natgillin/translations-raw huggingface dataset:
The safety and efficacy of Quinsair in children aged ˂ 18 years old have not yet been established (see section 4.2).
Varnost in učinkovitost zdravila Quinsair pri otrocih, starih &lt; 18 let, še nista bili dokazani (glejte poglavje 4.2).
The safety and efficacy of Quinsair in children aged ˂ 18 years old have not yet been established.
Varnost in učinkovitost zdravila Quinsair pri otrocih, starih &lt; 18 let, še nista bili dokazani.
The safety and efficacy of Renvela have not been established in adult patients with chronic kidney disease not on dialysis with serum phosphorus &lt; 1.78 mmol/l.
Varnosti in učinkovitosti zdravila Renvela pri odraslih s kronično boleznijo ledvic, ki niso na dializi, z ravnijo fosforja v serumu &lt; 1,78 mmol/l, niso ugotavljali.
The safety and efficacy of rilpivirine in children aged &lt; 12 years have not yet been established.
Varnost in učinkovitost rilpivirina pri otrocih starih &lt; 12 let še nista bili dokazani.
The safety and efficacy of Ristfor in children and adolescents from birth to &lt; 18 years of age have not been established.
Varnost in učinkovitost zdravila Ristfor pri otrocih in mladostnikih, od rojstva do starosti &lt; 18 let, nista bili dokazani.
The safety and efficacy of Selincro in children and adolescents &lt; 18 years of age have not been established.
Varnost in učinkovitost zdravila Selincro pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
The safety and efficacy of SIRTURO in children aged &lt; 18 years have not yet been established.
Varnost in učinkovitost zdravila SIRTURO pri otrocih, starih do 18 let, še nista bili dokazani.
The safety and efficacy of Sovaldi in children and adolescents aged &lt; 18 years have not yet been established.
Varnost in učinkovitost zdravila Sovaldi pri otrocih in mladostnikih, starih &lt; 18 let, še nista bili dokazani.
The safety and efficacy of tenofovir disoproxil fumarate in children with chronic hepatitis B aged 2 to &lt; 12 years or weighing &lt; 35 kg have not been established.
Varnost in učinkovitost dizoproksiltenofovirijevega fumarata pri otrocih s kroničnim hepatitisom B, starih 2 leti do &lt; 12 let ali s telesno maso &lt; 35 kg, še nista bili dokazani.
The safety and efficacy of the dose interval adjustments to every 72 or 96 hours in patients with creatinine clearance &lt; 30 ml/min have not been clinically evaluated.
Varnost in učinkovitost teh prilagoditev intervala odmerjanja na vsakih 72 ali 96 ur pri bolnikih z očistkom kreatinina &lt; 30 ml/min še nista bili klinično ovrednoteni.
The safety and efficacy of this medicinal product in children and adolescents aged 0 to &lt; 18 years have not yet been established.
Varnost in učinkovitost tega zdravila pri otrocih in mladostnikih v starosti od 0 do &lt; 18 let še nista ugotovljeni.
The safety and efficacy of this medicinal product in children and adolescents from birth to &lt; 18 years of age have not been established.
Varnost in učinkovitost tega zdravila pri otrocih in mladostnikih od rojstva do &lt; 18 let starosti nista ugotovljeni.
The safety and efficacy of trametinib has not been established in children and adolescents ( &lt; 18 years).
Varnost in učinkovitost trametiniba pri otrocih in mladostnikih ( &lt; 18 let) nista ugotovljeni.
The safety and efficacy of TREVICTA in children and adolescents &lt; 18 years of age have not been established.
Varnost in učinkovitost zdravila TREVICTA pri otrocih in mladostnikih, starih &lt; 18 let, nista bili dokazani.
The safety and efficacy of Velmetia in children and adolescents from birth to &lt; 18 years of age have not been established.
Varnost in učinkovitost zdravila Velmetia pri otrocih in mladostnikih, od rojstva do starosti &lt; 18 let, nista bili dokazani.
The safety and efficacy of vemurafenib has not been yet established in children and adolescents ( &lt; 18 years).
