natgillin/translations-raw huggingface dataset:
In a population pharmacokinetic analysis, patients with baseline total bilirubin concentrations of 1-2 mg/dl (n=19) had average steady state concentrations for total SN-38 that were increased by 37% (0.98 [95%CI: 0.94-1.02] and 1.29 [95%CI: 1.11-1.5] ng/ml, respectively) compared to patients with baseline bilirubin concentrations of < 1 mg/dl (n=329); however, there was no effect of elevated ALT/AST concentrations on total SN-38 concentrations.
V populacijski farmakokinetični analizi so imeli bolniki z izhodiščno koncentracijo skupnega bilirubina 1– 2 mg/dl (n=19) povprečno koncentracijo skupnega SN-38 v dinamičnem ravnovesju višjo za 37 % (0,98 [95- odstotni IZ: 0,94 –1,02] oziroma 1,29 [95-odstotni IZ: 1,11 – 1,5] ng/ml) v primerjavi z bolniki z izhodiščno koncentracijo bilirubina < 1 mg/dl (n=329), vendar pa zvišane koncentracije ALT/AST niso vplivale na skupne koncentracije SN-38.
In a population pharmacokinetic analysis, the apparent clearance (CL/F) and apparent volume of distribution (V/F) were 0.465 l/day and 15.7 l, respectively, in patients with psoriasis.
Med spremljanjem bolnika s psoriazo mora biti zdravnik pozoren na simptome eritrodermične psoriaze ali eksfoliativnega dermatitisa.
In a population pharmacokinetic study (NR16141), 14 children 2 to 8 years of age with CHC received Pegasys monotherapy at a dose of: 180 mcg x BSA of the child/1.73 m2.
V populacijski farmakokinetični študiji (NR16141) je 14 otrok, starih od 2 do 8 let, s kroničnim hepatitisom C prejemalo zdravilo Pegasys z odmerkom: 180 µg/1,73 m2 x telesna površina (TP) otroka.
In a population pharmacokinetics analysis in ankylosing spondylitis patients, the etanercept steady state AUCs were 466 ghr/ml and 474 ghr/ml for 50 mg Enbrel once weekly (N = 154) and 25 mg twice weekly (N = 148), respectively.
Pri analizi populacijske farmakokinetike pri bolnikih z ankilozirajočim spondilitisom so vrednosti AUC etanercepta v stanju dinamičnega ravnovesja pri uporabi zdravila Enbrel v odmerku 50 mg enkrat na teden (n = 154) znašale 466 μg·h/ml, pri uporabi zdravila Enbrel v odmerku 25 mg dvakrat na teden (n = 148) pa 474 μg·h/ml.
In a population pharmacokinetics analysis in ankylosing spondylitis patients, the etanercept steady state AUCs were 466 ghr/ml and 474 ghr/ml for 50 mg Enbrel once weekly (N= 154) and 25 mg twice weekly (N = 148), respectively.
Pri analizi populacijske farmakokinetike pri bolnikih z ankilozirajočim spondilitisom so vrednosti AUC etanercepta v stanju dinamičnega ravnovesja pri uporabi zdravila Enbrel v odmerku 50 mg enkrat na teden (n = 154) znašale 466 μg·h/ml, pri uporabi zdravila Enbrel v odmerku 25 mg dvakrat na teden (n = 148) pa 474 μg·h/ml.
In a population pharmacokinetics analysis of clinical trial experience there were 101 female and 169 male subjects for whom nadir neutrophil counts were available and 110 female and 174 male subjects for whom nadir platelet counts were available.
Za populacijsko farmakokinetično analizo so bili na voljo podatki iz kliničnih preskušanj – o najnižjih vrednostih nevtrofilcev pri 101 ženski in 169 moških ter o najnižjih vrednostih trombocitov pri 110 ženskah in 174 moških.
In a post authorisation safety study, the frequency of adverse reactions in a small number of very premature infants with renal/hepatic imparment appeared to be higher as compared to premature infants without organ impairment (see sections 4.4 and 4.8).
Študija o varnosti zdravila po pridobitvi dovoljenja za promet kaže, da je pogostnost neželenih učinkov, pri majhnem številu zelo zgodaj rojenih nedonošenčkov z okvaro jeter/ledvic višja, v primerjavi z nedonošenčki brez okvare organa (glejte poglavji 4.4 in 4.8).
In a post –authorisation safety study transient non-neutralising antibodies were seen in a child with congenital FXIII deficiency after several years of treatment with NovoThirteen.
