natgillin/translations-raw huggingface dataset:
The most commonly reported adverse reactions (occurring in &gt; 10% of patients) are tremor, renal impairment, hyperglycaemic conditions, diabetes mellitus, hyperkalaemia, infections, hypertension and insomnia.
Najpogosteje (pri &gt; 10 % bolnikov) so poročali o neželenih učinkih kot so tremor, okvara ledvic, hiperglikemična stanja, diabetes mellitus, hiperkaliemija, okužbe, hipertenzija in nespečnost.
The most commonly reported adverse reactions (occurring in &gt; 10% of patients) are tremor, renal impairment, hyperglycaemic conditions, diabetes mellitus, hyperkalaemia, infections, hypertension and insomnia.
Najpogosteje (pri &gt; 10 % bolnikov) so poročali o neželenih učinkih, kot so tremor, okvara ledvic, hiperglikemična stanja, diabetes mellitus, hiperkaliemija, okužbe, hipertenzija in nespečnost.
The most commonly reported adverse reactions (occurring in &gt; 10% of patients) are thrombocytopaenia, anaemia, pyrexia, hypertension, hypokalaemia, hypophosphataemia, urinary tract infection, hypercholesterolaemia, hyperglycaemia, hypertriglyceridaemia, abdominal pain, lymphocoele, peripheral oedema, arthralgia, acne, diarrhoea, pain, constipation, nausea, headache, increased blood creatinine, and increased blood lactate dehydrogenase (LDH).
Najpogosteje opisani neželeni učinki (pojavili so se pri  10 % bolnikov) so trombocitopenija, anemija, pireksija, zvišan krvni tlak, hipokaliemija, hipofosfatemija, okužba sečil, hiperholesterolemija, hiperglikemija, hipertrigliceridemija, bolečine v trebuhu, limfokela, periferni edemi, artralgija, akne, diareja, bolečine, zaprtje, navzea, glavobol, zvišanje kreatinina v krvi in zvišanje laktat-dehidrogenaze (LDH) v krvi.
The most commonly reported adverse reactions are upper gastrointestinal adverse reactions including abdominal pain, dyspepsia, oesophageal ulcer, dysphagia, abdominal distension and acid regurgitation ( &gt; 1 %).
Najbolj pogosto so poročali o neželenih učinkih v zgornjem delu prebavil, vključno z bolečino v trebuhu, dispepsijo, razjedo požiralnika, disfagijo, napetim trebuhom in refluksom kisline ( &gt; 1 %).
The most commonly reported adverse reactions for tacrolimus (occurring in &gt; 10% of patients) are tremor, renal impairment, hyperglycaemic conditions, diabetes mellitus, hyperkalaemia, infections, hypertension and insomnia.
Najpogostejši neželeni učinki, o katerih so poročali za takrolimus (pojavili so se pri &gt; 10 % bolnikov), so tremor, ledvična okvara, hiperglikemična stanja, sladkorna bolezen, hiperkaliemija, okužbe, hipertenzija in nespečnost.
The most commonly reported adverse reactions in surgical patients were cough, airway complication of anaesthesia, anaesthetic complications, procedural hypotension and procedural complication (Common (≥ 1/100 to &lt; 1/10)).
Neželeni učinki, o katerih so najpogosteje poročali pri kirurških bolnikih so bili kašelj, zapleti v dihalnih poteh pri anesteziji, zapleti pri anesteziji, s posegom povezana hipotenzija in s posegom povezan zaplet (pogosti (≥ 1/100 do &lt; 1/10)).
The most commonly reported adverse reactions leading to discontinuation (incidence &gt; 1%) in patients treated with Tecfidera were flushing (3%) and gastrointestinal events (4%).
Najpogosteje poročani neželeni učinki, ki so povzročili prekinitev zdravljenja (incidenca &gt; 1 %) pri bolnikih, zdravljenih z zdravilom Tecfidera, so bili vročinsko oblivanje (3 %) in prebavni dogodki (4 %).
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia ( &lt; 500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Najpogosteje opisani neželeni učinki na sam docetaksel so: nevtropenija (ki je bila reverzibilna in ni bila kumulativna; srednji čas do najmanjšega števila je bil 7 dni, srednje trajanje hude nevtropenije ( &lt; 500 celic/mm3) pa 7 dni), anemija, alopecija, navzea, bruhanje, stomatitis, driska in astenija.
