natgillin/translations-raw huggingface dataset:
Patients ≥75 years, of white race or female sex or those with worse baseline hepatic impairment (Child-Pugh A score of 6 compared to score of 5) appear to have reduced tolerability to lenvatinib.
Čini se da bolesnici ≥75 godina, bijele rase ili ženskog spola, ili oni s težim oštećenjem funkcije jetre na početku liječenja (Child-Pugh stadij A - 6 bodova u usporedbi sa 5 bodova) slabije podnose lenvatinib.
Table 1 Dose modifications from recommended lenvatinib daily dose in DTC patientsa
Tablica 1 Prilagodbe doze u odnosu na preporučenu dnevnu dozu lenvatiniba u bolesnika s DTC-oma
In 496 patients with HCC, dose modification (interruption or reduction) and discontinuation were the actions taken for an adverse reaction in 62.3% and 20.2% of patients, respectively.
U 496 bolesnika sa HCC-om, poduzete mjere zbrinjavanja nuspojava bile su prilagodba doze (privremeni prekid doziranja ili smanjenje doze) u 62,3% bolesnika, i trajni prekid liječenja u 20,2% bolesnika.
Cases of fistula formation or enlargement that involve areas of the body other than stomach or intestines were observed in clinical trials and in post-marketing experience (e.g. tracheal, tracheo-oesophageal, oesophageal, cutaneous, female genital tract fistulae).
Slučajevi stvaranja fistule ili njenog povećanja na drugim područjima tijela osim želuca ili crijeva opaženi su kliničkim ispitivanjima te nakon stavljanja lijeka u promet (npr. trahealna, traheoezofagealna, ezofagealna, kožna fistula, fistula ženskog genitalnog sustava).
What LENVIMA contains
Što LENVIMA sadrži
In patients with severe renal impairment, the recommended starting dose is 14 mg taken once daily.
U bolesnika s teškim oštećenjem funkcije bubrega, preporučena početna doza je 14 mg koja se uzima jedanput na dan.
There are not sufficient data for HCC patients with Child-Pugh B (moderate hepatic impairment, 3 patients treated with lenvima in the pivotal trial) and no data available in Child Pugh C HCC patients (severe hepatic impairment).
Nema dovoljno podataka za bolesnike sa HCC-om i Child-Pugh stadijem B (umjereno oštećenje funkcije jetre, 3 bolesnika liječena lenvatinibom u ključnom ispitivanju), te nema dostupnih podataka u bolesnika sa HCC-om i Child Pugh stadijem C (teško oštećenje jetre).
• changes in blood test results for potassium levels (low) and calcium levels (low)
• promjene u nalazima krvnih pretraga u razini kalija (snižena) i kalcija (snižena)
Thyroid function should be monitored before initiation of, and periodically throughout, treatment with lenvatinib.
Funkciju štitnjače treba pratiti prije započinjanja liječenja lenvatinibom te periodički tijekom čitavog liječenja.
Patients of age ≥75 years were more likely to experience Grade 3 or 4 hypertension, proteinuria, decreased appetite, and dehydration.
Bolesnici u dobi od ≥75 godina imali su veću vjerojatnost razvoja 3. ili 4. stupnja hipertenzije, proteinurije, smanjenog apetita i dehidracije.
Grades are based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Terminology Criteria for Adverse Events, CTCAE) Nacionalnog instituta za rak (engl.
Myocardial infarction includes myocardial infarction and acute myocardial infarction.
Infarkt miokarda uključuje infarkt miokarda i akutni infarkt miokarda.
Limited data are available on use in patients aged ≥75 years (see also section 4.8, Other special populations).
≥75 godina (vidjeti također dio 4.8 Druge posebne populacije).
Gastrointestinal perforation and fistula formation (see section 4.4)
Gastrointestinalna perforacija i stvaranje fistule (vidjeti dio 4.4)
In the sorafenib arm, median OS was 17.0 months (95% CI: 14.2, 18.8) for subjects who received posttreatment anticancer therapy (51%) and 7.9 months (95% CI: 6.6, 9.7) for those who did not.
U skupini na sorafenibu, medijan OS-a bio je 17,0 mjeseci (95%-tni CI: 14,2; 18,8) za ispitanike koji su primili terapiju protiv raka nakon liječenja (51%) i 7,9 mjeseci (95%-tni CI: 6,6; 9,7) za one koji nisu.
