FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients treated with docetaxel at 100 mg/m2 as single agent who have serum transaminase levels (ALT and/or AST) greater than 1.5 times the ULN concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN, there is a higher risk of developing severe adverse reactions such as toxic deaths including sepsis and gastrointestinal haemorrhage which can be fatal, febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia.
Slovenian: Pri bolnikih, zdravljenih s 100 mg docetaksela/m2 v monoterapiji, ki imajo serumski transaminazi (ALT, AST ali obe) zvišani nad 1,5-kratno ULN in hkrati zvišano serumsko alkalno fosfatazo nad 2,5-kratno ULN, obstaja večja nevarnost hudih neželenih učinkov, kot so smrti zaradi zastrupitve, vključno s sepso in gastrointestinalno krvavitvijo, ki sta lahko usodni, febrilne nevtropenije, okužb, trombocitopenije, stomatitisa in astenije.
English: The incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis (see section 4.8).
Slovenian: Incidenca nevtropenije, febrilne nevtropenije in nevtropeničnih okužb 4. stopnje se je zmanjšala pri bolnicah, ki so prejemale primarno profilakso z GCSF (glejte poglavje 4.8).
English: Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
Slovenian: O simptomatskem srčnem popuščanju so poročali pri 2,2 % bolnikov, ki so dobivali docetaksel in trastuzumab, in pri 0 % bolnikov, ki so dobivali samo docetaksel.
English: Patients with severe fluid retention such as pleural effusion, pericardial effusion and ascites should be monitored closely.
Slovenian: Bolnike s hudim zastajanjem tekočine, npr. s plevralnim izlivom, perikardialnim izlivom ali ascitesom, je treba skrbno nadzorovati.
English: DOCETAXEL KABI in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Slovenian: Zdravilo DOCETAKSEL KABI je v kombinaciji s cisplatinom in 5-fluorouracilom indiciran za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu.
English: The concomitant use of docetaxel with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) should be avoided (see section 4.5).
Slovenian: Izogibati se je treba sočasni uporabi docetaksela in močnih zaviralcev CYP3A4 (npr. ketokonazola, itrakonazola, klaritromicina, indinavirja, nefazodona, nelfinavirja, ritonavirja, sakvinavirja, telitromicina in vorikonazola) (glejte poglavje 4.5).
English: The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm.
Slovenian: V kraku s TCF je cikel zdravljenja trajal 3 tedne, v kraku s CF pa 4 tedne.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Ready to add to infusion solution.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pripravljeno za dodajanje raztopini za infundiranje.
English: Patients should be closely monitored for early manifestations of serious gastrointestinal toxicity (see sections 4.2, 4.4 Haematology, and 4.8).
Slovenian: Bolnike je treba skrbno nadzirati glede zgodnjih znakov resnih toksičnih učinkov na prebavila (glejte poglavja 4.2, 4.4 Hematologija in 4.8).
English: • Each vial is for single use and should be used immediately after opening.
Slovenian: • Viala je namenjena za enkratno uporabo in jo je treba uporabiti takoj po odprtju.
English: Patients with severe liver impairment (see sections 4.2 and 4.4).
Slovenian: Bolnikih s hudo okvaro jeter (glejte poglavji 4.2 in 4.4).
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes
Slovenian: • Indukcijska kemoterapija in nato kemoradioterapija (TAX 324) Organski sistemi po MedDRA
English: Surgery on the primary site of disease and/or neck could be considered at anytime following completion of CRT.
Slovenian: Operacija na primarnem mestu bolezni in/ali vratu je prišla v poštev kadarkoli po koncu kemoradioterapije.
English: Reporting of adverse effects
Slovenian: Poročanje o neželenih učinkih
English: When used in combination, docetaxel does not influence the clearance of doxorubicin and the plasma levels of doxorubicinol (a doxorubicin metabolite).
Slovenian: V kombinaciji uporabljeni docetaksel ne vpliva ne na očistek doksorubicina ne na koncentracijo doksorubicinola (presnovka doksorubicina) v plazmi.
English: • difficulty or painful swallowing
Slovenian: • težave ali bolečine pri požiranju,
English: Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
Slovenian: Priporočene prilagoditve odmerka v primeru toksičnih učinkov pri bolnikih, ki prejemajo docetaksel v kombinaciji s cisplatinom in 5-fluorouracilom (5-FU):
English: Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose.
