natgillin/translations-raw huggingface dataset:
According to the Memorial Sloan Kettering Cancer Center criteria for prognostic risk category, 46% were favorable (0 risk factors), 42% were intermediate (1 risk factor), and 13% were poor (2 or 3 risk factors).
Po kriterijih Centra za zdravljenje raka Memorial Sloan (Memorial Sloan Kettering Cancer Center) za prognostično kategorijo obetov je bilo 46 % z ugodnim (0 dejavnikov tveganja), 42 % s srednje ugodnim (1 dejavnik tveganja) in 13 % s slabim obetom (2 ali 3 dejavniki tveganja).
All events were Grade 3 or 4.
Vsi dogodki so bili 3. ali 4. stopnje.
Cabozantinib should be discontinued if hypertension is severe and persistent despite anti-hypertensive therapy and dose reduction of cabozantinib.
Z uporabo kabozantiniba je treba prenehati, če je hipertenzija resna ali trdovratna kljub zdravljenju z antihipertenzivi in zmanjšanju odmerka kabozantiniba.
Secondary efficacy endpoints were objective response rate (ORR) and overall survival (OS).
Sekundarna opazovana dogodka učinkovitosti sta bila stopnja objektivnega odziva (ORR) in celokupno preživetje (OS).
This could mean that your doctor needs to change the dose(s) that you take.
To pomeni, da bo morda zdravnik moral prilagoditi odmerek/odmerke, ki ga/jih jemljete.
• Low level of albumin in blood
• nizka raven albumina v krvi
Because of high plasma protein binding levels of cabozantinib (section 5.2) a plasma protein displacement interaction with warfarin may be possible.
Zaradi visoke stopnje vezave kabozantiniba na plazemske beljakovine (glejte poglavje 5.2) je možna interakcija z varfarinom v obliki izpodrivanja s plazemskih beljakovin.
• Alopecia (hair loss and thinning), hair colour change
• alopecija (izpadanje ali redčenje las in dlak), sprememba barve las oziroma dlak
Two non-conjugated metabolites (XL184N-oxide and XL184 amide cleavage product), which possess <1% of the on-target kinase inhibition potency of parent cabozantinib, each represent <10% of total drug-related plasma exposure.
Dva nekonjugirana presnovka (XL184-N-oksid in produkt cepitve XL184 amida), ki imata < 1 % ciljne zaviralne učinkovitosti kinaze izhodiščnega kabozantiniba, vsak predstavljata < 10 % skupne z zdravilom povezane izpostavljenosti v plazmi.
Effect of cabozantinib on other medicinal products The effect of cabozantinib on the pharmacokinetics of contraceptive steroids has not been investigated.
Učinka kabozantiniba na farmakokinetiko kontraceptivnih steroidov niso preučili.
During treatment with cabozantinib, all patients should be monitored for hypertension and treated as needed with standard anti-hypertensive therapy.
Med zdravljenjem s kabozantinibom je treba vse bolnike spremljati za pojav hipertenzije in jih po potrebi zdraviti s standardnimi antihipertenzivi.
Patheon France 40 Boulevard de Champaret 38300 Bourgoin-Jallieu FRANCE
Patheon France 40 Boulevard de Champaret 38300 Bourgoin-Jallieu FRANCIJA
A planned interim analysis of OS was conducted at the time of the PFS analysis and did not reach the interim boundary for statistical significance (202 events, HR=0.68 [0.51, 0.90], p=0.006).
Načrtovana vmesna analiza OS je bila opravljena v času analize PFS in ni dosegla vmesne meje za statistično značilnost (202 dogodka, HR = 0,68 [0,51; 0,90], p = 0,006).
It is used to treat: - advanced stages of a type of kidney cancer called renal cell carcinoma - liver cancer in adults who have been previously treated with a specific anticancer medicine (sorafenib).
Uporablja se za zdravljenje: - napredovalih stopenj raka ledvic, imenovanega karcinom ledvičnih celic, - raka jeter pri odraslih, ki so se predhodno že zdravili s specifičnim zdravilom za zdravljenje raka (sorafenib).
The majority of the patients were male (75%), with a median age of 62 years.
Večina bolnikov je bila moških (75 %) z mediano starosti 62 let.
