natgillin/translations-raw huggingface dataset:
In clinical studies, NO2 levels &gt; 3 ppm or methaemoglobin levels &gt; 7 % were treated by reducing the dose of, or discontinuing, INOmax.
V kliničnih študijah so koncentracije NO2 &gt; 3 ppm ali koncentracije methemoglobina &gt; 7 % zdravili z zmanjšanjem odmerka ali prekinitvijo zdravljenja z zdravilom INOmax.
In clinical studies, patients with CrCl (creatinine clearance)  60 mL/min were included and treated at the recommended dose.
V klinične študije so bili vključeni bolniki z OK (očistek kreatinina) &gt; 60 ml/min, ki so bili tudi zdravljeni s priporočenim odmerkom.
In clinical studies, patients with severe renal impairment (creatinine clearance &lt; 30 ml/min) or receiving dialysis were at greater risk of developing hypocalcaemia in the absence of calcium supplementation.
V kliničnih študijah so ugotovili, da je tveganje za pojav hipokalciemije brez dodajanja kalcija večje pri bolnikih s hudo okvaro ledvic (očistek kreatinina &lt; 30 ml/min) in bolnikih na dializi.
In clinical studies, the incidence of important elevations in creatine phosphokinase (CK ≥ 3 times the ULN, &lt; 5 times the ULN) was 1.92% for patients treated with Pravafenix.
Med bolniki, ki so v kliničnih študijah prejemali zdravilo Pravafenix, je incidenca pomembnih zvišanj kreatin- fosfokinaze (KF ≥ 3-kratnika ZMN &lt; 5-kratnika ZMN) znašala 1,92 %.
In clinical studies, there was limited representation of patients with severe renal impairment (defined as eGFR &lt; 30 mL/min/1.73 m2) (see section 5.2).
V kliničnih študijah je bilo malo bolnikov s hudo okvaro ledvic (opredeljeno kot ocenjena hitrost glomerulne filtracije &lt; 30 ml/min/1,73 m2) (glejte poglavje 5.2).
In clinical studies, Zinbryta increased the incidence of depression [5% vs 1% (placebo); 8% vs 6% (interferon beta-1a (intramuscular))]; the incidence of serious reactions of depression was &lt; 1% with Zinbryta.
V kliničnih študijah je zdravilo Zinbryta povečalo incidenco depresije [5 % v primerjavi z 1 % (placebo); 8 % v primerjavi s 6 % (interferon beta-1a (intramuskularno))]; incidenca resnih reakcij depresije z zdravilom Zinbryta je bila &lt; 1 %.
In clinical trials first degree AV block (PR prolongation &gt; 220 msec) developed in 3% of patients within 2 hours of Rapiscan administration; transient second degree AV block with one dropped beat was observed in one patient receiving Rapiscan.
V kliničnih študijah se je v roku 2 ur po dajanju zdravila Rapiscan pri 3% bolnikov pojavil AV blok prve stopnje (podaljšanje intervala PR &gt; 220 msek); prehodni AV blok druge stopnje z enim izpuščenim utripom so opazili pri enem bolniku, ki je prejel zdravilo Rapiscan.
In clinical trials in children 6 to &lt; 12 years of age, the most commonly reported adverse reactions were headache, pyrexia and upper abdominal pain.
Med kliničnimi preskušanji pri otrocih, starih 6 do &lt; 12 let, so bile neželene reakcije, o katerih so najpogosteje poročali, glavobol, zvišana telesna temperatura in bolečine v zgornjem delu trebuha.
In clinical trials non-cutaneous malignancies were reported in 1% (6/586) of patients with dabrafenib monotherapy, and 1% (3/209) of patients in study MEK115306 and &lt; 1% (3/350) of patients in study MEK116513 with dabrafenib in combination with trametinib.
