natgillin/translations-raw huggingface dataset:
In the BCIRG 006 study HER2 positive, EBC was defined as either lymph node positive or high risk node negative patients with no (pN0) lymph node involvement, and at least 1 of the following factors: tumour size greater than 2 cm, estrogen receptor and progesterone receptor negative, histological and/or nuclear grade 2-3, or age &lt; 35 years).
U ispitivanju BCIRG 006 HER2 pozitivni rani rak dojke bio je definiran bilo kao tumor s pozitivnim limfnim čvorovima ili visokorizični tumor s negativnim limfnim čvorovima te barem jednim od sljedećih čimbenika: tumor veći od 2 cm, negativni estrogenski i progesteronski receptori, histološki i/ili nuklearni gradus 2 do 3 ili dob &lt; 35 godina).
In the BCIRG 006 study HER2 positive, EBC was defined as either lymph node positive or high risk node negative patients with no (pN0) lymph node involvement, and at least 1 of the following factors: tumour size greater than 2 cm, estrogen receptor and progesterone receptor negative, histological and/or nuclear grade 2-3, or age &lt; 35 years.
U ispitivanju BCIRG 006 HER2 pozitivni rani rak dojke bio je definiran bilo kao tumor s pozitivnim limfnim čvorovima ili visokorizični tumor s negativnim limfnim čvorovima (pN0) te barem jednim od sljedećih čimbenika: tumor veći od 2 cm, negativni estrogenski i progesteronski receptori, histološki i/ili nuklearni gradus 2-3 ili dob &lt; 35 godina.
In the case of severe neutropenia ( &lt; 500 cells/mm3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
U slučajevima teške neutropenije ( 500 stanica/mm3 u trajanju od sedam dana ili dulje) za vrijeme liječenja docetakselom preporuča se smanjenje doze u sljedećim ciklusima liječenja ili primjena odgovarajućih simptomatskih mjera (vidjeti dio 4.2).
In the case of severe neutropenia ( &lt; 500 cells/mm3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
U slučajevima teške neutropenije ( 500 stanica/mm3 u trajanju od sedam dana ili dulje) za vrijeme liječenja docetakselom, preporuča se smanjenje doze u sljedećim ciklusima liječenja ili primjena odgovarajućih simptomatskih mjera (vidjeti dio 4.2).
In the case of severe neutropenia ( &lt; 500 cells/mm3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
U slučajevima teške neutropenije ( &lt; 500 stanica/mm3 u trajanju od sedam dana ili dulje) za vrijeme liječenja docetakselom, preporuča se smanjenje doze u sljedećim ciklusima liječenja ili primjena odgovarajućih simptomatskih mjera (vidjeti dio 4.2).
In the case of severe neutropenia ( &lt; 500 cells/mm3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
U slučajevima teške neutropenije ( 500 stanica/mm3 u trajanju od sedam dana ili dulje) za vrijeme liječenja docetakselom, preporučuje se smanjenje doze u sljedećim ciklusima liječenja ili primjena odgovarajućih simptomatskih mjera (vidjeti dio 4.2).
In the cases in which no specific dose recommendation is made, the following dose should be used: Patient weight: &lt; 75 kg =1,000 mg and &gt; 75 kg = 1,200 mg.
U slučajevima kada nema posebnih preporuka za doziranje, treba primijeniti sljedeću dozu: Tjelesna težina bolesnika: &lt; 75 kg=1000 mg, a &gt; 75 kg=1200 mg.
In the circulation, dexmedetomidine is largely bound to plasma proteins ( &gt; 90%).
U cirkulaciji je veliki dio deksmedetomidina vezan za proteine plazme ( &gt; 90%).
In the clinical development programme, 1,085 patients with a baseline eGFR 30 mL/min/1.73 m2 to &lt; 60 mL/min/1.73 m2 were evaluated.
