natgillin/translations-raw huggingface dataset:
In a pharmacokinetic study of celecoxib 200 mg administered once daily in healthy volunteers, genotyped as either CYP2C9*1/*1, CYP2C9*1/*3, or CYP2C9*3/*3, the median Cmax and AUC 0- 24 of celecoxib on day 7 were approximately 4-fold and 7-fold, respectively, in subjects genotyped as CYP2C9*3/*3 compared to other genotypes.
V farmakokinetični študiji celekoksiba 200 mg enkrat na dan pri zdravih prostovoljcih, genotipiziranih kot CYP2C9*1/*1, CYP2C9*1/*3 ali CYP2C9*3/*3, je bila pri preiskovancih, genotipiziranih kot CYP2C9*3/*3, sedmi dan mediana Cmax celekoksiba 4-krat tolikšna, njegova mediana AUC 0-24 pa 7- krat tolikšna kot pri drugih genotipih.
In a pharmacokinetic study of celecoxib 400 mg administered once daily in healthy volunteers, genotyped as either CYP2C9*1/*1, CYP2C9*1/*3, or CYP2C9*3/*3, the median Cmax and AUC 0- 24 of celecoxib on day 7 were approximately 4-fold and 7-fold, respectively, in subjects genotyped as CYP2C9*3/*3 compared to other genotypes.
V farmakokinetični študiji celekoksiba 200 mg enkrat na dan pri zdravih prostovoljcih, genotipiziranih kot CYP2C9*1/*1, CYP2C9*1/*3 ali CYP2C9*3/*3, je bila pri preiskovancih, genotipiziranih kot CYP2C9*3/*3, sedmi dan mediana Cmax celekoksiba 4-krat tolikšna, njegova mediana AUC 0-24 pa 7-krat tolikšna kot pri drugih genotipih.
In a pharmacokinetic study performed in healthy volunteers, concomitant use of low dose ritonavir (200 mg twice daily) with
V farmakokinetični raziskavi se je pri zdravih prostovoljcih, ki so sočasno jemali majhen
In a pharmacokinetic study with 7 patients, the co-administration of docetaxel with the strong CYP3A4 inhibitor ketoconazole leads to a significant decrease in docetaxel clearance by 49%.
V farmakokinetični študiji s 7 bolnicami je sočasna uporaba docetaksela in močnega zaviralca CYP3A4 ketokonazola zmanjšala očistek docetaksela za 49 % .
In a pharmacokinetic study with 7 patients, the co-administration of docetaxel with the strong CYP3A4 inhibitor ketoconazole leads to a significant decrease in docetaxel clearance by 49%.
V farmakokinetični študiji s 7 bolnicami je sočasna uporaba docetaksela in močnega zaviralca CYP3A4 ketokonazola zmanjšala očistek docetaksela za 49 %.
In a pharmacokinetic study with 7 patients, the co-administration of docetaxel with the strong CYP3A4 inhibitor ketoconazole leads to a significat decrease in docetaxel clearnace by 49%.
V farmakokinetični študiji s 7 bolnicami je sočasna uporaba docetaksela in močnega zaviralca CYP3A4 ketokonazola zmanjšala očistek docetaksela za 49 %.
In a pharmacokinetic trial 6 children (age 1 to less than 6 years old) with congenital FXIII A-subunit deficiency were exposed to one single i.v. dose of NovoThirteen 35 IU/kg.
V farmakokinetičnem preskušanju je 6 otrok (starih med 1 in 6 let) s prirojenim pomanjkanjem podenote A FXIII prejelo en intravenski odmerek 35 i.e./kg zdravila NovoThirteen.
In a pharmacokinetic trial in which patient demographics were comparable to those of the general seasonal allergic rhinitis population, 4% of the subjects achieved a higher concentration of desloratadine.
V preskušanju farmakokinetike zdravila, v katerem so bile demografske značilnosti bolnikov primerljive kot v splošni populaciji s sezonskim alergijskim rinitisom, so 4% preiskovancev dosegli višjo koncentracijo desloratadina.
In a phase 1 pharmacokinetic study, following intravenous administration, an approximate 25% difference between paediatric and adult patients in the area under the curve from time 0 to infinity (AUC[0-∞]) was observed; however, this difference was less than the 2-fold range in AUC(0-∞) observed for the paediatric patients.
