natgillin/translations-raw huggingface dataset:
In study ACLIFORM-COPD, Duaklir Genuair showed improvements in FEV1 at 1 hour post-dose relative to placebo and aclidinium of 299 ml and 125 ml, respectively (both p &lt; 0.0001) and improvements in trough FEV1 relative to placebo and formoterol of 143 ml and 85 ml, respectively (both p &lt; 0.0001).
U ispitivanju ACLIFORM-COPD, Duaklir Genuair je pokazao poboljšanja u FEV1 jedan sat nakon doze u odnosu na placebo od 299 ml, i u odnosu na aklidinij od 125 ml (oba p &lt; 0,0001), te poboljšanja najnižeg FEV1 u odnosu na placebo od 143 ml, i u odnosu na formoterol od 85 ml (oba p &lt; 0,0001).
In study AUGMENT, Brimica Genuair showed improvements in FEV1 at 1 hour post-dose relative to placebo and aclidinium of 284 ml and 108 ml (both p &lt; 0.0001), respectively, and improvements in trough FEV1 relative to placebo and formoterol of 130 ml (p &lt; 0.0001) and 45 ml (p=0.01), respectively.
U ispitivanju AUGMENT, Brimica Genuair je pokazao poboljšanja u FEV1 jedan sat nakon doze u odnosu na placebo od 284 ml, i u odnosu na aklidinij od 108 ml (oba p &lt; 0,0001), te poboljšanja najnižeg FEV1 u odnosu na placebo od 130 ml i u odnosu na formoterol od 45 ml (oba p &lt; 0,0001).
In study AUGMENT, Duaklir Genuair showed improvements in FEV1 at 1 hour post-dose relative to placebo and aclidinium of 284 ml and 108 ml (both p &lt; 0.0001), respectively, and improvements in trough FEV1 relative to placebo and formoterol of 130 ml (p &lt; 0.0001) and 45 ml (p=0.01), respectively.
U ispitivanju AUGMENT, Duaklir Genuair je pokazao poboljšanja u FEV1 jedan sat nakon doze u odnosu na placebo od 284 ml, i u odnosu na aklidinij od 108 ml (oba p &lt; 0,0001), te poboljšanja najnižeg FEV1 u odnosu na placebo od 130 ml i u odnosu na formoterol od 45 ml (oba p &lt; 0,0001).
In study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA Class III &amp; IV) in the Herceptin 1 year treatment arm was 0.8 %, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6 %.
U ispitivanju BO16348, nakon medijana praćenja od 8 godina, incidencija teškog kongestivnog zatajenja srca (NYHA klase III i IV) u skupini liječenoj 1 godinu lijekom Herceptin iznosila je 0,8%, dok je stopa blage simptomatske i asimptomatske disfunkcije lijeve klijetke iznosila 4,6%.
In Study C10-003, patients who enrolled in the study were required to have a platelet count &lt; lower limit of normal range (LLN), evidence of haemolysis such as an elevation in serum LDH above the upper limits of normal and serum creatinine level ≥97 percentile for age without the need for chronic dialysis.
Bolesnici uključeni u ispitivanje C10-003 morali su imati broj trombocita manji od donje granice normalnog raspona (LLN), dokazanu hemolizu kao što je povišenje LDH u serumu iznad gornje granice normale te kreatinin u serumu ≥97 percentila za dob, bez potrebe za kroničnom dijalizom.
In Study GO28141, the most common adverse reactions ( &gt; 20%) observed with a higher frequency in the Cotellic plus vemurafenib arm were diarrhoea, rash, nausea, pyrexia, photosensitivity reaction, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood creatine phosphokinase, and vomiting.
U ispitivanju GO28141, najčešće nuspojave ( &gt; 20%) primijećene s većom učestalošću u skupini koja je primala Cotellic plus vemurafenib bile su proljev, osip, mučnina, pireksija, reakcija fotoosjetljivosti, povišene vrijednosti alanin aminotransferaze, povišene vrijednosti aspartat aminotransferaze, povišene vrijednosti kreatin fosfokinaze u krvi i povraćanje.
