FrancophonIA/ELRC3.0 huggingface dataset:
English: When OPG-Fc was combined with hormonal therapy (tamoxifen) or chemotherapy (docetaxel) in these models, there was additive inhibition of skeletal tumour growth in breast, and prostate or lung cancer respectively.
Slovenian: Če je bil OPG-Fc v teh modelih kombiniran s hormonskim zdravljenjem (tamoksifen) ali kemoterapijo (docetaksel), so ugotovili dodatno zavrtje skeletne tumorske rasti pri raku dojke, prostate in pljuč.
English: Patients being treated with XGEVA should not be treated concomitantly with other denosumab containing medicinal products (for osteoporosis indications).
Slovenian: Bolniki, zdravljeni z zdravilom XGEVA, sočasno ne smejo prejemati drugih zdravil, ki vsebujejo denosumab (za indikacije pri osteoporozi).
English: It may contain trace amounts of clear to white particles.
Slovenian: Vsebuje lahko sledove prosojnih do belih delcev.
English: Clear, colourless to slightly yellow solution and may contain trace amounts of translucent to white proteinaceous particles.
Slovenian: Bistra, brezbarvna do rahlo rumena raztopina, ki lahko vsebuje sledove prosojnih do belih beljakovinskih delcev.
English: In patients with giant cell tumour of bone, denosumab binds to RANK ligand, significantly reducing or eliminating osteoclast-like giant cells.
Slovenian: Pri bolnikih z gigantocelularnim kostnim tumorjem se denosumab veže na RANK-ligand in znatno zmanjša ali odstrani osteoklastom podobne gigantske celice.
English: Low calcium levels in the blood
Slovenian: Nizka koncentracija kalcija v krvi
English: High calcium levels in the blood after stopping treatment with XGEVA Some patients with giant cell tumour of the bone have developed high calcium levels in the blood weeks to months after stopping treatment.
Slovenian: Visoka raven kalcija v krvi po prenehanju zdravljenja z zdravilom XGEVA Pri nekaterih bolnikih z gigantocelularnim kostnim tumorjem so se visoke ravni kalcija v krvi pojavljale še tedne do mesece po prenehanju zdravljenja.
English: HR (95% CI) / RRR (%)
Slovenian: HR (95 % IZ) / RRR (%)
English: • Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Slovenian: • Takoj se posvetujte z zdravnikom in zobozdravnikom, če se vam med zdravljenjem ali potem, ko je zdravnik končal vaše zdravljenje, pojavijo težave z usti ali zobmi, kot so majanje zob, bolečina ali oteklina, razjede, ki se ne celijo, ali izcedek, saj so to lahko znaki osteonekroze čeljustnice.
English: Clinical efficacy and safety in adults and skeletally mature adolescents with giant cell tumour of bone
Slovenian: Klinična učinkovitost in varnost pri odraslih in skeletno dozorelih mladostnikih z gigantocelularnim kostnim tumorjem
English: Your doctor should delay the start of your treatment if you have unhealed wounds in your mouth from dental procedures or oral surgery.
Slovenian: Zdravnik bo zakasnil začetek zdravljenja, če imate v ustih nezaceljene rane po zobnih posegih ali ustnih kirurških posegih.
English: Giant cell tumours of bone are characterised by neoplastic stromal cells expressing RANK ligand and osteoclast-like giant cells expressing RANK.
Slovenian: Za gigantocelularne kostne tumorje so značilne neoplastične celice strome z izraženim RANK-ligandom in osteoklastom podobne gigantske celice z izraženim RANK.
English: XGEVA is used in adults with advanced cancer to prevent serious complications caused by bone metastasis (e.g. fracture, pressure on the spinal cord or the need to receive radiation therapy or surgery).
Slovenian: Zdravilo XGEVA se uporablja pri odraslih bolnikih z napredovanim rakom za preprečitev resnih zapletov, ki jih povzročijo kostne metastaze (npr. zlomov, pritiska na hrbtenjačo ali potrebe po obsevanju ali operaciji).
English: • another medicine containing denosumab
Slovenian: • s kakšnim drugim zdravilom, ki vsebuje denosumab,
English: A decision must be made on whether to abstain from breast-feeding or to abstain from XGEVA therapy taking into account the benefit of breast-feeding to the newborn/infant and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem zdravljenja z zdravilom XGEVA, pri čemer je treba pretehtati prednosti dojenja za novorojenčka/dojenčka in prednosti zdravljenja za mater.