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia ( &lt; 500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Najpogosteje opisani neţeleni učinki na sam docetaksel so: nevtropenija (ki je bila reverzibilna in ni bila kumulativna; povprečni čas do najmanjšega števila je bil 7 dni, povprečno trajanje hude nevtropenije ( &lt; 500 celic/mm3) pa 7 dni), anemija, alopecija, navzeja, bruhanje, stomatitis, driska in astenija.
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia ( &lt; 500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Najpogosteje opisani neţeleni učinki na sam docetaksel so: nevtropenija (ki je bila reverzibilna in ni bila kumulativna; srednji čas do najmanjšega števila je bil 7 dni, srednje trajanje hude nevtropenije ( &lt; 500 celic/mm3) pa 7 dni), anemija, alopecija, navzeja, bruhanje, stomatitis, driska in astenija.
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia ( &lt; 500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Najpogosteje opisani neželeni učinki na sam docetaksel so: nevtropenija (ki je bila reverzibilna in ni bila kumulativna; povprečni čas do najmanjšega števila je bil 7 dni, povprečno trajanje hude nevtropenije ( &lt; 500 celic/mm3) pa 7 dni), anemija, alopecija, navzeja, bruhanje, stomatitis, driska in astenija.
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia ( &lt; 500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Najpogosteje opisani neželeni učinki na sam docetaksel so: nevtropenija (ki je bila reverzibilna in ni bila kumulativna; srednji čas do najmanjšega števila je bil 7 dni, srednje trajanje hude nevtropenije ( &lt; 500 celic/mm3) pa 7 dni), anemija, alopecija, navzeja, bruhanje, stomatitis, driska in astenija.
The most commonly reported related adverse reactions (occurring in &gt; 1% of patients) were: fungal infection, insomnia, dysgeusia, headache, dizziness, nausea, constipation, diarrhoea, vomiting, alanine aminotransferase increased, aspartate aminotransferase increased, pruritus, rash, renal failure acute, blood creatinine increased, urine abnormality (foamy urine), fatigue and chills.
Najbolj pogosto so poročali o naslednjih neželenih učinkih (pojavijo se pri &gt; 1 % bolnikov): glivične okužbe, nespečnost, sprememba okusa, glavobol, omotica, slabost, zaprtost, diareja, bruhanje, povečana vrednost alanin-aminotransferaze, povečana vrednost aspartat-aminotransferaze, pruritus, izpuščaj, akutna ledvična odpoved, povišan kreatinin v krvi, nenormalen urin (penast urin), utrujenost in mrzlica.
The most frequent adverse drug reactions ( &gt; 10.0% of patients) during treatment with SIRTURO in the controlled trials were nausea (35.3% in the SIRTURO group vs 25.7% in the placebo group), arthralgia (29.4% vs 20.0%), headache (23.5% vs 11.4%), vomiting (20.6% vs 22.9%) and dizziness (12.7% vs 11.4%).
V nadzorovanih kliničnih študijah so bili v času zdravljenja z zdravilom SIRTURO najbolj pogosti neželeni učinki (pri &gt; 10,0% bolnikov): navzea (35,3% v skupini z zdravilom SIRTURO v primerjavi s 25,7% v skupini s placebom), artralgija (29,4% v primerjavi z 20,0%), glavobol (23,5% v primerjavi z 11,4%), bruhanje (20,6% v primerjavi z 22,9%) in omotičnost (12,7% v primerjavi z 11,4%).
The most frequent event was a haematoma &lt; 5 cm at puncture site.
Najpogostejši neželeni učinek je bil hematom &lt; 5 cm na mestu vboda.
The most frequent Grade 3-4 adverse reactions (incidence ≥1/100 to &lt; 1/10) were stomatitis, anaemia, hyperglycaemia, infections, fatigue, diarrhoea, pneumonitis, asthenia, thrombocytopenia, neutropenia, dyspnoea, proteinuria, lymphopenia, haemorrhage, hypophosphataemia, rash, hypertension, pneumonia, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased and diabetes mellitus.
Najpogostejši neželeni učinki 3.-4. stopnje (z incidenco ≥1/100 do &lt; 1/10) so bili vnetje ustne sluznice, anemija, hiperglikemija, okužbe, utrujenost, diareja, pnevmonitis, astenija, trombocitopenija, nevtropenija, dispneja, proteinurija, limfopenija, krvavitev, hipofosfatemija, izpuščaj, hipertenzija, pljučnica, zvišana koncentracija alanin-aminotransferaze (ALT), zvišana koncentracija aspartat- aminotransferaze (AST) in sladkorna bolezen.
