FrancophonIA/ELRC3.0 huggingface dataset:
English: Neither age, sex, lymphoma grade, initial diagnosis, presence or absence of bulky disease, normal or high LDH nor presence of extranodal disease had a statistically significant effect (Fisher's exact test) on response to rituximab.
Croatian: Dob, spol, stupanj zloćudnosti limfoma, početna dijagnoza, prisutnost ili odsutnost proširenosti tumora, normalan ili povišeni LDH i ekstranodalna bolest nisu (prema Fisherovom testu vjerojatnosti) statistički značajno utjecali na odgovor na liječenje rituksimabom.
English: Progression‐free survival (PFS)
Croatian: Progression Free Survival)
English: In patients with relapsed/refractory CLL, the incidence of grade 3/4 hepatitis B infection (reactivation and primary infection) was 2% in R-FC vs 0% FC.
Croatian: U bolesnika s relapsirajućim/refraktornim KLL-om incidencija hepatitis B infekcije stupnja 3/4 (reaktivacija i primarna infekcija) iznosila je 2 % kod primjene R-FC terapije u odnosu na 0 % kod primjene FC terapije.
English: Infusion related adverse reactions of all kinds have been observed in 77% of patients treated with rituximab (including cytokine release syndrome accompanied by hypotension and bronchospasm in 10 % of patients) see section 4.8.
Croatian: U 77 % bolesnika liječenih rituksimabom primijećene su nuspojave vezane uz primjenu infuzije (uključujući sindrom otpuštanja citokina praćen hipotenzijom i bronhospazmom u 10 % bolesnika), vidjeti dio 4.8.
English: A corticosteroid medicine will usually be given by injection before the start of Rituzena treatment.
Croatian: Obično će se prije početka liječenja lijekom Rituzena primijeniti injekcija kortikosteroidnog lijeka.
English: Talk to your doctor, pharmacist or nurse before you are given Rituzena if:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite lijek Rituzena:
English: • The other ingredients are sodium chloride, tri-sodium citrate dihydrate, polysorbate 80 and water for injections.
Croatian: • Drugi sastojci su: natrijev klorid, natrijev citrat, polisorbat 80 i voda za injekcije.
English: Limited information from one study in relapsed/refractory CLL patients suggests that rituximab treatment may also worsen the outcome of primary hepatitis B infections.
Croatian: Ograničeni podaci iz jednog ispitivanja u bolesnika s relapsirajućim/refraktornim KLLom ukazuju da liječenje rituksimabom može također pogoršati ishod primarne infekcije hepatitisom B. Sve bolesnike mora se prije početka liječenja lijekom rituksimab testirati na virus hepatitisa B (HBV).
English: The incidence of ADRs of any grade was similar in
Croatian: Incidencija nuspojava bilo kojeg stupnja bila je slična u tim dvjema skupinama.
English: The prepared Rituzena solution should be administered as an intravenous infusion through a dedicated line.
Croatian: Pripremljenu otopinu lijeka Rituzena treba primijeniti intravenskom infuzijom kroz posebnu infuzijsku liniju.
English: The safety of immunisation with live viral vaccines, following rituximab therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended.
Croatian: Sigurnost imunizacije živim virusnim cjepivima nakon liječenja lijekom rituksimab nije ispitivana u bolesnika s NHL-om i KLL-om pa se cijepljenje živim virusnim cjepivima ne preporučuje.
English: Therefore, in patients with a known cardiac history, and those who experienced prior cardiopulmonary adverse reactions the risk of cardiovascular complications resulting from infusion reactions should be considered before treatment with rituximab and patients closely monitored during administration.
Croatian: Stoga se u bolesnika s anamnezom srčanih poremećaja i onih koji su ranije imali nuspojave na srcu i plućima prije liječenja lijekom rituksimab mora razmotriti rizik od razvoja kardiovaskularnih komplikacija kao posljedice reakcije na infuziju te ih se mora pažljivo nadzirati tijekom liječenja.
