FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of hepatic or renal insufficiency as covariates could not be thoroughly evaluated in the population PK model given the rarity of patients displaying clinically relevant liver or kidney insufficiencies.
Slovenian: Učinka insuficience jeter ali ledvic kot sospremenljivk v populacijskem farmakokinetičnem modelu ni bilo mogoče natančno oceniti zaradi malega števila bolnikov, ki kažejo klinično pomembne znake insuficience ledvic ali jeter.
English: However, individual safety data for the treatment-emergent ADA-positive cases were reviewed, and no AEs of interest were identified.
Slovenian: Kljub temu so bili posamezni podatki o varnosti za pozitivne primere ADA, ki so jih odkrili med zdravljenjem,
English: Mean CSF trough concentrations of nusinersen accumulated approximately 1.4- to 3-fold after multiple loading and maintenance doses, and reached a steady state within approximately 24 months.
Slovenian: Srednje najnižje koncentracije nusinersena v CSF so se po večkratnih začetnih in vzdrževalnih odmerkih nakopičile za približno 1,4- do 3-krat in dosegle stanje dinamičnega ravnovesja v približno 24 mesecih.
English: Other products that are in the same group of medicines as Spinraza have been shown to affect the cells in the blood which help clotting.
Slovenian: Za druga zdravila, ki pripadajo isti skupini zdravil kot zdravilo Spinraza, so dokazali, da vplivajo na krvničke, ki pomagajo pri strjevanju krvi.
English: An improvement in mean CHOP INTEND score over time was observed from baseline to day 1072 (mean change 21.30).
Slovenian: Izboljševanje povprečnega rezultata CHOP INTEND so skozi čas ugotavljali od izhodišča do 1072. dne (povprečna sprememba 21,30).
English: Biogen GmbH Tel: +49 (0) 89 99 6170
Slovenian: Deutschland Biogen GmbH Tel: +49 (0) 89 99 6170
English: Median age of onset of clinical signs and symptoms was 56 days and patients had either 2 SMN2 gene copies (n=17) or 3 SMN2 gene copies (n=2) (SMN2 gene copy number unknown for 1 patient).
Slovenian: Mediana starost ob nastopu kliničnih znakov in simptomov je bila 56 dni, bolniki pa so imeli bodisi po 2 kopiji gena za SMN2 (n=17) bodisi po 3 kopije gena za SMN2 (n=2) (število kopij gena za SMN2 za 1 bolnika je bilo neznano).
English: • If you or your child are allergic to nusinersen or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični ali je vaš otrok alergičen na nusinersen ali katero koli sestavino tega zdravila
English: Post-marketing experience
Slovenian: Izkušnje iz obdobja trženja zdravila
English: In patients with decreased consciousness, an evaluation for hydrocephalus should be considered.
Slovenian: Pri bolnikih z zmanjšano ravnijo zavesti je treba preveriti, ali imajo hidrocefalus.
English: A maintenance dose should be administered once every 4 months thereafter.
Slovenian: Nato je treba dati vzdrževalni odmerek enkrat na vsake
English: The median age at screening was 3 years, and the median age of onset of clinical signs and symptoms of SMA was 11 months.
Slovenian: mediana starost ob nastopu kliničnih znakov in simptomov SMA pa 11 mesecev.
English: What you need to know before you or your child are given Spinraza Spinraza must not be given:
Slovenian: Kaj morate vedeti, preden bodo vam ali vašemu otroku dali zdravilo Spinraza Zdravilo Spinraza se ne sme dati:
English: The primary endpoint, time to death or respiratory intervention (defined as invasive or non-invasive ventilation for ≥6 hours/day continuously for ≥7 consecutive days OR
Slovenian: Primarnega končnega opazovanega dogodka, torej časa do smrti ali respiratorne intervencije (ki je bila opredeljena kot invazivna ali neinvazivna ventilacija za ≥ 6 ur/dan neprekinjeno ≥ 7 zaporednih dni ALI traheostomija), ni bilo mogoče oceniti, ker je bilo takšnih dogodkov premalo.
English: Taken together, there is sufficient evidence to support a casual association between with nusinersen administration and hypersensitivity; and the PI should be updated accordingly.
Slovenian: Če povzamemo, je torej na voljo dovolj podpornih dokazov za vzročno povezanost med jemanjem nusinersena in preobčutljivostjo, zato je treba posodobiti informacije o zdravilu.
