natgillin/translations-raw huggingface dataset:
In the Phase 2 and 3 studies (3 studies), the incidence of PTLD was higher in belatacept-treated patients than in ciclosporin-treated patients (see section 4.8).
V študijah 2. in 3. faze (3 študije) je bila pojavnost PTLB večja pri bolnikih, ki so se zdravili z belataceptom, kot pri bolnikih, ki so se zdravili s ciklosporinom (glejte poglavje 4.8).
In the Phase 2 clinical trial of adult patients with previously treated Ph+ leukaemia, dose escalation to 600 mg once daily with food was allowed in patients who did not experience severe or persistent moderate-adverse reactions, under any of the following circumstances.
V kliničnem preskušanju 2. faze pri odraslih bolnikih s predhodno zdravljeno Ph+ levkemijo je bilo dovoljeno povečanje odmerka na 600 mg enkrat na dan s hrano, in sicer pri bolnikih, pri katerih se niso pojavili hudi ali dolgotrajni zmerni neželeni učinki, pod katerimikoli spodaj navedenimi pogoji.
In the phase 3 pivotal studies in MF bleeding events (including intracranial and gastrointestinal, bruising and other bleeding events) were reported in 32.6% of patients exposed to Jakavi and 23.2% of patients exposed to the reference treatments (placebo or best available therapy).
V ključnih študijah faze 3 z bolniki z mielofibrozo so poročali o krvavitvah (kar vključuje intrakranialne in gastrointestinalne krvavitve, podplutbe in druge krvavitve) pri 32,6 % bolnikov, ki so prejemali zdravilo Jakavi, in pri 23,2 % bolnikov, ki so prejemali primerjalno zdravilo (placebo ali najboljše razpoložljivo zdravljenje).
In the Phase 3 placebo-controlled study in patients with PAH, a transient increase in mean heart rate of 3–4 bpm at 2–4 hours post-dose was observed.
V študiji faze 3, nadzorovani s placebom, pri bolnikih s PAH so opazili prehodno povečanje povprečnega srčnega utripa za 3–4 utripov/minuto 2–4 ure po odmerku.
In the Phase 3 placebo-controlled study in patients with PAH, no increased risk of bleeding was detected with selexipag compared to placebo, including when selexipag was administered with anticoagulants (such as heparin, coumarin-type anticoagulants) or inhibitors of platelet aggregation.
V preskušanjih faze 3, nadzorovanih s placebom, pri bolniki s PAH, uporaba seleksipaga v primerjavi s placebom ni povzročila večjega tveganja za krvavitev, vključno z dajanjem seleksipaga skupaj z antikoagulanti (kot so heparin, kumarinski antikoagulanti) ali zaviralci agregacije trombocitov.
In the phase 3 pNET study hypothyroidism was reported in 6 patients (7.2%) receiving sunitinib and in one patient (1.2%) on placebo.
V študiji 3. faze pri pNET so o hipotiroidizmu poročali pri 6 bolnikih (7,2 %), ki so prejemali sunitinib, in pri 1 bolniku (1,2 %), ki je prejemal placebo.
In the phase 3 pNET study, one (1%) patient who received sunitinib had treatment-related fatal cardiac failure.
V študiji 3. faze pri pNET je pri enem (1 %) bolniku, ki je prejemal sunitinib, prišlo do z zdravljenjem povezanega srčnega popuščanja s smrtnim izidom.
In the phase 3 SABRINA trial (BO22334), local cutaneous reaction were reported in up to 20% of patients receiving subcutaneous MabThera.
V kliničnem preskušanju faze III SABRINA (BO22334) je do 20 % bolnikov, ki so prejemali podkožno obliko zdravila MabThera, navedlo lokalne kožne reakcije.
In the Phase 3 studies GS-US-236-0102 and GS-US-236-0103, bone fractures occurred in 27 subjects (3.9%) in the Stribild group, 8 subjects (2.3%) in the efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) group, and 19 subjects (5.4%) in the ATV/r+FTC/TDF group.
V študijah faze 3, GS-US-236-0102 in GS-US-236-0103, je prišlo do zlomov kosti pri 27 osebah (3,9 %) v skupini z zdravilom Stribild, pri 8 osebah (2,3 %) v skupini z efavirenzom/emtricitabinom/dizoproksiltenofovirijevim fumaratom (EFV/FTC/TDF) in pri 19 osebah (5,4 %) v skupini z ATV/r+FTC/TDF.