English: An SRE was defined as any of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.
Slovenian: Skeletni dogodek je bil opredeljen kot kar koli od naslednjega: patološki zlom (vretenčni ali nevretenčni), obsevalno zdravljenja kosti (vključno z uporabo radioizotopa), operacija kosti ali kompresija hrbtnega mozga.
English: Hypocalcaemia has very commonly been reported following XGEVA administration, mostly within the first 2 weeks.
Slovenian: Zelo pogosto so poročali o hipokalciemiji po aplikaciji zdravila XGEVA, predvsem v prvih 2 tednih po aplikaciji.
English: In mouse bone metastasis models of oestrogen receptor positive and negative human breast cancer, prostate cancer and non-small cell lung cancer, OPG-Fc reduced osteolytic, osteoblastic, and osteolytic/osteoblastic lesions, delayed formation of de novo bone metastases, and reduced skeletal tumour growth.
Slovenian: V mišjih modelih kostnih metastaz pri človeškem raku dojke, pozitivnem in negativnem za estrogenske receptorje, raku prostate in nedrobnoceličnem pljučnem raku je OPG-Fc zmanjšal osteolitične, osteoblastne in osteolitične/osteoblastne lezije, upočasnil nastajanje kostnih metastaz de novo in zmanjšal rast skeletnih tumorjev.
English: In Cohort 2 (patients with surgically salvageable disease whose planned surgery was associated with severe morbidity), 209 of the 228 evaluable patients treated with XGEVA had not undergone surgery by month 6.
Slovenian: V 2. kohorti (bolniki s kirurško rešljivo boleznijo, pri katerih je bil načrtovan kirurški poseg povezan s hudo obolevnostjo) do 6. meseca ni imelo kirurškega posega 209 od 228 ocenljivih bolnikov, zdravljenih z zdravilom XGEVA.
English: Supplementation of at least 500 mg calcium and 400 IU vitamin D daily is required in all patients, unless hypercalcaemia is present (see section 4.4).
Slovenian: Vsi bolniki morajo prejemati dodatek vsaj 500 mg kalcija in 400 i.e. vitamina D dnevno, razen če ima bolnik hiperkalciemijo (glejte poglavje 4.4).
English: In a combined pre-specified analysis from studies 1, 2 and 3, overall survival was similar between XGEVA and zoledronic acid (hazard ratio and 95% CI 0.99 [0.91, 1.07]).
Slovenian: V kombinirani, vnaprej opredeljeni analizi študij 1, 2 in 3 je bilo celokupno preživetje med uporabo zdravila XGEVA in zoledronske kisline podobno (razmerje ogroženosti in 95 % IZ 0,99 [0,91, 1,07]).
English: Inhibition of RANK/RANK ligand (RANKL) in animal studies has been coupled to inhibition of bone growth and lack of tooth eruption, and these changes were partially reversible upon cessation of RANKL inhibition (see section 5.3).
Slovenian: Zavrtje RANK/RANK-liganda (RANKL) je bilo v študijah na živalih povezano z zavrtjem rasti kosti in neizraščanjem zob; te spremembe so bile po prenehanju zavrtja RANKL deloma reverzibilne (glejte poglavje 5.3).
English: Knockout mouse studies suggest absence of RANKL during pregnancy may interfere with maturation of the mammary gland leading to impaired lactation post-partum (see section 5.3).
Slovenian: Študije na knockout miših kažejo, da lahko odsotnost RANKL-a med nosečnostjo prizadene dozorevanje mlečnih žlez in tako poslabša laktacijo po skotitvi (glejte poglavje 5.3).
English: In clinical trials, musculoskeletal pain was very common in both the denosumab and zoledronic acid treatment groups.
Slovenian: V kliničnih preskušanjih je bila mišično-skeletna bolečina zelo pogosta tako v skupini z denosumabom kot v skupini z zoledronsko kislino.
English: It is unknown whether denosumab is excreted in human milk.
Slovenian: Ni znano, ali se denosumab izloča v materino mleko.