English: Your doctor may prescribe Rituzena for the treatment of:
Croatian: Vam može propisati lijek Rituzena za liječenje sljedećih bolesti:
English: The following terms have been reported as adverse events during clinical trials, however, were reported at a similar or lower incidence in the rituximab-arms compared to control arms: haematotoxicity, neutropenic infection, urinary tract infection, sensory disturbance,
Croatian: Sljedeće su nuspojave prijavljene tijekom kliničkih ispitivanja, no njihova je incidencija bila slična ili manja u skupinama koje su primale rituksimab u odnosu na kontrolne skupine: hematotoksičnost, neutropenijska infekcija, infekcija mokraćnih puteva, poremećaj osjeta, vrućica.
English: It is not known whether Rituzena has an effect on you being able to drive or use any tools or
Croatian: Nije poznato utječe li Rituzena na sposobnost upravljanja vozilima ili rada s alatima i strojevima.
English: At 6 months, in the active-controlled, randomised, double-blind, multicentre, non-inferiority trial, in the rituximab group, 27%, 58% and 51% of patients with normal immunoglobulin levels at baseline, had low IgA, IgG and IgM levels, respectively compared to 25%, 50% and 46% in the cyclophosphamide group.
Croatian: U randomiziranom, dvostruko slijepom, multicentričnom, aktivnim lijekom kontroliranom ispitivanju neinferiornosti su nakon 6 mjeseci u skupini koja je primala rituksimab, vrijednosti IgA, IgG i IgM bile snižene u 27 %, 58 % odnosno 51 % bolesnika koji su na početku ispitivanja imali normalne vrijednosti imunoglobulina, u usporedbi s 25 %, 50 % odnosno 46 % bolesnika u skupini koja je primala ciklofosfamid.
English: Patients received 2 x 1,000 mg of rituximab separated by an interval of two weeks; in addition to methotrexate (10-25 mg/week).
Croatian: Bolesnici su primali 2 x 1000 mg rituksimaba u razmacima od dva tjedna kao dodatak metotreksatu (10 do 25 mg na tjedan).
English: Due to the long retention time of rituximab in B cell depleted patients, women of childbearing potential should use effective contraceptive methods during and for 12 months following treatment with rituximab.
Croatian: Kontracepcija u muškaraca i žena Zbog dugog vremena zadržavanja rituksimaba u bolesnika s deplecijom B-stanica, žene reproduktivne dobi moraju koristiti učinkovite metode kontracepcije tijekom i 12 mjeseci nakon terapije lijekom rituksimab.
English: The clinical relevance of HACA formation in rituximab-treated patients is unclear.
Croatian: Nije jasna klinička važnost stvaranja HACA antitijela u bolesnika liječenih rituksimabom.
English: Patient's
Croatian: Broj bolesnika
English: The incidence of infusion-related symptoms decreased substantially with subsequent infusions and is <1% of patients by the eighth cycle of rituximab-containing
Croatian: Incidencija pojave simptoma povezanih s infuzijom znatno se smanjila u narednim infuzijama te je do osmog ciklusa terapije koja je sadržavala rituksimab iznosila < 1 %.
English: Safety and efficacy of Rituzena have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin's lymphoma.
Croatian: Sigurnost i djelotvornost lijeka Rituzena u kombinaciji s drugim kemoterapijskim protokolima u liječenju difuznog ne-Hodgkinovog limfoma velikih B-stanica nisu ustanovljene.
English: This is a disease of the lymph tissue (part of the immune system) that affects B-Lymphocytes.
Croatian: Ne-Hodgkinov limfom je bolest limfnog tkiva (dijela imunološkog sustava) koja zahvaća B-limfocite.
English: Biotec House, Central Park, Western Avenue
Croatian: Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT, UK
English: Granulomatosis with polyangiitis and microscopic polyangiitis Rituzena, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Croatian: Granulomatoza s poliangiitisom i mikroskopski poliangiitis Rituzena je u kombinaciji s glukokortikoidima indicirana za poticanje remisije u odraslih bolesnika s teškom aktivnom granulomatozom s poliangitiisom (Wegenerova granulomatoza) (GPA) i mikroskopskim poliangiitisom (MPA).