U kliničkom razvojnom programu bilo je procijenjeno 1085 bolesnika s početnom vrijednosti eGFR 30 mL/min/1,73 m2 do &lt; 60 mL/min/1,73 m2.
In the clinical programme patients aged 1 to &lt; 3 years received 0.025 mg/kg zoledronic acid (up to a maximum single dose of 0.35 mg) every 3 months and patients aged 3 to 17 years received 0.05 mg/kg zoledronic acid (up to a maximum single dose of 0.83 mg) every 3 months.
Bolesnici uključeni u klinički program u dobi od 1 do &lt; 3 godine primali su 0,025 mg/kg zoledronatne kiseline (do najveće jednokratne doze od 0,35 mg) svaka 3 mjeseca, a bolesnici u dobi od 3 do 17 godina primali su 0,05 mg/kg zoledronatne kiseline (do najviše jednokratne doze od 0,83 mg) svaka 3 mjeseca.
In the clinical programme patients aged 1 to &lt; 3 years received 0.025 mg/kg zoledronic acid (up to a maximum single dose of 0.35 mg) every 3 months and patients aged 3 to 17 years received 0.05 mg/kg zoledronic acid (up to a maximum single dose of 0.83 mg) every 3 months.
Bolesnici uključeni u klinički program u dobi od 1 do &lt; 3 godine primali su 0,025 mg/kg zoledronatne kiseline (do najviše jednokratne doze od 0,35 mg) svaka 3 mjeseca, a bolesnici u dobi od 3 do 17 godina primali su 0,05 mg/kg zoledronatne kiseline (do najviše jednokratne doze od 0,83 mg) svaka 3 mjeseca.
In the clinical studies, patients with serum creatinine &gt; 400 micromol/l or &gt; 4.5 mg/dl were excluded.
Bolesnici s vrijednostima kreatinina u serumu &gt; 400 mikromola/l ili &gt; 4,5 mg/dl bili su isključeni iz kliničkih ispitivanja.
In the clinical studies, patients with serum creatinine &gt; 400 µmol/l or &gt; 4.5 mg/dl were excluded.
Bolesnici s vrijednostima kreatinina u serumu &gt; 400 μmol/l ili 4,5 mg/dl bili su isključeni iz kliničkih ispitivanja.
In the clinical studies, patients with serum creatinine &gt; 400 µmol/l or &gt; 4.5 mg/dl were excluded.
Bolesnici s vrijednostima kreatinina u serumu &gt; 400 μmol/l ili &gt; 4,5 mg/dl bili su isključeni iz kliničkih ispitivanja.
In the clinical studies, patients with serum creatinine &gt; 400 µmol/l or &gt; 4.5 mg/dl were excluded.
Bolesnici s vrijednostima kreatinina u serumu većima od 400 μmol/l ili 4,5 mg/dl bili su isključeni iz kliničkih ispitivanja.
In the clinical studies, patients with serum creatinine &gt; 400 μmol/l or &gt; 4.5 mg/dl were excluded.
Bolesnici s vrijednostima kreatinina u serumu &gt; 400 μmol/l ili &gt; 4,5 mg/dl bili su isključeni iz kliničkih ispitivanja.
In the clinical studies, patients with serum creatinine &gt; 400 μmol/l or &gt; 4.5 mg/dl were excluded.
Bolesnici s vrijednostima kreatinina u serumu većima od 400 μmol/l ili 4,5 mg/dl bili su isključeni iz kliničkih ispitivanja.
In the clinical trial evaluating MabThera maintenance treatment in relapsed/refractory follicular lymphoma, median IgG levels were below the lower limit of normal (LLN) ( &lt; 7 g/L) after induction treatment in both the observation and the MabThera groups.
U kliničkom ispitivanju terapije održavanja lijekom MabThera u relapsirajućem/refraktornom folikularnom limfomu, medijan vrijednosti IgG-a nakon početne terapije bio je ispod donje granice normalnih vrijednosti ( &lt; 7 g/l) i u opservacijskoj skupini i u skupini koja je primala lijek MabThera.
