natgillin/translations-raw huggingface dataset:
In studies of clinically-relevant duration (14-28 days), daptomycin administration was associated with minimal to mild degenerative/regenerative changes in skeletal muscle in the rat and dog.
U ispitivanjima s klinički značajnim trajanjem (14-28 dana), primjena daptomicina bila je povezana s minimalnim do blagim degenerativnim/regenerativnim promjenama u skeletnim mišićima u štakora i psa.
In studies of MabThera in patients with Waldenstrom’s macroglobulinaemia, transient increases in serum IgM levels have been observed following treatment initiation, which may be associated with hyperviscosity and related symptoms.
U ispitivanjima primjene lijeka MabThera u bolesnika s Waldenstromovom makroglobulinemijom primijećena su prolazna povećanja serumske razine IgM-a nakon početka liječenja, što može biti povezano s hiperviskoznošću i srodnim simptomima.
In studies of patients with metastatic advanced prostate cancer who were using an LHRH analogue, or were previously treated with orchiectomy, ZYTIGA was administered at a dose of 1,000 mg daily in combination with low dose prednisone or prednisolone (10 mg daily).
U ispitivanjima bolesnika s metastatskim uznapredovalim karcinomom prostate koji su liječeni analogom LHRH-a, ili su ranije podvrgnuti orhidektomiji, ZYTIGA je primjenjena u dozi od 1000 mg na dan u kombinaciji s niskom dozom prednizona ili prednizolona (10 mg na dan).
In studies of sepsis, 1015 patients received Kineret at doses up to 2 mg/kg/hour i.v. (~35 times the recommended dose in RA) over a 72 hour treatment period.
U ispitivanjima sepse, 1015 bolesnika primilo je Kineret u dozama do 2 mg/kg/sat intravenski (~35 puta više od preporučene doze za bolesnike s RA) tijekom razdoblja liječenja od 72 sata.
In studies of up to 9 months an overall mean decrease of 1% in height percentile (decrease of 2% in children (7-11 years) and increase of 0.3% in adolescents (12-17 years)) was observed in duloxetine- treated paediatric patients (see section 4.4).
U ispitivanjima u trajanju do 9 mjeseci, u pedijatrijskih bolesnika liječenih duloksetinom primijećena je ukupna srednja vrijednost smanjenja percentila visine za 1% (smanjenje za 2% u djece (7-11 godina) i porast od 0,3% u adolescenata (12-17 godina)) (vidjeti dio 4.4).
In studies performed in rats and rabbits no clinically relevant evidence of harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development was observed.
U studijama provedenim na štakorima i zečevima nisu primijećeni klinički značajni dokazi o štetnim učincima na trudnoću, embrio-fetalni razvoj, porođaj ili postnatalni razvoj.
In studies performed with spinosad only, the primary biliary, faecal and urinary metabolites in both rat and dog were identified as the demethylated spinosyns, glutathione conjugates of the parent compounds and N-demethylated spinosyns A and D. Excretion is primarily via the bile and faeces, and to a lesser extent in the urine.
U ispitivanjima koja su sadržavala samo spinosad, primarni bilijarni, fekalni i urinarni metaboliti u miševa i pasa identificirani su kao demetilirani spinosini, konjugati glutationa izvornih spojeva i N- demetiliranih spinosina A i D. Izlučivanje je primarno preko žuči i izmeta i manjim dijelom preko mokraće.
In studies to explore extending the dosing interval (40,000 IU once weekly and 80,000, 100,000, and 120,000 IU bi-weekly), a linear but non-dose-proportional relationship was observed between mean Cmax and dose, and between mean AUC and dose at steady state.
U ispitivanjima koja su istraživala produljenje intervala doziranja (40 000 IU jednom tjedno i 80 000, 100 000 i 120 000 IU jednom u 2 tjedna) uočeno je da je odnos između srednje vrijednosti Cmax i doze te srednje vrijednosti AUC i doze u stanju ravnoteže linearan, ali ne i proporcionalan dozi.
In studies to explore extending the dosing interval (40,000 IU once weekly and 80,000, 100,000, and 120,000 IU biweekly), a linear but non-dose-proportional relationship was observed between mean Cmax and dose, and between mean AUC and dose at steady state.
