FrancophonIA/ELRC3.0 huggingface dataset:
English: Women of childbearing potential taking panobinostat in combination with bortezomib and dexamethasone must use highly effective contraception for three months after stopping treatment (see sections 4.5 and 4.6 and bortezomib and dexamethasone SmPC).
Croatian: Žene reproduktivne dobi koje uzimaju panobinostat u kombinaciji s bortezomibom i deksametazonom moraju koristiti vrlo učinkovitu kontracepciju tri mjeseca nakon prekida liječenja (vidjeti dijelove 4.5 i 4.6 te Sažetak opisa svojstava lijeka za bortezomib i deksametazon).
English: Of note, whereas grade 3 and grade 4 neutropenia were observed in 28% and 7% of patients, respectively, febrile neutropenia was observed in 1% of patients (see section 4.8).
Croatian: Valja napomenuti da dok je neutropenija 3. odnosno 4. stupnja bila uočena u 28% odnosno 7% bolesnika, febrilna neutropenija bila je uočena u 1% bolesnika (vidjeti dio 4.8).
English: Limited experience with overdose has been reported during clinical studies.
Croatian: Tijekom kliničkih ispitivanja zabilježeno je ograničeno iskustvo s predoziranjem.
English: Multiple myeloma is a disorder of plasma cells (a type of blood cell) that grow out of control in the bone marrow.
Croatian: Multipli mijelom je poremećaj plazma stanica (vrsta krvne stanice) koje nekontrolirano rastu u koštanoj srži.
English: Omit dose Resume at reduced dose or with the same dose but with a once-weekly schedule
Croatian: Nastaviti u smanjenoj dozi ili u istoj dozi, ali po rasporedu jedanput na tjedan
English: Take Farydak on days 1, 3 and 5 and on days 8, 10 and 12.
Croatian: Uzmite Farydak 1., 3. i 5. dana te 8., 10. i 12. dana.
English: Prophylactic anti-emetics (e.g. prochlorperazine) may be considered at the discretion of the physician and in accordance with local medical practice.
Croatian: Profilaktički antiemetici (npr. proklorperazin) mogu se razmotriti prema odluci liječnika te u skladu s medicinskom praksom.
English: If continuous treatment with a strong CYP3A4 inhibitor is required, a dose escalation from 10 mg to 15 mg panobinostat may be considered based on patient tolerability.
Croatian: Ako je potrebno kontinuirano liječenje snažnim CYP3A4 inhibitorom, može se razmotriti povećanje doze panobinostata s 10 mg na 15 mg ovisno o bolesnikovoj podnošljivosti.
English: For patients >75 years of age, depending on the patient's general condition and concomitant diseases, an adjustment of the starting doses or schedule of the components of the combination regimen may be considered (see section 4.2).
Croatian: >75 godina, ovisno o bolesnikovom općem stanju i istodobno prisutnim bolestima, može se razmotriti prilagođavanje početnih doza ili rasporeda komponenti kombiniranog režima (vidjeti dio 4.2).
English: Avoid panobinostat use in patients who are taking CYP2D6 substrates with a narrow therapeutic index (including, but not limited to, pimozide).
Croatian: Treba izbjegavati primjenu panobinostata u bolesnika koji uzimaju CYP2D6 supstrate s uskim terapijskim indeksom (uključujući, između ostalih, pimozid).
English: Patients should be advised to contact their physician if severe gastrointestinal toxicity occurs and dose adjustment or discontinuation may be required (see section 4.4).
Croatian: Bolesnike treba uputiti da se obrate svom liječniku ako se pojavi teška gastrointestinalna toksičnost, a moglo bi biti potrebno prilagoditi dozu ili prekinuti primjenu (vidjeti dio 4.4).
English: ECG
Croatian: EKG
English: Please refer to Table 1 for cycles 1 to 8 and Table 2 for cycles 9-16.
Croatian: Provjerite Tablicu 1 za 1. do 8. ciklus te Tablicu 2 za 9.-16. ciklus.
English: QTcF >480 and <500 msec was recorded in 1.3% of patients and change from baseline of >60 msec was observed in 0.8% of patients.
Croatian: QTcF >480 i <500 msec bio je zabilježen u 1,3% bolesnika, a promjena u odnosu na početnu vrijednost >60 msec bila je uočena u 0,8% bolesnika.
