natgillin/translations-raw huggingface dataset:
The efficacy and safety of Envarsus and Prograf, both in combination with mycophenolate mofetil (MMF) or mycophenolate sodium (MPS) and corticosteroids, was compared in 324 stable kidney transplant recipients.
Djelotvornost i sigurnost Envarsusa i Prografa, oba u kombinaciji s mikofenolat mofetilom ili mikofenolatnatrijem i kortikosteroidima, uspoređena je u 324 stabilna primatelja presatka bubrega.
The efficacy and safety of enzalutamide in patients with metastatic castration-resistant prostate cancer who had received docetaxel and were using a LHRH analogue or had undergone orchiectomy were assessed in a randomised, placebo-controlled, multicentre phase 3 clinical trial.
Djelotvornost i sigurnost enzalutamida bile su procijenjene u randomiziranom, placebom kontroliranom multicentričnom kliničkom ispitivanju faze III u bolesnika s metastatskim karcinomom prostate rezistentnim na kastraciju koji su primali docetaksel i uzimali analog hormona LHRH ili im je napravljena orhidektomija.
The efficacy and safety of eslicarbazepine acetate has been demonstrated in four phase III double- blind placebo-controlled studies in 1,703 randomized adult patients with partial epilepsy refractory to treatment with one to three concomitant anti-epileptic medicinal products.
Djelotvornost i sigurnost eslikarbazepinacetata je dokazana u četiri dvostruko -slijepe placebom - kontrolirane studije faze III u 1703 randomiziranih odraslih bolesnika sa parcijalnom epilepsijom otpornom na liječenje s jednim do tri istodobna antiepileptička lijeka.
The efficacy and safety of eslicarbazepine acetate has been demonstrated in four phase III double- blind placebo-controlled studies in 1,703 randomized adult patients with partial epilepsy refractory to treatment with one to three concomitant anti-epileptic medicinal products.
Djelotvornost i sigurnost eslikarbazepinacetata je dokazana u četiri dvostruko slijepe placebom kontrolirane studije faze III u 1703 randomiziranih odraslih bolesnika sa parcijalnom epilepsijom otpornom na liječenje s jednim do tri istodobna antiepileptička lijeka.
The efficacy and safety of IKERVIS were evaluated in two randomised, double-masked, vehicle- controlled clinical studies in adult patients with dry eye disease (keratoconjunctivitis sicca) who met the International Dry Eye Workshop (DEWS) criteria.
Djelotvornost i sigurnost IKERVISA procijenjene su u dva randomizirana, dvostruko slijepa, vehikulumom kontrolirana klinička ispitivanja u odraslih bolesnika s dijagnozom sindroma suhog oka (keratokonjunktivitis sicca) koji su ispunili kriterije DEWS (International Dry Eye Workshop).
The efficacy and safety of Ilaris have been demonstrated in patients with varying degrees of disease severity and different CAPS phenotypes (including FCAS/FCU, MWS, and NOMID/CINCA).
Djelotvornost i sigurnost Ilarisa dokazani su kod bolesnika s različitim stupnjevima težine bolesti i različitim fenotipovima CAPS-a (uključujući FCAS/FCU, MWS i NOMID/CINCA).
The efficacy and safety of InductOs were demonstrated in a randomised, controlled, multicenter, non-inferiority study of 279 patients aged 19–78 years undergoing an open anterior lumbar interbody fusion procedure.
Djelotvornost i sigurnost primjene InductOsa dokazane su u randomiziranom, kontroliranom, multicentričnom ispitivanju neinferiornosti 279 bolesnika u dobi od 19–78 godina podvrgnutih postupku otvorene prednje interkorporalne fuzije lumbalne kralježnice.
The efficacy and safety of Instanyl (50, 100 and 200 micrograms) have been assessed in two randomised, double-blind, cross-over, placebo-controlled pivotal studies in 279 opioid-tolerant adult cancer patients (age 32-86 years) with breakthrough pain (BTP).
Djelotvornost i sigurnost Instanyla (50, 100 i 200 mikrograma) ocijenjena je u dva randomizirana, dvostruko slijepa, križna, placebom kontrolirana pivotalna ispitivanja na 279 odrasla bolesnika s karcinomom (dob 32-86 godina) na kroničnoj terapiji s opioidima i s probojnom boli.