In the Phase 3 studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, no overall differences in adverse events, serious adverse events, and serious infections in patients age 65 or older who received Enbrel were observed compared with younger patients.
V študijah tretje faze pri revmatoidnem artritisu, psoriatičnem artritisu in ankilozirajočem spondilitisu pri bolnikih, starih 65 let ali več, ki so prejeli zdravilo Enbrel, na splošno niso opazili nobenih razlik glede neželenih učinkov, resnih neželenih učinkov in resnih okužb v primerjavi z mlajšimi bolniki.
In the Phase 3 studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, no overall differences in adverse events, serious adverse events, and serious infections in patients age 65 or older who received etanercept were observed compared with younger patients.
V študijah tretje faze pri revmatoidnem artritisu, psoriatičnem artritisu in ankilozirajočem spondilitisu pri bolnikih, starih 65 let ali več, ki so prejeli etanercept, na splošno niso opazili nobenih razlik glede neželenih učinkov, resnih neželenih učinkov in resnih okužb v primerjavi z mlajšimi bolniki.
In the Phase 3 study GS-US-236-0103, bone mineral density (BMD) was assessed in a non-random subset of 120 subjects (Stribild group n = 54; ritonavir-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) group n = 66).
V študiji faze 3, GS-US-236-0103 so mineralno gostoto kosti (bone mineral density, BMD) ocenili v nerandomizirani podskupini s 120 osebami (skupina z zdravilom Stribild n = 54; skupina z atazanavirjem, okrepljenim z ritonavirjem (ATV/r) in emtricitabinom/dizoproksiltenofovirijevim fumaratom (FTC/TDF) n = 66).
In the Phase 3 trial of Humira in patients with paediatric Crohn’s disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6% (5/192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
V preskušanju faze 3 z zdravilom Humira pri bolnikih s pediatrično Crohnovo boleznijo, kjer so ocenjevali učinkovitost in varnost dveh telesni masi prilagojenih vzdrževalnih režimov odmerjanja, ki sta sledila telesni masi prilagojenemu začetnemu zdravljenju do 52 tednov zdravljenja, so se pojavila zvišanja ALT ≥ 3 x ULN pri 2,6 % (5/192) bolnikov, od katerih so štirje sočasno prejemali imunosupresive ob začetku preskušanja.
In the Phase 3 trial, patients were provided daily dietary supplements of vitamin E, linoleic acid, ALA, EPA and DHA.
V preskušanju 3. faze so bolniki prejemali dnevne prehranske dodatke vitamina E, linolne kisline, ALA, EPA in DHA.
In the Phase 3 trial, the pharmacokinetics of drotrecogin alfa (activated) were evaluated in 342 patients with severe sepsis administered a 96-hour continuous infusion at 24 g/kg/hr.
V preskušanju faze 3 so vrednotili farmakokinetiko drotrekogina alfa (aktiviranega) pri 342 bolnikih s hudo sepso, ki so prejeli 96-urno neprekinjeno infuzijo v odmerku 24 g/kg/h.
In the Phase I study (BO25532), the Herceptin 600 mg solution for injection in administration system was shown to be comparable (using a standard bioequivalence confidence interval of 0.8-1.25) with Herceptin 600 mg solution for injection in vial administered by syringe.
V študiji faze I (BO25532) so dokazali, da je zdravilo Herceptin 600 mg raztopina za injiciranje v aplikacijskem sistemu primerljivo (z uporabo standardnega bioekvivalenčnega intervala zaupanja 0,8 do 1,25) z zdravilom Herceptin 600 mg raztopina za injiciranje v viali, ki ga apliciramo z injekcijsko brizgo.
In the Phase I/II study, treatment with Ilaris had a rapid onset of action, with disappearance or clinically significant improvement of symptoms within one day after dosing.
V študiji faze I/II je zdravljenje z zdravilom Ilaris začelo hitro delovati, tako da so simptomi izzveneli ali se klinično pomembno izboljšali v enem dnevu po odmerjanju.
In the Phase II and III clinical trials, screening for eligibility required central testing for BRAF V600 mutation using a BRAF mutation assay conducted on the most recent tumour sample available.
V kliničnih preskušanjih II. in III. faze je presejanje za primernost zahtevalo centralno izvedeno testiranje glede mutacije BRAF V600 z uporabo testa za mutacijo BRAF na najnovejšem vzorcu tumorja, ki je bil na voljo.
In the Phase II and III UC studies through week 54, antibodies to golimumab were detected by the EIA method in 3% (26/946) of golimumab treated patients.