U ispitivanjima koja su istraživala produljenje intervala doziranja (40 000 IU jednom tjedno i 80 000, 100 000 i 120 000 IU jednom u 2 tjedna) uočeno je da je odnos između srednje vrijednosti Cmax i doze te srednje vrijednosti AUC i doze u stanju ravnoteže linearan, ali ne i proporcionalan dozi.
In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
U ispitivanjima u trajanju do 3 mjeseca na miševima te do godine dana na štakorima i psima, prevladavajući učinci bili su depresija središnjeg živčanog sustava (SŽS), antikolinergički učinci i periferni hematološki poremećaji.
In studies using the criteria- based up-titration regimen, a majority of patients achieved the pre-defined target LDL-C (based on their level of CV risk) on the 75 mg Q2W dose, and a majority of patients maintained treatment on the 75 mg Q2W dose.
U ispitivanjima u kojima se primjenjivao režim postupnog povećanja doze na temelju zadanih kriterija, većina bolesnika postigla je unaprijed određenu ciljnu vrijednost LDL-C (određenu na temelju njihove vrijednosti KV rizika) uz dozu od 75 mg jednom svaka 2 tjedna te je većina bolesnika nastavila liječenje dozom od 75 mg jednom svaka 2 tjedna.
In studies when adult patients received concurrent treatment with Enbrel plus anakinra, a higher rate of serious infections compared to Enbrel alone was observed and 2% of patients (3/139) developed neutropenia (absolute neutrophil count  1000/ mm3).
U ispitivanjima u kojima su odrasli bolesnici primali istodobno Enbrel i anakinru opažena je povećana stopa ozbiljnih infekcija u usporedbi sa samo Enbrelom, dok je 2% bolesnika (3/139) razvilo neutropeniju (apsolutni broj neutrofila < 1000/mm3 ).
In studies when adult patients received concurrent treatment with Enbrel plus anakinra, a higher rate of serious infections compared to Enbrel alone was observed and 2% of patients (3/139) developed neutropenia (absolute neutrophil count  1000/mm3).
U ispitivanjima u kojima su odrasli bolesnici primali istodobno Enbrel i anakinru opažena je povećana stopa ozbiljnih infekcija u usporedbi sa samo Enbrelom, dok je 2% bolesnika (3/139) razvilo neutropeniju (apsolutni broj neutrofila < 1000/mm3 ).
In studies when adult patients received concurrent treatment with Enbrel plus anakinra, a higher rate of serious infections compared to Enbrel alone was observed and 2% of patients (3/139) developed neutropenia (absolute neutrophil count  1000/mm3).
U ispitivanjima u kojima su odrasli bolesnici primali istodobno Enbrel i anakinru, opažena je povećana stopa ozbiljnih infekcija u usporedbi sa samo Enbrelom, dok je 2% bolesnika (3/139) razvilo neutropeniju (apsolutni broj neutrofila < 1000/mm3 ).
In studies when adult patients received concurrent treatment with Enbrel plus anakinra, a higher rate of serious infections compared to Enbrel alone was observed, and 2% of patients (3/139) developed neutropenia (absolute neutrophil count  1000/mm3).
U ispitivanjima u kojima su odrasli bolesnici primali istodobno Enbrel i anakinru, opažena je povećana stopa ozbiljnih infekcija u usporedbi sa samo Enbrelom, dok je 2% bolesnika (3/139) razvilo neutropeniju (apsolutni broj neutrofila < 1000/mm3 ).
In studies where tipranavir co- administered with low-dose ritonavir was used with or without enfuvirtide, it has been observed that the steady-state plasma tipranavir trough concentration of patients receiving enfuvirtide were 45% higher as compared to patients not receiving enfuvirtide.
U ispitivanjima u kojima je tipranavir s niskom dozom ritonavira rabljen sa ili bez enfuvirtida, primijećeno je da su koncentracije tipranavira na kraju dozirnog intervala u stanju dinamičke ravnoteže bile 45% više u bolesnika koji su primali enfuvirtid.
In studies with adults, data were obtained after two doses of Bexsero with a one month or two month interval between doses (see Table 7).
U ispitivanjima u odraslih podaci su dobiveni nakon dvije doze Bexsera s intervalom od jednog ili dva mjeseca između doza (vidjeti Tablicu 7).
In studies with daily i.v. dosing regimen, there was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in rats and rabbits.
U ispitivanjima primjene svakodnevne intravenske doze nije bilo dokaza izravne toksičnosti za plod ili teratogenih učinaka ibandronatne kiseline u zečeva i štakora.