V študiji o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom so pri otroku s prirojenim pomanjkanjem FXIII po večletnem zdravljenju z zdravilom NovoThirteen poročali o prehodnem pojavu nenevtralizirajočih protiteles.
In a Post-authorisation Safety Study that included 66 patients, Flebogamma DIF 100 mg/ml showed a higher rate (18.46%, n=24/130) of infusions associated with potentially related adverse events than Flebogamma DIF 50 mg/ml (2.22%, n=3/135).
V študiji o varnosti zdravila po pridobitvi dovoljenja za promet, v katero je bilo vključenih 66 bolnikov, je zdravilo Flebogamma DIF 100 mg/ml pokazalo več (18,46 %, n=24/130) infuzij s potencialno povezanimi neželenimi učinki kot zdravilo Flebogamma DIF 50 mg/ml (2,22 %, n=3/135).
In a post-hoc analysis in adenocarcinoma patients having progressed and entered the study ≥ 9 months since start of their first-line therapy the difference did not reach statistical significance (HR for OS: 0.89, 95% CI 0.66 - 1.19).
V post-hoc analizi pri bolnikih z napredovalim adenokarcinomom, ki so v študijo vstopili ≥ 9 mesecev od začetka zdravljenja v prvi liniji, razlika ni dosegla statistične pomembnosti (RO za CP: 0,89, 95 % IZ 0,66-1,19).
In a post-hoc analysis of a clinical trial of Revlimid in myelodysplastic syndromes, the estimated 2-year rate of progression to AML was 27.5 % in patients with IHC-p53 positivity and 3.6% in patients with IHC-p53 negativity (p=0.0038).
V post-hoc analizi kliničnega preskušanja zdravila Revlimid pri mielodisplastičnem sindromu je bil dveletni delež napredovanja v AML ocenjen na 27,5 % pri bolnikih s pozitivnim IHC-p53 in na 3,6 % pri bolnikih z negativnim IHC-p53 (p=0,0038).
In a pre- and postnatal development study in rats, limited changes in immune function were observed at 19-fold a human 10 mg/kg dose based on AUC (see section 5.3).
Pri študijah prenatalnega in postnatalnega razvoja pri podganah so pri odmerkih, ki so bili glede na AUC 19-krat večji od odmerka 10 mg/kg pri človeku, opazili manjše spremembe imunske funkcije (glejte poglavje 5.3).
In a pre-/postnatal development study performed in rats sitagliptin showed no adverse effects.
Študije, izvedene s sitagliptinom na podganah, niso pokazale neželenih učinkov na pre-/post-natalni razvoj.
in a pre-filled syringe
napolnjeni injekcijski brizgi
in a pre-filled syringe
v napolnjeni injekcijski
In a preplanned multivariate Cox analysis, superiority of capecitabine compared with bolus 5-FU/LV was demonstrated.
V vnaprej načrtovani multivariantni Coxovi analizi so dokazali superiornost kapecitabina v primerjavi s 5- FU/LV v obliki bolusa.
In a prespecified exploratory analysis, 60 of 73 MRD evaluable patients with CR/CRh* (82.2%) also had a MRD response (defined as MRD by PCR < 1 x 10-4).
V vnaprej opredeljeni eksploratorni analizi je imelo 60 od 73 bolnikov z minimalno rezidualno boleznijo, ki so bili primerni za analizo in so imeli CR/CRh* (82,2 %), tudi odziv minimalne rezidualne bolezni (opredeljen kot minimalna rezidualna bolezen s PCR < 1 x 10-4).
In a proportion of these the glycaemic response to prolonged-release exenatide was absent at the end of the controlled period of studies; 2.6 % of patients showed no glucose improvement with higher titre antibodies whereas 1.6 % showed no improvement while antibody negative.
Pri deležu je bil glikemični odziv na eksenatid v obliki s podaljšanim sproščanjem ob koncu kontroliranih študij odsoten; 2,6 % bolnikov ni pokazalo izboljšanja glukoze z višjimi titri protiteles, 1,6 % bolnikov pa ni pokazalo izboljšanja, ko so bili negativni za protitelesa.
In a prospective exploratory 6 month study in subjects with type 1 diabetes, alterations in the glucose pharmacodynamics with inhaled human insulin were not observed
V prospektivni eksploratorni 6-mesečni študiji na bolnikih z diabetesom tipa 1 niso našli dokazov za spremembe farmakodinamike glukoze pri uporabi humanega insulina za inhaliranje.
