natgillin/translations-raw huggingface dataset:
In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson’s disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
U kliničkim ispitivanjima u bolesnika s psihozom uzrokovanom lijekovima (agonisti dopamina) povezanom s Parkinsonovom bolešću, vrlo često, i češće nego s placebom, zabilježeno je pogoršanje simptoma parkinsonizma i halucinacija.
In clinical trials in RA, up to 3% of adult patients tested seropositive at least once during the study for antibodies capable of neutralising the biologic effects of anakinra.
U kliničkim ispitivanjima u bolesnika s RA do 3% testiranih odraslih bolesnika bili su seropozitivni najmanje jednom tijekom ispitivanja na protutijela sposobna za neutralizaciju bioloških učinaka anakinre.
In clinical trials in which subjects (N=201) received Prepandrix containing 3.75 microgram HA/AS03 of A/Indonesia/05/2005 (H5N1) strain, the types and frequencies of adverse reactions were comparable with those reported below.
Vrste i učestalost nuspojava u kliničkim ispitivanjima u kojima su ispitanici (N=201) primali Prepandrix koji sadrži 3,75 mikrograma HA/AS03 iz soja A/Indonesia/05/2005 (H5N1) bile su komparabilne onima navedenima u nastavku.
In clinical trials investigating other indications the following undesirable effects have been observed: Common: alanine aminotransferase increased (see section 4.4), aspartate aminotransferase increased (see section 4.4), hypernatraemia, hypoglycaemia, hyperuricaemia, syncope, dizziness, headache, malaise, diarrhoea, blood urine present.
U kliničkim ispitivanjima koja su istraživala druge indikacije, primijećene su sljedeće nuspojave: Često: povišena alanin aminotransferaza (vidjeti dio 4.4), povišena aspartat aminotransferaza (vidjeti dio 4.4) hipernatremija, hipoglikemija, hiperurikemija, sinkopa, omaglica, glavobolja, malaksalost, proljev, prisustvo krvi u urinu.
In clinical trials investigating other indications the following undesirable effects have been observed: Common: alanine aminotransferase increased (see section 4.4), aspartate aminotransferase increased (see section 4.4), hypernatraemia, hypoglycaemia, hyperuricaemia, syncope, dizziness, headache, malaise, diarrhoea, blood urine present.
U kliničkim ispitivanjima koja su istraživala druge indikacije, primijećene su sljedeće nuspojave: Često: povišena alanin aminotransferaza (vidjeti dio 4.4), povišena aspartat aminotransferaza (vidjeti dio 4.4), hipernatremija, hipoglikemija, hiperurikemija, sinkopa, omaglica, glavobolja, malaksalost, proljev, prisustvo krvi u urinu.
In clinical trials involving patients with relapsed small cell lung cancer, the dose limiting toxicity of oral topotecan monotherapy was found to be haematological.
U kliničkim ispitivanjima koja su uključivala bolesnike s recidivom karcinoma pluća malih stanica, hematotoksičnost se pokazala ključnom u ograničavanju jačine doze u monoterapiji oralnim topotekanom.
In clinical trials involving SIMBRINZA dosed twice-daily the most common adverse reactions were ocular hyperaemia and ocular allergic type reactions occurring in approximately 6-7% of patients, and dysgeusia (bitter or unusual taste in the mouth following instillation) occurring in approximately 3% of patients.
U kliničkim ispitivanjima koja su uključila SIMBRINZU primijenjenu dva puta dnevno, najučestalije nuspojave bile su okularna hiperemija i okularne reakcije alergijskog tipa, zabilježeno kod otprilike 6-7% bolesnika, i disgeuzija (gorak ili neobičan okus u ustima nakon primjene) zabilježena kod otprilike 3% bolesnika.
In clinical trials no safety problems were observed when leflunomide and NSAIDs metabolised by CYP2C9 were co-administered.
U kliničkim ispitivanjima nisu zabilježeni problemi sa sigurnošću primjene kad se leflunomid davao istodobno s nesteroidnim protuupalnim lijekovima koji se metaboliziraju pomoću CYP2C9.
