natgillin/translations-raw huggingface dataset:
Patients with renal impairment: Based on a pharmacokinetic study in cancer patients with mild to severe renal impairment, there is no evidence for an effect of creatinine clearance on the pharmacokinetics of intact drug and 5-FU. 
Bolesnici s oštećenjem bubrežne funkcije: Prema ispitivanjima farmakokinetike u bolesnika s karcinomom i s blagim do umjerenim oštećenjem bubrežne funkcije, nema dokaza da klirens kreatinina utječe na farmakokinetiku nepromijenjenog lijeka i 5-FU.
• blood clots in the deep veins, high or low blood pressure, hot flushes, cold limbs (extremities), purple spots on the skin 
• krvni ugrušci u dubokim venama, visok ili nizak krvni tlak, navale vrućine, hladni udovi
Periodic Safety Update Reports 
· Periodička izvješća o neškodljivosti
Antacid: the effect of an aluminium hydroxide and magnesium hydroxide-containing antacid on the pharmacokinetics of capecitabine was investigated. 
Ispitivan je učinak antacida koji sadrže aluminij hidroksid i magnezij hidroksid na farmakokinetiku kapecitabina.
Paraesthesia, Dysaesthesia, Peripheral neuropathy, Peripheral sensory neuropathy, Dysgeusia, Headache 
Poremećaji živčanog sustava parestezija, dizestezija, periferna neuropatija, periferna senzorna neuropatija, disgeuzija, glavobolja neurotoksičnost, tremor,
MARKETING AUTHORISATION NUMBER(S) EU/1/00/163/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/163/001
How to take Xeloda 
Kako uzimati lijek Xeloda
Given as monotherapy, the recommended starting dose for capecitabine in the adjuvant treatment of colon cancer, in the treatment of metastatic colorectal cancer or of locally advanced or metastatic breast cancer is 1250 mg/m2 administered twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 14 days followed by a 7-day rest period. 
Preporučena početna doza kapecitabina primijenjenog kao monoterapija u adjuvantnom liječenju karcinoma kolona, liječenju metastatskog kolorektalnog karcinoma ili u liječenju lokalno uznapredovalog ili metastatskog karcinoma dojke iznosi 1250 mg/m² i uzima se dvaput dnevno (ujutro i navečer; što je jednako ukupnoj dnevnoj dozi od 2500 mg/m²) tijekom 14 dana, nakon čega slijedi 7
• Hand-and-foot skin-reaction: if you have pain, swelling, redness or tingling of hands and/or feet 
• kožna reakcija na šakama i stopalima: ako osjećate bol, imate otečene i crvene šake i/ili stopala.
Thrombophlebitis Deep vein thrombosis, Hypertension, 
Krvožilni poremećaji tromboflebitis duboka venska tromboza, hipertenzija, petehije,
In first-line treatment the median progression-free survival in the intent-to-treat population was 5.8 months (95%CI 5.1 - 6.2 months) for capecitabine monotherapy and 7.8 months (95%CI 7.0 - 8.3 months; p=0.0002) for XELIRI. 
U prvoj liniji liječenja medijan vremena preživljenja bez progresije bolesti u populaciji bolesnika predviđenih za liječenje iznosio je 5,8 mjeseci (95% CI 5,1 - 6,2 mjeseca) za monoterapiju kapecitabinom i 7,8 mjeseci (95% CI 7,0 - 8,3 mjeseca; p=0,0002) za XELIRI protokol.
In the allrandomised population, capecitabine was shown to be superior to 5FU/LV for disease-free survival (hazard ratio 0.849; 95% CI 0.739 - 0.976; p = 0.0212), as well as for overall survival (hazard ratio 0.828; 95% CI 0.705 - 0.971; p = 0.0203). 
U cjelokupnoj randomiziranoj populaciji kapecitabin se pokazao superiornijim u odnosu na 5-FU/LV u preživljenju bez znakova bolesti (omjer hazarda 0,849; 95% CI: 0,739 - 0,976; p = 0,0212) kao i u sveukupnom preživljenju (omjer hazarda 0,828; 95% CI: 0,705 - 0,971; p = 0,0203).
