natgillin/translations-raw huggingface dataset:
In study GS-US-216-0114, hyperbilirubinaemia (> 1 x ULN) was common: 97.7% in the cobicistat- boosted atazanavir plus emtricitabine and tenofovir disoproxil fumarate fixed-dose combination group, and 97.4% in the ritonavir-boosted atazanavir plus emtricitabine and tenofovir disoproxil fumarate fixed-dose combination group through 144 weeks of treatment.
V študiji GS-US-216-0114 je bila do konca 144 tedna zdravljenja hiperbilirubinemija (> 1 x zgornje meje normalne vrednosti (ULN, upper limit of normal) pogosta: 97,7 % v skupini, zdravljeni z atazanavirjem, okrepljenim s kobicistatom, sočasno s fiksno kombinacijo emtricitabina in dizoproksiltenofovirat fumarata, in 97,4 % v skupini, zdravljeni z atazanavirjem, okrepljenim z ritonavirjem, sočasno s fiksno kombinacijo emtricitabina in dizoproksiltenofovirat fumarata.
In study GS-US-216-0114, through 144 weeks of treatment hyperbilirubinaemia (> 1 x ULN) was common: 97.7% in the atazanavir boosted with cobicistat plus emtricitabine and tenofovir disoproxil fumarate fixed-dose combination group, and 97.4% in the atazanavir boosted with ritonavir plus emtricitabine and tenofovir disoproxil fumarate fixed-dose combination group.
Med 144-tedenskim zdravljenjem v študiji GS-US-216-0114 je bila hiperbilirubinemija (> 1 x ZMN; zgornja meja normalne vrednosti) pogosta: 97,7 % v skupini z atazanavirjem, okrepljenim s kobicistatom, ter fiksno kombinacijo emtricitabina in dizoproksiltenofovirat fumarata, in 97,4 % v skupini z atazanavirjem, okrepljenim z ritonavirjem, ter fiksno kombinacijo emtricitabina in dizoproksiltenofovirat fumarata.
In study GS-US-236-0102 HIV-1 infected antiretroviral treatment-naïve adult patients received once- daily treatment of Stribild or once-daily treatment of fixed-dose combination of efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF).
V študiji GS-US-236-0102 so odrasli bolniki, okuženi z virusom HIV-1, ki se predhodno niso zdravili s protiretrovirusnimi zdravili, prejemali zdravilo Stribild enkrat dnevno s fiksno kombinacijo odmerkov efavirenza/emtricitabina/dizoproksiltenofovirijevega fumarata (EFV/FTC/TDF).
In study GS-US-236-0102, the mean increase from baseline in CD4+ cell count at Week 48 was
V študiji GS-US-236-0102 je bilo povprečno povečanje od začetne vrednosti za CD4+ število celic v
In study GS-US-236-0103 HIV-1 infected antiretroviral treatment-naïve adult patients received once daily treatment of Stribild or ritonavir-boosted atazanavir (ATV/r) plus fixed-dose combination of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).
V študiji GS-US-236-0103 so odrasli bolniki, okuženi z virusom HIV-1, ki se predhodno niso zdravili s protiretrovirusnimi zdravili, prejemali zdravilo Stribild ali atazanavir, okrepljen z ritonavirom (ATV/r) in fiksno kombinacijo odmerkov emtricitabina/dizoproksiltenofovirijevega fumarata (FTC/TDF).
In Study GS-US-236-0115 and Study GS-US-236-0121, patients had to be on either their first or second antiretroviral regimen with no history of virologic failure, have no current or past history of resistance to the antiretroviral components of Stribild and must have been suppressed on a PI+RTV or an NNRTI in combination with FTC/TDF (HIV-1 RNA < 50 copies/mL) for at least six months prior to screening.