In the CLL11 study, 27% (90 out of 336) of patients treated with Gazyvaro plus chlorambucil had moderate renal impairment (CrCl &lt; 50 mL/min).
U ispitivanju CLL11, 27% (90 od 336) bolesnika liječenih lijekom Gazyvaro i klorambucilom imalo je umjereno oštećenje funkcije bubrega (CrCl &lt; 50 ml/min).
In the combined studies of GEMINI I and II the adverse reactions that occurred in ≥5% were nausea, nasopharyngitis, upper respiratory tract infection, arthralgia, pyrexia, fatigue, headache, cough.
U kombiniranim ispitivanjima GEMINI I i II nuspojave koje su se javljale u &gt; 5% bile su mučnina, nazofaringitis, infekcija gornjeg dišnog sustava, artralgija, pireksija, umor, glavobolja, kašalj.
In the completed uncontrolled study 060103, 16 out of 45 (35.6%) of previously untreated patients with severe haemophilia A (FVIII &lt; 1%) and at least 25 EDs to FVIII developed FVIII inhibitors: 7 (15.6%) subjects developed high-titre inhibitors and 9 (20%) subjects developed low-titre inhibitors, 1 of which was also classified as a transient inhibitor.
U dovršenom nekontroliranom ispitivanju 060103, 16 od 45 (35,6%) prethodno neliječenih bolesnika s teškom hemofilijom A (FVIII &lt; 1%) i najmanje 25 dana izloženosti faktoru VIII razvilo je inhibitore FVIII: 7 (15,6%) ispitanika razvilo je inhibitore u visokom titru, a 9 (20%) ispitanika razvilo je inhibitore u niskom titru, od kojih je 1 također klasificiran kao prolazni inhibitor.
In the CONFIRMS study, the proportion of patients achieving the primary efficacy endpoint (sUA &lt;
Udio bolesnika koji su postigli primarni ishod djelotvornosti (razina mokraćne kiseline u serumu
In the controlled clinical trial population, the adverse reaction profile in patients with BMI &gt; 40 (86/1436 or 6%) showed no meaningful difference relative to patients with BMI ≤ 40.
U populaciji iz kontroliranih kliničkih ispitivanja, profil nuspojava u bolesnika sa ITM &gt; 40 (86/1436 ili 6%) nije pokazao značajne razlike u odnosu na bolesnike sa ITM ≤40.
In the controlled period of RA and PsA pivotal trials, mild ALT elevations ( &gt; 1 and &lt; 3 x upper limit of normal (ULN)) occurred in similar proportions of golimumab and control patients in the RA and PsA studies (22.1% to 27.4% of patients); in the AS and nr-Axial SpA studies, more golimumab-treated patients (26.9%) than control patients (10.6%) had mild ALT elevations.
U kontroliranom razdoblju pivotalnih ispitivanja u bolesnika s RA i PsA blago povećanje razine ALT-a ( &gt; 1 i &lt; 3 x iznad gornje granice normale (GGN)) nastupilo je u sličnom omjeru u bolesnika koji su primali golimumab i u bolesnika u kontrolnoj skupini (22,1% naprama 27,4% bolesnika); u ispitivanju u bolesnika s ankilozantnim spondilitisom i aksijalnim spondiloartritisom bez radiološkog dokaza blago povećanje razine ALT-a imalo je više bolesnika koji su primali golimumab (26,9%) nego onih u kontrolnoj skupini (10,6%).
In the controlled period of RA and PsA pivotal trials, mild ALT elevations ( &gt; 1 and &lt; 3 x upper limit of normal (ULN)) occurred in similar proportions of golimumab and control patients in the RA and PsA studies (22.1% to 27.4% of patients); in the AS and nr-Axial SpA studies, more golimumab-treated patients (26.9%) than control patients (10.6%) had mild ALT elevations.