English: However, treatment discontinuation due to these reactions was reported in a relatively small proportion of patients, with diarrhoea at 4.5% and nausea and vomiting at 0.5% each.
Croatian: Međutim, prekid liječenja uzrokovan tim nuspojavama bio je prijavljen u relativno malom udjelu bolesnika, zbog proljeva u 4,5%, a zbog mučnine i povraćanja u po 0,5%.
English: In patients with hepatic impairment receiving concomitant medicinal products which are strong CYP3A4 inhibitors, treatment with panobinostat should be avoided due to lack of experience and safety data in this patient population.
Croatian: U bolesnika s oštećenjem jetre koji istodobno primaju lijekove koji su snažni CYP3A4 inhibitori, liječenje panobinostatom treba izbjegavati zbog nedostatka iskustva i sigurnosnih podataka u toj bolesničkoj populaciji.
English: Farydak is always used together with two other medicines: bortezomib and dexamethasone.
Croatian: Farydak se uvijek koristi zajedno s još dva lijeka: bortezomibom i deksametazonom.
English: The treatment was discontinued in 2.9% of patients due to fatigue and asthenia.
Croatian: Liječenje je bilo prekinuto u 2,9% bolesnika zbog umora i astenije.
English: For patients experiencing severe adverse drug reactions other than thrombocytopenia, gastrointestinal toxicity, neutropenia or QTc prolongation, the recommendation is the following:
Croatian: Za bolesnike u kojih dođe do teških nuspojava osim trombocitopenije, gastrointestinalne toksičnosti, neutropenije ili produljenja QTc-a, preporuka je sljedeća:
English: Reduce bortezomib dose to 0.7 mg/m2 in the first treatment cycle.
Croatian: Smanjiti dozu bortezomiba na 0,7 mg/m2 u prvom ciklusu liječenja.
English: Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 in subsequent cycles based on patient tolerability.
Croatian: Razmotriti povećanje doze do 1,0 mg/m2 ili daljnje smanjenje doze do 0,5 mg/m2 u naknadnim ciklusima na temelju bolesnikove podnošljivosti.
English: Out of the pre-specified subgroup of patients with prior treatment with bortezomib and an immunomodulatory agent (N=193), 76% of patients had received at least two prior regimens.
Croatian: U unaprijed određenoj podskupini bolesnika koji su bili na prethodnoj terapiji bortezomibom i imunomodulatorom (N=193), 76% bolesnika je primilo najmanje dva prethodna režima.
English: Monitoring during your treatment with Farydak
Croatian: Praćenje tijekom liječenja Farydakom
English: Hepatic function abnormal, hyperbilirubinaemia a
Croatian: Poremećena jetrena funkcija, hiperbilirubinemija a
English: • reduced blood level of magnesium
Croatian: • smanjena razina magnezija u krvi
English: You should also do this for six months after you have stopped taking Farydak.
Croatian: Morate ih koristiti i šest mjeseci nakon što prestanete uzimati Farydak.
English: • clicking, rattling or crackling noise made by the lungs when breathing
Croatian: • zvuk klikanja, zveckanja ili pucketanja koji proizvode pluća kod disanja
English: A complete blood cell count must be performed before initiating treatment with panobinostat.
Croatian: Mora se napraviti kompletna krvna slika prije početka liječenja panobinostatom.
English: In addition any abnormal serum potassium, magnesium or phosphorus values should be corrected prior to initiation of Farydak therapy (see section 4.4).
Croatian: Uz to, sve poremećene vrijednosti kalija, magnezija ili fosfora u serumu treba ispraviti prije početka terapije Farydakom (vidjeti dio 4.4).
English: Panobinostat is used in combination treatment, therefore the prescribing information of bortezomib and dexamethasone should be consulted prior to initiation of treatment with panobinostat.
Croatian: Panobinostat se koristi u kombiniranoj terapiji, stoga je potrebno proučiti informacije o propisivanju bortezomiba i deksametazona prije početka liječenja panobinostatom.
English: No episodes of QTcF prolongation >500 msec were reported with the dose of 20 mg Farydak in the phase III clinical study, in combination with bortezomib and dexamethasone.
Croatian: Nisu bile prijavljene epizode produljenja QTcF-a >500 msec uz dozu od 20 mg Farydaka u kliničkom ispitivanju faze III, u kombinaciji s bortezomibom i deksametazonom.
