natgillin/translations-raw huggingface dataset:
In the pivotal Phase 3 SELECT trial (see section 5.1), the most commonly reported liver-related adverse reactions were hypoalbuminaemia (9.6% lenvatinib vs. 1.5% placebo) and elevations of liver enzyme levels, including increases in alanine aminotransferase (7.7% lenvatinib vs. 0 placebo), aspartate aminotransferase (6.9% lenvatinib vs. 1.5% placebo), and blood bilirubin (1.9% lenvatinib vs. 0 placebo). 
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), najčešće zabilježene nuspojave povezane s jetrom bile su hipoalbuminemija (9,6% lenvatinib naspram 1,5% placebo) i povišenje razine jetrenih enzima, uključujući povišenje razina alanin aminotransferaze (7,7% lenvatinib naspram 0 placebo), aspartat aminotransferaze (6,9% lenvatinib naspram 1,5% placebo) i bilirubina u krvi (1,9% lenvatinib naspram 0 placebo).
It has been determined that plasma protein binding in plasma from renally impaired subjects was similar to the respective matched healthy subjects and no concentration dependency was observed. 
Utvrđeno je da je vezanje za proteine plazme u ispitanika s oštećenjem funkcije bubrega slično odgovarajućim podudarnim zdravim ispitanicima te nije uočena ovisnost o koncentraciji.
The majority of cases recovered or resolved following dose interruption or reduction, which occurred in 13.0% and 13.4% of patients, respectively. 
Većina nuspojava se popravila ili povukla nakon privremenog prekida primjene ili sniženja doze, što se dogodilo u 13,0% odnosno 13,4% bolesnika.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eisai GmbH 
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Eisai GmbH
Hazard ratioa, b (95% CI) 
Omjer hazardaa, b (95% CI)
Some cases of bleeding have occurred secondarily to tumour shrinkage and fistula formation, e.g. tracheo-oesophageal fistulae. 
Neki slučajevi krvarenja dogodili su se kao posljedica smanjenja veličine tumora i stvaranja fistule, npr. traheoezofagealne fistule.
Adjusted Doseb (≥60 kg BW) 
Prilagođena dozab (≥60 kg tjelesne težine)
Reactions of Grade 3 or higher (including 1 reaction of Grade 4) occurred in 44.4% of lenvatinib-treated patients compared with 3.8% of placebo-treated patients. 
Nuspojave 3. ili višeg stupnja (uključujući jednu nuspojavu 4. stupnja) nastale su u 44,4% bolesnika liječenih lenvatinibom u usporedbi s 3,8% bolesnika koji su primali placebo.
≥60 kg BW 12 mg (three 4 mg capsules orally once daily) 
≥60 kg tjelesne težine 12 mg (tri kapsule od 4 mg peroralno jedanput dnevno)
In human liver microsomes, the demethylated form of lenvatinib (M2) was identified as the main metabolite. 
Demetilirani oblik lenvatiniba (M2) bio je utvrđen kao glavni metabolit u mikrosomima ljudske jetre.
The printing ink contains shellac, black iron oxide (E172), potassium hydroxide, propylene glycol. 
Boja za označavanje sadrži šelak, crni željezov oksid (E172), kalijev hidroksid, propilenglikol.
Increased blood thyroid stimulating hormone (see section 4.4 Impairment of thyroid stimulating hormone suppression / Thyroid dysfunction) 
Povišen tireotropin u krvi (vidjeti dio 4.4, Narušena supresija tireotropina / disfunkcija štitnjače)
The most frequently observed adverse drug reactions at these doses were hypertension, nausea, diarrhoea, fatigue, stomatitis, proteinuria, headache, and aggravation of PPE. 
Najčešće opažene nuspojave pri tim dozama bile su hipertenzija, mučnina, proljev, umor, stomatitis, proteinurija, glavobolja i pogoršanje PPE-a.
In the Phase 3 REFLECT trial (see section 5.1), cardiac dysfunction (including congestive cardiac failure, cardiogenic shock, and cardiopulmonary failure) was reported in 0.6% of patients (0.4% were Grade ≥ 3) in the lenvatinib-treated group. 
U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), srčana disfunkcija (uključujući kongestivno zatajenje srca, kardiogeni šok i kardiopulmonalno zatajenje) prijavljena je u 0,6% bolesnika (0,4% bilo je ≥ 3.stupnja) u skupini liječenoj lenvatinibom.
Lenvatinib exposure, based on AUC0-inf data, was 101%, 90%, and 122% of normal for subjects with mild, moderate, and severe renal impairment, respectively. 
