natgillin/translations-raw huggingface dataset:
Clinical trial information
Podaci iz kliničkih ispitivanja
Clinical trial results in the prevention of skeletal related events in patients with advanced malignancies involving bone
Rezultati kliničkih ispitivanja u prevenciji koštanih događaja u bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti
Clinical Trial: During clinical trials in other indications (totaling approximately 300 patients) 8% of patients reported a local and/or systemic hypersensitivity reactions.
Kliničko ispitivanje: Za vrijeme kliničkih ispitivanje drugih indikacija (ukupno u približno 300 bolesnika), 8% bolesnika prijavilo je lokalne i/ili sistemske reakcije preosjetljivosti.
Clinical trials are ongoing in previously untreated patients (PUPs) with ReFacto AF.
U tijeku su klinička ispitivanja s lijekom ReFacto AF u prethodno neliječenih bolesnika.
Clinical trials conducted in 61 patients with acquired haemophilia with a total of 100 treatment episodes, showed that certain adverse drug reactions were reported more frequently (1% based on treatment episodes): Arterial thromboembolic events (cerebral artery occlusion, cerebrovascular accident), venous thromboembolic events (pulmonary embolism and deep vein thrombosis), angina pectoris, nausea, pyrexia, erythematous rash and investigation of increased levels of fibrin degradation products.
Klinička ispitivanja provedena na 61 bolesniku sa stečenom hemofilijom u ukupno 100 slučajeva liječenja pokazala su da su određene nuspojave prijavljene češće (1% na temelju liječenih slučajeva): arterijska tromboembolija (okluzija cerebralne arterije, cerebrovaskularni incident), venska tromboembolija (pulmonarna embolija i duboka venska tromboza), angina pektoris, mučnina, pireksija, eritematozni osip i pretrage vezane uz povećanu razinu produkata nastalih razgradnjom fibrina.
Clinical trials conducted with regadenoson excluded patients with recent (within 3 months) myocardial infarction.
Klinička ispitivanja provedena s regadenosonom nisu uključivala bolesnike s nedavnim (unutar 3 mjeseca) infarktom miokarda.
Clinical trials evaluating use of ReFacto AF in children less than 6 years of age are ongoing.
Klinička ispitivanja u kojima se procjenjuje primjena lijeka ReFacto AF u djece u dobi do 6 godina još su u tijeku.
Clinical trials experience
Iskustva iz kliničkih ispitivanja
Clinical trials experience.
1Iskustvo tijekom kliničkih ispitivanja.
Clinical trials have been conducted with Competact tablets and co-administered pioglitazone and metformin (see section 5.1).
Klinička ispitivanja provedena su s tabletama Competact i istovremeno primijenjenima pioglitazonom i metforminom (vidjeti dio 5.1).
Clinical trials have been performed in children (61 patients aged 2 to 11) and children and adolescents (481 patients aged 9 to 19 years), comparing insulin lispro to human soluble insulin.
Klinička ispitivanja usporedbe inzulina lispro i topljivog humanog inzulina provedena su u djece (61 bolesnik u dobi od 2 do 11 godina), odnosno djece i adolescenata (481 bolesnik u dobi od 9 do 19 godina).
Clinical trials have shown Fortacin to increase the intra-vaginal ejaculatory latency time (IELT), increase control over ejaculation and reduce the feelings of distress in patients with premature ejaculation as measured by the Index of Premature Ejaculation (IPE).
Klinička su istraživanja pokazala da Fortacin povećava vrijeme odgode intravaginalne ejakulacije (intra-vaginal ejaculatory latency time – IELT), povećava kontrolu nad ejakulacijom i smanjuje osjećaj tjeskobe u pacijenata s preuranjenom ejakulacijom mjereno indeksom preuranjenje ejakulacije (Index of Premature Ejaculation – IPE).
Clinical trials have shown that Cholestagel and statins can be co-administered or dosed apart, and that Cholestagel and ezetimibe can be co- administered or dosed apart.
Klinička ispitivanja su pokazala da se Cholestagel i statini mogu uzimati istodobno ili odvojeno kao i da se Cholestagel i ezetimib mogu uzimati istodobno ili odvojeno.