English: The panobinostat fraction metabolised through CYP3A4 is approximately 40%.
Croatian: Frakcija panobinostata koja se metabolizira kroz CYP3A4 otprilike je 40%.
English: Apparent panobinostat renal clearance (CLR/F) was found to range from 2.4 to 5.5 l/h.
Croatian: Otkriveno je da je prividni klirens panobinostata putem bubrega (CLR/F) u rasponu od 2,4 do 5,5 l/h.
English: Hepatic dysfunction, primarily mild transient elevations in aminotransferases and total bilirubin, has been reported in patients during treatment with panobinostat.
Croatian: Disfunkcija jetre, prvenstveno blaga prolazna povišenja aminotransferaza i ukupnog bilirubina, prijavljena je u bolesnika tijekom liječenja panobinostatom.
English: Tell your doctor or pharmacist straight away during treatment with Farydak: - if you notice any signs of a gastrointestinal problem.
Croatian: Odmah se obratite svom liječniku ili ljekarniku tijekom liječenja Farydakom: - ako primijetite bilo kakve znakove želučano-crijevnog problema.
English: Panobinostat may prolong cardiac ventricular repolarisation (QT interval).
Croatian: Panobinostat bi mogao produljiti repolarizaciju srčanog ventrikula (QT interval).
English: The thyroid changes including hormones in dogs (decrease triodothyronine (T3)) and rats (decrease in triodothyronine (T3), tetraiodothyronine (T4) (males) and thyroid stimulating hormone (TSH)) were observed at exposures corresponding to 0.07-2.2 of the human AUC observed clinically.
Croatian: Promjene u štitnjači, uključujući hormone u pasa (sniženi trijodtironin (T3)) i štakora (sniženi trijodtironin (T3)), tiroksin (T4) (mužjaci) i tireotropin (TSH)), bili su uočeni pri izloženostima koje odgovaraju 0,07-2,2 klinički uočenog AUC-a kod ljudi.
English: Blood urea increased, glomerular filtration rate decreased, blood alkaline phosphatase increased, electrocardiogram QT prolonged, blood creatinine increased a, SGPT alanine transaminase (ALT) increased a, SGOT aspartate transaminase (AST) increased a a Frequency is based on laboratory values
Croatian: Povišena ureja u krvi, smanjena brzina glomerularne filtracije, povišena alkalna fosfataza u krvi, produljeni QT na elektrokardiogramu, povišeni kreatinin u krvi a, povišena SGPT alanin transaminaza (ALT) a, povišena SGOT aspartat transaminaza (AST) a a Učestalost se temelji na laboratorijskim vrijednostima
English: Platelets <50 x 109/l with bleeding
Croatian: <50 x 109/l s krvarenjem
English: A clinical study in cancer patients with impaired hepatic function showed that plasma exposure of panobinostat increased by 43% (1.4-fold) and 105% (2-fold) in patients with mild and moderate hepatic impairment, respectively.
Croatian: Kliničko ispitivanje u bolesnika oboljelih od raka s oštećenom jetrenom funkcijom pokazalo je da se izloženost panobinostata u plazmi povećala za 43% (1,4 puta) odnosno 105% (2 puta) u bolesnika s blagim odnosno umjerenim oštećenjem jetre.
English: In clinical studies in multiple myeloma, the exposure of panobinostat was decreased by approximately 20% by the concomitant use of dexamethasone, which is a dose-dependent mild/moderate CYP3A4 inducer.
Croatian: U kliničkim ispitivanjima multiplog mijeloma izloženost panobinostata smanjila se za otprilike 20% istodobnom primjenom deksametazona, koji je blagi/umjereni CYP3A4 induktor ovisan o dozi.
English: Prolongation of QT interval
Croatian: Produljenje QT intervala
English: Discontinuation of treatment may be considered if thrombocytopenia does not improve despite the treatment modifications described below and/or the patient requires repeated platelet transfusions.
Croatian: Može se razmotriti prekid liječenja ako se trombocitopenija ne ublaži usprkos niže opisanim modifikacijama liječenja i/ili ako su bolesniku potrebne opetovane transfuzije trombocita.
English: Increased levels of acetylated histones were observed in xenografts from mice that were treated with panobinostat.
Croatian: Povišene razine acetiliranih histona bile su uočene u ksenograftima miševa liječenih panobinostatom.
