natgillin/translations-raw huggingface dataset:
A total of 135 patients were enrolled: mean age was 50 years, 55% were female, and 48% had been receiving oral steroid therapy for at least 5 years.
Ukupno je uključeno 135 bolesnika: srednja dob bila je 50 godina, 55% ih je bilo ženskog spola, a 48% ih je primalo terapiju oralnim steroidima najmanje 5 godina.
A total of 14 surgeries were performed in 14 patients of which 13 were major surgeries and 1 was minor.
Ukupno je izvedeno 14 kirurških zahvata u 14 bolesnika, od čega 13 većih i 1 manji zahvat.
A total of 14,779 patients with type 2 diabetes mellitus, including 6,448 patients treated with 25 mg alogliptin and 2,476 patients treated with 12.5 mg alogliptin, participated in one phase 2 or 13 phase 3 (including the cardiovascular outcomes study) double-blind, placebo- or active-controlled clinical studies conducted to evaluate the effects of alogliptin on glycaemic control and its safety.
Ukupno 14.779 bolesnika sa šećernom bolešću tipa 2, uključujući 6.448 bolesnika liječenih s 25 mg alogliptina i 2476 bolesnika liječenih s 12,5 mg alogliptina sudjelovalo je u jednom ispitivanju faze 2 ili 13 dvostruko slijepih ispitivanja faze 3 (uključujući ispitivanje kardiovaskulartnih ishoda) kontroliranih placebom ili aktivnom kontrolom u kojima su procijenjeni djelovanje alogliptina na kontrolu glikemije i njegova sigurnost.
A total of 14.3% of patients receiving apremilast had observed weight loss between 5-10% while 5.7% of the patients receiving apremilast had observed weight loss greater than 10%.
U ukupno 14,3% bolesnika koji su primali apremilast opažen je gubitak težine između 5-10%, dok je u 5,7% bolesnika koji su primali apremilast opaženi gubitak težine bio veći od 10%.
A total of 1493 patients were randomised and treated with either placebo, apremilast 20 mg or apremilast 30 mg given orally twice daily.
Ukupno 1493 bolesnika randomizirano je i liječeno ili placebom ili apremilastom od 20 mg ili apremilastom od 30 mg davanim peroralno dvaput na dan.
A total of 15 paediatric patients (aged 2 months to 12 years) received Soliris in aHUS Study C09- 001r.
U ispitivanju aHUS-a C09-001r ukupno je 15 pedijatrijskih bolesnika (u dobi od 2 mjeseca do 12 godina) primalo Soliris.
A total of 15,776 individuals (10,495 subjects 16 through 26 years of age and 5,281 adolescents 9 through 15 years of age at enrolment) received Gardasil 9.
Ukupno je 15 776 osoba (10 495 ispitanika u dobi od 16 do 26 godina i 5281 adolescenata u dobi od 9 do 15 godina u trenutku uključenja) primilo Gardasil 9.
A total of 152 children (1 month to < 16 years of age) were treated with brivaracetam in a pharmacokinetic study and the related follow up study.
Ukupno je 152 djece (u dobi od 1 mjeseca do < 16 godina) primalo brivaracetam u farmakokinetičkom ispitivanju i njegovu nastavnom ispitivanju.
A total of 154 patients (methylnaltrexone bromide 0.15 mg/kg, n = 47; methylnaltrexone bromide 0.3 mg/kg, n = 55, placebo, n = 52) were treated in the double-blind period.
Tijekom dvostruko slijepog razdoblja ukupno je liječeno 154 bolesnika (metilnaltreksonbromid 0,15 mg/kg, n = 47; metilnaltreksonbromid 0,3 mg/kg, n = 55; placebo, n = 52).
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 1, every 3 weeks).
Ukupno 156 bolesnika randomizirano je za liječenje s 5-FU (800 mg/m2 dnevno, kontinuirana infuzija od prvog do petog dana svaka 3 tjedna) i cisplatinom (80 mg/m2 u obliku dvosatne infuzije 1. dan, svaka 3 tjedna).
