natgillin/translations-raw huggingface dataset:
In adults, absolute neutrophil counts &lt; 0.5x109/l at a median of 4 days post transplant occurred in 100% of patients and recovered at median day 10 and 13 days following autologous and allogeneic transplant respectively (median neutropenic period of 6 and 9 days respectively).
U odraslih se apsolutan broj neutrofila &lt; 0,5x109/l pri medijanu od 4 dana nakon presađivanja pojavio u 100% bolesnika i oporavio u medijanu od 10 dana nakon autolognog i 13 dana nakon alogenog presađivanja (medijan neutropenijskog razdoblja od 6, odnosno 9 dana).
In alignment with the effect on relapse rate, supportive analyses from Study 1 (CAMMS323) showed that LEMTRADA 12 mg/day led to significantly fewer LEMTRADA -treated patients experiencing severe relapses (61% reduction, p=0.0056) and signficantly fewer relapses that led to steroid treatment (58% reduction, p &lt; 0.0001) compared to IFNB-1a.
U skladu s učinkom na stopu relapsa, suportivne analize iz Ispitivanja 1 (CAMMS323) pokazale su da je primjena lijeka LEMTRADA u dozi od 12 mg/dan značajno smanjila broj bolesnika liječenih lijekom LEMTRADA u kojih je došlo do teških relapsa (smanjenje za 61%, p=0,0056) kao i broj relapsa koji iziskuju liječenje steroidima (smanjenje za 58%, p &lt; 0,0001) u usporedbi s primjenom IFNB-1a.
In ALK-positive NSCLC patients, the frequency of adverse reactions was generally similar for patients &lt; 65 years of age and patients 65 years of age with the exception of oedema and constipation, which were reported with greater frequency (≥15% difference) in Study 1014 among patients treated with crizotinib 65 years of age.
Kod bolesnika s ALK-pozitivnim NSCLC-om, učestalost nuspojava bila je općenito slična za bolesnike &lt; 65 godina starosti i bolesnike 65 godina starosti s izuzetkom edema i konstipacije, koji su prijavljivani s većom učestalosti (razlika ≥15%) u Ispitivanju 1014 među bolesnicima liječenima krizotinibom 65 godina starosti.
In all clinical studies 38–40% of patients were &gt; 60 years of age and 10–12% of patients were &gt; 70 years of age.
U svim kliničkim ispitivanjima 38-40% bolesnika bilo je u dobi ≥60 godina, a 10-12% bolesnika bilo je u dobi ≥70 godina.
In an additional Phase 4, randomised, two-dose level study, four MPS VI patients &lt; 1 year of age were treated at 1 or 2 mg/kg/week for 53 to 153 weeks.
U dodatnoj randomiziranoj studiji faze 4 s dvije doze, četiri MPS VI bolesnika mlađih od jedne godine života bili su liječeni s dozama 1 ili 2 mg/kg/tjedan tijekom 53 do 153 tjedna.
In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 24 months was higher in the Enbrel in combination with methotrexate group compared with the Enbrel alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p &lt; 0.05).
U analizi u kojoj se smatralo da su svi bolesnici koji su iz bilo kojeg razloga prekinuli sudjelovanje u ispitivanju imali napredovanje bolesti postotak bolesnika bez progresije (promjena TSS ≤ 0,5) u mjeseca bio je veći kod kombinacije Enbrela s metotreksatom u usporedbi sa skupinom koja je uzimala samo Enbrel i koja je uzimala samo metoreksat (62%, 50% odnosno 36%, p &lt; 0,05).
In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 24 months was higher in the Enbrel in combination with methotrexate group compared with the Enbrel alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p &lt; 0.05).
U analizi u kojoj se smatralo da su svi bolesnici koji su iz bilo kojeg razloga prekinuli sudjelovanje u ispitivanju imali napredovanje bolesti, postotak bolesnika bez progresije (promjena TSS ≤ 0,5) u mjeseca bio je veći kod kombinacije Enbrela s metotreksatom u usporedbi sa skupinom koja je uzimala samo Enbrel i koja je uzimala samo metoreksat (62%, 50% odnosno 36%, p &lt; 0,05).
In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 24 months was higher in the etanercept in combination with methotrexate group compared with the etanercept alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p &lt; 0.05).