Varnost in učinkovitost vemurafeniba pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
The safety and efficacy of Vipdomet in children and adolescents &lt; 18 years old have not been established.
Varnost in učinkovitost zdravila Vipdomet pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
The safety and efficacy of Vipidia in children and adolescents &lt; 18 years old have not been established.
Varnost in učinkovitost zdravila Vipidia pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
The safety and efficacy of Voncento in children &lt; 12 years with haemophilia A have not been established.
Varnost in učinkovitost zdravila Voncento pri otrocih &lt; 12 let s hemofilijo A še nista bili dokazani.
The safety and efficacy of Xeplion in children and adolescents &lt; 18 years of age have not been established.
Varnost in učinkovitost zdravila Xeplion pri otrocih, mlajših od 18 let, nista ugotovljeni.
The safety and efficacy of XGEVA have not been established in paediatric patients (age &lt; 18) other than skeletally mature adolescents with giant cell tumour of bone.
Odmerjanje za zdravljenje skeletno dozorelih mladostnikov z gigantocelularnim kostnim tumorjem, ki ni operabilen, ali pri katerem bi kirurška odstranitev verjetno povzročila hudo obolevnost, je enako kot za odrasle.
The safety and efficacy of Xigduo in children and adolescents aged 0 to &lt; 18 years have not yet been established.
Varnost in učinkovitost zdravila Xigduo pri otrocih in mladostnikih v starosti od 0 do &lt; 18 let nista ugotovljeni.
The safety and efficacy of Xiliarx in children and adolescents ( &lt; 18 years) have not been established.
Varnost in učinkovitost zdravila Xiliarx pri otrocih in mladostnikih ( &lt; 18 let) nista bili dokazani.
The safety and efficacy of Xydalba in children aged from birth to &lt; 18 years have not yet been established.
Varnost in učinkovitost zdravila Xydalba pri otrocih od rojstva do &lt; 18 let še nista ugotovljeni.
The safety and efficacy of Zinforo in children aged birth to &lt; 2 months have not been established.
Varnost in učinkovitost zdravila Zinforo pri otrocih od rojstva do &lt; 2 mesecev nista ugotovljeni.
The safety and efficacy of Zomarist in children and adolescents ( &lt; 18 years) have not been established.
Varnost in učinkovitost zdravila Zomarist pri otrocih in mladostnikih ( &lt; 18 let) nista bili dokazani.
The safety assessment of rilpivirine is based on Week 48 data from one single-arm open-label study (TMC278-C213) in 36 paediatric patients 12 to &lt; 18 years and weighing at least 32 kg.
Ocena varnosti rilpivirina temelji na podatkih iz 48. tedna ene odprte študije (TMC278-C213) z enim krakom pri 36 pediatričnih bolnikih, starih od 12 do &lt; 18 let, s telesno maso vsaj 32 kg.
The safety data from this study in patients aged 6 to &lt; 18 years appeared generally similar to that observed in adults.
Podatki o varnosti so bili pri bolnikih v tej raziskavi, starih 6 do &lt; 18 let, na splošno podobni kot pri odraslih.
The safety of alogliptin between the elderly (≥ 65 years old) and non-elderly ( &lt; 65 years old) was similar.
Varnost alogliptina pri starostnikih (starih 65 let ali starejših) in mlajših bolnikih (mlajših od 65 let) je bila podobna.
The safety of eltrombopag in severe aplastic anaemia was assessed in a single-arm, open-label trial (N=43) in which 12 patients (28%) were treated for &gt; 6 months and 9 patients (21%) were treated for
Varnost eltrombopaga pri zdravljenju hude aplastične anemije so ocenjevali v odprti študiji z eno samo skupino bolnikov (N=43), v kateri so 12 bolnikov (28 %) zdravili več kot 6 mesecev,
The safety of emtricitabine and tenofovir alafenamide was evaluated through 48 weeks in an open- label clinical study (GS-US-292-0106) in which HIV-1 infected, treatment-naïve paediatric patients aged 12 to &lt; 18 years received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet.