English: • cracked, chapped lips
Croatian: • ispucale, popucale usne
English: Treatment of tumour cells with panobinostat resulted in a dose-dependent increase in acetylation of histones H3 and H4 both in vitro and in xenograft animal pre-clinical models, demonstrating target inhibition.
Croatian: Liječenje tumorskih stanica panobinostatom rezultiralo je o dozi ovisnim povećanjem acetilacije histona H3 i H4 kako in vitro tako i u pretkliničkih životinjskih modela ksenografta, što dokazuje ciljanu inhibiciju.
English: Embryo foetal lethality and increases in skeletal anomalies (extra sternabrae, extra ribs, increases in minor skeletal variations, delayed ossification and variations of the sternabrae) were seen above exposures corresponding to 0.25 of the human clinical AUC.
Croatian: Embriofetalna smrtnost i povećanja u skeletnim anomalijama (dodatna sternebra, dodatna rebra, povećani broj manjih skeletnih varijacija, odgođena osifikacija i varijacije sternebra) bila su uočena iznad izloženosti koje odgovaraju 0,25 klinički uočenog AUC-a kod ljudi.
English: Mild, moderate and severe renal impairment based on baseline urinary creatinine clearance did not increase the panobinostat plasma exposure in mild, moderate and severe groups.
Croatian: Blago, umjereno i teško oštećenje bubrega na temelju početnog klirensa kreatinina putem mokraće nije povećalo izloženost panobinostata u plazmi u skupinama s blagim, umjerenim i teškim oštećenjem.
English: Medicinal products with laxative properties should be used with caution because of the potential for exacerbation of diarrhoea.
Croatian: Lijekovi s laksativnim svojstvima moraju se koristiti oprezno zbog mogućnosti egzacerbacije proljeva.
English: Mild and moderate hepatic impairment as per NCI-CTEP classification increased panobinostat plasma exposure by 43% and 105%, respectively.
Croatian: Blago i umjereno oštećenje jetre prema NCI-CTEP klasifikaciji povećalo je izloženost panobinostata u plazmi za 43% odnosno 105%.
English: 20.7% of patients experienced haemorrhage, most frequently epistaxis (4.7%), haematoma (2.6%), and conjunctival haemorrhage (2.1%).
Croatian: 20,7% bolesnika imalo je krvarenje, najčešće epistaksu (4,7%), hematom (2,6%) i krvarenje u konjunktivi (2,1%).
English: In the event of long QT interval prior to initiation of panobinostat (QTcF ≥480 msec at baseline), the start of treatment should be delayed until pre-dose average QTcF has returned to <480 msec.
Croatian: U slučaju dugog QT intervala prije početka liječenja panobinostatom (početni QTcF ≥480 msec), početak liječenja treba odgoditi dok se prosječni QTcF od prije doziranja ne vrati na <480 msec.
English: Approximately 40% of panobinostat is metabolised through CYP3A4.
Croatian: Otprilike 40% panobinostata metabolizira se putem CYP3A4.
English: Patients with neutropenia are prone to infection, mostly upper respiratory tract infection or pneumonia.
Croatian: Bolesnici s neutropenijom skloni su infekciji, uglavnom infekciji gornjeg dijela dišnog sustava ili pneumoniji.
English: Liver function tests
Croatian: Testovi jetrene funkcije
English: CTC grade 3 or 4 thrombocytopenia occurred in 256 patients, with a median onset time of one month.
Croatian: Trombocitopenija 3. ili 4. stupnja prema CTC-u pojavila se u 256 bolesnika, uz medijan vremena do nastupa od mjesec dana.
English: Adverse reactions observed were consistent with the safety profile, with events primarily involving haematological and gastrointestinal disorders such as thrombocytopenia, pancytopenia, diarrhoea, nausea, vomiting and anorexia.
Croatian: Uočene nuspojave bile su u skladu sa sigurnosnim profilom, pri čemu su događaji prvenstveno uključivali hematološke i gastrointestinalne poremećaje kao što su trombocitopenija, pancitopenija, proljev, mučnina, povraćanje i anoreksija.
English: Prior to initiating any cycle of therapy with panobinostat in combination with bortezomib and dexamethasone, platelet count should be at least ≥100 x 109/l (see section 4.4).
