FrancophonIA/ELRC3.0 huggingface dataset:
English: Following subcutaneous administration, inotersen is absorbed rapidly into systemic circulation in a dose-dependent fashion with the median time to maximum plasma concentrations (Cmax) of inotersen typically reached within 2 to 4 hours.
Croatian: Nakon potkožne primjene, inotersen se brzo apsorbira u sistemski krvotok ovisno o dozi, s medijanom vremena do maksimalne koncentracije inotersena u plazmi (Cmax) tipično dostignutim u roku od 2 do 4 sata.
English: 6.6 Special precautions for disposal and other handling Tegsedi should be inspected visually prior to administration.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Tegsedi treba vizualno pregledati prije upotrebe.
English: UPCR and eGFR should be monitored for 8 weeks following discontinuation of treatment.
Croatian: Potrebno je pratiti UPCR i eGFR tijekom 8 tjedana nakon prekida liječenja.
English: In the case of UPCR ≥ 2 g/g (226 mg/mmol), which is confirmed on repeat testing, dosing of inotersen should be paused while further evaluation for acute glomerulonephritis is performed.
Croatian: U slučaju da je UPCR ≥2 g/g (226 mg/mmol), što je potvrđeno ponovljenim testiranjem, potrebno je pauzirati doziranje inotersena dok se ne obavi daljnja procjena radi utvrđivanja akutnog glomerulonefritisa.
English: Prior to the launch of Tegsedi in each Member State (MS), the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Croatian: Prije stavljanja lijeka Tegsedi na tržište u svakoj državi članici, nositelj odobrenja će s nadležnim nacionalnim tijelom dogovoriti sadržaj i oblik edukacijskog materijala, uključujući komunikacijske medije, načine distribucije i sve druge aspekte programa.
English: Do not use if the expiry date has passed.
Croatian: Nemojte koristiti proizvod ako je rok valjanosti istekao.
English: The plunger will start to lift automatically which means that the plunger has been pushed fully down.
Croatian: Klip će se početi podizati automatski, što znači da je klip pritisnut do kraja prema dolje.
English: When the plunger comes to a stop, your injection is complete.
Croatian: Kada se klip zaustavi, injiciranje je dovršeno.
English: UPCR and eGFR should be monitored every 3 months or more frequently, as clinically indicated, based on history of chronic kidney disease and/or renal amyloidosis.
Croatian: Potrebno je pratiti UPCR i eGFR svaka 3 mjeseca ili češće, kako je klinički indicirano, na temelju povijesti kronične bolesti bubrega i/ili bubrežne amiloidoze.
English: These pro-inflammatory organ changes were observed at 1.4 to 6.6-fold the human AUC at the recommeded therapeutic dose in all animal species tested and were accompanied by increases of various plasma cytokines/chemokines.
Croatian: Te proupalne organske promjene opažene su pri AUC-u od 1,4 do 6,6x AUC-a u ljudi pri preporučenoj terapijskoj dozi u svih ispitivanih vrsta životinja i bile su popraćene povećanjima u raznim citokinama/kemokinama u plazmi.
English: Always hold by the body of the syringe.
Croatian: Uvijek držite štrcaljku za tijelo štrcaljke.
English: Slowly and firmly push the plunger all the way down until the medicine is injected.
Croatian: Polako i čvrsto pritisnite klip do kraja prema dolje da se injicira cijela količina lijeka.
English: Following distribution to the patient, can be stored 6 weeks below 30°C.
Croatian: Nakon izdavanja bolesniku, može se čuvati 6 tjedana ispod 30 °C.
English: Therefore, reduction in plasma TTR is expected to result in reduction of plasma retinol levels to below the lower limit of normal.
Croatian: Stoga se očekuje da će smanjenje TTR-a u plazmi rezultirati smanjenjem razina retinola u plazmi ispod donje granice normale.
English: Urine protein to creatinine ratio (UPCR) ≥ 113 mg/mmol (1 g/g) prior to treatment.
