FrancophonIA/ELRC3.0 huggingface dataset:
English: For the primary endpoint the pre-specified significance level for the one-sided p-value was 0.025.
Slovenian: Za primarni cilj opazovanja je bila vnaprej določena raven statistične značilnosti za enostransko vrednost p 0,025.
English: Cataract formation was observed in some animals after a relatively long period of intense inflammation, suggesting that the lens changes were secondary to severe inflammation.
Slovenian: Pri nekaterih živalih so opažali razvoj katarakte po sorazmerno dolgem obdobju intenzivnega vnetja, kar nakazuje, da so spremembe v leči nastale sekundarno po hudem vnetju.
English: Key outcome measures are summarised in Table 5 (RESTORE and Extension) and Figure 4 (RESTORE).
Slovenian: Glavna merila izidov so prikazana v preglednici 5 (študija RESTORE in podaljšanje te študije) in na sliki 4 (študija RESTORE).
English: Lucentis should not be administered concurrently with other anti-VEGF medicinal products (systemic or ocular).
Slovenian: Zdravila Lucentis se ne sme aplicirati sočasno z drugimi zdravili, ki delujejo proti VEGF, (sistemskimi ali očesnimi).
English: Results from both trials indicated that continued ranibizumab treatment may also be of benefit in patients who lost ≥15 letters of best-corrected visual acuity (BCVA) in the first year of treatment.
Slovenian: Rezultati obeh študij so pokazali, da lahko nadaljnje zdravljenje z ranibizumabom koristi tudi bolnikom, pri katerih je v prvem letu zdravljenja prišlo do poslabšanja najboljše ostrine vida s korekcijo (BCVA - best-corrected visual acuity) za ≥15 črk.
English: Pharmacotherapeutic group: Ophthalmologicals, antineovascularisation agents, ATC code: S01LA04
Slovenian: Farmakoterapevtska skupina: zdravila za očesne bolezni, zaviralci neovaskularizacije, oznaka ATC: S01LA04
English: When given on the same day, Lucentis should be administered at least 30 minutes after laser photocoagulation.
Slovenian: Pri uporabi obeh načinov zdravljenja na isti dan je treba zdravilo Lucentis aplicirati najmanj 30 minut po laserski fotokoagulaciji.
English: • Zone I, stage 1+, 2+, 3 or 3+ disease, or
Slovenian: • prizadetost predela I, stadij 1+, 2+, 3 ali 3+ ali
English: Key outcome measures from BRIGHTER and CRYSTAL are shown in Table 9.
Slovenian: Glavni izidi meritev v študijah BRIGHTER in CRYSTAL so prikazana v preglednici 9.
English: The interval between two doses injected into the same eye should be at least four weeks.
Slovenian: Interval med dvema odmerkoma, injiciranima v isto oko, mora biti najmanj štiri tedne.
English: Eligible patients had one of the following retinal findings in each eye:
Slovenian: Za študijo so bili primerni bolniki, ki so imeli na vsakem od obeh očes enega od naslednjih izvidov:
English: Lucentis specifically recognises and binds to a protein called human vascular endothelial growth factor A (VEGF-A) present in the eye.
Slovenian: Zdravilo Lucentis specifično prepozna in se veže na beljakovino, ki jo imenujemo človeški žilni endotelijski rastni dejavnik A (VEGF-A) in je prisotna v očesu.
English: The treatment interval should be extended by no more than two weeks at a time for wet AMD and may be extended by up to one month at a time for DME.
Slovenian: Pri vlažni obliki SDM je mogoče interval med dvema odmerkoma v enem koraku podaljšati za največ dva tedna, medtem ko ga je pri DME mogoče v enem koraku podaljšati za največ en mesec.
English: • the syringe cap is not detached from the Luer lock.
Slovenian: • da pokrovček brizge ni odlomljen od nastavka Luer lock,
English: Treatment should be discontinued in subjects with rhegmatogenous retinal detachment or stage 3 or 4 macular holes.
Slovenian: Zdravljenje je treba prekiniti pri osebah z regmatogenim odstopom mrežnice ali foramnom makule 3. ali 4. stopnje.
English: If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see Figure 6).