A total of 158 children received the recommended dose of oseltamivir once daily in a post-exposure prophylaxis study in households (n = 99), a 6-week paediatric seasonal prophylaxis study (n = 49) and a 12- week paediatric seasonal prophylaxis study in immunocompromised subjects (n = 10).
Ukupno je 158 djece primalo preporučenu dozu oseltamivira jednom dnevno i to u ispitivanju profilakse nakon izlaganja virusu u kućanstvima (n = 99), u 6-tjednoj pedijatrijskoj studiji sezonske profilakse (n = 49) te u 12- tjednoj pedijatrijskoj studiji sezonske profilakse u imunokompromitiranih bolesnika (n = 10) .
A total of 16 patients (4.4%) were  75 years old.
Ukupno je 16 bolesnica bilo starije od 75 godina.
A total of 166 patients in the crizotinib arm and 163 patients in the chemotherapy arm had completed the EORTC QLQ-C30 and LC13 questionnaires at baseline and at least 1 postbaseline visit.
Ukupno 166 bolesnika u skupini krizotiniba i 163 bolesnika u kemoterapijskoj skupini ispunilo je upitnike EORTC QLQ-C30 i LC13 na početku ispitivanja i najmanje jedanput nakon početnog posjeta.
A total of 1717 asymptomatic or mildly symptomatic chemotherapy-naive patients were randomized 1:1 to receive either enzalutamide orally at a dose of 160 mg once daily (N = 872) or placebo orally once daily (N = 845).
Ukupno 1717 asimptomatskih ili blago simptomatskih bolesnika koji ranije nisu primali kemoterapiju randomizirano je u omjeru 1:1 za uzimanje ili enzalutamida peroralno u dozi od 160 mg jedanput na dan (N = 872) ili placebo peroralno jedanput na dan (N = 845).
A total of 173 patients subsequently enrolled in an extension trial in which patients received 2 mg/kg of elosulfase alfa every week or 2 mg/kg every other week, and then all were switched to 2 mg/kg every week upon availability of the Week 24 results.
U produžetak ispitivanja naknadno je uključeno ukupno 173 ispitanika, a ispitanici su primali ili dozu elosulfaze alfa od 2 mg/kg svaki tjedan ili 2 mg/kg svaki drugi tjedan, a nakon dobivenih rezultata nakon 24. tjedna svi su prebačeni na dozu od 2 mg/kg svaki tjedan.
A total of 174 patients received dasatinib 70 mg twice daily (161 resistant and 13 intolerant to imatinib).
Ukupno je 174 bolesnika primilo dasatinib u dozi od 70 mg dvaput dnevno (161 s otpornošću i 13 s nepodnošljivošću na imatinib).
A total of 1774patients received avanafil, which was taken as needed at doses of 50 mg (one study), 100 mg and 200 mg (four studies), respectively.
Ukupno 1774 bolesnika primilo je avanafil, prema potrebi, u dozama od 50 mg (u jednom ispitivanju), 100 mg i 200 mg (obje doze u četiri ispitivanja).
A total of 180 subjects with alpha1-proteinase inhibitor deficiency characterized by a serum alpha1-proteinase inhibitor level < 11 μM (i.e. < 50 mg/dL as determined by nephelometry) and clinical evidence of emphysema, were randomized to receive a weekly 60 mg / kg bw intravenous dose of either Respreeza (93 subjects) or placebo (87 subjects) for up to 24 months.
Ukupno je 180 ispitanika s nedostatkom inhibitora alfa1-proteinaze s razinom inhibitora alfa1-proteinaze u serumu < 11 μM (tj. < 50 mg/dl određeno nefelometrijom) i kliničkim dokazima emfizema bilo randomizirano kako bi primali tjednu intravensku dozu od 60 mg/kg TT Respreeze (93 ispitanika) ili placebo (87 ispitanika) tijekom najviše 24 mjeseca.
