natgillin/translations-raw huggingface dataset:
In study GS-US-104-0352, 97 treatment-experienced patients 2 to < 12 years of age with stable, virologic suppression on stavudine- or zidovudine-containing regimens were randomised to either replace stavudine or zidovudine with tenofovir disoproxil fumarate (n = 48) or continue on their original regimen (n = 49) for 48 weeks.
U ispitivanju GS-US-104-0352, 97 prethodno liječenih pacijenata u dobi od 2 do < 12 godina sa stabilnom virološkom supresijom koji su prethodno bili liječeni režimima koji su sadržavali stavudin ili zidovudin bilo je randomizirano u skupine kojima se stavudin ili zidovudin zamijenio tenofovirdizoproksilfumaratom (n = 48) ili u skupine koje su nastavile primati prvobitni režim (n = 49) 48 tjedana.
In study GS-US-174-0103 a significantly greater proportion of patients in the tenofovir disoproxil fumarate group than in the adefovir dipivoxil group had normalised ALT and achieved HBsAg loss at week 48 (see Table 3 below).
U ispitivanju GS-US-174-0103 značajno veći udio pacijenata u skupini koja je dobivala tenofovirdizoproksilfumarat imao je normaliziranu razinu ALT-a u odnosu na skupinu pacijenata koja je dobivala adefovirdipivoksil te je nestanak HBsAG postignut u 48. tjednu (vidjeti tablicu 3).
In study GS-US-174-0103 a significantly greater proportion of patients in the tenofovir disoproxil fumarate group than in the adefovir dipivoxil group had normalised ALT and achieved HBsAg loss at week 48 (see Table 4 below).
U ispitivanju GS-US-174-0103 značajno veći udio pacijenata u skupini koja je dobivala tenofovirdizoproksilfumarat imao je normaliziranu razinu ALT-a u odnosu na skupinu pacijenata koja je dobivala adefovirdipivoksil te je nestanak HBsAG postignut u 48. tjednu (vidjeti tablicu 4 niže).
In study GS-US-174-0108, 45 patients (including 9 patients with lamivudine and/or adefovir dipivoxil resistance mutations at baseline) received tenofovir disoproxil fumarate for up to 168 weeks.
U ispitivanju GS-US-174-0108, 45 pacijenata (uključujući 9 pacijenata s mutacijom za rezistenciju na lamivudin i/ili adefovirdipivoksil na početku) primalo je tenofovirdizoproksilfumarat do 168 tjedana.
In study GS-US-174-0121, 141 patients with lamivudine resistance substitutions at baseline received tenofovir disoproxil fumarate for up to 240 weeks.
U ispitivanju GS-US-174-0121, 141 pacijent sa supstitucijama rezistencije na lamivudin na početku ispitivanja primao je tenofovirdizoproksilfumarat do 240 tjedana.
In study GS-US-216-0114, decreases in estimated creatinine clearance occurred early in treatment with cobicistat, after which they stabilised.
U ispitivanju GS-US-216-0114 smanjenja procijenjenog klirensa kreatinina pojavila su se rano kod liječenja kobicistatom nakon čega su se stabilizirala.
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.
U ispitivanju GS-US-216-0114, hiperbilirubinemija (> 1 x gornja granica normale (GGN)) je bila česta: 97,7% ispitanika u skupini koja je primala kobicistatom pojačani atazanavir s kombinacijom fiksne doze emtricitabina i tenofovirdizoproksilfumarata i 97,4% ispitanika u skupini koja je primala ritonavirom pojačani atazanavir s kombinacijom fiksne doze emtricitabina i tenofovirdizoproksil- fumarata tijekom 144 tjedna liječenja.
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.
U ispitivanju GS-US-216-0114 je hiperbilirubinemija (> 1 x iznad gornje granice normale [GGN]) tijekom 144 tjedna liječenja bila česta: javila se u 97,7% bolesnika u skupini koja je primala atazanavir pojačan kobicistatom plus fiksnu kombinaciju doza emtricitabina i tenofovirdizoproksilfumarata i u 97,4% bolesnika u skupini koja je primala atazanavir pojačani ritonavirom plus fiksnu kombinaciju doza emtricitabina i tenofovirdizoproksilfumarata.