U kontroliranom razdoblju pivotalnih ispitivanja u bolesnika s RA i PsA blago povećanje razine ALT-a ( &gt; 1 i &lt; 3 x iznad gornje granice normale (GGN)) nastupilo je u sličnom omjeru u bolesnika koji su primali golimumab i u bolesnika u kontrolnoj skupini (22,1% naprama 27,4% bolesnika); u ispitivanju u bolesnika s ankilozantnim spondilitisom i aksijalnim spondiloartritisom bez radiološkog dokaza,blago povećanje razine ALT-a imalo je više bolesnika koji su primali golimumab (26,9%) nego onih u kontrolnoj skupini (10,6%).
In the controlled period of the UC pivotal trials of golimumab induction, mild ALT elevations ( &gt; 1 and &lt; 3 x ULN) occurred in similar proportions of golimumab- treated and control patients (8.0% to 6.9%, respectively).
U kontroliranom razdoblju pivotalnih ispitivanja uvodne terapije golimumabom u bolesnika s UC, blago povećanje razine ALT-a ( &gt; 1 i &lt; 3 x GGN) nastupilo je u sličnom omjeru u bolesnika koji su primali golimumab i u bolesnika u kontrolnoj skupini (8,0% naprama 6,9% bolesnika).
In the controlled period of the UC pivotal trials of golimumab induction, mild ALT elevations ( &gt; 1 and &lt; 3 x ULN) occurred in similar proportions of golimumab-treated and control patients (8.0% to 6.9%, respectively).
U kontroliranom razdoblju pivotalnih ispitivanja uvodne terapije golimumabom u bolesnika s UC, blago povećanje razine ALT-a ( &gt; 1 i &lt; 3 x GGN) nastupilo je u sličnom omjeru u bolesnika koji su primali golimumab i u bolesnika u kontrolnoj skupini (8,0% naprama 6,9% bolesnika).
In the Double-blind, Active-controlled Phase of the 38-week trial, from baseline to last visit there was a mean decrease in prolactin levels in Abilify Maintena (−0.33 ng/ml) compared with a mean increase in oral aripiprazole tablets 10-30 mg (0.79 ng/ml; p &lt; 0.01).
U dvostruko slijepoj fazi s aktivnom kontrolom 38-tjednog ispitivanja, opažena je srednja vrijednost sniženja razine prolaktina od početne do one na posljednjem posjetu u skupini koja je primala Abilify Maintena (−0,33 ng/ml) u odnosu na srednju vrijednost povećanja u skupini koja je primala tablete oralnog aripiprazola od 10-30 mg (0,79 ng/ml; p &lt; 0,01).
In the early post-transplant period ( &lt; 40 days post-transplant), renal, cardiac and hepatic transplant patients had mean MPA AUCs approximately 30 % lower and Cmax approximately 40 % lower compared to the late post-transplant period (3-6 months post-transplant).
U ranom razdoblju nakon presađivanja ( &lt; 40 dana nakon presađivanja), srednji AUC MPA kod bolesnika s presađenim bubregom, srcem ili jetrom bio je otprilike 30 % niži, dok je Cmax bio otprilike 40 % niži u odnosu na kasnije razdoblje nakon presađivanja (3-6 mjeseci nakon presađivanja).
In the early post-transplant period ( &lt; 40 days post-transplant), renal, cardiac and hepatic transplant patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower compared to the late post-transplant period (3 – 6 months post-transplant).
U ranom razdoblju nakon presađivanja ( &lt; 40 dana nakon presađivanja) srednja vrijednost AUC-a MPA kod bolesnika s presađenim bubregom, srcem ili jetrom bila je otprilike 30% niža, dok je Cmax bio otprilike 40% niži u odnosu na kasnije razdoblje nakon presađivanja (3 - 6 mjeseci nakon presađivanja).
In the early post-transplant period ( &lt; 40 days post-transplant), renal, cardiac and hepatic transplant patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower compared to the late post-transplant period (3 – 6 months post-transplant).