English: Across both study arms, 54.5% of patients intended to undergo autologous PBSC transplantation, 95.8% patients utilised/planned to utilise a novel anti-myeloma agent (novel therapies include bortezomib, lenalidomide, or thalidomide) in first-line therapy, and 60.7% of patients had a previous SRE.
Slovenian: V obeh skupinah študije je imelo 54,5 % bolnikov predvideno avtologno presaditev matičnih celic periferne krvi, 95,8 % bolnikov je uporabljalo/načrtovalo uporabo inovativnega antimielomskega zdravila (inovativna zdravila obsegajo bortezomib, lenalidomid ali talidomid) v zdravljenju prve linije in 60,7 % bolnikov je predhodno imelo skeletni dogodek.
English: In male mice genetically engineered to express huRANKL (knock-in mice), which were subjected to a transcortical fracture, denosumab delayed the removal of cartilage and remodelling of the fracture callus compared to control, but biomechanical strength was not adversely affected.
Slovenian: Pri mišjih samcih z genskoinženirsko doseženim izraženjem huRANKL (t. i. knock-in miši), ki so jim povzročili transkortikalni zlom, je denosumab v primerjavi s primerjalnimi živalmi zakasnil odstranjevanje hrustanca in preoblikovanje kalusa zloma, biomehanična čvrstost pa ni bila prizadeta.
English: Clinical efficacy and safety in patients with bone metastases from solid tumours
Slovenian: Klinična učinkovitost in varnost pri bolnikih s kostnimi metastazami solidnih tumorjev
English: What XGEVA looks like and contents of the pack
Slovenian: Izgled zdravila XGEVA in vsebina pakiranja
English: In a post-hoc analysis of the combined dataset, the median time to worsening pain (> 4-point worst pain score) in patients with mild or no pain at baseline was delayed for XGEVA compared to zoledronic acid (198 versus 143 days) (p = 0.0002).
Slovenian: V post hoc analizi kombiniranega nabora podatkov je bil mediana čas do poslabšanja bolečin (> 4-točkovna najslabša ocena bolečin) pri bolnikih, ki izhodiščno niso imeli bolečin ali so imeli blage, z zdravilom XGEVA daljši kot z zoledronsko kislino (198 dni v primerjavi s 143 dnevi, p = 0,0002).
English: Available clinical data does not suggest an increased risk of malignancy in giant cell tumour of bone patients treated with XGEVA.
Slovenian: Razpoložljivi klinični podatki ne kažejo povečanega tveganja za malignost pri bolnikih z gigantocelularnim kostnim tumorjem, zdravljenih z zdravilom XGEVA.
English: First and subsequent SRE* Mean number/patient Rate ratio (95% CI) /
Slovenian: Prvi in nadaljnji SRE* Povprečno število/bolnika Razmerje deležev (95 % IZ) /
English: In subjects with advanced cancer, who received multiple doses of 120 mg every 4 weeks an approximate 2-fold accumulation in serum denosumab concentrations was observed and steady-state was achieved by 6 months, consistent with time-independent pharmacokinetics.
Slovenian: Pri preiskovancih z napredovalim rakom, ki so dobili večkratne odmerke 120 mg na 4 tedne so ugotovili približno 2-kratno kopičenje koncentracije denosumaba v serumu; stanje dinamičnega ravnovesja je bilo doseženo do 6 meseca, kar se sklada s farmakokinetiko, neodvisno od časa.
English: Patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis are at greater risk of developing hypocalcaemia.
Slovenian: Bolniki s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) ali bolniki na dializi imajo večje tveganje za pojav hipokalciemije.
English: XGEVA was evaluated in an international, randomised (1:1), double-blind, active-controlled study comparing XGEVA with zoledronic acid in patients with newly diagnosed multiple myeloma, study 4.
Slovenian: Zdravilo XGEVA so ocenili v mednarodni, randomizirani (1:1), dvojno slepi, z učinkovino kontrolirani študiji, ki je primerjala zdravilo XGEVA z zoledronsko kislino pri bolnikih z novodiagnosticiranim diseminiranim plazmocitomom, študija 4.
English: Based on duration of exposure, there are insufficient data in giant cell tumour of bone patients to assess risk of ONJ beyond 2 years.
