FrancophonIA/ELRC3.0 huggingface dataset:
English: This patient subsequently made a robust, though delayed, humoral and cellular response to the vaccine (see section 4.4).
Slovenian: Pri tem bolniku se je pozneje pojavil močan, čeprav zapoznel humoralni in celični odziv na cepivo (glejte poglavje 4.4).
English: Mon., Tue., Wed., Thu., Fri., Sat., Sun.
Slovenian: pon., tor., sre., čet., pet., sob., ned.
English: The treatment effect was similar in patients independent of rheumatoid factor status, age, gender, race, or disease status.
Slovenian: Učinek zdravljenja je bil pri bolnikih podoben ne glede na status revmatoidnega faktorja, starost, spol, raso ali stanje bolezni.
English: Durability of clinical responses
Slovenian: Trajnost kliničnih odzivov
English: Number of patients treated Total study duration
Slovenian: Število zdravljenih bolnikov Skupno trajanje študije
English: Tofacitinib should not be initiated in patients with active infections, including localised infections.
Slovenian: Zdravljenja s tofacitinibom se ne sme uvesti pri bolnikih z aktivnimi okužbami, vključno z lokaliziranimi okužbami.
English: ACR response
Slovenian: Odziv ACR
English: For patients with Baseline BSA ≥ 3% and PASI > 0.
Slovenian: Za bolnike z izhodiščno BSA ≥ 3 % in PASI > 0.
English: Maintenance (OCTAVE Sustain)
Slovenian: Vzdrževalno zdravljenje (OCTAVE Sustain)
English: Dosing should be interrupted until haemoglobin values have normalised.
Slovenian: Odmerjanje je treba prekiniti, dokler se vrednosti hemoglobina ne normalizirajo.
English: The risk of opportunistic infections is higher in Asian geographic regions (see section 4.8).
Slovenian: Tveganje za oportunistične okužbe je večje v azijskih geografskih regijah (glejte poglavje 4.8).
English: Tell your doctor if you notice any breathing difficulties.
Slovenian: Obvestite zdravnika, če opazite kakršnekoli težave z dihanjem.
English: Tofacitinib binds predominantly to albumin and does not appear to bind to 1-acid glycoprotein.
Slovenian: Tofacitinib se veže predvsem na albumin in ni videti, da bi se vezal na 1-kisli glikoprotein.
English: Your doctor should perform liver tests periodically.
Slovenian: Zdravnik mora občasno opraviti jetrne preiskave.
English: The safety and benefits of XELJANZ in children or adolescents have not yet been established.
Slovenian: Varnosti in koristi zdravila XELJANZ pri otrocih ali mladostnikih še niso dokazali.
English: Vaccination with live vaccines should occur at least 2 weeks but preferably 4 weeks prior to initiation of tofacitinib or in accordance with current vaccination guidelines regarding immunomodulatory medicinal products.
Slovenian: Cepljenje z živimi cepivi je treba opraviti najmanj 2 tedna, po možnosti pa 4 tedne pred začetkom zdravljenja s tofacitinibom ali v skladu z veljavnimi smernicami za cepljenje v povezavi z imunomodulatorji.
English: Time to onset was rapid (as early as week 2 in studies ORAL Solo, ORAL Sync, and ORAL Step) and the magnitude of response continued to improve with duration of treatment.
Slovenian: Čas do odziva je bil kratek (že po 2 tednih v preskušanjih ORAL Solo, ORAL Sync in ORAL Step), stopnja odziva pa se je s trajanjem zdravljenja še izboljševala.
English: Do not use this medicine if you notice the tablets show visible signs of deterioration (for example, are broken or discoloured).
Slovenian: Ne uporabljajte tega zdravila, če na tabletah opazite vidne znake kvarjenja (na primer, če so poškodovane ali spremenjene barve).
English: If the history of chickenpox is considered doubtful or unreliable it is recommended to test for antibodies against VZV.
Slovenian: Če je anamneza noric dvomljiva ali nezanesljiva, je priporočljivo opraviti test na protitelesa proti VZV.
English: Tell your doctor if you notice any painful blisters on your skin.
Slovenian: Obvestite zdravnika, če opazite boleče mehurje na koži.