A total of 184 infusions of Coagadex were given as a preventative measure.
Ukupno 184 infuzije lijeka Coagadex dale su se kao preventivna mjera.
A total of 1935 patients were randomised to double- blind medication and approximately 70% were also using a long-acting muscarinic antagonist (LAMA) through the course of the trial.
Dvostruko-slijepo je randomizirano ukupno 1935 bolesnika, a za trajanja ispitivanja je približno 70% također primjenjivalo dugodjelujuće muskarinske antagoniste (LAMA).
A total of 197 patients aged 15 years or older with severely, active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicenter, non-inferiority trial.
Ukupno je 197 bolesnika u dobi od 15 ili više godina s teškom aktivnom granulomatozom s poliangitisom (75%) i mikroskopskim poliangitisom (24%) sudjelovalo i liječeno u randomiziranom, dvostruko slijepom, multicentričnom, aktivnim lijekom kontroliranom ispitivanju neinferiornosti.
A total of 198 patients with complete clearance at day 57 (184 treated with Picato and 14 treated with vehicle) were followed for additionally 12 months.
Ukupno 198 bolesnika s potpunim ozdravljenjem lezije u 57. danu (184 liječenih lijekom Picato i 14 liječenih podlogom) praćeno je dodatnih 12 mjeseci.
A total of 2,106 patients received insulin glargine 100 units/ml in all trials combined.
Ukupno 2 106 bolesnika primilo je inzulin glargin od 100 jedinica/ml u svim ispitivanjima zajedno.
A total of 2,114 patients were treated in the active controlled DVT/PE prevention trial, RE-MEDY, and in the placebo-controlled DVT/PE prevention trial, RE-SONATE.
U aktivnom kontroliranom ispitivanju prevencije DVT/PE-a, RE-MEDY, te u placebom kontroliranom ispitivanju prevencije DVT/PE-a, RE-SONATE, ukupno je bilo liječeno 2114 bolesnika.
A total of 2,626 subjects (58% of the women included in the extension study i.e.
Ukupno 2626 ispitanika (58% žena uključenih u produžetak ispitivanja, tj.
A total of 2,866 patients were randomized and 2,856 patients were treated.
Ukupno je bilo randomizirano 2 866 bolesnika, a 2 856 bolesnika je bilo liječeno.
A total of 20 subjects (12 T/LAIV, 0.3%; 8 injectable influenza vaccine, 0.2%) were hospitalized in association with medically significant wheezing.
Ukupno je 20 ispitanika (12 za T/LAIV, 0,3%; 8 za cjepivo protiv influence koje se injicira, 0,2%) bilo hospitalizirano zbog medicinski značajnog piskanja pri disanju.
A total of 201 Cushing’s disease patients received Signifor in phase II and III studies.
Ukupno 201 bolesnik s Cushingovom bolešću primao je Signifor u ispitivanjima faze II i III.
A total of 211 adult and paediatric CAPS patients (including FCAS/FCU, MWS, and NOMID/CINCA) have received Ilaris in clinical trials.
Ukupno je 211 odraslih i pedijatrijskih bolesnika s CAPS-om (uključujući FCAS/FCU, MWS, i NOMID/CINCA) primalo Ilaris u kliničkim ispitivanjima.
A total of 217 subjects aged 18-65 years received IXIARO together with inactivated rabies vaccine (Rabipur) in a rapid immunisation schedule on Day 0 and Day 7 and 56 subjects received IXIARO alone in the conventional immunisation schedule on Day 0 and Day 28.
Ukupno je 217 ispitanika u dobi od 18 - 65 godina primilo cjepivo IXIARO s inaktiviranim cjepivom protiv bjesnoće (Rabipur) prema brzom rasporedu imunizacije na 0. dan i 7. dan, a 56 ispitanika primilo je samo cjepivo IXIARO prema konvencionalnom rasporedu imunizacije na 0. i 28. dan.
