natgillin/translations-raw huggingface dataset:
The European Medicines Agency has waived the obligation to submit the results of studies with XGEVA in all subsets of the paediatric population in the prevention of skeletal related events in patients with bone metastases and subsets of the paediatric population below the age of 12 in the treatment of giant cell tumour of bone (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom XGEVA za vse skupine pediatričnih bolnikov za preprečevanje skeletnih dogodkov pri bolnikih s kostnimi metastazami in za skupine pediatrične populacije, mlajše od 12 let, za zdravljenje gigantocelularnega kostnega tumorja (za podatke o uporabi pri pediatričnih bolnikih glejte poglavje 4.2).
The primary outcome measure was demonstration of non-inferiority of time to first on study skeletal related event (SRE) as compared to zoledronic acid.
Primarna mera izida je bil dokaz neinferiornosti časa do prvega skeletnega dogodka med študijo v primerjavi z zoledronsko kislino.
This medicinal product contains sorbitol.
Zdravilo vsebuje sorbitol.
If the level of calcium in your blood is low, your doctor may decide to give you calcium supplements before you start treatment with XGEVA.
Če imate nizko koncentracijo kalcija v krvi, se zdravnik lahko odloči za dajanje dodatkov kalcija še pred začetkom zdravljenja z zdravilom XGEVA.
In subjects who discontinued 120 mg every 4 weeks, the mean half-life was 28 days (range 14 to 55 days).
Pri preiskovancih, ki so prenehali prejemati 120 mg na 4 tedne, je bil povprečni razpolovni čas 28 dni (razpon: od 14 do 55 dni).
In 190 subjects evaluable for objective tumour response, 55 subjects had giant cell tumour of bone surgery, out of which 40 subjects had complete resections.
Od 190 bolnikov, ocenljivih glede objektivnega odziva tumorja, jih je 55 imelo kirurški poseg gigantocelularnega kostnega tumorja, od teh pa 40 popolno resekcijo.
Talk to your doctor before using XGEVA.
Pogovorite se z zdravnikom, preden dobite zdravilo XGEVA.
Study 5 enrolled 37 adult patients with histologically confirmed unresectable or recurrent giant cell tumour of bone.
Študija 5 je zajela 37 odraslih bolnikov s histološko potrjenim inoperabilnim ali recidivnim gigantocelularnim kostnim tumorjem.
Other medicines and XGEVA
Druga zdravila in zdravilo XGEVA
Density/Size4
Gostota/velikost4
Malignancy in giant cell tumour of bone or progression to metastatic disease is an infrequent event and a known risk in patients with giant cell tumour of bone.
Malignost pri gigantocelularnem kostnem tumorju ali napredovanje do metastatske bolezni je redek dogodek in je znano tveganje pri bolnikih z gigantocelularnim kostnim tumorjem.
You should not take XGEVA together with other medicines containing denosumab or bisphosphonates.
Zdravila XGEVA ne smete jemati skupaj z drugimi zdravili, ki vsebujejo denosumab, ali z bisfosfonati.
Superiority p-value
Vrednosti p za superiornost
Adolescent primates dosed with denosumab at 2.7 and 15 times (10 and 50 mg/kg dose) the clinical exposure had abnormal growth plates.
Pri adolescentnih primatih, ki so dobivali denosumab v odmerkih 2,7- in 15-kratne (odmerek 10 in 50 mg/kg) klinične izpostavljenosti, so ugotovili nenormalne rastne ploščice.
Most subjects were receiving or had received chemotherapy.
Večina bolnikov je trenutno ali pred tem prejemala kemoterapijo.
Clinically significant hypercalcaemia after treatment discontinuation has been reported in the post-marketing setting in paediatric patients (see section 4.4).
O klinično pomembni hiperkalciemiji po prenehanju zdravljenja so v obdobju trženja poročali pri pediatričnih bolnikih (glejte poglavje 4.4).
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).
Preprečevanje skeletnih dogodkov (patoloških zlomov, obsevanja kosti, kompresije hrbtenjače ali operacije kosti) pri odraslih z napredovanimi malignomi, ki zajamejo kosti (glejte poglavje 5.1).
If you become pregnant during treatment with XGEVA or less than 5 months after stopping treatment with XGEVA, please inform your doctor.
Če zanosite med zdravljenjem z zdravilom XGEVA ali manj kot 5 mesecev po koncu zdravljenja z zdravilom XGEVA, o tem obvestite svojega zdravnika.
Monitoring of calcium levels and adequate intake of calcium and vitamin D is especially important in patients with renal impairment (see section 4.4).
