natgillin/translations-raw huggingface dataset:
In addition, independent observational studies have not supported an increased risk of serious neuropsychiatric events in patients treated with varenicline compared to patients prescribed nicotine replacement therapy (NRT) or bupropion.
Poleg tega neodvisne opazovalne študije niso podprle povečanega tveganja za pojav resnih nevropsihiatričnih dogodkov pri bolnikih, zdravljenih z vareniklinom, v primerjavi z bolniki, ki so prejemali nadomestno zdravljenje z nikotinom (NRT) ali bupropion.
Week 1 Week 2-4
1. teden 2.-4. teden
Nicotine competes for the same human α4β2 nAChR binding site for which varenicline has higher affinity.
Nikotin pri človeku tekmuje za isto vezavno mesto α4β2 nAChR, za katero ima vareniklin veliko afiniteto.
No dosage adjustment is necessary for elderly patients (see section 5.2).
Prilagoditev odmerka pri starejših bolnikih ni potrebna (glejte poglavje 5.2).
Therefore, varenicline can effectively block nicotine's ability to fully activate α4β2 receptors and the mesolimbic dopamine system, the neuronal mechanism underlying reinforcement and reward experienced upon smoking.
Tako lahko vareniklin učinkovito onemogoči sposobnost nikotina za popolno aktiviranje receptorjev α4β2 in mezolimbičnega dopaminskega sistema, nevronskega mehanizma, ki je podlaga občutka okrepitve in ugodja pri kajenju.
Smoking cessation itself may result in changes to warfarin pharmacokinetics (see section 4.4).
Prenehanje kajenja lahko samo po sebi spremeni farmakokinetiko varfarina (glejte poglavje 4.4).
If you are not willing or able to set a target quit date within 2 weeks, you may choose your own target quit date within 5 weeks after starting treatment.
Če ne želite ali niste zmožni postaviti ciljnega datuma opustitve kajenja v dveh tednih, lahko izberete svoj datum opustitve kajenja v petih tednih po začetku zdravljenja.
In some cases as a result of stopping smoking, with or without CHAMPIX, an adjustment of the dose of other medicines may be necessary.
V nekaterih primerih je zaradi prenehanja kajenja z zdravilom CHAMPIX ali brez njega morda potrebno prilagoditi odmerek drugih zdravil.
Some of the patients requiring coronary revascularisation underwent the procedure as part of management of nonfatal MI and hospitalisation for angina.
Pri nekaterih od bolnikov, ki so potrebovali koronarno revaskularizacijo, je bila le-ta narejena kot del zdravljenja miokardnega infarkta brez smrtnega izida ali hospitalizacije zaradi angine pektoris.
In this study, the incidence of nausea, headache, vomiting, dizziness, dyspepsia, and fatigue was greater for the combination than for NRT alone.
V tej študiji je bila pojavnost navzee, glavobola, bruhanja, omotice, dispepsije in utrujenosti večja pri uporabi kombiniranega zdravljenja kot samega NRT.
Although there were no completed suicides, there was one suicidal attempt in a varenicline-treated subject whose lifetime history included several similar attempts.
Čeprav dejanskih samomorov ni bilo, so pri preskušancu, ki je prejemal vareniklin, poročali o enem poskusu samomora; preskušanec je v preteklosti večkrat poskušal storiti samomor.
The primary safety endpoint was a composite of neuropsychiatric adverse events that have been reported in post-marketing experience.
Glavni opazovani dogodek varnosti je bil sestavljen iz nevropsihiatričnih neželenih dogodkov, o katerih so poročali v obdobju trženja.
CA 9-24 n/N (%) Varenicline Bupropion NRT
CA 9-24 n/N (%) vareniklin bupropion NRT placebo
Apparent volume of distribution averaged 415 litres (%CV= 50) at steady-state.
Navidezni volumen porazdelitve je bil v stanju dinamičnega ravnovesja povprečno 415 litrov (% KV = 50).
Patients who are motivated to quit and who did not succeed in stopping smoking during prior CHAMPIX therapy, or who relapsed after treatment, may benefit from another quit attempt with CHAMPIX (see section 5.1).
Bolnikom, ki so za prenehanje motivirani in po predhodnem zdravljenju z zdravilom CHAMPIX niso opustili kajenja ali so po zdravljenju ponovno začeli kaditi, lahko koristi še en poskus opuščanja z zdravilom CHAMPIX (glejte poglavje 5.1).