In studies with nucleoside-naïve patients, on-treatment ALT elevations > 10 times ULN (upper limit of normal) and > 2 times baseline occurred in 2.6% of tenofovir disoproxil fumarate-treated patients.
U ispitivanjima na pacijentima koji prethodno nisu dobivali nukleozide tijekom liječenja zabilježeno je povišenje razine ALT-a čija je vrijednost bila 10 puta viša od gornje granice normale i više od dva puta viša od početnih vrijednosti u 2,6% pacijenata koji su primali tenofovirdizoproksilfumarat.
In studies with rats a reduction in fertility indices was observed at parentally toxic doses (see section 5.3).
U istraživanjima na štakorima opaženo je smanjenje indeksa plodnosti pri dozama toksičnim za roditelje (vidjeti dio 5.3).
In studies with VPRIV additional side effects have also been reported: Very common side effects are:
U ispitivanjima sa VPRIV-om također su prijavljene dodatne nuspojave: Vrlo česte nuspojave su:
In studies without antibacterial soaking, pyrexia or hyperthermia was reported in 35.6% of NexoBrid- treated patients compared with 18.6% in control patients.
U ispitivanjima bez antibakterijskih obloga pireksija ili hipertermija zabilježena je u 35,6% bolesnika liječenih NexoBridom u usporedbi s 18,6% kontrolnih ispitanika.
In studies, 93% of the patients receiving Vectibix had side effects affecting the skin, although most of these were mild or moderate.
U 93 % bolesnika koji su primali Vectibix u ispitivanjima pojavljivale su se nuspojave koje su utjecale na kožu, iako je većina ovih nuspojava bila blaga ili umjerena.
In studies, Aubagio was shown to reduce relapses and delay the progression of disability in patients with relapsing- remitting MS.
Ispitivanja su pokazala da Aubagio smanjuje relapse i odgađa napredovanje onesposobljenosti kod bolesnika s relapsno-remitirajućom multiplom sklerozom.
In studies, Cresemba’s effect was comparable to that of voriconazole in treating invasive aspergillosis.
Djelovanje lijeka Cresemba tijekom ispitivanja bilo je usporedivo s djelovanjem vorikonazola u liječenju invazivne aspergiloze.
In studies, the effectiveness of Genvoya was high and comparable to that of a medicine containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.
Učinkovitost lijeka Genvoya u ispitivanjima se pokazala visokom i usporedivom s učinkovitošću lijeka koji sadrži elvitegravir, kobicistat, emtricitabin i tenofovirdizoproksil.
In studies, the most common side effects with Sprycel (seen in more than 1 patient in 10) were infection, suppression of the bone marrow (decreasing numbers of blood cells), headache, haemorrhage (bleeding), pleural effusion (fluid around the lungs), dyspnoea (difficulty breathing),, diarrhoea, vomiting, nausea (feeling sick), abdominal pain (stomach ache), skin rash, musculoskeletal pain, fatigue (tiredness), swelling in the extremities and the face, pyrexia (fever), neutropenia (low levels of neutrophils), thrombocytopenia (low blood platelet counts) and anaemia (low red blood cell counts).
Najčešće nuspojave lijeka Sprycel (mogu se javiti u više od 1 na 10 osoba), koje su uočene u ispitivanjima, su infekcija, supresija koštane srži (smanjivanje broja krvnih stanica), glavobolja, hemoragija (krvarenje), pleuralna efuzija (tekućina oko pluća), dispneja (otežano disanje), proljev, povraćanje, mučnina (osjećaj slabosti9, abdominalna bol (bol u želucu), osip na koži, mišičnokoštana bol, iscrpljenost (umor), oticanje u ekstremitetima i licu, pireksija (vrućica), neutropenija (niske razine neutrofila), trombocitopenija (niski broj trombocita) i anemija (mali broj crvenih krvnih stanica).
In studies, the most common side effects with Tarceva when used as monotherapy for lung cancer were rash (seen in 75% of patients), diarrhoea (seen in 54% of patients), loss of appetite and tiredness (each seen in 52% of patients).
U ispitivanjima, najčešće nuspojave lijeka Tarceva kada se primjenjivao kao monoterapija za rak pluća bile su osip (zabilježen u 75 % bolesnika), proljev (zabilježen u 54 % bolesnika), gubitak apetita i umor (zabilježeni u 52 % bolesnika).
