natgillin/translations-raw huggingface dataset:
The percentages of patients with clinically meaningful improvements in TDI focal score (defined as an increase of at least 1 unit) were higher with Brimica Genuair than with placebo in ACLIFORM-COPD (64.8% compared to 45.5%; p &lt; 0.001) and AUGMENT (58.1% compared to 36.6%; p &lt; 0.0001).
Postotci bolesnika sa klinički značajnim poboljšanjem u ukupnom rezultatu TDI (definirano kao porast od najmanje 1 jedinice) bili su veći s Brimica Genuairom nego s placebom u ispitivanju AKLIFORM- COPD (64,8% u usporedbi s 45,5%; p &lt; 0,0001) i u ispitivanju AUGMENT (58,1% u usporedbi s 36,6%; p &lt; 0,0001).
The perfusion should be terminated if the cumulative leakage into the systemic circulation is &gt; 10%.
Perfuzija se prekida ako je kumulativno propuštanje u sistemsku cirkulaciju &gt; 10%.
The period of onset of hepatocellular injury (by ALT elevations &gt; 3xULN) was within 3 to 14 months after initiating treatment and these increases were reversible, with ALT returning to &lt; 3xULN within 1 to 4 months.
Razdoblje unutar kojeg je nastalo hepatocelularno oštećenje (prema porastu ALT-a &gt; 3 x GGN) bilo je unutar 3 do 14 mjeseci od početka liječenja, i ti su porasti bili reverzibilni, a ALT je pala &lt; 3 x GGN unutar 1 do 4 mjeseca.
The PFS benefit of Kd was consistently observed in all subgroups, including patients ≥ 75 years of age (n = 143), patients with high risk (n = 210) genetic mutations, and patients with baseline creatinine clearance of 30 - &lt; 50mL/min (n = 128).
Korist Kd liječenja je za PFS dosljedno primijećena u svim podskupinama, uključujući i bolesnike u dobi od ≥75 godina (n = 143) , bolesnike s genetičkim mutacijama visokog rizika (n = 210) i bolesnike s početnim klirensom kreatinina od 30 do &lt; 50 ml/min (n = 128).
The PFS benefit of KRd was consistently observed in all subgroups, including patients ≥ 75 years of age (n = 96), patients with high risk (n = 100) or unknown (n = 375) risk genetic mutations, and patients with baseline creatinine clearance of 30 - &lt; 50mL/min (n = 56).
Korist KRd liječenja je za PFS dosljedno primijećena u svim podskupinama, uključujući i bolesnike u dobi od ≥75 godina (n = 96) , bolesnike s genetičkim mutacijama visokog (n = 100) ili nepoznatog (n = 375) rizika i bolesnike s početnim klirensom kreatinina od 30 do &lt; 50 ml/min (n = 56).
The pharmacokinetic parameters of regadenoson have not yet been studied in the paediatric population ( &lt; 18 years).
Farmakokinetički parametri regadenosona još nisu ispitani u pedijatrijskoj populaciji ( &lt; 18 godina).
The pharmacokinetic parameters of riluzole after multiple dose administration (4.5 days of treatment at 50 mg riluzole bid) are not affected in the older people ( &gt; 70 years).
U starijih bolesnika ( &gt; 70 godina) nema utjecaja na farmakokinetičke parametre riluzola nakon primjene višekratnih doza (4,5 dana liječenja riluzolom u dozi od 50 mg dva puta na dan).
The pharmacokinetic profile of a 20 mg dose of tasimelteon was compared among 8 subjects with severe renal impairment (estimated glomerular filtration rate [eGFR] ≤ 29 mL/min/1.73m2), 8 subjects with end- stage renal disease (ESRD) (GFR &lt; 15 mL/min/1.73m2) requiring hemodialysis, and 16 healthy matched controls.