English: Patients who initiated Spinraza treatment in Study CS11 (n=20) had a median age of 4.0 years (range 3 - 8 years).
Slovenian: Mediana starosti bolnikov, ki so zdravljenje z zdravilom Spinraza začeli v študiji CS11 (n = 20), je bila 4,0 let (razpon 3-8 let).
English: There is a risk of side effects occuring after Spinraza is given by a lumbar puncture procedure (see section 3).
Slovenian: Obstaja tveganje, da se bodo po dajanju zdravila Spinraza s postopkom lumbalne punkcije pojavili neželeni učinki (glejte poglavje 3).
English: Single- and multiple-dose pharmacokinetics (PK) of nusinersen, administered via intrathecal injection, were determined in paediatric patients diagnosed with SMA.
Slovenian: Farmakokinetiko enkratnih in večkratnih odmerkov nusinersena, danega z intratekalno injekcijo, so izmerili pri pediatričnih bolnikih z diagnozo SMA.
English: If clinically indicated, platelet and coagulation laboratory testing is recommended prior to administration of Spinraza.
Slovenian: Če je klinično indicirano, je pred dajanjem zdravila Spinraza priporočljivo laboratorijsko testiranje trombocitov in koagulacije krvi.
English: To allow for long term follow up of these patients, at the end of Study CS3B, 89 patients (Spinraza: n=65; sham-control: n=24) enrolled in Study CS11 (SHINE).
Slovenian: Da bi omogočili dolgoročno sledenje teh bolnikov, je bilo ob zaključku študije CS3B v študijo CS11 (SHINE) vključenih 89 bolnikov (Spinraza: n = 65; kontrolni bolniki na placebu: n = 24).
English: The majority of patients (88%) have 3 copies of the SMN2 gene (8% have 2 copies, 2% have 4 copies, and 2% have an unknown copy number).
Slovenian: (88 %) je imela po 3 kopije gena za SMN2 (8 % jih je imelo po 2 kopiji, 2 % po 4 kopije, 2 % pa neznano število kopij).
English: Autopsy data from patients (n=3) show that nusinersen administered intrathecally is broadly distributed within the CNS achieving therapeutic levels in the target spinal cord tissues.
Slovenian: Obdukcijski podatki bolnikov (n=3) kažejo, da se intratekalno injicirani nusinersen na široko porazdeli po CŽS in doseže terapevtske koncentracije v tarčnih tkivih hrbtenjače.
English: MedDRA preferred term Spinraza frequency category, n=84
Slovenian: Razred pogostnosti pri zdravilu Spinraza, n=84
English: The primary route of elimination is expected via urinary excretion of nusinersen and its metabolites.
Slovenian: Pričakujejo, da je primarna pot izločanja nusinersena in njegovih presnovkov z urinom.
English: Not known (cannot be estimated from the available data) Table 1: Adverse reactions related to lumbar puncture procedure reported in CS4 (later onset SMA) with an incidence at least 5% higher in patients treated with Spinraza than sham-control
Slovenian: neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov) Preglednica 1: Neželeni učinki, povezani s postopkom lumbalne punkcije, o katerih so poročali v študiji CS4 (začetek SMA v poznejšem obdobju) s pogostnostjo, ki je vsaj za 5 % višja pri bolnikih, zdravljenih z zdravilom Spinraza, kot pri kontrolnih bolnikih na placebu
English: • Then around day 14, day 28 and day 63
Slovenian: • nato okrog 14., 28. in 63. dne; • nato enkrat na vsake 4 mesece.
English: The pharmacokinetics of nusinersen in patients with renal or hepatic impairment has not been studied.
Slovenian: Farmakokinetike nusinersena pri bolnikih z okvaro ledvic ali jeter niso proučevali.
English: Spinraza is administered as an intrathecal bolus injection over 1 to 3 minutes, using a spinal anaesthesia needle.
Slovenian: Zdravilo Spinraza se daje kot intratekalna bolusna injekcija z iglo za spinalno anestezijo, pri čemer injiciranje traja 1 do 3 minute.
English: At the interim analysis, all 25 patients (2 SMN2 gene copies, n=15; 3 SMN2 gene copies, n=10) were alive without permanent ventilation..