U ranom razdoblju nakon presađivanja ( &lt; 40 dana nakon presađivanja), srednja vrijednost AUC-a MPA kod bolesnika s presađenim bubregom, srcem ili jetrom bila je otprilike 30% niža, dok je Cmax bio otprilike 40% niži u odnosu na kasnije razdoblje nakon presađivanja (3 - 6 mjeseci nakon presađivanja).
In the early post-transplant period ( &lt; °40 days post-transplant), renal, cardiac and hepatic transplant patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower compared to the late post-transplant period (3 - 6°months post-transplant).
U ranom razdoblju nakon presađivanja ( &lt; 40 dana nakon presađivanja), srednji AUC MPA kod bolesnika s presađenim bubregom, srcem ili jetrom bio je otprilike 30% niži, dok je Cmax bio otprilike 40% niži u odnosu na kasnije razdoblje nakon presađivanja (3 - 6 mjeseci nakon presađivanja).
In the early post-transplant period ( &lt; °40 days post-transplant), renal, cardiac and hepatic transplant patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower compared to the late post-transplant period (3 - 6°months post-transplant).
U ranom razdoblju nakon presađivanja ( &lt; 40 dana nakon presađivanja), srednji AUC MPA kod bolesnika s presađenim bubregom, srcem ili jetrom bio je otprilike 30% niži, dok je Cmax bio otprilike 40% niži u odnosu na kasnije razdoblje nakon presađivanja (3 – 6 mjeseci nakon presađivanja).
In the early post-transplant period ( &lt; °40 days post-transplant), renal, cardiac and hepatic transplant patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower compared to the late post-transplant period (3 – 6°months post-transplant).
U ranom razdoblju nakon presađivanja ( &lt; 40 dana nakon presađivanja), srednji AUC MPA kod bolesnika s presađenim bubregom, srcem ili jetrom bio je otprilike 30% niži, dok je Cmax bio otprilike 40% niži u odnosu na kasnije razdoblje nakon presađivanja (3 - 6 mjeseci nakon presađivanja).
In the Einstein DVT study (see Table 3) rivaroxaban was demonstrated to be non-inferior to enoxaparin/VKA for the primary efficacy outcome (p &lt; 0.0001 (test for non-inferiority); hazard ratio: 0.680 (0.443 - 1.042), p=0.076 (test for superiority)).
U ispitivanju Einstein DVT (vidjeti tablicu 3) pokazano je da je rivaroksaban neinferioran u odnosu na enoksaparin/antagonist vitamina K za primarni ishod djelotvornosti (p &lt; 0,0001 (ispitivanje neinferiornosti); omjer hazarda: 0,680 (0,443 – 1,042), p=0,076 (ispitivanje superiornosti)).
In the Einstein DVT study (see Table 5) rivaroxaban was demonstrated to be non-inferior to enoxaparin/VKA for the primary efficacy outcome (p &lt; 0.0001 (test for non-inferiority); hazard ratio: 0.680 (0.443 - 1.042), p=0.076 (test for superiority)).
U ispitivanju Einstein DVT (vidjeti tablicu 5) pokazano je da je rivaroksaban neinferioran u odnosu na enoksaparin/antagonist vitamina K za primarni ishod djelotvornosti (p &lt; 0,0001 (ispitivanje neinferiornosti); omjer hazarda: 0,680 (0,443 – 1,042), p=0,076 (ispitivanje superiornosti)).
In the ERT-experienced trial, following 18 months of treatment with Galafold there was a statistically significant decrease in LVMi (p &lt; 0.05).
U ispitivanju s bolesnicima koji su prethodno primali ERT, a nakon 18-mjesečnog liječenja lijekom Galafold, došlo je do statistički značajnog smanjenja LVMi (p &lt; 0,05).