Dose changes within a treatment cycle 
Promjene doze tijekom liječenja u
Elderly patients (see section 4.2): 
Posebne populacije Stariji bolesnici (vidjeti dio 4.2)
• Steven-Johnson syndrome: if you experience painful red or purplish rash that spreads and blisters and/or other lesions begin to appear in the mucous membrane (e.g. mouth and lips), in particular if you had before light sensitivity, infections of the respiratory system (e.g. bronchitis) and/or fever. 
• Stevens-Johnsonov sindrom: ako dobijete bolan crveni ili ljubičasto-crveni osip koji se širi i počnu se javljati mjehurići i/ili druga oštećenja na sluznici (npr. u ustima i na usnicama),
- as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated. 
- kao monoterapija za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha kemoterapijskog protokola koji se sastojao od kombinacije taksana i antraciklina ili u slučajevima u kojima daljnje liječenje antraciklinima nije indicirano.
A total of 156 patients were randomised to treatment with 5-FU (800 mg/m2 per day, continuous infusion on days 1 to 5 every 3 weeks) and cisplatin (80 mg/m2 as a 2-hour infusion on day 
Ukupno 156 bolesnika randomizirano je za liječenje s 5-FU (800 mg/m2 dnevno, kontinuirana infuzija od prvog do petog dana svaka tri tjedna) i cisplatinom (80 mg/m2 u obliku dvosatne infuzije 1. dan, svaka 3 tjedna).
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 patients on capecitabine who developed hand-foot syndrome (HFS) had a longer overall survival compared to patients who did not develop HFS: median overall survival 1100 days (95% CI 1007;1200) vs 691 days (95% CI 638;754) with a hazard ratio of 0.61 (95% CI 0.56; 0.66). 
(karcinom kolona, kolorektalni karcinom, uznapredovali karcinom želuca i karcinom dojke) je pokazala da bolesnice koje su liječene kapecitabinom, a koje su razvile sindrom šaka-stopalo (HFS), imaju duži period ukupnog preživljenja u usporedbi s bolesnicama koje nisu razvile HFS: medijan ukupnog preživljenja iznosio je 1100 dana (95% CI 1007; 1200) u usporedbi s 691 danom (95% CI 638;754) s omjerom rizika od 0,61 (95% CI 0,56; 0,66).
Table 5 Summary of related ADRs reported in patients treated with capecitabine in combination treatment in addition to those seen with capecitabine monotherapy or seen at a higher frequency grouping compared to capecitabine monotherapy Body System 
Tablica 5 Sažetak povezanih nuspojava prijavljenih u bolesnika liječenih kapecitabinom u kombiniranom liječenju, a koje su dodatno primijećene uz one već zabilježene kod monoterapije kapecitabinom ili su se javljale s većom učestalošću od onih kod monoterapije kapecitabinom
+Neutropenia, +Leucopenia, Anaemia, +Neutropenic fever, Thrombocytopenia 
+neutropenija, +leukopenija, +anemija, +febrilna neutropenija, trombocitopenija depresija koštane srži, +febrilna neutropenija
Median OS was 23.1 months for FOLFIRI, 17.6 months for mIFL (p=0.09), and 18.9 months for XELIRI (p=0.27). 
Medijan OS-a bio je 23,1 mjesec za FOLFIRI, 17,6 mjeseci za mIFL (p=0,09) te 18,9 mjeseci za XELIRI
• Grade 4 -1st appearance 
· Stupanj 4 -1. pojavljivanje
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. 
U cjelokupnoj randomiziranoj populaciji testovi za utvrđivanje razlike između kapecitabina i 5-FU/LV u preživljenju bez znakova bolesti i ukupnom preživljenju pokazali su omjere rizika od 0,88 (95% CI 0,77 - 1,01; p = 0,068), odnosno 0,86 (95% CI 0,74 - 1,01; p = 0,060).
The study contained two parts: an initial 2-arm part in which 634 patients were randomised to two different treatment groups, including XELOX or FOLFOX-4, and a subsequent 2x2 factorial part in which 1401 patients were randomised to four different treatment groups, including XELOX plus placebo, FOLFOX-4 plus placebo, XELOX plus bevacizumab, and FOLFOX-4 plus bevacizumab. 
faktorijalnog dijela u kojem je 1401 bolesnik randomiziran u jednu od četiri različite terapijske skupine: XELOX i placebo, FOLFOX-4 i placebo, XELOX i bevacizumab te FOLFOX-4 i bevacizumab.