V farmakokinetični študiji faze I so po intravenski uporabi med pediatričnimi in odraslimi bolniki ugotovili približno 25 % razliko v površini pod krivuljo od časa 0 do neskončnosti (AUC(0–∞)); vendar je bila ta razlika manjša od 2-kratnega razpona AUC(0–∞), ugotovljenega pri pediatričnih bolnikih.
In a phase 1 study (see section 5.1), using a 10 mg/ml solution for subcutaneous injection specifically developed for the paediatric studies, the mean maximum blood concentrations (Cmax) were 243 ng/ml in the 2 to <6-year group, 255 ng/ml in the 6 to <12-year group and 224 ng/ml in the 12 to <18-year group after a single subcutaneous injection of 100 μg/kg (maximum 6 mg) lipegfilgrastim with the first cycle of chemotherapy.
V študiji faze 1 (glejte poglavje 5.1) so bile pri uporabi 10 mg/ml raztopine za subkutano injiciranje, specifično razvite za pediatrične študije, povprečne največje koncentracije v krvi (Cmax) 243 ng/ml v skupini 2 do < 6 let, 255 ng/ml v skupini 6 do < 12 let in 224 ng/ml v skupini 12 do < 18 let po enem subkutanem injiciranju 100 μg/kg (največ 6 mg) lipegfilgrastima s prvim ciklom kemoterapije.
In a phase 1 study assessing the effect of Betmiga on IOP using Goldmann applanation tonometry in
V študiji 1. faze so pri 310 zdravih preiskovancih ocenili vpliv zdravila Betmiga na očesni tlak z Goldmanovo aplanacijsko tonometrijo.
In a Phase 1 trial, asymptomatic grade 3 increases in transaminases (ALT/AST > 5 × ULN) and bilirubin (total bilirubin > 3 × ULN) were reported with concurrent administration of ipilimumab (3 mg/kg) and vemurafenib (960 mg BID or 720 mg BID).
V preskušanju 1. faze so pri sočasni uporabi ipilimumaba (3 mg/kg) in vemurafeniba (960 mg dvakrat na dan ali 720 mg dvakrat na dan) poročali o asimptomatskem zvišanju vrednosti transaminaz (ALT/AST > 5 × ZNV) in bilirubina (skupni bilirubin > 3 × ZNV) stopnje 3.
In a Phase 1/2 safety and exploratory efficacy study, 71 patients (59 patients, aged from 1 to 17 years, and 12 patients, aged from 18 to 21 years) received temsirolimus as a 60-minute intravenous infusion once weekly in three-week cycles.
V študiji 1./2. faze o varnosti in raziskovalni učinkovitosti, je 71 bolnikov (59 bolnikov, starih od 1 do 17 let, in 12 bolnikov, starih od 18 do 21 let) prejemalo temsirolimus v 60-minutni intravenski infuziji enkrat tedensko v tri tedne trajajočih ciklusih.
In a Phase 1/2 study, 71 patients (59 patients, aged from 1 to 17 years old, and 12 patients, aged 18 to 21 years) were administered temsirolimus at doses ranging from 10 mg/m2 to 150 mg/m2 (see section 5.1).
V študiji 1./2. faze so 71 bolnikom (59 bolnikov, starih od 1 do 17 let, in 12 bolnikov, starih od 18 do 21 let) dajali temsirolimus v odmerkih, ki so se gibali v območju od 10 mg/m2 do 150 mg/m2 (glejte poglavje 5.1).
In a phase 2 study in healthy Indian toddlers aged ≥1 year to <3 years, 24 children were vaccinated with 0.25 ml of IXIARO (the licensed dose for this age group) and 24 children received the adult 0.5 ml dose.
V študiji faze 2 pri zdravih indijskih malčkih, starih ≥ 1 leto do < 3 leta so 24 otrok cepili z odmerkom 0,25 ml cepiva IXIARO (odobreni odmerek za to starostno skupino) in 24 otrok je prejelo odmerek za odrasle 0,5 ml.
In a Phase 2 study of 225 patients with locally recurrent or metastatic clear cell renal cell carcinoma, objective response rate was 35 % and median duration of response was 68 weeks, as per independent review.
V študiji 2. faze, v katero je bilo vključenih 225 bolnikov z lokalno ponovitvijo ali metastatskim čistim karcinomom ledvičnih celic, je neodvisna presoja pokazala, da je bil objektivni delež odziva 35 %, mediana vrednost trajanja odziva pa 68 tednov.
