natgillin/translations-raw huggingface dataset:
The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/LDL/HDL cholesterol or triglycerides increased over time.
Udio bolesnika koji su imali klinički značajne nuspojave poput povećanja tjelesne težine, porasta vrijednosti glukoze, ukupnog/LDL/HDL kolesterola ili triglicerida porastao je s vremenom.
The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/LDL/HDL cholesterol or triglycerides increased over time.
Udio bolesnika koji su imali klinički značajne nuspojave, poput povećanja tjelesne težine, porasta vrijednosti glukoze, ukupnog/LDL/HDL kolesterola ili trigliceridima, porastao je s vremenom.
The proportion of patients who had both a reduction in weight and HbA1c ranged from 70 to 79 % (the proportion of patients who had a reduction of HbA1c ranged from 88 to 96 %).
Udio bolesnika u koji su imali i smanjenje tjelesne težine i sniženje razine HbA1c kretao se u rasponu od 70 do 79% (udio bolesnika koji su imali smanjenje HbA1c kretao se u rasponu od 88% do 96%).
The proportion of patients who had post-treatment ALT elevations in association with an increase in bilirubin levels was low and similar in patients receiving either lamivudine or placebo.
Udio bolesnika u kojih je zabilježen porast razina ALT nakon liječenja uz istodobni porast razina bilirubina, bio je malen i sličan u obje skupine bolesnika (lamivudin ili placebo).
The proportion of patients who increased or maintained their BMD at one year at both lumbar spine and total hip was 76.2 % in the 3 mg injection every 3 months arm and 67.2 % in the 2.5 mg daily orally arm (p=0.007).
Udio bolesnika koji je imao povećanu ili nepromijenjenu BMD lumbalne kralježnice i cijelog kuka nakon jedne godine iznosio je 76,2% u bolesnika koji su primali injekciju od 3mg svaka tri mjeseca te 67,2% u bolesnika koji su primali peroralno liječenje od 2,5mg jedanput dnevno (p=0,007).
The proportion of patients who responded to treatment was therefore similar in the two groups, but when only the damage to the cornea was considered, Ikervis was significantly better than the vehicle at reducing it.
Udio bolesnika koji su odgovorili na terapiju bio je stoga sličan u obje grupe, no samo ako je se promatralo oštećenje rožnice, Ikervis je bio značajno bolji od punila pri smanjivanju.
The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 12 was greater for Incruse 55 micrograms (44%) compared with placebo (26%) in the 12-week study.
U 12-tjednom ispitivanju je udio bolesnika koji su nakon 12 tjedana postigli barem MCID u SGRQ rezultatu (definiran kao smanjenje za 4 boda od početne vrijednosti) bio veći kod primjene lijeka Incruse od 55 mikrograma (44%) u usporedbi s primjenom placeba (26%).
The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 24 was greater for ANORO (49%) compared with placebo (34%) and each monotherapy component (44% for umeclidinium and 48% for vilanterol).
Udio bolesnika koji su nakon 24 tjedna postigli barem MCID u SGRQ rezultatu (definiran kao smanjenje za 4 boda od početne vrijednosti) bio je veći kod primjene lijeka ANORO (49%) u usporedbi s placebom (34%) ili bilo kojom od sastavnica u monoterapiji (44% za umeklidinij i 48% za vilanterol).
The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 24 was greater for LAVENTAIR (49%) compared with placebo (34%) and each monotherapy component (44% for umeclidinium and 48% for vilanterol).
Udio bolesnika koji su nakon 24 tjedna postigli barem MCID u SGRQ rezultatu (definiran kao smanjenje za 4 boda od početne vrijednosti) bio je veći kod primjene lijeka LAVENTAIR (49%) u usporedbi s placebom (34%) ili bilo kojom od sastavnica u monoterapiji (44% za umeklidinij i 48% za vilanterol).
The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 12 was greater for Incruse (38%) compared with placebo (15%) in the 12- week study.
U 12-tjednom ispitivanju je udio bolesnika koji su nakon 12 tjedana odgovorili barem najmanjom klinički važnom razlikom (engl. minimum clinically important difference, MCID) od 1 boda u ukupnom TDI rezultatu bio veći kod primjene lijeka Incruse (38%) u usporedbi s primjenom placeba (15%).