Slovenian: Glede na trajanje izpostavljenosti pri bolnikih z gigantocelularnim kostnim tumorjem ni dovolj podatkov za oceno tveganja za osteonekrozo čeljustnice v obdobju nad 2 leti.
English: The trials in patients with breast or prostate cancer included an XGEVA extension treatment phase (median overall exposure of 14.9 months; range: 0.1 - 67.2).
Slovenian: Preskušanja pri bolnicah z rakom dojke ali bolnikih z rakom prostate so obsegala podaljšano fazo zdravljenja z zdravilom XGEVA (mediana celotna izpostavljenost 14,9 meseca; razpon: 0,1 - 67,2).
English: The vial may be left outside the refrigerator to reach room temperature (up to 25°C) before injection.
Slovenian: Pred injiciranjem lahko vialo pustite zunaj hladilnika, da doseže sobno temperaturo (do 25 °C).
English: All patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with denosumab.
Slovenian: Vsem bolnikom je treba naročiti, da morajo med zdravljenjem z denosumabom vzdrževati dobro ustno higieno, redno opravljati zobozdravniške preglede in nemudoma obvestiti zdravnika, če se pojavi kakršen koli simptom v ustih, na primer majanje zob, bolečina, oteklina, rana, ki se ne celi, ali izcedek.
English: Study 2 other solid tumours** or multiple myeloma
Slovenian: Študija 2: drugi solidni tumorji** ali diseminirani plazmocitom
English: You may have low levels of calcium in your blood.
Slovenian: Morda imate nizko koncentracijo kalcija v krvi.
English: Please tell your doctor immediately if you develop any of these symptoms while being treated with XGEVA (may affect more than 1 in 10 people):
Slovenian: Zdravniku morate takoj povedati, če se vam med zdravljenjem z zdravilom XGEVA pojavi kateri od naslednjih simptomov (lahko se pojavijo pri več kot 1 od 10 bolnikov):
English: The recommended dose of XGEVA is 120 mg administered once every 4 weeks, as a single injection under the skin (subcutaneous).
Slovenian: Priporočeni odmerek zdravila XGEVA je 120 mg, ki ga prejmete enkrat na 4 tedne v obliki enkratne injekcije pod kožo (subkutano).
English: Patients being treated with XGEVA should not be treated concomitantly with bisphosphonates.
Slovenian: Bolniki, zdravljeni z zdravilom XGEVA, sočasno ne smejo prejemati bisfosfonatov.
English: Your healthcare professional will not administer XGEVA to you if you have a very low level of calcium in your blood which has not been treated.
Slovenian: Zdravnik vam zdravila XGEVA ne bo injiciral, če imate zelo nizko koncentracijo kalcija v krvi in to stanje ni bilo zdravljeno.
English: In phase III clinical trials of patients with advanced malignancies involving bone, median uNTx/Cr reductions of approximately 80% were maintained through 49 weeks of XGEVA treatment (120 mg every Q4W).
Slovenian: V kliničnih preskušanjih III. faze bolnikov z napredovanimi malignomi, ki so zajele kosti, se je mediana znižanja uNTx/Cr približno 80 % ohranilo v 49 tednih zdravljenja z zdravilom XGEVA (120 mg na vsake 4 tedne).
English: Neonatal RANK/RANKL knockout mice exhibited decreased body weight, reduced bone growth, altered growth plates and lack of tooth eruption.
Slovenian: Novoskotene RANK/RANKL knockout miši so imele manjšo telesno maso, upočasnjeno rast kosti, spremenjene rastne ploščice in niso jim izrasli zobje.
English: Clinically significant hypercalcaemia has also been reported in this patient group weeks to months following treatment discontinuation.
Slovenian: Tudi v tej skupini bolnikov so poročali o klinično pomembni hiperkalciemiji še tedne do mesece po prenehanju zdravljenja.
English: Similar fractures reported in association with bisphosphonates are often bilateral; therefore the contralateral femur should be examined in denosumab-treated patients who have sustained a femoral shaft fracture.
Slovenian: Podobni zlomi, opisani v zvezi z bisfosfonati, so pogosto obojestranski, zato je treba pri bolnikih, ki se zdravijo z denosumabom in so imeli zlom srednjega dela stegnenice, opraviti tudi pregled druge stegnenice.