In study GS-US-104-0321, 87 HIV-1 infected treatment-experienced patients 12 to &lt; 18 years of age were treated with tenofovir disoproxil fumarate (n = 45) or placebo (n = 42) in combination with an optimised background regimen (OBR) for 48 weeks.
U ispitivanju GS-US-104-0321, 87 prethodno liječenih pacijenata zaraženih virusom HIV-1, u dobi od 12 do 18 godina starosti, primali su tenofovirdizoproksilfumarat (n = 45) ili placebo (n = 42) u kombinaciji s optimiziranim pozadinskim režimom (OBR) tijekom 48 tjedana.
In study GS-US-104-0352, 97 treatment-experienced patients 2 to &lt; 12 years of age with stable, virologic suppression on stavudine- or zidovudine-containing regimens were randomised to either replace stavudine or zidovudine with tenofovir disoproxil fumarate (n = 48) or continue on their original regimen (n = 49) for 48 weeks.
U ispitivanju GS-US-104-0352, 97 prethodno liječenih pacijenata u dobi od 2 do &lt; 12 godina sa stabilnom virološkom supresijom koji su prethodno bili liječeni režimima koji su sadržavali stavudin ili zidovudin bilo je randomizirano u skupine kojima se stavudin ili zidovudin zamijenio tenofovirdizoproksilfumaratom (n = 48) ili u skupine koje su nastavile primati prvobitni režim (n = 49) 48 tjedana.
In study GS-US-183-0145, subgroup analyses by co-administered protease inhibitor showed similar rates of virologic success for elvitegravir and raltegravir within each protease inhibitor subgroup at weeks 48 and 96 (HIV-1 RNA &lt; 50 copies/mL) (Table 6).
U ispitivanju GS-US-183-0145 analize podskupina putem istovremeno primijenjenog inhibitora proteaze pokazale su slične stope virološkog uspjeha za elvitegravir i raltegravir unutar svake podskupine inhibitora proteaze u 48. i 96. tjednu (HIV-1 RNK &lt; 50 kopija/ml) (tablica 6).
In study GS-US-216-0114, hyperbilirubinaemia ( &gt; 1 x ULN) was common: 97.7% in the cobicistat- boosted atazanavir plus emtricitabine and tenofovir disoproxil fumarate fixed-dose combination group, and 97.4% in the ritonavir-boosted atazanavir plus emtricitabine and tenofovir disoproxil fumarate fixed-dose combination group through 144 weeks of treatment.
U ispitivanju GS-US-216-0114, hiperbilirubinemija ( &gt; 1 x gornja granica normale (GGN)) je bila česta: 97,7% ispitanika u skupini koja je primala kobicistatom pojačani atazanavir s kombinacijom fiksne doze emtricitabina i tenofovirdizoproksilfumarata i 97,4% ispitanika u skupini koja je primala ritonavirom pojačani atazanavir s kombinacijom fiksne doze emtricitabina i tenofovirdizoproksil- fumarata tijekom 144 tjedna liječenja.
In study GS-US-216-0114, through 144 weeks of treatment hyperbilirubinaemia ( &gt; 1 x ULN) was common: 97.7% in the atazanavir boosted with cobicistat plus emtricitabine and tenofovir disoproxil fumarate fixed-dose combination group, and 97.4% in the atazanavir boosted with ritonavir plus emtricitabine and tenofovir disoproxil fumarate fixed-dose combination group.
U ispitivanju GS-US-216-0114 je hiperbilirubinemija ( &gt; 1 x iznad gornje granice normale [GGN]) tijekom 144 tjedna liječenja bila česta: javila se u 97,7% bolesnika u skupini koja je primala atazanavir pojačan kobicistatom plus fiksnu kombinaciju doza emtricitabina i tenofovirdizoproksilfumarata i u 97,4% bolesnika u skupini koja je primala atazanavir pojačani ritonavirom plus fiksnu kombinaciju doza emtricitabina i tenofovirdizoproksilfumarata.