Clinical trials in adults with GHD
Klinička ispitivanja u odraslih s deficitom hormona rasta
Clinical trials in children with GHD
Klinička ispitivanja u djece s deficitom hormona rasta
Clinical trials in children with SGA
Klinička ispitivanja u djece koja su rođena mala za gestacijsku dob
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated a reduced number of episodes of nocturnal hypoglycaemia with insulin lispro compared to soluble human insulin.
Klinička ispitivanja u bolesnika sa šećernom bolešću tipa 1 i tipa 2 pokazala su smanjenje broja noćnih hipoglikemija kod primjene inzulina lispro u usporedbi s topljivim humanim inzulinom.
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated reduced postprandial hyperglycaemia with insulin lispro compared to soluble human insulin.
Klinička ispitivanja u bolesnika sa šećernom bolešću tipa 1 i tipa 2 pokazala su smanjenje pojave postprandijalne hiperglikemije kod primjene inzulina lispro u usporedbi s topljivim humanim inzulinom.
Clinical trials in peginterferon+ribavirin-experienced adults SAPPHIRE-II – genotype 1, peginterferon+ribavirin-experienced
Klinička ispitivanja u prethodno neliječenih odraslih ispitanika SAPPHIRE-I – prethodno neliječeni ispitanici s infekcijom genotipom 1
Clinical trials in PWS
Klinička ispitivanja kod Prader-Willijevog sindroma
Clinical trials in subjects with genotype 4 chronic hepatitis C
Klinička ispitivanja u ispitanika s kroničnim hepatitisom C genotipa 4
Clinical trials involving the administration of 2,476 doses of Fendrix to 82 pre-haemodialysis and haemodialysis patients and to 713 healthy subjects  15 years of age allowed to document the reactogenicity of the vaccine.
Klinička ispitivanja koja su uključivala primjenu 2476 doza cjepiva Fendrix i to u 82 bolesnika pred hemodijalizom i onih na hemodijalizi, i u 713 zdravih ispitanika starosti  15 godina, omogućila su dokumentiranje reaktogenosti cjepiva.
Clinical trials of pazopanib in combination with pemetrexed (non-small cell lung cancer (NSCLC)) and lapatinib (cervical cancer) were terminated early due to concerns over increased toxicity and/or mortality, and a safe and effective combination dose has not been established with these regimens.
Klinička ispitivanja pazopaniba u kombinaciji s pemetreksedom (karcinom pluća ne-malih stanica (NSCLC)) i lapatinibom (karcinom vrata maternice) su prekinuta ranije uslijed zabrinutosti zbog povećane toksičnosti i/ili smrtnosti, te sigurna i učinkovita kombinacija doza nije ustanovljena za ove režime liječenja.
Clinical trials of up to 2 years’ duration did not show any additional safety signals or unforeseen risks with vildagliptin monotherapy.
Klinička ispitivanja koja su trajala do 2 godine nisu pokazala dodatne sigurnosne signale ili nepredviđene rizike s vildagliptinom u monoterapiji.
Clinical trials of up to more than 2 years’ duration did not show any additional safety signals or unforeseen risks when vildagliptin was added on to metformin.
Klinička ispitivanja koja su trajala više od 2 godine nisu pokazala dodatne sigurnosne signale ili nepredviđene rizike kada je vildagliptin bio dodan metforminu.
Clinical trials performed with Vimizim assessed the impact of treatment on the systemic manifestations of MPS IVA in various domains including endurance, respiratory function, growth velocity, and mobility, as well as urine KS.
Klinička ispitivanja provedena s Vimizimom procijenila su učinak liječenja na sistemske manifestacije MPS IV A u raznim područjima uključujući izdržljivost, respiratornu funkciju, brzinu rasta i mobilnost, kao i učinak na KS u mokraći.
Clinical trials with a similar vaccine
Klinička ispitivanja sa sličnim cjepivom
Clinical trials with Celvapan (H1N1)v
Klinička ispitivanja s Celvapanom (H1N1)v
Clinical trials with filgrastim have included a small number of elderly patients but special studies have not been performed in this group and therefore specific dosage recommendations cannot be made.