The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 24 was greater for ANORO (58%) compared with placebo (41%) and each monotherapy component (53% for umeclidinium and 51% for vilanterol).
Udio bolesnika koji su nakon 24 tjedna odgovorili barem najmanjom klinički važnom razlikom (engl. minimum clinically important difference, MCID) od 1 boda u ukupnom TDI rezultatu bio je veći kod primjene lijeka ANORO (58%) u usporedbi s primjenom placeba (41%) ili bilo koje od sastavnica u monoterapiji (53% za umeklidinij i 51% za vilanterol).
The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 24 was greater for LAVENTAIR (58%) compared with placebo (41%) and each monotherapy component (53% for umeclidinium and 51% for vilanterol).
Udio bolesnika koji su nakon 24 tjedna odgovorili barem najmanjom klinički važnom razlikom (engl. minimum clinically important difference, MCID) od 1 boda u ukupnom TDI rezultatu bio je veći kod primjene lijeka LAVENTAIR (58%) u usporedbi s primjenom placeba (41%) ili bilo koje od sastavnica u monoterapiji (53% za umeklidinij i 51% za vilanterol).
The proportion of patients who were global symptom responders was statistically significantly higher than placebo for Truberzi
Udio bolesnika koji je odgovorio na liječenje u pogledu globalnih simptoma bio je statistički značajno viši nego placebo za Truberzi
The proportion of patients with an average weekly frequency of ≥3 Spontaneous Complete Bowel Movements (SCBMs) per week (ie, responders) over the 24-week double-blind treatment phase was not statistically different (p=0.367) between the prucalopride (25.1%) and placebo (20.7%) treatment groups.
Udio ispitanika s prosječnom tjednom učestalosti od tri ili više spontanih kompletnih pražnjenja crijeva na tjedan (tj. ispitanici koji su odgovorili na terapiju) u 24-tjednoj, dvostruko slijepoj fazi liječenja nije se statistički razlikovao (p=0,367) u skupini ispitanika liječenoj prukalopridom (25,1%) u usporedbi sa skupinom ispitanika koji su primali placebo (20,7%).
The proportion of patients with an average weekly frequency of ≥3 Spontaneous Complete Bowel Movements (SCBMs) per week (ie, responders) over the 24-week double-blind treatment phase was not statistically different (p=0.367) between the Resolor (25.1%) and placebo (20.7%) treatment groups.
Udio ispitanika s prosječnom tjednom učestalosti od tri ili više spontanih kompletnih pražnjenja crijeva na tjedan (tj. ispitanici koji su odgovorili na terapiju) u 24-tjednoj, dvostruko slijepoj fazi liječenja nije se statistički razlikovao (p=0,367) u skupini ispitanika liječenoj lijekom Resolor (25,1%) u usporedbi sa skupinom ispitanika koji su primali placebo (20,7%).
The proportion of patients with at least 15 letters improvement from baseline BCVA in the study eye at week 8 was more than 6-fold higher with OZURDEX (42.9%) compared to
Udio bolesnika s poboljšanjem od barem 15 slova u odnosu na početne vrijednosti BCVA u ispitivanom oku u 8. tjednu bio je više od 6 puta veći s lijekom OZURDEX (42,9%) u usporedbi s placebo postupkom (6,6%), p < 0,001.
The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8 % in the zoledronic acid-treated group versus 49.6 % in the placebo group (p=0.003).
Udio bolesnika s barem jednim koštanim događajem (isključujući hiperkalcemiju) iznosio je 29,8% u skupini liječenoj zoledronatnom kiselinom i 49,6% u skupini koja je primala placebo (p=0,003).
The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8% in the zoledronic acid -treated group versus 49.6% in the placebo group (p=0.003).
Udio bolesnika s barem jednim koštanim događajem (isključujući hiperkalcijemiju) bio je 29,8% u skupini liječenoj zoledronatnom kiselinom naspram 49,6% u placebo skupini (p=0,003).
The proportion of patients with detectable talimogene laherparepvec DNA in blood and urine was highest during the second cycle.
Udio bolesnika s detektibilnom količinom DNK virusa talimogene laherparepvec u krvi i urinu bio je najviši tijekom drugog ciklusa.