The efficacy and safety of Instanyl (50, 100 and 200 micrograms) have been assessed in two randomised, double-blind, cross-over, placebo-controlled pivotal studies in 279 opioid-tolerant adult cancer patients (age 32-86 years) with breakthrough pain (BTP).
Djelotvornost i sigurnost Instanyla (50, 100 i 200 mikrograma) ocijenjena je u dva randomizirana, dvostruko slijepa, ukrižena, placebom kontrolirana pivotalna ispitivanja na 279 odrasla bolesnika s karcinomom (dob 32-86 godina) na kroničnoj terapiji s opioidima i s probojnom boli.
The efficacy and safety of IntronA in combination with ribavirin has been studied in children and adolescents who have not been previously treated for chronic hepatitis C.
Djelotvornost i sigurnost lijeka IntronA u kombinaciji s ribavirinom ispitivane su u djece i adolescenata koji prethodno nisu bili liječeni zbog kroničnog hepatitisa C.
The efficacy and safety of IONSYS for treatment of acute, moderate to severe postoperative pain was evaluated in seven controlled studies in 1763 IONSYS patients: three placebo-controlled studies and four active-controlled studies.
Djelotvornost i sigurnost sustava IONSYS u liječenju akutne, umjerene do teške postoperativne boli procijenjena je u sedam kontroliranih ispitivanja u 1763 bolesnika sa sustavom IONSYS: tri placebom kontrolirana ispitivanja i četiri ispitivanja kontrolirana aktivnim lijekom.
The efficacy and safety of JEVTANA in combination with prednisone or prednisolone were evaluated in a randomised, open-label, international, multi-center, phase III study, in patients with hormone refractory metastatic prostate cancer previsouly treated with a docetaxel containing regimen.
Djelotvornost i sigurnost primjene lijeka JEVTANA u kombinaciji s prednizonom ili prednizolonom procijenjena je u randomiziranom, otvorenom, međunarodnom multicentričnom kliničkom ispitivanju faze III u bolesnika s hormonski rezistentnim metastatskim karcinomom prostate, koji su prethodno liječeni kemoterapijskim protokolom koji je uključivao docetaksel.
The efficacy and safety of ketoconazole in the treatment of Cushing’s syndrome from all causes have been described through several published retrospective studies, chart reviews and case reports.
Djelotvornost i sigurnost ketokonazola u liječenju Cushingovog sindroma, neovisno o uzroku, opisana je u nekoliko objavljenih retrospektivnih studija, analiza podataka o bolesnicima i prikazima slučajeva.
The efficacy and safety of Kineret in patients with AST/ALT ≥1.5 x upper level of normal have not been evaluated.
Djelotvornost i sigurnost Kinereta u bolesnika s vrijednostima AST/ALT ≥1,5 x u odnosu na gornju granicu normale nije ocijenjena.
The efficacy and safety of lenalidomide were evaluated in patients with mantle cell lymphoma in a phase II, multicenter, randomized open-label study versus single agent of investigator’s choice in patients who were refractory to their last regimen or had relapsed one to three times (Study MCL-002).
Djelotvornost i sigurnost lenalidomida procijenjene su u bolesnika s limfomom plaštenih stanica u multicentričnom, randomiziranom, otvorenom ispitivanju faze II, u usporedbi s primjenom samo jednog lijeka prema izboru liječnika ispitivača u bolesnika koji su se pokazali refraktorni na zadnji režim liječenja ili su imali od jednog do tri relapsa (ispitivanje MCL-002).
The efficacy and safety of lenalidomide were evaluated in patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality, with or without additional cytogenetic abnormalities, in two main studies: a Phase III, multicentre, randomised, double-blind, placebo-controlled, 3-arm study of two doses of oral lenalidomide (10 mg and 5 mg) versus placebo (MDS-004); and a Phase II, a multicentre, single-arm, open-label study of lenalidomide (10 mg) (MDS-003).