In Study GS-US-236-0115 and Study GS-US-236-0121, patients had to be on either their first or second antiretroviral regimen with no history of virologic failure, have no current or past history of resistance to the antiretroviral components of Stribild and must have been suppressed on a PI+RTV or an NNRTI in combination with FTC/TDF (HIV-1 RNA &lt; 50 copies/mL) for at least six months prior to screening.
U ispitivanjima GS-US-236-0115 i GS-US-236-0121 pacijenti su morali primati svoj prvi ili drugi antiretrovirusni režim bez prethodnog virološkog neuspjeha, nisu smjeli imati zabilježenu prošlu ili sadašnju rezistenciju na antiretrovirusne tvari u Stribildu i i virus je morao biti suprimiran PI+RTV-om ili NNRTI-jem u kombinaciji s FTC/TDF (HIV-1 RNK &lt; 50 kopija/ml) najmanje šest mjeseci prije probira.
In study GS-US-292-0109, switching from a tenofovir disoproxil fumarate-based regimen to E/C/F/TAF was superior in maintaining HIV-1 RNA &lt; 50 copies/mL compared to staying on the baseline regimen.
U ispitivanju GS-US-292-0109, prebacivanje s režima temeljenog na tenofovirdizoproksilfumaratu na E/C/F/TAF bilo je superiorno u održavanju HIV-1 RNK &lt; 50 kopija/ml u usporedbi s ostankom na početnom režimu.
In Study HPC3008 (see sections 4.8 and 5.1), transient grade 3 (2.5 to ≤5 X ULN) and grade 4 ( &gt; 5 X ULN) bilirubin increases during INCIVO treatment were seen in 39% and in 22% of the 59 patients on atazanavir/ritonavir, respectively.
U Ispitivanju HPC3008 (vidjeti dio 4.8 i 5.1), tijekom liječenja lijekom INCIVO, prolazni porasti bilirubina stupnja 3 (2,5 do ≤ 5 X GGN) i stupnja 4 ( &gt; 5 X GGN) zabilježeni su u 39% odnosno 22% od 59 bolesnika na atazanaviru/ritonaviru.
In study II, 65% of patients achieved a DAS28 &lt; 2.6 at week 104 compared to 48% at 52 weeks and 33% of patients at week 24.
U ispitivanju II, 65% bolesnika postiglo je DAS28 &lt; 2,6 u 104. tjednu u usporedbi s 48% bolesnika u 52. tjednu i 33% bolesnika u 24. tjednu.
In study III, the mean difference compared to placebo was -0.94h, 95% CI
U ispitivanju III srednja razlika u usporedbi s placebom je iznosila 0,94 h, 95% CI [-1,36, -0,51], p &lt; 0,0001.
In study PIPF-016, the decline of percent predicted FVC from Baseline at Week 52 of treatment was significantly reduced in patients receiving Esbriet (N=278) compared with patients receiving placebo (N=277; p &lt; 0.000001, rank ANCOVA).
U ispitivanju PIPF-016, pad postotka predviđenog FVC-a od početka ispitivanja do 52. tjedna liječenja bio je značajno niži u bolesnika koji su primali Esbriet (N=278) u usporedbi s bolesnicima koji su primali placebo (N=277, p &lt; 0,000001, rang ANCOVA).
In study RO-2455-404-RD when compared with the overall population, the total PDE4 inhibitory activity determined from ex vivo unbound fractions was found to be 15% higher in patients ≥75 years of age, and 11% higher in patients with baseline body weight &lt; 60 kg (refer to section 4.4).
U ispitivanju RO-2455-404-RD, inhibicijska aktivnost PDE4 određena na temelju ex vivo nevezane frakcije bila je, u usporedbi s cjelokupnom populacijom, 15% viša u bolesnika u dobi od ≥75 godina, te 11% viša u bolesnika s početnom tjelesnom težinom &lt; 60 kg (vidjeti dio 4.4).