Film-coating Hypromellose 2910 Titanium dioxide (E171) Triacetin
Filmska obloga hipromeloza 2910 titanov dioksid (E171) triacetin rumeni železov oksid (E172)
Also, some medicines can affect the way CABOMETYX works.
Prav tako lahko nekatera druga zdravila vplivajo na delovanje zdravila CABOMETYX.
Each film-coated tablet contains 15.54 mg lactose.
Ena filmsko obložena tableta vsebuje 15,54 mg laktoze.
Do not use this medicine after the expiry date which is stated on the blister, bottle label and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu, na nalepki plastenke in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Patients with both positive and negative MET status showed a favourable effect with CABOMETYX compared to sunitinib, with greater activity in patients with a positive MET status compared to patients with a negative MET status (HR=0.32 (0.16, 0.63) vs 0.67 (0.37, 1.23)) respectively.
Pri bolnikih z obema, pozitivnim in negativnim statusom MET, so ugotovili koristen učinek zdravila CABOMETYX v primerjavi s sunitinibom, z večjo aktivnostjo pri bolnikih s pozitivnim statusom MET v primerjavi z bolniki z negativnim statusom MET (HR = 0,32 (0,16; 0,63) v primerjavi z 0,67 (0,37; 1,23)).
Secondary efficacy endpoints were progression-free survival (PFS) and objective response rate (ORR), as assessed by the Investigator using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
Sekundarna opazovana dogodka učinkovitosti sta bila preživetje brez napredovanja bolezni (PFS; progression-free survival) in delež objektivnega odziva (ORR; objective response rate), ki ga je ocenil raziskovalec na osnovi različice 1.1 kriterijev za vrednotenje odziva pri solidnih tumorjih (RECIST; Response Evaluation Criteria in Solid Tumours).
- - if you are allergic to cabozantinib or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila CABOMETYX - če ste alergični na kabozantinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Re-initiate at a reduced dose.
Ponovno uvedite zdravljenje z zmanjšanim odmerkom.
Aneurysms and artery dissections
Anevrizme in disekcije arterije
Each bottle contains 30 film-coated tablets.
Vsaka plastenka vsebuje 30 filmsko obloženih tablet.
• Feeling drowsy, confused or loss of consciousness.
• občutek zaspanosti, zmedenost ali izguba zavesti.
Exploratory analyses of PFS and OS in the ITT population have also shown consistent results in favour of CABOMETYX compared to everolimus across different subgroups according to age (<65 vs. ≥65, sex, MSKCC risk group (favourable, intermediate, poor), ECOG status (0 vs. 1), time from diagnosis to randomisation (<1 year vs. ≥1 year), tumour MET status (high vs. low vs. unknown), bone metastases (absence vs. presence), visceral metastases (absence vs. presence), visceral and bone metastases (absence vs. presence), number of prior VEGFR-TKIs (1 vs. ≥2), duration of first VEGFRTKI (≤6 months vs. >6 months).
Raziskovalne analize PFS in OS v populaciji ITT so pokazale tudi skladne rezultate v korist zdravila CABOMETYX v primerjavi z everolimusom za različne podskupine glede na starost (< 65 v primerjavi z ≥ 65, spol, skupino tveganja MSKCC (ugoden, srednje ugoden, slab), status ECOG (0 v primerjavi z 1), čas od diagnoze do randomizacije (< 1 leto v primerjavi z ≥ 1 leto), status MET za tumor (visok v primerjavi z nizkim v primerjavi z neznanim), metastaze v kosteh (odsotnost v primerjavi s prisotnostjo), visceralne metastaze (odsotnost v primerjavi s prisotnostjo), visceralne in kostne metastaze (odsotnost v primerjavi s prisotnostjo), število predhodnih VEGFR-TKI (1 v primerjavi z ≥ 2), trajanje prvega VEGFR-TKI (≤ 6 mesecev v primerjavi z > 6 mesecev).
Events were Grade 2 or 3.
Dogodki so bili 2. ali 3. stopnje.
In a population PK analysis of cabozantinib using data collected from 1883 patients and 140 healthy volunteers following oral administration of a range of doses from 20 to 140 mg, the plasma terminal half-life of cabozantinib is approximately 110 hours.
V farmakokinetični analizi populacije kabozantiniba s podatki, zbranimi pri 1.883 bolnikih in 140 zdravih prostovoljcih, je končni razpolovni čas kabozantiniba v plazmi po peroralni uporabi odmerkov v razponu od 20 do 140 mg znašal približno 110 ur.