In a phase 2 study, ECG evaluations showed IMBRUVICA produced a mild decrease in QTcF interval (mean 7.5 ms).
V študiji faze 2 so posnetki EKG pokazali, da zdravilo IMBRUVICA povzroča blago skrajšanje intervala QTcF (povprečno za 7,5 ms).
In a phase 2 study, there were 2 cases of graft thrombosis, 1 each in MI and LI (incidence of 1.4% for both) versus 0 in the ciclosporin group.
V študiji 2. faze sta bila dva primera tromboze presadka, po eden pri obeh režimih zdravljenja z belataceptom (pri obeh pojavnost 1,4 %) v primerjavi z 0 pri uporabi ciklosporina.
In a phase 2, multicentre, open-label, single arm study, 38 treatment-naïve or pegIFN/RBV treatment experienced, non-cirrhotic subjects with genotype 1 infection who were on stable doses of methadone (N=19) or buprenorphine with or without naloxone (N=19) received 12 weeks of Exviera in combination with ombitasvir/paritaprevir/ritonavir and ribavirin.
V multicentrični, odprti študiji 2. faze z eno samo skupino je 38 še nezdravljenih bolnikov oz. bolnikov, že zdravljenih s pegIFN/RBV, brez ciroze in okuženih z genotipom 1, ki so dobivali stabilne odmerke metadona (N = 19) ali buprenorfina, z naloksonom ali brez njega, (N = 19) 12 tednov prejemalo zdravilo Exviera v kombinaciji z ombitasvirjem/paritaprevirjem/ritonavirjem in ribavirinom.
In a phase 3 clinical study of patients who failed prior chemotherapy with taxanes, 38% of patients treated with abiraterone acetate, versus 10% of patients treated with placebo, had at least a 50% decline from baseline in PSA levels.
V študiji faze 3 je pri bolnikih, pri katerih predhodna kemoterapija s taksani ni bila uspešna, prišlo do znižanja ravni PSA za najmanj 50% pri 38% bolnikov, ki so prejemali abirateronacetat, v primerjavi z 10% bolnikov, ki so prejemali placebo.
In a phase 3 clinical trial of patients who failed prior chemotherapy with docetaxel, 54% of patients treated with enzalutamide, versus 1.5% of patients who received placebo, had at least a 50% decline from baseline in PSA levels.
V kliničnem preskušanju 3. faze pri bolnikih, pri katerih predhodna kemoterapija z docetakselom ni bila uspešna, se j e koncentracija PSA zmanjšala za vsaj 50 % v primerjavi z izhodiščem pri 54 % bolnikov, zdravljenih z enzalutamidom, in pri 1,5 % bolnikov, ki so prejemali placebo.
In a Phase 3 placebo-controlled study in patients with PAH, hyperthyroidism was reported for 1.6% of patients in the selexipag group, compared to no case in the placebo group (see section 4.4).
V študiji faze 3, nadzorovani s placebom, pri bolnikih s PAH, so o hipertiroidizmu poročali pri 1,6 % bolnikov v skupini s seleksipagom v primerjavi z nobenim primerom v skupini s placebom (glejte poglavje 4.4).
In a Phase 3 placebo-controlled study in patients with PAH, mean absolute changes in haemoglobin at regular visits compared to baseline ranged from 0.34 to 0.02 g/dL in the selexipag group compared to 0.05 to 0.25 g/dL in the placebo group.
V študiji faze 3, nadzorovani s placebom, pri bolnikih s PAH, je bil povprečni razpon absolutnih sprememb v hemoglobinu ob rednih obiskih v primerjavi z izhodiščem od 0,34 do 0,02 g/dl v skupini s seleksipagom v primerjavi z 0,05 do 0,25 g/dl v skupini s placebom.
In a phase 3 study in adults (N=270) and older subjects (N=272) after vaccination with the A/Vietnam/1203/2004 strain vaccine the rate of subjects with cross-neutralising antibodies as measured by MN (titre ≥ 20) was as follows:
V študiji 3. faze pri odraslih (N=270) in pri starejših osebah (n=272) po cepljenju s cepivom seva A/Vietnam/1203/2004 je bil odstotek oseb z navzkrižnimi nevtralizacijskimi protitelesi, izmerjen z mikronevtralizacijo (titer > 20), naslednji:
In a phase 3 study in recipients of extended criteria donor (ECD) kidneys (Study 2), graft thrombosis occurred more frequently in the belatacept groups (4.3% and 5.1% for the MI and LI regimens respectively), versus 2.2% for ciclosporin.