The most frequently ( &gt; 25% of subjects) detected post-baseline RAVs in these subjects were amino acid substitutions V36M (61%) and R155K (68%) in subjects infected with genotype 1a viruses and T54A (42%), T54S (37%), A156S (26%) and V170A (32%) in subjects infected with genotype 1b viruses.
V obdobju po začetku zdravljenja so bile najpogosteje ( &gt; 25 % preiskovancev) ugotovljene RAV pri teh preiskovancih zamenjave aminokislin V36M (61 %) in R155K (68 %) pri preiskovancih, okuženih z virusi genotipa 1a, ter T54A (42 %), T54S (37 %), A156S (26 %) in V170A (32 %) pri preiskovancih, okuženih z virusi genotipa 1b.
The most frequently ( &gt; 5% of adult subjects treated) reported adverse reactions with fosamprenavir/ritonavir combination were gastrointestinal reactions (nausea, diarrhoea, abdominal pain and vomiting) and headache.
Najpogostejši neželeni učinki (zabeleženi pri &gt; 5 % zdravljenih odraslih) pri kombiniranem zdravljenju s fosmaprenavirjem/ritonavirjem so bili učinki na prebavila (navzea, driska, bolečine v trebuhu in bruhanje) in glavobol.
The most frequently reported adverse reaction ( &gt; 25 %) with an onset during the posaconazole intravenous phase of dosing with 300 mg once daily was diarrhoea (32 %).
Najpogosteje poročani neželeni učinek ( &gt; 25 %), ki se je pojavil med intravensko fazo uporabe posakonazola v odmerku 300 mg enkrat na dan, je bila driska (32 %).
The most frequently reported adverse reactions ( &gt; 10 %) with brivaracetam treatment were: somnolence (14.3 %) and dizziness (11.0 %).
Najpogosteje poročana neželena učinka ( &gt; 10 %) pri zdravljenju z brivaracetamom sta bila somnolenca (14,3 %) in omotica (11,0 %).
The most frequently reported adverse reactions ( &gt; 10%) with brivaracetam treatment were: somnolence (14.3 %) and dizziness (11.0 %).
Najpogosteje poročana neželena učinka ( &gt; 10 %) pri zdravljenju z brivaracetamom sta bila somnolenca (14,3 %) in omotica (11,0 %).
The most frequently reported adverse reactions ( &gt; 5%) during glycerol phenylbutyrate treatment were diarrhoea, flatulence, and headache (8.8% each); decreased appetite (7.0%), vomiting (6.1%); and fatigue, nausea and, skin odour abnormal (5.3% each).
Najpogostejši neželeni učinki ( &gt; 5 %) v času zdravljenja s fenilbutiratom so bili driska, flatulenca in glavobol (8,8 % vsak), zmanjšan apetit (7,0 %), bruhanje (6,1 %) in utrujenost, slabost in nenavaden telesni vonj (5,3 % vsak).
The most pronounced increases were observed in patients of low body weight ( &lt; 30 kg).
Najbolj izraženo zvišanje so opazili pri bolnikih z nizko telesno maso ( &lt; 30 kg).
The most relevant fracture reduction was observed among patients at high risk of fractures such as patients with previous fractures and in patients with a lumbar spine T-score of &lt; - 3.
Najpomembnejše zmanjšanje zlomov so opazili pri bolnicah s povečanim tveganjem za zlome, kot so bolnice s predhodnimi zlomi, in bolnice z lumbalno vrednostjo T &lt; - 3.
The most resistant variants with single amino acid substitution in genotype 2a and genotype 3a were F28S (EC50 &gt; 300 nM) and Y93H (EC50 &gt; 1,000 nM), respectively.
Pri genotipu 2a je bila najbolj odporna varianta z eno aminokislinsko substitucijo F28S (EC50 &gt; 300 nM), pri genotipu 3a pa Y93H (EC50 &gt; 1.000 nM).
The most serious adverse reaction reported in clinical trials with deferiprone is agranulocytosis (neutrophils &lt; 0.5x109/l), with an incidence of 1.1% (0.6 cases per 100 patient-years of treatment) (see section 4.4).