V študiji GS-US-236-0115 in študiji GS-US-236-0121 so bolniki morali prejemati bodisi prvi ali drugi protiretrovirusni režim brez anamneze virološkega neuspeha, biti brez trenutne ali pretekle rezistence na protiretrovirusne komponente zdravila Stribild in imeti supresijo s PI+RTV ali NNRTI v kombinaciji s FTC/TDF (HIV-1 RNA < 50 kopij/ml) vsaj šest mesecev pred presejanjem.
In Study GS-US-236-0121, virologic success rates were: Stribild 93.4% (271 of 290 patients) and SBR 88.1% (126 of 143 patients).
V študiji GS-US-236-0121 so bile stopnje virološkega uspeha: zdravilo Stribild 93,4 % (271 od 290 bolnikov) in SBR 88,1 % (126 od
In Study GS-US-236-0123, patients had to have previously only received RAL in combination with FTC/TDF as their first antiretroviral regimen for at least six months.
V študiji GS-US-236-0123 so bolniki pred tem lahko vsaj zadnjih šest mesecev prejemali samo RAL v kombinaciji s FTC/TDF kot svoj prvi protiretrovirusni režim.
In study GS-US-264-0106, 4 of the 469 patients who switched from a ritonavir-boosted protease inhibitor-based regimen to Eviplera had HIV-1 with reduced susceptibility to at least one component of Eviplera through week 48.
V študiji GS-US-264-0106 so 4 od 469 bolnikov, ki so prešli z režima zdravljenja na podlagi zaviralca proteaze, okrepljenega z ritonavirjem, na zdravilo Eviplera, imeli HIV-1 z zmanjšano občutljivostjo na vsaj eno od učinkovin zdravila Eviplera do konca 48. tedna.
In study GS-US-292-0104 and study GS-US-292-0111, patients received either E/C/F/TAF (n = 866) or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) (n = 867) once daily, both given as FDC tablets.
V študiji GS-US-292-0104 in v študiji GS-US-292-0111 so bolniki prejeli bodisi E/C/F/TAF (n = 866) bodisi elvitegravir/kobicistat/emtricitabin/dizoproksiltenofovirat fumarat (E/C/F/TDF) (n = 867) enkrat dnevno v obliki tablet FDC.
In study GS-US-292-0106, the efficacy, safety, and pharmacokinetics of E/C/F/TAF FDC tablet were evaluated in an open-label study of 50 HIV-1 infected, treatment-naïve adolescents.
V študiji GS-US-292-0106 so ocenili učinkovitost, varnost in farmakokinetiko tablet E/C/F/TAF FDC v odprti študiji s 50 predhodno nezdravljenimi mladostniki, okuženimi s HIV1.
In study GS-US-292-0106, the efficacy, safety, and pharmacokinetics of emtricitabine and tenofovir alafenamide were evaluated in an open-label study in which 50 HIV-1 infected, treatment-naïve adolescents received emtricitabine and tenofovir alafenamide (10 mg) given with elvitegravir and cobicistat as a fixed-dose combination tablet.
V študiji GS-US-292-0106 so ocenili učinkovitost, varnost in farmakokinetiko emtricitabina in alafenamidtenofovirja v odprti študiji, v kateri je 50 predhodno nezdravljenih mladostnikov, okuženih s HIV-1, prejemalo emtricitabin in alafenamidtenofovirat (10 mg) v kombinaciji z elvitegravirjem in kobicistatomom v obliki tablete s fiksno kombinacijo odmerkov.
In study GS-US-292-0106, the efficacy, safety, and pharmacokinetics of Genvoya were evaluated in an open-label study in HIV-1-infected, treatment-naïve adolescents.
V študiji GS-US-292-0106 so ocenili učinkovitost, varnost in farmakokinetiko zdravila Genvoya v odprti študiji s predhodno nezdravljenimi mladostniki, okuženimi s HIV-1.
In study GS-US-292-0109, switching from a tenofovir disoproxil fumarate-based regimen to E/C/F/TAF was superior in maintaining HIV-1 RNA < 50 copies/mL compared to staying on the baseline regimen.
