FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 790 male patients were allocated to the 2 treatment groups.
Slovenian: Skupno 790 moških je bilo vključenih v 2 terapevtski skupini:
English: • infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets
Slovenian: • okužbe, zmanjšanje števila rdečih krvnih celic (anemija), belih krvnih celic (ki so pomembne za premagovanje okužbe) in trombocitov
English: The premix solution should be used immediately after preparation.
Slovenian: Osnovno raztopino je treba uporabiti takoj po pripravi.
English: • ADT alone
Slovenian: • ADT samo.
English: Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/m is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Slovenian: Zavedati se je treba, da je to verjetno podcenjen delež, kajti znano je, da docetaksel sam v odmerku 100 mg/m2 povzroči nevtropenijo pri 97 % bolnikov, 76 % stopnje 4, na podlagi najnižjega števila celic v krvi.
English: Symptoms such as early abdominal pain and tenderness, fever, diarrhoea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly.
Slovenian: Simptomi kot so: abdominalne bolečine in občutljivost, zvišana telesna temperatura, driska z ali brez nevtropenije, so lahko zgodnja manifestacija resne gastrointestinalne toksičnosti ter jih je potrebno nemudoma ovrednotiti in zdraviti.
English: • swelling caused by faulty lymphatic drainage
Slovenian: • otekanje zaradi nepravilne limfatične drenaže
English: In about 20% of these cases there were no risk factors for acute renal failure such as concomitant nephrotoxic medicinal products and gastrointestinal disorders.
Slovenian: V približno 20 % teh primerov ni bilo nobenih dejavnikov tveganja za akutno ledvično odpoved, sočasnih nefrotoksičnih zdravil in bolezni prebavil.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če ni uporabljena takoj, so čas in pogoji shranjevanja odgovornost uporabnika.
English: Do not store above 25°C or below 2°C.
Slovenian: Ne shranjujte pri temperaturi nad 25°C ali pod 2°C.
English: Among the 1776 randomised patients 1086 (61%) had metastatic disease, 362 were randomised to docetaxel in combination with standard of care, 724 received standard of care alone.
Slovenian: Od 1776 randomiziranih bolnikov jih je 1086 (61 %) imelo metastatsko bolezen, 362 je bilo randomiziranih na docetaksel v kombinaciji s standardno oskrbo, 724 pa jih je prejemalo samo standardno oskrbo.
English: Once added to the infusion bag
Slovenian: Potem, ko je zdravilo dodano v infuzijsko vrečko
English: Shelf life in infusion bag: see the leaflet.
Slovenian: Rok uporabnosti v infuzijski vrečki: glejte navodilo.
English: Ready to add to infusion solution.
Slovenian: Pripravljeno za dodatek raztopini za infundiranje.
English: Docetaxel must not be used in patients with severe liver impairment since there is no data available (see sections 4.2 and 4.4).
Slovenian: Docetaksela se ne sme uporabljati pri bolnikih s hudo okvaro jeter, ker o uporabi pri njih ni podatkov (glejte poglavji 4.2 in 4.4).
English: • rises in blood sugar levels (diabetes)
Slovenian: • zvišanje koncentracije krvnega sladkorja (sladkorna bolezen)
English: Do not store above 25°C.
Slovenian: Ne shranjujte pri temperaturi nad 25°C.
English: • decrease of the sodium and/or magnesium in your blood (electrolyte balance disorders)
Slovenian: • znižanje natrija in /ali magnezija v krvi (motnje ravnotežja elektrolitov)
English: TAXOTERE must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Slovenian: Zdravila TAXOTERE NE smete dobiti, če ste noseči, razen če vam vaš zdravnik ne odredi drugače.
English: 4.1.3 Inject the entire contents of the syringe into the corresponding TAXOTERE vial.
Slovenian: 4.1.3 Vbrizgajte celotno vsebino injekcijske brizge v ustrezno vialo zdravila TAXOTERE.
English: The final analysis was performed when all patients had reached their 10-year follow-up visit (unless they had a DFS event or were lost to followup before).
Slovenian: Končna analiza je bila opravljena, ko so vse bolnice prišle na pregled po 10-letnem spremljanju (razen če se jim je prej pojavil dogodek DFS ali so se prej izgubile spremljanju).
English: If you develop severe skin reactions or any of the reactions listed above, immediately contact your doctor or healthcare professional.
Slovenian: Če se vam pojavi huda kožna reakcija ali kateri koli od zgoraj navedenih učinkov, se nemudoma posvetujte z zdravnikom ali drugim zdravstvenim delavcem.