Djelotvornost i sigurnost lenalidomida procijenjene su u bolesnika s anemijom ovisnom o transfuziji zbog mijelodisplastičnih sindroma niskog ili srednjeg - 1 rizika povezanih s citogenetskom abnormalnosti koja se očituje kao delecija 5q te s dodatnim citogenetskim abnormalnostima ili bez njih, u dva glavna ispitivanja: multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze III s 3 skupine ispitanika koji su primali dvije doze peroralnog lenalidomida (10 mg i 5 mg) u usporedbi s placebom (MDS-004), i multicentričnom otvorenom ispitivanju s jednom skupinom ispitanika koja je primala lenalidomid (10 mg) (MDS-003).
The efficacy and safety of lenalidomide were evaluated in two Phase III multi-centre, randomised, double- blind, placebo-controlled, parallel-group controlled studies (MM-009 and MM-010) of lenalidomide plus dexamethasone therapy versus dexamethasone alone in previously treated patients with multiple myeloma.
Djelotvornost i sigurnost lenalidomida procijenjene su u dva multicentrična, randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze III u paralelnim skupinama (MM-009 i MM-010) liječenim lenalidomidom i deksametazonom nasuprot primjeni samog deksametazona u prethodno liječenih bolesnika s multiplim mijelomom.
The efficacy and safety of linagliptin monotherapy was also evaluated in patients for whom metformin therapy is inappropriate, due to intolerability or contraindicated due to renal impairment, in a double- blind placebo-controlled study of 18 weeks duration.
Djelotvornost i sigurnost monoterapije linagliptinom ocjenjivane su također kod bolesnika za koje terapija metmorfinom nije prikladna zbog nepodnošljivosti ili kontraindiciranosti zbog oštećenja bubrega u dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 18 tjedana.
The efficacy and safety of lixisenatide in people aged ≥70 years with type 2 diabetes was evaluated in a double-blind, placebo-controlled study of 24 weeks duration.
Djelotvornost i sigurnost primjene liksisenatida u osoba u dobi od ≥70 godina sa šećernom bolešću tipa 2 procijenjene su u dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 24 tjedna.
The efficacy and safety of Lonsurf was compared between a high-exposure group (>median) and a low-exposure group (≤median) based on the median AUC value of trifluridine.
Djelotvornost i sigurnost Lonsurfa uspoređena je između skupine s visokom izloženosti (> medijana) i skupine s niskom izloženosti ( medijana) u odnosu na medijan AUC vrijenosti trifluridina.
The efficacy and safety of Lucentis have been assessed in three randomised, controlled studies of at least 12 months duration.
Djelotvornost i sigurnost Lucentisa procjenjivana je u okviru tri randomizirana, kontrolirana ispitivanja u trajanju od najmanje 12 mjeseci.
The efficacy and safety of MabThera in maintenance therapy has not been established.
Djelotvornost i sigurnost terapije održavanja lijekom MabThera nije ustanovljena.
The efficacy and safety of methylnaltrexone bromide in the treatment of opioid-induced constipation in patients receiving palliative care was demonstrated in two randomised, double-blind, placebo- controlled studies.
Djelotvornost i sigurnost metilnaltreksonbromida u liječenju konstipacije uzrokovane opioidima kod bolesnika koji primaju palijativnu skrb pokazana je u dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja.
The efficacy and safety of methylnaltrexone bromide in the treatment of opioid-induced constipation in patients with chronic non-cancer pain were demonstrated in a randomized, double-blind, placebo-controlled study (Study 3356).
Djelotvornost i sigurnost metilnaltreksonbromida u liječenju konstipacije uzrokovane opioidima u bolesnika s kroničnom nemalignom boli dokazane su u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju (ispitivanje 3356).
The efficacy and safety of methylnaltrexone bromide were also demonstrated in open-label treatment administered from Day 2 through Week 4 in Study 301, and in two open-label extension studies (301EXT and 302EXT) in which methylnaltrexone bromide was given as needed for up to 4 months (only 8 patients up to this point).
Djelotvornost i sigurnost metilnaltreksonbromida također su dokazane u otvorenoj fazi istraživanja liječenjem od 2. dana do 4. tjedna u ispitivanju 301, kao i u dva otvorena, produžena ispitivanja (301EXT i 302EXT), u kojima je metilnaltreksonbromid po potrebi davan do 4 mjeseca (samo 8 bolesnika toliko vremena).