In a prospective, multi-centre, randomised, double-blind, placebo-controlled study (AC-052-405 [BREATHE-5]), patients with pulmonary arterial hypertension WHO functional class III and Eisenmenger physiology associated with congenital heart disease received bosentan 62.5 mg twice daily for 4 weeks, then 125 mg twice daily for a further 12 weeks (n = 37, of whom 31 had a predominantly right to left, bidirectional shunt).
V prospektivni multicentrični randomizirani dvojno slepi s placebom nadzorovani študiji (AC-052- 405 [BREATHE-5]) so bolniki s PAH razreda III po klasifikaciji SZO in Eisenmengerjevo fiziologijo, povezano s kongenitalno srčno boleznijo, 4 tedne prejemali bosentan 2,5 mg dvakrat na dan, nato pa nadaljnjih 12 tednov 125 mg dvakrat na dan (n = 37, med katerimi jih je imelo 31 pretežno desno-levi dvosmerni šant).
In a prospective, multi-centre, randomised, double-blind, placebo-controlled study (AC-052-405 [BREATHE-5]), patients with pulmonary arterial hypertension WHO functional class III and Eisenmenger physiology associated with congenital heart disease received bosentan 62.5 mg twice daily for 4 weeks, then 125 mg twice daily for a further 12 weeks (n = 37, of whom 31 had a predominantly right to left, bidirectional shunt).
V prospektivni multicentrični randomizirani dvojno slepi s placebom nadzorovani študiji (AC-052- 405 [BREATHE-5]) so bolniki s PAH razreda III po klasifikaciji SZO in Eisenmengerjevo fiziologijo, povezano s kongenitalno srčno boleznijo, 4 tedne prejemali bosentan 62,5 mg dvakrat na dan, nato pa nadaljnjih 12 tednov 125 mg dvakrat na dan (n = 37, med katerimi jih je imelo 31 pretežno desno-levi dvosmerni šant).
In a prospective, multi-centre, randomised, double-blind, placebo-controlled study (AC-052-405 [BREATHE-5]), patients with pulmonary arterial hypertension WHO functional class III and Eisenmenger physiology associated with congenital heart disease received bosentan 62.5 mg twice daily for 4 weeks, then 125 mg twice daily for a further 12 weeks (n = 37, of whom 31 had a predominantly right to left, bidirectional shunt).
V prospektivni multicentrični randomizirani dvojno slepi s placebom nadzorovani študiji (AC-052-405 [BREATHE-5]) so bolniki s PAH razreda III po klasifikaciji SZO in Eisenmengerjevo fiziologijo, povezano s kongenitalno srčno boleznijo, 4 tedne prejemali bosentan 2,5 mg dvakrat na dan, nato pa nadaljnjih 12 tednov 125 mg dvakrat na dan (n = 37, med katerimi jih je imelo 31 pretežno desno-levi dvosmerni šant).
In a prospective, open label, international, multi-center, phase III trial 1193 patients with previously untreated advanced follicular lymphoma received induction therapy with R-CHOP (n=881), R-CVP (n=268) or R-FCM (n=44), according to the investigators’ choice.
V prospektivnem, odprtem, mednarodnem, multicentričnem preskušanju III. faze je 1.193 bolnikov s predhodno nezdravljenimi folikularnimi limfomi prejelo indukcijsko zdravljenje z R-CHOP (n = 881), R-CVP (n = 268) ali R-FCM (n = 44) po presoji raziskovalca.
In a prospective, open label, international, multi-centre, phase III trial 1193 patients with previously untreated advanced follicular lymphoma received induction therapy with R-CHOP (n=881), R-CVP (n=268) or R-FCM (n=44), according to the investigators’ choice.
V prospektivnem, odprtem, mednarodnem, multicentričnem preskušanju III. faze je 1.193 bolnikov s predhodno nezdravljenimi folikularnimi limfomi prejelo indukcijsko zdravljenje z R-CHOP (n = 881), R-CVP (n = 268) ali R-FCM (n = 44) po presoji raziskovalca.
In a prospective, open label, international, multi-centre, phase III trial, 465 patients with relapsed/refractory follicular lymphoma were randomised in a first step to induction therapy with either CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone; n=231) or MabThera plus CHOP (R-CHOP, n=234).