Although DPD deficiency cannot be precisely defined, it is known that patients with certain homozygous or certain compound heterozygous mutations in the DPYD gene locus (e.g. DPYD*2A, c.1679T>G, c.2846A>T and c.1236G>A/HapB3 variants), which can cause complete or near complete absence of DPD enzymatic activity (as determined from laboratory assays), have the highest risk of lifethreatening or fatal toxicity and should not be treated with Xeloda (see section 4.3). 
varijantama DPYD*2A, c.1679T>G, c.2846A>T i c.1236G>A/HapB3), koje mogu uzrokovati potpun ili gotovo potpun izostanak enzimske aktivnosti DPD-a (određuje se laboratorijskim testovima), imaju najveći rizik od po život opasne ili smrtonosne toksičnosti te se ne smiju liječiti lijekom Xeloda
Capecitabine has minor or moderate influence on the ability to drive and use machines. 
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Kapecitabin malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Full dose 1000 mg/m2 
Puna doza 1000 mg/m2
The following covariates were statistically significantly associated with a decreased risk of developing diarrhoea: increasing cumulative capecitabine dose (0.1*kg) and increasing relative dose intensity in the first six weeks. 
povećana kumulativna doza kapecitabina (0,1*kg) i povećanje intenziteta relativne doze u prvih šest tjedana.
Treatment with capecitabine monotherapy may be resumed when bilirubin decreases to ≤3.0 x ULN or hepatic aminotransferases decrease to ≤ 2.5 x ULN. 
Monoterapija kapecitabinom može se nastaviti kada vrijednosti bilirubina padnu £3,0 x iznad gornje granice normale, odnosno ako jetrene aminotransferaze padnu £ 2,5 x iznad gornje granice normale.
Capecitabine in combination therapy: 
Kapecitabin u kombiniranom liječenju
FOLFOX-4 or FOLFOX-4 + Bevacizumab 
FOLFOX-4 ili FOLFOX-4 i bevacizumab oksaliplatin 85 mg/m intravenski
• if you have diarrhoea 
• ako imate proljev
• bruising or reaction at the injection site (caused by medicines given by injection at the same time) 
• modrice ili reakcija na mjestu injekcije (posljedica primjene lijekova injekcijom u isto vrijeme) Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba):
In combination treatment, the recommended starting dose of capecitabine should be reduced to 800 - 1000 mg/m2 when administered twice daily for 14 days followed by a 7-day rest period, or to 625 mg/m2 twice daily when administered continuously (see section 5.1). 
800 - 1000 mg/m2 kada se primijenjuje dvaput dnevno tijekom 14 dana, nakon čega slijedi 7 dana pauze ili na 625 mg/m² dvaput dnevno pri kontinuiranoj (svakodnevnoj) primjeni (vidjeti dio 5.1).
If you stop taking Xeloda 
Ako prestanete uzimati lijek Xeloda:
However, grade 3 or 4 treatment-related adverse reactions were more frequent in patients ≥60 years of age compared to younger patients. 
³ 60 godina češće se razvijaju nuspojave 3. ili 4. stupnja nego u mlađih bolesnika.
• Grade 2 -1st appearance 
· Stupanj 2 -1. pojavljivanje
Full dose 1250 mg/m2 
Puna doza 1250 mg/m2
Oxaliplatin: no clinically significant differences in exposure to capecitabine or its metabolites, free platinum or total platinum occurred when capecitabine was administered in combination with oxaliplatin or in combination with oxaliplatin and bevacizumab. 
Oksaliplatin Kod primjene kapecitabina u kombinaciji s oksaliplatinom ili u kombinaciji s oksaliplatinom i bevacizumabom nisu uočene klinički značajne razlike u izloženosti kapecitabinu ili njegovim metabolitima, slobodnom platinu ili ukupnom platinu.