Varnost emtricitabina in alafenamidtenofovirata so ocenili v 48 tednih v odprti klinični študiji (GS-US-292-0106), v kateri so predhodno nezdravljeni pediatrični bolniki, okuženi s HIV-1 in stari od 12 do &lt; 18 let, prejemali emtricitabin in alafenamidtenofovirat v kombinaciji z elvitagravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov.
The safety of emtricitabine+tenofovir alafenamide was evaluated through 48 weeks in an open-label clinical study (GS-US-292-0106) in which 50 HIV-1 infected, treatment-naïve paediatric patients aged 12 to &lt; 18 years received emtricitabine+tenofovir alafenamide in combination with elvitegravir+cobicistat as a fixed-dose combination tablet.
Varnost emtricitabina + alafenamidtenofovirata so ocenili v 48 tednih z odprto klinično študijo (GS-US-292-0106), v kateri so predhodno nezdravljeni pediatrični bolniki, okuženi s HIV-1 in stari od 12 do &lt; 18 let, prejemali emtricitabin + alafenamidtenofovirat v kombinaciji z elvitegravirjem + kobicistatom v obliki tablete s fiksno kombinacijo odmerkov.
The safety of entecavir in paediatric patients from 2 to &lt; 18 years of age is based on two ongoing clinical trials in subjects with chronic HBV infection; one Phase 2 pharmacokinetic trial (study 028) and one Phase 3 trial (study 189).
Varnost entekavirja pri pediatričnih bolnikih, starih od 2 do &lt; 18 let, temelji na podatkih dveh kliničnih preskušanj, ki še potekata, in sicer enem farmakokinetičnem preskušanju 2. faze (študija 028) in enem preskušanju 3. faze (študija 189) pri bolnikih s kronično okužbo s HBV.
The safety of Epclusa has not been assessed in patients with severe renal impairment (eGFR &lt; 30 mL/min/1.73 m2) or ESRD requiring haemodialysis.
Varnost zdravila Epclusa ni bila ocenjena pri bolnikih s hudo ledvično okvaro (eGFR &lt; 30 ml/min/1,73 m2) ali pri bolnikih z boleznijo ledvic v končni fazi (ESRD), zaradi katere bolnik potrebuje hemodializo.
The safety of Exviera in children and adolescents aged &lt; 18 years has not yet been established.
Varnost zdravila Exviera še ni ugotovljena pri otrocih in mladostnikih, starih &lt; 18 let.
The safety of Genvoya in HIV-1 infected, treatment-naïve paediatric patients aged 12 to &lt; 18 years was evaluated through 48 weeks in an open-label clinical study (GS-US-292-0106).
Varnost zdravila Genvoya pri predhodno nezdravljenih pediatričnih bolnikih, okuženih s HIV-1, starih od 12 do &lt; 18 let, so ocenili v 48 tednih v odprti klinični študiji (GS-US-292-0106).
The safety of Harvoni has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] &lt; 30 mL/min/1.73 m2) or end stage renaldisease (ESRD) requiring haemodialysis.
Varnost zdravila Harvoni ni bila ocenjena pri bolnikih s hudo ledvično okvaro (ocenjena stopnja glomerularne filtracije [eGFR-estimated glomerular filtration rate] &lt; 30 ml/min/1,73 m2) ali pri bolnikih z boleznijo ledvic v končni fazi (ESRD-end stage renal disease), zaradi katere bolnik potrebuje hemodializo (glejte poglavje 5.2).
The safety of ledipasvir/sofosbuvir has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] &lt; 30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis (see section 5.2).
Varnost ledipasvirja/sofosbuvirja ni bila ocenjena pri bolnikih s hudo ledvično okvaro (ocenjena stopnja glomerularne filtracije [eGFR-estimated glomerular filtration rate] &lt; 30 ml/min/1,73 m2) ali pri bolnikih z boleznijo ledvic v končni fazi (ESRD-end stage renal disease), zaradi katere bolnik potrebuje hemodializo (glejte poglavje 5.2).
The safety of posaconazole has been assessed in &gt; 2,400 patients and healthy volunteers enrolled in clinical trials and from post-marketing experience.
Varnost posakonazola so ocenili pri &gt; 2.400 bolnikih in zdravih prostovoljcih, ki so bili vključeni v klinična preskušanja, ter na podlagi izkušenj v obdobju trženja.