Slovenian: Po odkritju prevelikega odmerjanja mora bolnik čim prej dobiti terapevtski G-CSF.
English: Docetaxel pharmacokinetics in the presence of prednisone was studied in patients with metastatic prostate cancer.
Slovenian: Farmakokinetiko docetaksela v prisotnosti prednizona so proučevali pri bolnikih z metastatskim rakom prostate.
English: Cardiac failure; Arrhythmia (no severe)
Slovenian: Srčne bolezni srčno popuščanje, aritmija (nobene hude)
English: • 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
Slovenian: • 174 in 251 bolnikih z rakom glave in vratu, ki so prejemali docetaksel v kombinaciji s cisplatinom in 5-fluorouracilom (predstavljeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki).
English: First episode: reduce 5-FU dose by 20%.
Slovenian: Prvi pojav: zmanjšajte odmerek 5-FU za 20 %.
English: Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4% of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF (see section 4.2).
Slovenian: Febrilna nevtropenija se je pojavila pri 12,1 % bolnikov, ki so dobivali profilakso z G-CSF, in pri 15,6 % tistih, ki je niso, nevtropenična okužba pa se je pojavila pri 3,4 %, ki so dobivali profilakso z G-CSF, in pri 12,9 % tistih, ki je niso (glejte poglavje 4.2).
English: Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information), anhydrous citric acid (for pH adjustment).
Slovenian: Pomožne snovi: polisorbat 80, brezvodni etanol (glejte navodilo za uporabo za več informacij), brezvodna citronska kislina (za uravnavanje pH).
English: Very rare cases of cutaneous lupus erythematosus and bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported with docetaxel.
Slovenian: Zelo redko so pri zdravljenju z docetakselom poročali o kožnem eritematoznem lupusu in o buloznih erupcijah, npr. o multiformnem eritemu, Stevens-Johnsonovem sindromu, toksični nekrolizi epidermisa.
English: For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is < 25,000 cells/mm3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m2.
Slovenian: Bolnikom, ki uvodoma dobijo docetaksel v odmerku 75 mg/m2 v kombinaciji s cisplatinom in imajo v predhodnem ciklu zdravljenja najmanjše število trombocitov < 25.000 celic/mm3, bolnikom, ki doživijo febrilno nevtropenijo, in bolnikom z resnimi nehematološkimi toksičnimi učinki je treba odmerek docetaksela v naslednjih ciklih zmanjšati na 65 mg/m2.
English: Adjuvant therapy for breast cancer
Slovenian: Adjuvantna terapija raka dojke
English: For capecitabine dose calculation according to body surface area, see capecitabine summary of product characteristics.
Slovenian: Za izračun odmerka kapecitabina glede na telesno površino glejte povzetek glavnih značilnosti kapecitabina.
English: Subgroup analyses across age, gender and race consistently favoured the TCF arm compared to the CF arm.
Slovenian: Analiza podskupin po starosti, spolu in rasi dosledno kaže prednost kraka s TCF pred krakom s CF.
English: Discontinue treatment if these toxicities persist (see section 4.4).
Slovenian: Če ti toksični učinki trajajo, zdravljenje prekinite (glejte poglavje 4.4).
English: Febrile neutropenia
Slovenian: febrilna nevtropenija
English: For more details see summary of product characteristics of trastuzumab.
Slovenian: Za nadaljnje podrobnosti glejte povzetek glavnih značilnosti trastuzumaba.
English: Previous therapy should have included an anthracycline.
Slovenian: Predhodna kemoterapija bi morala vključevati antraciklin.
English: Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats (see section 5.3).
Slovenian: Dokazano je, da je docetaksel pri kuncih in podganah embriotoksičen in fetotoksičen ter da pri podganah zmanjšuje plodnost (glejte poglavje 5.3).
English: Prednisone and dexamethasone
Slovenian: Prednizon in deksametazon
English: The required volume of DOCETAXEL KABI concentrate for solution for infusion must be injected via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Slovenian: Potrebno količino koncentrata za raztopino za infundiranje zdravila DOCETAKSEL KABI je treba vbrizgati preko ene injekcije (en odmerek) v 250-ml infuzijsko vrečo ali steklenico, ki vsebuje 5 % raztopino glukoze ali raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: The primary endpoint in this study, progression-free survival (PFS), was significantly longer in the TPF arm compared to the PF arm, p = 0.0042 (median PFS: 11.4 vs. 8.3 months respectively) with an overall median follow up time of 33.7 months.