Ispitivanja s filgrastimom uključivala su mali broj starijih bolesnika, no posebna ispitivanja u te dobne skupine nisu provedena te se ne mogu dati preporuke o specifičnom doziranju.
Clinical trials with IOA have shown that you may occasionally miss your regular monthly period after Day 24.
Klinička ispitivanja lijeka IOA pokazala su da je moguć povremeni izostanak redovitih mjesečnica nakon 24. dana.
Clinical trials with liraglutide indicate improved beta­cell function based on measures such as the homeostasis model assessment for beta­cell function (HOMA­B) and the proinsulin to insulin ratio.
Klinička ispitivanja liraglutida pokazuju poboljšanu funkciju beta stanica na osnovi parametara poput procjene modela homeostaze za funkciju beta stanica (HOMA-B) te omjera proinzulina i inzulina.
Clinical trials with Zoely have shown that you may occasionally miss your regular monthly period after Day 24.
Klinička ispitivanja lijeka Zoely pokazala su da je moguć povremeni izostanak redovitih mjesečnica nakon 24. dana.
Clinical vertebral fracture
Klinička fraktura kralježnice
Clinical vertebral fracture (2)
Vertebralni prijelom (2)
Clinical virology studies
Klinička virološka ispitivanja
Clinical Worsening Events
Događaji koji pokazuju kliničko pogoršanje
Clinically and statistically significantly more subjects on prolonged-release compared to immediate-release exenatide patients achieved an HbA1c reduction of ≤ 7 % or < 7 % in the two studies (p < 0.05 and p ≤ 0.0001 respectively).
U ta dva ispitivanja, klinički i statistički značajno više ispitanika na eksenatidu s produljenim oslobađanjem u usporedbi s primjenom eksenatida s trenutnim oslobađanjem lijeku Bydureon postiglo je smanjenje HbA1c na ≤ 7% (p < 0,05) ili < 7% (p < 0,0001).
Clinically and statistically significantly more subjects on prolonged-release compared to immediate-release exenatide patients achieved an HbA1c reduction of ≤ 7 % or < 7 % in the two studies (p < 0.05 and p ≤ 0.0001 respectively).
U ta dva ispitivanja, klinički i statistički značajno više ispitanika na eksenatidu s produljenim oslobađanjem u usporedbi s primjenom eksenatida s trenutnim oslobađanjem postiglo smanjenje HbA1c na ≤ 7% (p < 0,05) ili < 7% (p < 0,0001).
Clinically evaluable
Klinički ocjenjiva populacija
Clinically important disruptions of the blood-brain barrier
Klinički značajna oštećenja krvno-moždane barijere
Clinically important elevation (CK ≥ 10 times the ULN without muscular symptoms) was seen in 0.06% of the patients treated with Pravafenix. (see section 4.4).
Klinički značajno povišenje kreatin fosfokinaze (KF ≥ 10 puta GGN bez mišićnih simptoma) viđeno je kod 0,06% bolesnika liječenih Pravafenixom. (vidjeti dio 4.4).
Clinically important elevations in serum transaminases (ALT and/or AST ≥ 5 times the ULN) were seen in 0.38% of the patients treated with Pravafenix. (see section 4.4).
Klinički značajno povišenje transaminaza u serumu (ALT i/ili AST ≥ 5 puta GGN) viđen je kod 0,38% bolesnika liječenih Pravafenixom. (vidjeti dio 4.4).
Clinically meaningful improvement in hand function as determined by the URAM (Unite´ Rhumatologique des Affections de la Main) score was observed at Day 31 (-11.3) and Day 61 (-12.3).
Klinički značajno poboljšanje u funkciji šake utvrđeno na temelju rezultata na ljestvici URAM (Unite Rhumatologique des Affections de la Main) bilo je opaženo 31. (-11,3) i 61. dana (-12,3).
Clinically meaningful reductions in HbA1c compared to control were also observed regardless of baseline background medication dose.