Diarrhoea led to dose modifications, interruptions and discontinuations in 84/467 (18%), 69/467 (15%) and 5/467 (1%) of subjects, respectively.
Zaradi driske je bilo treba odmerek prilagoditi pri 84/467 (18 %) bolnikov, odmerjanje prekiniti pri 69/467 (15 %) bolnikov in zdravljenje ukiniti pri 5/467 (1 %) bolnikov.
Dose interruptions are recommended for management of CTCAE grade 3 or greater toxicities or intolerable grade 2 toxicities.
Prekinitev odmerka se priporoča pri obravnavi toksičnosti 3. ali višje stopnje toksičnosti po CTCAE (common terminology criteria for adverse events) ali nevzdržni toksičnosti 2. stopnje.
Progressive Disease a in accord with EU censoring b Stratification factors per IxRS comprise IMDC risk categories (intermediate risk, poor risk and bone metastasis (yes, no) c Estimated using the Cox proportional hazard model adjusted for stratification factors per IxRS.
Napredujoča bolezen a v skladu z EU krnjenjem b Faktorji stratifikacije po IxRS obsegajo kategorije tveganja po IMDC (srednje ugoden, slab prognostičen obet) in zasevke v kosteh (da, ne) c Ocenjeno s pomočjo Coxovega modela proporcionalne ogroženosti, prilagojeno glede na dejavnike stratifikacije po IxRS.
You should also use a barrier contraceptive (e.g. condom or diaphragm) whilst taking CABOMETYX and for at least 4 months after treatment has finished.
Zato morate med jemanjem zdravila CABOMETYX in še vsaj 4 mesece po koncu zdravljenja uporabljati tudi pregradno kontracepcijsko metodo (npr. kondom ali diafragmo).
• Feeling drowsy, confused or loss of consciousness due to liver problems
• občutek zaspanosti, zmedenost ali izguba zavesti zaradi težav z jetri
ECOG performance status (PS) 0: 53% or ECOG PS 1: 47%.
Stanje telesne zmogljivosti po lestvici ECOG 0: 53 % ali 1: 47 %.
Randomization was stratified by aetiology of disease (HBV [with or without HCV], HCV [without HBV], or other), geographic region (Asia, other regions) and by presence of extrahepatic spread of disease and/or macrovascular invasions (Yes, No).
Randomizacija je bila stratificirana glede na etiologijo bolezni (HBV [s HCV ali brez], HCV [brez HBV] ali drugo), geografsko regijo (Azija, druge regije) in prisotnost ekstrahepatične razširitve bolezni in/ali invazije v večje krvne žile (Da, Ne).
Concomitant medicinal products that are strong inhibitors of CYP3A4 should be used with caution, and chronic use of concomitant medicinal products that are strong inducers of CYP3A4 should be avoided (see sections 4.4 and 4.5).
Pri sočasni uporabi z drugimi zdravili, ki so močni zaviralci CYP3A4, je potrebna previdnost, kronično uporabo z zdravili, ki so močni induktorji CYP3A4, pa je treba preprečiti (glejte poglavji 4.4 in 4.5).
Close monitoring of overall safety is recommended in these patients (see sections 4.4
Pri teh bolnikih je priporočljivo skrbno spremljanje celokupne varnosti (glejte poglavji 4.4 in 5.2).
Table 1: Recommended CABOMETYX dose modifications for adverse reactions Adverse reaction and severity
Preglednica 1: Priporočena prilagoditev odmerka zdravila CABOMETYX pri neželenih učinkih Neželeni učinki in resnost
Figure 4: Kaplan-Meier curve of overall survival (CELESTIAL)
Slika 4: Kaplan-Meierjeva krivulja celokupnega preživetja (CELESTIAL)
You should not take CABOMETYX with food.
Zdravila CABOMETYX ne smete jemati s hrano.
Hazard ratio < 1 indicates progression-free survival in favor of cabozantinib
Razmerje ogroženosti < 1 kaže preživetje brez napredovanja bolezni v korist kabozantiniba
What you need to know before you take CABOMETYX 3.