CA* wk 9-12
CA* tedni 9-12
The use of CHAMPIX, bupropion, and NRT was not associated with an increased risk of CV AEs in smokers treated for up to 12 weeks and followed for up to 1 year compared to placebo, although because of the relatively low number of events overall, an association cannot be entirely ruled out.
Uporaba zdravila CHAMPIX, bupropiona in NRT v primerjavi s placebom pri kadilcih, ki so se zdravili do 12 tednov in so jih nato spremljali do 1 leta, ni bila povezana s povečanim tveganjem za pojav srčnožilnih neželenih učinkov, čeprav zaradi na splošno sorazmerno majhnega števila dogodkov povezave ni mogoče povsem izključiti.
As these skin reactions can be life threatening, patients should discontinue treatment at the first sign of rash or skin reaction and contact a healthcare provider immediately.
Ker so lahko te kožne reakcije smrtno nevarne, mora bolnik ob prvih znakih izpuščaja ali kožne reakcije prekiniti z zdravljenjem in se nemudoma posvetovati z zdravnikom.
Non-psychiatric Cohort
nepsihiatrična kohorta psihiatrična kohorta
Study 1 (n=1022)
študija 1 (n = 1.022)
Non-psychiatric Cohort N=3984
nepsihiatrična kohorta n = 3.984
If you develop a rash or if your skin starts to peel or blister you should stop taking CHAMPIX and seek emergency medical help.
Če se vam pojavi izpuščaj ali če se vaša koža začne lupiti oz. nastanejo mehurji, morate nemudoma prenehati jemati zdravilo CHAMPIX in poiskati nujno zdravniško pomoč.
CHAMPIX may have minor or moderate influence on the ability to drive and use machines.
Zdravilo CHAMPIX ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
The efficacy and safety of varenicline was evaluated in a randomised, double-blind, placebo-controlled study of 312 patients aged 12 to 19 years, who smoked an average of at least 5 cigarettes per day during the 30 days prior to recruitment, and had a score of at least 4 on the Fagerstrom Test for Nicotine Dependence scale.
Varnost in učinkovitost vareniklina so ocenili v randomizirani, dvojno slepi, s placebom nadzorovani študiji pri 312 bolnikih, starih od 12 do 19 let, ki so v 30 dneh pred vključitvijo v študijo v povprečju pokadili vsaj 5 cigaret na dan in so v Fagerstromovem testu odvisnosti od nikotina imeli oceno najmanj 4.
In patients treated with the recommended dose of 1 mg twice daily following an initial titration period the adverse event most commonly reported was nausea (28.6%).
Pri bolnikih, ki so po uvodnem obdobju titriranja dobivali priporočeni odmerek 1 mg dvakrat na dan, je bila najpogosteje zabeleženi neželeni učinek navzea (28,6 %).
If serious neuropsychiatric symptoms occur whilst on varenicline treatment, patients should discontinue varenicline immediately and contact a healthcare professional for re-evaluation of treatment.
Če se med zdravljenjem z vareniklinom pojavijo resni nevropsihiatrični simptomi, morajo bolniki nemudoma prekiniti zdravljenje z vareniklinom in se posvetovati z zdravstvenim delavcem, da bo ponovno ocenil zdravljenje.
CHAMPIX can also reduce the enjoyment of cigarettes if you do smoke when on treatment.
Zdravilo CHAMPIX lahko tudi zmanjša užitek, ki ga dajejo cigarete, če med zdravljenjem vseeno kadite.
Two identical double-blind clinical trials prospectively compared the efficacy of CHAMPIX (1 mg twice daily), sustained release bupropion (150 mg twice daily) and placebo in smoking cessation.
Dve identični dvojno slepi klinični preskušanji sta prospektivno primerjali učinkovitost zdravila CHAMPIX (1 mg dvakrat na dan), bupropiona s podaljšanim sproščanjem (150 mg dvakrat na dan) in placeba pri prenehanju kajenja.
Adverse drug reactions are based on evaluation of data from pre-marketing phase 2-3 studies and updated based on pooled data from 18 placebo-controlled pre- and post-marketing studies, including approximately 5,000 patients treated with varenicline.
