FrancophonIA/ELRC3.0 huggingface dataset:
English: Bortezomib was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered drugs in Block 3.
Croatian: Bortezomib je bio primijenjen samo u 1. i 2.bloku zbog izbjegavanja mogućeg preklapanja toksičnosti s istodobno primijenjenim lijekovima u bloku 3.
English: The majority of the patients in both groups completed treatment, 80% in the BzmbR-CAP group and 82% in the R-CHOP group.
Croatian: Većina bolesnika u obje skupine završilo je liječenje, 80 % u BzmbR-CAP skupini i 82 % u R-CHOP skupini.
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 na 1,0 mg/m2 ili daljnje smanjenje doze na 0,5 mg/m2 u sljedećim ciklusima na temelju bolesnikova podnošenja liječenja.
English: Ranbaxy Pharmacie Generiques 11-15, Quai de Dion Bouton 92800 Puteaux
Croatian: 11-15, Quai de Dion Bouton
English: The fraction of bortezomib bound to plasma proteins was not concentration-dependent.
Croatian: Udio bortezomiba vezanog za proteine plazme nije ovisio o koncentraciji.
English: Male and female patients of childbearing potential must use effective contraceptive measures during and for 3 months following treatment.
Croatian: Muškarci i žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja i do 3 mjeseca nakon liječenja.
English: Patients with pre-existing severe neuropathy may be treated with Bortezomib SUN only after careful risk/benefit assessment.
Croatian: Bolesnici s već prisutnom teškom neuropatijom mogu se liječiti Bortezomib SUN-om nakon pomne procjene omjera rizika i koristi.
English: No new safety concerns were observed when bortezomib was added to the standard paediatric pre B cell ALL chemotherapy backbone.
Croatian: Nisu zabilježena nova sigurnosna pitanja kada je bortezomib bio dodan standardnoj osnovnoj pedijatrijskoj kemoterapiji za pre-B-staničnu ALL.
English: A statistically significant benefit (p < 0.001) in favour of the BzmbR-CAP treatment group over the R-CHOP group was observed for TTP (median 30.5 versus 16.1 months), TNT (median 44.5 versus 24.8 months) and TFI (median 40.6 versus 20.5 months).
Croatian: Statistički značajna korist (p < 0,001) za BzmbR-CAP liječenu skupinu u odnosu na R-CHOP skupinu bila je zapažena za TTP (medijan 30,5 naspram 16,1 mjesec), TNT (medijan 44,5 naspram 24,8 mjeseci) i TFI (medijan 40,6 naspram 20,5 mjeseci).
English: > 3 x ULN
Croatian: > 3 x GGN
English: It is not necessary to protect the reconstituted medicinal product from light.
Croatian: Rekonstituiranu otopinu lijeka nije neophodno zaštititi od svjetlosti.
English: Bortezomib was not genotoxic when tested in the in vitro mutagenicity assay (Ames assay) and in vivo micronucleus assay in mice.
Croatian: Bortezomib nije bio genotoksičan kad se ispitivao in vitro mutagenim testom (Amesov test) i in vivo mikronukleusnim ispitivanjem u miševa.
English: Uncommon side effects (may affect up to 1 in 100 people) - hepatitis - severe allergic reaction (anaphylactic reaction) signs of which may include difficulty breathing,
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) - hepatitis - teška alergijska reakcija (anafilaktička reakcija) znakovi koji mogu uključiti otežano disanje,
English: 5 (2)b CR+nCR+PR 121 (38)b 56 (18)b 57 (45)d 29 (26)d 64 (34)b 27 (13)b CR+nCR+PR+M R Median duration Days (months) Time to response CR+PR(days)
Croatian: 5 (2)b CR+nCR+PR 121 (38)b 56 (18)b 57 (45)d 29 (26)d 64 (34)b 27 (13)b
English: It is, therefore, likely that bortezomib could have a potential effect on either male or female fertility.
Croatian: Stoga postoji velika vjerojatnost da bi bortezomib mogao utjecati na plodnost kako u mužjaka, tako i u ženke.