English: • if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of TAXOTERE
Slovenian: • če ste alergični na (preobčutljivi za) docetaksel ali katero koli sestavino zdravila TAXOTERE
English: ** PSA response: Prostate-Specific Antigen response: PSA level <0.2 ng/mL measured for two consecutive measurements at least 4 weeks apart.
Slovenian: **Odziv PSA: Odziv za prostato specifičnega antigena: koncentracija PSA < 0,2 ng/ml na dveh zaporednih meritvah v presledku vsaj 4 tednov.
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt am Main Germany
Slovenian: Sanofi-Aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt am Main Nemčija
English: TAXOTERE contains ethanol (alcohol)
Slovenian: Zdravilo TAXOTERE vsebuje etanol (alkohol)
English: Stomatitis/mucositis grade 3
Slovenian: Stomatitis/mukoziti s 3. stopnje
English: Inject the entire contents of the syringe into the corresponding TAXOTERE vial.
Slovenian: Vbrizgajte celotno vsebino injekcijske brizge v ustrezno vialo zdravila TAXOTERE.
English: CAUTION: Withdraw the required amount of this docetaxel concentrate (20 mg/ml) from the vial and add it directly into the infusion solution.
Slovenian: OPOZORILO: Odvzemite potrebno količino tega koncentrata docetaksela (20 mg/ml) iz viale in ga dodajte neposredno v raztopino za infundiranje.
English: Each blister pack contains:
Slovenian: En pretisni omot vsebuje:
English: Menopausal status Pre-Menopausal Post-Menopausal
Slovenian: Menopavzalno stanje Pred menopavzo Po menopavzi
English: You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy , because TAXOTERE may be harmful for the unborn baby.
Slovenian: Med zdravljenjem z zdravilom TAXOTERE ne smete zanositi in morate uporabljati učinkovito kontracepcijsko zaščito, ker zdravilo TAXOTERE lahko škoduje vašemu nerojenemu otroku.
English: The premix solution contains 10 mg/ml docetaxel and should be used immediately after preparation.
Slovenian: Osnovna raztopina vsebuje 10 mg docetaksela/ml in jo je treba uporabiti takoj po pripravi.
English: How to use TAXOTERE
Slovenian: Kako uporabljati zdravilo TAXOTERE
English: Docetaxel + standard of care Standard of care alone
Slovenian: Docetaksel + standardna oskrba
English: Second primary malignancies (including acute myeloid leukaemia, myelodysplastic syndrome and non-Hodgkin lymphoma) may occur several months or years after docetaxel-containing therapy.
Slovenian: Drugi primarni malignomi (vključno z akutno mieloično levkemijo, mielodisplastičnim sindromom in ne-Hodgkinovim limfomom) se lahko pojavijo več mesecev ali let po zdravljenju, ki vključuje docetaksel.
English: If you are a man being treated with TAXOTERE you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because docetaxel may alter male fertility.
Slovenian: Če ste moški, ki se zdravi z zdravilom TAXOTERE je priporočljivo, da ne zaplodite otroka med zdravljenjem in v obdobju 6 mesecev po koncu zdravljenja ter da pred začetkom zdravljenja poiščete nasvet glede ohranitve sperme, ker docetaksel lahko prizadene moško plodnost.
English: Full analysis set (intent-to-treat) Estimated median survival
Slovenian: 1celotna množica za analizo (z-namenom-zdravljenja) 2 ocenjeno mediano preživetje
English: 1000 mg/m per day for 5 days.
Slovenian: 1000 mg/m2/dan od 1. do 4. dneva.
English: Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
Slovenian: Odstranite injekcijsko brizgo in iglo ter ročno premešajte tako, da vialo ponavljaje obračate vsaj 45 sekund.
English: This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25% reduction in bidimensionally measured tumour size) was observed after 2 cycles.
Slovenian: To terapevtsko shemo so uporabljali vsake tri tedne za 4 cikle, če so po 2 ciklih opazili vsaj manjši odziv (≥ 25 % zmanjšanje dvodimenzionalno merjene velikosti tumorja).
English: Median duration of response to chemotherapy  radiotherapy (months) (95% CI)
Slovenian: Mediano trajanje odziva na kemoterapijo  radioterapijo (meseci) (95 % IZ)
English: TAXOTERE was administered as a 1-hour infusion, all other medicinal products were given intraveinously on day 1 every three weeks.