English: In the 99 rituximab patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197-285) at the 6-month primary endpoint.
Croatian: U 99 bolesnika liječenih rituksimabom ukupna stopa infekcija iznosila je približno 237 na 100 bolesnik-godina (95 % CI 197-285) u trenutku primarne mjere ishoda nakon 6 mjeseci.
English: The MAH must ensure that all physicians who are expected to prescribe Rituzena are
Croatian: Nositelj odobrenja mora osigurati da svi liječnici za koje se očekuje da će propisivati lijek Rituzena dobiju sljedeće materijale:
English: Toxic Epidermal Necrolysis (Lyell Syndrome) and Stevens-Johnson Syndrome, some with fatal outcome, have been reported very rarely.
Croatian: Vrlo su rijetko prijavljeni toksična epidermalna nekroliza (Lyellov sindrom) i Stevens-Johnsonov sindrom, ponekad sa smrtnim ishodom.
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and very rare (<1/10,000).
Croatian: Kategorije učestalosti definirane su kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često
English: Summary of the safety profile (non-Hodgkin's lymphoma and chronic lymphocytic leukaemia)
Croatian: Sažetak sigurnosnog profila (ne-Hodgkinov limfom i kronična limfocitna leukemija)
English: Cardiac events occurred at a rate of approximately 273 per 100 patient years (95% CI 149-470) at the 6-month primary endpoint.
Croatian: Srčani događaji prijavljeni su po stopi od 273 na 100 bolesnik-godina (95 % CI 149-470) u trenutku primarne mjere ishoda nakon 6 mjeseci.
English: All patients treated with rituximab for rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis must be given the patient alert card with each infusion.
Croatian: Svim bolesnicima s reumatoidnim artritisom, granulomatozom s poliangiitisom i mikroskopskim poliangiitisom koji se liječe lijekom rituksimab potrebno je uz svaku infuziju dati karticu s upozorenjima za bolesnika.
English: When sticking to the surface of this cell, rituximab causes the cell to die.
Croatian: Kada se rituksimab veže na površinu te stanice, uzrokuje njezinu smrt.
English: 20 Academy-ro 51 beon-gil
Croatian: 20 Academy-ro 51 beon-gil Yeonsu-gu, Incheon, 22014, Republika Korea
English: You will always be given Rituzena as a drip (intravenous infusion).
Croatian: Lijek Rituzena ćete uvijek primiti ukapavanjem u venu (intravenskom infuzijom).
English: Physicians should exercise caution when considering the use of rituximab in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection (see section 4.8).
Croatian: Liječnici trebaju biti oprezni ako razmatraju primjenu lijeka rituksimab u bolesnika s anamnezom rekurentnih ili kroničnih infekcija ili postojećim stanjima koje ih mogu dodatno predisponirati za ozbiljne infekcije (vidjeti dio 4.8).
English: The chemotherapy should be given after the Rituzena infusion.
Croatian: Kemoterapiju treba primijeniti nakon infuzije lijeka Rituzena.
English: doctor's name and phone number on the dentist you see - not just the specialist
Croatian: medicinskoj sestri ili stomatologu koje posjećujete, a ne samo liječniku specijalistu koji Vam propisuje lijek
English: 3infusion related reactions (generalised oedema,
Croatian: 3reakcije povezane s infuzijom (hipertenzija,
English: anaphylaxis tumour lysis syndrome, cytokine release syndrome4, serum sickness infusion-relate d acute reversible thrombocytop enia4
Croatian: Poremećaji imunološko g sustava anafilaksija sindrom lize tumora, sindrom otpuštanja citokina4, serumska bolest akutna reverzibilna trombocitopenij a povezana s infuzijom4
English: lung infiltration gastro-intestin al perforation7
Croatian: Poremećaji probavnog sustava gastrointestinalna perforacija7
English: The recommended dosage of Rituzena for induction of remission therapy of granulomatosis with polyangiitis and microscopic polyangiitis is 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total).
