FrancophonIA/ELRC3.0 huggingface dataset:
English: Grade 2 hand-foot syndrome is painful erythema and swelling of the hands and/or feet and/or discomfort affecting the patient's activities of daily living.
Slovenian: Za sindrom 2. stopnje so značilni boleča rdečina in otekanje rok ali nog ali obojih okončin oziroma neugodje, ki že vpliva na bolnikove vsakodnevne dejavnosti.
English: Combination therapy in first-line treatment of metastatic colorectal cancer Data from a multicentre, randomised, controlled phase III clinical study (NO16966) support the use of capecitabine in combination with oxaliplatin or in combination with oxaliplatin and bevacizumab for the first-line treatment of metastatic colorectal cancer.
Slovenian: Kombinirano zdravljenje v prvi liniji metastatskega kolorektalnega raka Podatki iz multicentrične, randomizirane, kontrolirane klinične študije faze III (NO16966) podpirajo uporabo kapecitabina v kombinaciji z oksaliplatinom ali v kombinaciji z oksaliplatinom in bevacizumabom v prvi liniji zdravljenja metastatskega kolorektalnega raka.
English: The overall objective response rates in the all-randomised population (investigator assessment) were 41.6% (capecitabine + docetaxel) vs. 29.7% (docetaxel alone); p = 0.0058.
Slovenian: Celokupni objektivni odziv celotne vključene populacije je bil po oceni raziskovalca 41,6 % v skupini, ki je jemala kapecitabin in docetaksel, ter 29,7 % v skupini, ki je jemala le docetaksel (p = 0,0058).
English: For PVC/PVdC/aluminium blisters Do not store above 30°C.
Slovenian: Za PVC/PVdC-Al pretisne omote Shranjujte pri temperaturi do 30 C.
English: skin loss, skin inflammation, nail disorder - pain in the joints or in the limbs (extremities), chest or back - fever, swelling in the limbs, feeling ill - problems with liver function (seen in blood tests) and increased blood bilirubin (excreted by the liver)
Slovenian: obarvanje kože, izgubo kože, vnetje kože, spremembe na nohtih, - bolečino v sklepih ali v okončinah, prsnem košu ali hrbtu, - povišano telesno temperaturo, otekanje okončin, slabo počutje, - težave z delovanjem jeter (ugotovljene pri krvnih preiskavah) in povišan bilirubin v krvi (ki se izloča preko jeter).
English: The results of a meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine showed that in all studies combined, female gender was statistically significantly associated with an increased risk of developing HFS and diarrhoea and with a decreased risk of developing neutropenia.
Slovenian: Meta-analiza 14 kliničnih preskušanj s podatki od več kot 4.700 bolnikov, zdravljenih s kapecitabinom, je pokazala, da je bil ženski spol statistično značilno povezan z večjim tveganjem za razvoj sindroma roka-noga in driske ter manjšim tveganjem za razvoj nevtropenije, če povzamemo vse študije.
English: Pregnancy and breast-feeding
Slovenian: - Nosečnost in dojenje.
English: Dose modifications for toxicity when capecitabine is used as a 3 weekly cycle in combination with other medicinal products should be made according to table 3 above for capecitabine and according to the appropriate summary of product characteristics for the other medicinal product(s).
Slovenian: Kadar se kapecitabin uporablja z drugimi zdravili v 3-tedenskih ciklih, je treba odmerke zaradi toksičnosti prilagajati v skladu z zgornjo preglednico 3 za kapecitabin in v skladu s primernim povzetkom glavnih značilnosti za drugo zdravilo oz. druga zdravila.
English: Table 4 Summary of related ADRs reported in patients treated with capecitabine monotherapy Body System Very Common
Slovenian: Povzetek z zdravljenjem povezanih neželenih učinkov, o katerih so poročali pri bolnikih, zdravljenih z monoterapijo s kapecitabinom
English: PVC/PVdC/aluminium blisters Do not store above 30°C.
Slovenian: PVC/PVdC/Al pretisni omoti Shranjujte pri temperaturi do 30 C.
English: Monotherapy with capecitabine in adjuvant colon cancer Data from one multicentre, randomised, controlled phase III clinical trial in patients with stage III (Dukes' C) colon cancer supports the use of capecitabine for the adjuvant treatment of patients with colon cancer (XACT Study; M66001).