V študiji 3. faze pri prejemnikih ledvice po razširjenih kriterijih za darovani organ (Študija 2), je bila pojavnost tromboze presadka pogostejša pri uporabi belatacepta (4,3 % pri BI režimu in 5,1 % pri MI režimu) kot pri uporabi ciklosporina (2,2 %).
In a phase 4 study 33 MPS I patients received 1 of 4 dose regimens: 100 U/kg IV every week (recommended dose), 200 U/kg IV every week, 200 U/kg IV every 2 weeks or 300 U/kg IV every weeks.
V 4. fazi študije je 33 bolnikov z MPS I prejemalo 1 izmed 4 režimov odmerjanja: 100 e/kg i.v. vsak teden (priporočeni odmerek), 200 e/kg i.v. vsak teden, 200 e/kg i.v. vsaka 2 tedna ali 300 e/kg i.v. vsaka 2 tedna.
In a phase I dose escalation study in NSCLC patients who were current smokers, pharmacokinetic analyses at steady-state indicated a dose proportional increase in erlotinib exposure when the Tarceva dose was increased from 150 mg to the maximum tolerated dose of 300 mg.
V študiji faze I s povečevanjem odmerka pri bolnikih z nedrobnoceličnim rakom pljuč so farmakokinetične analize v stanju dinamičnega ravnotežja pri bolnikih, ki so kadili, pokazale od odmerka odvisno povečanje izpostavljenosti erlotinibu, ko se je odmerek zdravila Tarceva povečeval iz 150 mg do največjega odmerka, ki so ga še prenašali, 300 mg.
In a Phase I study doses up to 56 ml of SonoVue were administered to normal volunteers without serious adverse events being reported.
V fazi I kliničnega preskušanja so zdravi prostovoljci prejeli do 56 ml zdravila SonoVue in niso poročali o resnih neželenih učinkih.
In a phase I study, there was one report of severe allergic reaction occurring after the first infusion of mifamurtide at 6 mg/m2 dose level.
V študiji I. faze so po prvem infundiranju mifamurtida v odmerku 6 mg/m2 poročali o enem primeru hude alergijske reakcije.
In a Phase I/II 48 week multicentre, open-label study (P1093/ING112578), the pharmacokinetic parameters, safety, tolerability and efficacy of Tivicay will be evaluated in combination regimens in HIV-1 infected adolescents.
V 48-tedenski multicentrični, odprti študiji (P1093/ING112578) I./II. faze bodo ocenjevali farmakokinetične parametre, varnost, prenašanje in učinkovitost zdravila Tivicay v kombiniranih terapevtskih shemah pri mladostnikih, okuženih z virusom HIV-1.
In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 100 μg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 x 109) was observed in younger children aged 0-5 yrs (8.9 days) compared to older children aged 6-11 years and 12-21 years (6 days and 3.7 days, respectively) and adults.
V multicentrični, randomizirani, odprti študiji II. faze pri pediatričnih bolnikih s sarkomom (n = 37), ki so dobili 100 µg/kg pegfilgrastima po 1. ciklusu kemoterapije z vinkristinom, doksorubicinom in ciklofosfamidom (VAdriaC/IE), so pri mlajših otrocih, starih od 0 do 5 let, ugotovili dolgotrajnejšo hudo nevtropenijo (nevtrofilci < 0,5 x 109) (8,9 dni) kot pri starejših otrocih, starih od 6 do 11 let (6 dni) in 12 do 21 let (3,7 dni) in pri odraslih.
In a phase II clinical trial (Study V87P6) safety of a pandemic mock-up adjuvanted H5N1 vaccine was evaluated in children and adolescent (see section 5.1 for more information).
V kliničnem preskušanju II. faze (študija V87P6) so ocenili varnost demonstracijskega cepiva proti pandemični gripi H5N1 z adjuvansom pri otrocih in mladostnikih (za več informacij glejte poglavje 5.1).
In a phase II clinical trial, 5-aminolaevulinic acid and protoporphyrin IX serum levels and 5- aminolaevulinic acid urine levels were measured before, 3 and 24 hours after administration of Ameluz for photodynamic treatment.
V fazi II kliničnega preskušanja so izmerili ravni 5-aminolevulinske kisline in protoporfirina IX v serumu in 5-aminolevulinske kisline v urinu, in sicer pred uporabo zdravila Ameluz pri fotodinamičnem zdravljenju ter 3 ure in 24 ur po njem.