Croatian: Omjer proteina i kreatinina u urinu (UPCR) ≥113 mg/mmol (1 g/g) prije liječenja.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of inotersen metabolites in milk (see section 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci u životinja pokazuju da se metaboliti inotersena izlučuju u mlijeko (vidjeti dio 5.3).
English: Patients undergoing liver transplant
Croatian: Bolesnici podvrgnuti transplantaciji jetre
English: The European Medicines Agency has waived the obligation to submit the results of studies with Tegsedi in all subsets of the paediatric population in transthyretin amyloidosis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Tegsedi u svim podskupinama pedijatrijske populacije s transtiretinskom amiloidozom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Tegsedi is available in pack sizes of either 1 or 4 pre-filled syringes.
Croatian: Tegsedi je dostupan u veličinama pakiranja od 1 ili 4 napunjene štrcaljke.
English: Pack sizes of 1 or 4 pre-filled syringes.
Croatian: Veličine pakiranja od 1 ili 4 napunjene štrcaljke.
English: Inotersen is not primarily cleared by metabolism in the liver, not a substrate for CYP450 oxidation, and metabolized broadly by nucleases in all tissues of distribution.
Croatian: Inotersen se ne uklanja prvenstveno metabolizmom u jetri, nije supstrat za CYP450 oksidaciju i metabolizira se opsežno nukleazama u svim tkivima distribucije.
English: Furthermore, results across the components of mNIS+7 and domains of Norfolk QoL-DN composite scores were consistent with the primary endpoint analysis, showing benefit in motor, sensory and autonomic neuropathies (Figure 2).
Croatian: Nadalje, rezultati svih sastavnih dijelova mNIS+7 i domena kompozitnih rezultata Norfolk QoL-DN odgovarali su analizi primarnih mjera ishoda, pokazujući korist s obzirom na motornu, osjetilnu i autonomnu neuropatiju (Slika 2).
English: Defined as all patients with a diagnosis of hereditary transthyretin amyloidosis with cardiomyopathy (hATTR-CM) at study entry or left ventricular wall thickness >1.3 cm on echocardiogram without a known history of persistent hypertension Duration from symptom onset to informed consent date
Croatian: Definirano kao svi bolesnici s dijagnozom nasljedne transtiretinske amiloidoze s kardiomiopatijom (hATTR-CM) pri ulasku u ispitivanje ili debljine stijenke lijeve klijetke >1,3 cm na ultrazvuku srca bez poznate perzistirajuće hipertenzije u anamnezi 3 Trajanje od pojave simptoma do datuma informiranog pristanka
English: • To undergo all blood or urine tests as arranged by their doctor;
Croatian: • da se podvrgnu pretragama krvi ili mokraće prema uputi liječnika;
English: - The other ingredients are water for injections, sodium hydroxide, and hydrochloric acid.
Croatian: - Drugi sastojci su voda za injekcije, natrijev hidroksid i kloridna kiselina.
English: You may see a drop of liquid at the end of the needle.
Croatian: Na kraju igle može se pojaviti kapljica tekućine.
English: Week 66 Change n LSM (SE) 95% CI Difference in LSM (Tegsedi - Placebo) 95% CI P-value
Croatian: Promjena u 66. tjednu n LSM (SE) 95% CI Razlika u LSM (Tegsedi - Placebo) 95% CI p-vrijednost
English: It is important to push the plunger all the way down.
Croatian: Važno je pritisnuti klip do kraja prema dolje.
English: It is unknown if continuation of your vitamin A supplementation with 3000 IU per day will be harmful to your unborn child in the first trimester of your pregnancy, but this dose should not be exceeded.
Croatian: A od 3000 IU dnevno biti štetan za Vaše nerođeno dijete u prvom tromjesečju trudnoće, ali ta se doza ne smije prekoračiti.
English: The elimination of inotersen involves both metabolism in tissues and excretion in urine.
Croatian: Eliminacija inotersena obuhvaća metabolizam u tkivima i izlučivanje u urinu.
English: Do not inject into the 3cm area around the belly-button (navel).
Croatian: Nemojte injicirati u područje 3 cm oko pupka.