U skupini liječenoj s 25 mg alogliptina klinički značajna sniženja HbA1c također su opažena bez obzira na osnovnu terapijsku dozu.
Clinically meaningful reductions in HbA1c compared to control were also observed regardless of baseline background treatment.
U skupini liječenoj s 25 mg alogliptina klinički značajna sniženja HbA1c opažena su bez obzira na osnovno liječenje.
Clinically meaningful reductions in HbA1c were maintained for 52 weeks.
Klinički značajna smanjenja vrijednosti HbA1c održana su tijekom 52 tjedna.
clinically monitored for
klinički nadzirati zbog moguće
clinically overt bleeding in excess of what was expected and leading to transfusion of ≥ 2 units packed cells or whole blood in excess of what was expected
klinički manifestno krvarenje veće od očekivanog koje vodi do transfuzije od ≥ 2 jedinica eritrocita ili punom krvi veće od očekivane
Clinically relevant ADRs reported in ≥1% and <5% of the ramucirumab plus docetaxel-treated patients in REVEL were hyponatraemia (4.8% ramucirumab plus docetaxel versus 2.4% for placebo plus docetaxel), proteinuria (3.3% ramucirumab plus docetaxel versus 0.8% placebo plus docetaxel) and gastrointestinal perforation (1% ramucirumab plus docetaxel versus 0.3% placebo plus docetaxel).
Klinički značajne nuspojave na lijek prijavljene u ≥ 1% i < 5% bolesnika liječenih ramucirumabom plus docetakselom u ispitivanju REVEL bile su hiponatrijemija (4,8% uz ramucirumab plus docetaksel naspram 2,4% uz placebo plus docetaksel), proteinurija (3,3% uz ramucirumab plus docetaksel naspram 0,8% uz placebo plus docetaksel) i perforacija u probavnom sustavu (1% uz ramucirumab plus docetaksel naspram 0,3% uz placebo plus docetaksel).
Clinically relevant ADRs reported in ≥1% and <5% of the ramucirumab plus FOLFIRI-treated patients in RAISE: gastrointestinal perforation (1.7% ramucirumab plus FOLFIRI versus 0.6% for placebo plus FOLFIRI).
Klinički značajna nuspojava na lijek prijavljena u ≥ 1% i < 5% bolesnika liječenih ramucirumabom plus protokolom FOLFIRI u ispitivanju RAISE bila je perforacija u probavnom sustavu (1,7% uz ramucirumab plus FOLFIRI naspram 0,6% uz placebo plus FOLFIRI).
Clinically relevant ADRs reported in ≥1% and <5% of the ramucirumab plus paclitaxel-treated patients in RAINBOW were gastrointestinal perforation (1.2% ramucirumab plus paclitaxel versus 0.3% for placebo plus paclitaxel) and sepsis (3.1% ramucirumab plus paclitaxel versus 1.8% placebo plus paclitaxel).
Klinički značajne nuspojave na lijek prijavljene u ≥ 1% i < 5% bolesnika liječenih ramucirumabom plus paklitakselom u ispitivanju RAINBOW bile su perforacija u probavnom sustavu (1,2% kod primjene ramucirumaba plus paklitaksela naspram 0,3% kod primjene placeba plus paklitaksela) i sepsa (3,1% kod primjene ramucirumaba plus paklitaksela naspram 1,8% kod primjene placeba plus paklitaksela).
Clinically relevant ADRs reported in ≥1% and <5% of the ramucirumab treated patients in REGARD were: neutropenia, arterial thromboembolic events (see sections 4.2 and 4.4), intestinal obstruction, epistaxis, and rash.
Klinički značajne nuspojave na lijek prijavljene u ≥ 1% i < 5% bolesnika liječenih ramucirumabom u ispitivanju REGARD bile su: neutropenija, arterijski tromboembolijski događaji (vidjeti dijelove 4.2 i 4.4), opstrukcija crijeva, epistaksa i osip.