A total of 22 paediatric and adolescents patients (aged 5 months to 17 years) received Soliris in aHUS Study C10-003.
U ispitivanju aHUS-a C10-003, Soliris su primila ukupno 22 pedijatrijska i adolescentna bolesnika (u dobi od 5 mjeseci do 17 godina).
A total of 225 patients aged ≥ 18 years of age with relapsed or refractory B-precursor ALL were exposed to BLINCYTO during clinical trials.
Tijekom kliničkih ispitivanja, ukupno je 225 bolesnika u dobi od ≥ 18 godina s recidivirajućim ili refraktornim ALL-om prekursora B limfocita bilo izloženo lijeku BLINCYTO.
A total of 225 patients were treated with subcutaneous Ilaris 150 mg and 229 patients were treated with intramuscular triamcinolone acetonide (TA) 40 mg at study entry, and when experiencing a new attack thereafter.
Ukupno je 225 bolesnika liječeno potkožnim Ilarisom 150 mg, a 229 bolesnika je liječeno intramuskularnim triamcinolon acetonidom (TA) 40 mg na početku ispitivanja, te nakon toga u slučaju novog napada.
A total of 226 (74.8%) of the Pom + LD-Dex patients and 95 (62.1%) of the HD-Dex patients were alive as of the cutoff date (07 Sep 2012).
Ukupno je 226 (74,8%) bolesnika koji su primali Pom + LD-Dex i 95 (62,1%) bolesnika koji su primali HD-Dex bilo živo do datuma prestanka prikupljanja podataka (07. rujna 2012.).
A total of 23,799 patients were randomised in the clinical program (ARISTOTLE: apixaban versus warfarin, AVERROES: apixaban versus ASA) including 11,927 randomised to apixaban.
U kliničkom je programu randomizirano ukupno 23 799 bolesnika (ARISTOTLE: apiksaban u usporedbi s varfarinom, AVERROES: apiksaban u usporedbi s ASK), uključujući 11 927 bolesnika randomiziranih da primaju apiksaban.
A total of 23/99 (23%) MabThera-treated patients in the trial tested positive for HACA by 18 months.
Ukupno je 23/99 (23%) bolesnika liječenih lijekom MabThera u ovom ispitivanju do 18. mjeseca bilo pozitivno na HACA-u.
A total of 235 patients with MPS IVA were enrolled and exposed to Vimizim in six clinical trials.
Ukupno je 235 bolesnika s MPS IV A uključeno i izloženo Vimizimu u šest kliničkih ispitivanja.
A total of 238 postmenopausal women, were randomly assigned to one of the following treatment groups; Preotact (100 micrograms parathyroid hormone), alendronate (10 mg), or the combination of both, and followed for 12 months.
Ukupno 238 žena u postmenopauzi raspoređeno je slučajnim odabirom u jednu od terapijskih grupa; Preotact (100 mikrograma paratireoidnog hormona), alendronat (10 mg), ili kombinacija oba lijeka, te praćeno tijekom 12 mjeseci.
A total of 246 ALK-positive NSCLC patients were enrolled who were treated at a Zykadia dose of 750 mg: 163 who had received prior treatment with an ALK inhibitor and 83 who were ALK inhibitor naïve.
Ukupno je bilo uključeno 246 bolesnika s ALK-pozitivnim NSCLC-om koji su se liječili dozom Zykadie od 750 mg: 163 koji su prethodno primali terapiju ALK inhibitorom te 83 koji ranije nisu primali ALK inhibitor.
A total of 2532 patients (1286 Preotact and 1246 placebo), aged 45-94 years (8.1% 45-54 years and 11.4% > 75 years), were randomised to receive 100 microgramsday or placebo with daily calcium (700 mg) and vitamin D (400 IU) supplementation.