English: It works by reducing production of transthyretin by the liver and so lowers the risk of fibres of transthyretin being deposited in body organs and causing symptoms.
Croatian: Djeluje tako što smanjuje proizvodnju transtiretina u jetri i time smanjuje rizik od nakupljanja vlakana transtiretina u tjelesnim organima i pojave simptoma.
English: Dosing frequency should be reduced to 284 mg every 2 weeks
Croatian: Učestalost doziranja treba smanjiti na 284 mg svaka 2 tjedna
English: Hold the pre-filled syringe by the body, with the needle facing away from you.
Croatian: Držite napunjenu štrcaljku za tijelo, s iglom okrenutom od Vas.
English: If you have an unplanned pregnancy you should stop taking inotersen.
Croatian: Ako neplanirano zatrudnite, morate prekinuti uzimanje inotersena.
English: • The list of signs and symptoms of thrombocytopenia, glomerulonephritis, and ocular toxicity due to vitamin A deficiency, highlighting that these might be severe or life-threatening, and advising patients to call immediately their doctor or attend the emergency room if such signs and symptoms appear;
Croatian: • popis znakova i simptoma trombocitopenije, glomerulonefritisa i okularne toksičnosti zbog nedostatka vitamina A, ističući da mogu biti teški ili po život opasni, te upozoravajući bolesnike da odmah nazovu liječnika ili da se upute na hitnu pomoć ako se pojave takvi znakovi i simptomi;
English: A responder analysis of mNIS+7 using thresholds ranging from a 0- to 30-point increase from baseline (using the safety set), showed the inotersen group had approximately a 2-fold higher response rate than the placebo group at each threshold tested, demonstrating consistency of response.
Croatian: Analiza bolesnika koji su odgovorili na liječenje mNIS+7 koristeći pragove povećanja s početne razine u rasponu od 0 do 30 bodova (koristeći set sigurnosti), pokazala je da je skupina liječena inotersenom imala približno 2 puta veću stopu odgovora nego skupina placeba pri svakom ispitanom pragu, što dokazuje dosljednost odgovora.
English: Inspection Area
Croatian: Područje za provjeru
English: PHARMACEUTICAL FORM Solution for injection (injection) Clear, colourless to pale yellow solution (pH 7.5 - 8.8)
Croatian: OBLIK Otopina za injekciju (injekcija) Bistra, bezbojna do blijedožuta otopina (pH 7,5 - 8,8)
English: Hereditary transthyretin amyloidosis is a genetic disease, which causes build-up of small fibres of a protein called transthyretin in the organs of your body stopping them from working properly.
Croatian: Nasljedna transtiretinska amiloidoza je genetska bolest, koja uzrokuje nakupljanje malih vlakana proteina zvanih transtiretin u organima tijela što sprječava njihov pravilan rad.
English: Inotersen showed no effects on fertility, embryo-foetal, or postnatal development in mice and rabbits at approximately 3-fold the maximum recommended human equivalent dose.
Croatian: Inotersen nije pokazao učinka na plodnost, embriofetalni ili postnatalni razvoj u miševa i kunića pri približno 3 puta većim dozama od maksimalno preporučene ekvivalente doze u ljudi.
English: • Advise HCPs that, due to the risks of thrombocytopenia and glomerulonephritis, patients should have their platelet count monitored at least every 2 weeks, and urine to protein creatinine ratio and estimated glomerular filtration rate monitored at least every 3 months;
Croatian: • savjetovati zdravstvenim radnicima da, zbog rizika od trombocitopenije i glomerulonefritisa, nadziru broj trombocita u bolesnika najmanje svaka 2 tjedna, te da nadziru omjer proteina i kreatinina u urinu i procijenjenu brzinu glomerularne filtracije najmanje svaka 3 mjeseca;
English: Animal studies did not indicate any impact of inotersen on male or female fertility.
Croatian: Ispitivanja na životinjama nisu ukazala na utjecaj inotersena na mušku ili žensku plodnost.
English: The apparent volume of distribution of inotersen at steady-state is 293 L in patients with hATTR.