Izloženost lenvatinibu, temeljena na podacima o AUC0-inf, u ispitanika s blagim, umjerenim i teškim oštećenjem funkcije bubrega iznosila je 101%, 90% odnosno 122% normalne izloženosti.
Table 2 Dose modifications from recommended lenvatinib daily dose in HCC patients Starting Dose 
Tablica 2 Prilagodbe doze u odnosu na preporučenu dnevnu dozu lenvatiniba u bolesnika s HCC-om
In the Phase 3 -REFLECT trial (see section 5.1), hypertension (including hypertension, increased blood pressure, increased diastolic blood pressure and orthostatic hypertension) was reported in 44.5% of lenvatinib-treated patients and Grade 3 hypertension occurred in 23.5%. 
U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), hipertenzija (uključujući hipertenziju, povišen krvni tlak, povišen dijastolički krvni tlak i ortostatsku hipertenziju) je zabilježena u 44,5% bolesnika koji su liječeni lenvatinibom, a hipertenzija 3.stupnja zabilježena je u 23,5%.
QT/QTc interval prolongation has been reported at a higher incidence in patients treated with lenvatinib than in patients treated with placebo (see section 4.8, Description of selected adverse reactions). 
Produljenje QT/QTc intervala zabilježeno je s većom incidencijom u bolesnika liječenih lenvatinibom nego u bolesnika koji su primali placebo (vidjeti dio 4.8, Opis odabranih nuspojava).
Patients of age ≥75 years were more likely to experience hypertension, proteinuria, decreased appetite, asthenia, dehydration, dizziness, malaise, peripheral oedema, pruritus and hepatic encephalopathy. 
Kod bolesnika u dobi od ≥75 godina postojala je veća vjerojatnost pojave hipertenzije, proteinurije, smanjenog apetita, astenije, dehidracije, omaglice, malaksalosti, perifernog edema, pruritusa i hepatičke encefalopatije.
No adjustment of starting dose is required on the basis of renal function in patients with mild or moderate renal impairment. 
Nije potrebna prilagodba početne doze na temelju funkcije bubrega u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega.
GI perforation or fistula 
Gastroinestinalna perforacija ili fistula
In the Phase 3 REFLECT trial (see section 5.1), the most commonly reported hepatotoxicity adverse reactions were increased blood bilirubin (14.9%), increased aspartate aminotransferase (13.7%), increased alanine aminotransferase (11.1%), hypoalbuminaemia (9.2%), hepatic encephalopathy (8.0%), increased gamma-glutamyltransferase (7.8%) and increased blood alkaline phosphatase (6.7%). 
U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), najčešće zabilježene nuspojave hepatotoksičnosti bile su porast bilirubina u krvi (14,9%), porast aspartat aminotransferaze (13,7%), porast alanin aminotransferaze (11,1%), hipoalbuminemija (9,2%), hepatička encefalopatija (8,0%), porast gamaglutamiltransferaze (7,8%) i porast alkalne fosfataze u krvi (6,7%).
In the Phase 3 REFLECT trial (see section 5.1), QT/QTc interval prolongation was reported in 6.9% of lenvatinib-treated patients. 
U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), produljenje QT/QTc intervala zabilježeno je u 6,9% bolesnika liječenih lenvatinibom.
The most important serious adverse reactions were renal failure and impairment (2.4%), arterial thromboembolisms (3.9%), cardiac failure (0.7%), intracranial tumour haemorrhage (0.7%), PRES / RPLS (0.2%), hepatic failure (0.2%), and arterial thromboembolisms (cerebrovascular accident (1.1%), transient ischaemic attack (0.7%), and myocardial infarction (0.9%). 
Najvažnije ozbiljne nuspojave bile su zatajenje i oštećenje funkcije bubrega (2,4%), arterijska tromboembolija (3,9%), zatajenje srca (0,7%), krvarenje intrakranijalnog tumora (0,7%), PRES / RPLS (0,2%), zatajenje jetre (0,2%) i arterijska tromboembolija (cerebrovaskularni inzult (1,1%), tranzitorna ishemijska ataka (0,7%) i infarkt miokarda (0,9%)).
Across clinical studies in which 1,327 patients received lenvatinib monotherapy in indications other than HCC, Grade ≥ 3 or greater haemorrhage was reported in 2% of patients, 3 patients (0.2%) had a Grade 4 haemorrhage and 8 patients (0.6%) had a Grade 5 reaction including arterial haemorrhage, haemorrhagic stroke, intracranial haemorrhage, intracranial tumour haemorrhage, haematemesis, melaena, haemoptysis and tumour haemorrhage. 