English: Patients screened positive for hepatitis B or C were excluded from clinical trials.
Slovenian: Bolnike, pri katerih je bil presejalni test za hepatitis B ali C pozitiven, so izključili iz kliničnih preskušanj.
English: In addition to this leaflet, your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given XELJANZ and during treatment with XELJANZ.
Slovenian: Poleg tega navodila za uporabo vam bo zdravnik dal tudi opozorilno kartico za bolnika, ki vsebuje pomembne varnostne informacije, ki jih morate poznati, preden vam dajo zdravilo XELJANZ in med zdravljenjem z zdravilom XELJANZ.
English: Combination with other therapies
Slovenian: Kombinacija z drugimi zdravili
English: Nominal p≤0.05;
Slovenian: Nominalna vrednost p ≤ 0,05;
English: When ANC is greater than 1,000, treatment should be resumed as clinically appropriate.
Slovenian: Ko je ANC večje od 1.000, je treba zdravljenje nadaljevati, kot je klinično primerno.
English: Keep this Patient Alert Card with you.
Slovenian: To opozorilno kartico imejte vedno pri sebi.
English: After intravenous administration, the volume of distribution is 87 L. Approximately 40% of circulating tofacitinib is bound to plasma proteins.
Slovenian: Po intravenski uporabi je volumen porazdelitve 87 l. Približno 40 % tofacitiniba v obtoku je vezanega na beljakovine v plazmi.
English: Possible serious side effects In rare cases, infection may be life-threatening.
Slovenian: Možni resni neželeni učinki V redkih primerih so okužbe lahko življenjsko ogrožajoče.
English: The number of patients with arthritis mutilans or axial involvement was too small to allow meaningful assessment.
Slovenian: Bolnikov z mutilirajočim artritisom ali aksialno prizadetostjo je bilo premalo, da bi lahko podali relevantno oceno.
English: *Spontaneous reporting data
Slovenian: * Podatki iz spontanih poročanj.
English: Evidence of persistence of efficacy with tofacitinib treatment for up to 7 years is also provided from data in the one ongoing and one completed open-label, long-term follow-up studies.
Slovenian: Dokazi o ohranjanju učinkovitosti zdravljenja s tofacitinibom do 7 let izhajajo tudi iz podatkov enega odprtega preskušanja, ki še poteka, in enega že zaključenega odprtega preskušanja dolgoročnega spremljanja.
English: When ALC is greater than 750, treatment should be resumed as clinically appropriate.
Slovenian: Ko je ALC večje od 750, je treba zdravljenje nadaljevati, kot je klinično primerno.
English: Physical function and health-related quality of life Improvement in physical functioning was measured by the HAQ-DI.
Slovenian: Telesna funkcija in z zdravjem povezana kakovost življenja Izboljšanje telesne funkcije so merili z HAQ-DI.
English: Changes in lipid parameters from baseline through the end of the study (6-24 months) in the controlled clinical studies in RA are summarised below:
Slovenian: Spremembe lipidnih parametrov od izhodišča do konca preskušanja (6-24 mesecev) v nadzorovanih kliničnih preskušanjih RA so povzete spodaj:
English: The carcinogenic potential of tofacitinib was assessed in 6-month rasH2 transgenic mouse carcinogenicity and 2-year rat carcinogenicity studies.
Slovenian: Kancerogeni potencial tofacitiniba so ocenili v 6-mesečnem preskušanju kancerogenosti pri transgenih miših rasH2 in v 2-letnem preskušanju kancerogenosti pri podganah.
English: Table 14 provides additional information regarding pertinent study design and population characteristics.
Slovenian: Preglednica 14 vsebuje dodatne informacije o ustrezni zasnovi preskušanj in značilnostih populacije.
English: Elderly patients 80 years of age were estimated to have less than 5% higher AUC relative to the mean age of 55 years.
Slovenian: Ocenjujejo, da je pri starejših bolnikih, starih 80 let, vrednost AUC za manj kot 5 % večja kot v populaciji s povprečno starostjo 55 let.