English: For patients with a response first documented at cycle 6, two additional treatment cycles were given.
Croatian: Bolesnicima za koje je odgovor na liječenje prvi put zabilježen u 6. ciklusu, primijenjena su dva dodatna ciklusa liječenja.
English: Inhibition of the proteasome results in cell cycle arrest and apoptosis.
Croatian: Inhibicija proteasoma rezultira zastojem staničnog ciklusa i apoptozom.
English: Caution should be exercised when bortezomib is combined with CYP3A4 or CYP2C19 substrates (see section 4.5).
Croatian: Potreban je oprez kad se bortezomib kombinira sa supstratima enzima CYP3A4 ili CYP2C19 (vidjeti dio 4.5).
English: There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS) in patients receiving bortezomib (see section 4.8).
Croatian: U rijetkim slučajevima prijavljena je akutna difuzna infiltrativna bolest pluća nepoznate etiologije, kao što je pneumonitis, intersticijska pneumonija, infiltracija pluća i akutni respiratorni distres sindrom (ARDS) u bolesnika koji su primali bortezomib (vidjeti dio 4.8).
English: Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m2 dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations.
Croatian: Nakon intravenske bolusne ili supkutane injekcije u dozi od 1,3 mg/m2 primijenjene bolesnicima s multiplim mijelomom (n=14 u intravenskoj skupini, n=17 u supkutanoj skupini), ukupna sistemska izloženost nakon primjene ponovljenih doza (AUCtrajanja) bila je jednaka za supkutane i intravenske primjene.
English: A statistically significant survival benefit in favour of the Bzmb+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including bortezomib-based regimens.
Croatian: Primijećeno je statistički značajno veće preživljenje u skupini liječenoj s Bzmb+M+P (HR=0,695; p=0,00043) usprkos naknadnim terapijama koje uključuju liječenje bortezomibom.
English: Median
Croatian: Medijana
English: In an exploratory efficacy analysis, a 67.3% response rate (including a 28.6% CR rate) as measured by hematologic response (M-protein) was reported in 49 evaluable patients treated with the maximum allowed doses of 1.6 mg/m2 weekly and 1.3 mg/m2 twice-weekly.
Croatian: U eksplorativnoj analizi djelotvornosti, stopa odgovora od 67,3 % (uključujući CR stopu od 28,6 %) prema mjerenju hematološkog odgovora (M-protein) bila je zabilježena u 49 procijenjenih bolesnika liječenih maksimalnim dopuštenim dozama od 1,6 mg/m2 na tjedan i 1,3 mg/m2 dvaput na tjedan.
English: This suggests that bortezomib distributes widely to peripheral tissues.
Croatian: Ovi podaci ukazuju da se bortezomib znatno distribuira u periferna tkiva.
English: Orthostatic/postural hypotension was not acutely related to bolus infusion of bortezomib.
Croatian: Ortostatska/posturalna hipotenzija nije bila akutno povezana s bolus infuzijom bortezomiba.
English: In patients, overdose more than twice the recommended dose has been associated with the acute onset of symptomatic hypotension and thrombocytopenia with fatal outcomes.
Croatian: U bolesnika je predoziranje dozom koja je više od dvostruko veća od preporučene bilo povezano s akutnim početkom simptomatske hipotenzije i trombocitopenije sa smrtnim ishodima.
English: Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with bortezomib treatment.
Croatian: Gastrointestinalna toksičnost, uključujući mučninu, proljev, povraćanje i zatvor, vrlo su česti kod liječenja bortezomibom.
English: Bortezomib SUN might cause tiredness, dizziness, fainting, or blurred vision.
Croatian: Bortezomib SUN može uzrokovati umor, omaglicu, nesvjesticu ili zamagljen vid.
English: Patients with mild hepatic impairment do not require a dose adjustment and should be treated per the recommended dose.
Croatian: Bolesnicima s blagim oštećenjem jetre prilagodba doze nije potrebna i treba ih liječiti preporučenim dozama.