U kliničkim ispitivanjima u kojima je 1327 bolesnika primilo monoterapiju lenvatiniba u indikacijama osim HCC-a, krvarenje ≥ 3.stupnja zabilježeno je u 2% bolesnika, 3 bolesnika (0,2%) imalo je krvarenje 4. stupnja, a 8 bolesnika (0,6%) imalo je nuspojavu 5. stupnja koja je uključivala arterijsko krvarenje, hemoragijski moždani udar, intrakranijalno krvarenje, krvarenje intrakranijalnog tumora, hematemezu, melenu, hemoptizu i krvarenje tumora.
NE (20.3, NE) 
NP (20,3, NP)
How long to take LENVIMA You will usually carry on taking this medicine as long as you are getting benefit. 
Obično ćete uzimati ovaj lijek sve dok od toga imate kliničku korist.
A haemorrhage event led to dose interruption or reduction in 3.2% and 0.8% patients respectively and to treatment discontinuation in 1.7% of patients. 
Slučaj krvarenja doveo je do privremenog prekida doziranja u 3,2% bolesnika ili do smanjenja doze u 0,8% bolesnika, a do trajnog prekida liječenja u 1,7% bolesnika.
Patients were eligible to participate if they had a liver function status of Child-Pugh class A and Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1. 
A i ocjenu općeg stanja prema ECOG (Eastern Cooperative Oncology Group) 0 ili 1.
Patients should be monitored for clinical symptoms or signs of cardiac decompensation, as dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2). 
Kod bolesnika je potrebno pratiti kliničke simptome ili znakove dekompenzacije srca jer može biti potrebno privremeno prekinuti doziranje, prilagoditi dozu ili trajno prekinuti primjenu (vidjeti dio 4.2).
Marketing Authorisation Holder Eisai GmbH 
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Eisai GmbH
Grade 3 reactions occurred in 3.4%, Grade 4 reactions in 0.2% and 7 patients (1.5%) had a grade 5 reaction including cerebral haemorrhage, upper gastrointestinal haemorrhage, intestinal haemorrhage and tumour haemorrhage. 
Nuspojave 3.stupnja javile su se u 3,4%, nuspojave 4.stupnja u 0,2%, a 7 bolesnika (1,5%) imalo je nuspojave 5.stupnja, uključujući cerebralno krvarenje, krvarenje u gornjem dijelu gastrointestinalnog sustava, intestinalno krvarenje i krvarenje tumora.
Oral inflammation includes: aphthous stomatitis, aphthous ulcer, gingival erosion, gingival ulceration, oral mucosal blistering, stomatitis, glossitis, mouth ulceration, and mucosal inflammation. 
Oralna upala uključuje: aftozni stomatitis, aftozni ulkus, gingivalnu eroziju, gingivalnu ulceraciju, mjehuriće na sluznici usne šupljine, stomatitis, glositis, ulceracije u ustima i upalu sluznice.
Pneumothorax 
pneumotoraks
Adjusted Doseb (<60 kg BW) 
Prilagođena dozab (<60 kg tjelesne težine)
• heart palpitations 
• osjećaj lupanja srca (palpitacije)
Oral pain includes: oral pain, glossodynia, gingival pain, oropharyngeal discomfort, oropharyngeal pain and tongue discomfort. 
Oralni bol uključuje: oralni bol, glosodiniju, gingivalni bol, orofaringealnu nelagodu, orofaringealni bol i nelagodu jezika.
In the Phase 3 REFLECT trial (see section 5.1), hypocalcaemia was reported in 1.1% of patients, with grade 3 reactions occurring in 0.4%. 
U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), hipokalcemija je prijavljena u 1,1% bolesnika, a nuspojave 3.stupnja zabilježene su u 0,4%.
In the pivotal Phase 3 SELECT trial (see section 5.1), hypertension (including hypertension, hypertensive crisis, increased diastolic blood pressure , and increased blood pressure) was reported in 72.8% of lenvatinib-treated patients and 16.0% of patients in the placebo-treated group. 
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), hipertenzija (koja uključuje hipertenziju, hipertenzivnu krizu, povišen dijastolički krvni tlak i povišen krvni tlak) zabilježena je u 72,8% bolesnika liječenih lenvatinibom i 16,0% bolesnika u skupini koja je primala placebo.