Slovenian: Zdravilo TAXOTERE je bilo uporabljeno v 1-urni infuziji, vsa druga zdravila pa intravensko 1. dan na tri tedne.
English: 2-year estimate (%)
Slovenian: 2-letna ocena (%)
English: In the pivotal study the initial docetaxel infusion was started the day following the first dose of trastuzumab.
Slovenian: V ključni študiji so s prvo infuzijo docetaksela začeli dan po prvem odmerku trastuzumaba.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Slovenian: Tako kot vsa druga zdravila, ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Method of administration For instructions on preparation and administration of the product, see section 6.6.
Slovenian: Za navodila glede priprave in dajanja zdravila glejte poglavje 6.6.
English: 5-fluorouracil (F) 750 mg/m per day as a continuous infusion for 5 days.
Slovenian: fluorouracil (F) 750 mg/m2 na dan v obliki neprekinjene infuzije 5 dni.
English: The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates  10% higher in patients who were 65 years of age or older compared to younger patients.
Slovenian: Incidenca naslednjih neželenih učinkov (vse stopnje)letargije, stomatitisa in nevtropenične okužbe - je bila pri bolnikih, starih 65 let ali več,  10 % večja kot pri mlajših bolnikih.
English: The most commonly reported adverse reactions of TAXOTERE alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Slovenian: Najpogosteje poročani neželeni učinki zdravila TAXOTERE samega so: zmanjšanje števila rdečih ali belih krvnih celic, alopecija, siljenje na bruhanje, bruhanje, razjede v ustih, driska in utrujenost.
English: • 545 patients (STAMPEDE study) who received docetaxel in combination with prednisone or prednisolone and ADT.
Slovenian: • 545 bolnikov (študija STAMPEDE), ki so prejemali docetaksel v kombinaciji s prednizonom ali prednizolonom in ADT.
English: In the case of severe neutropenia (< 500 cells/mm for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
Slovenian: Če se med zdravljenjem z docetakselom pojavi huda nevtropenija (< 500 celic/mm3 sedem dni ali več), je med naslednjimi ciklusi priporočljivo zmanjšati odmerek ali uporabiti ustrezne simptomatske ukrepe (glejte poglavje 4.2).
English: Acute leukaemia / Myelodysplastic syndrome.
Slovenian: Akutna levkemija / mielodisplastični sindrom
English: TAXOTERE has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: - For the treatment of advanced breast cancer, TAXOTERE could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Slovenian: Zdravnik vam je zdravilo TAXOTERE predpisal za zdravljenje raka dojke, posebne vrste pljučnega raka (nedrobnocelični pljučni rak), raka prostate, raka želodca ali raka glave in vratu: - Za zdravljenje napredovalega raka dojke se lahko zdravilo TAXOTERE uporablja sam ali v kombinaciji z doksorubicinom ali trastuzumabom ali kapecitabinom.
English: This volume has been established during the development of TAXOTERE to compensate for liquid loss during preparation of the premix (see section 4) due to foaming, adhesion to the walls of the vial and "dead-volume".
Slovenian: Ta polnilni volumen je bil določen med razvojem zdravila TAXOTERE za nadomestitev izgube tekočine, do katere pride med pripravo osnovne raztopine (glejte poglavje 4) zaradi penjenja, adhezije na stene viale in "mrtvega volumna".
English: Discard unused contents appropriately in accordance with local requirements.
Slovenian: Neporabljeno vsebino ustrezno zavrzite v skladu z lokalnimi zahtevami.
English: The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half-lives for the ,  and  phases of 4 min, 36 min and 11.1 h, respectively.
Slovenian: Kinetični profil docetaksela ni odvisen od odmerka in se sklada s trirazdelčnim farmakokinetičnim modelom, pri čemer je razpolovni čas faze α 4 minute, β 36 minut in γ 11,1 ure.
English: • feeling of numbness or pins and needles or pain in the joints or muscles
Slovenian: • občutek omrtvelosti, mravljinčenje ali bolečine v sklepih ali mišicah
English: Docetaxel belongs to the group of anti-cancer medicines called taxoids.
Slovenian: Docetaksel spada v skupino zdravil proti raku, imenovanih taksoidi.
English: • Standard of care alone
Slovenian: • standardna oskrba sama.
English: • Premix solution: The premix solution contains 10 mg/ml docetaxel and should be used immediately after preparation.
Slovenian: • Osnovna raztopina: Osnovna raztopina vsebuje 10 mg docetaksela/ml in jo je treba uporabiti takoj po pripravi.
English: The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m in phase I studies.