Slovenian: Primarni končni cilji v tej študiji, preživetje brez napredovanja bolezni (PFS), je bilo signifikantno daljše na kraku TPF kot na kraku PF, p = 0,0042 (mediano PFS: 11,4 proti 8,3 meseca), celotni mediani čas spremljanja pa je bil 33,7 meseca.
English: • swelling of the hands, feet, legs
Slovenian: • otekanje dlani, stopal, nog,
English: In patients who experienced either febrile neutropenia, neutrophil count < 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from 75 to 60 mg/m².
Slovenian: Pri bolnikih, ki so med zdravljenjem z docetakselom doživeli febrilno nevtropenijo, zmanjšanje števila nevtrofilcev na < 500 celic/mm3 za več kot en teden, hude ali kumulativne kožne reakcije ali hudo periferno nevropatijo, je treba odmerek docetaksela zmanjšati s 100 mg/m2 na 75 mg/m2 oz. s 75 na 60 mg/m2.
English: Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
Slovenian: Učinkovitost docetaksela pri zdravljenju bolnikov z adenokarcinomom želodca
English: • stomach upsets including nausea, vomiting and diarrhoea, constipation
Slovenian: • draženje želodca, vključno s slabostjo, bruhanjem in drisko, zaprtje,
English: Acute myeloid leukemia and myelodysplastic syndrome have been reported (frequency uncommon) in pivotal clinical studies in breast cancer with TAC regimen.
Slovenian: O akutni mieloični levkemiji in mielodisplastičnem sindromu so (s pogostnostjo "občasno") poročali v ključnih kliničnih študijah pri raku dojke s shemo TAC.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema:
English: In addition, dexamethasone did not affect protein binding of docetaxel.
Slovenian: Tudi deksametazon ni vplival na vezavo docetaksela na beljakovine.
English: Docetaxel is highly protein bound (> 95%).
Slovenian: Docetaksel je v veliki meri (> 95 %) vezan na beljakovine.
English: • tiredness; or flu-like symptoms
Slovenian: • utrujenost ali gripi podobni simptomi,
English: Infusion site reaction; Pain
Slovenian: reakcija na mestu infundiranja, bolečine
English: In first-line treatment, docetaxel 75 mg/m2 is given in combination therapy with doxorubicin (50 mg/m2).
Slovenian: Kot zdravljenje prvega izbora se docetaksel 75 mg/m2 daje v kombinaciji z doksorubicinom (50 mg/m2).
English: As with all parenteral products, DOCETAXEL KABI infusion solution should be visually inspected prior to use, and solutions containing a precipitate should be discarded.
Slovenian: Tako kot vsa zdravila za parenteralno uporabo je treba tudi raztopino za infundiranje zdravila DOCETAKSEL KABI pred uporabo vizualno pregledati, in če vsebuje precipitat, jo je treba zavreči.
English: At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (TPF/RT).
Slovenian: Na koncu kemoterapije (z najkrajšim presledkom 4 tedne in najdaljšim presledkom 7 tednov) so bolniki, ki jim bolezen ni napredovala, 7 tednov dobivali radioterapijo (RT) v skladu s smernicami ustanove (TPF/RT).
English: **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
Slovenian: *nekorigirani log-rang test **nekorigirani log-rang test, nekorigiran za multiple primerjave ***test hi-kvadrat, nekorigiran za multiple primerjave NP - ni podatka
English: Second episode: stop 5-FU only, at all subsequent cycles.
Slovenian: Drugi pojav: med vsemi naslednjimi cikli opustite le 5-FU.
English: • Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p = 0.009.
Slovenian: • Celotni delež odziva je bil v kraku AT značilno večji kot v kraku AC, p = 0,009.
English: Overall survival was also significantly longer (p = 0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%.
Slovenian: V kraku s TCF je bilo značilno daljše (p = 0,0201) tudi celotno preživetje, tveganje umrljivosti pa se je zmanjšalo za 22,7 %.
English: - The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and anhydrous citric acid (for pH adjustment).
Slovenian: - Pomožne snovi so polisorbat 80, brezvodni etanol (glejte poglavje 2) in brezvodna citronska kislina (za uravnavanje pH).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Fresenius Kabi Deutschland GmbH
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Fresenius Kabi Deutschland GmbH
English: The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomised multi-centre phase III study.