V kliničnih študijah so o nekožnih malignomih poročali pri 1 % (6/586) bolnikov, ki so prejemali dabrafenib v monoterapiji, in pri 1 % (3/209) bolnikov v študiji MEK115306 ter pri &lt; 1 % (3/350) bolnikov v študiji MEK116513 med tistimi, ki so prejemali dabrafenib v kombinaciji s trametinibom.
In clinical trials of patients with factor VII deficiency, formation of antibodies against NovoSeven and FVII is the only adverse drug reaction reported (frequency: common (≥ 1/100 to &lt; 1/10)).
Pojav protiteles proti zdravilu NovoSeven in FVII je edini neželeni učinek zdravila, opisan v kliničnih preskušanjih bolnikov s pomanjkanjem faktorja VII, izpostavljenih zdravilu NovoSeven (pogostnost: pogosto (≥ 1/100 do &lt; 1/10)).
In clinical trials these patients were defined by an endogenous serum LH level &lt; 1.2 IU/l.
V kliničnih preskušanjih so bile te bolnice določene na podlagi ravni endogenega LH v serumu &lt; 1,2 i.e./l.
In clinical trials these patients were defined by an endogenous serum LH level &lt; 1.2 IU/L.
V kliničnih študijah so bile te bolnice določene na podlagi ravni endogenega LH v serumu &lt; 1,2 i.e./l.
In clinical trials these patients were defined by an endogenous serum LH level &lt; 1.2 IU/l.
V kliničnih preskušanjih so te bolnice opredelili glede na serumsko raven endogenega LH &lt; 1,2 i.e./l.
In clinical trials where valsartan was compared with an ACE inhibitor, the incidence of dry cough was significantly (p &lt; 0.05) lower in patients treated with valsartan than in those treated with an ACE inhibitor (2.6% versus 7.9%, respectively).
V kliničnih preskušanjih, v katerih so valsartan primerjali z zaviralcem ACE, je bila pojavnost suhega kašlja med prejemniki valsartana značilno manjša kot pri prejemnikih zaviralca ACE (2,6 % med prvimi, 7,9 % med drugimi, p &lt; 0,05).
In clinical trials with OPTISON, undesirable effects were reported as adverse events with the following frequencies given in the table below: very common (≥1/10); common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000); not known (cannot be estimated from the available data).
V kliničnih preskušanjih s kontrastnim sredstvom OPTISON so o neželenih učinkih poročali z naslednjimi pogostnostmi, ki so navedene v spodnji preglednici: zelo pogosti (≥1/10); pogosti (≥1/100 do &lt; 1/10); občasni (≥1/1.000 do &lt; 1/100); redki (≥1/10.000 do &lt; 1/1.000); zelo redki ( &lt; 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
In clinical trials with oral olanzapine, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF &lt; 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
V kliničnih preskušanjih s peroralnim olanzapinom so bila klinično pomembna podaljšanja QTc (QT korekcija Fridericia [QTcF] ≥ 500 milisekund [msek] kadarkoli nad osnovno vrednostjo pri bolnikih z osnovno vrednostjo QTcF &lt; 500 msek) pri bolnikih, zdravljenih z olanzapinom, redka (od 0,1 % do 1 %), brez pomembnih razlik v spremljajočih srčnih dogodkih v primerjavi z bolniki, zdravljenimi s placebom.
In clinical trials with vedolizumab at doses ranging from 2 to 10 mg/kg, &gt; 95% saturation of α4β7 receptors on subsets of circulating lymphocytes involved in gut immune surveillance was observed in patients.
V kliničnih preskušanjih so pri odmerkih vedolizumaba v razponu od 2 do 10 mg/kg pri bolnikih opazili &gt; 95 % nasičenost α4β7 receptorjev pri podskupini limfocitov v obtoku, vključenih v črevesni imunski nadzor.
In clinical trials with zoledronic acid, patients with serum creatinine &gt; 265 micromol/l or &gt; 3.0 mg/dl were excluded.
V klinične študije niso vključevali bolnikov s serumskim kreatininom &gt; 265 mikromolov/l ali &gt; 3,0 mg/dl.