Slovenian: Samostojno adjuvantno zdravljenje s kapecitabinom pri raku kolona Podatki iz multicentričnega, randomiziranega, kontroliranega kliničnega preskušanja faze III pri bolnikih z rakom kolona stadija III (Dukes C) podpirajo uporabo kapecitabina za adjuvantno zdravljenje bolnikov z rakom kolona (študija X-ACT, M66001).
English: Monotherapy with capecitabine in metastatic colorectal cancer Data from two identically-designed, multicentre, randomised, controlled phase III clinical trials (SO14695; SO14796) support the use of capecitabine for first line treatment of metastatic colorectal cancer.
Slovenian: Samostojno zdravljenje s kapecitabinom pri metastatskem kolorektalnem raku Podatki dveh enako zasnovanih multicentričnih, randomiziranih, kontroliranih preskušanj faze III (SO14695, SO14796) podpirajo uporabo kapecitabina v prvi liniji zdravljenja metastatskega kolorektalnega raka.
English: In the all-randomised population, tests for difference of capecitabine vs 5-FU/LV in disease-free and overall survival showed hazard ratios of 0.88 (95% CI 0.77 - 1.01; p = 0.068) and 0.86 (95% CI 0.74 - 1.01; p = 0.060), respectively.
Slovenian: V celotni randomizirani populaciji so analize zdravljenja s kapecitabinom v primerjavi s 5-FU/LV v preživetju brez bolezni pokazale razmerje ogroženosti 0,88 (95-% interval zaupanja 0,77−1,01; p = 0,068), v celokupnem preživetju pa 0,86 (95-% interval zaupanja 0,74−1,01; p = 0,060).
English: FOLFOX-4+BV (EPP*: N=937; ITT**: N=1017)
Slovenian: FOLFOX-4/FOLFOX-4 + P/FOLFOX-4 + BEVACIZUMAB (EPP*: n = 937; ITT**: n =
English: Dose modifications applied should be applied for the precipitating adverse event as necessary (see section 4.2).
Slovenian: Odmerke prilagajamo, kot je to potrebno (glejte poglavje 4.2) glede na neželeni dogodek, ki je povzročil dehidracijo.
English: In the primary analysis for DFS in the ITT population, XELOX was shown to be significantly superior to 5-FU/LV (HR=0.80, 95% CI=[0.69; 0.93]; p=0.0045).
Slovenian: V primarni analizi preživetja brez bolezni v populaciji, ki so jo nameravali zdraviti (ITT, intent-to-treat), je bila shema XELOX signifikantno superiorna v primerjavi s 5-FU/LV (razmerje ogroženosti 0,80; 95-% interval zaupanja 0,69−0,93; p = 0,0045).
English: You must not breast-feed if you are taking Ecansya and for 2 weeks after the last dose.
Slovenian: Med zdravljenjem z zdravilom Ecansya in še 2 tedna po zadnjem odmerku zdravila ne smete dojiti.
English: Median survival was 442 days (capecitabine + docetaxel) vs. 352 days (docetaxel alone).
Slovenian: Mediana preživetja v skupini, ki je prejemala kapecitabin in docetaksel, je bila 442 dni, v skupini, ki je jemala le docetaksel, pa 352 dni.
English: Capecitabine 1000 mg/m 2 oral twice daily
Slovenian: kapecitabin 1.000 mg/m peroralno dvakrat na dan placebo ali bevacizumab
English: A comparison of XELOX plus bevacizumab versus FOLFOX-4 plus bevacizumab was a pre-specified exploratory analysis.
Slovenian: Primerjava zdravljenja po shemi XELOX v kombinaciji z bevacizumabom in zdravljenja po shemi FOLFOX-4 v kombinaciji z bevacizumabom je bila vnaprej določena eksploratorna analiza.
English: In this trial, 944 patients were randomised to 3-week cycles for 24 weeks with capecitabine (1000 mg/m2 twice daily for 2 weeks followed by a 1-week rest period) in combination with oxaliplatin (130 mg/m2 intravenous infusion over 2-hours on day 1 every 3 weeks); 942 patients were randomised to bolus 5-FU and leucovorin.
Slovenian: V tem preskušanju so 944 bolnikov randomizirali v zdravljenje s kapecitabinom (1.000 mg/m2 dvakrat na dan 2 tedna, sledil je enotedenski premor; te 3-tedenske cikle so ponavljali 24 tednov) v kombinaciji z oksaliplatinom (130 mg/m2 v 2-urni infuziji 1. dan vsake 3 tedne); 942 bolnikov so randomizirali v zdravljenje s 5-FU in levkovorinom v obliki bolusa.