Farmakokinetički profil doze tazimelteona od 20 mg uspoređen je među 8 ispitanika s teškim oštećenjem funkcije bubrega (procijenjena stopa glomerularne filtracije [eGFR] ≤ 29 mL/min/1,73 m2), 8 ispitanika sa završnim stadijem bolesti bubrega (GFR &lt; 15 mL/min/1,73 m2) kojima je potrebna hemodijaliza, te 16 zdravih odgovarajućih kontrola.
The pharmacokinetics and pharmacodynamics of dabigatran etexilate administered twice daily for three consecutive days (total 6 doses) at the end of standard anticoagulant therapy were assessed in an open-label safety and tolerability study in 9 stable adolescents (12 to &lt; 18 years).
Farmakokinetika i farmakodinamika dabigatraneteksilata primjenjivanog dvaput dnevno tri uzastopna dana (ukupno 6 doza) na kraju standardnog antikoagulacijskog liječenja ocjenjivane su u otvorenom ispitivanju sigurnosti i podnošljivosti na 9 stabilnih adolescenata (12 do &lt; 18 godina).
The pharmacokinetics in paediatric patients ( &lt; 18 years) have not yet been evaluated.
Farmakokinetika u pedijatrijskih bolesnika ( &lt; 18 godina) još nije ocijenjena.
The pharmacokinetics of alogliptin in children and adolescents &lt; 18 years old has not been established.
Farmakokinetika alogliptina u djece i adolescenata &lt; 18 godina starosti nije ispitana.
The pharmacokinetics of alogliptin in children and adolescents &lt; 18 years old has not been established.
Farmakokinetika alogliptina u djece i adolescenata &lt; 18 godina starosti nije utvrđena.
The pharmacokinetics of bortezomib are not influenced in patients with mild to moderate renal impairment (Creatinine Clearance [CrCL] &gt; 20 ml/min/1.73 m2); therefore, dose adjustments are not necessary for these patients.
U bolesnika s blagim do umjerenim oštećenjem bubrega (klirens kreatinina [CrCL] &gt; 20 ml/min/1,73 m2) farmakokinetika bortezomiba nije promijenjena, stoga prilagodbe doze u ovih bolesnika nisu potrebne.
The pharmacokinetics of darunavir in combination with ritonavir taken once daily in 12 ART-naïve paediatric patients, aged 12 to &lt; 18 years and weighing at least 40 kg, showed that PREZISTA/ritonavir 800/100 mg once daily results in darunavir exposure that was comparable to that achieved in adults receiving PREZISTA/ritonavir 800/100 mg once daily.
Farmakokinetika darunavira u kombinaciji s ritonavirom uzetih jedanput na dan, kod 12 pedijatrijskih bolesnika koji nisu prethodno liječeni, u dobi od 12 do &lt; 18 godina s težinom najmanje 40 kg, pokazala je da PREZISTA/ritonavir 800/100 mg jedanput na dan rezultira izloženošću darunaviru koja je usporediva s onom kod odraslih koji primaju lijek PREZISTA/ritonavir od 800/100 mg jedanput na dan.
The pharmacokinetics of dexmedetomidine in subjects with severe renal impairment (creatinine clearance &lt; 30 ml/min) is not altered relative to healthy subjects.
Farmakokinetička svojstva deksmedetomidina kod osoba s teškim poremećajem rada bubrega (klirens kreatinina &lt; 30 ml/min) jednaka su onima kod zdravih osoba.
The pharmacokinetics of dextromethorphan/quinidine have not been investigated systematically in elderly subjects (aged &gt; 65 years) although such subjects were included in the clinical programme (14% ≥65 years, 2% ≥75 years).
Farmakokinetike dekstrometorfana / kinidina nisu sustavno ispitivane u starijih ispitanika (u dobi &gt; 65 godina) iako su takvi ispitanici bili uključeni u klinički program (14% ≥65 godina, 2% ≥75 godina).
The pharmacokinetics of dolutegravir in 10 antiretroviral treatment-experienced HIV-1 infected adolescents (12 to &lt; 18 years of age) showed that Tivicay 50 mg once daily oral dosage resulted in dolutegravir exposure comparable to that observed in adults who received Tivicay 50 mg orally once daily.