Slovenian: Varnost in učinkovitost docetaksela v kombinaciji s prednizonom ali prednizolonom pri bolnikih z metastatskim hormonsko neodzivnim rakom prostate je bila ocenjena v randominizirani multicentrični študiji faze III.
English: In patients treated with docetaxel every three weeks, the incidence of related nail changes occurred at a rate ≥ 10% higher in patients who were 65 years of age or greater compared to younger patients.
Slovenian: Pri bolnikih zdravljenih z docetakselom vsake tri tedne, ki so bili starejši od 65 let, je bila incidenca pojavljanja z zdravljenjem povezanih sprememb na nohtih ≥ 10 % večja v primerjavi z mlajšimi bolniki.
English: Median survival was 442 days (docetaxel + capecitabine) vs. 352 days (docetaxel alone).
Slovenian: Mediana preživetja je bila 442 dni (docetaksel + kapecitabin) v prim.
English: Without affecting the primary endpoint, overall response rate (32% vs 25%, p = 0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p < 0.01) and median survival (15.3 months vs 12.7 months; p = 0.03).
Slovenian: Docetaksel ni vplival na primarno končno točko, celotni delež odziva (32 % v primerjavi s 25 %, p = 0,10), podaljšal pa je mediani čas do napredovanja bolezni (24,6 tedna v primerjavi s 15,6 tedna, p < 0,01) in mediano preživetje (15,3 meseca v primerjavi z 12,7 meseca, p = 0,03).
English: Pharmacotherapeutic group: antineoplastic agents, plant alkaloids and other natural products, taxanes, ATC Code: L01CD02
Slovenian: Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), Rastlinski alkaloidi in druge naravne učinkovine (zaviralci mitoze), Taksani, oznaka ATC: L01CD02
English: No statistically significant effect of prednisone on the pharmacokinetics of docetaxel was observed.
Slovenian: Niso opazovali statistično značilnih učinkov prednizona na farmakokinetiko docetaksela.
English: Each vial is for single use and should be used immediately after opening.
Slovenian: Viala je namenjena za enkratno uporabo in jo je treba uporabiti takoj po odprtju.
English: First episode: reduce docetaxel and 5-FU doses by 20%.
Slovenian: Prvi pojav: zmanjšajte odmerka docetaksela in 5-FU za 20 %.
English: 61352 Bad Homburg v.d.Höhe Germany
Slovenian: 61352 Bad Homburg v.d. Höhe Nemčija
English: Frequent monitoring of complete blood counts should be conducted on all patients receiving docetaxel.
Slovenian: Vsem bolnikom, ki prejemajo docetaksel, je treba pogosto pregledovati celotno krvno sliko.
English: The median time to progression was 186 days (docetaxel + capecitabine) vs. 128 days (docetaxel alone).
Slovenian: Mediana časa do napredovanja je bila 186 dni (docetaksel + kapecitabin) v prim.
English: Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level >1,500 cells/mm3 and platelets recover to a level >100,000 cells/mm3.
Slovenian: Bolniki ne smejo znova dobiti ciklov docetaksela, dokler se število nevtrofilcev ne poveča na > 1.500 celic/mm3 in število trombocitov na > 100.000 celic/mm3.
English: Women of childbearing potential/ Contraception in males and females Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
Slovenian: Ženske v rodni dobi/ Kontracepcija pri moških in ženskah Ženskam v rodni dobi, ki dobivajo docetaksel, je treba odsvetovati nosečnost; če zanosijo, morajo o tem takoj obvestiti lečečega zdravnika.
English: Preparation for the intravenous administration
Slovenian: Priprava za intravensko aplikacijo
English: • 406 patients who received docetaxel in combination with cisplatin.
Slovenian: • 406 bolnikih, ki so prejemali docetaksel v kombinaciji s cisplatinom.
English: Following chemotherapy, patients should receive chemoradiotherapy.
Slovenian: Po kemoterapiji morajo bolniki prejeti še kemoradioterapijo.
English: If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 to 60 mg/m2.
Slovenian: Če se kljub uporabi G-CSF pojavi febrilna nevtropenija, dolgotrajna nevtropenija ali nevtropenična okužba, je treba odmerek docetaksela zmanjšati s 75 na 60 mg/m2.
English: Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment.
Slovenian: Posvetujte se s svojim zdravnikom, če ste odvisni od alkohola, imate epilepsijo ali okvaro jeter.
English: The development of severe peripheral neurotoxicity requires a reduction of dose (see section 4.2).