V študiji GS-US-292-0109 je bil prehod z režima na osnovi dizoproksiltenofovirat fumarata na E/C/F/TAF boljši pri ohranjanju HIV-1 RNA < 50 kopij/ml v primerjavi z bolniki, ki so ostali na začetnem režimu.
In study GS-US-292-0109, the efficacy and safety of switching from either efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), FTC/TDF plus atazanavir (boosted by either cobicistat or ritonavir), or E/C/F/TDF to Genvoya were evaluated in a randomised, open- label study of virologically suppressed (HIV-1 RNA < 50 copies/mL) HIV-1 infected adults (n = 1,436).
V študiji GS-US-292-0109 so učinkovitost in varnost prehoda z efavirenza (EFV)/emtricitabina (FTC)/dizoproksiltenofovirata fumarata (TDF), FTC/TDF in atazanavirja (ojačanega s kobicistatom ali ritonavirjem) ali E/C/F/TDF na zdravilo Genvoya ocenili v randomizirani, odprti študiji pri odraslih z virusno supresijo, okuženih s HIV-1 (HIV-1 RNA < 50 kopij/ml) (n = 1.436).
In study GS-US-292-0112, the efficacy and safety of E/C/F/TAF FDC tablet were evaluated in an open-label clinical study of 242 HIV-1 infected, virologically suppressed patients with mild to moderate renal impairment (eGFRCG: 30-69 mL/min).
V študiji GS-US-292-0112 so učinkovitost in varnost E/C/F/TAF v obliki tablete FDC ocenili z odprto klinično študijo pri 242 bolnikih z virološko supresijo, okuženih z virusom HIV-1 in z blago do zmerno ledvično okvaro (eGFRCG: 30–69 ml/min).
In study GS-US-292-0112, the efficacy and safety of emtricitabine and tenofovir alafenamide were evaluated in an open-label clinical study in which 242 HIV-1 infected patients with mild to moderate renal impairment (eGFRCG: 30-69 mL/min) were switched to emtricitabine and tenofovir alafenamide (10 mg) given with elvitegravir and cobicistat as a fixed-dose combination tablet.
V študiji GS-US-292-0112 so učinkovitost in varnost emtricitabina in alafenamidtenofovirata ocenili v odprti klinični študiji, v kateri je 242 bolnikov, okuženih s HIV-1, z blago do zmerno ledvično okvaro (eGFRCG: 30-69 ml/min) prešlo na emtricitabin in alafenamidtenofovirat (10 mg) v kombinaciji z elvitegravirjem in kobicistatomom v obliki tablete s fiksno kombinacijo odmerkov.
In study GS-US-299-0102, patients were randomised in a 2:1 ratio to receive either fixed-dose combination D/C/F/TAF once daily (n = 103) or darunavir and cobicistat and emtricitabine/tenofovir disoproxil fumarate once daily (n = 50).
GS-US-299-0102 so bolnike randomizirali v razmerju 2:1, da so prejemali kombinacijo s fiksnim odmerkom D/C/F/TAF enkrat na dan (n = 103) ali darunavir in kobicistat in emtricitabin/dizoproksiltenofovirat fumarat enkrat na dan (n = 50).
In study GS-US-311-1089, the efficacy and safety of switching from emtricitabine/tenofovir disoproxil fumarate to Descovy while maintaining the third antiretroviral agent were evaluated in a randomised, double-blind study of virologically suppressed HIV-1 infected adults (n = 663).
V študiji GS-US-311-1089 so učinkovitost in varnost prehoda z emtricitabina/dizoproksiltenofovirata fumarata na zdravilo Descovy ob ohranitvi tretje protiretrovirusne učinkovine ocenili v randomizirani, dvojno slepi študiji odraslih, okuženih s HIV-1, z virološko supresijo (n = 663).
In study HPC2002, rash (grouped term) was reported in 10.7% of patients receiving 12 weeks of simeprevir and sofosbuvir without ribavirin versus 20.4% of patients receiving 12 weeks of simeprevir and sofosbuvir with ribavirin.