The safety of posaconazole oral suspension has been assessed in &gt; 2,400 patients and healthy volunteers enrolled in clinical trials and from post-marketing experience.
Varnost peroralne suspenzije posakonazola so ocenili pri &gt; 2.400 bolnikih in zdravih prostovoljcih, vključenih v klinična preskušanja, in na podlagi izkušenj med obdobjem trženja.
The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure &lt; 90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Varnost sildenafila ni raziskana pri naslednjih podskupinah bolnikov, pri katerih je njegova uporaba zato kontraindicirana: huda okvara jeter, hipotenzija (krvni tlak &lt; 90/50 mmHg), nedavna možganska kap ali miokardni infarkt in znane dedne degenerativne bolezni mrežnice, npr. retinitis pigmentosa (manjši del teh bolnikov ima genetske motnje mrežničnih fosfodiesteraz).
The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure &lt; 90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Varnost sildenafila ni raziskana pri naslednjih podskupinah bolnikov, zato je njegova uporaba pri njih kontraindicirana: huda okvara jeter, hipotenzija (krvni tlak &lt; 90/50 mmHg), nedavna možganska kap ali miokardni infarkt in znane dedne degenerativne bolezni mrežnice, npr. retinitis pigmentosa (manjši del teh bolnikov ima genetske motnje mrežničnih fosfodiesteraz).
The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure &lt; 90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Varnost sildenafila ni razsikana pri naslednjih podskupinah bolnikov, pri katerih je njegova uporaba zato kontraindicirana: huda okvara jeter, hipotenzija (krvni tlak &lt; 90/50 mmHg), nedavna možganska kap ali miokardni infarkt in znane dedne degenerativne bolezni mrežnice, npr. retinitis pigmentosa (manjši del teh bolnikov ima genetske motnje mrežničnih fosfodiesteraz).
The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure &lt; 90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Varnost sildenafila pri naslednjih podskupinah bolnikov ni raziskana, zato je njegova uporaba v teh skupinah kontraindicirana: huda okvara jeter, hipotenzija (krvni tlak &lt; 90/50 mmHg), nedavna možganska kap ali miokardni infarkt in znane hereditarne degenerativne bolezni mrežnice, npr. retinitis pigmentosa (majhen del teh bolnikov ima genetske motnje mrežničnih fosfodiesteraz).
The safety of Viekirax in children and adolescents aged &lt; 18 years has not yet been established.
Varnost zdravila Viekirax še ni ugotovljena pri otrocih in mladostnikih, starih &lt; 18 let.
The safety of voriconazole was also investigated in 158 additional paediatric patients aged 2 to &lt; 12 years in compassionate use programs.
Varnost vorikonazola so raziskali tudi v programih sočutne uporabe pri 158 dodatnih pediatričnih bolnikih, starih od 2 do &lt; 12 let.
The safety of voriconazole was investigated in 288 paediatric patients aged 2 to &lt; 12 years (169) and 12 to &lt; 18 years (119) who received voriconazole for prophylaxis (183 ) and therapeutic use (105 ) in clinical trials.
Varnost vorikonazola so raziskali pri 228 pediatričnih bolnikih, starih od 2 do &lt; 12 let (169) in od 12 do &lt; 18 let (119), ki so vorikonazol v kliničnih preskušanjih dobivali za profilakso (183) in terapijo (105).
The safety profile in healthy subjects &gt; 60 years of age, in immune-compromised subjects and patients with chronic disease conditions is similar to the safety profile in healthy subjects.
Varnostni profil pri zdravih osebah, starejših od 60 let, imunsko kompromitiranih osebah in bolnikih s kroničnimi boleznimi je bil podoben kot pri zdravih osebah.
The safety profile in these patients &lt; 18 years of age appears similar to the safety profile observed in adults.
Profil varnosti zdravila pri teh bolnikih, mlajših od 18 let, je videti podoben kot pri odraslih.
The safety profile in these patients &lt; 18 years of age appears similar to the safety profile observed in adults.