Kontrole koncentracije kalcija in ustrezen vnos kalcija in vitamina D so posebej pomembni za bolnike z okvaro ledvic (glejte poglavje 4.4).
Increased osteoclast activity, stimulated by RANKL, is a key mediator of bone destruction in metastatic bone disease and multiple myeloma.
Povečana aktivnost osteoklastov, ki jo spodbuja RANKL, je ključni posrednik razgradnje kosti pri metastatski bolezni kosti in diseminiranem plazmocitomu.
In studies demonstrating superiority of XGEVA to zoledronic acid, patients were offered open-label XGEVA in a pre-specified 2-year extension treatment phase.
V študijah, ki so pokazale superiornost zdravila XGEVA pred zoledronsko kislino, so bolnikom ponudili odprto uporabo zdravila XGEVA v vnaprej opredeljeni fazi 2-letnega podaljšanega zdravljenja.
Unhealed lesions from dental or oral surgery.
Nezaceljene lezije po zobnih ali ustnih kirurških posegih.
Excipient with known effects
Pomožne snovi z znanim učinkom
These could be signs that you have low calcium levels in the blood.
To so lahko znaki, da imate nizko koncentracijo kalcija v krvi.
While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to XGEVA administration.
Med zdravljenjem je izvajanje invazivnih zobozdravniških posegov dovoljeno le po skrbnem razmisleku in se jim je treba izogniti v bližini termina za odmerjanje zdravila XGEVA.
In Cohort 1 (patients with surgically unsalvageable disease), median time to disease progression was not reached, 21 of the 258 treated patients had disease progression.
V 1. kohorti (bolniki s kirurško nerešljivo boleznijo) mediani čas do napredovanja bolezni ni bil dosežen, bolezen je napredovala pri 21 od 258 zdravljenih bolnikov.
XGEVA is a solution for injection (injection).
Zdravilo XGEVA je raztopina za injiciranje (injekcija).
Lichenoid drug eruptions
Lihenoidne erupcije zdravila
• The vial should not be re-entered.
• V vialo se ne sme poseči več kot enkrat.
• rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions).
• izpuščaj na koži ali razjede v ustih (lihenoidne erupcije zdravila).
Study 3 prostate cancer
Študija 3: rak prostate
Study 3*
Študija 3*
What XGEVA is and what it is used for What you need to know before you use XGEVA How to use XGEVA
Kaj je zdravilo XGEVA in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo XGEVA Kako uporabljati zdravilo XGEVA Možni neželeni učinki
The cumulative incidence at one year was 1.1 % for denosumab and 0.6 % for zoledronic acid, respectively.
Kumulativna incidenca je pri enem letu znašala 1,1 % za denosumab in 0,6 % za zoledronsko kislino.
• Before administration, the XGEVA solution should be inspected visually.
• Pred uporabo je treba raztopino zdravila XGEVA vizualno pregledati.
Do not inject the solution if it is cloudy or discoloured.
Raztopine ne smete dajati, če je motna ali obarvana.
The alterations were not considered clinically-relevant, since pharmacodynamic effects based on bone turnover markers were consistent across a wide range of body weight.
Teh sprememb niso ocenili za klinično pomembne, ker so bili farmakodinamski učinki, ocenjeni z označevalci presnove kostnega tkiva, podobni pri zelo različnih telesnih masah.
This study did not control for prognostic factors and anti-neoplastic treatments.
V študiji ni bilo prilagoditve ("kontrole") za prognostične dejavnike in antineoplastična zdravljenja.
4 Class effect
4 Učinek skupine.
In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take:
Da boste zmanjšali tveganje za nastanek osteonekroze čeljustnice, morate upoštevati nekatere previdnostne ukrepe.
Study 6 enrolled 507 adult or skeletally mature adolescents with giant cell tumour of bone and evidence of measurable active disease.
Študija 6 je zajela 507 odraslih ali skeletno dozorelih mladostnikov z gigantocelularnim kostnim tumorjem in znaki merljive aktivne bolezni.
Proportion (%) (95% CI)1
Delež (%) (95 % IZ) 1
Upon enrolment of 282 patients, in Study 6 cohorts 1 and 2 combined, a clinically meaningful reduction in worst pain (i.e. ≥ 2-point decrease from baseline) was reported for 31.4% of patients at risk (i.e. those who had a worst pain score of ≥ 2 at baseline) within 1 week of treatment, and ≥ 50% at week 5.