V prospektivnem, odprtem, mednarodnem, multicentričnem preskušanju faze III je bilo 465 bolnikov, pri katerih so se folikularni limfomi ponovili ali se niso odzvali na zdravljenje, randomiziranih v prvi del indukcijskega zdravljenja s CHOP (ciklofosfamid, doksorubicin, vinkristin, prednizolon, n = 231) ali zdravljenje z zdravilom MabThera in CHOP (R-CHOP, n = 234).
In a prospective, pre-specified meta-analysis of independently adjudicated cardiovascular events from 12 phase 2 and 3 clinical studies involving 10,036 patients with type 2 diabetes, empagliflozin did not increase cardiovascular risk.
V prospektivni, vnaprej specificirani metaanalizi neodvisno ovrednotenih srčno-žilnih dogodkov v 12 kliničnih študija 2. in 3. faze, ki so zajele 10.036 bolnikov s sladkorno boleznijo tipa 2, empagliflozin ni povečal tveganja za bolezni srca in ožilja.
In a prospective, pre-specified meta-analysis of independently adjudicated cardiovascular events from 12 phase 2 and 3 clinical studies involving 10,036 patients with type 2 diabetes, empagliflozin did not increase cardiovascular risk.
V prospektivni, vnaprej specificirani metaanalizi neodvisno ovrednotenih srčno-žilnih dogodkov v 12 kliničnih študijah 2. in 3. faze, ki so zajele 10.036 bolnikov s sladkorno boleznijo tipa 2, empagliflozin ni povečal tveganja za bolezni srca in ožilja.
In a prospective, randomised, double-blind, placebo-controlled trial conducted in 375 anaemic patients with various non-myeloid malignancies receiving non-platinum chemotherapy, there was a significant reduction of anaemia-related sequelae (e.g. fatigue, decreased energy, and activity reduction), as measured by the following instruments and scales: Functional Assessment of Cancer Therapy- Anaemia (FACT-An) general scale, FACT-An fatigue scale, and Cancer Linear Analogue Scale (CLAS).
V prospektivni, randomizirani, dvojno slepi študiji, nadzorovani s placebom, v kateri je sodelovalo 375 bolnikov z anemijo z različnimi nemieloidnimi malignimi obolenji, ki so se zdravili s kemoterapijo brez platine, so z meritvami, ki so jih izvedli s pomočjo naslednjih inštrumentov in lestvic: splošna lestvica za funkcionalno oceno zdravljenja anemičnih bolnikov z rakom (FACT-An – Functional Assessment of Cancer Therapy-Anaemia), lestvica utrujenosti FACT-An in linearna analogna lestvica pri bolnikih z rakom (CLAS – Cancer Linear Analogue Scale), opazili pomembno zmanjšanje posledic, povezanih z anemijo (npr. utrujenost, zmanjšana energija in telesna aktivnost).
In a published study performed in Israel, using a two dose primary series plus booster dose in the second year of life the impact of Prevenar 13 on OM was documented in a population based active surveillance system with tympanocentesis culturing of middle ear fluid in Israeli children less than 2 years of age with OM.
V objavljeni študiji, ki so jo opravili v Izraelu, so v sistemu aktivnega spremljanja populacije dokumentirali učinek cepiva Prevenar 13 z osnovno shemo z dvema odmerkoma ter obnovitvenim odmerkom v drugem letu življenja na vnetje srednjega ušesa s kultiviranjem tekočine srednjega ušesa po timpanocentezi pri izraelskih otrocih z vnetjem srednjega ušesa, mlajših od 2 let.
In a rabbit developmental toxicity study at the maternally toxic dosage, there were foetal anomalies observed (fused sternebrae, and two foetuses had various visceral observations), and a slight decrease in foetal body weight.
V študiji škodljivih vplivov na razvoj pri kuncih so pri odmerkih, toksičnih za mater, opazili anomalije zarodka (fuzija prsnice, dva zarodka sta imela številne visceralne nepravilnosti) in rahlo zmanjšanje telesne mase zarodka.
In a rabbit embryotoxicity study an increase in the incidence of fetal cardiac vessel defects (1.12% in the treatment group versus 0.03% in historical controls) was observed for animals that were administered conestat alfa.
V študiji toksičnosti za zarodek na kuncih so opazili večjo pojavnost okvare srčnih žil ploda (1,12 % v zdravljeni skupini glede na 0,03 % v predhodnih kontrolah) pri živalih, ki so prejemale konestat alfa.
In a randomised active-controlled trial 18.2% (126/693) of microbiologically evaluable (ME) patients had complicated lower urinary tract infection (cLUTI), including 60/126 patients who were treated with ceftolozane/tazobactam.