Farmakokinetika dolutegravira u 10 adolescenata (12 do &lt; 18 godina) s HIV-1 infekcijom, koji su prethodno liječeni antiretroviroticima, pokazala je da peroralna primjena lijeka Tivicay u dozi od 50 mg jedanput na dan dovodi do izloženosti dolutegraviru usporedive s onom primijećenom u odraslih bolesnika koji su primali Tivicay u peroralnoj dozi od 50 mg jedanput na dan.
The pharmacokinetics of dulaglutide were evaluated in a clinical pharmacology study and were generally similar between healthy subjects and patients with mild to severe renal impairment (CrCl &lt; 30 ml/min), including end stage renal disease (requiring dialysis).
Farmakokinetika dulaglutida ocijenjena je u kliničkom farmakološkom ispitivanju, a načelno je bila slična u zdravih ispitanika i bolesnika s blagim do teškim oštećenjem bubrežne funkcije (CrCl &lt; 30 ml/min), uključujući bolesnike u terminalnoj fazi bubrežne bolesti (kojima je potrebna dijaliza).
The pharmacokinetics of ospemifene has not been evaluated in patients with severe hepatic impairment (Child-Pugh Class score &gt; 9).
Farmakokinetika ospemifena nije ispitana u bolesnica s teškim oštećenjem jetre (Child-Pugh Class ljestvica &gt; 9).
The pharmacokinetics of pioglitazone in children and adolescents &lt; 18 years old has not been established.
Farmakokinetika pioglitazona u djece i adolescenata &lt; 18 godina starosti nije ispitana.
The pharmacokinetics of rilpivirine in paediatric patients &lt; 12 years of age is under investigation.
Farmakokinetika rilpivirina u pedijatrijskih bolesnika u dobi &lt; 12 godina još se ispituje.
The pharmacokinetics of tocilizumab were determined using a population pharmacokinetic analysis on a database composed of 75 sJIA patients treated with 8 mg/kg (patients with a body weight ≥ 30 kg ) or 12 mg/kg (patients with a body weight &lt; 30 kg), given every 2 weeks.
Farmakokinetika tocilizumaba odredila se populacijskom farmakokinetičkom analizom iz baze podataka koja se sastojala od 75 bolesnika oboljelih od sJIA koji su primali 8 mg/kg (bolesnici tjelesne težine ≥ 30 kg) ili 12 mg/kg (bolesnici tjelesne težine &lt; 30 kg) svaka dva tjedna.
The pharmacokinetics of two doses of telmisartan were assessed as a secondary objective in hypertensive patients (n = 57) aged 6 to &lt; 18 years after taking telmisartan 1 mg/kg or 2 mg/kg over a four-week treatment period.
Farmakokinetika dvije doze telmisartana procijenjena je kao sekundarni cilj u bolesnika s hipertenzijom (n = 57) u dobi od 6 do &lt; 18 godina nakon uzimanja telmisartana 1 mg/kg ili 2 mg/kg tijekom razdoblja liječenja od četiri tjedna.
The pharmacokinetics of two doses of telmisartan were assessed as a secondary objective in hypertensive patients (n = 57) aged 6 to &lt; 18 years after taking telmisartan 1 mg/kg or 2 mg/kg over a four-week treatment period.
Farmakokinetika dviju doza telmisartana ocjenjivana je kao sekundarni cilj kod hipertenzivnih bolesnika (n = 57) u dobi 6 do &lt; 18 godina starosti nakon uzimanja telmisartana 1 mg/kg ili 2 mg/kg tijekom četverotjednog razdoblja liječenja.
The pharmacokinetics of two doses of telmisartan were assessed as a secondary objective in hypertensive patients (n = 57) aged 6 to &lt; 18 years after taking telmisartan 1 mg/kg or 2 mg/kg over a four-week treatment period.
Farmakokinetika dviju doza telmisartana ocjenjivana je kao sekundarni cilj kod hipertenzivnih bolesnika (n = 57) u dobi od 6 do &lt; 18 godina starosti nakon uzimanja telmisartana 1 mg/kg ili 2 mg/kg tijekom četverotjednog razdoblja liječenja.