Slovenian: V času vmesne analize je bilo živih vseh 25 bolnikov (s po 2 kopijama gena za SMN2, n = 15; s po 3 kopijami gena za SMN2, n = 10), ki niso prejemali trajne ventilacije.
English: In patients randomized to Spinraza in Study CS3B and including the experience in Study CS11, the median time to death or permanent ventilation was 73 weeks.
Slovenian: Pri bolnikih, ki so bili v študiji CS3B randomizirani na zdravilo Spinraza, vključno z bolniki z izkušnjami iz študije CS11, je bila mediana časa do smrti ali trajne ventilacije 73 tednov.
English: What Spinraza is and what it is used for
Slovenian: Kaj je zdravilo Spinraza in za kaj ga uporabljamo
English: Other products that are in the same group of medicines as Spinraza have been shown to affect the kidneys.
Slovenian: Za druga zdravila, ki pripadajo isti skupini zdravil kot zdravilo Spinraza, so dokazali, da vplivajo na ledvice.
English: Patients with profound hypotonia and respiratory failure at birth, where Spinraza has not been studied, may not experience a clinically meaningful benefit due to severe SMN protein deficiency.
Slovenian: Bolnikom z močno hipotonijo in odpovedjo dihanja ob rojstvu, pri katerih zdravila Spinraza niso proučevali, zdravilo mogoče ne bo klinično pomembno koristilo zaradi hudega pomanjkanja beljakovine preživetja motoričnega nevrona (survival motor neuron - SMN).
English: As a precautionary measure, it is preferable to avoid the use of Spinraza during pregnancy.
Slovenian: Iz previdnostnih razlogov se je uporabi zdravila Spinraza med nosečnostjo bolje izogibati.
English: Before you or your child are given Spinraza your doctor may decide to do a urine test to check that your or your child's kidneys are working normally.
Slovenian: Preden vam bodo dali zdravilo Spinraza, se lahko vaš zdravnik odloči, da bo naredil preiskavo urina, s katero bo preveril, če vaše ledvice ali ledvice vašega otroka normalno delujejo.
English: Biogen France SAS Tél: +33 (0)1 41 37 95 95
Slovenian: Tél: +33 (0)1 41 37 95 95
English: Spinraza must not be diluted.
Slovenian: Zdravila Spinraza ne smete redčiti.
English: Study CS11 enrolled infantile and later-onset patients including those who had completed studies CS3B, CS4 and CS12.
Slovenian: V študijo CS11 so bili vključeni bolniki z zgodnjim nastopom bolezni in bolniki, pri katerih se je bolezen razvila pozneje, vključno s tistimi, ki so zaključili sodelovanje v študijah CS3B, CS4 in CS12.
English: If a maintenance dose is delayed or missed, Spinraza should be administered as soon as possible and dosing continued every 4 months.
Slovenian: Če je odložen ali izpuščen vzdrževalni odmerek, je treba dati zdravilo Spinraza čimprej in nato nadaljevati z odmerjanjem na 4 mesece.
English: Reproductive toxicity
Slovenian: Toksičnost za razmnoževanje
English: The population PK analysis suggests that race is unlikely to affect the PK of nusinersen.
Slovenian: Populacijska farmakokinetična analiza kaže, da rasa verjetno ne vpliva na farmakokinetiko nusinersena.
English: What Spinraza looks like and contents of the pack
Slovenian: Izgled zdravila Spinraza in vsebina pakiranja
English: It is preferable to avoid the use of Spinraza during pregnancy and breast-feeding.
Slovenian: Uporabi zdravila Spinraza se je med nosečnostjo in dojenjem bolje izogibati.
English: Spinraza contains a small amount of sodium
Slovenian: Zdravilo Spinraza vsebuje majhno količino natrija
English: In vitro studies indicated that nusinersen is not an inducer or inhibitor of CYP450-mediated oxidative metabolism and therefore should not interfere with other medicinal products for these metabolic pathways.
Slovenian: Interakcije In vitro študije so pokazale, da nusinersen ni induktor ali inhibitor oksidativne presnove, posredovane s CYP450, in zato ne bi smel vplivati na druga zdravila, ki sodelujejo v teh presnovnih poteh.
English: Treatment with Spinraza should only be initiated by a physician with experience in the management of spinal muscular atrophy (SMA).
Slovenian: Zdravljenje z zdravilom Spinraza sme začeti le zdravnik, ki ima izkušnje z zdravljenjem spinalne mišične atrofije (SMA).