Med 12-tedenskim zdravljenjem s simeprevirjem v kombinaciji s sofosbuvirjem brez ribavirina v študiji HPC2002 so o izpuščaju (skupni termin) poročali pri 10,7% bolnikov v primerjavi z 20,4% bolnikov, ki so 12 tednov prejemali simeprevir v kombinaciji s sofosbuvirjem in ribavirinom.
In study HPC3007 (PROMISE), patients who relapsed after prior IFN-based therapy received simeprevir (150 mg once daily) + peginterferon alfa-2a + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
V študiji HPC3007 (PROMISE) so bolniki s ponovitvijo bolezni po predhodnem zdravljenju na podlagi IFN 12 tednov prejemali simeprevir (150 mg enkrat na dan) + peginterferon alfa-2a + ribavirin, nato pa naslednjih 12 ali 36 tednov peginterferon alfa-2a + ribavirin (glejte preglednici 17 in 18).
In Study HPC3008 (see sections 4.8 and 5.1), transient grade 3 (2.5 to ≤5 X ULN) and grade 4 (>5 X ULN) bilirubin increases during INCIVO treatment were seen in 39% and in 22% of the 59 patients on atazanavir/ritonavir, respectively.
V skupini 59 bolnikov, ki so prejemali atazanavir/ritonavir pri kombiniranem zdravljenju z zdravilom INCIVO v študiji HPC3008 (glejte poglavji 4.8 in 5.1) so pri 39% bolnikov opazili prehodno zvišanje koncentracije bilirubina stopnje 3 (2,5 do ≤5 X ULN) in pri 22% bolnikov zvišanje koncentracije bilirubina stopnje 4 (>5 X ULN).
In study HPC3011 (RESTORE), patients who were treatment-naïve or failed prior peg-IFN/RBV therapy received simeprevir (150 mg once daily) + peginterferon alfa-2a + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
V študiji HPC3011 (RESTORE) so še nezdravljeni bolniki ali bolniki, pri katerih predhodno zdravljenje s peg-IFN/RBV ni bilo uspešno, 12 tednov prejemali simeprevir (150 mg enkrat na dan) + peginterferon alfa-2a + ribavirin, nato pa naslednjih 12 ali 36 tednov peginterferon alfa-2a + ribavirin (glejte preglednici 17 in 18).
In study HPV-020, conducted in South Africa, 22 HIV uninfected and 42 HIV infected subjects (WHO clinical stage 1; ATP cohort for immunogenicity) received Cervarix.
V študiji HPV-020, ki so jo izvedli v Južni Afriki, je cepivo Cervarix prejemalo 22 s HIV neokuženih preiskovank in 42 s HIV okuženih preiskovank (klinični stadij 1 po ZSO; kohorta PP za imunogenost).
In study I, superiority of tocilizumab 8 mg/kg was demonstrated against the active comparator MTX.
V študiji I so dokazali superiornost 8 mg/kg tocilizumaba nad primerjalno učinkovino metotreksatom.
In study IFM-2005-01 bortezomib combined with dexamethasone [BDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
V študiji IFM-2005-01 so primerjali kombinacijo bortezomiba in deksametazona [BDx, n=240] s kombinacijo vinkristin-doksorubicin-deksametazon BzDx, n=242].
In Study II, 43% of the patients who had not achieved an ACR 20 response at 6 months developed an ACR 20 response at 12 months.
V študiji II je bil pri 43% bolnikov brez odziva ACR 20 po 6 mesecih odziv ACR 20 dosežen po 12 mesecih.
In Study II, among patients with clinically meaningful improvement at month 12, 88% retained the response at month 18, and 85% retained the response at month 24.
V študiji II se je po 18 mesecih odziv ohranil pri 88% bolnikov s klinično pomembnim izboljšanjem po 12 mesecih in po 24 mesecih pri 85% bolnikov s klinično pomembnim izboljšanjem po 12 mesecih.