Ukupno 2532 bolesnice (1.286 na Preotactu i 1.246 na placebu), u dobi 45-94 godina (8,1% 45-54 godina i 11,4%≥ 75 godina), randomizirane su u skupine gdje su primale 100 mikrograma/dan Preotacta ili placebo sa dnevnim dodatkom kalcija (700 mg) i vitamina D (400IJ).
A total of 257 patients with type 2 diabetes participated in a 24-week randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin (5 mg once daily) in combination with metformin plus sulphonylurea (SU) in patients with inadequate glycemic control (HbA1c ≥ 7% and ≤ 10%).
Ukupno je 257 bolesnika sa šećernom bolešću tipa 2 sudjelovalo u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 24 tjedna zbog procjene djelotvornosti i sigurnosti saksagliptina (5 mg jedanput na dan) u kombinaciji s metforminom i sulfonilurejom (SU) u bolesnika s neodgovarajuće kontroliranom glikemijom (HbA1c ≥ 7% i ≤ 10%).
A total of 257 patients with type 2 diabetes participated in a 24-week randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin (5 mg once daily) in combination with metformin plus sulphonylurea (SU) in patients with inadequate glycemic control (HbA1c ≥ 7% and ≤ 10%).
Ukupno je 257 bolesnika sa šećernom bolešću tipa 2 sudjelovalo u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 24 tjedna, koje je provedeno kako bi se ocijenile djelotvornost i sigurnosti primjene saksagliptina (5 mg jedanput na dan) u kombinaciji s metforminom i sulfonilurejom (SU) u bolesnika s neodgovarajućom kontrolom glikemije (HbA1c ≥ 7 % i ≤ 10%).
A total of 257 patients with type 2 diabetes participated in a 24-week randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin (5 mg once daily) in combination with metformin plus sulphonylurea (SU) in patients with inadequate glycemic control (HbA1c ≥ 7% and ≤ 10%).
Ukupno je 257 bolesnika sa šećernom bolešću tipa 2 sudjelovalo u, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 24 tjedna zbog procjene djelotvornosti i sigurnosti saksagliptina (5 mg jedanput na dan) u kombinaciji s metforminom i sulfonilurejom (SU) u bolesnika s neodgovarajuće kontroliranom glikemijom (HbA1c ≥ 7% i ≤ 10%).
A total of 26 bleeding episodes were treated with RIXUBIS, of which 23 bleeds were due to injury, 2 spontaneous and 1 of unknown origin.
Ukupno 26 epizoda krvarenja liječeno je lijekom RIXUBIS, od kojih su 23 bila krvarenja uzrokovana ozljedom, 2 spontana i 1 nepoznatog podrijetla.
A total of 29 major surgical procedures were performed and assessed in 19 subjects (17 adults, 1 adolescent and 1 paediatric patient <12 years of age) in study I and an extension study.
Ukupno je učinjeno i procijenjeno 29 većih kirurških zahvata u 19 ispitanika (17 odraslih, 1 adolescenta i 1 pedijatrijskog bolesnika < 12 godina) u ispitivanju I i produžetku ispitivanja.
A total of 2928 patients enrolled in OSLER-2.
U OSLER-2 ispitivanje ukupno je uključeno 2928 bolesnika.
A total of 30 spontaneous cases were received describing 31 adverse events according to the pre-defined preferred terms for urinary adverse events associated with umeclidinium bromide / vilanterol (UMEC/VI).
Ukupno je zaprimljeno 30 spontanih prijava koji opisuju 31 štetan događaj prema unaprijed definiranim preporučenim pojmovima za štetne događaje u mokraćnom sustavu povezane s primjenom umeklidinijeva bromida/vilanterola (UMEC/VI).