The proportion of patients with IgG levels below the LLN was about 60% in the MabThera group throughout the 2 year treatment period, while it decreased in the observation group (36% after
Udio bolesnika s razinom IgG-a ispod donje granice normalnih vrijednosti bio je oko 60% u skupini koja je primala lijek MabThera tijekom cjelokupnog dvogodišnjeg razdoblja liječenja, dok se u opservacijskoj skupini smanjio (36% nakon 2 godine).
The proportion of patients with impaired kidney function was 77% in patients on Nulojix and 85% in patients on cyclosporine A. Around 18% of patients on Nulojix had an episode of organ rejection within one year compared with 14% of patients on cyclosporine A.
Omjer bolesnika s oštećenom funkcijom bubrega bio je 77 % u bolesnika koji su primali Nulojix i 85 % u bolesnika koji su primali ciklosporin A. Epizoda odbacivanja organa tijekom jedne godine zabilježena je u 18 % bolesnika koji su primali Nulojix u usporedbi s 14 % bolesnika koji su primali ciklosporin A.
The proportion of patients with infections in C0168T72 was similar to that in the paediatric Crohn’s disease study (REACH) but higher than the proportion in the adults ulcerative colitis studies (ACT 1 and ACT 2).
Udio bolesnika s infekcijama u ispitivanju C0168T72 bio je sličan kao u ispitivanju Crohnove bolesti u pedijatrijskih bolesnika (REACH), ali veći nego udio u ispitivanjima ulceroznog kolitisa u odraslih (ACT 1 i ACT 2).
The proportion of patients with mild left ventricular hypertrophy decreased from 53% (10/19) to 17% (3/18), and mean left ventricular mass normalized for body surface area decreased by 0.9 Z-Score (n=17).
Udio bolesnika s umjerenom hipertrofijom lijeve klijetke smanjio se s 53% (10/19) na 17% (3/18), a srednja vrijednost mase lijeve klijetke, normalizirana prema tjelesnoj površini, smanjila se za 0,9 Z-vrijednosti (n=17).
The proportion of patients with serious adverse events was balanced between the treatment groups (tocilizumab 11.7% vs. adalimumab 9.9%).
Udio bolesnika s ozbiljnim nuspojavama bio je izjednačen između obje ispitivane skupine (tocilizumab 11,7%, adalimumab 9,9%).
The proportion of patients without emesis during 0-72 hours post-operatively was similar after palonosetron 1 µg/kg or 3 µg/kg (88% vs 84%).
Udio bolesnika bez emeze u trajanju od 0-72 sata poslije operacije bio je sličan nakon primjene palonosetrona 1 µg/kg ili 3 µg/kg (88% naspram 84%).
The proportion of responders was higher in subjects with a baseline viral load ≤ 100,000 copies/mL (78.6%, 22/28) as compared to those with a baseline viral load > 100,000 copies/mL (50.0%, 4/8).
Udio bolesnika s odgovorom bio je veći u ispitanika s početnim virusnim opterećenjem ≤ 100 000 kopija/ml (78,6%, 22/28) u usporedbi s onima s početnim virusnim opterećenjem > 100 000 kopija/ml (50,0%, 4/8).
The proportion of subjects experiencing adverse events (AE) and serious adverse events (SAE) was similar in the subjects aged <65 years and those aged ≥65 years.
Udio ispitanika u kojih su se pojavili štetni događaji i ozbiljni štetni događaji bio je sličan i među ispitanicima mlađima od 65 godina i među onima u dobi ≥ 65 godina.
The proportion of subjects reaching anti-HBs ≥ 10mIU/ml was 98.3% for concomitant vaccination and 100% for Twinrix given alone.
Udio ispitanika koji su dosegli anti-HBs ≥ 10mIU/ml je 98,3% kod istodobne primjene i 100% za Twinrix samostalno.
The proportion of subjects reaching anti-HBs  10 mIU/ml was 98.3% for concomitant vaccination and 100% for Twinrix alone.
Udio ispitanika koji su postigli anti-HBs ≥10 mIU/ml bio je 98,3% kod istodobnog cijepljenja i 100% kod cijepljenja samo cjepivom Twinrix.