Neželeni učinki temeljijo na oceni podatkov iz študij faz 2 in 3, opravljenih pred obdobjem trženja, in so posodobljeni na podlagi združenih podatkov iz 18 s placebom nadzorovanih študij, opravljenih pred obdobjem trženja in med njim, ki so vključevale približno 5.000 bolnikov, zdravljenih z vareniklinom.
CHAMPIX is indicated for smoking cessation in adults.
Zdravilo CHAMPIX je indicirano za prenehanje kajenja pri odraslih.
The meta-analysis showed that exposure to CHAMPIX resulted in a hazard ratio for MACE of 2.83 (95% confidence interval from 0.76 to 10.55, p=0.12) for patients during treatment and 1.95 (95% confidence interval from 0.79 to 4.82, p=0.15) for patients up to 30 days after treatment.
Meta analiza je pokazala, da je izpostavljenost zdravilu CHAMPIX imela za posledico razmerje tveganja za MACE, ki je znašalo 2,83 (95 % interval zaupanja od 0,76 do 10,55, p = 0,12) za bolnike med zdravljenjem in 1,95 (95 % interval zaupanja od 0,79 do 4,82, p = 0,15) za bolnike v obdobju do 30 dni po zdravljenju.
There were more events reported in patients in the psychiatric cohort in each treatment group compared with the non-psychiatric cohort, and the incidence of events in the composite endpoint was higher for each of the active treatments compared to placebo.
Pri bolnikih v psihiatrični kohorti so v vsaki zdravljeni skupini poročali o več dogodkih v primerjavi z nepsihiatrično kohorto, poleg tega je bila pojavnost dogodkov v sestavljenem opazovanem dogodku večja za vsako zdravljenje z učinkovino v primerjavi s placebom.
Following two-week titration, patients randomised to varenicline with a body weight >55 kg received 1 mg twice daily (high dose group) or 0.5 mg twice daily (low dose group), while patients with a body weight ≤55 kg received 0.5 mg twice daily (high dose group) or 0.5 mg once daily (low dose group).
Po dvotedenski titraciji so bolniki s telesno maso > 55 kg, ki so jih randomizirali na vareniklin, prejemali 1 mg dvakrat na dan (skupina z velikim odmerkom) oziroma 0,5 mg dvakrat na dan (skupina z majhnim odmerkom), medtem ko so bolniki s telesno maso ≤ 55 kg prejemali 0,5 mg dvakrat na dan (skupina z velikim odmerkom) oziroma 0,5 mg enkrat na dan (skupina z majhnim odmerkom).
Based on varenicline characteristics and clinical experience to date, CHAMPIX has no clinically meaningful drug interactions.
Glede na značilnosti vareniklina in dosedanje klinične izkušnje zdravilo CHAMPIX nima klinično pomembnih medsebojnih delovanj z drugimi zdravili.
Bottle: This medicine does not require any special storage conditions.
Plastenka: Za shranjevanje zdravila niso potrebna posebna navodila.
Analyses of clinical trial data did not show evidence of an increased risk of serious neuropsychiatric events with varenicline compared to placebo.
Analize podatkov iz kliničnih preskušanj niso dokazale povečanega tveganja za pojav resnih nevropsihiatričnih dogodkov pri vareniklinu v primerjavi s placebom.
There were no completed suicides reported in the psychiatric cohort.
V psihiatrični kohorti niso poročali o samomorih.
Varenicline has been shown to be dialyzed in patients with end stage renal disease (see section 5.2), however, there is no experience in dialysis following overdose.
Dokazano je, da se vareniklin dializira pri bolnikih s končno odpovedjo ledvic (glejte poglavje 5.2), ni pa izkušenj z dializiranjem po prevelikem odmerjanju.
As a precautionary measure, it is preferable to avoid the use of varenicline during pregnancy (see section 5.1).
Iz previdnostnih razlogov se je uporabi vareniklina med nosečnostjo bolje izogibati (glejte poglavje 5.1).
If you have problems with your kidneys, you should speak to your doctor before taking CHAMPIX.
Če imate težave z ledvicami, se morate pred jemanjem zdravila CHAMPIX pogovoriti z zdravnikom.
CA* wk 21-52
CA* tedni 21-52
Study in subjects with a history of major depressive disorder The efficacy of varenicline was confirmed in a randomised placebo-controlled trial in 525 subjects with a history of major depression in the past two years or under current stable treatment.