Resolves to <480 ms or baseline
Povlači se na <480 ms ili na početno stanje.
The most frequently reported adverse reactions (occurring in ≥30% of patients) are hypertension (44.0%), diarrhoea (38.1%), decreased appetite (34.9%), fatigue (30.6%), and decreased weight
Najčešće zabilježene nuspojave (pojavile su se u ≥30% bolesnika) su hipertenzija (44,0%), proljev (38,1%), smanjen apetit (34,9%), umor (30,6%) i smanjena tjelesna težina (30,4%).
Patients who had received 1 prior VEGF/VEGFR-targeted therapy (%) Number of progressions or deaths Median PFS in months (95% CI)
Bolesnici koji su prethodno primili 1 terapiju usmjerenu na VEGF/VEGFR (%) Broj progresija ili smrti Medijan PFS u mjesecima (95% CI)
The median duration of treatment was 5.7 months (Q1: 2.9, Q3: 11.1) in the lenvatinib arm and 3.7 months (Q1: 1.8, Q3: 7.4) in the sorafenib arm.
Medijan trajanja liječenja iznosio je 5,7 mjeseci (Q1: 2,9; Q3: 11,1) u skupini na lenvatinibu i 3,7 mjeseci (Q1: 1,8; Q3: 7,4) u skupini na sorafenibu.
The median OS had not been reached for either the lenvatinib group or the placebo crossover group.
Medijan ukupnog preživljenja nije postignut niti u skupini liječenoj lenvatinibom niti u skupini koja je prešla s placeba na lenvatinib.
Limited data are available for patients of ethnic origin other than Caucasian or Asian, and in patients aged ≥75 years.
Za bolesnike koji po etničkom porijeklu nisu bijelci ili azijati, i za bolesnike u dobi
Hepatic failure events were observed in male patients only.
Slučajevi zatajenja jetre zabilježeni su samo u muških bolesnika.
In the placebo group 0.8% of patients developed renal failure or impairment (0.8% were Grade ≥ 3).
U skupini koja je primala placebo, zatajenje ili oštećenje funkcije bubrega razvilo je 0,8% bolesnika (0,8% bilo je ≥3. stupnja).
The capsule shell contains hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
Ovojnica kapsule sadrži hipromelozu, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172).
Table 4 Recommended management of hypertension
Tablica 4 Preporučeno liječenje hipertenzije Razina krvnog tlaka
Grade 3 reactions occurred in 10.7% of lenvatinib-treated patients and none in placebotreated patients.
Nuspojave 3. stupnja nastale su u 10,7% bolesnika liječenih lenvatinibom i nijednog bolesnika koji je primao placebo.
The majority of cases had an outcome of recovered or resolved following dose interruption or reduction, which occurred in 16.9% and 10.7% of patients, respectively.
Ishod je u većini slučajeva bio oporavak ili povlačenje nuspojava nakon privremenog prekida primjene ili sniženja doze, što se dogodilo u 16,9% odnosno 10,7% bolesnika.
The pharmacokinetics of lenvatinib following a single 10-mg dose were evaluated in 6 subjects each with mild and moderate hepatic impairment (Child-Pugh A and Child-Pugh B, respectively).
Farmakokinetika lenvatiniba nakon jedne doze od 10 mg bila je procijenjena u 6 ispitanika koji su imali blago odnosno umjereno oštećenje funkcije jetre (Child-Pugh A odnosno Child-Pugh B).
In the pivotal Phase 3 SELECT trial (see section 5.1), 88% of all patients had a baseline TSH level less than or equal to 0.5 mU/L.
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1) 88% svih bolesnika imalo je na početku razinu TSH manju ili jednaku 0,5 mU/l.
The European Medicines Agency (EMA) has deferred the obligation to submit the results of a study with lenvatinib in one or more subsets of the paediatric population in the treatment of radioiodinerefractory differentiated thyroid cancer and has has waived the obligation to submit the results of studies with lenvatinib in one or more subsets of the paediatric population in the treatment of hepatocellular carcinoma (HCC).
Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lenvatiniba u jednoj ili više podskupina pedijatrijske populacije u liječenju diferenciranog raka štitnjače refraktornog na
Lenvatinib should be withheld in the event of development of QT interval prolongation greater than 500 ms. Lenvatinib should be resumed at a reduced dose when QTc prolongation is resolved to < 480 ms or baseline.