Slovenian: Če so v brizgi zračni mehurčki, s prstom rahlo potrkajte po brizgi, da se mehurčki dvignejo proti vrhu (glejte sliko 6).
English: Overall, ranibizumab treatment was well tolerated.
Slovenian: V celoti so bolniki zdravljenje z ranibizumabom dobro prenašali.
English: Injecting the entire volume of the pre-filled syringe could result in overdose.
Slovenian: Injiciranje celotnega volumna napolnjene injekcijske brizge bi pomenilo preveliko odmerjanje.
English: 1x 0.23 ml vial, 1 filter needle.
Slovenian: 1x 0,23-mililitrska viala, 1 igla s filtrom.
English: Please find information for adults on the other side of this leaflet.
Slovenian: Navodilo za uporabo pri odraslih osebah lahko najdete na drugi strani tega lista.
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
Slovenian: • Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet z zdravilom Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
English: A total of 868 patients (708 active and 160 control) were enrolled in these studies.
Slovenian: V te študije je bilo skupno vključenih 868 bolnikov (708 bolnikov, ki so prejemali aktivno zdravilo, in 160 kontrolnih bolnikov).
English: Patients should be instructed to report any symptoms suggestive of endophthalmitis or any of the above mentioned events without delay.
Slovenian: Bolnike je treba poučiti, da v primeru simptomov, ki nakazujejo endoftalmitis ali katerega od zgoraj naštetih dogodkov, to takoj sporočijo.
English: What Lucentis is and what it is used for
Slovenian: Kaj je zdravilo Lucentis in za kaj ga uporabljamo
English: For CNV secondary to pathologic myopia (PM), many patients may only need one or two injections during the first year (see section 5.1).
Slovenian: Številni bolniki s CNV zaradi degenerativne kratkovidnosti (PM - pathologic myopia) bodo morda potrebovali samo eno ali dve injekciji v prvem letu (glejte poglavje 5.1).
English: Table 6 Outcomes in study D2304 (RETAIN)
Slovenian: Preglednica 6 Izidi v študiji D2304 (RETAIN)
English: There is a potential for immunogenicity with Lucentis.
Slovenian: Pri zdravilu Lucentis obstaja možnost imunogenosti.
English: The treatment procedure may induce temporary visual disturbances, which may affect the ability to drive or use machines (see section 4.8).
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Postopek zdravljenja lahko povzroči začasne motnje vida, ki lahko motijo sposobnost vožnje in upravljanja s stroji (glejte poglavje 4.8).
English: Risk factors associated with the development of a retinal pigment epithelial tear after anti-VEGF therapy for wet AMD and potentially also other forms of CNV, include a large and/or high pigment epithelial retinal detachment.
Slovenian: Dejavniki tveganja, ki so povezani z nastankom raztrganja pigmentnega epitelija po uporabi zdravil, ki delujejo proti VEGF pri zdravljenju vlažne oblike SDM in morda tudi drugih oblik CNV, vključujejo obsežen in/ali visok odstop pigmentnega epitelija mrežnice.
English: Your doctor will advise you and decide how long you should be treated with Lucentis.
Slovenian: Zdravnik vam bo svetoval in določil, kako dolgo bi se morali zdraviti z zdravilom Lucentis.
English: The syringe is ready for injection.
Slovenian: Brizga je tako pripravljena za injiciranje.
English: 240 patients, who had previously completed the 12-month RESTORE study, were enrolled in the open-label, multicentre 24-month extension (RESTORE Extension) study.
Slovenian: 240 bolnikov, ki so že zaključili 12-mesečno zdravljenje v študiji RESTORE, so vključili v odprto multicentrično 24-mesečno podaljšanje študije (podaljšanje študije RESTORE).
English: The majority of adverse reactions reported following administration of Lucentis are related to the intravitreal injection procedure.
Slovenian: Večina neželenih učinkov, o katerih so poročali po odmerjanju zdravila Lucentis, je povezana s postopkom intravitrealnega injiciranja.
English: In total, up to three injections per eye may be administered within six months of treatment initiation if there are signs of disease activity.
Slovenian: Skupno lahko prejmejo največ tri injekcije na oko v šestih mesecih od začetka zdravljenja, če so prisotni znaki aktivne bolezni.