Najresnejši neželen učinek zdravljenja v kliničnem preskušanju deferiprona je bila agranulocitoza (vrednost nevtrofilcev &lt; 0,5 x 109/l) s pojavnostjo 1,1 % (0,6 pojavov bolezni na 100 bolnikov-let zdravljenja) (glejte poglavje 4.4).
The natural course of peripheral neuropathy to resolution to baseline due to cumulative toxicity of Abraxane after &gt; 6 courses of treatment was not evaluated and remains unknown.
Naravni potek periferne nevropatije do resolucije na izhodiščno raven zaradi kumulativne toksičnosti zdravila Abraxane po &gt; 6 zdravljenjih ni bil raziskan in ostaja neznan.
The neutropenia observed was reversible and not cumulative; the mean time to nadir was 13 days and the mean time to recovery from severe neutropenia ( &lt; 0.5 x 109/l) was 8 days.
Nevtropenija, ki so jo opazili, je bila reverzibilna in ni bila kumulativna; povprečni čas do najvišje točke je bil 13 dni in povprečni čas do okrevanja od hude nevtropenije ( &lt; 0,5 x 109/l) je bil 8 dni.
The NOAEL for fertility, early embryonic development and teratogenicity in rats was set at &gt; 900 times the human exposure.
Odmerek, pri katerem še ni opaziti toksičnega učinka na plodnost, zgodnji razvoj zarodka in teratogenost pri podganah, 900-krat presega mejo izpostavljenosti za človeka.
The NOAEL was &lt; 200 mg/kg/day for the dams and
Odmerek, pri katerem ni mogoče opaziti neželenih učinkov (NOAEL), je bil
The NOAEL was &lt; 200 mg/kg/day for the dams and 200 mg/kg/day for the fetuses (equal to the MRHD on a mg/m2 basis).
Odmerek, pri katerem ni mogoče opaziti neželenih učinkov (NOAEL), je bil &lt; 200 mg/kg/dan za samice in 200 mg/kg/dan za plodove (je enako največjemu priporočenemu odmerku pri ljudeh glede na mg/m2).
The NOAEL was &lt; 200 mg/kg/day for the dams and 200 mg/kg/day for the fetuses (equal to the MRHD on a mg/m2 basis).
Odmerek, pri katerem ni mogoče opaziti neželenih učinkov (NOAEL), je bil &lt; 200 mg/kg/dan za samice in 200 mg/kg/dan za plodove (je enako največjemu priporočenemu odmerku pri ljudeh glede na mg/m2.
The NOAEL was &lt; 200 mg/kg/day for the dams and 200 mg/kg/day for the foetuses (equal to the MRHD on a mg/m2 basis).
&lt; 200 mg/kg/dan za samice in 200 mg/kg/dan za zarodke (je enako največjemu priporočenemu odmerku pri ljudeh glede na mg).
The NOAEL was &lt; 200 mg/kg/day for the dams and 200 mg/kg/day for the foetuses (equal to the MRHD on a mg/m2 basis).
Odmerek, pri katerem ni mogoče opaziti neželenih učinkov (NOAEL), je bil &lt; 200 mg/kg/dan za samice in 200 mg/kg/dan za zarodke (je enako največjemu priporočenemu odmerku pri ljudeh glede na mg/m2).
The non-responder-population was comprised of 2 subgroups: prior partial responders (greater than or equal to 2 log10 reduction in HCV RNA at week 12, but not achieving HCV RNA undetectable at end of treatment with a peginterferon and ribavirin) and prior null responders (less than 2 log10 reduction in HCV RNA at week 12 of prior treatment with peginterferon and ribavirin).
Populacija bolnikov, ki se niso odzvali na predhodno zdravljenje, je zajemala 2 podskupini: bolnike, ki so se prej delno odzvali na zdravljenje (imeli so zmanjšanje vrednosti HCV RNK v 12. tednu za ≥ 2 log10, niso pa dosegli nemerljive HCV RNK ob koncu zdravljenja s peginterferonom in ribavirinom) in tiste bolnike, ki se prej niso odzvali na zdravljenje (ti so imeli zmanjšanje vrednosti HCV RNK v 12. tednu za &lt; 2 log10 pri predhodnem zdravljenju s peginterferonom in ribavirinom).