In study VI, which only included adults, a significantly higher proportion of patients in the abatacept plus methotrexate group (41%) achieved DAS28 (CRP)-defined remission (score &lt; 2.6) versus the methotrexate plus placebo group (23%) at year 1.
U Ispitivanju VI, u koje su uključeni samo odrasli bolesnici, nakon godinu dana liječenja je remisiju prema indeksu DAS28-CRP (rezultat &lt; 2,6) postigao značajno veći udio bolesnika u skupini abatacept i metotreksat (41%) u usporedbi s bolesnicima u skupini metotreksat i placebo (23%).
In study VI, which only included adults, a significantly higher proportion of patients in the abatacept plus methotrexate group (41%) achieved DAS28 (CRP)-defined remission (score &lt; 2.6) versus the methotrexate plus placebo group (23%) at year 1.
U Ispitivanju VI, u koje su uključeni samo odrasli bolesnici, nakon godinu dana liječenja je remisiju prema indeksu DAS28-CRP (rezultat &lt; 2,6) postigao značajno veći udio bolesnika u skupini abatacept plus metotreksat (41%) u usporedbi s bolesnicima u skupini metotreksat i placebo (23%).
In subjects &gt; 60 years of age, the most frequently reported adverse reaction after vaccination was injection site pain (32.6%).
U bolesnika starijih od 60 godina, najčešće prijavljena nuspojava nakon cijepljenja bila je bol na mjestu injiciranja (32,6%).
In subjects &gt; 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (59.0%), myalgia (20.6%), fatigue (17.9%), headache (17.6%) and arthralgia (14.3%).
U osoba starijih od 60 godina, najčešće prijavljene nuspojave nakon cijepljenja bile su bol na mjestu injiciranja (59,0%), mijalgija (20,6%), umor (17,9%), glavobolja (17,6%) i artralgija (14,3%).
In subjects &gt; 64 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (58.0%), muscle aches (19.7%), fatigue (13.5%), headache (12.4%) and joint pain (10.3%).
U osoba starijih od 64 godine, najčešće prijavljene nuspojave nakon cijepljenja bile su: bol na mjestu injiciranja (58,0%), bolovi u mišićima (19,7%), umor (13,5%), glavobolja (12,4%) i bol u zglobovima (10,3%).
In subjects treated with boceprevir who did not achieve SVR and with post-baseline samples analyzed for RAVs, interferon responsiveness was associated with detection of fewer RAVs, with 31% of these subjects having post-baseline RAVs compared to 69% of subjects with &lt; 1-log10 decline in viral load at Treatment Week 4.
U ispitanika liječenih boceprevirom koji nisu postigli trajan virološki odgovor, a čiji su uzorci, uzeti nakon početka ispitivanja, analizirani na prisutnost RAV-ova, odgovor na interferon povezan je s manjim brojem otkrivenih RAV-ova; RAV-ovi su ustanovljeni u 31% ovih ispitanika, u usporedbi sa 69% ispitanika u kojih je u 4. tjednu liječenja zabilježeno smanjenje virusnog opterećenja od &lt; 1-log10.
In subjects treated with boceprevir, interferon responsiveness (as defined by ≥ 1-log10 decline in viral load at Treatment Week 4) was associated with detection of fewer RAVs, with 6% of these subjects having RAVs compared to 41% of subjects with &lt; 1-log10 decline in viral load at Treatment Week 4 (poorly interferon responsive).
U ispitanika koji su primali boceprevir, bolji odgovor na interferon (definiran kao smanjenje virusnog opterećenja od ≥ 1-log10 u 4. tjednu liječenja) povezan je s manjim brojem otkrivenih RAV-ova; RAV-ovi su ustanovljeni u 6% ovih ispitanika, u usporedbi s 41% ispitanika u kojih je u 4. tjednu liječenja zabilježeno smanjenje virusnog opterećenja od &lt; 1-log10 (ispitanici sa slabim odgovorom na interferon).