Slovenian: Če se pojavijo hudi periferni nevrotoksični učinki, je treba odmerek zmanjšati (glejte poglavje 4.2).
English: For prostate cancer, the premedication is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.2).
Slovenian: Pri zdravljenju raka prostate je premedikacija peroralni deksametazon 8 mg, 12 ur, 3 ure in 1 uro pred infuzijo docetaksela (glejte poglavje 4.2).
English: Doxorubicin
Slovenian: Doksorubicin
English: Two patients in the TAC arm and 4 patients in the FAC arm died because of cardiac failure.
Slovenian: Dve bolnici v kraku s TAC in 4 bolnice v kraku s FAC so zaradi srčnega popuščanja umrle.
English: Patients treated with TCF should receive prophylactic G-CSF to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Slovenian: Bolniki, ki prejemajo TCF, morajo profilaktično prejemati G-CSF za zmanjšanje tveganja za zapleteno nevtropenijo (febrilno nevtropenijo, dolgotrajno nevtropenijo ali nevtropenično okužbo).
English: Second primary malignancies (frequency not known), including non-Hodgkin lymphoma have been reported in association with docetaxel when used in combination with other anticancer treatments known to be associated with second primary malignancies.
Slovenian: O drugih primarnih malignomih (pogostnost ni znana), vključno z ne-Hodgkinovim limfomom, so poročali v povezavi z docetakselom, kadar je bil ta uporabljen v kombinaciji z drugimi zdravili proti raku, za katera je znano, da so povezana s pojavom drugih primarnih malignomov.
English: Following the administration of a 100 mg/m2 dose given as a one-hour infusion a mean peak plasma level of 3.7 μg/ml was obtained with a corresponding AUC of 4.6 h.μg/ml.
Slovenian: Po aplikaciji odmerka 100 mg/m2 v enourni infuziji je bila povprečna največja koncentracija v plazmi 3,7 µg/ml, ustrezna AUC pa 4,6 h.µg/ml.
English: Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-Treat Analysis)
Slovenian: Učinkovitost zdravila docetaksel za indukcijsko zdravljenje bolnikov z inoperabilnim lokalno napredovanim SCCHN (analiza z namenom zdravljenja)
English: For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution.
Slovenian: Primer: za odmerek 140 mg docetaksela potrebujete 7 ml koncentrata docetaksela za raztopino.
English: Fluid retention includes events such as peripheral oedema and less frequently pleural effusion, pericardial effusion, ascites and weight gain.
Slovenian: Zastajanje tekočine je vključevalo pojave, kot so periferni edemi, redkeje plevralni izliv, perikardialni izliv, ascites in povečanje telesne mase.
English: DOCETAXEL KABI must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Slovenian: Zdravila DOCETAKSEL KABI NE smete dobiti, če ste noseči, razen če vam vaš zdravnik ne odredi drugače.
English: Patients receiving TCF should be closely monitored (see sections 4.2 and 4.8).
Slovenian: Bolnike, ki prejemajo TCF, je treba natančno nadzirati (glejte poglavji 4.2 in 4.8).
English: Patients treated with TCF had a longer time to 5% definitive deterioration of global health status on the QLQ-C30 questionnaire (p = 0.0121) and a longer time to definitive worsening of Karnofsky performance status (p = 0.0088) compared to patients treated with CF.
Slovenian: Pri bolnikih, zdravljenih s TCF, je bil v primerjavi s tistimi, ki so jih zdravili s CF, daljši tako čas do 5 % trajnega poslabšanja splošnega zdravstvenega stanja po vprašalniku QLQ-C30 (p = 0,0121) kot čas do trajnega poslabšanja stanja zmogljivosti po Karnofskem (p = 0,0088).
English: In this study, 358 patients with inoperable locally advanced SCCHN, and WHO performance status 0 or 1, were randomised to one of two treatment arms.
Slovenian: V tej študiji so 358 bolnikov z inoperabilnim lokalno napredovalim SCCHN in stanjem zmogljivosti po WHO 0 ali 1 randomizirali v enega od dveh terapevtskih krakov.
English: Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Slovenian: Opisani so redki primeri dehidracije zaradi dogodkov, povezanih s prebavili, vključno z enterokolitisom in gastrointestinalno perforacijo.
English: In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomised to one of two arms.
Slovenian: V tej študiji so 501 bolnika z lokalno napredovalim SCCHN in stanjem zmogljivosti 0 ali 1 po WHO randomizirali v enega od dveh krakov.