English: The usual dose of Spinraza is 12 mg.
Slovenian: Kako se daje zdravilo Spinraza Običajni odmerek zdravila Spinraza je 12 mg.
English: Baseline disease characteristics were largely similar in the Spinraza treated patients and sham-control patients except that Spinraza treated patients at baseline had a higher percentage compared to sham-control patients of paradoxical breathing (89% vs 66%), pneumonia or respiratory symptoms (35% vs 22%), swallowing or feeding difficulties (51% vs 29%) and requirement for respiratory support (26% vs 15%).
Slovenian: zdravljenih z zdravilom Spinraza, in pri kontrolnih bolnikih na placebu večinoma podobne, s to izjemo, da so imeli bolniki, zdravljeni z zdravilom Spinraza, v izhodišču večji delež paradoksnega dihanja (89 % proti 66 %), pljučnice ali respiratornih simptomov (35 % proti 22 %), težav s požiranjem ali hranjenjem (51 % proti 29 %) in potrebe po podpori dihanja (26 % proti 15 %).
English: If the vial remains unopened and the solution is not used, it should be returned back to the refrigerator.
Slovenian: Če viala ostane neodprta in raztopine ne uporabite, jo dajte nazaj v hladilnik.
English: If a loading dose is delayed or missed Spinraza should be administered as soon as possible, with at least 14 days between doses, and continue dosing at the prescribed frequency.
Slovenian: Izpuščeni ali odloženi odmerki Če je odložen ali izpuščen začetni odmerek, je treba dati zdravilo Spinraza čimprej, s tem, da naj bo presledek med odmerki vsaj 14 dni, in nato nadaljevati odmerjanje s predpisano pogostnostjo.
English: Spinraza is used to treat a genetic disease called spinal muscular atrophy (SMA).
Slovenian: Zdravilo Spinraza se uporablja za zdravljenje genetske bolezni, ki se imenuje spinalna mišična atrofija (SMA).
English: Among patients older than the WHO defined window for expected age of achievement (95th percentile), 17 of 22 (77%) had achieved walking alone.
Slovenian: Med bolniki, katerih starost ni v razponu pričakovane starosti za doseganje mejnikov po SZO (95. percentil), je 17 od 22 bolnikov (77 %) osvojilo mejnik samostojne hoje.
English: What you need to know before you or your child are given Spinraza 3.
Slovenian: Kaj morate vedeti, preden bodo vam ali vašemu otroku dali zdravilo Spinraza 3.
English: Of those with observed values at Month 15, a higher proportion of Spinraza treated subjects had improvement (73% vs 41%, respectively) and a lower proportion of Spinraza treated subjects had worsening (23% vs 44%, respectively) in total HFMSE score compared to sham-control.
Slovenian: Od tistih z ugotovljenimi vrednostmi v 15. mesecu se je celotni rezultat HFMSE izboljšal večjemu deležu bolnikov (73 % proti 41 %) in poslabšal manjšemu deležu bolniku, zdravljenih z zdravilom Spinraza (23% proti 44%) v primerjavi z bolniki, ki so prejemali placebo.
English: 2 Assessed using the Intent to Treat population (Spinraza n=84; Sham-control n=42); data for patients without a Month 15 visit were imputed using the multiple imputation method
Slovenian: 2Ocenjeno z uporabo populacije z namenom zdravljenja (zdravilo Spinraza n=84; kontrola s placebom n=42); podatki za bolnike brez pregleda v 15. mesecu so bili pripisani z metodo večkratne imputacije.
English: 3Least squares mean
Slovenian: 3Povprečje najmanjših kvadratov.
English: • On the first day of treatment, day 0
Slovenian: Zdravilo Spinraza se daje: • na prvi dan zdravljenja, dan 0;
English: Proportion of patients who achieved new motor milestones at 15 months4
Slovenian: Motorični mejniki po SZO Delež bolnikov, ki so po 15 mesecih dosegli kakšen nov motoričen mejnik4
English: Ultrasound (or other imaging techniques) may be considered to guide intrathecal administration of Spinraza, particularly in younger patients and in patients with scoliosis.
Slovenian: Mogoče bo za pomoč pri intratekalnem dajanju zdravila Spinraza prišel v poštev ultrazvok (ali druge tehnike slikanja), posebno pri mlajših bolnikih in pri bolnikih s skoliozo.