English: Patients ≥ 60 years of age treated with capecitabine plus docetaxel also had more early withdrawals from treatment due to adverse reactions compared to patients < 60 years of age.
Slovenian: Bolniki, stari 60 let ali več, zdravljeni s kapecitabinom in docetakselom, so v primerjavi z bolniki, mlajšimi od 60 let, zaradi neželenih učinkov v večjem številu zgodaj prekinili zdravljenje.
English: weeks followed by 1-week rest period and docetaxel 75 mg/m2 as a 1 hour intravenous infusion every
Slovenian: tedna, sledil je enotedenski premor, in docetaksel 75 mg/m2 v obliki enourne intravenske infuzije vsake 3 tedne).
English: ADRs are added to the appropriate frequency grouping according to the overall incidence from the pooled analysis.
Slovenian: Neželene učinke so v skupine razvrstili glede na njihovo pogostnost, pri tem so upoštevali celokupno incidenco iz analize podatkov o varnosti.
English: + For each term, the frequency count was based on ADRs of all grades.
Slovenian: Pri vsakem terminu so pri določitvi pogostnosti upoštevali neželene učinke vseh stopenj.
English: Ecansya 150 mg film-coated tablets Ecansya 300 mg film-coated tablets Ecansya 500 mg film-coated tablets capecitabine
Slovenian: Ecansya 150 mg filmsko obložene tablete Ecansya 300 mg filmsko obložene tablete Ecansya 500 mg filmsko obložene tablete kapecitabin
English: Administration of capecitabine should be interrupted if treatment-related elevations in bilirubin of >3.0 x ULN or treatment-related elevations in hepatic aminotransferases (ALT, AST) of >2.5 x ULN occur.
Slovenian: Jemanje kapecitabina moramo prekiniti, če se pojavi zvišanje ravni bilirubina nad 3,0-kratno zgornjo referenčno vrednost ali če se poveča aktivnost jetrnih aminotransferaz (ALT, AST) nad 2,5-kratno zgornjo referenčno vrednost.
English: The manifestations of acute overdose include nausea, vomiting, diarrhoea, mucositis, gastrointestinal irritation and bleeding, and bone marrow depression.
Slovenian: Znaki akutnega prevelikega odmerjanja so slabost, bruhanje, driska, mukozitis, vzdraženje prebavil in krvavitve ter depresija kostnega mozga.
English: Combination therapy
Slovenian: Kombinirano zdravljenje
English: - If you get any side effects talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: In this trial, 1987 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period and given as 3week cycles for 24 weeks) or 5-FU and leucovorin (Mayo Clinic regimen: 20 mg/m2 leucovorin intravenous followed by 425 mg/m2 intravenous bolus 5-FU, on days 1 to 5, every 28 days for 24 weeks).
Slovenian: V tem preskušanju so randomizirali 1.987 bolnikov v zdravljenje s kapecitabinom (1.250 mg/m2 dvakrat na dan 2 tedna, sledil je enotedenski premor, dobili so 3-tedenske cikle v 24 tednih) ali s 5-FU in levkovorinom (shema Mayo: 20 mg/m levkovorina intravensko, sledilo je 425 mg/m2 5-FU v obliki intravenskega bolusa vsakih 28 dni - na prvi do peti dan 24 tednov).
English: Standard and reduced dose calculations according to body surface area for starting doses of Ecansya of 1250 mg/m2 and 1000 mg/m2 are provided in tables 1 and 2, respectively.
Slovenian: Standardni in zmanjšani odmerki so za začetni odmerek zdravila Ecansya 1.250 mg/m2 glede na telesno površino izračunani v preglednici 1, za 1.000 mg/m 2 pa v preglednici 2.
English: Interferon alpha: the MTD of capecitabine was 2000 mg/m2 per day when combined with interferon alpha-2a (3 MIU/m2 per day) compared to 3000 mg/m2 per day when capecitabine was used alone.
Slovenian: Interferon alfa: Pri sočasnem jemanju kapecitabina z interferonom alfa (3 mio i. e./m 2 na dan) je bil največji prenosljivi odmerek kapecitabina 2.000 mg/m 2 na dan, pri jemanju samega kapecitabina pa
English: Your doctor may instruct you to decrease the dose and/or temporarily discontinue treatment with Ecansya.