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).
U ispitivanju GS-US-236-0102 odrasli pacijenti zaraženi virusom HIV-1 koji prije nisu bili liječeni antiretrovirusnim lijekovima primali su Stribild jedanput dnevno ili kombinaciju efavirenza / emtricitabina / tenofovirdizoproksilfumarata (EFV/FTC/TDF) u fiksnoj dozi jedanput dnevno.
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).
U ispitivanju GS-US-236-0103 odrasli pacijenti zaraženi virusom HIV-1 koji prije nisu bili liječeni antiretrovirusnim lijekovima primali su Stribild jedanput dnevno ili ritonavirom pojačani atazanavir (ATV/r) plus kombinaciju emtricitabina / tenofovirdizoproksilfumarata (FTC/TDF) u fiksnoj dozi jedanput dnevno.
In study GS-US-236-0103, 27 patients treated with Stribild had HIV-1 with the NNRTI-associated K103N substitution in reverse transcriptase at baseline and had virologic success (82% at Week 144) similar to the overall population (78%), and no emergent resistance to elvitegravir, emtricitabine, or tenofovir in their HIV-1.
U ispitivanju GS-US-236-0103, 27 pacijenata liječenih Stribildom imalo je HIV-1 sa supstitucijom K103N povezanom s NNRTI-om u reverznoj transkriptazi na početku ispitivanja, imalo je virološki uspjeh (82% u 144. tjednu) sličan ukupnoj populaciji (78%) i nije razvilo novonastalu rezistenciju na elvitegravir, emtricitabin i tenofovir u HIV-1.
In study GS-US-236-0103, the mean increase from baseline in CD4+ cell count at Week 48 was 207 cells/mm3 in the Stribild- treated patients and 211 cells/mm3 in the ATV/r+FTC/TDF-treated patients.
U ispitivanju GS-US-236-0103, srednja vrijednost povećanja od početne vrijednosti broja stanica CD4+ u 48. tjednu bila je 207 stanica/mm³ u pacijenata liječenih Stribildom i 211 stanica/mm³ u pacijenata liječenih ATV/r + FTC/TDF-om.
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.
U ispitivanjima GS-US-236-0115 i GS-US-236-0121 pacijenti su morali primati svoj prvi ili drugi antiretrovirusni režim bez prethodnog virološkog neuspjeha, nisu smjeli imati zabilježenu prošlu ili sadašnju rezistenciju na antiretrovirusne tvari u Stribildu i i virus je morao biti suprimiran PI+RTV-om ili NNRTI-jem u kombinaciji s FTC/TDF (HIV-1 RNK < 50 kopija/ml) najmanje šest mjeseci prije probira.
In Study GS-US-236-0115, virologic success rates were: Stribild 93.8% (272 of 290 patients); SBR 87.1% (121 of 139 patients).
U ispitivanju GS-US-236-0115 stope virološkog uspjeha iznosile su: za Stribild 93,8% (272 od 290 pacijenata), a za SBR 87,1% (121 od 139 pacijenata).
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).
U ispitivanju GS-US-236-0121 stope virološkog uspjeha iznosile su: za Stribild 93,4% (271 od 290 pacijenata), a za SBR 88,1% (126 od 143 pacijenta).
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.
U ispitivanju GS-US-236-0123 pacijenti su prethodno smjeli primati samo RAL u kombinaciji s FTC/TDF kao prvi antiretrovirusni režim tijekom najmanje šest mjeseci.
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.
U ispitivanju GS-US-264-0106, 4 od 469 pacijenata prebačenih s režima ritonavirom pojačanim inhibitorom proteaze na lijek Eviplera imalo je HIV-1 sa smanjenom osjetljivošću na barem jednu komponentu lijeka Eviplera do 48. tjedna.
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.
U ispitivanju GS-US-292-0104 i ispitivanju GS-US-292-0111, bolesnici su primali ili E/C/F/TAF (n = 866) ili elvitegravir/kobicistat/emtricitabin/tenofovirdizoproksilfumarat (E/C/F/TDF) (n = 867) jedanput na dan, s tim da su obje terapije davane u obliku tableta s fiksnom kombinacijom.
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.