English: Day 1, 2, 3, 4 Day 8, 9, 10, 11
Croatian: Dan 1, 2, 3, 4 Dan 8, 9, 10, 11
English: In the BzmbR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
Croatian: U BzmbR-CAP skupini, 22,5 % bolesnika primilo je transfuzije trombocita u usporedbi s 2,9 % bolesnika u R-CHOP skupini.
English: Seizures have been uncommonly reported in patients without previous history of seizures or epilepsy.
Croatian: Epileptički napadaji su manje često prijavljeni u bolesnika bez prethodnih epileptičkih napadaja ili epilepsije u anamnezi.
English: At the time of a pre-specified interim analysis, the primary endpoint, time to progression, was met and patients in the M+P arm were offered Bzmb+M+P treatment.
Croatian: U vrijeme unaprijed planirane privremene analize postigla se primarna mjera ishoda, vrijeme do progresije te je bolesnicima u M+P kraku studije bilo ponuđeno liječenje Bzmb+M+P.
English: This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%, p < 0.0001) for patients treated with combination therapy of bortezomib and pegylated liposomal doxorubicin.
Croatian: Ova prijevremena analiza je pokazala redukciju TTP rizika za 45 % (95 % CI; 29 - 57 %, p < 0,0001) za bolesnike koji su liječeni kombinacijskom terapijom bortezomiba i pegiliranog liposomalnog doksorubicina.
English: Grade ≥ 3 non-haematological toxicities considered to be related to Bortezomib SUN
Croatian: Nehematološke toksičnosti stupnja ≥ 3 za koje se smatra da su povezane s Bortezomib SUN-om
English: Patients were administered intravenous doses of 0.7 to 1.3 mg/m2 of bortezomib twice weekly.
Croatian: Bolesnicima su bile primijenjene intravenske doze od 0,7 do 1,3 mg/m2 bortezomiba dvaput tjedno.
English: Developmental toxicity studies in the rat and rabbit have shown embryo-fetal lethality at maternally toxic doses, but no direct embryo-foetal toxicity below maternally toxic doses.
Croatian: Ispitivanja razvojne toksičnosti u štakora i kunića pokazala su embrio-fetalne letalne učinke pri dozama toksičnima za majku, ali nije bilo izravne embrio-fetalne toksičnosti u dozama nižim od onih toksičnih za majku.
English: Previously untreated multiple myeloma
Croatian: Prethodno neliječeni multipli mijelom
English: Response rate populatione n=668
Croatian: Stopa odgovora populacijae n=668
English: Patients had IgG/IgA/Light chain myeloma in 63%/25%/8% instances, a median hemoglobin of 105 g/l, and a median platelet count of 221.5 x 109/l.
Croatian: Bolesnici su imali mijelom IgG/IgA/lakih lanaca u 63 %/25 %/8 % slučajeva, medijan hemoglobina od 105 g/l, i medijan broja trombocita od 221,5 x 109/l.
English: Anaphylactic shock, Amyloidosis, Type III immune complex mediated reaction
Croatian: Anafilaktički šok, amiloidoza, reakcija tipa III posredovana imunokompleksima
English: Additional adverse drug reactions identified associated with the use of the combination therapy (BzmbR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Croatian: Dodatne identificirane nuspojave povezane s primjenom kombiniranog liječenja (BzmbR-CAP) bile su infekcija hepatitisom B (< 1 %) i ishemija miokarda (1,3 %).
English: The primary efficacy endpoint of the study was post-induction response rate (CR+nCR).
Croatian: Primarni ishod djelotvornosti ispitivanja bio je post-indukcijska stopa odgovora (CR+nCR).
English: Hypersensitivity to the active substance, to boron or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar, na bor ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: • Additional risk minimisation measures In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Croatian: U svakoj zemlji članici, nositelj odobrenja će s nacionalnim nadležnim tijelom dogovoriti sadržaj i oblik edukacijskog materijala.