Slovenian: Zdravnik vam bo morda zmanjšal odmerek ali začasno prekinil zdravljenje z zdravilom Ecansya ali oboje, kar bo pomagalo zmanjšati verjetnost, da bi se nadaljevali ali postali resni.
English: INFORMATION IN BRAILLE Ecansya 300 mg
Slovenian: Ecansya 300 mg
English: Palmar-plantar erythrodysaesth esia syndrome**
Slovenian: Bolezni kože in podkožja palmarnoplantarna eritrodisestezija*
English: Renal impairment.
Slovenian: Ledvična okvara.
English: Combination therapy in second-line treatment of metastatic colorectal cancer Data from a multicentre, randomised, controlled phase III clinical study (NO16967) support the use of capecitabine in combination with oxaliplatin for the second-line treatment of metastastic colorectal cancer.
Slovenian: Kombinirano zdravljenje v drugi liniji metastatskega kolorektalnega raka Podatki iz multicentrične, randomizirane, kontrolirane klinične študije faze III (NO16967) podpirajo uporabo kapecitabina v kombinaciji z oksaliplatinom v drugi liniji zdravljenja metastatskega kolorektalnega raka.
English: +Fever,
Slovenian: +levkopenija,
English: 120 Patients were randomised to a modified XELIRI regimen with capecitabine 800 mg/m2 twice daily for two weeks followed by a 7-day rest period), irinotecan (200 mg/m2 as a 30 minute infusion on day 1 every 3 weeks), and bevacizumab (7.5 mg/kg as a 30 to 90 minute infusion on day 1 every 3 weeks); 127 patients were randomised to treatment with capecitabine (1000 mg/m2 twice daily for two weeks followed by a 7-day rest period), oxaliplatin (130 mg/m2 as a 2 hour infusion on day 1 every 3 weeks), and bevacizumab (7.5 mg/kg as a 30 to 90 minute infusion on day 1 every 3 weeks).
Slovenian: Randomizirali so 120 bolnikov v spremenjeno shemo XELIRI: kapecitabin (800 mg/m dvakrat na dan dva tedna, čemur je sledil 7-dnevni premor), irinotekan (200 mg/m2 v 30-minutni infuziji 1. dan vsake 3 tedne) in bevacizumab (7,5 mg/kg v 30 do 90-minutni infuziji 1. dan vsake 3 tedne).
English: Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopenia, Leukopenia, Haemolytic anaemia, International Normalised Ratio (INR) increased/ Prothrombin time prolonged
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija, anemija febrilna nevtropenija, pancitopenija, granulocitopenija, trombocitopenija, levkopenija, hemolitična anemija, zvišano internacionalno normalizirano razmerje/podaljšan protrombinski čas
English: The results indicate that XELOX is equivalent to FOLFOX-4 in terms of overall survival (see table 9).
Slovenian: Glede na rezultate za celokupno preživetje je zdravljenje po shemi XELOX enakovredno zdravljenju po shemi FOLFOX-4 (glejte preglednico 9).
English: Colon, colorectal and breast cancer
Slovenian: Rak kolona in kolorektalni rak ter rak dojk
English: The results of a meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine showed that in all studies combined, increasing age (by 10 year increments) was statistically significantly associated with an increased risk of developing HFS and diarrhoea and with a decreased risk of developing neutropenia.
Slovenian: Meta-analiza 14 kliničnih preskušanj s podatki od več kot 4.700 bolnikov, zdravljenih s kapecitabinom, je pokazala, da je bila višja starost (v korakih po 10 let) statistično značilno povezana z večjim tveganjem za razvoj sindroma roka-noga in driske ter manjšim tveganjem za razvoj nevtropenije, če povzamemo vse študije.
English: Grade 1 hand-foot syndrome is defined as numbness, dysesthesia/paresthesia, tingling, painless swelling or erythema of the hands and/or feet and/or discomfort which does not disrupt the patient's normal activities.
Slovenian: Sindrom roka-noga (znan tudi kot kožna reakcija na roki in nogi, palmarno-plantarna eritrodisestezija ali s kemoterapijo povzročena rdečina okončin): Sindrom 1. stopnje se kaže kot otrplost, disestezija ali parestezija, mravljinčenje, neboleče otekanje ali rdečina rok in nog ali obojih okončin oziroma kot neugodje, ki ne vpliva na bolnikove normalne dejavnosti.