Croatian: Preporučena doza lijeka Rituzena za poticanje remisije granulomatoze s poliangiitisom i mikroskopskog poliangiitisa iznosi 375 mg/m2 tjelesne površine primijenjeno intravenskom infuzijom jedanput tjedno tijekom 4 tjedna (ukupno četiri infuzije).
English: In the relapsed/refractory CLL study grade ¾ thrombocytopenia was reported in 11% of patients in the R-FC group compared to 9% of patients in
Croatian: U ispitivanju relapsirajućeg/refraktornog KLL-a trombocitopenija stupnja 3/4 prijavljena je u 11 % bolesnika u skupini koja je primala R-FC u usporedbi s 9 % bolesnika u skupini koja je primala FC.
English: Repeated treatment courses
Croatian: Višestruki ciklusi liječenja
English: Patients were randomised in a 1:1 ratio to receive either oral cyclophosphamide daily (2mg/kg/day) for 3-6 months or rituximab (375 mg/m2) once weekly for 4 weeks.
Croatian: Bolesnici su u omjeru 1:1 randomizirani da primaju ili peroralni ciklofosfamid (2 mg/kg na dan) svakodnevno tijekom 3-6 mjeseci ili rituksimab (375 mg/m2) jedanput tjedno tijekom 4 tjedna.
English: Corticosteroid medicine given by mouth may be started at any time by your doctor to treat your condition.
Croatian: Liječnik Vam za liječenje Vaše bolesti može u bilo kojem trenutku propisati kortikosteroide koji se uzimaju kroz usta.
English: Excipients: sodium chloride, tri-sodium citrate dihydrate, polysorbate 80, water for injections.
Croatian: Pomoćne tvari: natrijev klorid, natrijev citrat, polisorbat 80, voda za injekcije.
English: Less frequently, some patients may get pain at the infusion site, blisters, itching, sickness, tiredness, headache, breathing difficulties, tongue or throat swelling, itchy or runny nose, vomiting, flushing or palpitations, heart attack or low number of platelets.
Croatian: Rjeđe se u nekih bolesnika mogu pojaviti bol na mjestu infuzije, plikovi, svrbež, mučnina, umor, glavobolja, otežano disanje, natečenost jezika ili grla, svrbež ili curenje nosa, povraćanje, navale crvenila ili osjećaj lupanja srca, srčani udar ili malen broj krvnih pločica (trombocita).
English: The Patient information about Rituzena should contain the following key elements:
Croatian: Informacije za bolesnike o lijeku Rituzena moraju sadržavati sljedeće ključne elemente:
English: PML, reactivation of hepatitis B late neutropenia2 serum sicknesslike reaction
Croatian: PML, reaktivacija hepatitisa B
English: Physicians should exercise caution when considering the use of rituximab in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection, e.g. hypogammaglobulinaemia (see section 4.8).
Croatian: Liječnici trebaju biti oprezni ako razmatraju primjenu lijeka rituksimab u bolesnika s anamnezom rekurentnih ili kroničnih infekcija ili postojećim bolestima koje ih mogu dodatno predisponirati za ozbiljne infekcije, primjerice hipogamaglobulinemijom (vidjeti dio 4.8).
English: Since hypotension may occur during rituximab infusion, consideration should be given to withholding anti-hypertensive medicinal product 12 hours prior to the rituximab infusion.
Croatian: Budući da tijekom infuzije rituksimaba može doći do hipotenzije, treba razmotriti mogućnost izostavljanja antihipertenzivne terapije 12 sati prije primjene infuzije lijeka rituksimab.
English: System organ class Very common Common
Croatian: Organski sustav Vrlo često
English: The Physician information about Rituzena should contain the following key elements:
Croatian: Informacije za liječnike o lijeku Rituzena moraju sadržavati sljedeće ključne elemente:
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Rituzena.
Croatian: Ako se nešto od gore navedenoga odnosi na Vas (ili niste sigurni), obratite se svom liječniku,
English: Rituzena monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.