English: 1.7 mL solution in a single use vial (type I glass) with stopper (fluoropolymer coated elastomeric) and seal (aluminium) with flip-off cap.
Slovenian: 1,7 ml raztopine v viali (iz stekla tipa I) za enkratno uporabo z zamaškom (elastomeren, prekrit s fluoropolimerom) in tesnilom (aluminij) s snemno zaporko.
English: This medicine contains less than 1 mmol sodium (23 mg) per 120 mg, i.e. essentially ‘sodium-free'.
Slovenian: Zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na 120 mg, kar pomeni, da je praktično "brez natrija".
English: In a study of cynomolgus monkeys dosed with denosumab during the period equivalent to the first trimester of pregnancy, denosumab doses resulting in 9 times greater systemic exposure than the recommended human dose did not induce maternal toxicity or foetal harm during a period equivalent to the first trimester, although foetal lymph nodes were not examined.
Slovenian: V študiji na opicah cynomolgus, ki so prejemale denosumab med obdobjem, ki ustreza prvemu trimesečju nosečnosti, odmerki denosumaba, ki so povzročili 9-krat večjo sistemsko izpostavljenost kot priporočeni odmerek za človeka, niso povzročili maternalne toksičnosti ali škode za plod med obdobjem, ustreznim prvemu trimesečju, vendar pa niso raziskali bezgavk plodov.
English: Osteonecrosis of the external auditory canal3,4
Slovenian: pogostnost neznana osteonekroza zunanjega slušnega kanala3, 4
English: Efficacy results for XGEVA compared to zoledronic acid in patients with newly diagnosed multiple myeloma
Slovenian: Rezultati učinkovitosti zdravila XGEVA v primerjavi z zoledronsko kislino pri bolnikih z novodiagnosticiranim diseminiranim plazmocitomom
English: • high calcium levels in the blood (hypercalcaemia) after stopping treatment in patients with giant cell tumour of the bone,
Slovenian: • visoka raven kalcija v krvi (hiperkalciemija) po prenehanju zdravljenja pri bolnikih z gigantocelularnim kostnim tumorjem,
English: XGEVA is not recommended in patients with growing skeletons (see section 4.2).
Slovenian: Zdravilo XGEVA ni priporočljivo pri bolnikih, ki se jim skelet še razvija (glejte poglavje 4.2).
English: Denosumab 120 mg Q4W (N = 859) Zoledronic Acid 4 mg Q4W (N = 859)
Slovenian: Denosumab 120 mg na 4 tedne (N = 859) Zoledronska kislina 4 mg na 4 tedne (N = 859)
English: XGEVA was studied in an open-label trial that enrolled 18 skeletally mature adolescents with giant cell tumour of bone.
Slovenian: Zdravilo XGEVA so raziskali v odprtem preskušanju, ki je zajelo 18 skeletno dozorelih mladostnikov z gigantocelularnim kostnim tumorjem.
English: Kaplan-Meier plot for time to first on-study SRE in patients with newly diagnosed multiple myeloma
Slovenian: Kaplan-Meierjevi prikaz časa do prvega skeletnega dogodka med študijo pri bolnikih z novodiagnosticiranim diseminiranim plazmocitomom
English: Disease progression was similar between XGEVA and zoledronic acid in all three studies and in the pre-specified analysis of all three studies combined.
Slovenian: Napredovanje bolezni in celokupno preživetje pri bolnikih s kostnimi metastazami solidnih tumorjev Napredovanje bolezni je bilo podobno pri zdravilu XGEVA in zoledronski kislini v vseh treh študijah in v vnaprej opredeljeni analizi vseh treh študij skupaj.
English: Your doctor may recommend a dental examination before you start treatment with XGEVA.
Slovenian: Zdravnik vam bo morda svetoval, da pred začetkom zdravljenja z zdravilom XGEVA opravite zobozdravniški pregled.
English: If you are nursing during treatment with XGEVA, please inform your doctor.
Slovenian: Če med zdravljenjem z zdravilom XGEVA dojite, o tem obvestite zdravnika.
English: The recommended dose of XGEVA is 120 mg administered as a single subcutaneous injection once every 4 weeks into the thigh, abdomen or upper arm with additional 120 mg doses on days 8 and 15 of treatment of the first month of therapy.