In subjects with &lt; 1-log10 decline in viral load at TW 4 (poor interferon-responsiveness), treatment with the combination of Victrelis with peginterferon alfa-2b and ribavirin resulted in SVR rates of 2838%, respectively, compared to 4% in subjects treated with standard of care.
Među ispitanicima koji su u 4. tjednu liječenja imali smanjenje virusnog opterećenja za &lt; 1-log10 (slab odgovor na interferon), liječenjem kombinacijom lijeka Victrelis s peginterferonom alfa-2b i ribavirinom postignute su stope SVR od 2838%, u usporedbi s 4% ispitanika koji su primali standardnu terapiju.
In subjects with all three favourable baseline laboratory values (AFP &lt; 20 ng/mL, platelets ≥ 90 x 109/L, and albumin ≥ 35 g/L), relapse rates were similar in subjects treated for 12 or 24 weeks.
U ispitanika koji su prije početka liječenja ispunjavali kriterije za vrijednosti po sva tri parametra (AFP &lt; 20 ng/ml, broj trombicita ≥ 90 x 109/l i albumin ≥ 35 g/l), stope relapsa bile su slične kod ispitanika iz skupine koja je liječena 12 tjedana kao i kod ispitanika iz skupine koja je liječena 24 tjedna.
In subjects with end-stage renal disease (ESRD) (CrCl &lt; 10 ml/min) requiring haemodialysis, a dose of 16.5 mg tenofovir disoproxil following completion of haemodialysis is predicted to limit tenofovir systemic accumulation to exposures approximately 2-fold compared to those observed in patients with normal renal function receiving tenofovir disoproxil (as fumarate) 245 mg film-coated tablets.
U ispitanika s bolešću bubrega u završnoj fazi (CrCl &lt; 10 ml/min) kojima je potrebna hemodijaliza, doza od 16,5 mg tenofovirdizoproksila nakon dovršetka hemodijalize predviđeno ograničava sustavnu akumulaciju tenofovira na izloženosti od oko 2-struko veće u usporedbi s onim zapaženim u pacijenata s normalnom funkcijom bubrega koji primaju tenofovirdizoproksil (u obliku tenofovirdizoproksilfumarata) 245 mg filmom obloženih tableta.
In subjects with mild (creatinine clearance  50 - &lt; 80 mL/min) and moderate (creatinine clearance
U bolesnika s blagim (klirens kreatinina  50 - &lt; 80 ml/min) i umjerenim (klirens kreatinina  30
In subjects with moderate renal impairment (patients with CrCl &lt; 60 ml/min or eGFR &lt; 60 ml/min/1.73 m2), a higher proportion of subjects treated with dapagliflozin had adverse reactions of increase in creatinine, phosphorus, parathyroid hormone (PTH) and hypotension, compared with placebo.
Među bolesnicima s umjerenim oštećenjem funkcije bubrega (bolesnici kojima je CrCl &lt; 60 ml/min ili eGFR &lt; 60 ml/min/1,73 m2), nuspojave u vidu povišenih vrijednosti kreatinina, fosfora i paratiroidnog hormona (PTH) te hipotenzije imao je veći udio ispitanika liječenih dapagliflozinom nego onih koji su uzimali placebo.
In subjects with moderate renal impairment (patients with CrCl &lt; 60 ml/min or eGFR &lt; 60 ml/min/1.73 m2), a higher proportion of subjects treated with dapagliflozin had adverse reactions of increase in creatinine, phosphorus, parathyroid hormone (PTH) and hypotension, compared with placebo.
Među osobama s umjerenim oštećenjem bubrežne funkcije (bolesnici u kojih je CrCl &lt; 60 ml/min ili eGFR &lt; 60 ml/min/1,73 m2) nuspojave u vidu povišenih vrijednosti kreatinina, fosfora i paratiroidnog hormona (PTH) te hipotenzije imao je veći udio ispitanika liječenih dapagliflozinom u usporedbi s onima koji su primali placebo.