In clinical trials with zoledronic acid, patients with serum creatinine &gt; 265 µmol/l or &gt; 3.0 mg/dl were excluded.
Bolniki s serumskim kreatininom &gt; 265 µmol/l ali &gt; 3,0 mg/dl so bili iz kliničnih preskušanj z zoledronsko kislino izključeni.
In clinical trials with zoledronic acid, patients with serum creatinine &gt; 265 µmol/l or &gt; 3.0 mg/dl were excluded.
Bolniki s serumskim kreatininom &gt; 265 μmol/l ali &gt; 3,0 mg/dl so bili iz kliničnih preskušanj z zoledronsko kislino izključeni
In clinical trials with zoledronic acid, patients with serum creatinine &gt; 265 μmol/l or &gt; 3.0 mg/dl were excluded.
Bolniki s serumskim kreatininom &gt; 265 µmol/l ali &gt; 3,0 mg/dl so bili iz kliničnih preskušanj z zoledronsko kislino izključeni.
In clinical trials with zoledronic acid, patients with serum creatinine &gt; 265 μmol/l or &gt; 3.0 mg/dl were excluded.
Bolniki s serumskim kreatininom &gt; 265 μmol/l ali &gt; 3,0 mg/dl so bili iz kliničnih preskušanj z zoledronsko kislino izključeni.
In clinical trials with zoledronic acid, patients with serum creatinine &gt; 265 μmol/l or &gt; 3.0 mg/dl were excluded.
Bolniki z vrednostmi serumskega kreatinina &gt; 265 µmol/l ali &gt; 3,0 mg/dl so bili iz kliničnih študij z zoledronsko kislino izključeni.
In clinical trials with Zometa, patients with serum creatinine
Bolniki s serumskim kreatininom &gt; 265 µmol/l ali
In clinical trials, 51 adolescents with CF (≥ 12 to &lt; 18 years old) received Quinsair 240 mg twice daily and 6 adolescents with CF received Quinsair 120 mg (n = 3) or 240 mg (n = 3) once daily.
V kliničnih preskušanjih je 51 mladostnikov s CF (≥ 12 do &lt; 18 let) dvakrat na dan prejemalo 240 mg zdravila Quinsair in 6 mladostnikov s CF je enkrat na dan prejemalo 120 mg zdravila Quinsair (n = 3) ali 240 mg zdravila Quinsair (n = 3).
In clinical trials, a higher incidence of severe liver injury with fatal outcome was observed in Japanese patients (~1.5%) treated with Stivarga compared with non- Japanese patients ( &lt; 0.1%).
V kliničnih preskušanjih so večjo incidenco hude okvare jeter s smrtnim izidom opazili pri japonskih bolnikih (~1,5 %), zdravljenih z zdravilom Stivarga, v primerjavi z nejaponskimi bolniki ( &lt; 0,1 %).
In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF &lt; 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
V kliničnih preskušanjih so bila klinično pomembna podaljšanja QTc (QT korekcija Fridericia [QTcF] ≥ 500 milisekund [msek] kadarkoli nad osnovno vrednostjo pri bolnikih z osnovno vrednostjo QTcF &lt; 500 msek) pri bolnikih, zdravljenih z olanzapinom, občasna (od 0,1 % do 1 %), brez pomembnih razlik v spremljajočih srčnih dogodkih v primerjavi z bolniki, zdravljenimi s placebom.
In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF &lt; 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
V kliničnih preizkušanjih so bila klinično pomembna podaljšanja intervala QTc (interval QT, popravljen po Fridericiju /Friderici QT correction, QTcF/, ≥ 500 milisekund /ms/ kadarkoli nad osnovno vrednostjo pri bolnikih z osnovno vrednostjo QTcF &lt; 500 ms) pri bolnikih, zdravljenih z olanzapinom, redka (od 0,1 % do 1 %) in brez pomembnih razlik v spremljajočih srčnih dogodkih v primerjavi z bolniki, zdravljenimi s placebom.