U analizi u kojoj se smatralo da su svi bolesnici koji su iz bilo kojeg razloga prekinuli sudjelovanje u ispitivanju imali napredovanje bolesti, postotak bolesnika bez progresije (promjena TSS ≤ 0,5) u mjeseca bio je veći kod kombinacije etanercepta s metotreksatom u usporedbi sa skupinom koja je uzimala samo etanercept ili koja je uzimala samo metoreksat (62%, 50% odnosno 36%, p &lt; 0,05).
In an embryo-foetal developmental toxicity study performed in mice, the murine surrogate crossed the placenta to a limited extent (foetal-to-maternal serum concentration ratio &lt; 1%) and did not induce embryo-foetal toxicity or teratogenicity.
U ispitivanju embrio-fetalne razvojne toksičnosti provedenom u miševa, mišji surogat prešao je placentalnu barijeru u ograničenom rasponu (omjer koncentracija u serumu fetusa u odnosu na majku &lt; 1%) i nije inducirao embrio-fetalnu toksičnost ili teratogenost.
In an integrated analysis of HZC102970 and HZC102871 at week 52, an improvement was seen when comparing the fluticasone furoate/vilanterol 92/22 micrograms versus vilanterol 22 micrograms in adjusted mean trough FEV1 (42 mL 95% CI: 19, 64mL, p &lt; 0.001).
U objedinjenoj analizi ispitivanja HZC102970 i HZC102871 u 52. tjednu usporedba flutikazonfuroata/vilanterola od 92/22 mikrograma i vilanterola od 22 mikrograma pokazala je poboljšanje u prilagođenoj srednjoj najnižoj vrijednosti FEV1 (42 ml 95% CI: 19, 64 ml, p &lt; 0,001).
In an intravenous study in dogs, transient increases in heart rate and decreases in blood pressure and minimal prolongation of the QTc interval ( &lt; 10 msec) were observed at exposures ranging from 4.2 to 14.6-fold the clinical exposure following the 500 mg dose.
U ispitivanju intravenske primjene u pasa, zapaženi su prolazni porast srčane frekvencije i smanjenje krvnog tlaka te minimalno produljenje QTc intervala ( &lt; 10 msek) kod izloženosti u rasponu od 4,2 do 14,6 puta većih od kliničke izloženosti nakon doze od 500 mg.
In an open label trial comparing the efficacy and safety of liraglutide (1.2 mg and 1.8 mg) and sitagliptin (a DPP­4 inhibitor, 100 mg) in patients inadequately controlled on metformin therapy (mean HbA1c 8.5%), liraglutide at both doses was statistically superior to sitagliptin treatment in reducing HbA1c after 26 weeks (­1.24%, ­1.50% vs ­0.90%, p &lt; 0.0001).
U otvorenom ispitivanju u kojem je uspoređivana djelotvornost i sigurnost liraglutida (1,2 mg i 1,8 mg) i sitagliptina (DPP-4 inhibitor, 100 mg) u bolesnika koji nisu odgovarajuće kontrolirani liječenjem metforminom (srednja vrijednost HbA1c 8,5%), liraglutid je u obje doze bio statistički superiorniji u odnosu na liječenje sitagliptinom u smanjenju HbA1c nakon 26 tjedana (-1,24%, -1,50% naspram -0,90%, p &lt; 0,0001).
In an open label trial comparing the efficacy and safety of liraglutide 1.8 mg with lixisenatide 20 mcg in 404 patients inadequately controlled on metformin therapy (mean HbA1c 8.4%), liraglutide was superior to lixisenatide in reducing HbA1c after 26 weeks of treatment (­1.83% vs. ­1.21%, p &lt; 0.0001).
U otvorenom ispitivanju u kojem je uspoređivana djelotvornost i sigurnost liraglutida 1,8 mg i liksisenatida 20 µg u 404 bolesnika koji nisu odgovarajuće kontrolirani liječenjem metforminom (srednja vrijednost HbA1c 8,4%), liraglutid je bio superioran liksisenatidu u smanjenju HbA1c nakon 26 tjedana liječenja (-1,83% naspram -1,21%, p &lt; 0,0001).
In an open-label Phase 3 study, 18 of 23 patients with HoFH developed hepatic steatosis (hepatic fat &gt; 5.56%) as measured by nuclear magnetic resonance spectroscopy (MRS) (see section 5.1).
U otvorenom ispitivanju faze 3, 18 od 23 bolesnika s HoFH-om razvilo je masnu jetru (mast u jetri &gt; 5,56%) mjereno spektroskopskom metodom nuklearne magnetske rezonancije (MRS) (vidjeti dio 5.1).