The pharmacokinetics of velpatasvir was studied with a single dose of 100 mg velpatasvir in HCV negative patients with severe renal impairment (eGFR &lt; 30 mL/min by Cockcroft-Gault).
Farmakokinetika velpatasvira bila je ispitana u HCV-negativnih bolesnika s teškim oštećenjem bubrega (eGFR &lt; 30 ml/min prema Cockcroft-Gaultu) nakon jedne doze od 100 mg velpatasvira.
The pharmacokinetics of Vipdomet in children and adolescents &lt; 18 years old has not been established.
Farmakokinetika Vipdometa u djece i adolescenata &lt; 18 godina starosti nije utvrđena.
The phase 3 studies conducted with ZYTIGA excluded patients with uncontrolled hypertension, clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association Class (NYHA) III or IV heart failure (study 301) or Class II to IV heart failure (study 302) or cardiac ejection fraction measurement of &lt; 50%.
U ispitivanjima faze III provedenim s lijekom ZYTIGA nisu uključivani bolesnici s nekontroliranom hipertenzijom, klinički značajnom bolešću srca koja se manifestirala infarktom miokarda ili arterijskim trombotičkim događajima u prethodnih 6 mjeseci, bolesnici s teškom ili nestabilnom anginom te bolesnici sa zatajivanjem srca stupnja III i IV (ispitivanje 301) ili sa zatajivanjem srca stupnja II do IV (ispitivanje 302), prema New York Heart Association (NYHA) ili ejekcijskom frakcijom srca &lt; 50%.
The Phase 3 trials of lumacaftor/ivacaftor included 81 patients with ppFEV1 &lt; 40 at baseline.
U ispitivanja lumakaftora/ivakaftora faze 3 bio je uključen 81 bolesnik s ppFEV1 &lt; 40 na početku ispitivanja.
The placebo- adjusted mean improvement in 6MWD was 44.6 m (95% CI: 24.3 to 64.9; p &lt; 0.001) for the 5 mg dose, and 52.5 m (95% CI: 28.8 to 76.2; p &lt; 0.001) for the 10 mg dose.
Placebom prilagođeno srednje poboljšanje 6MWD je iznosilo 44,6 m (95% CI: 24,3 do 64,9; p &lt; 0,001) za dozu od 5 mg, a 52,5 m (95% CI: 28,8 do 76,2; p &lt; 0,001) za dozu od 10 mg.
The placebo-adjusted improvement in mean 6MWD at week 12 compared to baseline was 30.6 m (95% CI: 2.9 to 58.3; p=0.008) and 59.4 m (95% CI: 29.6 to 89.3; p &lt; 0.001) for the 5 mg group, in ARIES 1 and 2 respectively.
Placebom prilagođeno poboljšanje srednjeg 6MWD u 12-tom tjednu, u usporedbi s početnim je iznosilo 30,6 m (95% CI: 2,9 do 58,3; p=0,008) u ispitivanju ARIES-1, i 59,4 m (95% CI: 29,6 do 89,3; p &lt; 0,001) u ARIES-2, za grupe ispitanika na 5 mg ispitivanog lijeka.
The placebo-adjusted improvement in mean 6MWD at week 12 in patients in the 10 mg group in ARIES-1 was 51.4 m (95% CI: 26.6 to 76.2; p &lt; 0.001).
Placebom prilagođeno srednje poboljšanje 6MWD u 12-tom tjednu, u bolesnika na 10 mg u ARIES-1 je iznosilo 51,4 m (95% CI: 26,6 do 76,2; p &lt; 0,001).
The placebo-adjusted median increase in 6MWD was 17 metres (p=0.09; 95 % CI: : -7.1, 43.0; Pre- specified Hodges-Lehman method) (mean 23 metres, 95 % CI; -2.4, 47.8) in those patients who received tadalafil 40 mg in addition to their concomitant bosentan (n=39), and was 39 metres (p &lt; 0.01, 95 % CI:13.0, 66.0; Pre-specified Hodges-Lehman method) (mean 44 metres, 95 % CI: 19.7, 69.0) in those patients who received tadalafil 40 mg alone (n=37).