V času faz II in III so v študijah pri bolnikih z ulceroznim kolitisom v času do 54. tedna z metodo EIA ugotovili protitelesa proti golimumabu pri 3 % (26/946) bolnikov, zdravljenih z golimumabom.
In the phase II pivotal study, muscle spasms, myalgia, myopathy and cases of CK elevations were observed.
V ključni študiji faze II so opažali mišične spazme, mialgijo, miopatijo in primere zvišanja vrednosti kreatin- kinaze.
In the phase II SAA clinical study with eltrombopag, the incidence of new cytogenetic abnormalities was observed in 19% of patients [8/43 (where 5 of them had changes in chromosome 7)].
V klinični študiji faze II z eltrombopagom pri bolnikih s hudo aplastično anemijo so pojavljanje novih citogenetskih nepravilnosti opažali pri 19 % bolnikov [8/43 (pri čemer je pri 5 od teh bolnikov prišlo do sprememb na kromosomu 7)].
In the Phase II studies, the incidence of ILD was 6.2% in patients of Japanese ethnicity, 1.2% in patients of non-Japanese Asian ethnicity and 2.4% in non-Asian patients.
V študijah II. faze je bila pojavnost intersticijske bolezni pljuč pri bolnikih japonske etnične pripadnosti 6,2 %, pri bolnikih nejaponske azijske etnične pripadnosti 1,2 % in pri neazijskih bolnikih 2,4 %.
In the phase II study, AUC0-8h and Cmax at day 1 were 22.1 ± 12.7 µgh/mL and 4.1 ± 2.3 µg/mL.
V študiji faze II sta bili AUC0-8h in Cmax na dan 1 22,1 ± 12,7 µgh/ml in 4,1 ± 2,3 µg/ml.
In the Phase II, all 148 patients were on lenalidomide treatment.
V študiji faze II se je vseh 148 bolnikov zdravilo z lenalidomidom.
In the Phase IIb, open label study (C209), where patients with no treatment options received other QT- prolonging medicinal products used to treat tuberculosis, including clofazimine, concurrent use with SIRTURO resulted in additive QT prolongation, proportional to the number of QT prolonging medicinal products in the treatment regimen.
V odprti študiji faze IIb (C209) v kateri so bolniki, pri katerih ni bilo druge možnosti, za zdravljenje tuberkuloze prejeli tudi druge učinkovine, ki podaljšujejo interval QT (vključno s klofaziminom) je sočasna uporaba z zdravilom SIRTURO vodila v dodatno podaljšanje intervala QT, ki je bilo sorazmerno s številom učinkovin, ki podaljšujejo interval QT v shemi zdravljenja.
In the Phase IIb, open-label study (C209), 6.9% (16/233) patients died.
V odprti študiji faze IIb (C209) je umrlo 6,9% (16/233) bolnikov.
In the Phase III (RECOURSE) clinical trial, treatment-related infections occurred more frequently in Lonsurf-treated patients (5.6%) compared to those receiving placebo (1.9%).
V kliničnem preskušanju III. faze (RECOURSE) so se okužbe, povezane z zdravljenjem, pojavljale pogosteje v skupini, zdravljeni z zdravilom Lonsurf (5,6 %), kot pri skupini, ki je prejemala placebo (1,9 %).
In the Phase III active-controlled trial, the magnitude of decrease in oxygen saturation was comparable between Zalviso and i.v. patient-controlled morphine groups.
V z zdravilno učinkovino nadzorovanem preskušanju 3. faze je bilo zmanjšanje saturacije s kisikom primerljivo pri skupini z zdravilom Zalviso in skupini z intravenskim morfijem, ki ga nadzirajo bolniki.
In the phase III clinical study, no relevant differences in safety or efficacy were observed between patients with mild renal impairment (creatinine clearance [CLCR]: 50 to 80 mL/min) and normal renal function.
V klinični študiji III. faze niso opazili pomembnih razlik v varnosti ali učinkovitosti med bolniki z blago ledvično okvaro (očistek kreatinina [CLCR]: 50 do 80 ml/min) in bolniki z normalnim delovanjem ledvic.
In the phase III clinical trials, median reductions of approximately 80% were maintained in uNTx/Cr after 3 months of treatment in 2075 XGEVA-treated advanced cancer patients’ naïve to IV- bisphosphonate.