In another clinical study (D-Pan-H5N1-010), 297 subjects aged &gt; 60 years (stratified in ranges from 61 to 70, 71 to 80 and &gt; 80 years of age) received either a single or a double dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
U drugom kliničkom ispitivanju (D-Pan-H5N1-010), 297 ispitanika u dobi &gt; 60 godina (razvrstani u raspone od 61 do 70, 71 do 80 i &gt; 80 godina) primilo je ili jednostruku ili dvostruku dozu AS03- adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004 (H5N1) na 0. i 21. dan.
In another clinical study (D-Pan-H5N1-010), 297 subjects aged &gt; 60 years (stratified in ranges from 61 to 70, 71 to 80 and &gt; 80 years of age) received either a single or a double dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
U drugom kliničkom ispitivanju (D-Pan-H5N1-010), 297 ispitanika u dobi &gt; 60 godina (stratificirani u raspone od 61 do 70, 71 do 80 i &gt; 80 godina) primilo je ili jednostruku ili dvostruku dozu AS03- adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004 (H5N1) na 0. i 21. dan.
In another study involving 91 patients with type 2 diabetes and chronic renal impairment (creatinine clearance &lt; 50 ml/min), the safety and tolerability of treatment with sitagliptin at 25 or 50 mg once daily were generally similar to placebo.
U drugom ispitivanju u koje je uključen 91 bolesnik s dijabetesom tipa 2 i kroničnim oštećenjem funkcije bubrega (klirens kreatinina &lt; 50 ml/min), sigurnost i podnošljivost liječenja sitagliptinom u dozi od 25 ili 50 mg jedanput na dan općenito su bile slične placebu.
In antiretroviral-naive patients treated with a combination of abacavir, lamivudine, zidovudine and efavirenz in a small, ongoing, open label pilot study, the proportion of patients with undetectable viral load ( &lt; 400 copies/ml) was approximately 90 % with 80 % having &lt; 50 copies/ml after 24 weeks of treatment.
U malom, otvorenom, pilot ispitivanju koje je u tijeku u bolesnika koji ranije nisu primali antiretrovirusne lijekove udio bolesnika s virusnim opterećenjem kojeg se ne može otkriti ( &lt; 400 kopija/ml) nakon 24 tjedna liječenja s kombinacijom abakavira, lamivudina, zidovudina i efavirenza bio je oko 90% od čega je 80% imalo &lt; 50 kopija/ml.
In AS001 clinical trial, at Week 12 ASAS20 responses were achieved by 58% of patients receiving Cimzia 200 mg every 2 weeks and 64% of patients receiving Cimzia 400 mg every 4 weeks as compared to 38% of patients receiving placebo (p &lt; 0.01).
U AS001 kliničkom istraživanju, u 12. tjednu ASAS20 odgovori postignuti su od strane 58% bolesnika koji su primali 200 mg Cimzije svaka 2 tjedna i 64% bolesnika koji su primali 400 mg svaka 4 tjedna u usporedbi s 38% bolesnika koji su primali placebo (p &lt; 0,01).
In asfotase alfa clinical studies adverse events of craniosynostosis (associated with increased intracranial pressure), including worsening of pre-existing craniosynostosis have been reported in hypophosphatasia patients &lt; 5 years of age.
U kliničkim ispitivanjima asfotaze alfa, nuspojave kraniosinostoze (povezane s povećanim intrakranijalnim tlakom), uključujući pogoršanje postojeće kraniosinostoze, zabilježene su u bolesnika s hipofosfatazijom u dobi od &lt; 5 godina.
In assisted reproductive techniques, there is an increased risk of OHSS with a serum estradiol &gt; 3,000 pg/mL (11,000 pmol/L) and 18 or more follicles of 11 mm or more in diameter.
Kod metoda potpomognute oplodnje postoji povećani rizik od OHSS-a uz estradiol u serumu &gt; 3000 pg/ml (11 000 pmol/l) i 18 ili više folikula od 11 mm ili više u promjeru.
In both of these studies tenofovir disoproxil fumarate was significantly superior to adefovir dipivoxil for the primary efficacy endpoint of complete response (defined as HBV DNA levels &lt; 400 copies/ml and Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis).