In study II, patients were randomly assigned to receive placebo (229 patients), or rasagiline 1 mg/day (231 patients) or the catechol-O–methyl transferase (COMT) inhibitor, entacapone, 200 mg taken along with scheduled doses of levodopa (LD)/decarboxylase inhibitor (227 patients), and were treated for 18 weeks.
V študiji II so bolniki naključno prejemali placebo (229 bolnikov) ali razagilin 1 mg/dan (231 bolnikov) ali katehol-o-metil-transferazni inhibitor (COMT) entakapone 200 mg, skupaj s predvidenimi odmerki levodope (LD)/dekarboksilazni inhibitor (227 bolnikov); zdravljeni so bili 18 tednov.
In study II, patients were randomly assigned to receive placebo (229 patients), or rasagiline 1 mg/day (231 patients) or the catechol-O–methyl transferase (COMT) inhibitor, entacapone, 200 mg taken along with scheduled doses of levodopa (LD)/decarboxylase inhibitor (227 patients), and were treated for 18 weeks.
V študiji II so bolniki naključno prejemali placebo (229 bolnikov) ali razagilin 1 mg/dan (231 bolnikov) ali katehol-o-metil-transferazni inhibitor (COMT), entakapon 200 mg, skupaj s predvidenimi odmerki levodope (LD)/dekarboksilazni inhibitor (227 bolnikov); zdravljeni so bili 18 tednov.
In Study II, the baseline median TSS was 31.7 in abatacept-treated patients and 33.4 in placebo-treated patients.
V študiji II je bila srednja izhodiščna vrednost TSS pri bolnikih, ki so prejemali abatacept 31,7, pri bolnikih, ki so prejemali placebo, pa 33,4.
In study III, the mean difference compared to placebo was -0.94h, 95% CI
V študiji III je bila v primerjavi s placebom povprečna razlika -0,94 ur, 95% CI [-1,36, -0,51]; p < 0,0001.
In Study IV, there were 37 patients with COPD treated with abatacept and 17 treated with placebo.
V študiji IV je 37 bolnikov s KOPB prejemalo abatacept, 17 pa placebo.
In Study IV, there were 37 patients with COPD treated with intravenous abatacept and 17 treated with placebo.
V študiji IV je 37 bolnikov s KOPB prejemalo abatacept intravensko, 17 pa placebo.
In study LYM-3002, colony stimulating factor support was given to 78% of patients in the BR-CAP arm and 61% of patients in the R-CHOP arm.
V študiji LYM-3002 je podporno zdravljenje s kolonijami spodbujajočih faktorjev prejelo 78% bolnikov v skupini BR-CAP in 61% bolnikov v skupini R-CHOP.
In study LYM-3002, colony stimulating factor support was given to 78% of patients in the BzR-CAP arm and 61% of patients in the R-CHOP arm.
V študiji LYM-3002 je podporno zdravljenje s kolonijami spodbujajočih faktorjev prejelo 78% bolnikov v skupini BzR-CAP in 61% bolnikov v skupini R-CHOP.
In study MCL-002 in the ITT population, there was an overall apparent increase in deaths within 20 weeks in the lenalidomide arm 22/170 (13%) versus 6/84 (7%) in the control arm.
V študiji MCL-002 v populaciji ITT se je v celoti vidno zvečala incidenca smrti v 20 tednih v skupini z lenalidomidom 22/170 (13 %) proti 6/84 (7 %) v kontrolni skupini.
In study MCL-002 there was overall an apparent increase in early (within 20 weeks) deaths.
V študiji MCL-002 se je v celoti jasno zvečala incidenca zgodnjih (v 20 tednih) smrti.
In study MCL-002 there was overall an apparent increase in early (within 20 weeks) deaths.
V študiji MCL-002 se je v celoti vidno zvečala incidenca zgodnjih (v 20 tednih) smrti.
In Study MCL-002, approximately 10% of lenalidomide-treated patients experienced TFR compared to 0% in the control arm.
V študiji MCL-002 je imelo reakcijo izbruha tumorja približno 10 % bolnikov, zdravljenih z lenalidomidom, v primerjavi z 0 % v kontrolni skupini.