Clinically Relevant Bleeding (Major and CRNM)b, n (%)
Klinički značajno krvarenje (veliko i CRNM),b n (%)
clinically relevant bradycardia
klinički značajnom bradikardijom
clinically relevant bradycardia (persistent heart rate < 50 bpm);
klinički značajnom bradikardijom (frekvencija srca trajno < 50 otkucaja u minuti);
Clinically relevant changes in tenofovir pharmacokinetics in patients with hepatic impairment were not observed in patients with mild to moderate hepatic impairment, and no tenofovir alafenamide dose adjustment is required in patients with mild to moderate hepatic impairment.
Nisu zapaţene klinički vaţne promjene u farmakokinetici tenofovira u bolesnika s blagim do umjerenim oštećenjem funkcije jetre te stoga nije potrebna prilagodba doze tenofoviralafenamida u bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
Clinically relevant changes in tenofovir pharmacokinetics in patients with hepatic impairment were not observed in patients with mild to moderate hepatic impairment, and no tenofovir alafenamide dose adjustment is required in patients with mild to moderate hepatic impairment.
Nisu zapažene klinički važne promjene u farmakokinetici tenofovira u bolesnika s blagim do umjerenim oštećenjem funkcije jetre te stoga nije potrebna prilagodba doze tenofoviralafenamida u bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
Clinically relevant changes in tenofovir pharmacokinetics in patients with hepatic impairment were not observed.
Nisu zapažene klinički važne promjene u farmakokinetici tenofovira u pacijenata s oštećenjem funkcije jetre.
Clinically relevant changes in tenofovir pharmacokinetics were not observed in patients with mild to moderate hepatic impairment, and no tenofovir alafenamide dose adjustment is required in patients with mild to moderate hepatic impairment.
Nisu zapažene klinički važne promjene u farmakokinetici tenofovira u bolesnika s blagim do umjerenim oštećenjem funkcije jetre te stoga nije potrebna prilagodba doze tenofoviralafenamida u bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
Clinically relevant CTC toxicities that were reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Među klinički značajne oblike toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i ≤ 5% bolesnika randomiziranih u skupinu koja je primala cisplatin i pemetreksed, ubrajaju se: zatajenje bubrega, infekcija, vrućica, neutropenijska vrućica, povišene vrijednosti AST-a, ALT-a i GGT-a, urtikarija i bol u prsima.
Clinically relevant CTC toxicity of any grade that was reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritis/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Među klinički značajne oblike toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i  5% bolesnika randomiziranih da primaju pemetreksed ubrajaju se: neutropenijska vrućica, infekcija, snižen broj trombocita, proljev, konstipacija, alopecija, pruritus/svrbež, vrućica (bez neutropenije), površinske bolesti oka (uključujući konjunktivitis), pojačano suzenje, omaglica i motorička neuropatija.
Clinically relevant CTC toxicity of any grade that was reported in ≥ 1% and  5% of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritis/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Među klinički značajne oblike toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i  5% bolesnika randomiziranih da primaju pemetreksed ubrajaju se: neutropenijska vrućica, infekcija, snižen broj trombocita, proljev, konstipacija, alopecija, pruritus/svrbež, vrućica (bez neutropenije), površinske bolesti oka (uključujući konjunktivitis), pojačano suzenje, omaglica i motorička neuropatija.
Clinically relevant CTC toxicity that was reported in < 1% of the patients that were randomly assigned to pemetrexed include: allergic reaction/hypersensitivity, erythema multiforme, supraventricular arrhythmia and pulmonary embolism.
Klinički značajni oblici toksičnost prema CTC kriterijima prijavljeni u < 1% bolesnika randomiziranih da primaju pemetreksed uključuju: alergijske reakcije/reakcije preosjetljivosti, multiformni eritem, supraventrikularnu aritmiju i plućnu emboliju.
Clinically relevant CTC toxicity that was reported in < 1% of the patients that were randomly assigned to pemetrexed include: allergic reaction/hypersensitivity, erythema multiforme, supraventricular arrhythmia and pulmonary embolism.