Croatian: Prividni volumen distribucije inotersena u stanju dinamičke ravnoteže je 293 l u bolesnika sa hATTR.
English: Hepatic enzymes should be measured 4 months after initiation of treatment with inotersen and annually thereafter or more frequently as clinically indicated, in order to detect cases of hepatic impairment (see section 4.8).
Croatian: Potrebno je mjeriti jetrene enzime 4 mjeseca nakon početka liječenja inotersenom i jedanput godišnje nakon toga, ili češće ako je klinički indicirano, radi otkrivanja slučajeva oštećenja jetrene funkcije (vidjeti dio 4.8).
English: This prevents the synthesis of TTR protein in the liver, resulting in significant reductions in the levels of mutated and wild type TTR protein secreted by the liver into the circulation.
Croatian: To sprječava sintezu TTR proteina u jetri, što rezultira značajnim smanjenjem u razinama mutiranog i divljeg tipa TTR proteina koji jetra izlučuje u krvotok.
English: In the pivotal NEURO-TTR study, in the inotersen treatment group, robust reduction in circulating TTR levels was observed throughout the 15-month treatment period, with mean percent changes from baseline in serum TTR ranging from 68.41% to 74.03% (median range: 74.64% to 78.98%) from Week 13 to Week 65 (Figure 1).
Croatian: U pivotalnom ispitivanju NEURO-TTR, u skupini liječenoj inotersenom opaženo je znatno smanjenje u razinama TTR-a u cirkulaciji tijekom razdoblja liječenja od 15 mjeseci, sa srednjom vrijednosti postotka promjena u odnosu na početne vrijednosti TTR-a u serumu u rasponu od 68,41% do 74,03% (medijan raspona: 74,64% do 78,98%) od 13. tjedna do 65. tjedna (slika 1).
English: However, increasing vitamin A supplementation to above 3000 IU per day during pregnancy is unlikely to correct plasma retinol levels due to the mechanism of action of inotersen and may be harmful to the mother and foetus.
Croatian: A iznad 3000 IU dnevno tijekom trudnoće ispraviti razine retinola u plazmi zbog mehanizma djelovanja inotersena i može biti štetno za majku i plod.
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave lijeka prikazane su u padajućem nizu prema ozbiljnosti.
English: Based on the population pharmacokinetic analysis, age, body weight, sex or race has no clinically relevant effect on inotersen exposure.
Croatian: Na temelju populacijske farmakokinetičke analize, dob, tjelesna masa, spol ili rasa nemaju klinički značajan utjecaj na izloženost inotersenu.
English: Baseline demographic and disease characteristics are shown in Table 3.
Croatian: Početni demografski podaci i početna obilježja bolesti prikazani su u Tablici 3.
English: Women of child-bearing potential have to use effective contraception during treatment with inotersen.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja inotersenom.
English: You doctor will measure these, and if they are already low, this should be corrected and any symptoms resolved before you start treatment with Tegsedi.
Croatian: Liječnik će Vam izmjeriti te vrijednosti i, ako su već niske, treba ih ispraviti a svi simptomi, ako postoje, trebaju se povući prije početka liječenja lijekom Tegsedi.
English: Elderly No dose adjustment is required in patients aged 65 and over (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika u dobi od 65 i više godina (vidjeti dio 5.2).
English: On reinitiation of treatment dose frequency should be reduced to 284 mg every 2 weeks.
Croatian: Kod ponovnog započinjanja liječenja učestalost doziranja treba smanjiti na 284 mg svaka 2 tjedna.
English: The MAH shall ensure that in each MS where Tegsedi is marketed, all patients who are expected to been administered the products are provided with a patient alert card (wallet size), aiming at preventing and/or minimising the important identified risks of thrombocytopenia, glomerulonephritis, and the important potential risk of ocular toxicity due to vitamin A deficiency, and reminding patients:
Croatian: Nositelj odobrenja će osigurati da u svakoj državi članici gdje se Tegsedi stavlja u promet svi bolesnici predviđeni za primanje lijeka dobiju karticu s upozorenjima za bolesnika (džepne veličine), s ciljem sprječavanja i/ili minimiziranja važnih poznatih rizika trombocitopenije, glomerulonefritisa i važnog mogućeg rizika od okularne toksičnosti zbog nedostatka vitamina A, uz napomenu bolesnicima:
English: The NEURO-TTR multicentre, double-blind, placebo-controlled trial was comprised of 172 treated patients with hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN).