A total of 305 (36.1%) of all patients were not evaluable for MMR at 48 months (98 in the nilotinib 300 mg BID group, 88 in the nilotinib 400 mg BID group and 119 in the imatinib group) due to missing/unevaluable PCR assessments (n=18), atypical transcripts at baseline (n=8), or discontinuation prior to the 48-month time point (n=279).
Kod ukupno 305 (36,1%) bolesnika nije bilo moguće ocijeniti MMR u 48. mjesecu (98 u skupini koja je primala 300 mg dva puta na dan, 88 u skupini koja je primala 400 mg dva puta na dan i 119 u skupini koja je primala imatinib) zbog nedostajućih/neocjenjivih PCR nalaza (n=18), atipičnih transkripcija na početku (n=8) ili prekida sudjelovanja prije vremenske točke u 48. mjesecu (n=279).
A total of 323 patients 65 years of age and older, including 53 patients 75 years and older, received abatacept in placebo-controlled clinical trials.
U placebom kontroliranim kliničkim ispitivanjima abatacept su primala ukupno 323 bolesnika u dobi od 65 ili više godina, uključujući i 53 bolesnika u dobi od 75 ili više godina.
A total of 33% of patients were ≥65 years of age and 11% were ≥75 years of age.
Ukupno je 33% bolesnika bilo u dobi od ≥65 godina, a 11% u dobi od ≥75 godina.
A total of 347 stable responders participated in a withdrawal and retreatment evaluation in an open- label extension study.
Ukupno je 347 bolesnika sa stabilnim odgovorom na terapiju sudjelovalo u procjeni ukidanja i ponovnog uvođenja terapije u otvorenom produžetku ispitivanja.
A total of 350 patients were randomized (randomization ratio 1:1).
Ukupno 350 bolesnika bilo je randomizirano (omjer randomizacije 1:1).
A total of 392/3095 (12.7%) patients with rheumatoid arthritis tested positive for HACA in clinical studies following therapy with MabThera.
U kliničkim ispitivanjima je nakon terapije lijekom MabThera ukupno 392/3095 (12,7%) oboljelih od reumatoidnog artritisa bilo pozitivno na HACA-u.
A total of 4 patients (1%) treated with OZURDEX had procedures in the study eye for the treatment of IOP elevation.
Ukupno 4 bolesnika, 1%, liječenih lijekom OZURDEX imali su zahvate na ispitivanom oku radi liječenja povišenog IOT-a.
A total of 4,204 patients were treated with Taltz in clinical development studies in plaque psoriasis.
Ukupno su 4204 bolesnika liječena lijekom Taltz u ispitivanjima kod plak psorijaze tijekom kliničkog razvoja lijeka.
A total of 4,550 women (2,343 Prolia & 2,207 placebo) who missed no more than one dose of investigational product in the pivotal study described above and completed the month 36 study visit agreed to enrol in a 7-year, multinational, multicentre, open-label, single-arm extension study to evaluate the long-term safety and efficacy of Prolia.
Ukupno 4550 žena (2343 Prolia i 2207 placebo) koje nisu propustile više od jedne doze ispitivanog lijeka u pivotalnom ispitivanju koje je opisano u prethodom tekstu i koje su završile posjet u 36. mjesecu studije pristalo je uključiti se u 7-godišnje, multinacionalno, multicentrično, otvoreno, produljeno ispitivanje na jednoj skupini kako bi se procijenila dugotrajna sigurnost primjene i djelotvornost lijeka Prolia.
A total of 40 cases were excluded from analysis as they contained only hepatic events or non-specific abdominal pain, without a diagnosis of pancreatitis or elevated serum lipase and/or amylase.
Ukupno 40 slučajeva je isključeno iz analize jer su sadržavali samo hepatičke događaje ili nespecifičnu abdominalnu bol, bez dijagnoze pankreatitisa ili povišenih serumskih lipaza i/ili amilaza.
A total of 401 patients were enrolled from which 203 were treated with Enbrel.
Uključen je ukupno 401 bolesnik od čega su 203 liječena Enbrelom.