In studies, the most common side effects with Tysabri (seen in between 1 and 10 patients in 100) were urinary tract infection (infection of the structures that carry urine), nasopharyngitis (inflammation of the nose and throat), urticaria (itchy rash), headache, dizziness, vomiting, nausea (feeling sick), arthralgia (joint pain), rigors (shaking chills), pyrexia (fever) and fatigue (tiredness).
Najčešće su nuspojave lijeka Tysabri zabilježene u ispitivanjima (uočene u između 1 i 10 na 100 bolesnika) upala mokraćnog sustava (upala struktura koje prenose urin), nazofaringitis (upala nosa i grla), urtikarija (osip praćen svrbežom), glavobolja, omaglica, povraćanje, mučnina (osjećaj slabosti), artralgija (bol u zglobovima), tresavica (zimica), pireksija (vrućica) i iscrpljenost (umor).
In studies,some eye-related side-effects have been reported both in patients using Strensiq and those who were not, probably associated with hypophosphatasia.
U ispitivanjima su zabilježene neke nuspojave povezane s očima, vjerojatno povezane s hipofosfatazijom, i u bolesnika koji su primali Strensiq i u onih koji ga nisu primali.
In study 007 the efficacy of Cervarix against 12-month persistent HPV-16/18 infection was 100% (95% CI: 80.5; 100).
U ispitivanju 007 djelotvornost cjepiva Cervarix protiv 12-mjesečne perzistentne infekcije HPV-16/18 iznosila je 100% (95% CI: 80,5; 100).
In study 0102 [ANC ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, no blood blasts, BM blasts < 5 % and no extramedullary disease]
CHR: Studija 0102 [ABN ≥1,5 x 109/l, trombociti ≥100 x 109/l, nema blasta u krvi, blasti u KS <5 % i nema ekstramedularne bolesti]
In study 0126, decreases in haemoglobin during treatment were very common with 32.5% (13/40 subjects) experiencing a decline in haemoglobin to <10 g/dL, 1 of whom also had a decline to <8.5 g/dL.
U ispitivanju 0126, sniženje hemoglobina tijekom liječenja bilo je vrlo često, s 32,5% (13/40) ispitanika u kojih je hemoglobin bio snižen na < 10 g/dl, među kojima je u jednog bio snižen na < 8,5 g/dl.
In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm3 was observed in 4 % (8/194) of patients and decrease in platelets below 50,000/mm3 was observed in 4 % (8/194) of patients receiving PegIntron in combination with ribavirin.
U Ispitivanju 1 (vidjeti dio 5.1) smanjenje apsolutnog broja neutrofila na manje od 500 stanica/mm3 zabilježeno je u 4% (8/194) bolesnika, a smanjenje broja trombocita ispod 50 000/mm3 također u 4% (8/194) bolesnika koji su primali PegIntron u kombinaciji s ribavirinom.
In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm3 was observed in 4 % (8/194) of patients and decrease in platelets below 50,000/mm3 was observed in 4 % (8/194) of patients receiving ViraferonPeg in combination with ribavirin.
U Ispitivanju 1 (vidjeti dio 5.1) smanjenje apsolutnog broja neutrofila na manje od 500 stanica/mm3 zabilježeno je u 4% (8/194) bolesnika, a smanjenje broja trombocita ispod 50 000/mm3 također u 4% (8/194) bolesnika koji su primali ViraferonPeg u kombinaciji s ribavirinom.
In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm3 was observed in 4% (8/194) of patients and decrease in platelets below 50,000/mm3 was observed in 4% (8/194) of patients receiving ribavirin capsules in combination with peginterferon alfa-2b.
U Ispitivanju 1 (vidjeti dio 5.1) smanjenje apsolutnog broja neutrofila ispod vrijednosti od 500 stanica/mm3 opaženo je u 4 % (8/194) bolesnika, a smanjenje broja trombocita ispod 50 000/mm3 opaženo je u 4 % (8/194) bolesnika koji su primali kapsule lijeka Ribavirin Mylan u kombinaciji s peginterferonom alfa-2b.
In Study 1 by Year 3, mean calculated GFR was 21 ml/min/1.73 m2 higher with belatacept, and 10% and 20% of patients reached CKD stage 4/5 (GFR < 30 ml/min/1.73 m2) with belatacept versus ciclosporin, respectively.