English: The concentration of the resulting solution will be 2.5 mg/ml.
Croatian: Koncentracija dobivene otopine bit će 2,5 mg/ml.
English: Median survival for the Bzmb+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Croatian: Medijan preživljenja za skupinu koja je primala Bzmb+M+P bio je 56,4 mjeseci u odnosu na 43,1 za skupinu koja je primala M+P.
English: Grade 1 with pain or Grade 2 (moderate symptoms; limiting instrumental Activities of Daily Living (ADL)**)
Croatian: 1. stupanj s bolovima ili 2. stupanj (umjereni simptomi; ograničavaju instrumentalne aktivnosti svakodnevnog života (ADL od engl.
English: Over a bortezomib concentration range of 0.01 to 1.0 μg/ml, the in vitro protein binding averaged 82.9% in human plasma.
Croatian: U rasponu koncentracije bortezomiba od 0,01 do 1,0 μg/ml, vezanje za proteine ljudske plazme in vitro u prosjeku je iznosilo 82,9 %.
English: Six Bortezomib SUN cycles are recommended, although for patients with a response first documented at cycle 6, two additional Bortezomib SUN cycles may be given.
Croatian: Preporučuje se šest ciklusa liječenja Bortezomib SUN-om, iako se bolesnicima za koje je odgovor prvi put zabilježen u 6. ciklusu mogu dati dva dodatna ciklusa liječenja Bortezomib SUNom.
English: One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the BzmbTDx and TDx groups, respectively.
Croatian: Jednu autolognu transplantaciju matičnih stanica primilo je 105 (81 %) bolesnika odnosno 78 (61 %) bolesnika u BzmbTDx i TDx skupini.
English: Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Bortezomib SUN Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: In vitro studies indicate that bortezomib is a weak inhibitor of the cytochrome P450 (CYP) isozymes 1A2, 2C9, 2C19, 2D6 and 3A4.
Croatian: In vitro ispitivanja pokazuju da je bortezomib slabi inhibitor izoenzima citokroma P450 (CYP) 1A2, 2C9, 2C19, 2D6 i 3A4.
English: When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see section 4.6).
Croatian: Kada se primjenjuje talidomid, potrebna je posebna pažnja vezana uz mjere prevencije i testiranje na trudnoću (vidjeti dio 4.6).
English: The mean elimination half-life (t1/2) of bortezomib upon multiple dosing ranged from 40-193 hours.
Croatian: Prosječno poluvrijeme eliminacije (t1/2) bortezomiba nakon višekratnog doziranja kretao se u rasponu od 40 - 193 sata.
English: In patients with MCL, transient neutropenia that was reversible between cycles was observed, with no evidence of cumulative neutropenia.
Croatian: U bolesnika s limfomom plaštenih stanica, zabilježena je prolazna reverzibilna neutropenija između ciklusa, bez dokaza kumulativne neutropenije.
English: In the Phase II study, patients who did not obtain an optimal response to therapy with bortezomib alone were able to receive high-dose dexamethasone in conjunction with bortezomib.
Croatian: U ispitivanju faze II, bolesnici koji nisu postigli optimalni terapijski odgovor kod liječenja samo bortezomibom mogli su primiti visoku dozu deksametazona zajedno s bortezomibom.
English: It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of Bortezomib SUN therapy.
Croatian: Također se preporučuje da bolesnici u kojih postoji terapijski odgovor, ali nije postignuta kompletna remisija, prime ukupno 8 ciklusa terapije Bortezomib SUN-om.
English: It is unknown if the pharmacokinetics of bortezomib are influenced in patients with severe renal impairment not undergoing dialysis (CrCL < 20 ml/min/1.73 m2).
Croatian: Nije poznato je li farmakokinetika bortezomiba promijenjena u bolesnika s teškim oštećenjem bubrega koji nisu na dijalizi (CrCL < 20 ml/min/1,73 m2).
English: The concentration of the resulting solution will be 1 mg/ml.
Croatian: Koncentracija dobivene otopine bit će 1 mg/ml.