In clinical trials, decreased systolic blood pressure ( &gt; 35 mm Hg) was observed in 7% of patients and decreased diastolic blood pressure ( &gt; 25 mm Hg) was observed in 4% of patients within 45 minutes of Rapiscan administration.
V kliničnih študijah so pri 7% bolnikov opazili znižan sistolični krvni tlak ( &gt; 35 mm Hg) in pri 4% bolnikov znižan diastolični krvni tlak ( &gt; 25 mm Hg), ki sta se pojavila v 45 minutah po dajanju zdravila Rapiscan.
In clinical trials, more than 70 % of patients required a decrease in their daily levodopa dose if their daily dose of levodopa was &gt; 600 mg or if patients had moderate or severe dyskinesias before beginning treatment.
V kliničnih preskušanjih je več kot 70 % bolnikov potrebovalo zmanjšanje dnevnega odmerka levodope, če so jemali več kot 600 mg levodope na dan ali pa so pred začetkom zdravljenja imeli zmerno ali hudo diskinezijo.
In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level &lt; 1.2 IU/l as measured in a central laboratory.
V kliničnih preskušanjih so bile bolnice s hudim pomanjkanjem FSH in LH opredeljene na podlagi serumske ravni endogenega LH &lt; 1,2 i.e./l, izmerjene v centralnem laboratoriju.
In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level &lt; 1.2 IU/L as measured in a central laboratory.
V kliničnih preskušanjih so določili bolnice s hudim pomanjkanjem FSH in LH na podlagi serumske ravni endogenega LH &lt; 1,2 i.e./l, izmerjene v centralnem laboratoriju.
In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level &lt; 1.2 IU/L as measured in a central laboratory.
V kliničnih študijah so določili bolnice s hudim pomanjkanjem FSH in LH na podlagi serumske ravni endogenega LH &lt; 1,2 i.e./l, izmerjene v centralnem laboratoriju.
In clinical trials, rapid tapering (over periods &lt; 1 month) resulted in recurrence of diarrhoea or colitis in some patients.
V kliničnih preskušanjih sta se pri hitrem zmanjšanju odmerka (v obdobju, krajšem od enega meseca) driska ali kolitis pri posameznih bolnikih ponovila.
In clinical trials, smaller bleeding sites ( &lt; 10 cm2) used 0.5 g to 1 g on average.
V kliničnih preskušanjih so za manjše krvaveče predele ( &lt; 10 cm2) povprečno uporabili 0,5 g do 1 g.
In clinical trials, these patients were defined by an endogenous serum LH level &lt; 1.2 IU/l.
V kliničnih preskušanjih so te bolnice opredelili glede na serumsko raven endogenega LH &lt; 1,2 i.e./l.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST &gt; 1.5 × ULN associated with alkaline phosphatase &gt; 2.5 × ULN, and bilirubin &gt; 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
V ključni klinični študiji docetaksela v kombinaciji s cisplatinom in 5-fluorouracilom pri bolnikih z adenokarcinomom želodca so izključili bolnike z ALT in/ali AST &gt; 1,5 x ULN ter hkrati alkalno fosfatazo &gt; 2,5 x ULN in bilirubinom &gt; 1 x ULN; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksela se ne sme uporabljati, če ni strogo indiciran.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST &gt; 1.5 × ULN associated with alkaline phosphatase &gt; 2.5 × ULN, and bilirubin &gt; 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
V ključni klinični študiji docetaksela v kombinaciji s cisplatinom in 5-fluorouracilom pri bolnikih z adenokarcinomom želodca so izključili bolnike z ALT in/ali AST &gt; 1,5 x ULN ter hkrati alkalno fosfatazo &gt; 2.5 x ULN in bilirubinom &gt; 1 x ULN; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksela se ne sme uporabljati, če ni strogo indiciran.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST &gt; 1.5 × ULN associated with alkaline phosphatase &gt; 2.5 × ULN, and bilirubin &gt; 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