English: The majority of patients treated with ranibizumab 0.2 mg (78.1%) received a single injection per eye.
Slovenian: Večina bolnikov, zdravljenih z ranibizumabom v odmerku 0,2 mg, (78,1 %) je prejela po eno injekcijo na oko.
English: What Lucentis is used for Lucentis is used in adults to treat several eye diseases causing vision impairment.
Slovenian: Zdravilo Lucentis se uporablja pri odraslih za zdravljenje nekaterih bolezni oči, pri katerih pride do okvare vida.
English: The injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required).
Slovenian: Postopek injiciranja je treba opraviti v aseptičnih pogojih, kar vključuje kirurško dezinfekcijo rok, uporabo sterilnih rokavic, sterilnega pokritja in sterilnega očesnega spekuluma (ali drugega ustreznega instrumenta) ter možnost sterilne paracenteze (če bi bila potrebna).
English: - Store in a refrigerator (2°C - 8°C).
Slovenian: - Shranjujte v hladilniku (2 °C - 8 °C).
English: *Ranibizumab is a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology.
Slovenian: *Ranibizumab je fragment humaniziranega monoklonskega protitelesa, pridobljen iz celic bakterije Escherichia coli s tehnologijo rekombinantne DNA.
English: Data from two studies (MONT BLANC, BPD952A2308 and DENALI, BPD952A2309) conducted post approval confirmed the efficacy of Lucentis but did not demonstrate additional effect of the combined administration of verteporfin (Visudyne PDT) and Lucentis compared to Lucentis monotherapy.
Slovenian: Podatki dveh študij (MONT BLANC, BPD952A2308 in DENALI, BPD952A2309), ki so ju izvajali po pridobitvi dovoljenja za promet z zdravilom, so potrdili učinkovitost zdravila Lucentis, niso pa pokazali, da bi imelo kombinirano zdravljenje z verteporfinom (PDT z zdravilom Visudyne) in zdravilom Lucentis boljši učinek kot zdravilo Lucentis v monoterapiji.
English: • the solution looks clear, colourless to pale yellow and does not contain any particles.
Slovenian: • da je raztopina videti bistra in brezbarvna do bledo rumena ter ne vsebuje nobenih delcev.
English: - Lucentis is not recommended during breast-feeding because it is not known whether Lucentis passes into human milk.
Slovenian: - Uporaba zdravila Lucentis ni priporočljiva v obdobju dojenja, saj ni znano ali zdravilo Lucentis prehaja v materino mleko.
English: This is something you may not notice, therefore your doctor may monitor this after each injection.
Slovenian: Tega morda ne boste opazili, zato bo po vsakem injiciranju vaš zdravnik izmeril očesni tlak.
English: In both studies, the improvement of vision was accompanied by a continuous and significant reduction in the macular oedema as measured by central retinal thickness.
Slovenian: V obeh študijah je izboljševanje vida spremljalo stalno in pomembno zmanjševanje makularnega edema, kar so merili z debelino osrednjega dela mrežnice.
English: Carefully remove the needle cap by pulling it straight off (see Figure 5).
Slovenian: Previdno odstranite pokrovček igle, in sicer tako, da ga potegnete naravnost z igle (glejte sliko 5).
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Preden prejmete to zdravilo natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: • Group I (ranibizumab 0.5 mg, dosing regimen driven by “stability” criteria defined as no change in BCVA compared to two preceding monthly evaluations).
Slovenian: • skupina I (0,5 mg ranibizumaba, shema odmerjanja na podlagi kriterijev “stabilnosti”, ki so bili opredeljeni kot odsotnost spremembe BCVA v primerjavi z ocenami predhodnih dveh mesečnih pregledov);
English: All components are sterile and for single use only.
Slovenian: Vse komponente so sterilne in namenjene samo za enkratno uporabo.
English: The filter needle is not for injection.
Slovenian: Igla s filtrom ni namenjena injiciranju.
English: A total of 191 eyes (48.5%) were randomised to ranibizumab 0.5 mg and 203 eyes (51.5%) eyes were randomised to PRP.