English: HRb (95% CI)=0.63 p-valued < 0.001
Croatian: HRb (95 % CI)=0,63 p-vrijednostd < 0,001
English: 56.4 mo
Croatian: 56,4 mjeseci
English: Cochran Mantel-Haenszel test. b Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ] in BzmbDx group and 52/242 [21%] in VDDx group).
Croatian: b Odnosi se na stope odgovora nakon druge transplantacije za ispitanike koji su prošli drugu transplantaciju (42/240 [18 % ] u BzmbDx skupini i 52/242 [21 %] u VDDx skupini).
English: The effect of hepatic impairment on the pharmacokinetics of bortezomib was assessed in a Phase I study during the first treatment cycle, including 61 patients primarily with solid tumors and varying degrees of hepatic impairment at bortezomib doses ranging from 0.5 to 1.3 mg/m2.
Croatian: Učinak oštećenja jetre na farmakokinetiku bortezomiba procijenio se u ispitivanju faze I tijekom prvog ciklusa liječenja, uključujući primarno 61 bolesnika s primarno solidnim tumorima i raznim stupnjevima oštećenja jetre u dozama bortezomiba u rasponu od 0,5 do 1,3 mg/m2.
English: Most patients required treatment for their orthostatic hypotension.
Croatian: U većine je bolesnika bilo potrebno liječiti ortostatsku hipotenziju.
English: The solution should be injected subcutaneously, at a 45-90° angle.
Croatian: Otopina se mora injicirati supkutano pod kutom od 45 - 90°.
English: a Intent to Treat (ITT) population b p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p <
Croatian: Intent to treat) b p-vrijednost iz stratificiranog log-rank testa; analiza po liniji liječenja isključuje stratifikaciju po prethodnim liječenjima;
English: Caution is advised when treating patients with a history of syncope receiving medicinal products known to be associated with hypotension; or who are dehydrated due to recurrent diarrhoea or vomiting.
Croatian: Savjetuje se oprez kad se liječe bolesnici koji imaju sinkopu u anamnezi i primaju lijekove za koje se zna da su povezani s hipotenzijom ili koji su dehidrirani zbog rekurentnog proljeva ili povraćanja.
English: With a median duration of follow-up of 40 months, median OS (56.3 months in the R-CHOP group, and not reached in the BzmbR-CAP group) favoured the BzmbR-CAP group, (estimated HR=0.80; p=0.173).
Croatian: S medijanom trajanja praćenja od 40 mjeseci, medijan OS (56,3 mjeseci u R-CHOP skupini, i nije postignut u BzmbR-CAP skupini) bio je u korist BzmbR-CAP skupine, (procijenjeni HR=0,80; p=0,173).
English: Secondary endpoints included, time to progression (TTP), time to next anti-lymphoma treatment (TNT), duration of treatment free interval (TFI), overall response rate (ORR) and complete response (CR/CRu) rate, overall survival (OS) and response duration.
Croatian: Sekundarni ishodi su uključili, vrijeme do progresije (TTP), vrijeme do sljedećeg liječenja limfoma (od engl. time to next anti-lymphoma treatment, TNT), trajanje intervala bez liječenja (od engl. treatment free interval TFI), ukupnu stopu odgovora (od engl. overall response rate, ORR) i stopu kompletnog odgovora (od engl. complete response, CR/CRu), ukupno preživljenje (od engl. overall survival, OS) i trajanje odgovora.
English: Instructions for reconstitution Bortezomib SUN must be reconstituted by a healthcare professional.
Croatian: Upute za rekonstituciju Bortezomib SUN mora rekonstituirati zdravstveni radnik.
English: Bortezomib SUN treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however Bortezomib SUN may be administered by a healthcare professional experienced in use of chemotherapeutic agents.
Croatian: Liječenje Bortezomib SUN-om se mora započeti pod nadzorom liječnika koji je iskusan u liječenju bolesnika s rakom, međutim Bortezomib SUN može primijeniti zdravstveni radnik koji je iskusan u primjeni kemoterapije.