U oba ispitivanja tenofovirdizoproksilfumarat pokazao se značajno superiornijim u odnosu na adefovirdipivoksil s obzirom na primarnu mjeru ishoda djelotvornosti, a to je bio potpuni odgovor na liječenje (definiran kao razine HBV DNK &lt; 400 kopija/ml i kao poboljšanje rezultata na Knodellovoj nekroupalnoj ljestvici za najmanje dva boda bez pogoršanja Knodellove fibroze).
In both RAISE and TRA100773B the response to eltrombopag relative to placebo was similar irrespective of ITP medicinal product use, splenectomy status and baseline platelet count (≤ 15,000/µl, &gt; 15,000/µl) at randomisation.
U oba ispitivanja - RAISE i TRA100773B, odgovor na eltrombopag u odnosu na placebo je bio sličan, bez obzira na primjenu drugih lijekova za liječenje ITP-a, splenektomiranost bolesnika ili početni broj trombocita (≤ 15 000/µl, &gt; 15 000/µl) na početku randomizacije.
In both studies esomeprazole 20 mg was significantly better compared to placebo for the primary endpoint, complete resolution of heartburn, defined as no heartburn episodes during the last 7 days prior to the final visit (33.9% - 41.6% vs. placebo 11.9 – 13.7%, (p &lt; 0.001).
U oba je ispitivanja esomeprazol u dozi od 20 mg postigao značajno bolje rezultate u usporedbi s placebom u primarnoj mjeri ishoda, potpunom povlačenju žgaravice što se definira kao izostanak epizode žgaravice tijekom posljednjih 7 dana prije završnog posjeta (33,9%- 41,6% u odnosu na 11,9-13,7% kod bolesnika koji su primali placebo, (p &lt; 0,001).
In both studies, treatment with epoetin theta resulted in a significant haemoglobin response (p &lt; 0.001), defined as an increase in haemoglobin of ≥ 2 g/dl without transfusion, and a significant reduction in transfusion requirements (p &lt; 0.05) in comparison to placebo.
U oba ispitivanja, liječenje epoetinom theta dovelo je do značajnog hemoglobinskog odgovora (p &lt; 0,001) koji se definira kao porast hemoglobina od ≥ 2 g/dl bez transfuzije te do značajnog smanjenja potreba za transfuzijom (p &lt; 0,05) u odnosu na skupinu koja je primala placebo.
In C-EARLY, Cimzia+MTX-treated patients reported significant improvements at Week 52 compared to placebo+MTX in pain as assessed by the Patient Assessment of Arthritis Pain (PAAP) – 48,5 vs - 44,0 (least square mean) (p &lt; 0.05).
U C-EARLY ispitivanju, u bolesnika liječenih Cimzijom+MTX zabilježeno je značajno smanjenje boli u 52. tjednu koja je ocijenjena bolesnikovom ocjenom boli uzrkovane artritisom (PAAP, engl.
In case CrCl is &lt; 60 ml/min (eGFR &lt; 60 ml/min/1.73m2), Jentadueto is contraindicated (see section 4.3).
U slučaju da je CrCl &lt; 60 ml/min. (eGFR &lt; 60 ml/min./1,73m2), Jentadueto je kontraindiciran (vidjeti dio 4.3).
In case of an increase of ALT or AST &gt; 3 ULN, decrease of neutrophil count &lt; 2,000/mm3 or any other severe adverse events, treatment should be modified as follows:
U slučaju povećanja ALT ili AST &gt; 3 GGN, pada broja neutrofila &lt; 2000/mm3 ili bilo koje druge teške nuspojave, liječenje treba izmijeniti kako slijedi:
In case of interruptions due to aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations &gt; 3x upper limit of normal (ULN), once transaminases have returned to baseline values, treatment with Ofev may be reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full dose (150 mg twice daily) (see sections 4.4 and 4.8).
U slučaju privremenog prekida liječenja zbog povišenih vrijednosti aspartat aminotransferaze (AST) ili alanin aminotransferaze (ALT) D 3x od gornje granice normale (GGN), nakon što se vrijednosti transaminaza vrate na početne vrijednosti, liječenje Ofevom može se ponovno započeti u smanjenoj dozi (100 mg dvaput dnevno), koja se postupno može povećavati do pune doze (150 mg dvaput dnevno) (vidjeti dijelove 4.4 i 4.8).
In case of positive semiquantitative dipstick results (protein &gt; 30 mg/dl), urinalysis should be performed to determine urinary protein creatinine (UPC) ratio, and a blood sample to measure creatinine, albumin and BUN.