Slovenian: Skupno 191 oči (48,5 %) je bilo randomiziranih na prejemanje 0,5 mg ranibizumaba, 203 očesa (51,5 %) pa so bila randomizirana na PRFK.
English: Your baby's doctor may monitor this after each injection.
Slovenian: Otrokov zdravnik bo verjetno to izmeril po vsakem injiciranju.
English: Before the injection, your baby's doctor will wash your baby's eyes carefully to prevent infection.
Slovenian: Pred injiciranjem bo otrokov zdravnik pazljivo izpral otrokove oči, da bi preprečil okužbo.
English: If a patient died or switched study treatment before or at week 24, then the patient was considered as having active ROP and unfavourable structural outcomes at week 24.
Slovenian: Če je bolnik umrl ali prešel na drug način študijskega zdravljenja pred 24. tednom, je štel med tiste z aktivno retinopatijo nedonošenčkov (ROP) in prisotnimi neugodnimi strukturnimi spremembami v 24. tednu.
English: Mean change in visual acuity (letters) (SD)
Slovenian: povprečna sprememba ostrine vida (črke) (SD)
English: Lucentis can be administered in patients who have received previous laser photocoagulation.
Slovenian: Zdravilo Lucentis je mogoče aplicirati bolnikom, ki so jim predhodno opravili lasersko fotokoagulacijo.
English: There is limited experience in patients older than 75 years with DME.
Slovenian: Pri bolnikih, ki so starejši od 75 let in imajo DME, je izkušenj malo.
English: Cmax was dose proportional over the dose range of 0.05 to 1.0 mg/eye.
Slovenian: Cmax je bila sorazmerna odmerku v obsegu odmerkov med 0,05 do 1,0 mg/oko.
English: BCVA improved from baseline to Month 12 in all five patients, ranging from 5 to 38 letters (mean of 16.6 letters).
Slovenian: BCVA se je od izhodišča do konca 12. meseca izboljšala pri vseh petih bolnikih, in sicer v okviru od 5 do 38 črk (v povprečju od za 16,6 črk).
English: Renal impairment Dose adjustment is not needed in patients with renal impairment (see section 5.2).
Slovenian: Okvara ledvic Pri bolnikih z okvaro ledvic prilagajanje odmerkov ni potrebno (glejte poglavje 5.2).
English: Lucentis has not been studied in patients who have previously received intravitreal injections, in patients with active systemic infections, or in patients with concurrent eye conditions such as retinal detachment or macular hole.
Slovenian: Uporabe zdravila Lucentis niso proučevali pri bolnikih, ki so predhodno prejemali intravitrealne injekcije, pri bolnikih z aktivnimi sistemskimi okužbami in pri bolnikih, ki imajo sočasne očesne bolezni, kot sta odstop mrežnice ali foramen makule.
English: Treatment initiation at the time of diagnosis should be considered.
Slovenian: Treba je razmisliti o možnosti začetka zdravljenja takoj po postavitvi diagnoze.
English: The absence of ranibizumab-mediated effects on embryo-foetal development is plausibly related mainly to the inability of the Fab fragment to cross the placenta.
Slovenian: Odsotnost vpliva ranibizumaba na razvoj zarodka oziroma plodu je verjetno povezana predvsem z nezmožnostjo Fab fragmenta za prehajanje preko posteljice.
English: The mean number of ranibizumab injections given in the study eye over 12 months was 3 (ranged from 2 to 5).
Slovenian: Povprečno število injekcij ranibizumaba, ki so jih bolniki prejeli v 12 mesecih, je bilo 3 (od 2 do 5).
English: The patient information pack should be provided in both the form of patient information booklets and an audio-CD that contain following key elements:
Slovenian: Komplet navodil za bolnika mora vsebovati tako brošure kot zvočno zgoščenko, ki vsebujejo sledeče ključne vsebine:
English: At Month 2, all patients received open-label treatment with ranibizumab as needed.
Slovenian: Po koncu 2. meseca so bolniki začeli prejemati odprto zdravljenje z ranibizumabom po potrebi.
English: PRP (N=199)
Slovenian: PRFK (N=199)
English: Hold the syringe at eye level and carefully push the plunger until the edge below the dome of the rubber stopper is aligned with the dose mark (see Figure 7).