U Ispitivanju 1 je, do 3. godine, prosječni izračunati GFR uz belatacept bio viši za 21 ml/min/1,73 m2, a 10% bolesnika liječenih belataceptom i 20% bolesnika liječenih ciklosporinom doseglo je stadij CKD 4/5 (GFR < 30 ml/min/1,73 m2).
In Study 1, only 4% of patients in the Omidria group compared to 23% of patients in the placebo group had a pupil diameter < 6 mm at the time of cortical clean-up, and 3% of patients in the Omidria group compared to 28% of patients in the placebo group had a pupil constriction ≥2.5 mm (P<0.0001 in both instances, Chi-Square test).
U ispitivanju 1, samo je 4% bolesnika u grupi koja je liječena lijekom Omidria, u usporedbi s 23% bolesnika u grupi koja je primila placebo, imalo promjer zjenice < 6 mm u trenutku uklanjanja kortikalnog materijala, te 3% bolesnika u grupi liječenoj lijekom Omidria u usporedbi s 28% bolesnika u grupi koja je primala placebo, imalo je konstrikciju zjenice ≥2,5 mm (P<0,0001 u oba slučaja, hi-kvadrat test).
In Study 1, patients had the following median baseline characteristics: age 39 years, disease duration
U Ispitivanju 1 bolesnici su imali sljedeće vrijednosti medijana za značajke na početku ispitivanja: starost 39 godina, trajanje bolesti 7,0 godina, EDSS bodovi 2,0.
In Study 1, pharmacodynamics was assessed in 57 newly diagnosed paediatric patients with standard-risk ALL who received three intramuscular doses of Oncaspar (2500 Units/m2), one each during induction and two delayed intensification treatment phases.
U Ispitivanju 1 farmakodinamika je ocijenjena u 57 novodijagnosticiranih pedijatrijskih bolesnika sa ALL standardnog rizika koji su primili tri intramuskularne doze Oncaspara (2500 jedinica/m2), jednu tijekom indukcije i dvije tijekom faze kasne intenzifikacije liječenja.
In Study 1, the CMH weighted mean difference (Omidria – placebo) in the mean AUC was -5.20 mm [95% confidence interval: -7.31, -3.09] (P < 0.001).
U ispitivanju 1, CMH ponderirana srednja razlika (Omidria - placebo) u srednjem AUC iznosila je -5,20 mm [95% interval pouzdanosti: -7,31, -3,09] (P < 0,001).
In Study 1, the most common adverse reactions were infections, including two life-threatening infections (1 patient in each arm).
U Ispitivanju 1 najčešće nuspojave bile su infekcije, uključujući dvije infekcije opasne po život (1 bolesnik u svakoj skupini).
In Study 1, the proportion of patients who withdrew was higher in the Selincro group than in the placebo group (50% versus 32%, respectively).
U ispitivanju 1, omjer bolesnika koji su odustali bio je veći u skupini koja je primala Selincro nego u skupini koja je primala placebo (50% naspram 32%).
In Study 1005, the adjusted geometric mean Ctrough, ss of crizotinib in mild (N=191) and moderate (N=65) renal impairment groups were 9.1% and 15% higher, respectively, than those in patients with normal renal function.
U Ispitivanju 1005, prilagođena geometrijska sredina Ctrough, ss krizotiniba u skupinama s blagim (N=191) i umjerenim (N=65) oštećenjem funkcije bubrega bila je 9,1% odnosno 15% viša nego u bolesnika s normalnom funkcijom bubrega.
In study 1100.1090, from which the majority of related adverse events (n=28) were received, patients on placebo had a higher incidence of events of granulocytopenia (3.3 %) than patients on nevirapine (2.5 %).
U ispitivanju 1100.1090 iz kojeg potječe većina prijavljenih nuspojava (n=28), bolesnici na placebu imali su višu incidenciju događaja granulocitopenije (3,3%) nego bolesnici na nevirapinu (2,5%).
In study 1100.1090, from which the majority of related adverse events (n=28) were received, patients on placebo had a higher incidence of events of granulocytopenia (3.3 %) than patients on nevirapine (2.5 %).
U studiji 1100.1090 iz kojeg potječe većina prijavljenih nuspojava (n=28), bolesnici na placebu imali su višu incidenciju događaja granulocitopenije (3,3%) nego belesnici na nevirapinu (2,5%).
In study 1100.1090, from which the majority of related adverse events (n=28) were received, patients on placebo had a higher incidence of events of granulocytopenia (3.3%) than patients on nevirapine (2.5%).