U slučaju pozitivnih polukvantitativnih rezultata mjerenja papirnom trakom (bjelančevine &gt; 30 mg/dl), treba provesti analizu mokraće kako bi se utvrdio omjer bjelančevina i kreatinina u mokraći (UPC), te uzeti uzorak krvi za mjerenje kreatinina, albumina i ureje u krvi.
In case of specific changes in liver values (AST/ALT &gt; 3 x ULN; total bilirubin ≥ 2 x ULN and
U slučaju specifičnih promjena jetrenih vrijednosti (AST/ALT &gt; 3 x GGN; ukupni bilirubin
In case of specific elevations of aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) values to &gt; 3 x upper limit normal (ULN) in conjunction with an increase of total bilirubin to ≥ 2 x ULN and alkaline phosphatase (ALKP) &lt; 2 x ULN (see Table 2) treatment with Vargatef should be interrupted.
U slučaju specifičnog porasta vrijednosti aspartat aminotransferaze (AST)/ alanin aminotransferaze (ALT) na &gt; 3 x gornje granice normale (GGN) u kombinaciji s porastom ukupnog bilirubina na ≥ 2 x GGN i alkalne fosfataze (AP) &lt; 2 x GGN (vidjeti tablicu 2), liječenje Vargatefom mora se prekinuti.
In case of UPC ratio &gt; 2 or albumin &lt; 0.75 lower limit of normal (LLN), treatment should be interrupted until albumin and UPC values have returned to limit value (UPC ratio &lt; 2 and albumin &gt; 0.75 LLN), treatment can then be continued at the same dose.
U slučaju da je omjer UPC &gt; 2 ili albumin &lt; 0.75 donje granice normale (DGN), liječenje treba prekinuti dok se albumin i UPC vrijednosti ne vrate u granične vrijednosti (omjer UPC &lt; 2 i albumin &gt; 0.75 DGN), zatim se liječenje može nastaviti u istoj dozi.
In children &lt; 3 years old that mainly suffer from PCG (primary congenital glaucoma), surgery (e.g. trabeculotomy/goniotomy) remains the first line treatment.
U djece &lt; 3 godine starosti koja većinom boluju od primarnog kongenitalnog glaukoma, kirurški zahvat (npr. trabekulotomija/goniotomija) ostaje prva linija liječenja.
In children &lt; 9 kg, a therapeutic drug monitoring may be justified on a case by case basis, in particular in extremely young children and neonates (see section 5.2).
U djece &lt; 9 kg praćenje terapijskog lijeka može biti opravdano ovisno o slučaju, naročito kada se radi o izrazito mladoj djeci i novorođenčadi (vidjeti dio 5.2).
In children aged 2 months to &lt; 3 years, the following side effects have been observed more frequently compared to children aged 3 years to &lt; 12 years, adolescents and adults:
Kod djece u dobi od 2 mjeseca do &lt; 3 godine sljedeće su nuspojave primijećene češće u usporedbi s djecom u dobi od 3 godine do &lt; 12 godina, adolescentima i odraslima:
In children aged 6-35 months who received two doses of 0.25 ml of Pandemrix (H1N1), there was an increase in reports of pain, redness and swelling at the injection site as well as fever ( &gt; 38°C), drowsiness, irritability and loss of appetite after the second dose compared to the first dose.
U djece u dobi od 6-35 mjeseci koja su primila dvije doze od 0,25 ml Pandemrixa (H1N1), nakon druge doze u usporedbi s prvom dozom povećan je broj prijavljenih slučajeva boli, crvenila i oticanja na mjestu injiciranja kao i vrućice ( &gt; 38°C), omamljenosti, razdražljivosti i gubitka apetita.
In children, thrombocytopenia ( &lt; 25x109/l or requiring platelet transfusion) occurred in 100% of patients.
U djece se trombocitopenija ( &lt; 25x109/l ili potreba za transfuzijom trombocita) pojavila u 100% bolesnika.
In clinical studies aliskiren has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥150 μmol/l or 1.70 mg/dl in women and ≥177 μmol/l or 2.00 mg/dl in men and/or estimated GFR &lt; 30 ml/min/1.73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension.
U kliničkim ispitivanjima aliskiren nije ispitivan u hipertenzivnih bolesnika s teškim oštećenjem bubrežne funkcije (kreatinin u serumu ≥150 μmol/l ili 1,70 mg/dl u žena, te ≥177 μmol/l ili 2,00 mg/dl u muškaraca i/ili procijenjena brzina glomerularne filtracije (GFR) &lt; 30 ml/min/1,73 m2), dijalizom, nefrotskim sindromom ili renovaskularnom hipertenzijom u anamnezi.