V ključni klinični študiji docetaksela v kombinaciji s cisplatinom in 5-fluorouracilom pri bolnikih z adenokarcinomom želodca so izključili bolnike z ALT in/ali AST &gt; 1,5 × ULN ter hkrati alkalno fosfatazo &gt; 2,5 × ULN in bilirubinom &gt; 1 x ULN; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksela se ne sme uporabljati, če ni strogo indiciran.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST &gt; 1.5 × ULN associated with alkaline phosphatase &gt; 2.5 × ULN, and bilirubin &gt; 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
V ključni klinični študiji docetaksela v kombinaciji s cisplatinom in 5-fluorouracilom pri bolnikih z adenokarcinomom želodca so izključili bolnike z ALT in/ali AST &gt; 1,5 × ULN ter hkrati alkalno fosfatazo &gt; 2,5 × ULN in bilirubinom &gt; 1 × ULN; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksela se ne sme uporabljati, če ni strogo indiciran.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST &gt; 1.5 × ULN associated with alkaline phosphatase &gt; 2.5 × ULN, and bilirubin &gt; 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
V ključnem kliničnem preskušanju docetaksela v kombinaciji s cisplatinom in 5-fluorouracilom pri bolnikih z adenokarcinomom želodca so izključili bolnike z ALT in/ali AST &gt; 1,5 x ZMRO ter hkrati alkalno fosfatazo &gt; 2,5 x ZMRO in bilirubinom &gt; 1 x ZMRO; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksel se ne sme uporabljati, če ni strogo indiciran.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST &gt; 1.5 × ULN associated with alkaline phosphatase &gt; 2.5 × ULN, and bilirubin &gt; 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
V ključni klinični študiji docetaksela v kombinaciji s cisplatinom in 5-fluorouracilom pri bolnikih z adenokarcinomom želodca so izključili bolnike z ALT in/ali AST &gt; 1,5 * ULN ter hkrati alkalno fosfatazo &gt; 2,5 * ULN in bilirubinom &gt; 1 * ULN; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksela se ne sme uporabljati, če ni strogo indiciran.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST &gt; 1.5 × ULN associated with alkaline phosphatase &gt; 2.5 × ULN, and bilirubin &gt; 1 x UNL; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
V ključnem kliničnem preskušanju docetaksela v kombinaciji s cisplatinom in 5-fluorouracilom pri bolnikih z adenokarcinomom ţelodca so izključili bolnike z ALT in/ali AST &gt; 1,5 × ZMRO ter hkrati alkalno fosfatazo &gt; 2,5 × ZMRO in bilirubinom &gt; 1 × ZMRO; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksel se ne sme uporabljati, če ni izrecno indiciran.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST &gt; 1.5 × ULN associated with alkaline phosphatase &gt; 2.5 × ULN, and bilirubin &gt; 1 x UNL; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
V ključnem kliničnem preskušanju docetaksela v kombinaciji s cisplatinom in 5-fluorouracilom pri bolnikih z adenokarcinomom želodca so izključili bolnike z ALT in/ali AST &gt; 1,5 × ZMRO ter hkrati alkalno fosfatazo &gt; 2,5 × ZMRO in bilirubinom &gt; 1 × ZMRO; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksel se ne sme uporabljati, če ni izrecno indiciran.
in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours &gt; 2 cm in diameter (see sections 4.4 and 5.1).
v kombinaciji z neoadjuvantno kemoterapijo, čemur sledi adjuvantno zdravljenje z zdravilom Herceptin, za lokalno napredovalo (tudi vnetno) bolezen ali tumorje &gt; 2 cm v premeru (glejte poglavji 4.4 in 5.1).
In COMFORT-I, 45.9% subjects in the Jakavi group achieved a ≥50% improvement from baseline in the week 24 total symptom score (measured using MFSAF diary v2.0), as compared to 5.3% in the placebo group (p &lt; 0.0001 using chi-square test).