Slovenian: Farmakokinetiko docetaksela so ocenili pri onkoloških bolnikih po uporabi 20-115 mg/m2 v študijah I.
English: • one single-dose vial of concentrate and,
Slovenian: • eno eno-odmerno vialo koncentrata in
English: Number of patients Median overall survival (months) All patients
Slovenian: Mediano celokupno preživetje (meseci) Vsi bolniki
English: • Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash.
Slovenian: • Stevens-Johnsonov sindrom (SJS) in toksična epidermalna nekroliza (TEN) (mehurji, lupljenje ali krvavitev na katerem koli predelu kože (tudi na ustnicah, očeh, v ustih, nosu, na spolovilih, dlaneh in stopalih), z izpuščajem ali brez njega.
English: In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m every three weeks, with trastuzumab administered weekly.
Slovenian: Za kombinacijo s trastuzumabom je priporočeni odmerek docetaksela 100 mg/m2 vsake tri tedne, s tedensko aplikacijo trastuzumaba.
English: The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient.
Slovenian: Raztopino za infundiranje v infuzijski vrečki je treba uporabiti v 6 urah na temperaturi do 25°C, to vključuje tudi 1 uro infundiranja bolniku.
English: See also section “TAXOTERE contains ethanol (alcohol)” below.
Slovenian: Glejte tudi poglavje "Zdravilo TAXOTERE vsebuje etanol (alkohol)" spodaj.
English: Neutropenia (Grade 4)
Slovenian: Nevtropenija (4. stopnje)
English: Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m² in all subsequent cycles (see sections 4.4 and 4.8).
Slovenian: Bolnicam, ki se jim pojavi febrilna nevtropenija in/ali nevtropenična okužba, je treba odmerek docetaksela v vseh nadaljnjih ciklusih zmanjšati na 60 mg/m2 (glejte poglavji 4.4 in 4.8).
English: *a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC.
Slovenian: *a razmerje ogroženosti Vrednost (TAC/FAC) manj kot 1 pomeni, da je kombinacija TAC povezana z daljšim preživetjem brez bolezni kot kombinacija FAC.
English: This fill volume has been established during the development of TAXOTERE to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and "dead-volume".
Slovenian: Ta polnilni volumen je bil določen med razvojem zdravila TAXOTERE za nadomestitev izgube tekočine, do katere pride med pripravo osnovne mešanice zaradi penjenja, adhezije na stene viale in "mrtvega volumna".
English: Stomatitis/mucositis grade 4
Slovenian: Stomatitis/mukoziti s 4. stopnje
English: Docetaxel +ADT
Slovenian: Docetaksel + ADT ADT samo
English: - For the treatment of early breast cancer with or without lymph node involvement, TAXOTERE could be administered in combination with doxorubicin and cyclophosphamide.
Slovenian: - Za zdravljenje zgodnjega raka dojke brez ali s prizadetostjo bezgavk se zdravilo TAXOTERE lahko aplicira v kombinaciji z doksorubicinom in ciklofosfamidom.
English: 4.1.4 Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
Slovenian: 4.1.4 Odstranite injekcijsko brizgo in iglo ter ročno premešajte tako, da vialo ponavljaje obračate vsaj 45 sekund.
English: (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: (ALT, AST ali obe) zvišani nad 1,5-kratno ULN in hkrati zvišano serumsko alkalno fosfatazo nad 2,5kratno 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: • tiredness; or flu-like symptoms
Slovenian: • utrujenost ali gripi podobni simptomi
English: 1 vial of solvent for TAXOTERE
Slovenian: 1 viala vehikla za zdravilo TAXOTERE
English: The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates  10% higher in patients who were 75 years of age or greater versus less than 65 years.
Slovenian: Incidenca z zdravljenjem povezane zvišane telesne temperature, diareje, anoreksije in perifernih edemov se je pojavljala  10 % večkrat pri bolnikih nad 75 let v primerjavi z mlajšimi od 65 let.
English: Treatment difference: 6.2% [95% CI: 0.2; 12.3]
Slovenian: razlika zdravljenj: 6,2 % [95 % IZ: 0,2, 12,3]
English: Treatment difference: 5.4% [95% CI: -1.1; 12.0]
Slovenian: razlika zdravljenj: 5,4 % [95 % IZ: -1,1, 12,0]
English: TAXOTERE 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 TAXOTERE je v kombinaciji s cisplatinom in 5-fluorouracilom indiciran za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu.
English: D.
Slovenian: B.