The median time to onset in lenvatinib-treated patients was 16 days. 
Medijan vremena do nastupa hipertenzije u bolesnika liječenih lenvatinibom iznosio je 16 dana.
Reactions of Grade 3 or 4 severity occurred in 5.0% of lenvatinibtreated vs 0 placebo-treated patients. 
Nuspojave 3. ili 4. stupnja težine nastale su u 5,0% bolesnika liječenih lenvatinibom naspram 0 bolesnika koji su primali placebo.
Close monitoring of the overall safety is recommended in patients with mild or moderate hepatic impairment (see also sections 4.2 and 5.2). 
U bolesnika s blagim ili umjerenim oštećenjem funkcije jetre preporučuje se pomno praćenje ukupnog sigurnosnog profila (vidjeti također dijelove 4.2 i 5.2).
• feeling very tired or weak 
• osjećaj velikog umora ili slabosti
Patients with baseline hypertension had a higher incidence of Grade 3 or 4 hypertension, proteinuria, diarrhoea, and dehydration, and experienced more serious cases of dehydration, hypotension, pulmonary embolism, malignant pleural effusion, atrial fibrillation, and GI symptoms (abdominal pain, diarrhoea, vomiting). 
Bolesnici s hipertenzijom na početku ispitivanja imali su višu incidenciju 3. ili 4. stupnja hipertenzije, proteinurije, proljeva i dehidracije te su imali ozbiljnije slučajeve dehidracije, hipotenzije, plućne embolije, malignog pleuralnog izljeva, atrijske fibrilacije i gastrointestinalnih simptoma (abdominalni bol, proljev, povraćanje).
Hypertension and proteinuria tend to occur early during lenvatinib treatment (see sections 4.4 and 4.8, Description of selected adverse reactions). 
Hipertenzija i proteinurija imaju tendenciju nastajanja rano u tijeku liječenja lenvatinibom (vidjeti dijelove 4.4 i 4.8 Opis odabranih nuspojava).
The most important serious adverse reactions were hepatic failure (2.8%), hepatic encephalopathy (4.6%), oesophageal varices haemorrhage (1.4%), cerebral haemorrhage (0.6%), arterial thromboembolic events (2.0%) including myocardial infarction (0.8%), cerebral infarction (0.4%) and cerebrovascular accident (0.4%) and renal failure/impairment events (1.4%). 
Najvažnije ozbiljne nuspojave bile su zatajenje jetre (2,8%), hepatička encefalopatija (4,6%), krvarenje varikoziteta jednjaka (1,4%), cerebralno krvarenje (0,6%), arterijski tromboembolijski događaji (2,0%) uključujući infarkt miokarda (0,8%), moždani udar (0,4%) i cerebrovaskularni inzult (0,4%) te zatajenje/oštećenje funkcije bubrega (1,4%).
Electrolytes (magnesium, potassium and calcium) should be monitored periodically during treatment. 
Tijekom liječenja potrebno je razmotriti potrebu povremenog praćenja elektrolita (magnezija, kalija i kalcija).
Asian patients had a higher incidence than Caucasian patients of proteinuria, decreased neutrophil count, decreased platelet count, decreased white blood count and PPE syndrome, while Caucasian patients had a higher incidence of fatigue, hepatic encephalopathy, acute kidney injury, anxiety, asthenia, nausea, thrombocytopenia and vomiting. 
Kod bolesnika azijskog podrijetla postojala je veća incidencija nego kod bolesnika bijele rase što se tiče proteinurije, smanjenog broja neutrofila, smanjenog broja trombocita, smanjenog broja bijelih krvnih stanca i PPE sindroma, dok je kod bolesnika bijele rase bila veća incidencija umora, hepatičke encefalopatije, akutnog oštećenja bubrega, tjeskobe, astenije, mučnine, trombocitopenije i povraćanja.
Patients with baseline hepatic impairment had a higher incidence of hypertension and PPE, and a higher incidence of Grade 3 or 4 hypertension, asthenia, fatigue, and hypocalcaemia compared with patients with normal hepatic function. 
Bolesnici s oštećenjem funkcije jetre na početku ispitivanja imali su višu incidenciju hipertenzije i PPE-a, kao i višu incidenciju 3. ili 4. stupnja hipertenzije, astenije, umora i hipokalcemije u usporedbi s bolesnicima s normalnom funkcijom jetre.