Varnostni profil zdravila je pri teh bolnikih, mlajših od 18 let, videti podoben kot pri odraslih.
The safety profile of eribulin in elderly patients (≥ 65 years of age) was similar to that of patients &lt; 65 years of age except for asthenia/fatigue which showed an increasing trend with age.
Varnostni profil eribulina za starejše bolnike (≥65 let starosti) je bil podoben kot pri bolnikih, starih &lt; 65 let, razen astenije/utrujenosti, ki sta z naraščajočo starostjo kazali trend naraščanja.
The safety, efficacy and population pharmacokinetics of Kuvan were studied in a multicentre, open-label, randomised, controlled study in children &lt; 4 years old with a confirmed diagnosis of PKU.
Varnost, učinkovitost in populacijsko farmakokinetiko zdravila Kuvan so preučili v multicentrični, odprti, randomizirani, nadzorovani študiji pri otrocih, starih &lt; 4 leta, s potrjeno diagnozo PKU.
The safety, efficacy, and pharmacokinetics of nintedanib have not been studied in patients with severe renal impairment ( &lt; 30 ml/min creatinine clearance).
Varnosti, učinkovitosti in farmakokinetike nintedaniba pri bolnikih s hudo ledvično okvaro (očistek kreatinina &lt; 30 ml/min) niso proučevali.
The Seattle Angina Questionnaire showed significant effects on several dimensions, including angina frequency (p  0.001), compared to placebo-treated patients.
Vprašalnik o angini Seattle je pokazal pomembne učinke na več razsežnosti, vključno s pogostnostjo angine (p &lt; 0,001), v primerjavi z bolniki, ki so jih zdravili s placebom.
The second major trial evaluated a maximum of 6 courses of either paclitaxel (135 mg/m² over 24 hours) followed by cisplatin (75 mg/m²) or control in over 400 patients with stage III/IV primary ovarian cancer, with a &gt; 1 cm residual disease after staging laparotomy, or with distant metastases.
V drugem večjem preskušanju so pri več kot 400 bolnicah s primarnim rakom jajčnikov faze III/IV, z a &gt; 1- centimetrsko osnovno boleznijo po lapratomiji ali z oddaljenimi metastazami, ocenili do 6 krogov zdravljenja s paklitakselom (135 mg/m2 v 24 urah) in nato cisplatinom (75 mg/m2) ali kontrolo.
The secondary endpoint of complete resolution of heartburn, defined as no heartburn on the patient’s diary card for 7 consecutive days, was statistically significant at both week 1 (10.0% - 15.2% vs placebo 0.9% - 2.4%, p = 0.014, p &lt; 0.001) and week 2 (25.2% - 35.7% vs placebo 3.4% - 9.0%, p &lt; 0.001).
Sekundarni opazovani dogodek, popolno prenehanje zgage, opredeljen kot odsotnost zgage v bolnikovem dnevniku 7 zaporednih dni, je bil statistično pomemben po enem tednu (10,0–15,2 % v primerjavi s placebom 0,9–2,4 %, p = 0,014, p &lt; 0,001) in po 2 tednih (25,2–35,7 % v primerjavi s placebom 3,4–9,0 %, p &lt; 0,001).
The seroprotection rates (proportion of individuals reaching seroprotective level anti-HBs &gt; 10 mIU/ml) were unaffected (96.5% for concomitant vaccination and 97.5% for hepatitis B vaccine only).
Odstotek serozaščite (delež oseb, pri katerih je bila dosežena raven serozaščite anti-HBs &gt; 10 mi.e./ml) je ostal nespremenjen (96,5 % pri sočasnem cepljenju in 97,5 % pri cepljenju samo s cepivom proti hepatitisu B).
The significant reductions in HbA1c observed with 25 mg alogliptin plus 30 mg pioglitazone and metformin were consistent over the entire 52-week treatment period compared to 45 mg pioglitazone and metformin (p &lt; 0.001 at all time points).
Pomembna znižanja vrednosti HbA1c, ki so bila opažena pri uporabi alogliptina v odmerku 25 mg v kombinaciji s 30 mg pioglitazona in z metforminom, so bila konsistentna skozi celotno 52-tedensko obdobje zdravljenja v primerjavi z zdravljenjem s 45 mg pioglitazona in z metforminom (p &lt; 0,001 v vseh časovnih točkah).