V kliničnih preskušanjih III. faze se je mediana približno 80 % znižanje uNTx/kreatinin po 3 mesecih zdravljenja ohranilo pri 2.075 bolnikih z napredovanim rakom, ki so prejemali zdravilo XGEVA in pred tem še niso dobivali intravenskega bisfosfonata.
In the Phase III pJIA study through week 48, antibodies to golimumab were detected by the drug-tolerant EIA method in 40% (69/172) of golimumab treated children of which a majority had a titre lower than 1:1000.
V III. fazi študije pJIA so do 48. tedna z metodo EIA, ki je tolerantna za zdravilo, zaznali protitelesa proti golimumabu pri 40 % (69/172) otrok, zdravljenih z golimumabom, pri čemer je bil pri večini titer manjši od 1:1.000.
In the Phase III studies in RA, PsA, AS, and UC, no overall differences in adverse events (AEs), serious adverse events (SAEs), and serious infections in patients age 65 or older who received Simponi were observed compared with younger patients.
V študijah faze III pri bolnikih z RA, PsA, AS in UK na splošno niso opazili nobenih razlik v neželenih učinkih (NU), resnih neželenih učinkih (RNU) in resnih okužbah pri bolnikih, starih 65 let ali več, ki so prejemali zdravilo Simponi, v primerjavi z mlajšimi bolniki.
In the phase III studies MEK115306 (n = 209) and MEK116513 (n = 350) with trametinib in combination with dabrafenib in patients with unresectable or metastatic melanoma, 56 patients (27%) and 77 patients (22%) respectively were ≥65 years of age; 11 patients (5%) and 21 patients (6%) respectively were ≥75 years of age.
V študijah faze III MEK115306 (n = 209) in MEK116513 (n = 350) s trametinibom v kombinaciji z dabrafenibom pri bolnikih z inoperabilnim ali metastatskim melanomom je bilo 56 bolnikov (27 %) oziroma 77 bolnikov (22 %) starih najmanj 65 let; 11 bolnikov (5 %) oziroma 21 bolnikov (6 %) pa je bilo starih najmanj 75 let.
In the Phase III studies MEK115306 (n=209) and MEK116513 (n=350) with dabrafenib in combination with trametinib in patients with unresectable or metastatic melanoma, 56 patients (27%) and 77 patients (22%) respectively were ≥65 years of age, 11 patients (5%) and 21 patients (6%) respectively were ≥75 years of age.
V študijah faze III MEK115306 (n = 209) in MEK116513 (n = 350) z dabrafenibom v kombinaciji s trametinibom pri bolnikih z inoperabilnim ali metastatskim melanomom je bilo 56 bolnikov (27 %) oziroma 77 bolnikov (22 %) starih najmanj 65 let; 11 bolnikov (5 %) oziroma 21 bolnikov (6 %) pa je bilo starih najmanj 75 let.
In the phase III studies, injection site related reactions (e.g. injection site pain, injection site discomfort) were all grade 1 or 2 in severity and were comparable between pasireotide intramuscular use and octreotide intramuscular use treated patients.
V študijah faze III so bile vse reakcije na mestu injiciranja (na primer bolečina na mestu injiciranja in neprijeten občutek na mestu injiciranja) stopnje 1 ali 2 in primerljive med bolniki, ki so prejemali pasireotid za intramuskularno uporabo, in tistimi, ki so prejemali oktreotid za intramuskularno uporabo.
In the Phase III study (HPV-015) in women 26 years and older, at the 48-month time point, i.e.
V študiji III. faze (HPV-015) pri ženskah, starih 26 let in več, so med ženskami, ki so bile ob vstopu v študijo seronegativne, po 48 mesecih (tj.
In the Phase III study comparing bortezomib administered intravenously versus subcutaneously, the incidence of Grade  2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
V študiji faze III z bortezomibom, ki je primerjala intravensko in subkutano dajanje zdravila, je bila pogostnost dogodkov periferne nevropatije  2. stopnje v skupini, ki je prejemala zdravilo subkutano 24%, v skupini, ki je prejemala zdravilo intravensko pa 41% (p=0,0124).
In the phase III study D2301 (RESTORE), 345 patients were randomised in a 1:1:1 ratio to receive ranibizumab 0.5 mg monotherapy and sham laser photocoagulation, combined ranibizumab 0.5 mg and laser photocoagulation or sham injection and laser photocoagulation.