• DPD Deficiency: if you have a known DPD deficiency, you are at an increased risk of acute early-onset of toxicity and severe, life-threatening, or fatal adverse reactions caused by XELODA (e.g. stomatitis, mucosal inflammation, diarrhoea, neutropenia, and neurotoxicity). 
• nedostatak DPD-a: ako imate nedostatak DPD-a, imate povećan rizik od akutnog ranog nastupa toksičnosti i teških, po život opasnih ili smrtonosnih nuspojava koje uzrokuje lijek
Cutaneous lupus erythematosus (rare), Severe skin reactions such as StevensJohnson Syndrome and toxic Epidermal Necrolysis (very rare) (see section 4.4.) 
StevensJohnsonova sindroma i toksične epidermalne nekrolize (vrlo rijetko) (vidjeti dio
Rash, Alopecia, Erythema, Dry skin, Pruritus, Skin hyperpigmentation, Rash macular, Skin desquamation, Dermatitis, Pigmentation disorder, Nail disorder 
osip, alopecija eritem, suha koža, svrbež, hiperpigmentacija kože, makularni osip, ljuštenje kože, dermatitis,
Women of childbearing potential/Contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with capecitabine. 
Žene reproduktivne dobi potrebno je savjetovati da tijekom liječenja kapecitabinom izbjegavaju trudnoću.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/163/002 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/163/002
-2nd appearance -3rd appearance 
-2. pojavljivanje -3. pojavljivanje
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. 
Rezultati metaanalize 14 kliničkih ispitivanja sa više od 4700 bolesnika liječenih kapecitabinom pokazali su da je u svim ispitivanjima zajedno ženski spol statistički značajno povezan s povećanim rizikom razvoja sindroma šaka-stopalo i proljeva te sa smanjenim rizikom razvoja neutropenije.
LIST OF EXCIPIENTS Also contains anhydrous lactose See package leaflet for further information. 
Također sadrži bezvodnu laktozu.Vidjeti uputu o lijeku za dodatne informacije.
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 3-week cycles for 24 weeks) or 5-FU and leucovorin (Mayo Clinic regimen: 20 mg/m2 leucovorin IV followed by 425 mg/m2 intravenous bolus 5-FU, on days 1 to 5, every 28 days for 24 weeks). 
tom ispitivanju slučajnim odabirom 1987 bolesnika liječeno je kapecitabinom (1250 mg/m2 dvaput dnevno kroz 2 tjedna nakon čega slijedi jednotjedna pauza, ciklusi u 3-tjednim intervalima u razdoblju od 24 tjedna) ili 5-FU i leukovorinom (Mayo protokol: 20 mg/m2 leukovorina i.v. i 425 mg/m2 5-FU intravenski u bolusu od prvog do petog dana, svakih 28 dana u razdoblju od 24 tjedna).
Data from one multicentre, randomised, controlled phase 3 clinical trial in patients with stage III (Dukes' C) colon cancer supports the use of capecitabine in combination with oxaliplatin (XELOX) for the adjuvant treatment of patients with colon cancer (NO16968 study). 
Podaci iz multicentričnog, randomiziranog kontroliranog kliničkog ispitivanja faze III u bolesnika s karcinomom kolona stadija III (Dukes C) podržavaju primjenu kapecitabina u kombinaciji s oksaliplatinom (XELOX) u adjuvantnom liječenju bolesnika s karcinomom kolona (ispitivanje NO16968).
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. 
Metaanaliza 14 kliničkih ispitivanja na više od 4700 bolesnika liječenih monoterapijom kapecitabinom ili kapecitabinom u različitim kemoterapijskim protokolima, u različitim indikacijama (karcinom kolona, kolorektalni karcinom, karcinom želuca i karcinom dojke) pokazala je da se sindrom šakastopalo (svi stupnjevi) razvio u 2066 (43%) bolesnika nakon medijana vremena od
Capecitabine 1000 mg/m oral twice daily 
kapecitabin 1000 mg/m oralno dvaput dnevno placebo ili bevacizumab
4.5 Interaction with other medicinal products and other forms of interaction 
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Ispitivanja interakcija provedena su samo u odraslih osoba.
In combination with docetaxel, the recommended starting dose of capecitabine in the treatment of metastatic breast cancer is 1250 mg/m2 twice daily for 14 days followed by a 7- day rest period, combined with docetaxel at 75 mg/m2 as a 1 hour intravenous infusion every 3 weeks. 