U otvorenom ispitivanju GS-US-292-0106 u 50 adolescenata zaraženih virusom HIV-1 koji prethodno nisu bili liječeni, procijenjene su djelotvornost, sigurnost i farmakokinetika tablete s fiksnom kombinacijom E/C/F/TAF.
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.
U otvorenom ispitivanju GS-US-292-0106 u kojem je 50 adolescenata zaraţenih virusom HIV-1 koji prethodno nisu bili liječeni primalo fiksnu kombinaciju emtricitabina i tenofoviralafenamida (10 mg) s elvitegravirom i kobicistatom u jednoj tableti procijenjene su djelotvornost, sigurnost i farmakokinetika emtricitabina i tenofoviralafenamida.
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.
U otvorenom ispitivanju GS-US-292-0106 u adolescenata zaraženih virusom HIV-1 koji prethodno nisu bili liječeni procijenjene su djelotvornost, sigurnost i farmakokinetika lijeka Genvoya.
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.
U ispitivanju GS-US-292-0109, prebacivanje s režima temeljenog na tenofovirdizoproksilfumaratu na E/C/F/TAF bilo je superiorno u održavanju HIV-1 RNK < 50 kopija/ml u usporedbi s ostankom na početnom režimu.
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).
U otvorenom kliničkom ispitivanju GS-US-292-0112 na 242 virološki suprimirana bolesnika zaražena virusom HIV-1 s blagim do umjerenim oštećenjem funkcije bubrega (eGFRCG: 30-69 ml/min) procijenjena je djelotvornost i sigurnost E/C/F/TAF tablete s fiksnom kombinacijom.
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.
U otvorenom kliničkom ispitivanju GS-US-292-0112 procijenjena je djelotvornost i sigurnost emtricitabina i tenofoviralafenamida u 242 bolesnika zaraţena virusom HIV-1 s blagim do umjerenim oštećenjem funkcije bubrega (eGFRCG: 30-69 ml/min) koji su bili prebačeni na fiksnu kombinaciju emtricitabina i tenofoviralafenamida (10 mg) s elvitegravirom i kobicistatom u jednoj tableti.
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).
U ispitivanju GS-US-299-0102, bolesnici su bili randomizirani u omjeru 2:1 kako bi primali fiksnu kombinaciju D/C/F/TAF jednom dnevno (n = 103) ili darunavir, kobicistat i emtricitabin/tenofovirdizoproksilfumarat jednom dnevno (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).
U randomiziranom, dvostruko slijepom ispitivanju GS-US-311-1089 procjenjivane su djelotvornost i sigurnost prebacivanja odraslih bolesnika (n = 663) zaraţenih virusom HIV-1 kod kojih je virus bio suprimiran s reţima emtricitabin/tenofovirdizoproksilfumarat na lijek Descovy uz zadrţavanje liječenja trećim antiretrovirusnim lijekom.
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).
U ispitivanju HPC3007 (PROMISE), bolesnici koji su doživjeli relaps nakon prethodne terapije temeljene na IFN primali su simeprevir (150 mg jedanput dnevno) + peginterferon alfa-2a + ribavirin tijekom 12 tjedana, nakon čega je slijedilo 12 ili 36 dodatna tjedna peginterferona alfa-2a + ribavirina (vidjeti tablice 17 i 18).
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).
U ispitivanju HPC3011 (RESTORE), bolesnici koji prethodno nisu bili liječeni ili su doživjeli neuspjeh prethodne terapije s peg-IFN/RBV primali su simeprevir (150 mg jedanput dnevno) + peginterferon alfa-2a + ribavirin tijekom 12 tjedana, nakon čega je slijedilo 12 ili 36 dodatnih tjedana peginterferona alfa-2a + ribavirin (vidjeti tablice 17 i 18).
In study HPC3021 (PLUTO), patients received simeprevir + sofosbuvir for 12 weeks (see table 11).
U ispitivanju HPC3021 (PLUTO), bolesnici su primali simeprevir + sofosbuvir tijekom 12 tjedana (vidjeti tablicu 11).
In study I, 404 patients were randomly assigned to receive placebo (138 patients), rasagiline 1 mg/day (134 patients) or rasagiline 2 mg/day (132 patients) and were treated for 26 weeks, there was no active comparator.