Kaj morate vedeti, preden boste vzeli zdravilo CABOMETYX
Grade 1 and Grade 2 adverse reactions which are tolerable and easily managed
Neželeni učinki 1. stopnje in 2. stopnje, ki jih bolnik prenaša in jih je možno enostavno obravnavati
In rat and dog repeat-dose toxicity studies up to 6 months duration, target organs for toxicity were GI tract, bone marrow, lymphoid tissues, kidney, adrenal and reproductive tract tissues.
V študijah toksičnosti pri ponavljajočih se odmerkih pri podganah in psih, ki so trajale do 6 mesecev, so bili ciljni organi za toksičnost prebavila, kostni mozeg, limfoidno tkivo, ledvice, tkivo nadledvične žleze in rodila.
CABOMETYX contains lactose (a type of sugar).
Zdravilo CABOMETYX vsebuje laktozo (vrsta sladkorja).
Patients could have received one other prior systemic therapy for advanced disease in addition to sorafenib.
Bolniki so poleg sorafeniba predhodno lahko prejeli tudi katero drugo predhodno sistemsko zdravljenje zaradi napredovale bolezni.
For patients with worsening of liver function tests considered related to cabozantinib treatment (i.e. where no alternative cause is evident), the dose modification advice in Table 1 should be followed (see section
Pri bolnikih, pri katerih se presodi, da je prišlo do poslabšanja rezultatov preiskav delovanja jeter zaradi zdravljenja s kabozantinibom (npr. če ni drugega očitnega vzroka), je treba upoštevati nasvet za prilagoditev odmerka v preglednici 1 (glejte poglavje 4.2).
A 19% increase in the Cmax of the tablet formulation (CABOMETYX) compared to the capsule formulation (COMETRIQ) was observed.
Opazili so 19-% povečanje Cmax pri obliki s tabletami (zdravilo CABOMETYX) v primerjavi s kapsulami (zdravilo COMETRIQ).
CABOMETYX is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.
Zdravilo CABOMETYX je v monoterapiji indicirano za zdravljenje hepatocelularnega karcinoma (HCK) pri odraslih bolnikih, ki so se predhodno že zdravili s sorafenibom.
Four metabolites were present in plasma at exposures (AUC) greater than 10% of parent: XL184-N-oxide, XL184 amide cleavage product, XL184 monohydroxy sulfate, and 6-desmethyl amide cleavage product sulfate.
V plazmi so bili prisotni štirje presnovki po izpostavitvah (AUC), večjih od 10 % izhodiščne spojine: XL184-N-oksid, produkt cepitve XL184 amida, XL184 monohidroksi sulfat in produkt cepitve 6-desmetil amid sulfata.
Only limited QoL data are available after this period.
Po tem obdobju je na voljo le malo podatkov o kakovosti življenja.
• A burning or stinging sensation of the tongue
• pekoč ali zbadajoč občutek v jeziku
NOAEL for embryofoetal toxicity and teratogenic findings were below human clinical exposure levels at intended therapeutic dose.
NOAEL za toksičnost embria-zarodka in izsledki o teratogenosti so bili pod ravnmi klinične izpostavljenosti pri ljudeh pri nameravanih terapevtskih odmerkih.
Primary PFS analysis Population Intent-To-Treat Population
Populacija za primarno analizo PFS
If you get side effects, your doctor may tell you to take CABOMETYX at a lower dose.
Če opazite neželene učinke, vam bo zdravnik morda naročil, da jemljite manjše odmerke zdravila CABOMETYX.
Hepatocellular Carcinoma (HCC)
Hepatocelularni karcinom (HCK)
No cabozantinib-treated subjects in this study had a confirmed QTcF >500 ms, nor did any cabozantinib-treated subjects in the RCC or HCC studies (at a dose of 60 mg).
Nobena oseba, ki je bila zdravljena s kabozantinibom v tej študiji, ni imela potrjenega QTcF > 500 ms, niti ga ni imela nobena oseba, zdravljena s kabozantinibom v študijah, izvedenih pri bolnikih s KLC ali bolnikih s HCK (pri odmerku 60 mg).
Clinical data in Hepatocellular Carcinoma
Klinični podatki pri hepatocelularnem karcinomu
Consider re-initiating at a reduced dose.
Razmislite o ponovni uvedbi zdravljenja z zmanjšanim odmerkom.