V randomiziranem, z zdravilno učinkovino nadzorovanem preskušanju, se je pri 18,2 % (126/693) mikrobiološko ocenljivih bolnikov pojavila zapletena okužba spodnjih sečil (cLUTI), vključno s 60/126 bolnikov, ki so bili zdravljeni s ceftolozanom/tazobaktamom.
In a randomised clinical study (M02-418), 190 antiretroviral-naïve adults were treated once daily with emtricitabine and tenofovir disoproxil fumarate in combination with lopinavir/ritonavir given once or twice daily.
V randomizirani klinični študiji (M02-418) so 190 odraslih, ki še niso bili zdravljeni s protiretrovirusnim zdravilom, enkrat dnevno zdravili z emtricitabinom in dizoproksiltenofovirijevim fumaratom v kombinaciji z lopinavirjem/ritonavirjem enkrat ali dvakrat na dan.
In a randomised clinical study (M02-418), 190 antiretroviral-naïve adults were treated once daily with emtricitabine and tenofovir disoproxil in combination with lopinavir/ritonavir given once or twice daily.
V randomizirani klinični študiji (M02-418) so 190 odraslih, ki še niso bili zdravljeni s protiretrovirusnim zdravilom, enkrat dnevno zdravili tudi z emtricitabinom in dizoproksiltenofoviratom v kombinaciji z lopinavirjem/ritonavirjem enkrat ali dvakrat na dan.
In a randomised clinical study 114 paediatric patients aged 2 to 18 with chronic kidney disease receiving or not receiving dialysis who were anaemic (haemoglobin < 10.0 g/dl) and not being treated with an ESA were administered darbepoetin alfa weekly (n = 58) or once every two weeks (n = 56) for the correction of anaemia.
V randomizirani klinični študiji je 114 pediatričnih bolnikov, starih od 2 do 18 let s kronično boleznijo ledvic in zdravljenih ali nezdravljenih z dializo, ki so bili anemični (hemoglobin < 10,0 g/dl) in niso prejemali ESA, za korekcijo anemije dobivalo darbepoetin alfa vsak teden (n = 58) ali vsaka dva tedna (n = 56).
In a randomised comparative phase III trial, 398 subjects over 65 years of age received 0.1 ml of IDflu by intradermal route and 397 subjects over 65 years of age received 0.5 ml of a trivalent inactivated adjuvanted (MF-59 containing) influenza vaccine at the same dosage administered by intramuscular route.
V randomiziranem primerjalnem preskušanju faze III je 398 oseb, starih 65 in več let, prejelo 0,1 ml cepiva IDflu intradermalno, 397 oseb, starih 65 let in več, pa je prejelo 0,5 ml trivalentnega inaktiviranega cepiva proti gripi z adjuvansom (ki vsebuje MF-59) v enakem odmerku intramuskularno.
In a randomised comparative phase III trial, 398 subjects over 65 years of age received 0.1 ml of INTANZA by intradermal route and 397 subjects over 65 years of age received 0.5 ml of a trivalent inactivated adjuvanted (MF-59 containing) influenza vaccine at the same dosage administered by intramuscular route.
V randomiziranem primerjalnem preskušanju faze III je 398 oseb, starih 65 in več let, prejelo 0,1 ml cepiva INTANZA intradermalno, 397 oseb, starih 65 let in več, pa je prejelo 0,5 ml trivalentnega inaktiviranega cepiva proti gripi z adjuvansom (ki vsebuje MF-59) v enakem odmerku intramuskularno.
In a randomised controlled open-label study in 235 patients with Staphylococcus aureus bacteraemia (i.e, at least one positive blood culture of Staphylococcus aureus prior to receiving the first dose) 19 of 120 patients treated with Cubicin met the criteria for RIE.
V randomizirani kontrolirani odprti študiji z 235 bolniki, ki so imeli bakteriemijo s Staphylococcus aureus (to pomeni, da so imeli pred prvim odmerkom vsaj eno hemokulturo pozitivno na Staphylococcus aureus), je 19 od 120 bolnikov ustrezalo kriterijem za infekcijski endokarditis desne strani.
In a randomised controlled study, the incidence of myeloid malignancy (acute myeloid leukaemia/myelodysplastic syndrome) was the same in patients receiving MEPACT plus chemotherapy as in patients receiving only chemotherapy (2.1%).