The nosocomial pneumonia (NP) studies excluded known or suspected pulmonary disease like granulomatous diseases, lung cancer, or other malignancy metastatic to the lungs; cystic fibrosis or active tuberculosis; Legionella pneumophila pneumonia; meningitis, endocarditis, or osteomyelitis; refractory shock defined as supine systolic blood pressure &lt; 90 mm Hg for &gt; 2 hours with evidence of hypoperfusion or requirement for high-dose sympathomimetic agents.
Iz študij bolnišnične pljučnice so bile izključene znane pljučne bolezni in sumi nanje, kot so granulomatozne bolezni, pljučni rak ali druge maligne metastaze pljuč; cistična fibroza ali aktivna tuberkoloza, pljučnica Legionella pneumophila; meningitis, endokarditis ali osteomielitis; refraktorni šok, opredeljen kot počasen sistolični krvni pritisk &lt; 90 mm Hg za &gt; 2 uri z dokazano hipoperfuzijo ali potrebo po visokemu odmerku simpatomimetikov.
The number of normal sperm was significantly reduced ( &lt; 10%) relative to controls and the percent abnormal sperm (detached heads or no heads) were significantly increased (up to 3%).
Število normalnih semenčic se je pomembno zmanjšalo ( &lt; 10 %) v primerjavi s kontrolnimi živalmi, odstotek nenormalnih semenčic (z odstranjenimi glavicami ali brez njih) pa je bil pomembno povečan (do 3 %).
The number of patients who returned to a normal IIEF domain score ( &gt; 26) were 53% on vardenafil compared to 9% on placebo.
53-odstotkov bolnikov, ki so jemali vardenafil je ponovno imelo normalno erektilno funkcijo ( &gt; 26) v primerjavi z 9-odstotki bolnikov, ki so jemali placebo.
The number of patients with viral load &lt; 50 copies/mL was 9 of 13 for the same period.
V enakem obdobju je imelo 9 od 13 bolnikov virusno breme &lt; 50 kopij/ml.
The number of prior systemic regimen received was 1 for 27% of patients, 2 for 51% of patients, and &gt; 2 for 21% of patients.
Število predhodnih režimov sistemskega zdravljenja je bilo naslednje: 1 pri 27 % bolnikov, 2 pri 51 % bolnikov in &gt; 2 pri 21 % bolnikov.
The objective response rate (complete response [CR] plus partial response [PR]) per independent radiological review was significantly (p &lt; 0.0001) higher in the lenvatinib-treated group (64.8%) than in the placebo-treated group (1.5%).
Objektivna odzivnost (popolni odziv [CR] plus delni odziv [PR]) po neodvisnem radiološkem pregledu je bila značilno (p &lt; 0,0001) večja v skupini, zdravljeni z lenvatinibom (64,8 %), kot v skupini, ki je prejemala placebo (1,5 %).
The observed incidence of the less severe form of neutropenia (neutrophils &lt; 1.5x109/l) is 4.9% (2.5 cases per 100 patient-years).
Opažena pojavnost manj resne oblike nevtropenije (vrednost nevtrofilcev &lt; 1,5 x 109/l) je 4,9 % (2,5 pojavov bolezni na 100 bolnikov-let).
The observed treatment difference (95% CI) between ivacaftor and placebo was 10.7% (7.3, 14.1) (P &lt; 0.0001).
Cilj študije Razlika zaradi vrednost P Razlika zaradi vrednost P zdravljenjaa zdravljenjaa (95 % CI) (95 % CI)
The observed WRC in pitolisant group was about half of WRC in the placebo group: the effect size of pitolisant compared with placebo was summarized by the ratio rate rR(Pt/Pb), rR=0.512; 95%CI [0.435 to 0.603]; p &lt; 0.0001).
Opaženi WRC v skupini s pitolizantom je bil približno polovica WRC v skupini s placebom: velikost učinka pitolizanta v primerjavi s placebom je povzeta glede na razmerje incidence rR (Pt/Pb), rR = 0,512; 95-% IZ (0,435 do 0,603); p &lt; 0,0001).
The occurrence of anaemia (haemoglobin &lt; 10 g/dl) has been observed in up to 15% of chronic hepatitis C patients in clinical trials on the combined treatment of Pegasys with ribavirin.
Pojavnost anemije (hemoglobin &lt; 10 g/dl) so opazili pri do 15 % bolnikov s kroničnim hepatitisom C v kliničnih preskušanjih kombiniranega zdravljenja zdravila Pegasys in ribavirina.