U ispitivanju 1100.1090, iz kojeg je zaprimljena većina povezanih nuspojava (n=28), incidencija granulocitopenije bila je viša u bolesnika koji su dobivali placebo (3,3%) nego u onih koji su uzimali nevirapin (2,5%).
In study 1100.1486 (VERxVE) antiretroviral-naïve patients received a lead-in dose of Viramune 200 mg immediate-release once daily for 14 days (n=1,068) and then were randomised to receive either Viramune 200 mg immediate-release twice daily or Viramune 400 mg prolonged-release once daily.
U ispitivanju 1100.1486 (VERxVE) “neliječeni” bolesnici antiretrovirusnom terapijom primali su uvodnu dozu Viramunea 200 mg s trenutnim oslobađanjem jednom dnevno tijekom 14 dana (n=1068) te su zatim ranodmizirani za ili Viramune 200 mg s trenutnim oslobađanjem dvaput dnevno ili Viramune 400 mg s produljenim oslobađanjem jednom dnevno.
In Study 19, 18 patients were identified with a somatic tumour BRCA mutation (a mutation in the tumour but wildtype in the germline).
U ispitivanju 19, kod 18 bolesnica je nađena somatska tumorska BRCA mutacija (mutacija u tumoru ali divlji tip u zametnim stanicama).
In Study 2 by Year 3, mean calculated GFR was 11 ml/min/1.73 m2 higher with belatacept, and 27% and 44% of patients reached CKD stage 4/5 (GFR < 30 ml/min/1.73 m2) with belatacept versus ciclosporin, respectively.
U Ispitivanju 2 je, do 3. godine, prosječni izračunati GFR uz belatacept bio viši za 11 ml/min/1,73 m2, a 27% bolesnika liječenih belataceptom i 44% bolesnika liječenih ciklosporinom doseglo je stadij CKD 4/5 (GFR < 30 ml/min/1,73 m2).
In Study 2, a Phase 1 study, 16 of 37 patients with CD were treated with siltuximab, at the recommended dose of 11 mg/kg every 3 weeks
U Ispitivanju 2, ispitivanju faze 1, 16 od 37 bolesnika s CD bilo je liječeno siltuksimabom, pri preporučenoj dozi od 11 mg/kg svaka 3 tjedna.
In Study 2, only 4% of patients in the Omidria group compared to 23% of patients in the placebo group had a pupil diameter < 6 mm at cortical clean-up, and 1% of patients in the Omidria group compared to 27% of patients in the placebo group had a pupil constriction ≥2.5 mm (P<0.0001, Chi-Square test).
U ispitivanju 2, samo je 4% bolesnika u grupi koja je liječena lijekom Omidria, u usporedbi s 23% bolesnika u grupi koja je primila placebo, imalo promjer zjenice < 6 mm u trenutku kortikalnog čišćenja, te 1% bolesnika u grupi liječenoj lijekom Omidria u usporedbi s 27% bolesnika u grupi koja je primala placebo placebo, imalo je konstrikciju zjenice ≥2,5 mm (P<0,0001, hi-kvadrat test).
In Study 2, patients had the following median baseline characteristics: age 37 years, disease duration 6.0 years, EDSS score 2.5. In addition, 17% of patients had an EDSS score >3.5, 32% had
U Ispitivanju 2 bolesnici su imali sljedeće vrijednosti medijana za značajke na početku ispitivanja: starost 37 godina, trajanje bolesti 6,0 godina i EDSS bodova 2,5.
In Study 2, the CMH weighted mean difference (Omidria – placebo) in the mean AUC was 0.59 mm [95% confidence interval: 0.49, 0.69] (P < 0.0001).
U ispitivanju 2, CMH ponderirana srednja razlika (Omidria - placebo) u srednjoj vrijednosti područja ispod krivulje (AUC) iznosila je 0,59 mm [95% interval pouzdanosti: 0,49; 0,69] (P < 0,0001).
In study 301, overall the most frequently reported events during the MTT were cough in 18 (4.8%) subjects, wheezing/bronchospasm in eight (2.1%) subjects and chest discomfort in six (1.6%) subjects.
U ispitivanju 301, najučestalije nuspojave zabilježene tijekom MTT-a bile su kašalj u 18 (4,8%) ispitanika, piskanje/bronhospazam u osam (2,1%) ispitanika i nelagoda u prsima u šest (1,6%) ispitanika.