V študiji faze III z oznako D2301 (RESTORE) so 345 bolnikov randomizirali v razmerju 1:1:1 tako, da so prejemali bodisi ranibizumab 0,5 mg v monoterapiji skupaj z zgolj navidezno lasersko fotokoagulacijo, bodisi kombinirano zdravljenje z ranibizumabom 0,5 mg in z lasersko fotokoagulacijo ali zgolj navidezno injiciranje in pravo lasersko fotokoagulacijo.
In the Phase III study in patients with newly diagnosed chronic phase CML, treatment was discontinued for adverse reactions in 5% of SPRYCEL-treated patients and 4% of imatinib-treated patients with a minimum of 12 months follow-up.
V študiji III. faze pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju je bilo po najmanj 12-mesečnem obdobju spremljanja zdravljenje zaradi neželenih učinkov prekinjeno pri 5% bolnikov, ki so prejemali zdravilo SPRYCEL in pri 4% bolnikov, ki so prejemali imatinib.
In the Phase III study in patients with newly diagnosed CML in chronic phase receiving 300 mg nilotinib twice daily, the change from baseline in mean time-averaged QTcF interval at steady state was 6 msec.
V študiji faze III je pri bolnikih z novo odkrito KML v kronični fazi, ki so prejemali odmerek 300 mg nilotiniba dvakrat dnevno, v ravnovesnem stanju prišlo do srednjega časovno povprečnega podaljšanja intervala QTcF za 6 milisekund glede na izhodišče.
In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with bortezomib+melphalan+prednisone compared with melphalan+prednisone (14% versus 4% respectively).
V študiji faze III, pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom, je bila splošna pojavnost reaktivacije virusa herpes zoster pri bolnikih zdravljenih z bortezomibom + melfalanom + prednizonom pogostejša, kot pri bolnikih zdravljenih z melfalanom + prednizonom (14% v primerjavi s 4%).
In the Phase III study MEK115306, cuSCC occurred in 3% (6/209) of patients receiving trametinib in combination with dabrafenib and 10% (22/211) of patients receiving dabrafenib as a single agent.
V študiji faze III MEK115306 je do ploščatoceličnega karcinoma kože prišlo pri 3 % (6/209) bolnikov, ki so prejemali trametinib v kombinaciji z dabrafenibom, in pri 10 % (22/211) bolnikov, ki so prejemali dabrafenib kot samostojno zdravilo.
In the Phase III study MEK116513, cuSCC occurred in 1% (5/350) of patients receiving trametinib in combination with dabrafenib and 18% (63/349) of patients receiving vemurafenib as a single agent.
V študiji faze III MEK116513 je do ploščatoceličnega karcinoma kože prišlo pri 1 % (5/350) bolnikov, ki so prejemali trametinib v kombinaciji z dabrafenibom, in pri 18 % (63/349) bolnikov, ki so prejemali vemurafenib kot samostojno zdravilo.
In the phase III study RE-LY (see section 5.1.) the overall rate of myocardial infarction (MI) was 0.82, 0.81, and 0.64 % / year for dabigatran etexilate 110 mg twice daily, dabigatran etexilate 150 mg twice daily and warfarin, respectively, an increase in relative risk for dabigatran of 29 % and 27 % compared to warfarin.
V raziskavi faze III RE-LY je skupna pojavnost miokardnih infarktov na leto med zdravljenjem z dabigatran eteksilatom v odmerkih po 110 mg dvakrat na dan dosegla 0,82 %, dabigatran eteksilatom v odmerkih po 150 mg dvakrat na dan 0,81 %, in varfarinom 0,64 %, kar pomeni numerično povečanje relativnega tveganja ob dabigatranu za 29 % in 27 % v primerjavi z varfarinom (glejte poglavje 5.1).
In the phase III study RE-LY (see section 5.1.) the overall rate of myocardial infarction (MI) was 0.82, 0.81, and 0.64 % / year for dabigatran etexilate 110 mg twice daily, dabigatran etexilate 150 mg twice daily and warfarin, respectively, an increase in relative risk for dabigatran of 29 % and 27 % compared to warfarin.
V raziskavi III. faze RE-LY je skupna pojavnost miokardnih infarktov na leto med zdravljenjem z dabigatran eteksilatom v odmerkih po 110 mg dvakrat na dan dosegla 0,82 %, dabigatran eteksilatom v odmerkih po 150 mg dvakrat na dan 0,81 %, in varfarinom 0,64 %, kar pomeni numerično povečanje relativnega tveganja ob dabigatranu za 29 % in 27 % v primerjavi z varfarinom (glejte poglavje 5.1).