Klinički značajni oblici toksičnosti prema CTC kriterijima prijavljeni u < 1% bolesnika randomiziranih u skupinu koja je primala pemetreksed uključuju: alergijske reakcije/reakcije preosjetljivosti, multiformni eritem, supraventrikularnu aritmiju i plućnu emboliju.
Clinically relevant drug interactions between mirabegron and medicinal products that inhibit, induce or are a substrate for one of the CYP isozymes or transporters are not expected except for the inhibitory effect of mirabegron on the metabolism of CYP2D6 substrates.
Ne očekuje se klinički značajna interakcija izmeĎu mirabegrona i lijekova koji inhibiraju, induciraju ili su supstrat u reakcijama za jedan od izoenzima CYP ili staničnim transporterima, osim inhibicijskog učinka mirabegrona na metabolizam supstrata CYP2D6.
Clinically relevant Grade 3 and Grade 4 laboratory toxicities were similar between integrated Phase 2 results from three single agent pemetrexed studies (n=164) and the Phase 3 single agent pemetrexed study described above, with the exception of neutropenia (12.8 % versus 5.3 %, respectively) and alanine aminotransferase elevation (15.2 % versus 1.9 %, respectively).
Klinički značajni oblici toksičnosti stupnja 3 i 4 utvrđeni laboratorijskim pretragama bili su podjednaki u objedinjenim rezultatima triju ispitivanja faze II pemetrekseda u monoterapiji (n = 164) i rezultatima gore opisanog kliničkog ispitivanja faze III pemetrekseda u monoterapiji, s iznimkom neutropenije (12,8% naspram 5,3%) i povišenih vrijednosti alanin aminotransferaze (15,2% naspram 1,9%).
clinically relevant heart failure with reduced left-ventricular ejection fraction
klinički značajnim zatajenjem srca sa smanjenom ejekcijskom frakcijom lijeve klijetke
Clinically relevant non-major
Klinički značajna manja krvarenja
Clinically relevant or severe abnormalities of routine haematological or biochemistry laboratory values are presented in Table 3.
Klinički značajne ili teške abnormalnosti rutinskih hematoloških ili biokemijskih laboratorijskih vrijednosti prikazane su u Tablici 3.
Clinically relevant plasma levels are largely determined by the time for the sufentanil plasma concentration to drop from Cmax to 50 % of Cmax after discontinuation of dosing (context sensitive half- time or CST½) rather than by the terminal half-life.
Klinički značajne razine u plazmi većinom su određene vremenom potrebnim da plazmatska koncentracija sufentanila s Cmax padne na 50% Cmax nakon prekida doziranja (poluvijek ovisan o kontekstu ili od engl. context sensitive half-time, CST½), a ne terminalnim poluvijekom.
Clinically relevant reactions (including Grade ≥3) associated with antiangiogenic therapy observed in ramucirumab-treated patients across clinical studies were: gastrointestinal perforations, infusion- related reactions and proteinuria (see sections 4.2 and 4.4).
Klinički značajne nuspojave (uključujući nuspojave ≥ 3. stupnja) povezane s antiangiogenom terapijom primijećene u bolesnika liječenih ramucirumabom u svim kliničkim ispitivanjima bile su: perforacije u probavnom sustavu, reakcije na infuziju i proteinurija (vidjeti dijelove 4.2 i 4.4).
Clinically relevant toxicity that was reported in < 1 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Klinički značajni oblici toksičnosti prema CTC kriterijima prijavljeni u < 1% bolesnika randomiziranih u skupinu koja je primala pemetreksed uključuju supraventrikularne aritmije.
Clinically relevant toxicity that was reported in < 1% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Klinički značajne toksičnosti prema CTC kriterijima prijavljene u < 1% bolesnika randomiziranih da primaju pemetreksed uključuju: alergijsku reakciju/preosjetljivost, multiformni eritem, supraventrikularnu aritmiju i plućnu emboliju.
Clinically relevant toxicity that was reported in < 1% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Klinički značajne toksičnosti prijavljene u < 1% bolesnika randomiziranih u skupinu koja je primala cisplatin i pemetreksed uključuju: povišene vrijednosti GGT-a, bol u prsištu, aritmiju i motoričku neuropatiju.