Študija pri preskušancih s hudo depresivno motnjo v anamnezi Učinkovitost vareniklina so potrdili v randomiziranem, s placebom nadzorovanem preskušanju pri 525 preskušancih, ki so imeli hudo depresijo v anamnezi v zadnjih dveh letih ali so bili trenutno stabilno zdravljeni.
In clinical studies in humans, varenicline showed low abuse potential.
V kliničnih študijah pri ljudeh je bil potencial zlorabe pri vareniklinu majhen.
Semen analysis abnormal, C-reactive protein increased, blood calcium decreased * Frequencies are estimated from a post-marketing, observational cohort study
Redki nenormalna analiza sperme, povečana vrednost C-reaktivnega proteina, znižana raven kalcija v krvi * Pogostnosti so ocenjene na podlagi kohortne opazovalne študije iz obdobja trženja.
R-Pharm Germany GmbH Heinrich-Mack-Str. 35, 89257 Illertissen Germany or
R-Pharm Germany GmbH Heinrich-Mack-Str. 35, 89257 Illertissen Nemčija ali
If you accidentally take more CHAMPIX than your doctor prescribed, you must seek medical advice or go to the nearest hospital casualty department immediately.
Če ste vzeli večji odmerek zdravila CHAMPIX, kot bi smeli Če ste pomotoma vzeli več zdravila CHAMPIX, kot vam je predpisal zdravnik, morate nemudoma zaprositi za zdravniški nasvet ali oditi v ambulanto za nujno pomoč najbližje bolnišnice.
In male rats dosed for 2 years with varenicline, there was a dose-related increase in the incidence of hibernoma (tumour of the brown fat).
Pri podganjih samcih, ki so 2 leti dobivali vareniklin, so ugotovili od odmerka odvisno povečanje pojavnosti hibernoma (tumorja rjavega maščevja).
Use of CHAMPIX with other therapies for smoking cessation Consult your doctor before using CHAMPIX in combination with other smoking cessation therapies.
Uporaba zdravila CHAMPIX z drugimi zdravili za opustitev kajenja Pred uporabo zdravila CHAMPIX v kombinaciji z drugimi zdravili za opustitev kajenja se posvetujte z zdravnikom.
Patients who cannot tolerate adverse reactions of CHAMPIX may have the dose lowered temporarily or permanently to 0.5 mg twice daily.
Bolnikom, ki ne prenašajo neželenih učinkov zdravila CHAMPIX, lahko odmerek začasno ali stalno zmanjšamo na 0,5 mg dvakrat na dan.
Patients treated with CHAMPIX had a superior rate of CO-confirmed abstinence during weeks 9 through 12 and from weeks 9 through 52 compared to subjects treated with placebo.
Bolniki, zdravljeni z zdravilom CHAMPIX, so imeli boljšo s CO preverjeno abstinenco od 9. do 12. tedna in od 9. do 52. tedna v primerjavi z bolniki, ki so prejemali placebo.
After the 40 week non-treatment phase, a key secondary endpoint for both studies was the Continuous Abstinence Rate (CA) at week 52.
Po 40-tedenski fazi brez zdravila je bil sekundarni opazovani dogodek v obeh študijah delež trajne abstinence (CA - Continuous Abstinence Rate) v 52. tednu.
There have been post marketing reports of increased intoxicating effects of alcohol in patients treated with varenicline.
V obdobju trženja so poročali o povečanih intoksikacijskih učinkih alkohola pri bolnikih, zdravljenih z vareniklinom.
The results for the 4W CQR (weeks 9 through 12) and CA rate (weeks 9 through 52) are shown in the following table:
Rezultati za 4W-CQR (od 9. do 12. tedna) in odstotek CA (od 9. do 52. tedna) so prikazani v naslednji preglednici:
Patients experiencing these symptoms should discontinue treatment with varenicline and contact a health care provider immediately.
Bolniki, ki zaznajo te simptome, morajo zdravljenje z vareniklinom prekiniti in se nemudoma posvetovati z zdravnikom.
The efficacy of CHAMPIX in smoking cessation is a result of varenicline's partial agonist activity at the α4β2 nicotinic receptor where its binding produces an effect sufficient to alleviate symptoms of craving and withdrawal (agonist activity), while simultaneously resulting in a reduction of the rewarding and reinforcing effects of smoking by preventing nicotine binding to α4β2 receptors (antagonist activity).