In clinical studies for the treatment of community-acquired pneumonia, in adults, 25 % of evaluable patients treated with ertapenem had severe disease (defined as pneumonia severity index &gt; III).
U kliničkim ispitivanjima liječenja izvanbolnički stečene pneumonije u odraslih osoba, 25% bolesnika liječenih ertapenemom koje je bilo moguće ocijeniti imalo je težak oblik bolesti (definiran kao indeks težine pneumonije &gt; III).
In clinical studies Rasilez has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μmol/l or 1.70 mg/dl in women and ≥ 177 μmol/l or 2.00 mg/dl in men and/or estimated GFR &lt; 30 ml/min/1.73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension.
U kliničkim ispitivanjima Rasilez nije ispitivan u hipertenzivnih bolesnika s teškim oštećenjem bubrežne funkcije (kreatinin u serumu ≥150 μmol/l ili 1,70 mg/dl u žena, te ≥177 μmol/l ili 2,00 mg/dl u muškaraca i/ili procijenjena brzina glomerularne filtracije (GFR) &lt; 30 ml/min/1,73 m2), dijalizom, nefrotskim sindromom ili renovaskularnom hipertenzijom u anamnezi.
In clinical studies using Lymphoseek, study investigators employed a threshold rule for positive localisation of technetium Tc 99m that was estimated using the background radioactivity counts plus three standard deviations from the mean background count level (i.e., the three-sigma rule, representing &gt; 99.7% probable difference from background) [see Table 4].
U kliničkim ispitivanjima lijeka Lymphoseek, ispitivači su koristili pravilo praga za pozitivnu lokalizaciju tehnecija Tc 99m koji je procijenjen zbrajanjem pozadinske radioaktivnosti plus tri standardne devijacije prosječnog pozadinskog broja (primjerice, tri sigma pravilo, predstavljajući &gt; 99,7% izglednu razliku u odnosu na pozadinu) [vidjeti tablicu 4.].
In clinical studies with axitinib for the treatment of patients with RCC, patients with serum creatinine &gt; 1.5 times the ULN or calculated creatinine clearance &lt; 60 mL/min were excluded.
U klinička ispitivanja aksitiniba u terapiji bolesnika s RCC-om nisu uključivani bolesnici s vrijednostima serumskog kreatinina &gt; 1,5 puta iznad GGN ili izračunatim klirensom kreatinina &lt; 60 ml/min.
In clinical studies with Kyprolis, cardiac failure was reported in approximately 7% of subjects ( &lt; 5% of subjects had grade ≥ 3 events), myocardial infarction was reported in approximately 2% of subjects ( &lt; 1.5% of subjects had grade ≥ 3 events) and myocardial ischaemia was reported in approximately 1% of subjects ( &lt; 1% of subjects had grade ≥ 3 events).
U kliničkim ispitivanjima lijeka Kyprolis, zatajenje srca je bilo prijavljeno u otprilike 7% ispitanika ( &lt; 5% ispitanika imalo je događaj 3. ili višeg stupnja), infarkt miokarda je bio prijavljen u otprilike 2% ispitanika ( &lt; 1,5% ispitanika imalo je događaj 3. ili višeg stupnja), a ishemija miokarda je bila prijavljena u otprilike 1% ispitanika ( &lt; 1% ispitanika imalo je događaj 3. ili višeg stupnja).
In clinical studies with TOBI, most patients with P. aeruginosa isolates with tobramycin MICs &lt; 128 µg/ml at baseline showed improved lung function following treatment with TOBI.
U kliničkim ispitivanjima s TOBI, većina bolesnika s izolatima P. aeruginosa s vrijednostima MIK za tobramicin &lt; 128 μg/ml na početku, pokazala je poboljšanje plućne funkcije nakon liječenja s TOBI.
In clinical studies, &gt; 90 % of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days.
U kliničkim je ispitivanjima &gt; 90 % ispitanika odgovorilo na te doze, a medijan vremena potrebnog za korekciju neutropenije iznosio je 2 dana.
In clinical studies, &gt; 90% of patients responded at these doses, achieving a reversal of neutropenia in a median of 2 days.
U kliničkim studijama, &gt; 90% bolesnika je odgovorilo na te doze, postižući obrat neutropenije s medijanom od 2 dana.