In subjects with severe renal impairment (estimated creatinine clearance &lt; 30 ml/min), varenicline exposure was increased 2.1-fold.
U ispitanika s teškim oštećenjem bubrežne funkcije (procijenjeni klirens kreatinina &lt; 30 ml/min) izloženost vareniklinu povećala se 2,1 puta.
In subjects with severe renal impairment (estimated creatinine clearance &lt; 30 ml/min), varenicline exposure was increased 2.1-fold.
U ispitanika s teškim oštećenjem bubrežne funkcije (procijenjeni klirens kreatinina &gt; 30 ml/min) izloženost vareniklinu povećala se 2,1 puta.
In systemic circulation, micafungin is highly bound to plasma protein ( &gt; 99%), primarily to albumin.
U sistemskoj je cirkulaciji mikafungin uglavnom vezan za proteine plazme ( &gt; 99%), prvenstveno za albumin.
In table 2 below all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency (very common (≥1/10); common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
U Tablici 2. ispod, sve nuspojave koje su se javile s većom incidencijom u odnosu na placebo i u više od jednog bolesnika popisane prema organskim sustavima i učestalosti pojavljivanja (vrlo često (≥ 1/10), često (≥ 1/100 i &lt; 1/10), manje često (≥ 1/1000 i &lt; 1/100), rijetko (≥ 1/10 000 i &lt; 1/1000), vrlo rijetko ( &lt; 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
In table 2 below all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency: very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000), not
U Tablici 2 u nastavku, sve nuspojave koje su se javile s većom incidencijom u odnosu na placebo i u više od jednog bolesnika popisane su prema organskim sustavima i učestalosti pojavljivanja: vrlo često (≥ 1/10), često (≥ 1/100 i &lt; 1/10), manje često (≥ 1/1000 i &lt; 1/100), rijetko (≥ 1/10 000 i
In the 12-month study, the improvement versus placebo for tiotropium was 83 ml (p &lt; 0.001).
U 12-mjesečnom ispitivanju, poboljšanje u odnosu na placebo za tiotropij bilo je 83 ml (p &lt; 0,001).
In the 12-month study, the improvements were 87 ml at 5 minutes and 143 ml at 15 minutes (both p &lt; 0.001).
U 12-mjesečnom ispitivanju, poboljšanja su bila 87 ml nakon 5 minuta i 143 ml nakon 15 minuta (oba p &lt; 0,001).
In the 301 trial, patients with baseline ALT and AST ≥ 2.5 x ULN in the absence of liver metastases and &gt; 5 x ULN in the presence of liver metastases were excluded.
Iz ispitivanja 301, isključeni su bolesnici s početnim vrijedostima ALT-a i AST-a ≥ 2,5 x GGN ako nije bilo metastaza u jetri, odnosno &gt; 5 x GGN ako su bile prisutne metastaze u jetri.
In the 6-month study, Enurev Breezhaler increased FEV1 after the first dose with an improvement of 93 ml within 5 minutes and 144 ml within 15 minutes of dosing, compared to placebo (both p &lt; 0.001).
U 6-mjesečnom ispitivanju, Enurev Breezhaler je povećao FEV1 nakon prve doze s poboljšanjem od 93 ml u rok od 5 minuta te 144 ml u roku od 15 minuta od primjene doze, u usporedbi s placebom (oba p &lt; 0,001).
In the 6-month study, Seebri Breezhaler increased FEV1 after the first dose with an improvement of 93 ml within 5 minutes and 144 ml within 15 minutes of dosing, compared to placebo (both p &lt; 0.001).
U 6-mjesečnom ispitivanju, Seebri Breezhaler je povećao FEV1 nakon prve doze s poboljšanjem od 93 ml u rok od 5 minuta te 144 ml u roku od 15 minuta od primjene doze, u usporedbi s placebom (oba p &lt; 0,001).