In clinical trials non-cutaneous malignancies were reported in 1% (6/586) of patients with dabrafenib monotherapy, and 1% (3/209) of patients in study MEK115306 and <1% (3/350) of patients in study MEK116513 with dabrafenib in combination with trametinib.
U kliničkim ispitivanjima zloćudne bolesti koje nisu zahvatile kožu prijavljene su u 1% (6/586) bolesnika s monoterapijom dabrafenibom, i u 1% (3/209) bolesnika u ispitivanju MEK115306 i u < 1% (3/350) bolesnika u studiji MEK116513 s dabrafenibom u kombinaciji s trametinibom.
In clinical trials of 118 children and adolescents (3 to 16 years of age), 6 % discontinued therapy due to adverse reactions.
U kliničkim ispitivanjima sa 118 djece i adolescenata (3 do 16 godina) 6% bolesnika prekinulo je liječenje zbog nuspojava.
In clinical trials of 118 children and adolescents 3 to 16 years of age treated with combination therapy of interferon alfa-2b and ribavirin 6 % discontinued therapy due to adverse events.
U kliničkim ispitivanjima sa 118 djece i adolescenata dobi od 3 do 16 godina koji su liječeni kombiniranom terapijom interferona alfa-2b i ribavirina, 6% bolesnika prekinulo je liječenje zbog nuspojava.
In clinical trials of 118 children or adolescents 3 to 16 years of age, treated with combination therapy of interferon alfa-2b and ribavirin, 6 % discontinued therapy due to adverse events.
U kliničkim ispitivanjima sa 118 djece i adolescenata dobi od 3 do 16 godina koji su liječeni kombiniranom terapijom interferona alfa-2b i ribavirina, 6% bolesnika prekinulo je liječenje zbog nuspojava.
In clinical trials of 48 weeks treatment and 24 weeks follow-up, the safety profile for Pegasys in chronic hepatitis B was similar to that seen in chronic hepatitis C. With the exception of pyrexia the frequency of the majority of the reported adverse reactions was notably less in CHB patients treated with Pegasys monotherapy compared with HCV patients treated with Pegasys monotherapy (see Table
Klinička ispitivanja liječenja u trajanju od 48 tjedana i praćenja tijekom sljedeća 24 tjedna, pokazala su da je sigurnosni profil lijeka Pegasys u kroničnom hepatitisu B sličan profilu zabilježenom kod kroničnog hepatitisa C. Izuzev vrućice, učestalost većine prijavljenih nuspojava zamjetno je niža u bolesnika liječenih samo lijekom Pegasys s kroničnim hepatitisom B u usporedbi s bolesnicima s HCV-om liječenih samo lijekom Pegasys. (vidjeti tablicu 9).
In clinical trials of 48 weeks treatment and 24 weeks follow-up, the safety profile for Pegasys in chronic hepatitis B was similar to that seen in chronic hepatitis C. With the exception of pyrexia the frequency of the majority of the reported adverse reactions was notably less in CHB patients treated with Pegasys monotherapy compared with HCV patients treated with Pegasys monotherapy (see Table 9).
Klinička ispitivanja liječenja u trajanju od 48 tjedana i praćenja tijekom sljedeća 24 tjedna, pokazala su da je sigurnosni profil lijeka Pegasys u kroničnom hepatitisu B sličan profilu zabilježenom kod kroničnog hepatitisa C. Izuzev vrućice, učestalost većine prijavljenih nuspojava zamjetno je niža u bolesnika liječenih samo lijekom Pegasys s kroničnim hepatitisom B u usporedbi s bolesnicima s HCV-om liječenih samo lijekom Pegasys. (vidjeti tablicu 9).
In clinical trials of HBV infected patients, the most frequently occurring adverse reaction to tenofovir disoproxil fumarate was nausea (5.4%).
U kliničkim ispitivanjima s pacijentima zaraženima HBV-om, najčešće zabilježena nuspojava na tenofovirdizoproksilfumarat bila je mučnina (5,4%).
In clinical trials of metastatic carcinoma of the colon or rectum, there was no increased risk of post- operative bleeding or wound healing complications observed in patients who underwent major surgery 28-60 days prior to starting Avastin.