The proportion of subjects reaching anti-HBs  10 mIU/ml was 98.3% for concomitant vaccination and 100% for Twinrix alone.
Udio ispitanika koji su postigli anti-HBs≥10 mIU/ml bio je 98,3% kod istodobnog cijepljenja i 100% kod cijepljenja samo cjepivom Twinrix.
The proportion of subjects receiving supportive medicinal products at baseline (anticoagulants, digoxin, calcium channel blockers, diuretics and/or oxygen) was similar in the combined sildenafil treatment group (47.7 %) and the placebo treatment group (41.7 %).
Udio ispitanika koji su na početku liječenja primali suportivnu terapiju (antikoagulanse, digoksin, blokatore kalcijevih kanala, diuretike i/ili kisik) bio je podjednak u kombiniranoj skupini liječenoj sildenafilom (47,7%) i skupini koja je primala placebo (41,7%).
The proportion of subjects who permanently discontinued treatment due to adverse reactions was 1.4% for subjects receiving placebo, 0.5% for subjects receiving sofosbuvir + ribavirin for 12 weeks, 0% for subjects receiving sofosbuvir + ribavirin for 16 weeks, 11.1% for subjects receiving peginterferon alfa
Udio ispitanika u kojih je liječenje trajno prekinuto zbog nuspojava iznosio je 1,4% među ispitanicima koji su primali placebo, 0,5% među ispitanicima koji su primali sofosbuvir + ribavirin tijekom
The proportion of subjects who received the booster dose in the ATP cohort was 92.3% in both analyses.
Udio ispitanika u ATP kohorti koji su primili dodatnu dozu iznosio je 92,3% u obje analize.
The proportion of subjects with HIV-1 RNA < 50 copies/mL at week 48 (TLOVR) was 72.2% (26/36).
Udio ispitanika s HIV-1 RNA < 50 kopija/ml u 48. tjednu (TLOVR) bio je 72,2% (26/36).
The proportion of subjects with hSBA ≥ 1:8 was non-inferior to ACWY-PS for all four serogroups and statistically superior for serogroups A and Y (Table 10).
Udio ispitanika s hSBA ≥ 1:8 je bio neinferioran prema ACWY-PS za sve serogrupe, a bio je statistički superioran za serogrupe A i Y (Tablica 10).
The proportion of subjects with measurable disease at baseline who had an objective response was 36% in the ZYTIGA group and 16% in the placebo group (p < 0.0001).
Udio ispitanika s mjerljivom bolesti na početku, koji su imali objektivni odgovor bio je 36% u skupini s lijekom ZYTIGA i 16% u placebo skupini (p < 0.0001).
The proportion of virologic failures was lower in subjects with a baseline viral load ≤ 100,000 copies/mL (17.9%, 5/28) as compared to those with a baseline viral load > 100,000 copies/mL (37.5%, 3/8).
Udio viroloških nesupjeha bio je niži u ispitanika s početnim virusnim opterećenjem ≤ 100 000 kopija/ml (17,9%, 5/28) u usporedbi s onima s početnim virusnim opterećenjem > 100 000 kopija/ml (37,5%, 3/8).
The proportion of virological failures was 22.2% (8/36).
Udio viroloških neuspjeha bio je 22,2% (8/36).
The proportion was significantly larger than observed with insulin degludec (40.9%, odds ratio 2.28, p < 0.0001) and similar to that observed with liraglutide (57.7%, odds ratio 1.13, p=0.3184).
Taj je udio bio značajno veći nego onaj primijećen s degludek inzulinom (40,9%; omjer šansi: 2,28; p < 0,0001), a sličan onome primijećenom s liraglutidom (57,7%; omjer šansi: 1,13; p = 0,3184).
The proportions of patients taking placebo who achieved this goal were 28% and 26% respectively.
Postotak bolesnika koji su uzimali placebo, a kod kojih je ostvaren taj cilj, iznosio je 28 %, odnosno 26 %.
The proportions of patients with no signs of viral activity in their blood at follow-up were 32% with Pegasys and 22% with lamivudine in the HBeAg-positive patients, and 43% with Pegasys and 29% with lamivudine in the HBeAg-negative patients.