The single dose pharmacokinetic disposition of tigecycline was not altered in patients with renal insufficiency (creatinine clearance 30 ml/min, n=6).
Pri bolnikih z insuficienco ledvic (očistek kreatinina &lt; 30 ml/min, n = 6) se farmakokinetika tigeciklina po enkratnem odmerku ni spremenila.
The starting dose in each group was assigned depending on weight with three groups: ≥20 to &lt; 50 kg, ≥50 to &lt; 80 kg, and ≥80 to ≤150 kg.
Začetne odmerke za posamezno skupino so določili glede na telesno maso v treh skupinah: ≥20 do &lt; 50 kg, ≥50 do &lt; 80 kg in ≥80 do ≤150 kg.
The starting dose was 0.02 mg/kg bid in age-subset [6-12[months, 0.05 mg/kg bid in [1-3[ years and [3-18[ years &lt; 40 kg, and 2.5 mg bid in [3-18[ years and ≥ 40 kg.
Začetni odmerek ivabradina pri podskupini bolnikov, starih [6-12[ mesecev, je bil 0,02 mg/kg dvakrat na dan, pri podskupini bolnikov, starih [1-3[ leta, in bolnikih, starih [3-18[ let, ki so tehtali manj kot 40 kg, je bil odmerek 0,05 mg/kg dvakrat na dan, pri bolnikih, starih [3-18[ let, ki so tehtali 40 kg ali več, pa je bil odmerek 2,5 mg dvakrat na dan.
The strata were baseline weekly itch severity score ( &lt; 13 vs. ≥13) and baseline weight ( &lt; 80 kg vs. ≥80 kg).
Bolnike so stratificirali glede na izhodiščno oceno izraženosti srbenja v enem tednu ( &lt; 13 v primerjavi z ≥13) in glede na izhodiščno telesno maso ( &lt; 80 kg v primerjavi z ≥80 kg).
The strong effect on vertebral fractures was furthermore reflected by a statistically significant reduction of height loss compared to placebo (p &lt; 0.0001).
Močan vpliv na zlome vretenc se je kazal tudi s statistično pomembno manjšo izgubo telesne višine v primerjavi s placebom (p &lt; 0,0001).
The strong effect on vertebral fractures was furthermore reflected by a statistically significant reduction of height loss compared to placebo (p &lt; 0.0001).
Močan vpliv na zlome vretenc se je kazal tudi s statistično značilno manjšo izgubo telesne višine v primerjavi s placebom (p &lt; 0,0001).
The strong effect on vertebral fractures was furthermore reflected by a statistically significant reduction of height loss compared to placebo (p &lt; 0.0001).
Močan vpliv na zlome vretenc se je kazal tudi z značilno manjšo izgubo telesne višine v primerjavi s placebom (p &lt; 0,0001).
The studies showed a difference of 15 % between treatment groups (61% for Visudyne-treated patients compared to 46% placebo-treated patients, p &lt; 0.001, ITT analysis).
Študiji sta pokazali 15 % razliko med obravnavanima skupinama (61 % za bolnike, zdravljene z zdravilom Visudyne, v primerjavi s 46 % za bolnike, ki so dobivali placebo, p &lt; 0,001, analiza ITT).
The study demonstrated a clinically and statistically significant relative risk reduction of 18% in the rate of the primary composite endpoint of cardiovascular mortality and hospitalisation for worsening heart failure (hazard ratio: 0.82, 95%CI [0.75;0.90] – p &lt; 0.0001) apparent within 3 months of initiation of treatment.
Študija je dokazala klinično in statistično značilno relativno zmanjšanje tveganja za 18 % za primarni končni izid, sestavljen iz srčno-žilne umrljivosti in hospitalizacije zaradi poslabšanja srčnega popuščanja (razmerje tveganja: 0,82, 95 % interval zaupanja [0,75;0,90] - p &lt; 0,0001), vidnega po 3 mesecih po začetku zdravljenja.