Croatian: Monoterapija lijekom Rituzena indicirana je u liječenju bolesnika oboljelih od folikularnog limfoma stadija III-IV koji su rezistentni na kemoterapiju ili su u drugom odnosno sljedećem relapsu nakon kemoterapije.
English: Response rate and CR rates analysed using Chi-squared Test. NR: not reached; n.a.: not applicable *: only applicable to patients achieving a CR, nPR, PR **: only applicable to patients achieving a CR
Croatian: ND: nije dostignuto; n.p.: nije primjenjivo *: primjenjivo samo za bolesnike koji su postigli CR, nPR ili PR **: primjenjivo samo za bolesnike koji su postigli CR
English: Units 2100, 2110, 2010, 2120, 2130 and 2500
Croatian: Units 2100, 2110, 2010, 2120, 2130 and 2500 Phase 18, Central Park Bridgend Industrial Estate Bridgend, CF31 3TY, UK
English: Rituzena is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Croatian: Rituzena je dostupna u sterilnim, jednokratnim apirogenim bočicama, bez konzervansa.
English: How much and how often you will receive your treatment If you are being treated for non-Hodgkin's Lymphoma
Croatian: Koliko ćete lijeka primiti i koliko često a) Bolesnici koji se liječe od ne-Hodgkinova limfoma ako se liječite samo lijekom Rituzena
English: This should be followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day, and tapered as rapidly as possible based on clinical need)
Croatian: Nakon toga, tijekom i nakon liječenja lijekom Rituzena treba peroralno davati prednizon u dozi od 1 mg/kg na dan (ne više od 80 mg na dan i što brže postupno smanjivati dozu, ovisno o kliničkoj potrebi).
English: The safety of immunisation with live viral vaccines following rituximab therapy has not been studied.
Croatian: Sigurnost cijepljenja živim virusnim cjepivima nakon terapije lijekom rituksimab nije ispitivana.
English: Serious infections, including fatalities, can occur during therapy with rituximab (see section 4.8).Rituximab should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3) or severely immunocompromised patients (e.g. where levels of CD4 or CD8 are very low).
Croatian: Rituksimab se ne smije primijeniti bolesnicima s aktivnom teškom infekcijom (npr. tuberkulozom, sepsom i oportunističkim infekcijama, vidjeti dio 4.3) ili teško imunokompromitiranim bolesnicima (npr. kada su razine CD4 ili CD8 stanica vrlo niske).
English: In placebo-controlled periods of clinical trials, 0.94% (13/1382) of rituximab treated patients and
Croatian: U placebom kontroliranim razdobljima kliničkih ispitivanja u 0,94 % (13/1382) bolesnika liječenih rituksimabom te 0,27 % (2/731) bolesnika koji su primali placebo razvila se teška neutropenija.
English: The most common symptoms were allergic reactions like headache, pruritus, throat irritation, flushing, rash, urticaria, hypertension, and pyrexia.
Croatian: Najčešći simptomi bile su alergijske reakcije, kao što su glavobolja, svrbež, iritacija grla, navale crvenila, osip, urtikarija,
English: CLL affects B-lymphocytes, which originate in the bone marrow and develop in the lymph nodes.
Croatian: Kronična limfocitna leukemija zahvaća B-limfocite, koji nastaju u koštanoj srži, a razvijaju se u limfnim čvorovima.
English: Table 2 Summary of adverse drug reactions reported in clinical trials or during post marketing surveillance occurring in patients with rheumatoid arthritis receiving
Croatian: Tablica 2 Sažetak nuspojava prijavljenih u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet u bolesnika s reumatoidnim artritisom koji su primali rituksimab
English: These symptoms are usually reversible with interruption of rituximab infusion and administration of an anti-pyretic, an antihistaminic, and, occasionally, oxygen, intravenous saline or bronchodilators, and glucocorticoids if required.
Croatian: Ti se simptomi obično povlače nakon prekida infuzije rituksimaba i primjene antipiretika, antihistaminika te ponekad kisika, intravenske primjene fiziološke otopine ili bronhodilatatora te po potrebi glukokortikoida.