Croatian: Prije početka bilo kojeg ciklusa terapije panobinostatom u kombinaciji s bortezomibom i deksametazonom broj trombocita mora biti najmanje ≥100 x 109/l (vidjeti dio 4.4).
English: Additional blood counts should be considered during the “rest period” - e.g. on days 15 and/or 18, especially in patients ≥65 years and patients with a baseline platelet count below 150 x 109/l.
Croatian: Potrebno je razmotriti dodatne krvne slike tijekom „razdoblja stanke“ - npr. 15. i/ili 18. dana, osobito u bolesnika ≥65 godina i bolesnika s početnom razinom trombocita ispod
English: Clinical efficacy in patients with relapsed and relapsed and refractory multiple myeloma (Study D2308 - Panorama 1)
Croatian: Klinička djelotvornost u bolesnika s rekurentnim te rekurentnim i refraktornim multiplim mijelomom (Ispitivanje D2308 - Panorama 1)
English: Concomitant use of anti-arrhythmic medicinal products (including, but not limited to, amiodarone, disopyramide, procainamide, quinidine and sotalol) and other substances that are known to prolong the QT interval (including, but not limited to, chloroquine, halofantrine, clarithromycin, methadone, moxifloxacin, bepridil and pimozide) is not recommended.
Croatian: Istodobna primjena antiaritmika (uključujući, između ostalih, amiodaron, disopiramid, prokainamid, kvinidin i sotalol) i drugih tvari za koje se zna da produljuju QT interval (uključujući, između ostalih, klorokin, halofantrin, klaritromicin, metadon, moksifloksacin, bepridil i pimozid) nije preporučena.
English: ECG (electrocardiogram) abnormalities have been reported in patients treated with panobinostat + bortezomib + dexamethasone, mainly involving ST-T depression (21.7%) and T wave changes (39.6%).
Croatian: Abnormalnosti na EKG-u (elektrokardiogramu) zabilježene su u bolesnika liječenih panobinostatom + bortezomibom + deksametazonom, a uglavnom su uključivale depresiju ST-T segmenta (21,7%) i promjene u T valu (39,6%).
English: QTcF should be <480 msec prior to initiation of treatment with panobinostat (see below section on dose adjustments and section 4.4).
Croatian: QTcF treba biti <480 msec prije početka liječenja panobinostatom (vidjeti u nastavku dio o prilagođavanjima doze i dio 4.4).
English: Given its cytostatic/cytotoxic mode of action, breast-feeding is contraindicated during Farydak treatment (see section 4.3).
Croatian: Zbog njegovog citostatičnog/citotoksičnog načina djelovanja, dojenje je kontraindicirano tijekom liječenja Farydakom (vidjeti dio 4.3).
English: QTc prolongation was observed and was mostly mild in degree: QTcF interval >450 msec and ≤480 msec was reported in 10.8% of patients, with maximum increase from baseline >30 msec and ≤60 msec in 14.5% of patients.
Croatian: Uočeno je produljenje QTc-a koje je uglavnom bilo blago: QTcF interval >450 msec i ≤480 msec bio je prijavljen u 10,8% bolesnika, uz maksimalno povećanje od početne vrijednosti >30 msec i ≤60 msec u 14,5% bolesnika.
English: Platelet count should be ≥100 x 109/l prior to initiating any cycle of treatment (see section 4.2).
Croatian: Broj trombocita treba biti ≥100 x 109/l prije početka bilo kojeg ciklusa liječenja (vidjeti dio 4.2).
English: Monitoring recommendations
Croatian: Preporuke za praćenje
English: Tell a doctor or a pharmacist straight away if you notice any of these side effects:
Croatian: Odmah se obratite svom liječniku ili ljekarniku ako primijetite bilo koju od sljedećih nuspojava:
English: The recommended starting dose of panobinostat is 20 mg, taken orally once a day, on days 1, 3, 5, 8, 10 and 12 of a 21-day cycle.
Croatian: Preporučena početna doza panobinostata je 20 mg, koja se uzima peroralno jedanput na dan, i to 1., 3., 5., 8., 10. i 12. dana 21-dnevnog ciklusa.
English: Concomitant administration of medicinal products that are known to cause QTc prolongation should be used with caution (see section 4.5).
Croatian: Istodobna primjena lijekova za koje je poznato da uzrokuju produljenje QTc-a mora se provoditi oprezno (vidjeti dio 4.5).