The efficacy and safety of naloxegol was established in two replicate double-blind, placebo-controlled studies in patients with OIC and non-cancer related pain (Kodiac 4 and Kodiac 5).
Djelotvornost i sigurnost naloksegola utvrđene su u dvama dvostruko slijepim, placebom kontroliranim ispitivanjima jednakog dizajna u bolesnika s konstipacijom uzrokovanom primjenom opioida i boli koja nije uzrokovana rakom (Kodiac 4 i Kodiac 5).
The efficacy and safety of NEVANAC 3 mg/ml in the prevention and treatment of postoperative pain and inflammation associated with cataract surgery has been demonstrated in two masked, double blind, placebo-controlled clinical trials in a total of 1339 patients.
Djelotvornost i sigurnost primjene NEVANAC-a 3 mg/ml u prevenciji i liječenju postoperativne boli i upale povezanih s operacijom katarakte dokazana je u dva maskirana, dvostruko slijepa, placebom kontrolirana klinička ispitivanja na ukupno 1339 bolesnika.
The efficacy and safety of Nivestim has been assessed in randomised, controlled phase III study in breast cancer.
Djelotvornost i sigurnost primjene Nivestima ispitane su u randomiziranim kontroliranim ispitivanjima faze III u bolesnica s rakom dojke.
The efficacy and safety of Numient in patients with advanced stage Parkinson’s disease have been evaluated in 2 double-blind, active-controlled studies: parallel study ADVANCE-PD (study IPX066-B09-02; 22 weeks) and cross-over study ASCEND-PD (study IPX066-B-09-06 Part 1; 11 weeks).
Djelotvornot i sigurnost Numienta u bolesnika s uznapredovalom Parkinsonovom bolešću procijenjene su u dva dvostruko slijepa ispitivanja s aktivnom kontrolom: paralelno ispitivanje ADVANCE-PD (ispitivanje IPX066-B09-02; 22 tjedna) i ukriženo ispitivanje ASCEND-PD (ispitivanje IPX066-B-09- 06 1. dio, 11 tjedana).
The efficacy and safety of olaratumab was assessed in a Phase 1b/2, multi-centre study in anthracycline naïve patients with histologically or cytologically confirmed, advanced soft tissue sarcoma not amenable to receive surgery or radiotherapy with curative intent.
Djelotvornost i sigurnost olaratumaba ocjenjivale su se u multicentričnom ispitivanju faze 1b/2 provedenom u bolesnika s histološki ili citološki potvrđenim uznapredovalim sarkomom mekog tkiva prethodno neliječenih antraciklinom koji nisu bili pogodni za kurativno kirurško ili radioterapijsko liječenje.
The efficacy and safety of Omidria was evaluated in two Phase 3, randomised, multicentre, double- masked, placebo-controlled clinical trials in 808 adult patients undergoing intraocular lens replacement.
Djelotvornost i sigurnost lijeka Omidria ocijenjeni su u dva randomizirana, multicentrična, dvostruko maskirana, placebom kontrolirana klinička ispitivanja Faze 3 provedena u 808 odraslih bolesnika podvrgnutih zamjeni intraokularne leće.
The efficacy and safety of opicapone has been demonstrated in two Phase 3 double-blind, placebo and active (Study 1 only) controlled studies in 1,027 randomized adult patients with Parkinson’s disease treated with levodopa/DDCI (alone or in combination with other antiparkinsonian drugs) and end-of- dose motor fluctuations for up to 15 weeks.
Djelotvornost i sigurnost opikapona pokazana je u dva dvostruko slijepa, placebom i aktivno (samo Ispitivanje 1) kontrolirana ispitivanja faze 3 u 1027 randomiziranih odraslih bolesnika s Parkinsonovom bolešću liječenih kombinacijom levodopa/DDCI (samom ili u kombinaciji s drugim antiparkinsonicima) i motoričkim fluktuacijama pri kraju doze sve do 15 tjedana.
The efficacy and safety of pazopanib in STS were evaluated in a pivotal phase III randomised, double-blind, placebo-controlled multi-centre trial (VEG110727).
Sigurnost i djelotvornost pazopaniba u STS-u procijenjena je u ključnom randomiziranom, dvostruko slijepom, placebo kontroliranom multicentričnom ispitivanju faze III (VEG110727).