U kombinaciji s docetakselom preporučena početna doza kapecitabina u liječenju metastatskog karcinoma dojke je 1250 mg/m² i uzima se dvaput dnevno tijekom 14 dana nakon čega slijedi 7 dana pauze, dok je doza docetaksela 75 mg/m² i primjenjuje se svaka 3 tjedna u jednosatnoj intravenskoj infuziji.
• Grade 3 -1st appearance 
· Stupanj 3 -1. pojavljivanje
Pulmonary embolism, Pneumothorax, Haemoptysis, Asthma, Dyspnoea exertional 
pneumotoraks, hemoptiza, astma, zaduha pri naporu
For patients with partial DPD deficiency (such as those with heterozygous mutations in the DPYD gene) and where the benefits of Xeloda are considered to outweigh the risks (taking into account the suitability of an alternative non-fluoropyrimidine chemotherapeutic regimen), these patients must be treated with extreme caution and frequent monitoring with dose adjusment according to toxicity. 
i za koje se smatra da koristi liječenja lijekom Xeloda nadmašuju rizike (uzimajući u obzir prikladnost nekog drugog kemoterapijskog protokola koji ne uključuje fluoropirimidin), liječenje treba provoditi uz izniman oprez i sa čestim praćenjem uz prilagodbu doze sukladno toksičnosti.
Uncommon ADRs reported for capecitabine in combination therapy are consistent with the ADRs reported for capecitabine monotherapy or reported for monotherapy with the combination medicinal product (in literature and/or respective summary of product characteristics). 
Manje česte nuspojave koje su prijavljene kod kapecitabina u kombiniranoj terapiji su u skladu s nuspojavama prijavljenima kod monoterapije kapecitabinom ili prijavljenima kod monoterapije lijekom koji se može primjenjivati u kombinaciji s kapecitabinom (kombinacijski lijek)
In patients with severe leukopenia, neutropenia, or thrombocytopenia, In patients with severe hepatic impairment, 
• Bolesnici s teškom leukopenijom, neutropenijom ili trombocitopenijom,
• if you have or had heart problems (for example an irregular heartbeat or pains to the chest, jaw and back brought on by physical effort and due to problems with the blood flow to the heart) 
čeljusti i leđima uzrokovane fizičkim naporom ili otežanim dotokom krvi u srce)
Xeloda with food and drink You should take Xeloda no later than 30 minutes after meals. 
Lijek Xeloda uzmite najkasnije 30 minuta nakon jela.
• bowel obstruction, collection of fluid in the abdomen, inflammation of the small or large intestine, the stomach or the oesophagus, pain in the lower abdomen, abdominal discomfort, heartburn (reflux of food from the stomach), blood in the stool jaundice (yellowing of skin and eyes) 
• opstrukcija crijeva, nakupljanje tekućine u trbuhu, upala tankog ili debelog crijeva, želuca ili jednjaka, bol u donjem dijelu trbuha, nelagoda u trbuhu, žgaravica (povrat hrane iz želuca), krv u stolici
For combination with irinotecan, the recommended starting dose is 800 mg/m2 when administered twice daily for 14 days followed by a 7-day rest period combined with irinotecan 200 mg/m2 on day 1. 
Kada se primjenjuje u kombinaciji s irinotekanom, preporučena početna doza je 800 mg/m² dvaput dnevno tijekom 14 dana, nakon čega slijedi 7 dana pauze uz primjenu irinotekana u dozi od
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. 
Rezultati metaanalize 14 kliničkih ispitivanja sa više od 4700 bolesnika liječenih kapecitabinom pokazali su da je u svim ispitivanjima starija životna dob (u intervalima od 10 godina) statistički značajno povezana s povećanim rizikom razvoja sindroma šaka-stopalo i proljeva i smanjenim rizikom razvoja neutropenije.
Brivudine: a clinically significant interaction between brivudine and fluoropyrimidines (e.g. capecitabine, 5-Fluorouracil, tegafur), resulting from the inhibition of dihydropyrimidine dehydrogenase by brivudine, has been described. 
kapecitabina, 5-fluorouracila, tegafura), koja proizlazi iz inhibicije dihidropirimidin dehidrogenaze brivudinom.