U kliničkim ispitivanjima u indikaciji metastatskog karcinoma kolona ili rektuma nije zabilježen povećan rizik od postoperativnog krvarenja ili komplikacija pri zacjeljivanju rana u bolesnika koji su bili podvrgnuti većem kirurškom zahvatu 28 do 60 dana prije početka liječenja lijekom Avastin.
In clinical trials of newly diagnosed multiple myeloma in transplant non eligible patients, lenalidomide combined therapy was less tolerated in patients older than 75 years of age compared to the younger population.
U kliničkim ispitivanjima novodijagnosticiranog multiplog mijeloma u bolesnika koji nisu prikladni za transplantaciju, bolesnici stariji od 75 godina slabije su podnosili liječenje kombiniranom terapijom lenalidomidom nego mlađa populacija bolesnika.
In clinical trials of newly diagnosed multiple myeloma patients eligible for transplant, an increased incidence rate of hematologic SPM has been observed in patients receiving lenalidomide immediately following high- dose melphalan and Autologous Stem Cell Transplant (ASCT) compared with patients who received placebo (1.27 to 1.56 versus 0.46 to 0.53 per 100 person-years, respectively).
U kliničkim ispitivanjima bolesnika s novodijagnosticiranim multiplim mijelomom koji su prikladni za transplantaciju, porast stope incidencije drugih primarnih hematoloških malignih bolesti opažen je u bolesnika koji su primali lenalidomid neposredno nakon visoke doze melfalana i transplantacije autolognih matičnih stanica u usporedbi s bolesnicima koji su primali placebo (1,27 do 1,56 naspram 0,46 do 0,53 na 100 osoba-godina).
In clinical trials of newly diagnosed multiple myeloma patients not eligible for transplant, a 4.9-fold increase in incidence rate of hematologic SPM (cases of AML, MDS) has been observed in patients receiving lenalidomide in combination with melphalan and prednisone until progression (1.75 per 100 person-years) compared with melphalan in combination with prednisone (0.36 per 100 person-years).
U kliničkim ispitivanjima bolesnika s novodijagnosticiranim multiplim mijelomom koji nisu prikladni za transplantaciju, opažena stopa incidencije drugih primarnih hematoloških malignih bolesti (slučajevi akutne mijeloične leukemije (AML), mijelodisplastičnog sindroma (MDS)) bila je 4,9 puta veća u bolesnika koji su primali lenalidomid u kombinaciji s melfalanom i prednizonom do napredovanja bolesti (1,75 na 100 osoba-godina) u usporedbi s onima koji su primali melfalan u kombinaciji s prednizonom (0,36 na 100 osoba-godina).
In clinical trials of ovarian cancer, Grade 3-5 wound healing complications were observed in up to 1.2% of patients in the bevacizumab arm versus 0.1% in the control arm (NCI-CTCAE v.3).
U kliničkim ispitivanjima karcinoma jajnika, komplikacije pri zacjeljivanju rana stupnja 3-5 zabilježene su u 1,2% bolesnica u skupini koja je primala bevacizumab u odnosu na 0,1% u kontrolnoj skupini (NCI-CTCAE v.3).
In clinical trials of patients with Duchenne muscular dystrophy (nmDMD) caused by a nonsense mutation, the most frequent adverse reactions at the recommended dose were nausea, vomiting, and headache.
U kliničkim ispitivanjima provedenima na bolesnicima oboljelima od Duchenneove mišićne distrofije (DMD) s besmislenom mutacijom)) uzrokovane besmislenom mutacijom, najčešće nuspojave u preporučenoj dozi bile su mučnina, povraćanje i glavobolja.
In clinical trials of patients with factor VII deficiency, formation of antibodies against NovoSeven and FVII is the only adverse drug reaction reported (frequency: common (≥ 1/100 to < 1/10)).
U kliničkim ispitivanjima u bolesnika s nedostatkom faktora VII, stvaranje protutijela na NovoSeven i FVII jedina je prijavljena nuspojava (učestalost: često (≥ 1/100 i < 1/10)).
In clinical trials of TESAVEL as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
U kliničkim ispitivanjima lijeka TESAVEL kao monoterapije ili kao dio kombinirane terapije s lijekovima za koje nije poznato da uzrokuju hipoglikemiju (tj. metforminom i/ili agonistom PPAR), stope prijavljenih hipoglikemija u bolesnika koji su uzimali sitagliptin bile su podjednake onoj u bolesnika koji su uzimali placebo.