In a Phase II dose-finding, double-blind, placebo-controlled clinical study with silodosin 4 or 8 mg once daily, a greater improvement in American Urologic Association (AUA) symptom index score was observed with silodosin 8 mg (-6.8±5.8, n=90; p=0.0018) and silodosin 4 mg (-5.7±5.5, n=88; p=0.0355) as compared to placebo (-4.0±5.5, n=83).
V dvojno slepi s placebom nadzorovani klinični študiji faze II za določanje odmerka s 4 ali 8 mg silodozinom enkrat na dan je bilo v primerjavi s placebom (-4,0±5,5, n=83) pri uporabi 8 mg silodozina (-6,8±5,8, n=90; p=0,0018) in 4 mg silodozina (-5,7±5,5, n=88; p=0,0355) opaženo večje izboljšanje točkovnega rezultata po vprašalniku Ameriškega urološkega združenja (AUA - American Urologic Association).
In a phase II randomised placebo-controlled study of 48 hospitalised patients treated with Enbrel or placebo for moderate to severe alcoholic hepatitis, Enbrel was not efficacious, and the mortality rate in patients treated with Enbrel was significantly higher after 6 months.
V randomizirani, s placebom nadzorovani študiji II. faze, v kateri so proučevali 48 hospitaliziranih bolnikov, zdravljenih z zdravilom Enbrel ali placebom zaradi zmernega do hudega alkoholnega hepatitisa, zdravilo Enbrel ni bilo učinkovito in stopnja smrtnosti bolnikov, zdravljenih z zdravilom Enbrel, je bila po 6 mesecih pomembno večja.
In a Phase II study aimed at evaluating infliximab in congestive heart failure (CHF), higher incidence of mortality due to worsening of heart failure were seen in patients treated with infliximab, especially those treated with the higher dose of 10 mg/kg (i.e. twice the maximum approved dose).
V študiji faze II, katere cilj je bil ovrednotiti infliksimab pri kongestivnem srčnem popuščanju (CHF - congestive heart failure), so pri bolnikih, zdravljenih z infliksimabom, ugotavljali večjo incidenco smrtnosti zaradi poslabšanja srčnega popuščanja, še posebej pri tistih, ki so prejemali večji odmerek 10 mg/kg (dvakrat več od največjega odobrenega odmerka).
In a Phase II study aimed at evaluating infliximab in congestive heart failure (CHF), higher incidence of mortality due to worsening of heart failure were seen in patients treated with infliximab, especially those treated with the higher dose of 10 mg/kg (i.e. twice the maximum approved dose).
V študiji faze II, katere cilj je bil ovrednotiti infliksimab pri kongestivnem srčnem popuščanju (CHF-congestive heart failure), so pri bolnikih, zdravljenih z infliksimabom, ugotavljali večjo incidenco smrtnosti zaradi poslabšanja srčnega popuščanja, še posebej pri tistih, ki so prejemali večji odmerek 10 mg/kg (dvakrat več od največjega odobrenega odmerka).
In a Phase II study aimed at evaluating Remicade in congestive heart failure (CHF), higher incidence of mortality due to worsening of heart failure were seen in patients treated with Remicade, especially those treated with the higher dose of 10 mg/kg (i.e. twice the maximum approved dose).
V študiji faze II, katere cilj je bil ovrednotiti zdravilo Remicade pri kongestivnem srčnem popuščanju (CHF-congestive heart failure), so pri bolnikih, zdravljenih s tem zdravilom, ugotavljali večjo incidenco smrtnosti zaradi poslabšanja srčnega popuščanja, še posebej pri tistih, ki so prejemali večji odmerek 10 mg/kg (dvakrat več od največjega odobrenega odmerka).
In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and OS were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care.
V študiji III. študije pri predhodno zdravljenih bolnikih sta bila čas do napredovanja (12,3 tedna v prim. s 7 tedni) in celotno preživetje z docetakselom v odmerku 75 mg/m2 značilno daljša kot z najboljšo podporno oskrbo.
In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/m2 compared to Best Supportive Care.
V študiji III. faze pri predhodno zdravljenih bolnikih sta bila čas do napredovanja (12,3 tedna v prim. s 7 tedni) in celotno preživetje z docetakselom v odmerku 75 mg/m2 značilno daljša kot z najboljšo podporno oskrbo.