English: In a small number of patients (n = 23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, AST  1.5 times the ULN associated with alkaline phosphatase  2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2).
Slovenian: Pri majhnem številu bolnikov (n = 23) z biokemičnimi izvidi, ki so nakazovali blago do zmerno okvaro jetrne funkcije (ALT, AST ≥ 1,5-kratna ULN hkrati z alkalno fosfatazo ≥ 2,5-kratno ULN), se je celotni očistek v povprečju zmanjšal za 27 % (glejte poglavje 4.2).
English: • 3 years.
Slovenian: • 3 leta
English: • stomach upsets including nausea, vomiting and diarrhoea, constipation
Slovenian: • draženje želodca, vključno s slabostjo, bruhanjem in drisko, zaprtje
English: Docetaxel1 n = 94
Slovenian: Docetaksel1 n = 94
English: It should be used within 6 hours (including the one hour infusion intravenous administration).
Slovenian: Porabiti jo je potrebno v 6 urah (to vključuje tudi 1 uro infundiranja bolniku).
English: 2-year Survival (%)
Slovenian: 2-letno preživetje (%)
English: 256 patients were randomised to treatment with docetaxel alone (100 mg/m as a 1 hour intravenous infusion every 3 weeks).
Slovenian: 256 bolnic so randomizirali na zdravljenje z docetakselom samim (100 mg/m2 v 1-urni intravenski infuziji na 3 tedne).
English: The severity of adverse events of TAXOTERE may be increased when TAXOTERE is given in combination with other chemotherapeutic agents.
Slovenian: Izrazitost neželenih učinkov zdravila TAXOTERE se lahko poveča, če dobivate zdravilo TAXOTERE v kombinaciji z drugimi kemoterapevtiki.
English: 4.2.1 More than one premix vial may be necessary to obtain the required dose for the patient.
Slovenian: 4.2.1 Za odmerek, ki ga potrebuje bolnik, utegne biti potrebna več kot ena viala z osnovno raztopino.
English: Docetaxel plus trastuzumab1 n = 92
Slovenian: Docetaksel in trastuzumab1 n = 92
English: You must not breast-feed while you are treated with TAXOTERE.
Slovenian: Med zdravljenjem z zdravilom TAXOTERE ne smete dojiti.
English: Contains anhydrous ethanol (see leaflet)
Slovenian: Vsebuje brezvodni etanol (glejte navodilo za uporabo)
English: Each vial is of single use and should be used immediately.
Slovenian: Viala je namenjena za enkratno uporabo in jo je treba uporabiti takoj.
English: These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4), the COSTART and the MedDRA terms.
Slovenian: Neželeni učinki so bili opisani po merilih NCI Common Toxicity Criteria (3. stopnja = S3, 3.4. stopnja = S3/4, 4. stopnja = S4) in z izrazi COSTART in MedDRA.
English: decrease  20% (13.1% versus 6.1%), absolute LVEF decrease  30% (6.2% versus 1.1%).
Slovenian: s 6,1 %), absolutno zmanjšanje LVEF ≥ 30 % (6,2 % v prim.
English: It is important that you read the entire contents of this guide prior to the preparation of either the TAXOTERE premix solution or the TAXOTERE infusion solution
Slovenian: Pomembno je, da pred pripravo osnovne raztopine zdravila TAXOTERE ali raztopine za infundiranje zdravila TAXOTERE v celoti preberete ta navodila.
English: CAUTION: Dilution required with the entire contents of the solvent vial.
Slovenian: OPOZORILO: Razredčite s celotno vsebino viale z vehiklom.
English: c The time to clinical progression = the time from randomization until clinical progression (i.e., increased symptoms of bone metastases; progression according to RECIST; or clinical deterioration due to cancer according to the investigator's opinion).
Slovenian: c Čas do kliničnega napredovanja = čas od randomizacije do kliničnega napredovanja (tj. porasta simptomov metastaz v kosteh, napredovanje po merilih RECIST ali klinično poslabšanje zaradi raka po mnenju raziskovalca).
English: Surgery on the primary site of disease and/or neck could be considered at any time following completion of CRT.
Slovenian: Operacija na primarnem mestu bolezni in/ali vratu je prišla v poštev kadarkoli po koncu kemoradioterapije.
English: Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00
Slovenian: Ireland sanofi-aventis Ireland Ltd. Tel: +353 (0) 1 403 56 00
English: Rare cases of myocardial infarction have been reported.
Slovenian: Opisani so bili redki primeri miokardnega infarkta.