In clinical trials of up to 2 years duration in postmenopausal women with CE/bazedoxifene, cases of VTE have been reported (see section 4.8).
U kliničkim ispitivanjima u trajanju do 2 godine u postmenopauzalnih žena s konjugiranim estrogenima i bazedoksifenom zabilježeni su slučajevi VTE (vidjeti dio 4.8).
In clinical trials of up to 2 years duration, CE/bazedoxifene was associated with an increase from baseline in the concentration of serum triglycerides of approximately 16% at month 12 and 20% at month 24.
U kliničkim ispitivanjima u trajanju do 2 godine, konjugirani estrogeni/bazedoksifen su povezani s povećanjem koncentracije triglicerida u serumu s početne razine za otprilike 16% nakon 12 mjeseci, a 20% nakon 24 mjeseca.
In clinical trials on cancer patients treated with filgrastim, the most frequent undesirable effect was musculoskeletal pain which was mild or moderate in 10% and in 3% of patients respectively.
U kliničkim ispitivanjima u onkoloških bolesnika liječenih filgrastimom, najčešća nuspojava bila je mišićno-koštana bol, koja je bila blaga u 10% ili umjerena u 3% bolesnika.
In clinical trials on cancer patients, the most frequent undesirable effect was musculoskeletal pain which was mild or moderate in 10%, and severe in 3% of patients.
U kliničkim ispitivanjima u onkoloških bolesnika, najčešća nuspojava bila je mišićno-koštana bol, koja je bila blaga ili umjerena u 10% i teška u 3% bolesnika.
In clinical trials patients were administered aciclovir 200 mg twice a day or equivalent.
U kliničkim su ispitivanjima bolesnici dobivali aciklovir u dozi od 200 mg dvaput na dan ili ekvivalent.
In clinical trials rufinamide discontinuation was achieved by reducing the dose by approximately 25% every two days.
U kliničkim se ispitivanjima prekid primjene rufinamida postigao snižavanjem doze za približno 25% svaka dva dana.
In clinical trials side effects reported commonly (may affect up to 1 in 10 people) by patients with pulmonary arterial hypertension were facial flushing and nausea.
Nuspojave koje su u kliničkim ispitivanjima često prijavili (mogu se javiti u do 1 na 10 osoba) bolesnici s plućnom arterijskom hipertenzijom bile su navale crvenilao i mučnina.
In clinical trials sildenafil was administered to more than 8000 patients aged 19-87.
U kliničkim ispitivanjima, sildenafil je primijenjen u više od 8000 bolesnika u dobi 19-87 godina.
In clinical trials Synflorix elicited an immune response to all ten serotypes included in the vaccine, but the magnitude of the responses varied between serotypes.
U kliničkim ispitivanjima Synflorix je izazvao imunološki odgovor na svih deset serotipova sadržanih u cjepivu, ali jačina odgovora je varirala između serotipova.
In clinical trials the efficacy of ceftolozane/tazobactam was lower in patients with moderate renal impairment compared with those with normal or mildly impaired renal function at baseline.
U kliničkim je ispitivanjima djelotvornost ceftolozana/tazobaktama bila manja u bolesnika s umjereno oštećenom funkcijom bubrega nego u onih s normalnom ili blago oštećenom funkcijom bubrega na početku ispitivanja.
In clinical trials the following reactions were reported at a ≥ 1 % difference in frequency from placebo: vertigo, nausea, pain in limb, dizziness, depression, dyspnoea.
U kliničkim su ispitivanjima sljedeće nuspojave zabilježene uz razliku učestalosti od ≥ 1% kod primjene lijeka FORSTEO u odnosu na placebo: vrtoglavica, mučnina, bol u udovima, omaglica, depresija, dispneja.
In clinical trials the most frequently reported ocular adverse reactions following injection of Macugen are: anterior chamber inflammation, eye pain, increased intraocular pressure, punctate keratitis, vitreous floaters and vitreous opacities.