V študiji COMFORT-I je pri 45,9 % preiskovancev v skupini z zdravilom Jakavi prišlo do najmanj 50-odstotnega izboljšanja skupne ocene vseh simptomov od izhodišča do konca 24. tedna (kar so ocenjevali s pomočjo dnevnika z obrazcem MFSAF različica 2.0) v primerjavi s 5,3 % bolnikov s takim izboljšanjem v skupini s placebom (p &lt; 0,0001 pri uporabi testa hi-kvadrat).
In contrast, starting passage with mutants with mutation Q148H (fold change 1), a variety of raltegravir associated secondary mutations accumulated with a consequent increase of fold change to values &gt; 10.
Nasprotno pa so pri začetku z mutanti, ki so vključevali mutacijo Q148H (sprememba občutljivosti 1), opazili vrsto sekundarnih mutacij s posledičnim porastom vrednosti spremembe občutljivosti &gt; 10.
In contrast, starting with mutants harbouring mutation Q148H (FC 1), a variety of secondary mutations were seen with a consequent increase of FC to values &gt; 10.
Nasprotno pa so pri začetku z mutanti, ki so vključevali mutacijo Q148H (FC 1), opazili vrsto sekundarnih mutacij s posledičnim porastom vrednosti FC &gt; 10.
In contrast, the administration of eltrombopag 2 hours before or 4 hours after a high-calcium meal or with low-calcium food [ &lt; 50 mg calcium] did not alter plasma eltrombopag exposure to a clinically significant extent (see sections 4.2 and 5.2).
Nasprotno pa odmerjanje eltrombopaga 2 uri pred ali 4 ure po obroku z veliko vsebnostjo kalcija ali skupaj z obrokom z majhno vsebnostjo kalcija [ &lt; 50 mg kalcija] ni vplivalo na koncentracijo eltrombopaga v plazmi v klinično pomembnem obsegu (glejte poglavji 4.2 in 5.2).
In controlled clinical studies, 10 patients (0.5%) experienced a seizure out of 2051 patients treated with a daily dose of 160 mg enzalutamide, whereas one patient ( &lt; 0.1%) receiving placebo and one patient (0.3%) receiving bicalutamide, experienced a seizure.
V nadzorovanih kliničnih študijah je 10 (0,5 %) od 2.051 bolnikov, zdravljenih z dnevnim odmerkom enzalutamida 160 mg, doživelo konvulzije, medtem ko je konvulzije doživel en bolnik ( &lt; 0,1 %), ki je dobival placebo, in en bolnik (0,3 %), ki je prejemal bikalutamid.
In controlled studies, 1 year of lamivudine therapy significantly suppressed HBV DNA replication (34-57 % of patients were below the assay detection limits (Abbott Genostics solution hybridization assay, LLOD &lt; 1.6pg/ml)], normalised ALT level (40-72 % of patients), induced HBeAg seroconversion (HBeAg loss and HBeAb detection with HBV DNA loss [by conventional assay], 16- 18 % of patients), improved histology (38-52 % of patients had a  2 point decrease in the Knodell Histologic Activity Index [HAI]) and reduced progression of fibrosis (in 3-17 % of patients) and progression to cirrhosis.
V nadzorovanih študijah je enoletno zdravljenje z lamivudinom znatno zavrlo replikacijo HBV DNA [pri 34 do 57 % bolnikov je bila pod mejo dokazljivosti s testom (Abbott Genostics hibridizacijski test v raztopini, LLOD &lt; 1,6 pg/ml)], normaliziralo aktivnost ALT (pri 40 do 72 % bolnikov), sprožilo serokonverzijo HBeAg (izginotje HBeAg ter pojav protiteles HBeAb z izginotjem HBV DNA z običajnimi testi pri 16 do 18 % bolnikov), izboljšalo histološko sliko (pri 38 do 52 % bolnikov se je Knodell-ov histološki indeks aktivnosti HAI znižal za ≥ 2 točki) in zmanjšalo progresijo fibroze (pri 3 do 17 % bolnikov) in progresijo v cirozo.