In the ERT-naïve trial, analyses of the Gastrointestinal Symptoms Rating Scale demonstrated that treatment with Galafold was associated with statistically significant (p &lt; 0.05) improvements versus placebo from baseline to month 6 in the diarrhoea domain, and in the reflux domain for patients with symptoms at baseline.
U ispitivanju s bolesnicima koji prethodno nisu primali ERT, analize ljestvice za ocjenu gastrointestinalnih simptoma pokazale su da je liječenje lijekom Galafold bilo povezano sa statistički značajnim (p &lt; 0,05) poboljšanjima u odnosu na skupinu koja je primala placebo od početka ispitivanja do 6. mjeseca u području proljeva te refluksa za bolesnike koji su imali simptome na početku ispitivanja.
In the ERT-naïve trial, Galafold resulted in a statistically significant decrease in LVMi (p &lt; 0.05); the mean change from baseline in LVMi at Month 18 to 24 was -7.7 (95% CI: -15.4, -0.01; n=27).
U ispitivanju s bolesnicima koji nisu prethodno primali ERT, Galafold je doveo do statistički značajnog smanjenja LVMi (p &lt; 0,05); srednja vrijednost promjene u odnosu na početnu vrijednost LVMi od 18. do 24. mjeseca iznosila je –7,7 (95 % CI: -15,4; -0,01; n = 27).
In the event of decreased platelet count to Grade 3 or greater ( &lt; 50,000/mm3), do not administer trastuzumab emtansine until platelet counts recover to Grade 1 (≥ 75,000/mm3) (see section 4.2).
U slučaju smanjenja broja trombocita stupnja 3 ili višeg ( &lt; 50 000/mm3), trastuzumab emtanzin se ne smije primijeniti dok se broj trombocita ne vrati na vrijednost stupnja 1 (≥ 75 000/mm3) (vidjeti dio 4.2).
In the event of rapidly elevating transaminase levels (ALT/AST, &gt; 5 times upper limit of normal, ULN), discontinuation of Zerit and any potentially hepatotoxic medicinal products should be considered.
U slučaju brzog porasta razina transaminaza (ALT/AST &gt; 5 puta iznad gornje granice normalnih vrijednosti, ULN) treba razmotriti prekid primjene lijeka Zerit i potencijalno hepatotoksičnih lijekova.
In the event of rapidly elevating transaminase levels (ALT/AST, &gt; 5 times upper limit of normal, ULN), discontinuation of Zerit and any potentially hepatotoxic medicinal products should be considered.
U slučaju brzog porasta razina transaminaza (ALT/AST, &gt; 5 puta iznad gornje granice normalnih vrijednosti, ULN), treba razmotriti prekid primjene lijeka Zerit i potencijalno hepatotoksičnih lijekova.
In the event of recurrence of ANC
U slučaju da je ABN ponovno &lt; 1,0 x109/l
In the event of recurrence of ANC &lt; 1.0 x 109/l and/or platelets &lt; 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 400 mg.
U slučaju da je ABN ponovno &lt; 1,0 x 109/l i/ili trombociti &lt; 50 x 109/l, treba ponoviti 1. korak i nastaviti primjenu imatiniba u smanjenoj dozi od 400 mg.
In the event of recurrence of ANC &lt; 1.0 x109/l and/or platelets &lt; 50 x109/l, repeat step 1 and resume imatinib at reduced dose of 260 mg/m2.
U slučaju da je ABN ponovno &lt; 1,0 x109/l i/ili trombociti &lt; 50 x109/l, treba ponoviti 1. korak i nastaviti primjenu imatiniba u smanjenoj dozi od 260 mg/m².
In the first study in 49 patients with moderate to severe COPD, the rate of FEV1 reduction &gt; 15% from baseline was 12% and 6% following Rapiscan and placebo dosing, respectively (p=0.31).
U prvom ispitivanju na 49 bolesnika s umjerenom do teškom KOBP stopa smanjenja FEV1 &gt; 15% od početnih vrijednosti bila je 12% odnosno 6% nakon primjene doze Rapiscana odnosno placeba (p = 0,31).