English: The mean CHOP INTEND score at last assessment was 61.0 (46 - 64) amongst patients with 2 SMN2 copies and 62.6 (58 - 64) amongst those with 3 SMN2 copies.
Slovenian: Povprečni rezultat CHOP INTEND je bil med bolniki s po 2 kopijama gena za SMN2 ob zadnji oceni 61,0 (46-64), med bolniki s po 3 kopijami gena za SMN2 pa je bil 62,6 (58-64).
English: Unopened vials of Spinraza can be removed from and returned to the refrigerator if necessary.
Slovenian: Neodprte viale zdravila Spinraza lahko vzamete iz hladilnika in jih spet vrnete nazaj v hladilnik, če je to potrebno.
English: If you or your child miss a dose of Spinraza, speak with your doctor so that Spinraza can be given as soon as possible.
Slovenian: Če izpustite ali če vaš otrok izpusti odmerek zdravila Spinraza, se posvetujte z zdravnikom, tako da boste prejeli ali bo vaš otrok prejel zdravilo Spinraza čimprej.
English: Of the twelve patients (50%) who had not met the definition of permanent ventilation in Study CS3B, 7 patients (58%) were alive without permanent ventilation in Study CS11.
Slovenian: Od 12 bolnikov (50 %), ki v študiji CS3B niso dosegli odzivnosti, opredeljene s trajno ventilacijo, je bilo v študiji CS11 živih 7 bolnikov (58 %), ki niso prejemali trajne ventilacije.
English: Motor function Motor milestones3
Slovenian: Motorični mejniki3
English: -1.0 (95% CI: -2.5, 0.5)
Slovenian: -1,0 (95-% IZ: -2,5, 0,5)
English: Patients were randomized 2:1 to either Spinraza (as per the approved dosing regimen) or sham-control, with a length of treatment ranging from 6 to 442 days.
Slovenian: Bolnike so randomizirali v razmerju 2:1, bodisi na zdravilo Spinraza (po odobrenem režimu odmerjanja) bodisi na kontrolo s placebom, zdravljenje pa je trajalo od 6 do 442 dni.
English: The mean 6MWT distance was 278.5 meters (SD 206.46) at Day 253 and 333.6 metres (SD 176.47) at Day 1050.
Slovenian: Povprečna razdalja 6MWT je bila 278,5 metra (SD 206,46) po 253 dneh in 333,6 metra (SD 176,47) po 1050 dneh.
English: 3.9 (95% CI: 3.0, 4.9) p=0.0000001
Slovenian: 3,9 (95-% IZ: 3,0, 4,9) p=0,0000001
English: There may also be difficulties with giving a medicine by this method in very young patients and those with scoliosis (twisted and curved spine).
Slovenian: Možne so tudi težave zaradi dajanja zdravila na ta način pri zelo mladih bolnikih in pri tistih s skoliozo
English: Among patients without permanent ventilation at the baseline of Study CS11, a majority were alive and without permanent ventilation at the time of interim analysis.
Slovenian: Med bolniki, ki v izhodišču študije CS11 niso prejemali trajne ventilacije, je bila v času vmesne analize večina živa in ni prejemala trajne ventilacije.
English: • If you or your child gets any side effects, talk to your doctor or nurse.
Slovenian: • Če opazite pri sebi ali svojem otroku kateri koli neželeni učinek, se posvetujte z zdravnikom ali medicinsko sestro.
English: CS7 is a phase 2, randomized, double-blind, sham-procedure study in symptomatic patients diagnosed with infantileonset SMA (≤6 months) or later-onset SMA (>6 months) and 2 or 3 copies of SMN2 (Part 1), followed by a long-term open label extension phase (Part 2).
Slovenian: CS7 je randomizirana, dvojno slepa, s placebom kontrolirana študija 2. faze, ki je bila opravljena pri simptomatičnih bolnikih, ki so jim postavili diagnozo simptomatične SMA z nastopom pri dojenčku (≤ 6 mesecev) ali simptomatične SMA s poznejšim začetkom (> 6 mesecev) s po 2 ali 3 kopijami gena za SMN2 (1. del), ki ji sledi dolgoročna odprta podaljšana faza študije (2. del).
English: Time to onset was reported in 11 of these 20, and ranged from directly following the injection to 1 week after the injection.