The efficacy and safety of perampanel in patients with myoclonic seizures have not been established.
Djelotvornost i sigurnost perampanela u bolesnika s miokloničkim napadajima nisu ustanovljene.
The efficacy and safety of Plegridy was assessed from the placebo-controlled first year of a 2 year randomised, double-blind, clinical study in patients with relapsing remitting multiple sclerosis (the ADVANCE study).
Djelotvornost i sigurnost Plegridyja je ocijenjena iz placebom kontrolirane prve godine 2-godišnjeg, randomiziranog, dvostruko slijepog kliničkog ispitivanja u bolesnika s relapsnom remitirajućom multiplom sklerozom (RRMS) (ADVANCE studija).
The efficacy and safety of pomalidomide in combination with dexamethasone were evaluated in a Phase III multi-centre, randomised, open-label study (CC-4047-MM-003), where pomalidomide plus low-dose dexamethasone therapy (Pom+LD-Dex) was compared to high-dose dexamethasone alone (HD-Dex) in previously treated adult patients with relapsed and refractory multiple myeloma, who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
Djelotvornost i sigurnost pomalidomida u kombinaciji s deksametazonom evaluirane su u multicentričnom, randomiziranom, otvorenom ispitivanju faze III (CC-4047-MM-003), u kojem je terapija pomalidomidom s niskom dozom deksametazoma (Pom + LD-Dex) bila uspoređena s monoterapijom visokim dozama deksametazona (HD-Dex) u prethodno liječenih odraslih bolesnika s relapsnim i refraktornim oblikom multiplog mijeloma, koji su prethodno liječeni s najmanje dvije linije terapije, uključujući lenalidomid i bortezomib i kod kojih je bolest progredirala tijekom zadnje terapije.
The efficacy and safety of pregabalin as adjunctive treatment for epilepsy in paediatric patients below the age of 12 and adolescents has not been established.
Djelotvornost i sigurnost pregabalina kao dodatna terapija za epilepsiju u pedijatrijskih bolesnika mlađih od 12 godina i adolescenata nisu ustanovljene.
The efficacy and safety of Protopic was assessed in more than 18,500 patients treated with tacrolimus ointment in Phase I to Phase III clinical trials.
Djelotvornost i sigurnost Protopica bila je procijenjena u više od 18 500 bolesnika liječenih takrolimus mašću u kliničkim ispitivanjima, u fazama I do III.
The efficacy and safety of Rapiscan were determined relative to adenosine in two randomised, double- blind studies (ADVANCE MPI 1 and ADVANCE MPI 2) in 2,015 patients with known or suspected coronary artery disease who were referred for a clinically-indicated pharmacologic stress MPI.
Djelotvornost i sigurnost Rapiscana određena je u odnosu na adenozin u dva randomizirana dvostruko slijepa ispitivanja (ADVANCE MPI 1 i ADVANCE MPI 2) na 2015 bolesnika s postojećom ili sumnjom na postojanje koronarne bolesti koji su upućeni radi klinički indiciranog farmakološkog stresa radi MPI.
The efficacy and safety of Resolor in paediatric patients (aged 6 months to 18 years) with functional constipation, were evaluated in an 8-week double-blind, placebo-controlled trial (N = 213), followed by a 16 week open-label comparator-controlled (Polyethylene glycol 4000) study of up to 24 weeks (N = 197).
Djelotvornost i sigurnost lijeka Resolor u pedijatrijskih bolesnika (u dobi od 6 mjeseci do 18 godina) s funkcionalnom konstipacijom procijenjene su u 8-tjednom, dvostruko slijepom, placebom kontroliranom ispitivanju (N= 213), nakon čega je uslijedilo otvoreno ispitivanje kontrolirano s usporednim lijekom (polietilenglikol 4000) u trajanju do 24 tjedana (N= 197).
The efficacy and safety of Resolor in paediatric patients (aged 6 months to 18 years) with functional constipation, were evaluated in an 8-week double-blind, placebo-controlled trial (N = 213), followed by a 16 week open-label comparator-controlled (Polyethylene glycol 4000) study of up to 24 weeks (N = 197).