In the first-line study, after a median observation time of 48.1 months, the median PFS was 55 months in the R-FC group and 33 months in the FC group (p &lt; 0.0001, log-rank test).
U ispitivanju u prvoj liniji liječenja, nakon medijana promatranja od 48,1 mjeseca, medijan preživljenja bez progresije bolesti (PFS) iznosio je 55 mjeseci u R-FC skupini i 33 mjeseca u FC skupini (p &lt; 0,0001, log-rang test).
In the Full Analysis Set (vaccinated subjects regardless of their antibody titre at baseline), high seroprotection rates of &gt; 99% were elicited to mumps and rubella post-dose 2, regardless of the age of the vaccinee at the first dose.
U analizi cjelokupnih podataka (cijepljene osobe bez obzira na njihov titar antitijela na početku), visoka stopa seroprotekcije od &gt; 99% je postignuta za parotitis i rubelu nakon 2. doze cjepiva, bez obzira na dob cjepljenika prilikom primanja prve doze cjepiva.
In the healthy volunteer study, fast acetylators were defined by having a caffeine metabolite ratio &gt; 0.3 and slow acetylators with a caffeine metabolite ratio &lt; 0.2 .
U ispitivanjima na zdravim dobrovoljcima brzi acetilatori definirani su kao oni s omjerom metabolita kofeina većim od 0,3, a spori acetilatori s omjerom metabolita kofeina manjim od 0,2.
In the Hokusai-VTE study (Table 10) edoxaban was demonstrated to be non-inferior to warfarin for the primary efficacy outcome, recurrent VTE, which occurred in 130 of 4,118 subjects (3.2%) in the edoxaban group versus 146 of 4,122 subjects (3.5%) in the warfarin group [HR (95% CI): 0.89 (0.70, 1.13); p &lt; 0.0001 for non-inferiority].
U ispitivanju Hokusai-VTE (tablica 10), edoksaban se pokazao neinferiornim varfarinu u primarnom ishodu djelotvornosti, recidivirajućem VTE-u, koji je nastao u 130 od 4118 ispitanika (3,2%) u skupini liječenoj edoksabanom naspram 146 od 4122 ispitanika (3,5%) u skupini liječenoj varfarinom [HR (95% CI): 0,89 (0,70, 1,13); p &lt; 0,0001 za neinferiornost].
In the HORIZONS study both major and minor bleeding occurred commonly (1/100 and &lt; 1/10).
Velika i mala krvarenja često su se pojavljivala u ispitivanju HORIZONS (1/100 i &lt; 1/10).
In the in vitro mouse lymphoma assay, eltrombopag was marginally positive ( &lt; 3-fold increase in mutation frequency).
U in vitro probi mišjeg limfoma, eltrombopag je bio granično pozitivan (porast učestalosti mutacija &lt; 3 puta).
In the INOT27 trial, 795 preterm infants (GA &lt; 29 weeks) with hypoxic respiratory failure were randomised to receive either INOmax (n=395) in a dose of 5 ppm or nitrogen (placebo n=400), beginning within the first 24 hours of life and treated for at least 7 days, up to 21 days.
U ispitivanju INOT27, 795 nedonoščadi (gestacijska dob &lt; 29 tjedana) s hipoksičnom respiratornom insuficijencijom bilo je randomizirano u skupine koje su primale INOmax (n=395) u dozi od 5 ppm ili dušik (placebo n=400), liječenje je započeto u prva 24 sata života i trajalo je najmanje 7 dana, do najviše 21 dan.
In the integrated data, 26.5% in the JETREA group compared with 10.1% in the placebo group achieved VMA resolution at Day 28 (p &lt; 0.001).
U integriranim podacima, u 26,5% bolesnika u JETREA skupini u usporedbi s 10,1% u skupini placebo VMA se povukla 28. dana (p &lt; 0,001%).