Slovenian: Brizgo držite v višini oči in previdno potiskajte bat, dokler se rob krivine gumijastega tesnila ne poravna z odmerno oznako (glejte sliko 7).
English: The corresponding visual acuity gain in patients with ≥12 months disease duration was 8.6 and 8.4 letters in the respective studies.
Slovenian: V navedenih dveh študijah je ustrezno izboljšanje ostrine vida pri bolnikih s trajanjem bolezni ≥12 mesecev znašalo 8,6 oziroma 8,4 črk.
English: If, in the physician's opinion, visual and anatomical parameters indicate that the patient is not benefiting from continued treatment, Lucentis should be discontinued.
Slovenian: Če po mnenju zdravnika vizualni in anatomski parametri nakazujejo, da neprekinjeno zdravljenje ne vpliva pozitivno na bolnika, je treba z zdravljenjem z zdravilo Lucentis prekiniti.
English: Limited data on bilateral use of Lucentis (including same-day administration) do not suggest an increased risk of systemic adverse events compared with unilateral treatment.
Slovenian: Omejena količina podatkov glede hkratnega zdravljenja obeh očes z zdravilom Lucentis (vključno z zdravljenjem v istem dnevu) ne nakazuje povečanega tveganja za sistemske neželene učinke v primerjavi z zdravljenjem samo enega očesa.
English: All components are for single use only.
Slovenian: Vse komponente so namenjene enkratni uporabi.
English: Serum concentrations in a limited number of DME patients indicate that a slightly higher systemic exposure cannot be excluded compared to those observed in neovascular AMD patients.
Slovenian: Koncentracije v serumu pri manjšem številu bolnikov z DME kažejo, da pri takih bolnikih ni mogoče izključiti možnosti za nekoliko višjo sistemsko koncentracijo v primerjavi s tisto, ki so jo opažali pri bolnikih z neovaskularno SDM.
English: In this study 277 patients were randomised in a 2:2:1 ratio to the following arms:
Slovenian: V tej študiji so 277 bolnikov randomizirali v razmerju 2:2:1 v naslednje skupine:
English: The MAH shall ensure that, following discussions and agreements with the National Competent Authorities in each Member State where Lucentis is marketed, at launch and after launch all ophthalmological clinics where Lucentis is expected to be used are provided with an up-to-date patient information pack.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora po usklajevanju in pridobitvi soglasja pristojnih nacionalnih oblasti v vsaki državi članici, v kateri se zdravilo Lucentis trži, zagotoviti, da bo v času prihoda zdravila na trg in po njem vsem oftalmološkim klinikam, na katerih je mogoče pričakovati uporabo zdravila Lucentis, priskrbel najnovejši komplet navodil za bolnika.
English: Bilateral intravitreal administration of ranibizumab to cynomolgus monkeys at doses between 0.25 mg/eye and 2.0 mg/eye once every 2 weeks for up to 26 weeks resulted in dose-dependent ocular effects.
Slovenian: Pri obojestranskem intravitrealnem apliciranju ranibizumaba opicam javanski makak v odmerkih med 0,25 mg/oko in 2,0 mg/oko na 2 tedna v obdobju do 26 tednov je prišlo do od velikosti odmerka odvisnih učinkov na očeh.
English: Nevertheless, a case was described with high maternal ranibizumab serum levels and presence of ranibizumab in foetal serum, suggesting that the anti-ranibizumab antibody acted as (Fc region containing) carrier protein for ranibizumab, thereby decreasing its maternal serum clearance and enabling its placental transfer.
Slovenian: Ne glede na to so opisali primer z visoko koncentracijo ranibizumaba v materinem serumu in prisotnostjo ranibizumaba v plodovem serumu, kar kaže, da so protitelesa proti ranibizumabu delovala kot prenašalni protein (z Fc regijo) za ranibizumab, s čimer so zmanjšala izločanje ranibizumaba iz materinega seruma in omogočila prehajanje preko posteljice.