• Abscess (collection of pus, with swelling and inflammation)
• absces (nabiranje gnoja z oteklostjo in vnetjem)
Patients (N=157) with previously untreated, locally advanced or metastatic RCC with a clear cell component were randomized (1:1) to receive CABOMETYX (N=79) or sunitinib (N=78).
Bolniki (N = 157) s predhodno nezdravljenim, lokalno napredovalim ali metastatskim KLC s komponento svetle celice so bili randomizirani (1:1) za prejemanje zdravila CABOMETYX (N = 79) ali sunitiniba (N = 78).
These may be signs of a condition called reversible posterior leukoencephalopathy syndrome (RPLS).
To so lahko znaki bolezni, ki se imenuje sindrom posteriorne reverzibilne levkoencefalopatije (RPLS, reversible posterior leukoencephalopathy syndrome).
The European Medicines Agency has waived the obligation to submit the results of studies with CABOMETYX in all subsets of the paediatric population in treatment of hepatocellular carcinoma, and kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney) (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom CABOMETYX za vse podskupine pediatrične populacije za zdravljenje hepatocelularnega karcinoma in karcinoma ledvic ali karcinoma ledvične ponvice (razen za nefroblastom, nefroblastomatozo, sarkom svetlih celic, mezoblastni nefrom, renalni medularni karcinom in rabdoidni tumor ledvic) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Table 2: Adverse drug reactions (ADRs) reported in clinical trials in patients treated with cabozantinib
Preglednica 2: Neželeni učinki zdravila, o katerih so poročali v kliničnih preskušanjih pri bolnikih, ki so se zdravili s kabozantinibom
In patients with mild hepatic impairment no dose adjustment is required.
Pri bolnikih z blago okvaro jeter odmerka ni treba prilagajati.
• Low level of a type of white blood cell (lymphocytes)
• nizko število vrste belih krvnih celic (limfociti)
Patients who have inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, peritonitis, diverticulitis, or appendicitis), have tumour infiltration in the GI tract, or have complications from prior GI surgery (particularly when associated with delayed or incomplete healing) should be carefully evaluated before initiating cabozantinib therapy and subsequently they should be monitored closely for symptoms of perforations and fistulas including abscesses and sepsis.
Bolnike, ki imajo vnetno bolezen črevesja (npr. Crohnovo bolezen, ulcerozni kolitis, peritonitis, divertikulitis ali apendicitis), ki imajo tumorsko infiltracijo prebavil ali so imeli pred posegom na prebavilih zaplete (zlasti v povezavi z zapoznelim ali nepopolnim celjenjem), je treba pred uvedbo zdravljenja s kabozantinibom skrbno oceniti, nato pa natančno spremljati za pojav simptomov perforacij in fistul, vključno z abscesi in sepso.
Median time to onset of all events was 4.1 weeks.
Mediani čas do pojava vseh dogodkov je bil 4,1 tedna.
In the 2-year rat carcinogenicity study, cabozantinibrelated neoplastic findings consisted of an increased incidence of benign pheochromocytoma, alone or in combination with malignant pheochromocytoma/complex malignant pheochromocytoma of the adrenal medulla in both sexes at exposures well below the intended exposure in humans.
V 2-letni študiji kancerogenosti pri podganah so s kabozantinibom povezane neoplastične spremembe obsegale večjo pojavnost benignega feokromocitoma, samega ali v kombinaciji z malignim feokromocitomom/zapletenim malignim feokromocitomom sredice nadledvične žleze pri obeh spolih, pri izpostavljenosti, ki je bila bistveno manjša od pričakovane izpostavljenosti pri ljudeh.
Objective Response Rate n (%) by Investigator Complete responses
Delež objektivnega odziva n (%) po oceni raziskovalca Popolni odzivi
When using cabozantinib, periodic monitoring with ontreatment ECGs and electrolytes (serum calcium, potassium, and magnesium) should be considered.
Pri uporabi kabozantiniba je treba med zdravljenjem razmisliti o periodičnem spremljanju z EKG-jem in nadzoru elektrolitov (kalcij, kalij in magnezij v serumu).
Patients (N=658) with advanced RCC with a clear cell component who had previously received at least 1 prior VEGF receptor tyrosine kinase inhibitor (VEGFR TKI) were randomized (1:1) to receive CABOMETYX (N=330) or everolimus (N=328).