Udio bolesnika bez znakova virusne aktivnosti u krvi prilikom praćenja iznosio je 32 % s lijekom Pegasys i 22 % s lamivudinom u HBeAg-pozitivnih bolesnika te 43 % s lijekom Pegasys te 29 % s lamivudinom kod HBeAg-negativnih bolesnika.
The proportions of subjects who were interferon intolerant, ineligible, or unwilling were 9%, 44%, and 47%, respectively.
Udio ispitanika koji nisu podnosili, nisu bili pogodni ili nisu pristali na interferon iznosio je 9%, 44% odnosno 47%.
The proportions of subjects with PedACR50/70/90 at Week 12 and Week 24 were 90.3%/61.3%/38.7% and 83.3%/73.3%/36.7%, respectively.
Udio ispitanika s pedijatrijskim odgovorom ACR50/70/90 u 12. i 24. tjednu bio je 90,3%/61,3%/38,7%, odnosno 83,3%/73,3%/36,7%.
The proposed changes to sections 4.6 and 4.8 of the SmPC and the leaflet are detailed in Annex 1 of this assessment report.
Predložene izmjene dijelova 4.6 i 4.8 Sažetka opisa svojstava lijeka i Upute o lijeku detaljno su prikazane u Dodatku 1 ovog izvješća o ocjeni.
The proposed dose modifications are based on extrapolation of limited data, and their safety and effectiveness have not been clinically evaluated.
Predložene prilagodbe doze temelje se na ekstrapolaciji ograničenih podataka, a sigurnost i učinkovitost njihove primjene još nisu klinički ispitane.
The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes mellitus.
Prospektivno randomizirano (UKPDS) ispitivanje ustanovilo je dugotrajnu korist intenzivne kontrole glukoze u krvi kod šećerne bolesti tipa 2.
The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Prospektivno randomizirano (UKPDS) ispitivanje je utvrdilo dugotrajne pozitivne učinke intenzivne kontrole glukoze u krvi u bolesnika s dijabetesom tipa 2.
The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Prospektivno randomizirano (UKPDS) ispitivanje ustanovilo je dugotrajnu korist intenzivne kontrole glukoze u krvi kod dijabetesa tipa 2.
The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Prospektivno randomizirano (UKPDS) ispitivanje ustanovilo je dugotrajnu korist intenzivne kontrole glukoze u krvi kod šećerne bolesti tipa 2.
The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Prospektivno randomizirano (UKPDS) ispitivanje utvrdilo je dugotrajnu korist intenzivne regulacije glikemije u šećernoj bolesti tipa 2.
The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
U prospektivnom randomiziranom ispitivanju (UKPDS) utvrđen je dugoročni povoljni učinak intenzivne kontrole glukoze u krvi u bolesnika sa šećernom bolešću tipa 2.
The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
U prospektivnom randomiziranom ispitivanju (UKPDS) utvrđeni su dugoročni korisni učinci intenzivne kontrole glukoze u krvi u bolesnika s dijabetesom tipa 2.
The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
U prospektivnom randomiziranom ispitivanju (UKPDS) utvrđeni su dugoročni povoljni učinci intenzivne regulacije glikemije u bolesnika sa šećernom bolešću tipa 2.
The prospective randomised UKPDS (UK Prospective Diabetes Study) study has established the long- term benefit of intensive blood glucose control in type 2 diabetes.
Prospektivno randomizirano ispitivanje UKPDS (UK Prospective Diabetes Study) potvrdilo je dugotrajnu korist intenzivne kontrole glukoze u krvi u šećernoj bolesti tipa 2.
The protection against B-CAP before booster dose and at the time or after booster dose was 13.6% (95% CI: -11.3; 33.0) and 21.7% (95% CI: 3.4; 36.5) respectively.
Zaštita od B-CAP prije dodatne doze iznosila je 13,6% (95% CI: -11,3; 33,0), a zaštita u vrijeme ili nakon primjene dodatne doze 21,7% (95% CI: 3,4; 36,5).
The protective cap is removed from the injection needle and air is expelled from the syringe and needle by holding the syringe vertically and gently pressing the plunger upwards.
Potrebno je skinuti zaštitni pokrov s injekcijske igle i istisnuti zrak iz štrcaljke i igle držeći uspravno štrcaljku i nježno pritišćući klip prema gore.
The protective efficacy of a dose of hepatitis B immunoglobulin at birth followed by 3 doses of a previous formulation of Merck’s recombinant hepatitis B vaccine has been demonstrated for neonates born to mothers positive for both hepatitis B virus surface antigen (HBsAg) and hepatitis B virus e antigen (HBeAg).
Doza imunoglobulina protiv hepatitisa B pri rođenju uz naknadno 3 doze prethodne formulacije Merckovog rekombinantnog cjepiva protiv hepatitisa B pokazala je protektivnu djelotvornost kod novorođenčadi majki pozitivnih na površinski antigen virusa hepatitisa B (HBsAg) i antigen e virusa hepatitisa B (HBeAg).
The protective vaccine efficacy after two doses of Rotarix observed against severe rotavirus gastro- enteritis up to 2 years of age is presented in the following table:
Zaštitna djelotvornost cjepiva opažena protiv teškog oblika rotavirusnog gastroenteritisa nakon dvije doze cjepiva Rotarix, do kraja 2. godine života prikazana je u sljedećoj tablici:
The protein binding of brimonidine has not been studied.
Nije ispitivano vezanje brimonidina na proteine.
The protein binding of ritonavir in human plasma is approximately 98 - 99% and is constant over the concentration range of 1.0 – 100 g/ml.
Oko 98-99% ritonavira u ljudskoj plazmi veže se na proteine i to je vezanje nepromijenjeno u rasponu koncentracija od 1,0 do 100 g /ml.
The protein is known as epidermal growth factor receptor (EGFR).
Taj se protein naziva receptorom epidermalnog faktora rasta (engl. epidermal growth factor receptor, EGFR).
The protein product of the proto-oncogene RAS (rat sarcoma) is a central down-stream signal- transducer of EGFR.
Proteinski produkt proto-onkogena RAS (rat sarcoma) središnji je nizvodni prijenosnik signala EGFR-a.
The proteins are assembled in ‘virus-like particles’ (structures that look like HPV, so that the body can recognise them easily).
Bjelančevine su skupljene u „čestice nalik virusu” (strukture koje izgledaju kao HPV kako bi ih tijelo lakše prepoznalo).
The proteins are assembled in ‘virus-like particles’ (structures that look like HPV, so that the body can recognise them easily).
Bjelančevine su skupljene u „čestice slične virusu” (strukture koje izgledaju poput HPV-a, tako da ih tijelo može lakše prepoznati).
The proteins are assembled in ‘virus-like particles’ (structures that look like HPV, so that the body can recognise them easily).
Proteini se skupljaju u „čestice slične virusu” (strukture koje izgledaju poput HPV-a, tako da ih tijelo može lakše prepoznati).
The protocol allowed patients to receive dexamethasone if they had had a less than optimal response to VELCADE alone.
Prema planu ispitivanja, bolesnici su mogli primiti deksametazon ako je njihov odgovor na liječenje samo VELCADEom bio slabiji od optimalnog.
The protocol of study GAO4753g defined patients with iNHL including FL as the study population.
Protokol ispitivanja GAO4753g definirao je kao ispitivanu populaciju bolesnike s iNHL-om, uključujući FL.
The protocol pre-specified interim analysis after 520 deaths showed a statistically significant superiority in overall survival in patients treated with enzalutamide compared to placebo (Table 3 and Figures 4 and 5).
Protokolom planirana prijevremena analiza nakon 520 smrti pokazala je statistički značajnu superiornost u ukupnom preživljenju bolesnika liječenih enzalutamidom u usporedbi s placebom (Tablica 3 i Slike 4 i 5).
The protocol should be submitted to the Committee for review and agreement promptly, and no later than 3 months after the Commission Decision granting the marketing authorisation, in order to allow for the study to be conducted in the stipulated period.
Plan ispitivanja treba promptno predati Povjerenstvu za pregled i odobrenje, i to ne kasnije od 3 mjeseca nakon što Povjerenstvo odobri stavljanje u promet, kako bi se omogućilo da se ispitivanje obavi u za to predviđenom razdoblju.