English: ADRs are added to the appropriate frequency grouping (Very common or Common) according to the highest incidence seen in any of the major clinical trials and are only added when they were seen in addition to those seen with capecitabine monotherapy or seen at a higher frequency grouping compared to capecitabine monotherapy (see table 4).
Slovenian: Dodani so samo, če so jih opazili poleg neželenih učinkov, opaženih pri samostojnem zdravljenju s kapecitabinom, ali pa so jih opazili pogosteje (spadajo v višjo skupino po pogostnosti) kot pri samostojnem zdravljenju s kapecitabinom (glejte preglednico 4).
English: Ecansya 500 mg film-coated tablets Each film-coated tablet contains 500 mg capecitabine.
Slovenian: Ecansya 500 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 500 mg kapecitabina.
English: Premedication with an oral corticosteroid such as dexamethasone according to the docetaxel summary of product characteristics should be started prior to docetaxel administration for patients receiving the capecitabine plus docetaxel combination.
Slovenian: Bolniki, ki se sočasno zdravijo s kapecitabinom in docetakselom, morajo v skladu s povzetkom glavnih značilnosti zdravila za docetaksel začeti prejemati premedikacijo s peroralnim kortikosteroidom, kot je deksametazon, preden prejmejo docetaksel.
English: Paraesthesia, Dysaesthesia, Peripheral neuropathy, Peripheral sensory neuropathy, Dysgeusia, Headache
Slovenian: Bolezni živčevja parestezija, disestezija, periferna nevropatija, periferna senzorična nevropatija, disgevzija, glavobol nevtrotoksičnost, tremor, nevralgija, preobčutljivostne reakcije, hipestezija
English: Constipation, Dyspepsia Upper gastrointestinal haemorrhage, Mouth ulceration, Gastritis, Abdominal distension, Gastroesophageal reflux disease, Oral pain, Dysphagia, Rectal haemorrhage, Abdominal pain lower, Oral dysaesthesia, Paraesthesia oral, Hypoaesthesia oral, Abdominal discomfort
Slovenian: mediastinalnega prostora Bolezni prebavil zaprtje, dispepsija krvavitev iz zgornjih prebavil, razjede v ustih, gastritis, abdominalna distenzija, gastroezofagealna refluksna bolezen, bolečina v ustih, disfagija, rektalna krvavitev, bolečina v spodnjem abdomnu, oralna disestezija, oralna parestezija, oralna hipestezija, nelagodje v trebuhu
English: fungal infections (including those of the mouth), influenza, gastroenteritis, tooth abscess - lumps under the skin (lipoma) - decreases in blood cells including platelets, thinning of blood (seen in tests) - allergy - diabetes, decrease in blood potassium, malnutrition, increased blood triglycerides - confusional state, panic attacks, depressed mood, decreased libido - difficulty speaking, impaired memory, loss of movement coordination, balance disorder,
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) vključujejo: - okužbo krvi, okužbo sečil, okužbo kože, okužbe nosu in žrela, glivične okužbe (vključno s tistimi v ustih), gripo, gastroenteritis, zobni absces, - bule pod kožo (lipome), - zmanjšanje števila krvnih celic, vključno s trombociti, redčenje krvi (ugotovljeno pri preiskavah), - alergijo, - sladkorno bolezen, znižanje kalija v krvi, podhranjenost, zvišane trigliceride v krvi, - zmedeno stanje, napade panike, depresivno razpoloženje, zmanjšan libido, - težave z govorjenjem, okrnjen spomin, izgubo gibalne koordinacije, motnje ravnotežja,
English: INFORMATION IN BRAILLE Ecansya 150 mg
Slovenian: Ecansya 150 mg
English: Ecansya 300 mg film-coated tablets (tablets) are white to off white, oblong shaped, biconvex tablets of 14.6 mm in length and 6.7 mm in width, debossed with "300" on one side and plain on other side.
Slovenian: Ecansya 300 mg filmsko obložene tablete (tablete) so bele ali kremne bele barve, podolgovate oblike, bikonveksne, dolžine 14,6 mm in debeline 6,7 mm, z vtisnjeno oznako "300" na eni strani in brez oznake na drugi strani.
English: INFORMATION IN BRAILLE Ecansya 500 mg
Slovenian: Ecansya 500 mg
English: Breast cancer
Slovenian: Rak dojk
English: Ecansya 300 mg film-coated tablets Each film-coated tablet contains 300 mg capecitabine.
Slovenian: Ecansya 300 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 300 mg kapecitabina.