• changes in urine tests for protein (high) and urinary infections (increased frequency in urination and pain in passing urine) 
• promjene u nalazu pretrage mokraće na bjelančevine (povišene) i mokraćne infekcije (povećana učestalost mokrenja i bolno mokrenje)
Hypomagnesaemia includes hypomagnesaemia and decreased blood magnesium. 
Hipomagnezemija uključuje hipomagnezemiju i sniženi magnezij u krvi.
Adverse reactions that most commonly led to dose reductions (in ≥5% of patients) were hypertension, proteinuria, diarrhoea, fatigue, PPE, decreased weight, and decreased appetite. 
Nuspojave koje su najčešće dovele do sniženja doze (u ≥5% bolesnika) bile su hipertenzija, proteinurija, proljev, umor, PPE, smanjena tjelesna težina i smanjeni apetit.
Consider resuming at reduced dose if resolves to Grade 0-1. 
Ako se povuče na 0.-1. stupanj, razmisliti o nastavku primjene u sniženoj dozi.
Hazard ratio (95% CI)b,c 
Omjer hazarda (95% CI)b,c
If urine dipstick proteinuria ≥2+ is detected, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2). 
Ako se urinskom test-trakom otkrije proteinurija ≥2+, može biti potrebno privremeno prekinuti doziranje, prilagoditi dozu ili prestati s primjenom (vidjeti dio 4.2).
Liver-related reactions of Grade 3 or higher (including 1 Grade 5 case of hepatic failure) occurred in 5.4% of lenvatinib-treated patients compared with 0.8% in placebo-treated patients. 
Nuspojave 3. ili višeg stupnja povezane s jetrom (uključujući jedan slučaj zatajenja jetre 5. stupnja) nastale su u 5,4% bolesnika liječenih lenvatinibom u usporedbi s 0,8% bolesnika koji su primali placebo.
CI, confidence interval; NE, not estimable; OS, overall survival; PFS, progression-free survival; RPSFT, rank preserving structural failure time model; VEGF/VEGFR, vascular endothelial growth factor / vascular endothelial growth factor receptor. 
CI, interval pouzdanosti; NP, ne može se procijeniti; OS, ukupno preživljenje; PFS, preživljenje bez progresije bolesti; RPSFT model (engl.
LENVIMA 4 mg hard capsules LENVIMA 10 mg hard capsules lenvatinib 
LENVIMA 4 mg tvrde kapsule LENVIMA 10 mg tvrde kapsule lenvatinib
Hazard ratio (99% CI)b,c P-valueb 
Omjer hazarda (99% CI)b,c P-vrijednostb
Adverse reactions that most commonly led to dose modifications (in ≥5% of patients) were decreased appetite, diarrhoea, proteinuria, hypertension, fatigue, PPE and decreased platelet count. 
Nuspojave koje su najčešće dovele do prilagodbe doze (u ≥5% bolesnika) bile su smanjen apetit, proljev, proteinurija, hipertenzija, umor, PPE i smanjen broj trombocita.
Growth retardation, secondary delay of physical development, and lesions attributable to pharmacologic effects (incisors, femur [epiphyseal growth plate], kidneys, adrenals, and duodenum) were also observed in juvenile rats. 
U mladih štakora također su bili opaženi zastoj u rastu, posljedično usporen fizički razvoj i lezije koje su se mogle pripisati farmakološkim učincima (sjekutići, femur [epifizna ploča rasta], bubrezi, nadbubrežne žlijezde i duodenum).
4 mg (one 4 mg capsule) orally every other day 
4 mg (jedna kapsula od 4 mg) peroralno svaki drugi dan
In the Phase 3 REFLECT trial (see section 5.1), diarrhoea was reported in 38.7% of patients treated with lenvatinib (4.2% were Grade ≥ 3). 
U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), proljev je zabilježen u 38,7% bolesnika liječenih lenvatinibom (4,2% bilo je ≥3.stupnja).
Hazard ratio is for lenvatinib vs. sorafenib, based on a Cox model including treatment group as a factor. 
Zaključni datum prikupljanja podataka: 13.11.2016. a Omjer hazarda za lenvatinib naspram sorafeniba, na temelju Coxovog modela koji uključuje terapijsku skupinu kao čimbenik.
Cardiac dysfunction (see section 4.4) 
Srčana disfunkcija (vidjeti dio 4.4)
Patients with baseline renal impairment had a higher incidence of Grade 3 or 4 hypertension, proteinuria, fatigue, stomatitis, oedema peripheral, thrombocytopenia, dehydration, prolonged QT, hypothyroidism, hyponatraemia, increased blood thyroid stimulating hormone, pneumonia compared with subjects with normal renal function. 