A total of 401 patients were enrolled, from which 203 were treated with Enbrel.
Uključen je ukupno 401 bolesnik od čega su 203 liječena Enbrelom.
A total of 405 patients were randomised to receive either nivolumab (n = 272) administered intravenously over 60 minutes at 3 mg/kg every 2 weeks or chemotherapy (n = 133) which consisted of the investigator’s choice of either dacarbazine (1000 mg/m2 every 3 weeks) or carboplatin (AUC 6 every 3 weeks) and paclitaxel (175 mg/m2 every 3 weeks).
Ukupno je 405 bolesnika bilo randomizirano u skupine koje su primale ili nivolumab (n = 272) u dozi od 3 mg/kg primijenjenoj intravenski tijekom 60 minuta svaka 2 tjedna ili kemoterapiju (n = 133), koja se, sukladno izboru ispitivača, sastojala ili od dakarbazina (1000 mg/m2 svaka 3 tjedna) ili od karboplatina (AUC 6 svaka 3 tjedna) i paklitaksela (175 mg/m2 svaka 3 tjedna).
A total of 41 patients took part in the clinical study and received at least one dose of cholic acid.
Ukupno je 41 bolesnik sudjelovao u kliničkom ispitivanju i primio je najmanje jednu dozu kolatne kiseline.
A total of 417 patients were randomised to the ONIVYDE+5-FU/LV arm (N=117), ONIVYDE monotherapy arm (N=151) and 5-FU/LV arm (N=149).
Ukupno 417 bolesnika randomizirano je za skupinu koja je primala ONIVYDE+5-FU/LV (N=117), za skupinu koja je primala ONIVYDE u monoterapiji (N=151) te za skupinu koja je primala 5-FU/LV (N=149).
A total of 418 patients were randomised to receive either nivolumab (n = 210) administered intravenously over 60 minutes at 3 mg/kg every 2 weeks or dacarbazine (n = 208) at 1000 mg/m2 every 3 weeks.
Ukupno je 418 bolesnika bilo randomizirano u skupine koje su primile ili nivolumab (n = 210) u dozi od 3 mg/kg, primijenjen intravenski tijekom 60 minuta svaka 2 tjedna, ili dakarbazin (n = 208) u dozi od 1000 mg/m2 svaka 3 tjedna.
A total of 423 subjects were randomised 1:1 to either combination (N = 211) or dabrafenib (N = 212).
Randomizirano je ukupno 423 ispitanika u omjeru 1:1 na kombinaciju (N=211) ili na dabrafenib (N=212).
A total of 449 patients were randomized to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Ukupno 449 bolesnika randomizirano je te su dobivali ili docetaksel 100 mg/m2 u jednosatnoj infuziji kao monoterapiju ili paklitaksel 175 mg/m2 u trosatnoj infuziji.
A total of 455 patients with type 2 diabetes participated in a 24-week randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin in combination with a stable dose of insulin (baseline mean: 54.2 Units) in patients with inadequate glycaemic control (HbA1c
Ukupno je 455 bolesnika sa šećernom bolešću tipa 2 sudjelovalo u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 24 tjedna koje je provedeno zbog procjene djelotvornosti i sigurnosti saksagliptina u kombinaciji sa stabilnom dozom inzulina (prosječna početna doza: 54,2 jedinice) u bolesnika koji su imali neodgovarajuću kontrolu glikemije (HbA1c ≥ 7,5% i
A total of 460 patients (methylnaltrexone bromide 12 mg once daily, n = 150, methylnaltrexone bromide 12 mg every other day, n = 148, placebo, n = 162) were treated in the double-blind period.
Ukupno 460 bolesnika (metilnaltreksonbromid u dozi od 12 mg jedanput dnevno, n=150, metilnaltreksonbromid u dozi od 12 mg svaki drugi dan, n=148, placebo, n=162) je liječeno u dvostruko slijepom razdoblju.