In study MCL-002, TLS was reported for one patient in each of the two treatment arms.
V študiji MCL-002 so poročali o sindromu tumorske lize pri enem bolniku v vsaki od obeh skupin zdravljenja.
In study MDS-004, in which 205 patients were equally randomised to receive lenalidomide 10 mg, 5 mg or placebo, the primary efficacy analysis consisted of a comparison of the transfusion-independence response rates of the 10 mg and 5 mg lenalidomide arms versus the placebo arm (double-blind phase 16 to 52 weeks and open-label up to a total of 156 weeks).
V študiji MDS-004, v kateri so enakomerno razporedili 205 bolnikov, ki so prejemali lenalidomid v odmerkih10 mg in 5 mg ali placebo, je analizo primarne učinkovitosti predstavljala primerjava stopenj odzivov neodvisnosti od transfuzij v skupinah z 10 mg in 5 mg lenalidomida in v skupini s placebom (dvojno slepa faza 16 do 52 tednov in odprta faza do celotnega trajanja 156 tednov).
In study MenACWY-TT-014, the induction of immune memory was assessed one month after the administration of a fifth of the dose of ACWY-PS vaccine (10 µg of each polysaccharide) to children in the third year of life previously primed in the study MenACWY-TT-013 with Nimenrix or a licensed Men C-CRM vaccine at the age of 12 to 14 months.
V študiji MenACWY-TT-014 so indukcijo imunskega spomina ocenili en mesec po uporabi petega odmerka cepiva ACWY-PS (10 µg vsakega polisaharida) pri otrocih v tretjem letu življenja, ki so predhodno v študiji MenACWY-TT-013, ko so bili stari od 12 do 14 mesecev, prejeli osnovno cepljenje s cepivom Nimenrix ali odobrenim cepivom MenC-CRM.
In study MenACWY-TT-028, the persistence of the immune response was evaluated by hSBA 1 year after vaccination in children 6-10 years of age primed in study MenACWY-TT-027 (Table 10) (see section 4.4).
V študiji MenACWY-TT-028 so trajanje imunskega odziva ocenili s hSBA 1 leto po cepljenju pri otrocih, starih od 6 do 10 let, ki so prejeli osnovno cepljenje v študiji MenACWY-TT-027 (preglednica 10) (glejte poglavje 4.4).
In study MenACWY-TT-039, serum bactericidal activity was also measured using human serum as the source of complement (hSBA) as a secondary endpoint (Table 2).
V študiji MenACWY-TT-039 so kot sekundarni opazovani dogodek merili tudi baktericidno aktivnost v serumu, in sicer s človeškim serumom kot virom komplementa (hSBA) (preglednica 2).
In study MenACWY-TT-043, the persistence of the immune response was evaluated 5 years after vaccination in adolescents primed in study MenACWY-TT-036 (Table 12).
V študiji MenACWY-TT-043 so trajanje imunskega odziva ocenili 5 let po cepljenju pri mladostnikih, ki so prejeli osnovno cepljenje v študiji MenACWY-TT-036 (preglednica 12).
In study MenACWY-TT-088, the persistence of the immune response was evaluated by rSBA and hSBA up to 44 months after vaccination in children 2-10 years of age primed in study MenACWY- TT-081 (Table 9).
V študiji MenACWY-TT-088 so trajanje imunskega odziva ocenili z rSBA in hSBA do 44 mesecev po cepljenju pri otrocih, starih od 2 do 10 let, ki so prejeli osnovno cepljenje v študiji MenACWY-TT- 081 (preglednica 9).
In study MMY-3010 induction treatment with bortezomib combined with thalidomide and dexamethasone [BTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
V študiji MMY-3010 so primerjali uvajalno zdravljenje z bortezomibom v kombinaciji s talidomidom in deksametazonom [BTDx, n=130] s kombinacijo thalidomid-deksametazon [TDx, n=127].