In the phase III study with trametinib in patients with unresectable or metastatic melanoma (n = 211), 49 patients (23%) were ≥65 years of age, and 9 patients (4%) were ≥75 years of age.
V študiji trametiniba III. faze pri bolnikih z inoperabilnim ali metastatskim melanomom (n = 211) je bilo 49 bolnikov (23 %) starih ≥ 65 let, 9 bolnikov (4 %) pa ≥ 75 let.
In the Phase III study, 69 patients were on lenalidomide 5 mg, 69 patients on lenalidomide 10 mg and 67 patients were on placebo during the double-blind phase of the study.
V študiji faze III je 69 bolnikov prejemalo lenalidomid 5 mg, 69 bolnikov lenalidomid 10 mg in 67 bolnikov placebo med dvojno slepo fazo študije.
In the phase III study, cases of ONJ have been reported in 0.67% patients (4/600) in the Xofigo arm compared to 0.33% patients (1/301) in the placebo arm.
V študiji III. faze so poročali o primerih osteonekroze čeljusti pri 0,67 % (4/600) bolnikov, ki so prejemali zdravilo Xofigo, v primerjavi z 0,33 % bolnikov (1/301), ki so prejemali placebo.
In the Phase III trials DUET-1 and DUET-2, mutations that developed most commonly in patients with virologic failure to the INTELENCE containing regimen were V108I, V179F, V179I, Y181C and Y181I, which usually emerged in a background of multiple other NNRTI resistance-associated mutations (RAMs).
V preskušanjih III. faze DUET-1 in DUET-2 so bile mutacije, ki so se najpogosteje razvile pri bolnikih, pri katerih je bila shema zdravljenja z zdravilom INTELENCE virološko neuspešna, naslednje: V108I, V179F, V179I, Y181C in Y181I in so se običajno pojavile ob več drugih osnovnih mutacijah, povezanih z odpornostjo na NNRTI (RAM - Resistance-Associated Mutation).
In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% versus 28.6% (study MN301), and 49.4% versus 26.3% (study US301).After
V preskušanjih III. faze je bil delež odziva po ACR na leflunomid 20 mg/dan v primerjavi s placebom 54,6 % proti 28,6 % (študija MN301) in 49,4 % proti 26,3 % (študija US301).
In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% vs.
V preskušanjih III. faze je bil delež odziva po ACR na leflunomid 20 mg/dan v primerjavi s placebom 54,6 % proti 28,6 % (študija MN301) in
In the phase IIIb study D2304 (RETAIN), 372 patients were randomised in 1:1:1 ratio to receive: ranibizumab 0.5 mg with concomitant laser photocoagulation on a treat-and-extend (TE) regimen, ranibizumab 0.5 mg monotherapy on a TE regimen, ranibizumab 0.5 mg monotherapy on a PRN regimen.
V študiji faze IIIb z oznako D2304 (RETAIN) so 372 bolnikov randomizirali v razmerju 1:1:1 tako, da so prejemali: ranibizumab 0,5 mg s sočasno lasersko fotokoagulacijo po shemi “Zdravi in podaljšaj”, ranibizumab 0,5 mg v monoterapiji po shemi “Zdravi in podaljšaj”, ranibizumab 0,5 mg v monoterapiji po shemi pro re nata.
In the phase IIIb study D2304 (RETAIN), 372 patients were randomised in 1:1:1 ratio to receive: ranibizumab 0.5 mg with concomitant laser photocoagulation on a treat-and-extend (TE) regimen, ranibizumab 0.5 mg monotherapy on a TE regimen, ranibizumab 0.5 mg monotherapy on a PRN regimen.
V študiji faze IIIb z oznako D2304 (RETAIN) so 372 bolnikov randomizirali v razmerju 1:1:1 tako, da so: ranibizumab 0,5 mg s sočasno lasersko fotokoagulacijo po shemi “Zdravi in podaljšaj”, ranibizumab 0,5 mg v monoterapiji po shemi “Zdravi in podaljšaj”, ranibizumab 0,5 mg v monoterapiji po shemi pro re nata.
In the Phase IIIb trial in Crohn’s disease, SONIC, placebo patients received AZA 2.5 mg/kg/day as active control in addition to placebo infliximab infusions.
V preskušanju IIIb faze SONIC pri bolnikih s Crohnovo boleznijo, so bolniki iz placebo skupine, poleg placebo infuzij infliksimaba, prejemali kot kontrolno učinkovino AZA v odmerku 2,5 mg/kg na dan.