U ispitivanju I su 404 bolesnika metodom slučajnog odabira bili raspodijeljeni da prime placebo (138 bolesnika), razagilin 1 mg/dan (134 bolesnika) ili razagilin 2 mg/dan (132 bolesnika) i bili su liječeni 26 tjedana, nije bilo aktivnog komparatora.
In study I, ACR responses were assessed at 7 years in 43 patients with 72% ACR 20 responses, 58% ACR 50 responses, and 44% ACR 70 responses.
U Ispitivanju I, ACR odgovori su ocijenjeni nakon 7 godina u 43 bolesnika, pri čemu je njih 72% postiglo odgovor ACR20, 58% odgovor ACR50, a 44% odgovor ACR70.
In Study I, improvements in the physical and mental component summary scores of the SF-36 were also significant compared to placebo.
U ispitivanju I uočeno je i značajno poboljšanje rezultata za cjelokupnu fizičku i mentalnu komponentu iz upitnika SF-36 u usporedbi s placebom.
In study I, superiority of tocilizumab 8 mg/kg was demonstrated against the active comparator MTX.
U ispitivanju I pokazala se superiornost tocilizumaba u dozi od 8 mg/kg u odnosu na aktivni usporedni lijek MTX.
In Study I, tocilizumab was administered intravenously every four weeks as monotherapy.
U Ispitivanju I tocilizumab se primjenjivao intravenski svaka četiri tjedna kao monoterapija.
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.
U Ispitivanju II 43% bolesnika koji nisu postigli odgovor ACR20 nakon 6 mjeseci razvilo je odgovor ACR20 nakon 12 mjeseci.
In study II, ACR responses were assessed at 5 years in 270 patients with 84% ACR 20 responses, 61% ACR 50 responses, and 40% ACR 70 responses.
U Ispitivanju II, ACR odgovori su ocijenjeni nakon 5 godina u 270 bolesnika, pri čemu je njih 84% postiglo odgovor ACR20, 61% odgovor ACR50, a 40% odgovor ACR70.
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.
Među bolesnicima koji su imali klinički značajno poboljšanje nakon 12 mjeseci u Ispitivanju II, odgovor se održao u njih 88% nakon 18 mjeseci, a u njih 85% nakon 24 mjeseca.
In Study II, in patients with an inadequate response to MTX, inhibition of structural joint damage was assessed radiographically and expressed as change in modified Sharp score and its components, the erosion score and joint space narrowing score.
U ispitivanju II se kod bolesnika s neprimjerenim odgovorom na MTX radiološki procijenila inhibicija strukturalnih oštećenja zglobova i izrazila kao promjena u modificiranom stupnjevanju prema Sharpu i njegovim sastavnicama, stupnju erozije i stupnju suženja zglobnog prostora.
In Study II, the baseline median TSS was 31.7 in abatacept-treated patients and 33.4 in placebo-treated patients.
U Ispitivanju II je početni medijan TSS-a bio 31,7 u bolesnika liječenih abataceptom, odnosno 33,4 u bolesnika koji su primali placebo.
In study II, the mean difference in the number of hours spent in the “OFF” state compared to placebo was
U ispitivanju II, srednja razlika u broju sati provedenih u „OFF“ stanju u usporedbi s placebom je iznosila -0,78 h, 95 % CI [-1,18, -0,39], p=0,0001.
In study III, ACR responses were assessed at 5 years in 91 patients with 74% ACR 20 responses, 51% ACR 50 responses, and 23% ACR 70 responses.
U Ispitivanju III, ACR odgovori su ocijenjeni nakon 5 godina u 91 bolesnika, pri čemu je njih 74% postiglo odgovor ACR20, 51% odgovor ACR50, a 23% odgovor ACR70.
In Study III, patients receiving reslizumab 3 mg/kg had significantly larger increases in FEV1 from baseline compared to placebo (treatment difference: 160 mL, p=0.0018).
U Ispitivanju III, bolesnici koji su primali reslizumab u dozi od 3 mg/kg imali su značajno veće povećanje FEV1 u odnosu na početnu vrijednost u usporedbi s onima koji su primali placebo (terapijska razlika: 160 ml, p=0,0018).