Bolniki (N = 658) z napredovalim KLC s komponento svetle celice, ki so pred tem prejeli vsaj 1 predhodni zaviralec receptorskih tirozinkinaz VEGF (VEGFR TKI), so bili randomizirani (1:1) za prejemanje zdravila CABOMETYX (N = 330) ali everolimusa (N = 328).
• Dry skin, severe itching of skin, acne
• suha koža, hudo srbenje, akne
Following oral administration of cabozantinib, peak cabozantinib plasma concentrations are reached at 3 to 4 hours post-dose.
Po peroralni uporabi kabozantiniba so najvišje koncentracije kabozantiniba v plazmi dosežene 3 do 4 ure po odmerku.
Cabozantinib is eliminated mainly via the hepatic route.
Kabozantinib se v glavnem izloča preko jeter.
If your next dose is due in less than 12 hours, then do not take the dose that you have missed.
- Če je do naslednjega odmerka manj kot 12 ur, ne vzemite izpuščenega odmerka.
Cabozantinib should be discontinued in patients who develop an acute myocardial infarction or any other clinically significant thromboembolic complication.
Z uporabo kabozantiniba je treba prenehati pri bolnikih, pri katerih se razvije akutni miokardni infarkt ali drugi klinično pomembni znaki zapletov trombembolije.
In rabbits, cabozantinib produced foetal soft tissue changes (reduced spleen size, small or missing intermediate lung lobe) and increased foetal incidence of total malformations.
Pri kuncih je kabozantinib povzročil spremembe mehkega tkiva pri zarodku (zmanjšano velikost vranice, majhen ali manjkajoč vmesni pljučni lobus) in večjo incidenco skupnih malformacij pri plodu.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
Sindrom reverzibilne posteriorne levkoencefalopatije (RPLS)
Uncommon Not Known
Neznana pogostnost
• Fits, headaches, confusion, or finding it difficult to concentrate.
• konvulzije, glavoboli, zmedenost ali težave pri koncentraciji.
Blood pressure should be well-controlled prior to initiating cabozantinib.
Pred uvedbo kabozantiniba je treba dobro obvladati krvni tlak.
Cases of hepatic encephalopathy in HCC patients can be attributed to the development of electrolyte disturbances.
Pri bolnikih s HCK se primeri jetrne encefalopatije lahko pripišejo razvoju elektrolitskih motenj.
Predisposing risk factors for severe haemorrhage in the advanced HCC population may include tumour invasion of major blood vessels and the presence of underlying liver cirrhosis resulting in oesophageal varices, portal hypertension, and thrombocytopenia.
Dejavniki nagnjenosti k tveganju za hudo krvavitev pri populaciji bolnikov z napredovalim HCK lahko vključujejo invazijo tumorja v večje krvne žile in prisotnost osnovne ciroze jeter s posledičnimi varicami požiralnika, portalno hipertenzijo in trombocitopenijo.
Talk to your doctor BEFORE taking CABOMETYX if you or your partner are considering or planning to have a baby after your treatment has finished.
PRED uporabo zdravila CABOMETYX se posvetujte z zdravnikom, če vi ali vaša partnerica po koncu zdravljenja razmišljate o zanositvi ali jo načrtujete.
The no observed adverse effect level (NOAEL) for these findings were below human clinical exposure levels at intended therapeutic dose.
Raven brez vidnega neželenega učinka (NOAEL, no observed adverse effect level) za te izsledke je bila pod ravnmi klinične izpostavljenosti pri nameravanih terapevtskih odmerkih pri ljudeh.
For intermediate risk disease, one or two of the following risk factors were met, while for poor risk, three or more factors were met: time from diagnosis of RCC to systemic treatment < 1 year, Hgb < LLN, Corrected calcium > ULN, KPS < 80%, Neutrophil count > ULN and Platelet count > ULN.
Pri srednje ugodnem prognostičnem obetu je bil izpolnjen eden ali dva, pri slabem prognostičnem obetu pa trije ali več od naslednjih dejavnikov tveganja: čas od diagnoze KLC do sistemskega zdravljenja < 1 leto, Hgb < spodnje meje normalne vrednosti, korigirani kalcij > zgornje meje normalne vrednosti, KPS < 80 %, število nevtrofilcev > zgornje meje normalne vrednosti in število trombocitov > zgornje meje normalne vrednosti.