English: Since hypotension may occur during rituximab administration, consideration should be given to withholding anti-hypertensive medicines 12 hours prior to the rituximab infusion.
Croatian: S obzirom da tijekom primjene lijeka rituksimab može doći do hipotenzije, potrebno je razmotriti mogućnost izostavljanja antihipertenzivne terapije 12 sati prije davanja infuzije lijeka rituksimab.
English: The recommended dosage of Rituzena in combination with chemotherapy for previously untreated and relapsed/refractory patients is 375 mg/m2 body surface area administered on day 0 of the first treatment cycle followed by 500 mg/m2 body surface area administered on day 1 of each subsequent cycle for 6 cycles in total.
Croatian: Preporučena doza lijeka Rituzena u kombinaciji s kemoterapijom za prethodno neliječene bolesnike i bolesnike koji nisu odgovorili na liječenje ili su u relapsu iznosi 375 mg/m2 tjelesne površine primijenjeno nultog dana prvog ciklusa liječenja, nakon čega slijedi 500 mg/m2 tjelesne površine primijenjeno prvog dana svakog sljedećeg ciklusa, tijekom ukupno 6 ciklusa.
English: What Rituzena is and what it is used for What you need to know before you use Rituzena
Croatian: Što je Rituzena i za što se koristi Što je Rituzena
English: Mean terminal elimination half-life after the second infusion, following the second course, was 19 days for 2 x 500 mg dose and ranged from 21 to 22 days for the 2 x 1000 mg dose.
Croatian: Srednje terminalno poluvrijeme eliminacije nakon druge infuzije i drugog ciklusa iznosilo je 19 dana za dozu od 2 x 500 mg te od 21 do 22 dana za dozu od 2 x 1000 mg.
English: The difference between the treatment groups with respect to overall survival showed a significant clinical difference (p=0.029, log-rank test stratified by centre): survival rates at 53 months were 80.9% for patients in the R-CVP group compared to 71.1 % for patients in the CVP group．
Croatian: log-rang test stratificiran prema centru): stope preživljenja nakon 53 mjeseca bile su 80,9 % za bolesnike u R-CVP skupini, u usporedbi sa 71,1 % za bolesnike u CVP skupini.
English: The Patient Alert Card for Rituzena in non-oncology indications should contain the following key
Croatian: Kartica s upozorenjima za bolesnika za lijek Rituzena u neonkološkim indikacijama mora sadržavati sljedeće ključne elemente:
English: Therefore vaccination with live virus vaccines is not recommended whilst on rituximab or whilst peripherally B cell depleted.
Croatian: Stoga se ne preporučuje cijepljenje živim virusnim cjepivima za vrijeme primjene lijeka rituksimab odnosno dok je prisutna deplecija B-stanica u perifernoj krvi.
English: Patients in both arms received 1000mg of pulse intravenous (IV) methylprednisolone (or another equivalent-dose glucocorticoid) per day for 1 to 3 days, followed by oral prednisone (1 mg/kg/day, not exceeding 80 mg/day).
Croatian: Bolesnici u obje skupine su tijekom 1 do 3 dana primali pulsnu intravensku (i.v.) terapiju metilprednizolonom u dozi od 1000 mg na dan (ili drugi glukokortikoid u ekvivalentnoj dozi), a zatim peroralni prednizon (1 mg/kg na dan, ali ne više od 80 mg na dan).
English: The complete response rate after cycle 8 was 76.2 % in the R-CHOP group and 62.4 % in the CHOP
Croatian: Nakon 24 mjeseca procjene ukupnog preživljenja iznosile su 68,2 % za R-CHOP skupinu, odnosno 57,4 % za CHOP skupinu.
English: 95.1%b CI (−3.2%, 24.3%) a a Non-inferiority was demonstrated since the lower bound (−3.2%) was higher than the pre-determined b The 95.1% confidence level reflects an additional 0.001 alpha to account for an interim efficacy analysis.
Croatian: b Razina pouzdanosti od 95,1 % odražava dodatni alfa od 0,001 koji uzima u obzir privremenu analizu djelotvornosti.