Lenvatinib treba nastaviti primjenjivati u sniženoj dozi kada se produljenje QTc intervala smanji na <480 ms ili na početnu vrijednost.
Lenvatinib exposure, based on dose-adjusted AUC0-t and AUC0-inf data, was 119%, 107%, and 180% of normal for subjects with mild, moderate, and severe hepatic impairment, respectively.
Izloženost lenvatinibu, temeljena na podacima za AUC0-t i AUC0-inf prilagođenima dozi, u ispitanika s blagim, umjerenim i teškim oštećenjem funkcije jetre bila je 119%, 107% odnosno 180% normalne izloženosti.
The most frequently reported adverse reactions (occurring in ≥30% of patients) are hypertension (68.6%), diarrhoea (62.8%), decreased appetite (51.5%), decreased weight (49.1%), fatigue (45.8%), nausea (44.5%), proteinuria 36.9%), stomatitis (35.8%), vomiting (34.5%), dysphonia (34.1%), headache (34.1%), and palmar-plantar erythrodysaesthesia syndrome (PPE) (32.7%).
Najčešće zabilježene nuspojave (pojavile su se u ≥30% bolesnika) su hipertenzija (68,6%), proljev (62,8%), smanjeni apetit (51,5%), smanjena tjelesna težina (49,1%), umor (45,8%), mučnina (44,5%), proteinurija (36,9%), stomatitis (35,8%), povraćanje (34,5), disfonija (34,1%), glavobolja (34,1%) i sindrom palmarno-plantarne eritrodizestezije (PPE) (32,7%).
Grade 4
4. stupnja
Four (1.5%) subjects treated with lenvatinib attained a CR and 165 subjects (63.2%) had a PR, while no subjects treated with placebo had a CR and 2 (1.5%) subjects had a PR.
Četiri (1,5%) ispitanika liječena lenvatinibom postigla su potpuni odgovor, a 165 ispitanika (63,2%) imalo je djelomični odgovor, dok niti jedan od ispitanika liječenih placebom nije imao potpuni odgovor, a 2 (1,5%) ispitanika imala su djelomični odgovor.
Capsule shell Hypromellose Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Ovojnica kapsule hipromeloza titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
In the Phase 3 REFLECT trial (see section 5.1), 89.6% of patients had a baseline TSH level of less than the upper limit of normal.
U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), 89,6% bolesnika imalo je razinu TSH-a na početku ispitivanja nižu od gornje granice normale.
Interrupt until resolved to Grade 0-1 or baselined
Privremeni prekid doziranja do povlačenja na stupanj 0-1 ili na početne vrijednostid
Progression-Free Survival (PFS)a Number of progressions or deaths (%) Median PFS in months (95% CI)
Preživljenje bez progresije bolesti (PFS)a Broj progresija ili smrti (%) Medijan PFS u mjesecima (95% CI)
• changes in blood test results for kidney function and kidney failure
• promjene u rezultatima krvnih pretraga za funkciju bubrega i zatajenje bubrega
Patients who had received 0 prior VEGF/VEGFR-targeted therapy (%) Number of progressions or deaths Median PFS in months (95% CI)
Bolesnici koji su prethodno primili 0 terapija usmjerenih na VEGF/VEGFR (%) Broj progresija ili smrti Medijan PFS u mjesecima (95% CI)
It has been determined that plasma protein binding in plasma from hepatically 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 jetre slično odgovarajućim podudarnim zdravim ispitanicima te nije uočena ovisnost o koncentraciji.
Liverrelated reactions led to dose interruptions and reductions in 4.6% and 2.7% of patients, respectively, and to permanent discontinuation in 0.4%.
Nuspojave povezane s jetrom dovele su do privremenog prekida primjene ili sniženja doze u 4,6% odnosno 2,7% bolesnika, a do trajnog prestanka liječenja u 0,4% bolesnika.
Radioiodine-refractory differentiated thyroid cancer
Diferencirani rak štitnjače refraktoran na radioaktivni jod
Your doctor may consider stopping LENVIMA if you will be undergoing a major surgical procedure as LENVIMA may affect wound healing.
vaš liječnik može razmotriti prekid davanja LENVIME jer taj lijek može utjecati na cijeljenje rana.
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.