In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care.
V fazi III. študije pri predhodno zdravljenih bolnikih sta bila čas do napredovanja (12,3 tedna v prim. s 7 tedni) in celotno preživetje z docetakselom v odmerku 75 mg/m² značilno daljša kot z najboljšo podporno oskrbo.
In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care.
V študiji III. faze pri predhodno zdravljenih bolnikih sta bila čas do napredovanja (12,3 tedna v prim. s 7 tedni) in celotno preţivetje z docetakselom v odmerku 75 mg/m2 značilno daljša kot z najboljšo podporno oskrbo.
In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care.
V študiji III. faze pri predhodno zdravljenih bolnikih sta bila čas do napredovanja (12,3 tedna v prim. s 7 tedni) in celotno preživetje z docetakselom v odmerku 75 mg/m2 značilno daljša kot z najboljšo podporno oskrbo.
In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care.
V študiji III. faze pri predhodno zdravljenih bolnikih sta bila čas do napredovanja (12,3 tedna v prim. s 7 tedni) in celotno preživetje z docetakselom v odmerku 75 mg/m² značilno daljša kot z najboljšo podporno oskrbo.
In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care.
V študiji III. študije pri predhodno zdravljenih bolnikih sta bila čas do napredovanja (12,3 tedna v prim. s 7 tedni) in celotno preživetje z docetakselom v odmerku 75 mg/m2 značilno daljša kot z najboljšo podporno oskrbo.
In a phase III, open label, multicentre, randomized clinical study (GAO4753g (GADOLIN)), 396 patients with iNHL who had no response during treatment or who progressed within 6 months following the last dose of rituximab or a rituximab-containing regimen (including rituximab monotherapy as part of induction or maintenance treatment) were evaluated.
V odprti, multicentrični, randomizirani klinični študiji faze III (GAO4753g (GADOLIN)) so ocenili 396 bolnikov z iNHL, ki se niso odzvali na zdravljenje ali jim je bolezen napredovala v 6 mesecih po zadnjem odmerku rituksimaba oz. sheme z rituksimabom (vključno z monoterapijo z rituksimabom v okviru indukcijskega ali vzdrževalnega zdravljenja).
In a pivotal clinical trial including evaluation of 288 subjects with dementia with Lewy bodies (DLB) (144 subjects), Alzheimer’s disease (124 subjects), vascular dementia (9 subjects) or other (11 subjects), the results of an independent, blinded visual assessment of the DaTSCAN images were compared to the clinical diagnosis as determined by physicians experienced in the management and diagnosis of dementias.
V osrednji klinični študiji, ki je vključevala oceno 288 bolnikov z demenco z Lewyjevimi telesci (DLB) (144 bolnikov), Alzheimerjevo boleznijo (124 bolnikov), vaskularno demenco (9 bolnikov) ter drugih (11 bolnikov), so bili rezultati slepe neodvisne vizualne ocene zdravila DaTSCAN slik primerjani s kliničnimi diagnozami, kot so jih diagnosticirali zdravniki, z izkušnjami v zdravljenju in diagnostiricanju demenc.
In a placebo controlled study in MDR-TB patients receiving 100 mg delamanid twice daily the mean placebo corrected increases in QTcF from baseline were 7.6 ms at 1 month and 12.1 ms at 2 months.
V s placebom kontrolirani študiji s 100 mg delamanida dvakrat na dan pri bolnikih z MDR-TB, je bilo za placebo popravljeno povprečno povečanje QTcF od izhodišča 7,6 ms pri 1 mesecu in 12,1 ms pri 2 mesecih.
In a placebo-controlled study (n=288, Safety population), following 2 weeks treatment in preparation for invasive procedures, 6 of 143 (4%) adult patients with chronic liver disease receiving eltrombopag experienced 7 TEEs of the portal venous system and 2 of 145 (1%) subjects in the placebo group experienced 3 TEEs.
V s placebom nadzorovani študiji (n=288, varnostna populacija), se je po 2-tedenskem zdravljenju v sklopu priprav na invazivne posege pri 6 od143 (4 %) odraslih bolnikov s kronično boleznijo jeter, ki so prejemali eltrombopag, pojavilo 7 trombemboličnih dogodkov v portalnem venskem sistemu in pri 2 od 145 (1 %) preiskovancev v skupini s placebom 3 trombembolični dogodki.