Croatian: Multicentrično, dvostruko slijepo i placebom kontrolirano ispitivanje NEURO-TTR uključivalo je 172 liječenih bolesnika s nasljednom transtiretinskom amiloidozom s polineuropatijom (hATTR-PN).
English: If glomerulonephritis is excluded, dosing may be resumed if clinically indicated and following improvement of renal function (see section 4.3).
Croatian: Ako je glomerulonefritis isključen, doziranje se može nastaviti ako je klinički indicirano, i to nakon poboljšanja funkcije bubrega (vidjeti dio 4.3).
English: What Tegsedi contains - The active substance is inotersen.
Croatian: Što Tegsedi sadrži - Djelatna tvar je inotersen.
English: Inotersen is not a substrate for CYP450 metabolism, and is metabolised in tissues by endonucleases to form shorter inactive oligonucleotides that are the substrates for additional metabolism by exonucleases.
Croatian: Inotersen nije supstrat za CYP450 metabolizam, a u tkivima ga metaboliziraju endonukleaze koje formiraju kraće neaktivne oligonukleotide koji su supstrati za dodatni metabolizam od strane egzonukleaza.
English: Recommendations for adjustments to monitoring frequency and inotersen dosing are specified in Table 1 (see section 4.2).
Croatian: Preporuke za prilagođavanje učestalosti praćenja i doziranja inotersena navedene su u Tablici 1 (vidjeti dio 4.2).
English: The most frequently observed events included events associated with injection site reactions (includes injection site pain, erythema, pruritus, swelling, rash, induration, bruising and haemorrhage).
Croatian: Najčešće prijavljeni događaji uključivali su one vezane uz reakcije na mjestu injiciranja (to uključuje bol na mjestu injiciranja, eritem, svrbež, oticanje, osip, otvrdnuće, masnice i krvarenje).
English: Platelet count should be monitored every 2 weeks during treatment with inotersen and for 8 weeks following discontinuation of treatment.
Croatian: Potrebno je pratiti broj trombocita svaka 2 tjedna tijekom liječenja inotersenom i tijekom 8 tjedana nakon prekida liječenja.
English: Daily until 2 successive values above 25.
Croatian: Svakodnevno do postizanja 2 puta zaredom vrijednosti iznad 25.
English: Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Croatian: 6.1 Popis pomoćnih tvari voda za injekcije kloridna kiselina (za prilagodbu pH) natrijev hidroksid (za prilagodbu pH)
English: Some patients treated with inotersen have also developed a decline in their kidney function without having had glomerulonephritis.
Croatian: U nekih bolesnika liječenih inotersenom javilo se smanjenje funkcije bubrega bez da su imali glomerulonefritis.
English: The study evaluated 284 mg inotersen administered as one subcutaneous injection once per week, for 65 weeks of treatment.
Croatian: U ispitivanju se ocjenjivalo liječenje inotersenom u dozi od 284 mg primijenjenih u obliku jedne supkutane injekcije jedanput tjedno, tijekom 65 tjedana liječenja.
English: Each pre-filled syringe should be used only once and then placed in a sharps disposal container for disposal.
Croatian: Svaka napunjena štrcaljka se smije upotrijebiti samo jedanput i zatim odložiti u spremnik za oštre predmete radi zbrinjavanja.
English: Do not use this medicine if you notice that the contents are cloudy or contains particles.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je sadržaj zamućen ili sadrži čestice.
English: Do not inject where skin is bruised, tender, red or hard.
Croatian: Nemojte injicirati tamo gdje je koža osjetljiva, crvena, otvrdnula ili ako je prisutna modrica.