Učinkovitost zdravila CHAMPIX pri prenehanju kajenja je posledica delno agonističnega delovanja vareniklina na nikotinskih receptorjih α4β2, kjer njegova vezava zadostuje za ublažitev simptomov hlepenja in odtegnitve (agonistično delovanje), hkrati pa s preprečevanjem vezave nikotina na receptorje α4β2 zmanjšuje s kajenjem povezana občutka okrepitve in ugodja (antagonistično delovanje).
If you forget to take CHAMPIX
Če ste pozabili vzeti zdravilo CHAMPIX
These could include changes of mood (like feeling depressed, irritable, frustrated or anxious), sleeplessness, difficulty concentrating, decreased heart rate and increased appetite or weight gain.
Ti lahko vključujejo spremembe razpoloženja (npr. občutek potrtosti, razdražljivosti, frustriranosti ali tesnobe), nespečnost, težave s koncentracijo, upočasnjen srčni utrip, povečanje apetita ali pridobivanje telesne mase.
This study showed the benefit of an additional 12-week treatment with CHAMPIX 1 mg twice daily for the maintenance of smoking cessation compared to placebo; superiority to placebo for CA was maintained through week 52.
Ta študija je pokazala, da dodatno 12-tedensko zdravljenje z zdravilom CHAMPIX v odmerku 1 mg dvakrat na dan za vzdrževanje prenehanja kajenja v primerjavi s placebom koristi; večja učinkovitost pri doseganju CA v primerjavi s placebom se je ohranila do vključno 52. tedna.
The percentage of subjects with suicide-related events in the active treatment phase compared to post-treatment phase was unchanged in the varenicline group; in the placebo group, this percentage was lower in the post-treatment phase.
Delež preskušancev s samomorom povezanimi dogodki v obdobju prejemanja zdravila v primerjavi z obdobjem po končanem prejemanju zdravila je bil nespremenjen v skupini, ki je prejemala vareniklin; v skupini, ki je prejemala placebo, je bil ta delež v obdobju po končanem prejemanju zdravila manjši.
Tablets' core
Jedro tablet
CA* wk 15-24
CA* tedni 15-24
Children and adolescents CHAMPIX is not recommended for use in paediatric patients as efficacy was not demonstrated.
Uporaba zdravila CHAMPIX pri pediatričnih bolnikih ni priporočljiva, saj učinkovitost ni bila dokazana.
Overall, a small number of MACE occurred during treatment in the trials included in the meta-analysis (CHAMPIX 7 [0.17%]; placebo 2 [0.07%]).
Na splošno je med zdravljenjem v preskušanjih, ki so bila vključena v meta analizo, prišlo do majhnega števila primerov MACE (CHAMPIX 7 [0,17 %]; placebo 2 [0,07 %]).
After 12 weeks of treatment, if you have stopped smoking, your doctor may recommend an additional 12 weeks of treatment with CHAMPIX 1 mg film-coated tablets twice daily to help avoid returning back to smoking.
Če ste po 12 tednih zdravljenja opustili kajenje, vam zdravnik lahko svetuje dodatnih 12 tednov zdravljenja s filmsko obloženimi tabletami CHAMPIX 1 mg dvakrat na dan.
In both cohorts, subjects treated with varenicline demonstrated statistical superiority of CO-confirmed abstinence during weeks 9 through 12 and 9 through 24 compared to subjects treated with bupropion, nicotine patch and placebo (please see table below).
V obeh kohortah so preskušanci, ki so se zdravili z vareniklinom, pokazali statistično superiornost v s CO preverjeni abstinenci med 9. in 12. tednom ter med 9. in 24. tednom v primerjavi s preskušanci, ki so se zdravili z bupropionom, nikotinskim obližem in placebom (glejte naslednjo preglednico).
Cardiovascular safety assessment study in subjects with and without a history of psychiatric disorder The cardiovascular (CV) safety of CHAMPIX was evaluated in the Study in Subjects with and without a History of Psychiatric Disorder (parent study; see section 5.1 - Neuropsychiatric safety) and its nontreatment extension, the Cardiovascular Safety Assessment Study, which enrolled 4595 of the 6293 subjects who completed the parent study (N=8058) and followed them through week 52.