Slovenian: Priporočeni odmerek zdravila XGEVA je 120 mg enkrat na 4 tedne v enkratni subkutani injekciji v stegno, trebuh ali nadlaket ter dodaten odmerek 120 mg 8. in 15. dan zdravljenja v prvem mesecu terapije.
English: First SRE or HCM Median time (months)
Slovenian: Prvi skeletni dogodek ali HCM Mediani čas (meseci)
English: Please tell your doctor and dentist immediately if you experience any of these symptoms while being treated with XGEVA or after stopping treatment (may affect up to 1 in 10 people):
Slovenian: Zdravniku in zobozdravniku morate takoj povedati, če se vam med zdravljenjem z zdravilom XGEVA ali po končanju vašega zdravljenja, pojavi kateri od naslednjih simptomov (lahko se pojavijo pri največ 1 od 10 bolnikov):
English: Overall of 225 patients for whom giant cell tumours of bone surgery (excluding lung metastases only) was planned, 109 had no surgery performed and 84 underwent a less morbid procedure than planned at baseline.
Slovenian: V celoti ni imelo opravljenega kirurškega posega 109 od 225 bolnikov, pri katerih je bil načrtovan kirurški poseg gigantocelularnega kostnega tumorja (izključujoč samo metastaze na pljučih), 84 bolnikov pa je imelo opravljen manj težaven kirurški poseg, kot je bil sprva načrtovan.
English: New primary malignancy
Slovenian: pogosti novonastali primarni malignom1
English: 71.6% (95% CI: 64.6, 77.9) of patients (table 4) assessed by any of the modalities, with the majority of responses defined by a reduction in fluorodeoxyglucose PET activity or increase in density measured in CT/HU, only 25.1% of the patients had a response per RECIST.
Slovenian: V celoti je zdravilo XGEVA doseglo objektiven odziv tumorja v 71,6 % (95 % IZ: 64,6, 77,9) bolnikov (preglednica 4) ocenjen na vse načine, pri čemer je bila večina odzivov opredeljena z zmanjšanjem aktivnosti PET s fluorodeoksiglukozo ali s povečanjem gostote, izmerjene na CT/HU, le 25,1 % bolnikov je imelo odziv po RECIST.
English: In subjects with multiple myeloma who received 120 mg every 4 weeks, median trough levels varied by less than 8% between months 6 and 12.
Slovenian: Pri bolnikih z diseminiranim plazmocitomom, ki so prejemali 120 mg na 4 tedne, se je mediana najnižja koncentracija od 6. do 12. meseca razlikovala za manj kot 8 %.
English: First SRE Median time (months)
Slovenian: Prvi SRE Mediana čas (meseci)
English: XGEVA contains denosumab, a protein (monoclonal antibody) that works to slow down bone destruction caused by cancer spreading to the bone (bone metastasis) or by giant cell tumour of bone.
Slovenian: Denosumab je beljakovina (monoklonsko protitelo), ki deluje tako, da upočasni razgradnjo kosti, nastalo zaradi širjenja raka v kost (kostne metastaze) ali zaradi gigantocelularnega kostnega tumorja.
English: Discontinuation of XGEVA therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient based on an individual benefit-risk assessment.
Slovenian: Pri bolnikih, pri katerih obstaja sum na atipičen zlom stegnenice, je treba razmisliti o prenehanju uporabe zdravila XGEVA ob vrednotenju bolnika glede na individualno oceno koristi in tveganja.
English: XGEVA zoledronic acid
Slovenian: zoledronska kislina
English: Adverse reactions reported in patients with advanced malignancies involving bone, multiple myeloma, or with giant cell tumour of bone MedDRA system organ class Frequency category
Slovenian: Neželeni učinki, poročani pri bolnikih z napredovanimi malignomi, ki so zajeli kosti, diseminiranim plazmocitomom ali z gigantocelularnim kostnim tumorjem Organski sistem po MedDRA Kategorija pogostnosti
English: No treatment-related pattern in individual cancers or cancer groupings was apparent.
Slovenian: Pri posameznih rakih ali skupinah rakov ni bilo mogoče razbrati nobenega vzorca, povezanega z zdravljenjem.
English: NR 26.4
Slovenian: ND 26,4 20,6