Medijan povećanja 6MWD-a korigiran za placebo iznosio je 17 metara (p = 0,09; 95% CI: -7,1; 43,0; prethodno definirana Hodges- Lehmanova metoda) (prosječno 23 metra, 95% CI: -2,4; 47,8) u onih bolesnika koji su primali tadalafil u dozi od 40 mg kao dodatak istodobno primijenjenom bosentanu (n = 39), a 39 metara (p &lt; 0,01, 95% CI: 13,0; 66,0; prethodno definirana Hodges-Lehmanova metoda) (prosječno 44 metara, 95% CI: 19,7; 69,0) u onih bolesnika koji su primali samo tadalafil u dozi od 40 mg (n = 37).
The plasma AUC for subjects with mild (CrCL &gt; 50 - 80 mL/min), moderate (CrCL 30 - 50 mL/min) and severe (CrCL &lt; 30 mL/min but not undergoing dialysis) renal impairment was increased by 32%, 74%, and 72%, respectively, relative to subjects with normal renal function (see section 4.2 for dose reduction).
AUC u plazmi ispitanika s blagim (CrCL &gt; 50 - 80 ml/min), umjerenim (CrCL 30 - 50 ml/min) i teškim (CrCL &lt; 30 ml/min, ali ne na dijalizi) oštećenjem funkcije bubrega bio je povećan 32%, 74% odnosno 72% u odnosu na ispitanike s normalnom funkcijom bubrega (vidjeti dio 4.2 za sniženje doze).
The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance &lt; 20 ml/min (see also section 4.2.).
AUC zonisamida u plazmi povećao se za 35% u ispitanika s klirensom kreatinina &lt; 20 ml/min (vidjeti također dio 4.2).
The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance &lt; 20 ml/min.
AUC zonisamida u plazmi bio je povećan za 35% u ispitanika s klirensom kreatinina &lt; 20 ml/min.
The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance &lt; 20 ml/min.
AUC zonisamida u plazmi povećao se za 35% u ispitanika s klirensom kreatinina &lt; 20 ml/min.
The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance &lt; 20 ml/min (see also section 4.2.).
AUC zonisamida u plazmi bio je povećan za 35% u ispitanika s klirensom kreatinina &lt; 20 ml/min (vidjeti također dio 4.2).
The plasma AUCs for subjects with mild (CrCL &gt; 50 - 80 mL/min), moderate (CrCL 30 - 50 mL/min) and severe (CrCL &lt; 30 mL/min but not undergoing dialysis) renal impairment were increased by 32%, 74%, and 72%, respectively, relative to subjects with normal renal function.
AUC u plazmi u ispitanika s blagim (CrCL &gt; 50 - 80 ml/min), umjerenim (CrCL 30 - 50 ml/min) i teškim (CrCL &lt; 30 ml/min ali ne na dijalizi) oštećenjem funkcije bubrega bio je povećan za 32%, 74% odnosno 72% u odnosu na onaj kod ispitanika s normalnom funkcijom bubrega.
The plasma protein binding of bedaquiline is &gt; 99.9% in all species tested, including human.
Vezanje bedakilina na proteine plazme je &gt; 99,9% u svih ispitivanih vrsta, uključujući ljude.
The plasma protein binding of ONIVYDE is negligible ( &lt; 0.44% of total irinotecan in ONIVYDE).
Vezanje lijeka ONIVYDE za proteine plazme je zanemarivo ( &lt; 0,44% ukupnog irinotekana u lijeku ONIVYDE).
The plasma protein binding was &gt; 98%.
Vezanje za proteine plazme bilo je &gt; 98%.
The plunger only moves a little with each injection and you may not notice that it moves.
Klip se sa svakom injekcijom samo neznatno pomiče, pa možda nećete ni primijetiti da se pomiče.