In study MMY-3010 induction treatment withbortezomib combined with thalidomide and dexamethasone [BzTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
V študiji MMY-3010 so primerjali uvajalno zdravljenje z bortezomibom v kombinaciji s talidomidom in deksametazonom [BzTDx, n=130] s kombinacijo thalidomid-deksametazon [TDx, n=127].
In study MMY2002, 106 patients with relapsed and refractory multiple myeloma received 16 mg/kg DARZALEX until disease progression.
V študiji MMY2002 je 106 bolnikov s ponovljenim in neodzivnim diseminiranim plazmocitomom prejemalo zdravilo DARZALEX v odmerku 16 mg/kg do napredovanja bolezni.
In study NR15961, patients concurrently treated with stavudine and interferon therapy with or without ribavirin, the incidence of pancreatitis and/or lactic acidosis was 3% (12/398).
V študiji NR15961 je bila incidenca pankreatitisa in/ali laktacidoze pri bolnikih, sočasno zdravljenih s stavudinom in interferonom z dodanim ribavirinom ali brez, 3 % (12/398).
In study PIPF-004, the decline of percent predicted FVC from Baseline at Week 72 of treatment was significantly reduced in patients receiving Esbriet (N=174) compared with patients receiving placebo (N=174; p=0.001, rank ANCOVA).
V študiji PIPF–004 je bil pri bolnikih, ki so prejemali zdravilo Esbriet (n = 174), padec v odstotkih predvidene forsirane vitalne kapacitete glede na izhodiščno vrednost v 72. tednu pomembno zmanjšan v primerjavi z bolniki, ki so prejemali placebo (n = 174, p = 0,001, rang ANCOVA).
In study PIPF-006, treatment with Esbriet (N=171) did not reduce the decline of percent predicted FVC from Baseline at Week 72 compared with placebo (N=173; p=0.501).
V študiji PIPF–006 zdravljenje z zdravilom Esbriet (n = 171) ni zmanjšalo padca odstotka predvidene forsirane vitalne kapacitete v 72. tednu glede na izhodiščno vrednost v primerjavi s placebom (n = 173, p = 0,501).
In study PIPF-016, the decline of percent predicted FVC from Baseline at Week 52 of treatment was significantly reduced in patients receiving Esbriet (N=278) compared with patients receiving placebo (N=277; p<0.000001, rank ANCOVA).
V študiji PIPF–016 je bil pri bolnikih, ki so prejemali zdravilo Esbriet (n = 278), padec v odstotkih predvidene forsirane vitalne kapacitete glede na izhodiščno vrednost v 52. tednu zdravljenja pomembno zmanjšan v primerjavi z bolniki, ki so prejemali placebo (n = 277; p < 0,000001, rang ANCOVA).
In study PROAB3006, seven cases (3 %) were reported in 245 NRTI-experienced subjects treated with amprenavir and in 27 (11 %) of 241 subjects treated with indinavir, in combination with various NRTIs for a median duration of 56 weeks (p< 0.001).
V študiji PROAB3006 so poročali o sedmih primerih (3 %) pri 245 predhodno z NRTI-ji že zdravljenih osebah, ki so se zdravile z amprenavirjem, in o 27 primerih (11 %) pri 241 osebah, ki so se 56 tednov (srednji čas zdravljenja, p < 0,001) zdravile z indinavirjem v kombinaciji z različnimi NRTI-ji.
In study PX 171 009 the incidence of venous thromboembolic events was 15.3% in the KRd arm and 9.0% in the Rd arm.
V študiji PX-171-009 je bila incidenca venskih tromboemboličnih dogodkov v skupini KRd 15,3 % in v skupini Rd 9 %.
In Study SC-I, abatacept administered subcutaneously (SC) was non-inferior relative to intravenous (IV) infusions of abatacept with respect to ACR 20 responses up to 6 months of treatment.
V študiji SC-I subkutana (s.c.) uporaba abatacepta ni bila inferiorna v primerjavi z intravenskim (i.v.) infundiranjem glede na odziv ACR 20 do 6. meseca zdravljenja.