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 
Poremećaji probavnog sustava zatvor, dispepsija krvarenje u gornjem dijelu probavnog sustava, ulceracije usne šupljine, gastritis, distenzija abdomena, gastroezofagealna refluksna bolest, bol u usnoj šupljini, disfagija, rektalno krvarenje, bol u donjem dijelu abdomena, oralna dizestezija, oralna parestezija, oralna hipoestezija, nelagoda u abdomenu
In this trial, 160 patients were randomised to treatment with capecitabine (1000 mg/m2 twice daily for 2 weeks followed by a 7-day rest period) and cisplatin (80 mg/m2 as a 2-hour infusion every 3 weeks). 
U tom je ispitivanju 160 bolesnika slučajnim odabirom liječeno kapecitabinom (1000 mg/m2 dvaput dnevno u trajanju od 2 tjedna, nakon čega slijedi pauza od 7 dana) i cisplatinom (80 mg/m2 u obliku dvosatne infuzije svaka 3 tjedna).
Colon, colorectal and advanced gastric cancer: meta-analysis A meta-analysis of six clinical trials (studies SO14695, SO14796, M66001, NO16966, NO16967, M17032) supports capecitabine replacing 5-FU in mono- and combination treatment in gastrointestinal cancer. 
Metaanaliza šest kliničkih ispitivanja (SO14695, SO14796, M66001, NO16966, NO16967, M17032)
Lipoma 
Bevacizumab
Angina unstable, Angina pectoris, Myocardial ischaemia/infarction, Atrial fibrillation, Arrhythmia, Tachycardia, Sinus tachycardia, Palpitations 
Srčani poremećaji nestabilna angina, angina pektoris, ishemija miokarda/infarkt, fibrilacija atrija, aritmija, tahikardija, sinusna tahikardija, palpitacije fibrilacija ventrikula (rijetko), produljenje QT- intervala (rijetko), Torsade de pointes (rijetko), bradikardija, vazospazam (rijetko)
In this trial, 255 patients were randomised to treatment with capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period and docetaxel 75 mg/m2 as a 1 hour intravenous infusion every 3 weeks). 
U tom je ispitivanju slučajnim odabirom 255 bolesnica liječeno kapecitabinom (1250 mg/m2 dvaput dnevno tijekom 2 tjedna, nakon čega je slijedila jednotjedna pauza i 75 mg/m2 docetaksela u jednosatnoj intravenskoj infuziji svaka 3 tjedna).
The primary efficacy analyses in the per protocol population demonstrated non-inferiority in overall survival for capecitabine- vs 5-FU-based regimens (hazard ratio 0.86; 95% CI 0.8 - 0.99) and for oxaliplatin- vs cisplatin-based regimens (hazard ratio 0.92; 95% CI 0.80 - 1.1). 
Analize osnovnih parametara djelotvornosti u populaciji prema protokolu pokazale su da liječenje kapecitabinom u usporedbi s protokolima koji sadrže 5-FU (omjer hazarda 0,86; 95% CI 0,8 do 0,99) i liječenje oksaliplatinom u usporedbi s protokolima koji sadrže cisplatin (omjer hazarda 0,92; 95% CI 0,80 do 1,1) nije lošije.
The XELIRI regimens included capecitabine 1000 mg/m2 twice daily on days 1 to 14 of a three-week cycle combined with irinotecan 250 mg/m2 on day1. 
XELIRI protokol obuhvaćao je primjenu kapecitabina u dozi od 1000 mg/m2 dvaput dnevno od 1. do 14. dana trotjednog ciklusa u kombinaciji s irinotekanom u dozi od 250 mg/m2 1. dana.
All indications: 
u različitim indikacijama.
Advanced gastric cancer: 
Uznapredovali karcinom želuca
PRIMARY ANALYSI S XELOX/XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017) 
Tablica 7 Ključni rezultati djelotvornosti iz analize o neinferiornosti u ispitivanju NO16966 PRIMARNA ANALIZA XELOX / XELOX + P / XELOX + BV (EPP*: N = 967; ITT**: N = 1017)