English: The dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment in the event of:
Slovenian: Apliciranje odmerka je treba odložiti vsaj do naslednjega dogovorjenega datuma za zdravljenje v naslednjih primerih:
English: Treatment success, as measured by the absence of active ROP and absence of unfavourable structural outcomes in both eyes 24 weeks after the first study treatment, was highest with ranibizumab 0.2 mg (80%) compared to laser therapy (66.2%) (see Table 10).
Slovenian: Uspešnost zdravljenja, opredeljena kot odsotnost aktivne retinopatije nedonošenčkov (ROP) in odsotnost neugodnih strukturnih sprememb v obeh očesih 24 tednov po prvem študijskem zdravljenju, je bila največja v skupini z 0,2 mg ranibizumaba (80 %) v primerjavi s skupino z lasersko terapijo (66,2 %) (glejte preglednico 10).
English: In all groups, ranibizumab was administered monthly until BCVA was stable for at least three consecutive monthly assessments.
Slovenian: V vseh skupinah so ranibizumab odmerjali enkrat mesečno, dokler BCVA ni bila stabilna pri najmanj treh zaporednih mesečnih določanjih ostrine vida.
English: - Inform your doctor if you have a prior history of eye conditions or eye treatments, or if you have had a stroke or experienced transient signs of stroke (weakness or paralysis of limbs or face, difficulty speaking or understanding).
Slovenian: - Zdravniku povejte, če ste imeli že kdaj prej katero od očesnih bolezni ali ste si zdravili oči oziroma ste imeli kdaj možgansko kap ali prehodne znake možganske kapi (šibkost ali ohromelost okončin ali obraza, oteženo govorjenje ali razumevanje).
English: Your baby's doctor will advise you and decide how long your baby should be treated with Lucentis.
Slovenian: Otrokov zdravnik vam bo svetoval in določil, kako dolgo bi se moral vaš otrok zdraviti z zdravilom Lucentis.
English: Additional side effects that have been observed with Lucentis in adults are listed below.
Slovenian: Dodatni neželeni učinki, ki so jih opažali pri uporabi zdravila Lucentis pri odraslih, so navedeni spodaj.
English: All injections will be administered by the eye doctor.
Slovenian: Vsa injiciranja bo opravil očesni zdravnik.
English: In both studies, a rapid and statistically significant decrease from baseline in central retinal subfield thickness was observed at Month 1.
Slovenian: V obeh študijah so po 1 mesecu opažali hitro in statistično značilno zmanjšanje debeline centralnega dela mrežnice glede na izhodišče.
English: Available data in adolescent patients aged 12 to 17 years with visual impairment due to CNV are described in section 5.1.
Slovenian: Razpoložljivi podatki za mladoletne bolnike, ki so stari od 12 do 17 let in imajo okvaro vida zaradi CNV, so navedeni v poglavju 5.1.
English: In Group II, which is the recommended posology (see section 4.2), 50.9% of patients required 1 or 2 injections, 34.5% required 3 to 5 injections and 14.7% required 6 to 12 injections over the 12-month study period.
Slovenian: V 12-mesečnem študijskem obdobju je v skupini II, v kateri so bolniki prejemali zdravilo v skladu s priporočeno shemo (glejte poglavje 4,2), 50,9 % bolnikov potrebovalo 1 ali 2 injekciji, 34,5 % jih je potrebovalo 3 do 5 injekcij, 14,7 % pa jih je potrebovalo 6 do 12 injekcij.
English: All injections will be administered by your eye doctor.
Slovenian: Vsa injiciranja bo opravil vaš očesni zdravnik.
English: Lucentis can be used for people of 65 years of age and over without dose adjustment.
Slovenian: Starostniki (stari 65 let ali več) Zdravilo Lucentis se lahko uporablja pri ljudeh, starih 65 let ali več, brez prilagajanja odmerka.
English: It is unknown whether Lucentis is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo Lucentis izloča v materino mleko.
English: Table 7 DRSS improvement or worsening of ≥2 or ≥3 steps at year 1 in Protocol S (LOCF Method)
Slovenian: Preglednica 7 Izboljšanje ali poslabšanje ocene DRSS za ≥2 ali ≥3 stopnje po 1 letu v študiji Protocol S po metodi prenosa zadnje ocene naprej (LOCF - Last Observation Carried Forward)