Djelotvornost i sigurnost lijeka Resolor u pedijatrijskim bolesnicima (u dobi od 6 mjeseci do 18 godina) s funkcionalnom konstipacijom procijenjene su u 8-tjednom dvostruko slijepom, placebom kontroliranom ispitivanju (N= 213), nakon čega je uslijedilo otvoreno ispitivanje kontrolirano s usporednim lijekom (polietilen glikol 4000) u trajanju do 24 tjedana (N= 197).
The efficacy and safety of Ryzodeg has been studied in a randomised controlled clinical trial in children and adolescents with diabetes mellitus type 1 for a period of 16 weeks (n=362).
Djelotvornost i sigurnost lijeka Ryzodeg ispitivane su u randomiziranom, kontroliranom kliničkom ispitivanju provedenom u djece i adolescenata sa šećernom bolešću tipa 1 tijekom razdoblja od 16 tjedana (n=362).
The efficacy and safety of switching from a ritonavir-boosted protease inhibitor in combination with two NRTIs to Eviplera STR was evaluated in a randomised, open-label study in virologically suppressed HIV-1 infected adults.
Djelotvornost i sigurnost prebacivanja s ritonavirom pojačanog inhibitora proteaze u kombinaciji s dva NRTI-ja na režim jednom tabletom lijeka Eviplera procijenjena je u randomiziranom, otvorenom ispitivanju u virološki suprimiranih odraslih pacijenata zaraženih virusom HIV-1.
The efficacy and safety of tacrolimus ointment in maintenance treatment of mild to severe atopic dermatitis was assessed in 524 patients in two Phase III multicentre clinical trials of similar design, one in adult patients (≥ 16 years) and one in paediatric patients (2-15 years).
Djelotvornost i sigurnost takrolimus masti u terapiji održavanja kod blagog do teškog atopijskog dermatitisa bila je procijenjena u 524 bolesnika u fazi III dva multicentrična, randomizirana klinička ispitivanja sličnog ustroja, jednog u odraslih bolesnika (≥ 16 godina) i jednog u pedijatrijskih bolesnika (2-15 godina).
The efficacy and safety of Taltz was demonstrated regardless of age, gender, race, body weight, PASI baseline severity, plaques location, concurrent psoriatic arthritis, and previous treatment with a biologic.
Djelotvornost i sigurnost lijeka Taltz dokazana je neovisno o dobi, spolu, rasi, tjelesnoj težini, početnoj težini bolesti prema PASI rezultatu, lokaciji plakova, istodobnom psorijatičnom artritisu i prethodnom liječenju biološkim lijekom.
The efficacy and safety of Tarceva as maintenance after first-line chemotherapy for NSCLC was investigated in a randomized, double-blind, placebo-controlled trial (BO18192, SATURN).
Djelotvornost i sigurnost lijeka Tarceva u terapiji održavanja nakon prve linije kemoterapije raka pluća nemalih stanica ispitivale su se u randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju (BO18192, SATURN).
The efficacy and safety of Tarceva as second-/ third-line therapy was demonstrated in a randomised, double-blind, placebo-controlled trial (BR.21), in 731 patients with locally advanced or metastatic NSCLC after failure of at least one chemotherapy regimen.
Djelotvornost i sigurnost primjene lijeka Tarceva u drugoj i trećoj liniji liječenja pokazana je u randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju (BR.21), provedenom u 731 bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica nakon neuspjeha primjene barem jednog kemoterapijskog protokola.
The efficacy and safety of Tarceva in combination with gemcitabine as a first-line treatment was assessed in a randomised, double-blind, placebo-controlled trial in patients with locally advanced, unresectable or metastatic pancreatic cancer.
Djelotvornost i sigurnost primjene lijeka Tarceva u kombinaciji s gemcitabinom u prvoj liniji liječenja ispitivana je u randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju u bolesnika s lokalno uznapredovalim, neoperabilnim ili metastatskim rakom gušterače.
The efficacy and safety of the product has not been established in dogs below 2.5 kg body weight or under 4 months of age.
Djelotvornost i neškodljivost proizvoda nisu utvrđene u pasa ispod 2,5 kg tjelesne težine ili mlađih od 4 mjeseca.