In the 6-month study, Tovanor Breezhaler increased FEV1 after the first dose with an improvement of 93 ml within 5 minutes and 144 ml within 15 minutes of dosing, compared to placebo (both p &lt; 0.001).
U 6-mjesečnom ispitivanju, Tovanor Breezhaler je povećao FEV1 nakon prve doze s poboljšanjem od 93 ml u rok od 5 minuta te 144 ml u roku od 15 minuta od primjene doze, u usporedbi s placebom (oba p &lt; 0,001).
In the active controlled studies, all patients were aged &gt; 6years old (range 6-66 years) with an FEV1 % predicted at screening of between 24% and 76%.
U aktivno kontroliranim ispitivanjima svi su bolesnici imali &gt; 6 godina (raspon 6-66 godina) uz FEV1 na probiru između 24% i 76% od predviđene vrijednosti.
In the additional phase 3 CONFIRMS study, for which results became available after the marketing authorisation for ADENURIC was first issued, the primary efficacy endpoint was the proportion of patients whose serum urate level was &lt; 6.0 mg/dL at the final visit.
U dodatnom ispitivanju faze 3, CONFIRMS, za koje su rezultati postali dostupni nakon odobrenja za stavljanje ADENURICA u promet, primarni ishod ispitivanja bio je omjer bolesnika kod kojih je na zadnjoj kontroli razina urata u serumu bila &lt; 6,0 mg/dl.
In the adolescent (13-17 years) schizophrenia population with aripiprazole exposure of 5 to 30 mg up to 72 months, incidence of low serum prolactin levels in females ( &lt; 3 ng/ml) and males ( &lt; 2 ng/ml) was 25.6% and 45.0%, respectively.
U populaciji adolescenata (u dobi od 13 do 17 godina) sa shizofrenijom koji su bili izloženi aripiprazolu u dozi od 5 do 30 mg do 72 mjeseca, incidencija niskih razina prolaktina u serumu u djevojaka ( &lt; 3 ng/ml) iznosila je 25,6 %, a u mladića ( &lt; 2 ng/ml) 45,0 %.
In the age groups 3 to &lt; 12 years (n=36) and 12 to &lt; 18 years (n=26), mean IOP reduction at Week 12 in the travoprost group was similar to that in the timolol group.
U dobnim skupinama od 3 do &lt; 12 godina (n=36) i od 12 do &lt; 18 godina (n=26), srednja vrijednost sniženja IOT-a u 12. tjednu u skupini koja je primala travoprost bila je slična onoj u skupini koja je primala timolol.
In the anti-TNFα-IR patients subgroup, only the 300 mg dose showed significantly higher response rate for ACR 20 compared to placebo (p &lt; 0.05) and demonstrated clinical meaningful benefit over 150 mg on multiple secondary endpoints.
U podskupini bolesnika s neodgovarajućim odgovorom na anti-TNFα, samo je doza od 300 mg pokazala značajno višu stopu odgovora za ACR 20 u usporedbi s placebo (p &lt; 0,05) i pokazala klinički značajnu korist u odnosu na 150 mg s obzirom na više sekundarnih ishoda.
In the ARIES-E open label long term extension study, the 2 year risk of developing serum aminotransferase elevations &gt; 3xULN in patients treated with ambrisentan was 3.9%.
U otvorenom dugoročnom produženom ispitivanju ARIES E, dvogodišnji rizik od razvoja povećanih serumskih razina aminotransferaze &gt; 3xGGN u bolesnika liječenih ambrisentanom bio je 3,9%.
In the ARIES-E open label long term extension study, the 2 year risk of developing serum aminotransferase elevations &gt; 3xULN in patients treated with ambrisentan was 3.9%.
U otvorenom dugoročnom produženom ispitivanju ARIES-E, dvogodišnji rizik od razvoja povećanih serumskih razina aminotransferaze &gt; 3xGGN u bolesnika liječenih ambrisentanom bio je 3,9%.