Študija za oceno srčnožilne varnosti pri preskušancih s psihiatrično motnjo v anamnezi ali brez nje Srčnožilno varnost zdravila CHAMPIX so ovrednotili v Študiji pri preskušancih s psihiatrično motnjo v anamnezi ali brez nje (matična študija; glejte poglavje 5.1 - Nevropsihiatrična varnost) in v podaljšanju te študije brez zdravljenja, imenovanem Študija za oceno srčnožilne varnosti, v katero so vključili 4.595 od 6.293 preskušancev, ki so zaključili matično študijo (n = 8.058), in jih spremljali do vključno 52. tedna.
Single and multiple-dose pharmacokinetics of varenicline have been investigated in paediatric patients aged 12 to 17 years old (inclusive) and were approximately dose-proportional over the 0.5 mg to 2 mg daily dose range studied.
Farmakokinetiko vareniklina po enkratnem in večkratnem odmerjanju so raziskovali pri pediatričnih bolnikih, starih od 12 do (vključno) 17 let, ta farmakokinetika pa je bila približno sorazmerna odmerku pri odmerkih v območju od 0,5 mg do 2 mg na dan, ki so jih raziskovali.
These are equivalent to an estimated increase of 6.5 MACE events and 6.3 MACE events per 1,000 patient-years, respectively of exposure.
To je enakovredno ocenjenemu povečanju števila dogodkov MACE, ki znaša 6,5 na 1.000 bolnikov-let med zdravljenjem, in 6,3 na 1.000 bolnikov-let v obdobju do 30 dni po zdravljenju.
The treatment discontinuation rate due to adverse reactions was 11.4% for varenicline compared with 9.7% for placebo.
Delež prekinitev zdravljenja zaradi neželenih učinkov je bil 11,4 % pri bolnikih, ki so dobivali vareniklin, in 9,7 % pri tistih, ki so dobivali placebo.
Patient reported craving, withdrawal and reinforcing effects of smoking Across both Studies 1 and 2 during active treatment, craving and withdrawal were significantly reduced in patients randomised to CHAMPIX in comparison with placebo.
Bolniki so navajali hlepenje, odtegnitvene učinke in okrepitvene učinke kajenja V obeh študijah, študiji 1 in študiji 2, je bilo med uporabo učinkovine hlepenja in odtegnitvenih učinkov statistično pomembno manj med bolniki, ki so bili randomizirani na zdravilo CHAMPIX, kot med tistimi, ki so dobivali placebo.
Champix is for oral use.
Zdravilo Champix je namenjeno za peroralno uporabo.
CHAMPIX comes as a white tablet (0.5 mg) and a light blue tablet (1 mg).
Zdravilo CHAMPIX je na voljo v obliki belih tablet (0,5 mg) in svetlomodrih tablet (1 mg).
Liver function test abnormal
Preiskave Pogosti nenormalni izvidi testov jetrne funkcije
The primary safety endpoint was a composite of the following neuropsychiatric (NPS) adverse events: severe events of anxiety, depression, feeling abnormal, or hostility, and/or moderate or severe events of agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behaviour or completed suicide.
Glavni opazovani dogodek varnosti je bil sestavljen iz naslednjih nevropsihiatričnih (NPSNeuropsychiatric) neželenih dogodkov: huda anksioznost, depresija, nenormalno počutje ali sovražnost in/ali zmerna do huda agitacija, agresija, blodnje, halucinacije, morilske misli, manija, panika, paranoja, psihoza, samomorilne misli, samomorilno vedenje ali samomor.
Subjects with cardiovascular disease
Preskušanci s srčnožilnimi boleznimi
The key cardiovascular safety analysis included occurrence and timing of a composite endpoint of Major Adverse Cardiovascular Events (MACE), defined as cardiovascular death, nonfatal MI, and nonfatal stroke.
Ključna analiza srčnožilne varnosti je vključevala pojavljanje in čas pojavljanja sestavljenega opazovanega dogodka izrazitejši srčnožilni neželeni učinki (MACE - Major Adverse Cardiovascular Events), ki so definirani kot srčnožilna smrt, miokardni infarkt brez smrtnega izida in možganska kap brez smrtnega izida.
In addition, the table shows the subset of the composite NPS AE endpoint of severe intensity:
Poleg tega preglednica prikazuje tudi podskupino hudih AE sestavljenega opazovanega dogodka NPS: