FrancophonIA/ELRC3.0 huggingface dataset:
English: Tarceva in combination with gemcitabine was studied in 569 patients with pancreatic cancer that was advanced, unresectable (that cannot be removed by surgery) or metastatic.
Croatian: Kod raka gušterače, lijek Tarceva u kombinaciji s gemcitabinom ispitivan je na 569 bolesnika s uznapredovalim, neoperabilnim (koji se ne može kirurški odstraniti) ili metastatskim rakom gušterače.
English: How is Tarceva used?
Croatian: Kako djeluje Tarceva?
English: Patients taking Tarceva survived for an average of 6.7 months, compared with 4.7 months for the patients taking placebo.
Croatian: Bolesnici koji su primali lijek Tarceva preživjeli su u prosjeku 6,7 mjeseci, u usporedbi s 4,7 mjeseci u slučaju bolesnika koji su primali placebo.
English: • The fourth study compared Tarceva with placebo in 731 patients in whom at least one previous chemotherapy treatment had not worked.
Croatian: • u četvrtom ispitivanju lijek Tarceva uspoređen je s placebom na 731 bolesniku kod kojih barem jedna prethodna kemoterapija nije bila djelotvorna.
English: • The second study compared Tarceva with placebo (a dummy treatment) in 889 patients with advanced or metastatic NSCLC whose disease had not got worse after 4 cycles of treatment with platinum-containing chemotherapy.
Croatian: • u drugom ispitivanju lijek Tarceva uspoređivan je s placebom (prividnim liječenjem) na 889 bolesnika s uznapredovalim ili metastatskim NSCLC-om, kod kojih se bolest nije pogoršala nakon četiri ciklusa kemoterapije na bazi platine.
English: • The first study compared Tarceva with chemotherapy in 173 patients with advanced NSCLC with activating EGFR mutations who had not received previous chemotherapy.
Croatian: • u prvom ispitivanju lijek Tarceva uspoređivan je s kemoterapijom na 173 bolesnika s uznapredovalim NSCLC-om s aktivirajućim mutacijama EGFR-a koji prethodno nisu primili kemoterapiju.
English: • A third study compared Tarceva with placebo in 643 patients with advanced NSCLC whose cancer cells did not have EGFR activating mutations and whose disease was stable after 4 cycles of treatment with platinum-containing chemotherapy.
Croatian: • u trećem ispitivanju lijek Tarceva uspoređivan je s placebom na 643 bolesnika s uznapredovalim NSCLC-om kod kojih stanice raka nisu imale aktivirajuće mutacije EGFR-a i kod kojih je bolest bila stabilna nakon četiri ciklusa kemoterapije na bazi platine.
English: Patients with metastatic cancer taking Tarceva as initial therapy lived without their disease getting worse for an average of 5.9 months, compared with 5.1 months in those taking placebo.
Croatian: Bolesnici s metastatskim rakom koji su primali lijek Tarceva kao početnu terapiju živjeli su u prosjeku 5,9 mjeseci bez pogoršanja bolesti, u usporedbi s 5,1 mjesecom u slučaju bolesnika koji su primali placebo.
English: • patients without EGFR activating mutations in whom previous chemotherapy has not worked and other treatments are unsuitable.
Croatian: • bolesnika bez aktivirajućih mutacija EGFR-a u kojih prethodna kemoterapija nije bila uspješna, a drugi oblici liječenja nisu prikladni.
English: For the full list of side effects and restrictions with Tarceva, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Tarceva potražite u uputi o lijeku.
English: • patients with EGFR activating mutations in whom previous chemotherapy has not worked;
Croatian: • bolesnika s aktivirajućim mutacijama EGFR-a u kojih kemoterapija nije bila djelotvorna;
English: Patients taking Tarceva lived for an average of 10.4 months without their disease getting worse compared with 5.1 months for those receiving chemotherapy medicines.
Croatian: Bolesnici na terapiji lijekom Tarceva živjeli su u prosjeku 10,4 mjeseci bez pogoršanja bolesti, u usporedbi s 5,1 mjeseci u bolesnika liječenih kemoterapijskim lijekovima.
English: Overall, Tarceva marginally increased how long patients lived without their disease getting worse and how long they survived.
Croatian: Sveukupno gledajući, terapija lijekom Tarceva dovela je do neznatnog produljenja života bolesnika bez pogoršanja bolesti i do neznatnog povećanja stope preživljenja.
English: The greatest benefit was in a subgroup of 49 patients with EGFR activating mutations: those taking Tarceva (22 patients) lived for an average of 44.6 weeks without their disease getting worse, compared with 13 weeks for those taking placebo (27 patients).
Croatian: Bolesnici koji su primali lijek Tarceva (22 bolesnika) živjeli su u prosjeku 44,6 tjedana bez pogoršanja bolesti, u usporedbi s 13 tjedana u slučaju bolesnika koji su primali placebo (27 bolesnika).
English: The side effects reported with Tarceva are considered manageable.
Croatian: Smatra se da je moguće kontrolirati nuspojave lijeka Tarceva zabilježene pri njegovoj primjeni.
English: 1 ml (140 mg/ml) 1 pre-filled pen
Croatian: 1 ml (140 mg/ml) 1 napunjena brizgalica
English: 1 ml (140 mg/ml) 1 pre-filled syringe
Croatian: 1 ml (70 mg/ml) 1 napunejna brizgalica
English: 1 ml (120 mg/ml) 1 pre-filled syringe
Croatian: 1 ml (120 mg/ml) 1 napunjena brizgalica
English: 48 months
Croatian: 48 mjeseci
English: No new significant safety signals were identified.
Croatian: Nije zabilježen nijedan novi značajan sigurnosni signal.
English: • Always take this medicine with a meal or some food.
Croatian: • Uvijek uzmite ovaj lijek s obrokom ili nekom hranom.
English: This medicine is not recommended in patients below 18 years old.
Croatian: Ovaj se lijek ne preporučuje u bolesnika mlađih od 18 godina.
English: The blisters are packaged in a carton.
Croatian: Blisteri su pakirani u kutije.
English: Date of first authorisation: 18 September 2017
Croatian: Datum prvog odobrenja: 18. rujan 2017.
English: Xermelo was taken within 15 minutes before, or within 1 hour after food.
Croatian: Xermelo su uzimali unutar 15 minuta prije ili unutar 1 sata poslije jela.
English: Talk to a doctor.
Croatian: Obratite se liječniku.
English: You should not take this medicine if you are pregnant or might become pregnant.
Croatian: Ne smijete uzimati ovaj lijek ako ste trudni ili biste mogli zatrudnjeti.
English: This is to check that your liver is working normally.
Croatian: To je kako bi se provjerilo da Vam jetra radi normalno.
English: 13522 Tallinn Estonia
Croatian: 13522 Tallinn
English: Number of patients Responder, n (%)
Croatian: Broj bolesnika Bolesnici s odgovorom, n (%)
English: No specific study has been performed in the elderly population.
Croatian: U starije populacije nije provedeno posebno ispitivanje.
English: Available data suggest that clinical response is usually achieved within 12 weeks of treatment.
Croatian: Dostupni podaci ukazuju na to da se klinički odgovor obično postiže unutar 12 tjedana liječenja.
English: These may be signs that your liver is not working properly.
Croatian: To mogu biti znakovi da Vam jetra ne radi pravilno.
English: EU/1/17/1224/001 EU/1/17/1224/002
Croatian: EU/1/17/1224/002
English: It is not known how telotristat may affect the baby.
Croatian: Nije poznato kako telotristat može utjecati na dijete.
English: Xermelo should be taken with food (see sections 5.1 and 5.2).
Croatian: Xermelo treba uzimati s hranom (vidjeti dijelove 5.1 i 5.2).
English: Breast Cancer Resistance Protein (BCRP)
Croatian: Protein rezistencije raka dojke (BCRP)
English: • Swollen stomach
Croatian: • otečen trbuh
English: There were 12 patients who were “very satisfied”, and all of them were on telotristat.
Croatian: Bilo je 12 bolesnika koji su bili „vrlo zadovoljni“ i svi su uzimali telotristat.
English: Most events were mild or moderate and did not limit study treatment.
Croatian: Većina događaja bili su blagi ili umjereni i nisu ograničili liječenje u okviru ispitivanja.
English: Torre Realia, Plaza de Europa, 41-43 08908 L'Hospitalet de Llobregat Barcelona
Croatian: Torre Realia, Plaza de Europa, 41-43 08908 L'Hospitalet de Llobregat
English: Some cases had more than one event of intestinal obstruction.
Croatian: Neki su slučajevi imali više od jednog događaja opstrukcije crijeva.
English: Talk to your doctor or pharmacist before taking Xermelo:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Xermelo:
English: You should tell your doctor about every medicine.
Croatian: Trebate reći liječniku za svaki lijek koji uzimate.
English: The majority of intestinal obstruction events were serious (56 cases) and 33 cases were medically confirmed.
Croatian: Većina događaja opstrukcije crijeva bila je ozbiljna (56 slučajeva), a 33 slučaja medicinski su potvrđena.
English: LP-951757 was pharmacologically inactive at TPH1 in vitro.
Croatian: LP-951757 je bio farmakološki neaktivan kod TPH1 in vitro.
English: Tell your doctor straight away if you notice any of the following signs and symptoms that suggest that your liver may not be working properly:
Croatian: Odmah obavijestite liječnika ako opazite neki od sljedećih znakova i simptoma koji ukazuju na to da Vam jetra možda ne radi pravilno:
English: • Swelling (build-up of fluid in the body)
Croatian: • oticanje (nakupljanje tekućine u tijelu)
English: Most patients (92.1%) had fewer than 4 BM per day and all except 9 were treated by SSA therapy.
Croatian: Većina bolesnika (92,1%) imala je manje od 4 pražnjenja crijeva na dan, a svi osim njih 9 bili su liječeni terapijom SSA-om.
English: This is because Xermelo can affect the way some other medicines work, or other medicines can affect the way Xermelo works.
Croatian: To je potrebno zbog toga što Xermelo može utjecati na način na koji djeluju neki drugi lijekovi ili drugi lijekovi mogu utjecati na način na koji djeluje Xermelo.
English: • You should keep having injections of somatostatin analogues (lanreotide or octreotide) when taking
Croatian: • Potrebno je nastaviti s injekcijama analoga somatostatina (lanreotid ili oktreotid) dok uzimate
English: The carcinogenic potential of telotristat etiprate was studied in transgenic mice (26 weeks) and rats (104 weeks).
Croatian: Kancerogeni potencijal telotristatetiprata ispitivan je na transgeničnim miševima (26 tjedana) i štakorima (104 tjedna).
English: The tablets are packaged in a PVC/PCTFE/PVC/Al blister.
Croatian: Tablete su pakirane u PVC/PCTFE/PVC/Al blisterima.
English: The maximum dose of Xermelo is 750 mg in 24 hours.
Croatian: Najveća doza lijeka Xermelo iznosi 750 mg u razdoblju od 24 sata.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne i razvojne toksičnosti.
English: Monitoring for suboptimal efficacy is recommended.
Croatian: Preporučuje se praćenje zbog moguće suboptimalne djelotvornosti.
English: • Your doctor may carry out blood tests before you start taking this medicine and while you are taking it.
Croatian: • Liječnik će Vam možda provesti pretrage krvi prije nego što počnete uzimati ovaj lijek, i provoditi ih dok ga uzimate.
English: • Depression, you may experience decreased self-esteem, lack of motivation, sadness or low mood
Croatian: • depresija, možete iskusiti osjećaj smanjenog samopoštovanja, nedostatak motivacije, tugu ili loše raspoloženje
English: Your doctor will prescribe this medicine if your diarrhoea is not well controlled with injections of other medicines called ‘somatostatin analogues' (lanreotide or octreotide).
Croatian: Liječnik će Vam propisati ovaj lijek ako proljev koji imate nije dobro kontroliran injekcijama drugih lijekova koji se nazivaju „analozi somatostatina“ (lanreotid ili oktreotid).
English: Your doctor will also monitor your liver.
Croatian: liječnik će Vam pratiti rad jetre.
English: A cumulative search identified 62 relevant cases some of which with a close temporal relationship with the initiation of treatment with telotristat.
Croatian: Kumulativnom pretragom identificirano je 62 relevantna slučaja, od kojih su neki bili u bliskoj vremenskoj povezanosti s početkom liječenja telotristatom.
English: Do not stop taking Xermelo without talking with your doctor.
Croatian: Nemojte prestati uzimati Xermelo a da se prije niste posavjetovali s liječnikom.
English: In a phase 3 study of similar design (TELECAST), a total of 76 patients were evaluated for efficacy.
Croatian: U ispitivanju faze 3 sličnog dizajna (TELECAST), djelotvornost je procijenjena u ukupno 76 bolesnika.
English: The clinical significance of the decrease in brain 5-HIAA with or without a concomitant decrease in brain 5-HT is unknown.
Croatian: Klinička značajnost smanjenja 5-HIAA u mozgu s istodobnim smanjenjem 5-HT u mozgu ili bez njega nije poznata.
English: Your doctor will decide for how long you should take Xermelo.
Croatian: Liječnik će odlučiti koliko dugo trebate uzimati Xermelo.
English: • if you have liver problems.
Croatian: • ako imate tegoba s jetrom.
English: Therapy with telotristat should not be resumed unless the liver injury can be explained by another cause.
Croatian: Terapija telotristatom ne smije se nastaviti osim ako oštećenje jetre nije moguće objasniti drugim uzrokom.
English: Following administration of 500 mg tid, the apparent terminal half-life was approximately 11 hours.
Croatian: Nakon primjene doze od 500 mg TID, prividni terminalni poluvijek bio je približno 11 sati.
English: A total of 135 patients were evaluated for efficacy.
Croatian: Djelotvornost je procijenjena u ukupno 135 bolesnika.
English: Moreover, in the long-term safety study (LX1606.1-302-CS), the incidence of depression was 21% and there is a probable biological mechanism that telotristat reduces the production of serotonin that may lead to symptoms of depression.
Croatian: Štoviše, u ispitivanju dugoročne sigurnosti primjene telotristata (LX1606.1-302-CS) incidencija depresije bila je 21%, te postoji vjerojatan biološki mehanizam putem kojeg telotristat smanjuje proizvodnju serotonina, što može dovesti do simptoma depresije.
English: These have not been associated with concomitant elevations in total serum bilirubin.
Croatian: Te povišene vrijednosti nisu bile povezane s istodobnim povišenjima ukupnog bilirubina u serumu.
English: The potential for in vivo drug interaction via inhibition of BCRP is considered low.
Croatian: Potencijal za in vivo interakciju lijekova putem inhibicije BCRP-a smatra se niskim.
English: In rats, there were no adverse effects on male and female fertility.
Croatian: U štakora nije bilo štetnih učinaka na plodnost mužjaka i ženki.
English: Therefore, intake of higher doses is not recommended (see section 5.2).
Croatian: Stoga se ne preporučuje uzimanje viših doza (vidjeti dio 5.2).
English: Talk to your doctor or pharmacist:
Croatian: Obratite se liječniku ili ljekarniku:
English: In phase 3 clinical trials, telotristat was routinely combined with loperamide with no evidence of safety concerns.
Croatian: U kliničkim ispitivanjima faze III, telotristat se rutinski kombinirao s loperamidom bez dokaza da dovodi u pitanje sigurnost.
English: België/Belgique/Belgien, Luxembourg/Luxemburg
Croatian: België/Belgique/Belgien, Luxembourg/Luxemburg Ipsen NV
English: If constipation develops, the use of telotristat and other concomitant therapies affecting bowel motility should be re-evaluated.
Croatian: Ako se razvije konstipacija, potrebno je ponovno procijeniti primjenu telotristata i drugih istodobnih terapija koje utječu na motilitet crijeva.
English: Adverse reactions are listed by MedDRA body system organ class and by frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Croatian: Nuspojave su navedene prema MedDRA-inoj klasifikaciji organskih sustava te prema učestalosti na temelju sljedećeg dogovora: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka ).
English: The mean Cmax, and AUC0-inf for the active metabolite, 1'-hydroxymidazolam, were also decreased by 34%, and 48%, respectively.
Croatian: Srednje vrijednosti Cmax i AUC0-inf za aktivni metabolit, 1'-hidroksimidazolam, bile se također smanjene za 34% odnosno 48%.
English: Based on the small increase observed, clinically meaningful interactions with P-gp and MRP-2 substrates are unlikely.
Croatian: Na temelju malog opaženog povećanja, klinički značajne interakcije sa supstratima P-gp-a i MRP-2 nisu vjerojatne.
English: The majority was eliminated in the faeces.
Croatian: Veći dio eliminirao se stolicom.
English: Through inhibition of peripheral TPH1, telotristat reduces the production of serotonin, thus alleviating symptoms associated with carcinoid syndrome.
Croatian: Inhibicijom perifernog TPH1 telotristat smanjuje proizvodnju serotonina, čime ublažava simptome povezane s karcinoidnim sindromom.
English: Your doctor will do blood tests to check your liver and will decide whether you should keep taking this medicine.
Croatian: • Liječnik će Vam napraviti pretrage krvi kako bi provjerio rad jetre i prema tome će odlučiti smijete li nastaviti uzimati ovaj lijek.
English: This medicine works by reducing the amount of serotonin made by the tumour.
Croatian: Ovaj lijek djeluje tako što smanjuje količinu serotonina koju tumor stvara.
English: Xermelo and these medicines reduce the number of your bowel movements and taken together, they can cause severe constipation.
Croatian: Xermelo i ti lijekovi smanjuju broj pražnjenja crijeva i ako se uzimaju zajedno, mogu dovesti do teškog zatvora.
English: Management of overdose Treatment of an overdose should include general symptomatic management.
Croatian: Zbrinjavanje predoziranja Liječenje predoziranja mora uključiti opće simptomatsko zbrinjavanje.
English: The tablets are white to off-white, film-coated and oval shaped.
Croatian: Tablete su bijele do bjelkaste boje, obložene film-ovojnicom i ovalnog oblika.
English: Least Square mean difference 97.5% CL for difference p value
Croatian: 97,5% CL za razliku p-vrijednost
English: The recommended dose is one tablet (250 mg) three times a day.
Croatian: Preporučena doza je jedna tableta (250 mg) tri puta na dan.
English: What Xermelo looks like and contents of the pack
Croatian: Kako Xermelo izgleda i sadržaj pakiranja
English: Serotonin plays a critical role in regulating several major physiological processes, including secretion, motility, inflammation, and sensation of the gastrointestinal tract, and is over-secreted in patients with carcinoid syndrome.
Croatian: Serotonin ima ključnu ulogu u regulaciji nekoliko glavnih fizioloških procesa, uključujući sekreciju, motilitet, upalu i osjetljivost probavnog sustava, a u bolesnika s karcinoidnim sindromom se prekomjerno luči.
English: You should keep having injections of these other medicines when taking Xermelo.
Croatian: Morate nastaviti primati injekcije tih lijekova i kada uzimate Xermelo.
English: Percentage of patients with durable responseb
Croatian: Postotak bolesnika s postojanim odgovoromb
English: Since telotristat ethyl is rapidly converted to its active metabolite, which is > 25× more active than telotristat ethyl, no dose adjustments are required when using Xermelo with acid reducers.
Croatian: Budući da se etiltelotristat brzo pretvara u svoj aktivni metabolit, koji je > 25× aktivniji od etiltelotristata, nije potrebna prilagodba doze kada se Xermelo koristi s lijekovima koji smanjuju želučanu kiselinu.
English: Patients should be advised to report any symptoms of depression, depressed mood and decreased interest to their physicians.
Croatian: Bolesnicima treba savjetovati da obavijeste liječnika o svakom simptomu depresije, depresivnog raspoloženja i smanjenog interesa.
English: No decrease in brain 5-HT and 5-HIAA levels were observed after intravenous application of active metabolite.
Croatian: Smanjenje razina 5-HT i 5-HIAA u mozgu nije opaženo nakon intravenske primjene aktivnog metabolita.
English: Laboratory monitoring of hepatic enzymes prior to and during telotristat therapy is recommended as clinically indicated.
Croatian: Preporučuje se laboratorijsko praćenje jetrenih enzima prije i tijekom terapije telotristatom kako je klinički indicirano.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for telotristat, the scientific conclusions of the CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za telotristat, znanstveni zaključci CHMP-a su sljedeći:
English: This might also be shown by changes in your blood test results, such as an increase of liver enzymes: gamma-glutamyl transferase (very common, may affect more than 1 in 10 people), transaminases and blood alkaline phosphatase (common, may affect up to 1 in 10 people).
Croatian: To se može očitovati i promjenom u nalazima pretrage krvi, kao što je povećanje razina jetrenih enzima: gama-glutamil transferaze (vrlo često, može se pojaviti u više od 1 na 10 osoba), transaminaza i alkalne fosfataze u krvi (često, može se pojaviti u do 1 na 10 osoba).
English: Institut Produits Synthèse (IPSEN) AB Kista Science Tower Färögatan 33
Croatian: Institut Produits Synthèse (IPSEN) AB Kista Science Tower
English: Telotristat induced CYP2B6 in vitro (see section 5.2).
Croatian: Telotristat je inducirao CYP2B6 in vitro (vidjeti dio 5.2).
English: • medicines to treat depression, such as bupropion or sertraline.
Croatian: • lijekove za liječenje depresije, kao što su bupropion ili sertralin
English: • Breathing problems, rapid heartbeat, fever, incontinence (uncontrollable urination), confusion, dizziness or agitation.
Croatian: • problemi s disanjem, ubrzan rad srca, vrućica, inkontinencija (nekontrolirano mokrenje), zbunjenost, vrtoglavica ili uznemirenost.
English: QOL was generally stable over the course of the study.
Croatian: Općenito, kvaliteta života bila je stabilna tijekom ispitivanja.
English: Xermelo is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se uzimati lijek Xermelo tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Patients should not take a double dose to make up for a missed dose.
Croatian: Bolesnici ne smiju uzeti dvostruku dozu kako bi nadoknadili propuštenu dozu.
English: Serious constipation was observed in 3 patients treated with a higher dose (500 mg) in the overall safety population (239 patients).
Croatian: Ozbiljna konstipacija opažena je u 3 bolesnika liječena višim dozama (500 mg) u ukupnoj sigurnosnoj populaciji (239 bolesnika).
English: The adverse event was observed in clinical trials with frequency “very common” and is being reported from post-marketing setting.
Croatian: Ovaj štetan događaj zabilježen je u kliničkim ispitivanjima s učestalošću „vrlo često“, a prijavljuje se i tijekom razdoblja nakon stavljanja lijeka u promet.
English: Patients should be monitored for signs and symptoms of constipation.
Croatian: Bolesnike je potrebno pratiti zbog mogućih znakova i simptoma konstipacije.
English: Xermelo contains lactose (a type of sugar).
Croatian: Xermelo sadrži laktozu (vrsta šećera).
English: Although patients with carcinoid syndrome may have a predisposition for depression, there were 38 post-marketing cases indicative of depression and depression-related events including two cases with positive dechallenge.
Croatian: Iako bolesnici s karcinoidnim sindromom mogu imati predispoziciju za depresiju, nakon stavljanja lijeka u promet prijavljeno je 38 slučajeva koji ukazuju na depresiju i događaje povezane s depresijom, uključujući dva slučaja s povlačenjem nuspojave nakon prekida primjene lijeka (pozitivnim dechallenge-om).