The plunger only moves a little with each injection, and you may not notice that it moves.
Klip se sa svakom injekcijom samo neznatno pomiče pa možda nećete ni primijetiti da se pomiče.
The population pharmacokinetic analysis showed that median clearance differed slightly between the elderly group (patients ≥ 65, median CL = 1.07 l/h) and the non-elderly group (patients &lt; 65, median CL = 1.22 l/h), however the range of clearance was similar.
Populacijska farmakokinetička analiza pokazala je blagu razliku u medijan klirensa (CL) između starije (bolesnici u dobi od  65 godina, medijan CL = 1,07 l/h) i mlađe dobne skupine (bolesnici u dobi od &lt; 65 godina, medijan CL = 1,22 l/h), međutim, raspon klirensa je bio sličan.
The possibility of experiencing gastrointestinal adverse reactions (see section 4.8) may increase when orlistat is taken with a diet high in fat (e.g. in a 2000 kcal/day diet, &gt; 30 % of calories from fat equates to &gt; 67 g of fat).
Mogućnost pojave gastrointestinalnih nuspojava (vidjeti dio 4.8.) može se povećati u slučajevima uzimanja orlistata uz obroke koji sadrže visok udio masti (primjerice, u dnevnoj prehrani od 2000 kcal, &gt; 30% kalorija iz masti jednako je &gt; 67 g masti).
The potential for these events in patients with unstable and/or symptomatic brain metastases or low platelets ( &lt; 75,000) is not established as patients with these conditions were excluded from clinical trials.
Potencijal za te događaje u bolesnika s nestabilnim i/ili simptomatskim metastazama na mozgu ili niskom razinom trombocita ( &lt; 75 000) nije utvrđen budući da su bolesnici s tim stanjima bili isključeni iz kliničkih ispitivanja.
The predominant ( &gt; 90%) metabolite, GS-331007, is inactive.
Glavni ( &gt; 90%) metabolit, GS-331007, nije aktivan.
The presence of extensive renal damage (eGFR &lt; 60mL/min) may limit the renal response to enzyme replacement therapy.
Opsežno oštećenje bubrega (eGFR &lt; 60 ml/min) može ograničiti odgovor bubrega na enzimsku nadomjesnu terapiju.
The primary analysis of cardiac toxicity showed the risk of developing a cardiac event as a function of cumulative anthracycline dose was significantly lower with Caelyx than with doxorubicin (HR=3.16, p &lt; 0.001).
Primarna analiza kardiotoksičnosti pokazala je da je rizik od razvoja srčanog poremećaja kao posljedice kumulativne doze antraciklina bio značajno niži uz Caelyx nego doksorubicin (HR=3,16, p &lt; 0,001).
The primary efficacy analysis of the study results showed no statistically significant difference between the group on teduglutide 0.10 mg/kg/day and the placebo group, while the proportion of subjects receiving the recommended teduglutide dose of 0.05 mg/kg/day achieving at least a 20% reduction of parenteral nutrition at Week 20 and 24 was statistically significantly different versus placebo (46% versus 6.3%, p &lt; 0.01).
Primarna analiza djelotvornosti rezultata ispitivanja nije pokazala statistički značajnu razliku između skupina koje su uzimale 0,10 mg/kg/dan teduglutida i placebo, dok je udio bolesnika koji su uzimali preporučenu dozu od 0,05 mg/kg/dan i postigli smanjenje parenteralne prehrane od barem 20% u tjednima 20 i 24 bio statistički značajno veći u odnosu na placebo (46% naspram 6,3%, p &lt; 0,01).
The primary efficacy endpoint for this study was the achievement and maintenance of confirmed HIV- 1 RNA concentrations &lt; 400 copies/ml over 48 weeks.
Primarna mjera ishoda za djelotvornost u ovom ispitivanju bila je postizanje i održavanje potvrđene koncentracije HIV-1 RNK &lt; 400 kopija/ml tijekom 48 tjedana.
The primary efficacy endpoint in the APEX and FACT studies was the proportion of patients whose last 3 monthly serum uric acid levels were &lt; 6.0 mg/dL (357 µmol/L).
Primarni ishod djelotvornosti u ispitivanjima APEX i FACT bio je omjer bolesnika kod kojih su razine mokraćne kiseline u serumu u posljednja 3 mjeseca bile &lt; 6,0 mg/dl (357 µmol/l).
The primary efficacy endpoint was the percentage of “responders”, defined as those patients without steatorrhoea ( &lt; 30% faecal fat content) and without signs and symptoms of malabsorption after one and two weeks of treatment with Enzepi.
Primarna mjera ishoda djelotvornosti bila je postotak bolesnika koji su odgovorili na liječenje, što je definirano kao bolesnici bez steatoreje ( &lt; 30% sadržaj fekalnih masti) i bez znakova i simptoma malapsorpcije nakon jednog ili dva tjedna liječenja lijekom Enzepi.
The primary efficacy endpoint was to compare the proportion of patients achieving biochemical control (defined as mean GH levels &lt; 2.5 μg/l and normalisation of sex- and age-adjusted IGF-1) at week 24 with pasireotide intramuscular use 40 mg or 60 mg versus continued treatment with active control (octreotide intramuscular use 30 mg or lanreotide deep subcutaneous injection 120 mg), separately.
Mjera primarnog ishoda djelotvornosti bila je usporediti udio bolesnika koji postignu biokemijsku kontrolu (definiranu kao srednje razine GH-a &lt; 2,5 μg/l i normalizacija IGF-1 prilagođenog za spol i dob) u 24. tjednu uz pasireotid 40 mg ili 60 mg primijenjen intramuskularno naspram kontinuiranog liječenja aktivnom kontrolom (oktreotid 30 mg primijenjen intramuskularno ili duboka supkutana injekcija 120 mg lanreotida), odvojeno.
The primary efficacy outcome, a composite of symptomatic PE, symptomatic DVT, symptomatic superficial-vein thrombosis extension, symptomatic superficial-vein thrombosis reoccurrence, or Death up to Day 47, was significantly reduced from 5.9% in placebo patients to 0.9% in those receiving fondaparinux 2.5 mg (relative risk reduction: 85.2%; 95% CIs, 73.7% to 91.7% [p &lt; 0.001]).
Primarni ishod djelotvornosti, udruženi događaji simptomatske PE, simptomatske DVT, simptomatskog proširenja tromboze površinske vene, ponovne pojave simptomatske tromboze površinske vene ili smrtnog ishoda do 47-og dana, je značajno smanjen s 5,9% u bolesnika na placebu, na 0,9% u onih koji su primali fondaparinuks 2,5 mg (relativna redukcija rizika: 85,2%; 95% CI, 73,7% do 91,7% [p &lt; 0,001]).
The primary endpoint at Day 8 showed that dolutegravir 50 mg twice daily was superior to placebo, with an adjusted mean treatment difference for the change from Baseline in Plasma HIV-1 RNA of -1.2 log10 copies/mL (95% CI -1.5 - - 0.8log10 copies/mL, p &lt; 0.001).
Primarna mjera ishoda nakon 8 dana pokazala je da je dolutegravir u dozi od 50 mg dvaput na dan superioran u odnosu na placebo, uz prilagođenu srednju razliku između liječenja s obzirom na promjenu plazmatske koncentracije HIV-1 RNK od -1,2 log10 kopija/ml u odnosu na početnu vrijednost (95% CI -1,5
The primary endpoint in the CP patients was major cytogenetic response (MCyR), defined as elimination (CCyR, complete cytogenetic response) or significant reduction to &lt; 35% Ph+ metaphases (partial cytogenetic response) of Ph+ haematopoietic cells.
Primarni ishod u bolesnika u kroničnoj fazi bio je veliki citogenetski odgovor (MCyR), definiran kao eliminacija (CCyR, kompletni citogenetski odgovor) ili značajno smanjenje na &lt; 35% Ph+ metafaza (djelomični citogenetski odgovor) Ph+ hematopoetskih stanica.