English: Glomerulonephritis is a condition of your kidneys, where they do not work properly due to inflammation and kidney damage.
Croatian: Glomerulonefritis je stanje bubrega kod kojeg bubrezi ne funkcioniraju ispravno zbog upale i oštećenja bubrega.
English: Tegsedi is a clear, colourless to pale yellow solution (pH 7.5 - 8.8) for injection (injection) in a pre-filled syringe.
Croatian: Tegsedi je bistra, bezbojna do blijedožuta otopina (pH 7,5 - 8,8) za injekciju (injekcija) u napunjenoj štrcaljki.
English: What Tegsedi is and what it is used for
Croatian: Što je Tegsedi i za što se koristi
English: Do not touch the area again before injecting.
Croatian: Očišćeno područje nemojte više dirati prije injiciranja.
English: Tegsedi is indicated for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).
Croatian: Tegsedi je indiciran u liječenju 1. stadija ili 2. stadija polineuropatije u odraslih bolesnika s nasljednom transtiretinskom amiloidozom (engl. hereditary transthyretin amyloidosis, hATTR).
English: If you are of child-bearing age and intend to use Tegsedi, you should practise effective contraception.
Croatian: Ako ste u reproduktivnoj dobi i namjeravate primijeniti Tegsedi, morate koristiti učinkovitu kontracepciju.
English: Subgroup n (Placebo, Inotersen)
Croatian: Podskupina n (placebo, inotersen)
English: The selective binding of inotersen to the TTR messenger RNA (mRNA) causes the degradation of both mutant and wild type (normal) TTR mRNA.
Croatian: Selektivno vezanje inotersena za TTR glasničku RNK (mRNK) izaziva razgradnju TTR mRNK mutiranog i divljeg (normalna) tipa.
English: There is no information available on the effects of inotersen on human fertility.
Croatian: Nisu dostupni podaci o učincima inotersena na plodnost u ljudi.
English: If you forget to use Tegsedi
Croatian: Ako ste zaboravili primijeniti Tegsedi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1296/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1296/001
English: If a woman intends to become pregnant, inotersen and vitamin A supplementation should be discontinued and plasma vitamin A levels should be monitored and have returned to normal before conception is attempted.
Croatian: Ako žena namjerava zatrudniti, potrebno je prekinuti primjenu inotersena i suplementacije vitaminom A, pratiti razine vitamina A u plazmi, te ih vratiti u normalu prije pokušaja začeća.
English: Stage 1
Croatian: 1. stadij
English: Although the population PK analysis did not identify clinically relevant effects of some nephrotoxic medicines on the clearance of inotersen or on the potential for an effect on renal function, a systematic assessment of co-administration of inotersen and potentially nephrotoxic medicinal products has not been conducted.
Croatian: Iako populacijska farmakokinetička analiza nije pokazala klinički relevantne učinke određenih nefrotoksičkih lijekova na klirens inotersena ili na potencijalni učinak na funkciju bubrega, nije provedena sustavna procjena istodobne primjene inotersena i potencijalno nefrotoksičnih lijekova.
English: Thereafter, vitamin A supplementation of 3000 IU per day should be resumed in the second and third trimester if plasma retinol levels have not yet returned to normal, because of the increased risk of vitamin A deficiency in the third trimester.
Croatian: A od 3000 IU dnevno u drugom i trećem tromjesečju ako se razine retinola u plazmi još nisu vratile u normalu jer postoji povećan rizik od nedostatka vitamina A u trećem tromjesečju.
English: The high volume of distribution suggests inotersen extensively distributes into tissues following SC administration.
Croatian: Veliki volumen distribucije ukazuje da se inotersen opsežno raspodjeljuje u tkiva nakon supkutane primjene.
English: Age (years), mean (SD) Age 65 years and older, n (%) Male, n (%) mNIS+7, mean (SD)
Croatian: Dob (godine), srednja vrijednost (SD) Dob 65 godina ili više, n (%) Muškarac, n (%) mNIS+7, srednja vrijednost (SD) Norfolk QoL-DN, srednja vrijednost (SD) Stadij bolesti, n (%)