English: XELJANZ is used for the treatment of the following inflammatory diseases:
Slovenian: Zdravilo XELJANZ se uporablja za zdravljenje naslednjih vnetnih bolezni:
English: Benign testicular interstitial (Leydig) cell tumours were observed in rats: benign Leydig cell tumours in rats are not associated with a risk of Leydig cell tumours in humans.
Slovenian: Pri podganah so opazili benigne tumorje intersticijskih (Leydigovih) celic v modih: benigni tumorji Leydigovih celic pri podganah niso povezani s tveganjem za tumorje Leydigovih celic pri človeku.
English: Table 7 provides information regarding the pertinent study design and population characteristics.
Slovenian: Preglednica 7 vsebuje informacije o ustrezni zasnovi preskušanj in značilnostih populacije.
English: • Pregnancy and lactation (see section 4.6).
Slovenian: • Nosečnost in dojenje (glejte poglavje 4.6).
English: This condition is an inflammatory disease of the joints, often accompanied by psoriasis.
Slovenian: To je vnetna bolezen sklepov, ki jo pogosto spremlja psoriaza.
English: Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5).
Slovenian: Tofacitinib je mogoče uporabiti kot monoterapijo v primeru intolerance na MTX ali kadar zdravljenje z MTX ni primerno (glejte poglavji 4.4 in 4.5).
English: If you notice any of the following serious side effects you need to tell a doctor straight away.
Slovenian: Če opazite kateregakoli izmed naslednjih resnih neželenih učinkov, takoj obvestite zdravnika.
English: If you do not respond well enough or the medicine is not tolerated, you may be given XELJANZ to reduce the sign and symptoms of active psoriatic arthritis and improve the ability to perform daily activities.
Slovenian: Če se na to zdravilo ne boste dovolj dobro odzvali ali ga ne boste prenašali, vam bodo morda dali zdravilo XELJANZ za zmanjšanje znakov in simptomov aktivnega psoriatičnega artritisa in izboljšanje sposobnosti izvajanja vsakodnevnih dejavnosti.
English: Risk of infection may be higher with increasing degrees of lymphopenia and consideration should be given to lymphocyte counts when assessing individual patient risk of infection.
Slovenian: Tveganje za okužbo je lahko večje z naraščanjem stopnje limfopenije, zato je treba pri ocenjevanju tveganja za okužbo pri posameznem bolniku upoštevati število limfocitov.
English: Health-related quality of life was assessed by the Short Form Health Survey (SF-36).
Slovenian: Z zdravjem povezano kakovost življenja so ocenili s kratkim vprašalnikom o zdravju (SF-36 - 36-Item Short Form Health Survey).
English: Pfizer Europe MA EEIG (as MA holder logo)
Slovenian: Pfizer Europe MA EEIG (kot logo imetnika dovoljenja za promet)
English: Tofacitinib tablets may be crushed and taken with water.
Slovenian: Tofacitinib tablete lahko zdrobite in vzamete z vodo.
English: Less than or equal to 2 g/dL decrease and greater than or equal to 9.0 g/dL
Slovenian: Priporočilo zmanjšanje za 2 g/dl ali manj in vrednost, večja od ali enaka 9,0 g/dl
English: XELJANZ must not be used during pregnancy.
Slovenian: Zdravila XELJANZ ne smete uporabljati med nosečnostjo.
English: Patients were required to have active plaque psoriasis at the screening visit.
Slovenian: Bolniki so morali imeti aktivno psoriazo v plakih ob presejalnem obisku.
English: You may also be at higher risk of certain lung problems.
Slovenian: Morda obstaja tudi večje tveganje za nekatere težave s pljuči.
English: Nominal p<0.001;
Slovenian: nominalna vrednost p < 0,001;
English: For patients with Baseline score > 0.
Slovenian: Za bolnike z izhodiščno oceno > 0.
English: If you have active psoriatic arthritis you will be first given another medicine to treat your psoriatic arthritis.
Slovenian: Če imate aktivni psoriatični artritis, vam bodo najprej dali drugo zdravilo, ki ga uporabljamo za zdravljenje psoriatičnega artritisa.
English: Your doctor may also stop treatment temporarily or permanently if blood tests show low white blood cell or red blood cell counts.
Slovenian: Zdravnik lahko vaše zdravljenje začasno ali trajno prekine, če rezultati krvnih preiskav pokažejo majhno število belih ali rdečih krvnih celic.
English: Table 8: Proportion (%) of patients with an ACR response ORAL Solo: DMARD inadequate responders
Slovenian: Preglednica 8: Delež (%) bolnikov z odzivom ACR ORAL Solo: bolniki z nezadostnim odzivom na DMARD
English: Patients should be managed according to clinical guidelines for the management of hyperlipidaemia.
Slovenian: Bolnike je treba obravnavati skladno s kliničnimi smernicami za zdravljenje hiperlipidemije.
English: Signs of serious infections (common) include
Slovenian: Znaki resnih okužb (pogosti) vključujejo:
English: Your doctor should test your cholesterol levels 8 weeks after you start receiving XELJANZ.
Slovenian: Zdravnik mora preveriti vaše ravni holesterola 8 tednov po začetku jemanja zdravila XELJANZ.
English: This is the empty shell from the prolonged-release tablet after the medicine has been absorbed by your body.
Slovenian: To je prazna ovojnica tablete s podaljšanim sproščanjem, ki ostane po absorpciji zdravila v telesu.
English: Health-related and quality of life outcomes
Slovenian: Izidi, povezani z zdravjem in kakovostjo življenja
English: Don't take XELJANZ 10 mg twice daily if you have any of the following conditions: - Are taking combined hormonal contraceptives or hormone replacement therapy - Have heart failure (when the heart does not work as well as it should) - Have had blood clots in the veins - Have cancer - Will have or have recently had major surgery
Slovenian: Ne jemljite zdravila XELJANZ 10 mg dvakrat na dan, če imate kateregakoli od naslednjih stanj: - jemljete kombinirane hormonske kontraceptive ali nadomestno hormonsko terapijo, - imate srčno popuščanje (ko srce ne deluje tako dobro, kot bi moralo), - imate krvne strdke v venah, - imate raka, - boste imeli ali ste pred kratkim imeli večji operativni poseg.
English: In RA patients, the oral clearance of tofacitinib does not vary with time, indicating that treatment with tofacitinib does not normalise CYP enzyme activity.
Slovenian: Pri bolnikih z RA se peroralni očistek tofacitiniba ne spreminja s časom, kar kaže na to, da zdravljenje s tofacitinibom ne normalizira aktivnosti encimov CYP.
English: Patients treated with tofacitinib should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care.
Slovenian: Pri bolnikih, ki se zdravijo s tofacitinibom, je treba dejavnike tveganja (npr. hipertenzijo, hiperlipidemijo) obravnavati kot del standardne oskrbe.
English: • with a history of a serious or an opportunistic infection,
Slovenian: • z resnimi ali oportunističnimi okužbami v anamnezi,
English: Of the 4,271 patients who enrolled in RA studies I-VI (see section 5.1), a total of 608 RA patients were 65 years of age and older, including 85 patients 75 years and older.
Slovenian: Od 4.271 bolnikov, ki so bili vključeni v Preskušanja I-VI pri bolnikih z RA (glejte poglavje 5.1), je bilo skupno 608 bolnikov z RA starih 65 let in več, vključno s 85 bolniki, starimi 75 let in več.
English: You can take XELJANZ with or without food.
Slovenian: Zdravilo XELJANZ lahko jemljete s hrano ali brez nje.
English: ALC less than 500
Slovenian: ALC manjše od 500
English: In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions.
Slovenian: V primeru prevelikega odmerjanja je bolnika priporočljivo spremljati glede znakov in simptomov neželenih učinkov.
English: Tofacitinib has no or negligible influence on the ability to drive and use machines.
Slovenian: Tofacitinib nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: In human cells, tofacitinib preferentially inhibits signalling by heterodimeric cytokine receptors that associate with JAK3 and/or JAK1 with functional selectivity over cytokine receptors that signal via pairs of JAK2.
Slovenian: V človeških celicah tofacitinib prednostno zavira prenašanje signalov prek heterodimernih citokinskih receptorjev, povezanih z JAK3 in/ali JAK1 z večjo funkcionalno selektivnostjo kot za citokinske receptorje, ki signale prenašajo prek parov z JAK2.
English: • who have underlying conditions that may predispose them to infection.
Slovenian: • z osnovnimi stanji, ki lahko zvečajo dovzetnost za okužbe.
English: There are limited data in patients aged 75 years and older.
Slovenian: Podatki pri bolnikih, starih 75 let in več, so omejeni.
English: As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes (see section 4.8).
Slovenian: Ker je incidenca okužb v populacijah starejših in diabetikov na splošno večja, je pri zdravljenju starejših bolnikov in bolnikov z diabetesom potrebna previdnost (glejte poglavje 4.8).
English: The safety and efficacy of tofacitinib in children aged 0 to less than 18 years have not been established.
Slovenian: Varnost in učinkovitost tofacitiniba pri otrocih, starih od 0 do manj kot 18 let, nista bili dokazani.
English: Examination of age, sex, race, baseline disease activity and PsA subtype did not identify differences in response to tofacitinib.
Slovenian: Pri pregledu starosti, spola, rase, aktivnosti bolezni ob izhodišču in podtipa PsA niso odkrili razlik v odzivu na tofacitinib.
English: (see section 4.2).
Slovenian: 3 (glejte poglavje 4.2),
English: Population PK analysis in RA patients indicated that systemic exposure (AUC) of tofacitinib in the extremes of body weight (40 kg, 140 kg) were similar (within 5%) to that of a 70 kg patient.
Slovenian: Analiza populacijske farmakokinetike pri bolnikih z RA je pokazala, da je sistemska izpostavljenost (AUC) tofacitinibu pri bolnikih z ekstremno telesno maso (40 kg, 140 kg) podobna (znotraj 5 %) kot pri bolniku s telesno maso 70 kg.
English: Once daily Do not swallow the desiccant.
Slovenian: enkrat na dan Ne zaužijte sušilnega sredstva.
English: Your doctor may also perform other tests, for example to check your blood cholesterol levels or monitor the health of your liver.
Slovenian: Zdravnik vam bo morda opravil tudi druge preiskave, na primer za preverjanje ravni holesterola v krvi ali spremljanje delovanja jeter.
English: Following initiation, routine monitoring of liver tests and prompt investigation of the causes of any observed liver enzyme elevations are recommended to identify potential cases of drug-induced liver injury.
Slovenian: Po uvedbi zdravljenja sta priporočljiva rutinsko spremljanje jetrnih testov in takojšnja raziskava vzrokov kakršnegakoli opaženega zvečanja vrednosti jetrnih encimov z namenom odkrivanja morebitnih primerov z zdravilom povzročene poškodbe jeter.
English: The decision to use live vaccines prior to tofacitinib treatment should take into account the pre-existing immunosuppression in a given patient.
Slovenian: Pri odločitvi o uporabi živih cepiv pred zdravljenjem s tofacitinibom je treba upoštevati predhodno imunosupresijo pri posameznem bolniku.
English: Discontinuation and monitoring criteria for lymphopenia are discussed in section 4.2.
Slovenian: Kriteriji za prekinitev zdravljenja in spremljanje limfopenije so opisani v poglavju 4.2.
English: Tofacitinib had no effects on male fertility, sperm motility or sperm concentration.
Slovenian: Tofacitinib ni imel učinka na plodnost pri samcih, gibljivost spermijev ali koncentracijo sperme.
English: Improvements from baseline in SF-36v2 and FACIT-F were maintained through month 6 (OPAL BROADEN and OPAL BEYOND) and month 12 (OPAL BROADEN).
Slovenian: Izboljšanja ocen SF-36v2 in FACIT-F glede na izhodišče so se ohranila do 6. meseca (OPAL BROADEN in OPAL BEYOND) oziroma 12. meseca (OPAL BROADEN).
English: Note: Reference group is administration of tofacitinib alone.
Slovenian: Opomba: referenčna skupina je skupina, ki je prejemala samo tofacitinib.
English: Very rare (may affect up to 1 in 10,000 people): tuberculosis involving the brain and spinal cord, meningitis.
Slovenian: Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): tuberkuloza, ki zajame možgane in hrbtenjačo, meningitis.
English: Classification
Slovenian: Razvrstitev
English: The tablets are provided in blisters containing 14 tablets.
Slovenian: Tablete so na voljo v pretisnih omotih, ki vsebujejo 14 tablet.
English: Patients randomised to adalimumab (active-control arm) received 40 mg subcutaneously every 2 weeks for 12 months.
Slovenian: Bolniki, ki so jih randomizirali v skupino z adalimumabom (skupina z aktivno kontrolo), so 12 mesecev prejemali 40 mg subkutano vsaka 2 tedna.
English: Ratio relative to reference
Slovenian: Razmerje glede na referenčno skupino
English: Elevations in lipid parameters (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) were first assessed at 1 month following initiation of tofacitinib in the controlled double-blind clinical trials of RA.
Slovenian: Zvečanja vrednosti lipidnih parametrov (celokupni holesterol, holesterol LDL, holesterol HDL, trigliceridi) so prvič ocenili 1 mesec po začetku zdravljenja s tofacitinibom v nadzorovanih dvojno slepih kliničnih preskušanjih RA.
English: Patients with RA, particularly those with highly active disease may be at a higher risk (up to several-fold) than the general population for the development of lymphoma.
Slovenian: Pri bolnikih z RA, zlasti tistih z zelo aktivno boleznijo, je lahko tveganje za razvoj limfoma večje (tudi do nekajkrat) kot pri splošni populaciji.
English: Other serious infections that were not reported in clinical studies may also occur (e.g., coccidioidomycosis).
Slovenian: Pojavijo se lahko tudi druge resne okužbe, o katerih v kliničnih preskušanjih niso poročali (npr. kokcidioidomikoza).
English: Each prolonged-release tablet contains 152.23 mg of sorbitol.
Slovenian: Ena tableta s podaljšanim sproščanjem vsebuje 152,23 mg sorbitola.
English: The European Medicines Agency has deferred the obligation to submit results of studies with tofacitinib in one or more subsets of the paediatric population in juvenile idiopathic arthritis and in ulcerative colitis (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s tofacitinibom za eno ali več podskupin pediatrične populacije z juvenilnim idiopatskim artritisom in z ulceroznim kolitisom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: ANC less than 500
Slovenian: ANC manjše od 500
English: The most common serious adverse reactions were serious infections (see section 4.4).
Slovenian: Najpogostejši resni neželeni učinki so bile resne okužbe (glejte poglavje 4.4).
English: Lab Value (g/dL)
Slovenian: Laboratorijska vrednost (g/dl)
English: Analysis of erosion and JSN scores were consistent with overall results.
Slovenian: Analizi ocen erozije sklepov in JSN sta bili skladni s celokupnimi rezultati.
English: Caution is also recommended in patients with a history of chronic lung disease as they may be more prone to infections.
Slovenian: Previdnost je priporočljiva tudi pri bolnikih s kroničnimi pljučnimi boleznimi v anamnezi, saj so lahko dovzetnejši za okužbe.
English: Other findings at doses exceeding human exposures included effects on the hepatic and gastrointestinal systems.
Slovenian: Druge ugotovitve pri odmerkih, ki presegajo izpostavljenost pri človeku, so vključevale učinke na jetrni in prebavni sistem.
English: XELJANZ may increase your risk of certain cancers.
Slovenian: Zdravilo XELJANZ lahko zveča tveganje za pojav nekaterih vrst raka.
English: Key features Monotherapy Various csDMARDs
Slovenian: Ključne lastnosti monoterapija različna csDMARD
English: Excipient with known effect Each film-coated tablet contains 118.88 mg of lactose.
Slovenian: Pomožna snov z znanim učinkom Ena filmsko obložena tableta vsebuje 118,88 mg laktoze.
English: Some patients have presented with disseminated rather than localised disease.
Slovenian: Pri nekaterih bolnikih bolezen ni bila lokalizirana, ampak razširjena.
English: The efficacy results based on the endoscopic readings at the study sites were consistent with the results based on the central endoscopy readings.
Slovenian: Rezultati učinkovitosti, ki so temeljili na pregledu endoskopskih posnetkov na mestu kliničnega preskušanja, so bili skladni z rezultati, ki so temeljili na centraliziranem pregledu endoskopskih posnetkov.