsening respiratory symptoms and are suspected to have developed ILD/pneumonitis, interrupt IBRANCE immediately and evaluate the patient.
Slovenian: Pri bolnikih, pri katerih se pojavijo novi respiratorni simptomi ali se respiratorni simptomi poslabšajo in obstaja sum na pojav ILD/pnevmonitisa, takoj prekinite zdravljenje z zdravilom IBRANCE in ocenite bolnika.
English: Grade 1 or 2
Slovenian: Prilagoditve odmerka stopnja 1 ali 2
English: Avoid grapefruit and grapefruit juice while you are taking IBRANCE as it may increase the side effects of IBRANCE.
Slovenian: Med jemanjem zdravila IBRANCE se izogibajte grenivki in grenivkinemu soku, saj lahko okrepita neželene učinke zdravila IBRANCE.
English: It may therefore have risk of foetal harm if used during pregnancy.
Slovenian: Pri uporabi med nosečnostjo zato lahko obstaja tveganje za poškodbo ploda.
English: IBRANCE is used to treat patients with certain types of breast cancer (hormone receptor-positive, human epidermal growth factor receptor 2-negative) which have spread beyond the original tumour and/or to other organs.
Slovenian: Zdravilo IBRANCE se uporablja za zdravljenje bolnikov z določenimi vrstami raka dojk (pozitivnega na hormonske receptorje in negativnega na receptorje humanega epidermalnega rastnega faktorja 2), ki so se razširili izven prvotnega tumorja in/ali na druge organe.
English: • Pimozide used to treat schizophrenia and chronic psychosis.
Slovenian: • pimozid, ki se uporablja za zdravljenje shizofrenije in kronične psihoze.
English: The adverse reactions are listed by system organ class and frequency category.
Slovenian: Neželeni učinki so navedeni po organskih sistemih in pogostnosti.
English: IBRANCE hard capsules come in different strengths.
Slovenian: Zdravilo IBRANCE trde kapsule je na voljo v različnih jakostih.
English: Coadministration of CYP3A inducers may lead to decreased palbociclib exposure and consequently a risk for lack of efficacy.
Slovenian: Sočasna uporaba induktorjev CYP3A lahko zmanjša izpostavljenost palbociklibu in posledično ogrozi učinkovitost zdravila.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE33.
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinske kinaze; oznaka ATC: L01XE33.
English: Actual foetal exposure and cross-placenta transfer have not been examined.
Slovenian: Dejanske izpostavljenosti ploda in prehajanja skozi placento niso ugotavljali.
English: d Leukopenia includes the following PTs: Leukopenia, White blood cell count decreased.
Slovenian: d. Levkopenija vključuje naslednje PT: levkopenija, zmanjšanje števila belih krvnih celic.
English: • difficulty breathing or shortness of breath
Slovenian: • oteženo dihanje ali kratka sapa,
English: • Quinidine generally used to treat heart rhythm problems.
Slovenian: • kinidin, ki se običajno uporablja za zdravljenje težav s srčnim ritmom,
English: Given the reduced effect on gastric pH of H2-receptor antagonists and local antacids compared to PPIs, no clinically relevant effect of H2-receptor antagonists or local antacids on palbociclib exposure is expected when palbociclib is taken with food.
Slovenian: Ob upoštevanju zmanjšanega učinka antagonistov receptorjev H2 in lokalnih antacidov na želodčni pH v primerjavi z zaviralci protonske črpalke ni pričakovati nobenega klinično pomembnega učinka antagonistov receptorjev H2 ali lokalnih antacidov na izpostavljenost palbociklibu, če palbociklib zaužijemo s hrano.
English: In each treatment arm the majority of patients were White, had documented sensitivity to prior hormonal therapy, and were postmenopausal.
Slovenian: V obeh zdravljenih skupinah je bila večina bolnic belopoltih, imele so dokumentirano občutljivost na predhodno hormonsko zdravljenje in so bile v postmenopavzalnem obdobju.
English: • Clarithromycin and telithromycin antibiotics used to treat bacterial infections.
Slovenian: • klaritromicin in telitromicin, antibiotika, ki se uporabljata za zdravljenje bakterijskih okužb,
English: Do not take a double dose to make up for the forgotten capsules.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: The study met its primary endpoint of prolonging investigator-assessed PFS at the interim analysis conducted on 82% of the planned PFS events; the results crossed the prespecified Haybittle-Peto efficacy boundary (α=0.00135), demonstrating a statistically significant prolongation in PFS and a clinically meaningful treatment effect.
Slovenian: Preskušanje je doseglo svoj primarni cilj izboljšanja PFS, ocenjenega s strani raziskovalca ob vmesni analizi, opravljeni za 82 % načrtovanih dogodkov PFS; rezultati so presegli vnaprej določeno mejo učinkovitosti Haybittle-Peto (α = 0,00135), kar dokazuje statistično pomembno podaljšanje PFS in klinično pomemben učinek zdravljenja.
English: Effects of palbociclib on the pharmacokinetics of other medicinal products
Slovenian: Učinki palbocikliba na farmakokinetiko drugih zdravil
English: If Grade 3 on Day 15, continue IBRANCE at the current dose to complete cycle and repeat complete blood count on Day 22.
Slovenian: V primeru nevtropenije stopnje 3 na 15. dan nadaljujte zdravljenje s trenutnim odmerkom zdravila IBRANCE, da zaključite cikel, in na 22. dan ponovno preglejte celotno krvno sliko.
English: OR (measurable disease) [% (95% CI)] CBR [% (95% CI)]
Slovenian: OR (merljiva bolezen) [% (95 % IZ)] CBR [% (95 % IZ)]