Bolesnici s oštećenjem funkcije bubrega na početku ispitivanja imali su višu incidenciju 3. ili 4. stupnja hipertenzije, proteinurije, umora, stomatitisa, perifernog edema, trombocitopenije, dehidracije, produljenog QT intervala, hipotireoze, hiponatremije, povišenog tireotropina u krvi i pneumonije u usporedbi s ispitanicima s normalnom funkcijom bubrega.
(1 capsule of 10 mg and 1 capsule of 4 mg). 
kapsula od 10 mg i 1 kapsula od 4 mg).
Management of adverse reactions may require dose interruption, adjustment, or discontinuation of lenvatinib therapy (see section 4.4). 
Zbog zbrinjavanja nuspojava možda će biti potrebno privremeno prekinuti doziranje, prilagoditi dozu ili prestati s primjenom lenvatiniba (vidjeti dio 4.4).
Screening for and subsequent treatment of oesophageal varices in patients with liver cirrhosis should be performed as per standard of care before starting treatment with lenvatinib 
Potrebno je provesti probir na varikozitete jednjaka u bolesnika s cirozom jetre i provesti naknadno liječenje u skladu sa standardnom skrbi prije početka primjene lenvatiniba.
Arterial thromboembolisms (see section 4.4) 
Arterijska tromboembolija (vidjeti dio 4.4)
The dose is usually 12 mg once a day (3 capsules of 4 mg) if you weigh 60 kg or more and 8 mg once a day (2 capsules of 4 mg) if you weigh less than 60kg. 
Doza je obično 12 mg jedanput dnevno (3 kapsule od 4 mg) ako težite 60 kg ili više i
Reactions that occurred at an incidence of ≥ 0.75% above placebo were: epistaxis (11.9%), haematuria (6.5%), contusion (4.6%), gingival bleeding (2.3%), haematochezia (2.3%), rectal haemorrhage (1.5%), haematoma (1.1%), haemorrhoidal haemorrhage (1.1%), laryngeal haemorrhage (1.1%), petechiae (1.1%), and intracranial tumour haemorrhage (0.8%). 
Nuspojave čija je incidencija nastanka bila ≥0,75% viša od one kod placeba bile su: epistaksa (11,9%), hematurija (6,5%), kontuzija (4,6%), krvarenje iz desni (2,3%), hematohezija (2,3%), rektalno krvarenje (1,5%), hematom (1,1%), hemoroidalno krvarenje (1,1%), laringealno krvarenje (1,1%), petehije (1,1%) krvarenje intrakranijalnog tumora (0,8%).
• have a history of heart problems or stroke 
• ste imali srčane tegobe ili moždani udar
In the pivotal Phase 3 SELECT trial (see section 5.1), 5.0% of patients developed renal failure and 1.9% developed renal impairment (3.1% of patients had a Grade ≥ 3 event of renal failure or impairment). 
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1) 5,0% bolesnika razvilo je zatajenje bubrega, a 1,9% oštećenje funkcije bubrega (3,1% bolesnika imalo je zatajenje ili oštećenje funkcije bubrega ≥3. stupnja).
Chemotherapeutic agents 
Kemoterapijski lijekovi
Hazard ratio (95% CI)b, e P-value b, e 
Omjer hazarda (95% CI)b, e P-vrijednostb, e
PRES, also known as RPLS, has been reported in patients treated with lenvatinib (<1%; see section 4.8, Description of selected adverse reactions). 
U bolesnika liječenih lenvatinibom zabilježen je PRES, poznat i kao RPLS (<1%; vidjeti dio 4.8, Opis odabranih nuspojava).
In the pivotal Phase 3 SELECT trial (see section 5.1), QT/QTc interval prolongation was reported in 8.8% of lenvatinib-treated patients and 1.5% of patients in the placebo group. 
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), produljenje QT/QTc intervala zabilježeno je u 8,8% bolesnika liječenih lenvatinibom i 1,5% bolesnika u skupini koja je primala placebo.
In the pivotal Phase 3 SELECT trial (see section 5.1), diarrhoea was reported in 67.4% of patients in the lenvatinib-treated group (9.2% were Grade ≥ 3) and in 16.8% of patients in the placebo group (none were Grade ≥ 3). 
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), proljev je zabilježen u 67,4% bolesnika u skupini liječenoj lenvatinibom (9,2% bilo je ≥3. stupnja) i u 16,8% bolesnika u skupini koja je primala placebo (nijedan slučaj ≥3. stupnja).