The occurrence of osteosarcoma only occurred at doses that produced systemic exposures &gt; 27-times higher than that observed in humans at the 100 micrograms dose.
Osteosarkom se je pojavil le pri odmerkih, ki so povzročili sistemsko izpostavitev, ki je bila  27-krat večja od izpostavitve pri človeku po odmerku 100 g.
The only vaccine related injection-site adverse reaction that was more frequent among recipients of ProQuad than among recipients of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck &amp; Co. Inc. was rash at the injection site.
Edini s cepljenjem povezan neželen učinek, ki je bil pri prejemnikih cepiva ProQuad pogostejši kot pri prejemnikih cepiva z živim virusom noric (Oka/Merck) in cepiva proti ošpicam, mumpsu in rdečkam izdelovalca Merck &amp; Co., Inc., je bil izpuščaj na mestu injiciranja.
The only vaccine-related systemic adverse reactions reported at a significantly greater rate in individuals who received the earlier formulation of ProQuad compared to individuals who received the measles, mumps, and rubella vaccine manufactured by Merck &amp; Co., Inc. and Varicella Vaccine live (Oka/Merck) were fever (≥39.4°C rectal equivalent or abnormal) and measles-like rash.
Edina s cepljenjem povezana sistemska neželena učinka, o katerih so značilno pogosteje poročali pri otrocih, ki so dobili predhodno obliko cepiva ProQuad, v primerjavi s posamezniki, ki so prejeli cepivo proti ošpicam, mumpsu in rdečkam izdelovalca Merck &amp; Co., Inc. in cepivo z živim virusom noric (Oka/Merck), sta bila zvišana telesna temperatura (ekvivalentno ≥ 39,4 °C rektalno ali nenormalna) ter ošpicam podoben izpuščaj.
The oral median lethal dose (LD50) of tolvaptan in rats and dogs is &gt; 2000 mg/kg.
Peroralni mediani smrtni odmerek (LD50) tolvaptana pri podganah in psih je &gt; 2000 mg/kg.
The ORR was 27.9% and 0% for subjects in the cabozantinib arm and placebo arm, respectively (p &lt; 0.0001; Table 2).
ORR je bil 27,9 % za osebe v skupini s kabozantinibom in 0 % za osebe v skupini s placebom (p &lt; 0,0001; preglednica 2).
The OS and PFS benefit was observed consistently, in all relevant pre-specified subgroups, including race, geographic region, age ( &lt; 65; ≥ 65), sex, ECOG PS, KRAS status, time since diagnosis of first metastasis, number of metastatic sites, and primary tumour site.
Podaljšanje OS in PFS so dosledno pokazali v vseh ustreznih predhodno določenih podskupinah vključno glede na etnično pripadnost, geografsko regijo, starost ( &lt; 65; ≥ 65), spol, PS po ECOG, status KRAS, čas od prve diagnoze metastatske bolezni, število mest metastaz in mesto primarnega tumorja.
The overall adverse reaction profile for morbidly obese patients (BMI &gt; 40) does not suggest a meaningful difference in safety compared to patients with BMI ≤ 40.
Splošni profil neželenih učinkov pri bolezensko debelih bolnikih (ITM &gt; 40) ne kaže na pomembne razlike v varnosti v primerjavi z bolniki z ITM ≤ 40.
The overall exposure of adolescents (12 to ≤17 years) and children (2 to &lt; 12 years) to deferasirox after single and multiple doses was lower than that in adult patients.
Celotna izpostavljenost deferasiroksu po enkratnem in po večkratnih odmerkih je bila pri mladostnikih (12 do ≤17 let) in otrocih (2 do &lt; 12 let) nižja kot pri odraslih bolnikih.
The overall incidence of transaminase increases &gt; 3 xULN (not necessarily comprising an adverse event) in the voriconazole clinical programme was 18.0% (319/1,768) in adults and 25.8% (73/283) in paediatric subjects who received voriconazole for pooled therapeutic and prophylaxis use.
Celokupna incidenca zvišanja ravni aminotransferaz na &gt; 3-kratnik zgornje meje normalnih vrednosti [ZMN] (kar ni nujno pomenilo neželenega učinka) je bila pri preskušancih, ki so prejemali vorikonazol pri terapevtski in profilaktični uporabi v kliničnem programu vorikonazola 18,0 % (319/1.768) pri odraslih in 25,8 % (73/283) pri pediatričnih preskušancih.