U kliničkim ispitivanjima najčešće prijavljene očne nuspojave nakon injekcije lijeka su: upala prednje komore, bol oka, povišen intraokularni tlak, točkasti keratitis, plutajuće čestice u staklovini i zamućenje staklovine.
In clinical trials the number of herpes zoster/herpes zoster-like rashes within the 42-day postvaccination was low in both ZOSTAVAX and placebo groups.
U kliničkim je ispitivanjima broj slučajeva osipa herpes zostera/nalik herpes zosteru unutar 42 dana nakon cijepljenja bio nizak i u skupini cijepljenoj cjepivom ZOSTAVAX i u skupini koja je primala placebo.
In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/l.
U kliničkim ispitivanjima te su pacijentice definirane razinom endogenog LH u serumu < 1,2 IU/l.
In clinical trials with 553 patients, the most common adverse reactions were:
U kliničkim ispitivanjima koja su uključivala 553 bolesnika, najčešće nuspojave bile su:
In clinical trials with Ameluz, local skin reactions at the application site were observed in up to 96% of the subjects.
U kliničkim ispitivanjima s lijekom Ameluz, u do 96% ispitanika primijećene su lokalne reakcije na koži na mjestu primjene.
In clinical trials with AMMONAPS, 56 % of the patients experienced at least one adverse event and 78 % of these adverse events were considered as not related to AMMONAPS.
U kliničkim ispitivanjima lijeka AMMONAPS 56% ispitanika imalo je barem jednu nuspojavu, dok se za 78% tih nuspojava smatra da nisu povezane s lijekom AMMONAPS.
In clinical trials with aripiprazole, there were no significant differences in the incidence rates of hyperglycaemia-related adverse reactions (including diabetes) or in abnormal glycaemia laboratory values compared to placebo.
U kliničkim ispitivanjima s aripiprazolom nije bilo značajnih razlika u stopi incidencije nuspojava povezanih s hiperglikemijom (uključujući šećernu bolest) ili u abnormalnim laboratorijskim vrijednostima glikemije u usporedbi s placebom.
In clinical trials with different formulations (H5N3, H9N2 and H5N1) approximately 3400 subjects were exposed to the mock-up vaccines.
U kliničkim ispitivanjima s različitim formulacijama (H5N3, H9N2 i H5N1) približno 3400 ispitanika bilo je izloženo je „mock-up“ cjepivima.Većina reakcija bila je blage naravi, kratkog trajanja
In clinical trials with eltrombopag in SAA, 4% of patients (5/133) were diagnosed with MDS.
U kliničkim ispitivanjima s eltrombopagom kod teške aplastične anemije, u 4% bolesnika (5/133) dijagnosticiran je MDS.
In clinical trials with olanzapine powder for solution for injection or ZYPADHERA, olanzapine was not associated with a persistent increase in absolute QT or in QTc intervals.
U kliničkim ispitivanjima s olanzapin praškom za otopinu za injekciju, odnosno lijekom ZYPADHERA, nije uočena povezanost olanzapina s perzistentnim povećanjem apsolutnog QT ili QTc-intervala.
In clinical trials with oral olanzapine, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF<500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
U kliničkim ispitivanjima s oralnim olanzapinom klinički značajna produljenja QTc-intervala (Fridericia QT korekcija [QTcF] ≥ 500 milisekundi [ms] u bilo kojem trenutku nakon početka liječenja u bolesnika koji su na početku liječenja olanzapinom imali vrijednost QTcF < 500 ms) bila su manje česta (0,1% do 1%) i bez značajnih razlika u povezanim srčanim događajima u usporedbi s placebom.
In clinical trials with pazopanib, events of cardiac dysfunction such as congestive heart failure and decreased left ventricular ejection fraction (LVEF) have occurred (see section 4.8).
U kliničkim ispitivanjima pazopaniba zabilježeni su slučajevi disfunkcije srca kao što su kongestivno zatajenje srca i smanjenje ejekcijske frakcije lijeve klijetke (LVEF) (vidjeti dio 4.8).
In clinical trials with pioglitazone, the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
U kliničkim ispitivanjima pioglitazona, incidencija povišenja ALT-a za više od tri puta iznad gornje granice normale bila je jednaka onoj za placebo, ali manja od one viđene u skupinama koje su kao usporedni lijek primale metformin ili sulfonilureju.