Slovenian: O času nastopa neželenega učinka v razponu od neposredno po injiciranju do 1 tedna po injiciranju so poročali pri 11 od zgoraj omenjenih 20 primerov.
English: At the final analysis, a statistically significant greater percentage of patients achieved the definition of a motor milestone responder in the Spinraza group (51%) compared to the sham-control group (0%) (p<0.0001).
Slovenian: V končni analizi je v skupini bolnikov, zdravljenih z zdravilom Spinraza, statistično značilno večji delež bolnikov, ki so dosegli odzivnost, opredeljeno z motoričnimi mejniki (a motor milestone responder) (51 % delež), kot pa v kontrolni skupini bolnikov na placebu (0 % delež) (p<0,0001).
English: At day 700, 7 out of 11 patients (64%) with 2 SMN2 gene copies and 0 out of 5 patients (0%) with 3 SMN2 copies, met the protocol-defined criteria of clinically manifested SMA, however, these patients were gaining weight and achieving WHO milestones, inconsistent with Type I SMA.
Slovenian: Čeprav je na 700. dan 7 od 11 bolnikov (64 %) (vsak s po 2 kopijama gena za SMN2) in 0 od 5 bolnikov (0%) (vsak s po 3 kopijami gena za SMN2) izpolnjevalo s protokolom opredeljena merila klinično izražene SMA, so ti bolniki pridobivali telesno maso in dosegali mejnike SZO ki niso bili skladni s SMA tipa I. Primerjavo doseganja motoričnih mejnikov med bolniki s simptomatično SMA z nastopom pri dojenčku in predsimptomatično SMA kaže slika 3.
English: Some of these patients had needed to have a device called a ventriculo-peritoneal shunt implanted to treat the hydrocephalus.
Slovenian: Nekaterim od teh bolnikov je bilo treba za zdravljenje hidrocefalusa vstaviti pripravo, ki se imenuje ventrikulo-peritonealni spoj.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for nusinersen, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za nusinersen je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: Of the 8 patients with later-onset SMA, 4 out of 5 patients (80%; 95% CI: 38, 96) in the Spinraza group and 2 out of 3 (67%; 95% CI: 21, 94) in the sham-control group met this definition of response.
Slovenian: Od 8 bolnikov, ki so jim postavili diagnozo simptomatične SMA s poznejšim začetkom, je 4 od 5 bolnikov (80 %; 95-% IZ: 38, 96) v skupini bolnikov, zdravljenih z zdravilom Spinraza, in 2 od 3 bolnikov (67 %; 95-% IZ: 21, 94) v kontrolni skupini bolnikov na placebu izpolnilo merila za doseganje tako opredeljene odzivnosti.
English: 1CS4 was stopped following positive statistical analysis on the primary endpoint at interim analysis (statistically significant improvement from baseline HFMSE score was observed in Spinraza treated patients compared to the sham-control patients (Spinraza vs. sham-control: 4.0 vs. -1.9; p=0.0000002))
Slovenian: 1Študijo CS4 so prekinili po pozitivni statistični analizi primarnega končnega opazovanega dogodka pri vmesni analizi (statistično značilno izboljšanje od izhodiščnega rezultata HFMSE so ugotovili pri bolnikih, zdravljenih z zdravilom Spinraza, v primerjavi z bolniki, ki so prejemali placebo (zdravilo Spinraza proti kontroli s placebom: 4,0 proti -1,9;
English: Patients were randomized 2:1 to either Spinraza (dosed with 3 loading doses and maintenance doses every 6 months) or sham-control, with a length of treatment ranging from 324 to 482 days.
Slovenian: Bolnike so randomizirali v razmerju 2:1, bodisi na zdravilo Spinraza (ti so prejemali po 3 začetne odmerke in vzdrževalne odmerke vsakih 6 mesecev) bodisi na kontrolo s placebom, zdravljenje pa je trajalo 324 do 482 dni.
English: 4 Assessed using the Month 15 Efficacy Set (Spinraza n=66; Sham control n=34); analyses are based on imputed data when there are missing data.
Slovenian: 4Ocenjeno z naborom v 15. mesecu za oceno učinkovitosti (Month 15 Efficacy Set) (zdravilo Spinraza n=66; kontrola s placebom n=34); kjer podatki manjkajo, analize temeljijo na metodi imputacije podatkov.