English: The results indicate that XELOX is equivalent to FOLFOX-4 in terms of overall survival (see table 7).
Slovenian: Glede na rezultate za celokupno preživetje je zdravljenje po shemi XELOX enakovredno zdravljenju po shemi FOLFOX-4 (glejte preglednico 7).
English: Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection, Rhinitis, Influenza,
Slovenian: Infekcijske in parazitske bolezni herpes zoster, okužba sečil, oralna kandidoza, okužba zgornjih dihal, rinitis, gripa, okužba, oralni herpes
English: You must not take brivudine (an anti-viral medicine for the treatment of shingles or chickenpox) at the same time as capecitabine treatment (including during any rest periods when you are not taking any capecitabine tablets).
Slovenian: Med zdravljenjem s kapecitabinom (vključno z obdobji premora, ko tablet kapecitabina ne jemljete), ne smete jemati brivudina (protivirusnega zdravila za zdravljenje pasovca ali noric).
English: Median PFS and overall survival (OS) times were shorter for XELIRI versus FOLFIRI (PFS 5.9 versus 9.6 months and OS 14.8 versus 19.9 months), in addition to which excessive rates of diarrhoea were reported in patients receiving the XELIRI regimen (41% XELIRI, 5.1% FOLFIRI).
Slovenian: Mediana preživetja brez napredovanja bolezni (PFS) in celokupnega preživetja (OS) je bila krajša za XELIRI v primerjavi s FOLFIRI (PFS 5,9 v primerjavi z 9,6 meseca in OS 14,8 v primerjavi z 19,9 meseca).
English: Treatment should not be restarted until the patient is rehydrated and any precipitating causes have been corrected or controlled.
Slovenian: Dokler se bolniku stanje popolnoma ne popravi in niso vsi sprožitveni dejavniki pod nadzorom oz. niso odstranjeni, ne smemo pričeti s ponovnim zdravljenjem.
English: Vaginal haemorrhage
Slovenian: Ledvična okvara
English: Ecansya 500 mg film-coated tablets (tablets) are peach coloured, oblong shaped, biconvex tablets of 15.9 mm in length and 8.4 mm in width, debossed with "500" on one side and plain on other side.
Slovenian: Ecansya 500 mg filmsko obložene tablete (tablete) so bele ali kremne bele barve, podolgovate oblike, bikonveksne, dolžine 15,9 mm in debeline 8,4 mm, z vtisnjeno oznako "500" na eni strani in brez oznake na drugi strani.
English: Diarrhoea.
Slovenian: bolnikih.
English: The analysis for the secondary endpoint of RFS supports these results with a HR of 0.78 (95% CI=[0.67; 0.92]; p=0.0024) for XELOX vs. 5-FU/LV.
Slovenian: Analiza preživetja brez ponovitve bolezni (sekundarni cilj preskušanja) te rezultate podpira; razmerje ogroženosti je bilo 0,78 za shemo XELOX v primerjavi s 5-FU/LV (95-% interval zaupanja 0,67−0,92; p = 0,0024).
English: A meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications (colon, colorectal, gastric and breast cancer) showed that HFS (all grades) occurred in 2066 (43%) patients after a median time of 239 [95% CI 201, 288] days after starting treatment with capecitabine.
Slovenian: Meta-analiza 14 kliničnih preskušanj s podatki od več kot 4.700 bolnikov, zdravljenih s kapecitabinom samim ali v kombinaciji z različnimi shemami kemoterapije pri več indikacijah (rak kolona, kolorektalni rak, rak želodca in rak dojk) je pokazala, da se je sindrom roka-noga (vseh stopenj) pojavil pri 2.066 bolnikih (43 %).
English: (130 mg/m 2 on day 1).
Slovenian: 3.000 mg/m 2 na dan.
English: Capecitabine was at least equivalent to intravenous 5-FU/LV in disease-free survival in per protocol population (hazard ratio 0.92; 95% CI 0.80-1.06).
Slovenian: Glede na preživetje brez bolezni v populaciji po protokolu je bil kapecitabin vsaj ekvivalenten intravenskemu 5-FU/LV (razmerje ogroženosti 0,92; 95-% interval zaupanja 0,80−1,06).
English: Capecitabine and its metabolites are predominantly excreted in urine; 95.5% of administered capecitabine dose is recovered in urine.
Slovenian: Kar 95,5 % zaužitega odmerka kapecitabina se izloči z urinom, z blatom pa le 2,6 % odmerka.