V randomizirani nadzorovani študiji je bila pojavnost mieloidnih novotvorb (akutna mieloična levkemija/mielodisplastični sindrom) pri bolnikih, ki so se zdravili z zdravilom MEPACT in s kemoterapijo, enaka kot pri bolnikih, ki so se zdravili samo s kemoterapijo (2,1 %).
In a randomised double-blind clinical trial, 737 patients were treated with fondaparinux 2.5 mg once daily for 7 +/- 1 days following hip fracture surgery.
V naključnem dvojno slepem kliničnem preskušanju so 737 bolnikov zdravili s fondaparinuksom v odmerku 2,5 mg enkrat na dan 7 dni +/- 1 dan po operaciji zloma kolka.
In a randomised double-blind clinical trial, 839 patients were treated with fondaparinux 2.5 mg once daily or placebo for 6 to 14 days.
V randomiziranem dvojno slepem kliničnem preskusu so zdravili 839 bolnikov s fondaparinuksom v odmerku 2,5 mg enkrat na dan ali placebom 6 do 14 dni dolgo.
In a randomised open-label study (APV30003) in protease inhibitor experienced patients with virological failure (less than or equal to two PIs) the fosamprenavir with ritonavir (700 / 100 mg twice daily or 1400 / 200 mg once daily) did not demonstrate non-inferiority to lopinavir / ritonavir with regard to viral suppression as measured by the average area under the curve minus baseline (AAUCMB) for plasma HIV-1 RNA over 48 weeks (the primary end point).
V randomizirani odprti študiji (APV30003) pri z zaviralci proteaz predhodno že zdravljenih bolnikih, pri katerih je prišlo do virološkega neuspeha (z dvema PI ali manj), se je izkazalo, da kombinacija fosamprenavir z ritonavirjem (700 mg/100 mg dvakrat dnevno ali 1.400 mg/200 mg enkrat dnevno) ni manj učinkovita od kombinacije lopinavir/ritonavir, upoštevaje supresijo virusa z merjenjem povprečne površine pod krivuljo zmanjšane za izhodiščne vrednosti (AAUCMB) HIV-1 RNA v plazmi tekom 48 tednov (primarni opazovani dogodek).
In a randomised phase III study of 678 patients (age range from 1.4 to 30.6 years) with newly-diagnosed resectable high-grade osteosarcoma, the addition of adjuvant mifamurtide to chemotherapy either doxorubicin cisplatin and methotrexate with or without ifosfamide, resulted in a relative reduction in the risk of death of 28% (p = 0.0313, hazard ratio (HR) = 0.72 [95% confidence interval (CI): 0.53, 0.
V randomizirani študiji III. faze, v kateri je sodelovalo 678 bolnikov (starih od 1,4 do 30,6 let) z novo diagnosticiranim operabilnim osteosarkomom visoke stopnje, je dodajanje mifamurtida kot adjuvanta kemoterapiji z doksorubicinom ali cisplatinom in metotreksatom z ali brez ifosfamida povzročilo relativno zmanjšanje tveganja za smrt za 28 % (p = 0,0313, razmerje tveganja (HR) = 0,72 [95 % interval zaupanja (CI): 0,53, 0,97]).
In a randomised placebo-controlled study, conducted in PPHN patients (FUTURE-4), a total of 13 neonates were treated with the bosentan dispersible tablet formulation at a dose of 2 mg/kg twice daily (8 patients were on placebo).
V randomizirani, s placebom kontrolirani študiji pri bolnikih s PPHN (FUTURE-4), je bilo skupno 13 novorojenčkov zdravljenih z bosentanom v obliki disperzibilnih tablet v odmerku 2 mg/kg dvakrat dnevno (8 bolnikov je dobivalo placebo).
In a randomised trial comparing pazopanib and sunitinib in RCC (VEG108844), subjects had baseline and follow up LVEF measurements.
V randomiziranem primerjalnem preskušanju pazopaniba in sunitiniba pri karcinomu ledvičnih celic (VEG108844) so preiskovancem opravili izhodiščno meritev in kontrolne meritve LVEF.
In a randomised, 2-way crossover study, 35 healthy subjects were administered a single oral dose of axitinib (5 mg) in the absence and presence of 400 mg ketoconazole for 7 days.
V randomizirani, dvosmerni navzkrižni študiji so 35 zdravim osebam dali enkraten odmerek aksitiniba (5 mg) v odsotnosti in prisotnosti 400 mg ketokonazola v obdobju 7 dni.