In clinical trials with pioglitazone, there was evidence of dose-related weight gain, which may be due to fat accumulation and, in some cases, associated with fluid retention.
U kliničkim ispitivanjima pioglitazona bilo je dokaza povećanja tjelesne težine povezanog s dozom, što može biti zbog nakupljanja masnog tkiva i u nekim slučajevima, povezano sa zadržavanjem tekućine.
In clinical trials with trametinib monotherapy one case of accidental overdose was reported; a single dose of 4 mg.
U kliničkim ispitivanjima monoterapije trametinibom prijavljen je jedan slučaj slučajnog predoziranja, jednom dozom od 4 mg.
In clinical trials with TRAVATAN, the most common adverse reactions were ocular hypearemia and iris hyperpigmentation, occurring in approximately 20% and 6% of patients respectively.
U kliničkim ispitivanjima s TRAVATANOM najčešće zabilježene nuspojave bile su okularna hiperemija i hiperpigmentacija irisa, a pojavile su se kod približno 20% odnosno 6 % bolesnika.
In clinical trials with vedolizumab at doses ranging from 2 to 10 mg/kg, >95% saturation of α4β7 receptors on subsets of circulating lymphocytes involved in gut immune surveillance was observed in patients.
U kliničkim ispitivanjima vedolizumaba u dozama od 2 do 10 mg/kg kod bolesnika je uočeno zasićenje receptora α4β7 veće od 95% na podskupinu cirkulirajućih limfocita uključenih u imunološki nadzor crijeva.
In clinical trials with zoledronic acid, patients with serum creatinine > 265 µmol/l or > 3.0 mg/dl were excluded.
Bolesnici s vrijednošću kreatinina u serumu > 265 μmol/l ili >3,0 mg/dl bili su isključeni iz kliničkih ispitivanja.
In clinical trials with zoledronic acid, patients with serum creatinine > 265 μmol/l or > 3.0 mg/dl were excluded.
U kliničkim ispitivanjima Zoledronatne kiseline bolesnici s vrijednošću kreatinina u serumu > 265 μmol/l ili > 3,0 mg/dl bili su isključeni iz ispitivanja.
In clinical trials with Zometa, patients with serum creatinine
Bolesnici s vrijednošću kreatinina u serumu >265 μmol/l ili
In clinical trials with ZYPADHERA, the only adverse reaction reported at a statistically significantly higher rate in the ZYPADHERA group than in the placebo group was sedation (ZYPADHERA 8.2%, placebo 2.0%).
U kliničkim ispitivanjima lijeka ZYPADHERA jedina nuspojava koja se javljala statistički značajno češće u skupini ispitanika koji su primali lijek ZYPADHERA u odnosu na skupinu koja je primala placebo bila je sedacija (ZYPADHERA 8,2%, placebo 2%).
In clinical trials, 3 patients out of a total of 2,560 patients treated with Tecfidera experienced serious flushing symptoms that were probable hypersensitivity or anaphylactoid reactions.
U kliničkim ispitivanjima 3 od ukupno 2560 bolesnika liječenih Tecfiderom su imali ozbiljne simptome crvenila uz osjećaj vrućine, koji su vjerojatno reakcije preosjetljivosti ili anafilaktoidne reakcije.
In clinical trials, 34% of Tecfidera treated patients experienced flushing.
U kliničkim ispitivanjima kod 34% bolesnika liječenih Tecfiderom pojavilo se crvenilo uz osjećaj vrućine.
In clinical trials, 39 infantile-onset patients were treated with Myozyme for more than three years (168 weeks with a median of 121 weeks; see section 5.1).
U kliničkim ispitivanjima lijeka Myozyme 39 bolesnika s infantilnim oblikom bolesti liječeno je dulje od 3 godine (168 tjedana s medijanom od 121 tjedna; vidjeti dio 5.1).
In clinical trials, 40% of patients treated with TRISENOX experienced at least one QT corrected (QTc) interval prolongation greater than 500 msec.
U kliničkim ispitivanjima je 40% bolesnika liječenih TRISENOXOM iskusilo najmanje jedan korigirani produžetak QT (QTc) intervala veći od 500 ms.