English: The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511; 95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Croatian: Analiza je pokazala poboljšani ORR (CR+PR) (omjer izgleda 3,769; 95 % CI 2,045 - 6,947; p < 0,001), PFS (omjer hazarda 0,511; 95 % CI 0,309 - 0,845; p=0,008), TTP (omjer hazarda 0,385; 95 % CI 0,212 - 0,698; p=0,001) za bortezomib u kombinaciji s deksametazonom nad monoterapijom bortezomibom.
English: You will receive 4 cycles (12 weeks).
Croatian: Primit ćete 4 ciklusa (12 tjedna).
English: Table 12: Efficacy results from study IFM-2005-01 Endpoints
Croatian: Tablica 12: Rezultati djelotvornosti iz ispitivanja IFM-2005-01 Mjere ishoda
English: Nine treatment cycles of this combination therapy are administered.
Croatian: Primjenjuje se devet ciklusa ovog kombiniranog liječenja.
English: It is recommended that patients be carefully monitored for symptoms of neuropathy such as a burning sensation, hyperesthesia, hypoesthesia, paraesthesia, discomfort, neuropathic pain or weakness.
Croatian: Preporučuje se pažljivo praćenje bolesnika zbog simptoma neuropatije kao što su osjećaj žarenja, hiperestezija, hipoestezija, parestezija, nelagoda, neuropatska bol ili slabost.
English: No clinical data are available for bortezomib with regard to exposure during pregnancy.
Croatian: Nema dostupnih kliničkih podataka o izloženosti bortezomibu tijekom trudnoće.
English: In the unlikely event of an overdose, your doctor will monitor you for side effects.
Croatian: U slučaju predoziranja, koje nije vjerojatno, liječnik će Vas pratiti radi nuspojava.
English: The matched-pair analysis is a statistical method in which patients in the treatment group (e.g. bortezomib in combination with dexamethasone) and patients in the comparison group (e.g. bortezomib) are made comparable with respect to confounding factors by individually pairing study subjects.
Croatian: Analiza odgovarajućih parova je statistička metoda u kojoj se bolesnici u liječenoj skupini (npr. bortezomib u kombinaciji s deksametazonom) i bolesnici u usporednoj skupini (npr. bortezomib) učine usporedivima s obzirom na zbunjujuće čimbenike tako da se individualno uparuju ispitanici u ispitivanju.
English: Based on a population pharmacokinetic analysis, clearance of bortezomib increased with increasing body surface area (BSA).
Croatian: Na temelju populacijske farmakokinetičke analize klirens bortezomiba povećava se s porastom površine tijela
English: d p-value from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+) NA=not applicable, NE=not estimated TTP-Time to Progression
Croatian: d p-vrijednost iz Cochran Mantel-Haenszelovog hi-kvadrat testa prilagođena za čimbenike stratifikacije; analiza po liniji terapije isključuje stratifikaciju po prethodnim liječenjima * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+) NA=nije primjenjivo, NE=nije procijenjeno TTP=Vrijeme do progresije bolesti CI=Interval pouzdanosti
English: PRES is a rare, often reversible, rapidly evolving neurological condition, which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances.
Croatian: PRES je rijetko neurološko stanje koje je često reverzibilno, brzo se razvija, a može biti predstavljeno napadajima, hipertenzijom, glavoboljom, letargijom, smetenošću, sljepoćom i drugim poremećajima vida i neurološkim poremećajima.
English: Phase II
Croatian: Faza II
English: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma Prior to initiating a new cycle of therapy:
Croatian: Prilagodbe doza tijekom liječenja za bolesnike s prethodno neliječenim limfomom plaštenih stanica Prije početka novog ciklusa liječenja:
English: Antiviral prophylaxis was administered to 26% of the patients in the Bzmb+M+P arm.
Croatian: Antivirusna profilaksa se primijenila u 26 % bolesnika u skupini koja je primala Bzmb+M+P.