English: If you are a sexually active woman, you should have a pregnancy test before starting Farydak treatment and you must use a highly effective method of contraception during treatment with Farydak.
Croatian: Ako ste seksualno aktivna žena, morate napraviti test na trudnoću prije početka liječenja Farydakom i morate koristiti visoko učinkovitu metodu kontracepcije za vrijeme liječenja Farydakom.
English: Based on non-clinical findings, male fertility may be compromised by treatment with Farydak (see section 5.3).
Croatian: Na temelju nekliničkih nalaza, liječenje Farydakom moglo bi smanjiti mušku plodnost (vidjeti dio 5.3).
English: The efficacy and safety of panobinostat in combination with bortezomib and dexamethasone were evaluated in a randomised, double-blind, placebo-controlled, multicentre phase III study in patients with relapsed or relapsed and refractory multiple myeloma who had received 1-3 prior lines of therapies.
Croatian: Djelotvornost i sigurnost panobinostata u kombinaciji s bortezomibom i deksametazonom bile su ocjenjivane u randomiziranom, dvostruko slijepom, placebom kontroliranom multicentričnom ispitivanju faze III u bolesnika s rekurentnim ili rekurentnim i refraktornim multiplim mijelomom koji su prethodno primili 1-3 linije terapije.
English: At the first sign of abdominal cramping, loose stools or onset of diarrhoea, it is recommended that the patient be treated with anti-diarrhoeal medicinal product (e.g. loperamide) or any additional treatment in accordance with local treatment guidelines.
Croatian: Na prvi znak grčeva u abdomenu, mekih stolica ili nastupa proljeva preporučuje se liječiti bolesnika antidijaroikom (npr. loperamidom) ili bilo kojom dodatnom terapijom u skladu s lokalnim smjernicama za liječenje.
English: If patients experience thrombocytopenia, panobinostat may need to be temporarily withheld and the subsequent dose may need to be reduced (see Table 3).
Croatian: Ako se u bolesnika pojavi trombocitopenija, možda će biti potrebno privremeno prekinuti primjenu panobinostata te smanjiti narednu dozu (vidjeti Tablicu 3).
English: Given panobinostat's cytostatic/cytotoxic mode of action, the potential risk to the foetus is high.
Croatian: S obzirom na citostatični/citotoksični način djelovanja panobinostata, potencijalni rizik za fetus je visok.
English: If a diagnosis of invasive systemic fungal infection is made, panobinostat should be discontinued and appropriate anti-fungal therapy instituted.
Croatian: Ako se utvrdi dijagnoza invazivne sistemske gljivične infekcije, treba prekinuti primjenu panobinostata te uvesti odgovarajuću terapiju antimikoticima.
English: • vomiting blood, black or bloody stools, passage of fresh blood through the anus, usually in or with stools (signs of gastrointestinal bleeding)
Croatian: • povraćanje krvi, crna ili krvava stolica, prolaz svježe krvi kroz anus, obično u stolici ili uz stolicu (znakovi krvarenja u probavnom sustavu)
English: Dose adjustments
Croatian: Prilagođavanja doze
English: Fatigue and asthenia were reported in 41.2% and 22.0% of patients, respectively.
Croatian: Umor i astenija bili su prijavljeni u 41,2% odnosno 22,0% bolesnika.
English: • severe headache, feeling weak or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (potential signs of nervous system problems such as bleeding or swelling in the skull or brain)
Croatian: • teška glavobolja, osjećaj slabosti ili paraliza udova ili lica, poteškoće u govoru, iznenadni gubitak svijesti (potencijalni znakovi problema sa živčanim sustavom kao što su krvarenje ili oticanje u lubanji ili mozgu)
English: • feeling thirsty, high urine output, increased appetite with weight loss (signs of a high level of sugar in the blood)
Croatian: • osjećaj žeđi, velika proizvodnja mokraće, povećani apetit uz gubitak tjelesne težine (znakovi visoke razine šećera u krvi)
English: Colitis, haematemesis, gastrointestinal pain
Croatian: Kolitis, hematemeza, gastrointestinalna bol
English: Grade 3 asthenia was observed in 9.4% of the patients, with no patients experiencing asthenia at CTC grade 4.
Croatian: Astenija 3. stupnja bila je uočena u 9,4% bolesnika, pri čemu nijedan bolesnik nije imao asteniju 4. stupnja prema CTC-u.