In study III, patients were randomly assigned to receive placebo (159 patients), rasagiline 0.5 mg/day (164 patients), or rasagiline 1 mg/day (149 patients), and were treated for
U ispitivanju III, bolesnici su metodom slučajnog odabira bili raspodijeljeni da prime placebo (159 bolesnika), razagilin 0,5 mg/dan (164 bolesnika) ili razagilin
In study III, the mean difference compared to placebo was -0.94h, 95% CI
U ispitivanju III srednja razlika u usporedbi s placebom je iznosila 0,94 h, 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.
U Ispitivanju IV je bilo 37 bolesnika s KOPB-om koji su liječeni abataceptom i 17 koji su primali placebo.
In Study IV, there were 37 patients with COPD treated with intravenous abatacept and 17 treated with placebo.
U Ispitivanju IV je bilo 37 bolesnika s KOPB-om koji su liječeni abataceptom intravenski i 17 koji su primali placebo.
In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
U ispitivanju LYM-3002 u kojem je bortezomib primijenjen s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (R-CAP),incidencija periferne neuropatije u kombiniranim režimima prikazana je u tablici ispod:
In study LYM-3002 in which VELCADE was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
U ispitivanju LYM-3002 u kojem je VELCADE primijenjen s rituksimabom, ciklofosfamidom, doksorubicinom I prednizonom (R-CAP), incidencija periferne neuropatije u kombiniranim režimima prikazana je u tablici ispod:
In study LYM-3002 in which VELCADE was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
U ispitivanju LYM-3002 u kojem je VELCADE primijenjen s rituksimabom, ciklofosfamidom, doksorubicinom I prednizonom (R-CAP),incidencija periferne neuropatije u kombiniranim režimima prikazana je u tablici ispod:
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.
U ispitivanju LYM-3002, potpora u vidu faktora stimulacije kolonija primijenjena je na 78% bolesnika u BzR-CAP skupini te na 61% bolesnika u R-CHOP skupini.
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.
U ispitivanju MCL-002, u populaciji predviđenoj za liječenje (ITT) zabilježeno je sveukupno vidljivo povećanje broja smrti unutar 20 tjedana u skupini koja je primala lenalidomid; 22/170 (13%) naspram 6/84 (7%) u kontrolnoj skupini.
In Study MCL-002, approximately 10% of lenalidomide-treated patients experienced TFR compared to 0% in the control arm.
U ispitivanju MCL-002, reakcija razbuktavanja tumora nastala je u približno 10% bolesnika liječenih lenalidomidom u usporedbi s 0% bolesnika u kontrolnoj skupini.
In study MCL-002, TLS was reported for one patient in each of the two treatment arms.
U ispitivanju MCL-002, sindrom lize tumora zabilježen je u po jednog bolesnika iz obje liječene skupine.
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).
U ispitivanju MDS-004, u kojemu je 205 bolesnika jednoliko randomizirano u skupine koje su primale lenalidomid 10 mg, 5 mg ili placebo, analizu primarne djelotvornosti činila je usporedba stopa odgovora neovisnosti o transfuziji u skupinama koje su primale 10 mg i 5 mg lenalidomida naspram skupine koja je primala placebo (dvostruko slijepa faza od 16 do 52 tjedna, i otvorena faza do ukupno 156 tjedana).
In Study Men ACWY-TT-104 the immune response following one or two doses of Nimenrix given 2 months apart was evaluated one month after the last vaccination.
U Men ACWY-TT-104 ispitivanju imunološki odgovor nakon jedne ili dvije doze Nimenrixa dane u razmaku od 2 mjeseca, procijenjen je jedan mjesec nakon zadnjeg cijepljenja.
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.
U ispitivanju MenACWY-TT-014, indukcija imunološkog pamćenja je procijenjena jedan mjesec nakon primjene petine doze cjepiva ACWY-PS (10 µg svakog polisaharida) u djece u trećoj godini života, koja su prethodno u ispitivanju MenACWY-TT-013 u dobi od 12 do 14 mjeseci primila osnovno cijepljenje cjepivom Nimenrix ili odobrenim cjepivom MenC-CRM.