Po vključitvi 282 bolnikov, kombinirano v 1. in 2. kohorto študije 6, so o klinično pomembnem zmanjšanju najhujše bolečine (tj. ≥ 2 točki manjše od izhodišča) poročali pri 31,4 % bolnikov s tveganjem (tj. tistih, ki so imeli izhodiščno oceno najhujše bolečine ≥ 2) v 1. tednu zdravljenja in ≥ 50 % v 5. tednu.
Pre-existing hypocalcaemia must be corrected prior to initiating therapy with XGEVA.
Obstoječo hipokalciemijo je treba odpraviti še pred začetkom zdravljenja z zdravilom XGEVA.
Study 1*
Študija 1*
The following convention has been used for the classification of the adverse reactions based on incidence rates in four phase III, two phase II clinical studies and post-marketing experience (see table 1): very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data.
faze in iz izkušenj v obdobju trženja zdravila (glejte tabelo 1), je uporabljen naslednji dogovor: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in pogostnost neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
The median number of doses administered was 16 for XGEVA and 15 for zoledronic acid.
Mediano število uporabljenih odmerkov zdravila XGEVA je bilo 16 in zoledronske kisline 15.
In clinical trials, XGEVA has been administered in combination with standard anti-cancer treatment and in subjects previously receiving bisphosphonates.
V kliničnih preskušanjih so zdravilo XGEVA dajali v kombinaciji s standardnim zdravljenjem proti raku in preiskovancem, ki so predhodno prejemali bisfosfonate.
Patients undergoing chemotherapy and/or radiotherapy, taking steroids or anti-angiogenic medicines (used to treat cancer), undergoing dental surgery, who do not receive routine dental care, have gum disease or who are smokers, may have a higher risk of developing osteonecrosis of the jaw.
Bolniki, ki prejemajo kemoterapijo in/ali radioterapijo, jemljejo steroide ali antiangiogena zdravila (uporabljajo se za zdravljenje raka), imajo zobozdravstven kirurški poseg, niso deležni redne zobozdravstvene oskrbe, imajo bolezen dlesni ali so kadilci, imajo lahko večje tveganje za nastanek osteonekroze čeljustnice.
Since the biological activity of denosumab in animals is specific to nonhuman primates, evaluation of genetically engineered (knockout) mice or use of other biological inhibitors of the RANK/RANKL pathway, such as OPG-Fc and RANK-Fc, were used to evaluate the pharmacodynamic properties of denosumab in rodent models.
Ker je biološka aktivnost denosumaba pri živalih specifična za ne-humane primate, so za oceno farmakodinamičnih lastnosti denosumaba pri glodalcih uporabili genetsko spremenjene ("knockout") miši ali druge biološke zaviralce poti RANK/RANKL poti, npr. OPG-Fc in RANK-Fc.
Once removed from the refrigerator, XGEVA may be stored at room temperature (up to 25°C) for up to 30 days in the original container.
Ko vzamete zdravilo XGEVA iz hladilnika, ga lahko shranjujete pri sobni temperaturi (do 25 °C ) do 30 dni v originalnem vsebniku.
The risk of developing hypocalcaemia and accompanying elevations in parathyroid hormone increases with increasing degree of renal impairment.
Tveganje za pojav hipokalciemije in spremljajočega zvišanja paratiroidnega hormona se povečuje s povečano stopnjo okvare ledvic.
Baseline pre-treatment analgesic use in cohort 1 and cohort 2 was graded on a seven point scale, where 74.8% of patients reported no or mild analgesic use (i.e. analgesic score ≤ 2) and 25.2% of patients used strong opioids (i.e. analgesic score 3 to 7).
Izhodiščno uporabo analgetikov pred zdravljenjem so v 1. in 2. kohorti ocenjevali na sedemstopenjski lestvici, pri čemer je 74,8 % bolnikov poročalo, da analgetikov niso uporabljali ali so uporabljali blage (tj. ocena analgetikov ≤ 2), 25,2 % bolnikov pa je uporabljalo močne opioide (tj. ocena analgetikov 3 do 7).
XGEVA has been administered in clinical studies using doses up to 180 mg every 4 weeks and 120 mg weekly for 3 weeks.
Zdravilo XGEVA so v kliničnih študijah uporabljali v odmerkih do 180 mg na 4 tedne in 120 mg na teden 3 tedne.
First and subsequent SRE Mean number of events/patient Rate ratio (95% CI) Skeletal morbidity rate per year
Prvi in nadaljnji skeletni dogodki Povprečno število dogodkov/bolnika Razmerje deležev (95 % IZ) Deleže skeletne obolevnosti na leto
Zoledronic Acid (N = 859)
Zoledronska kislina (N = 859)
In a mouse model of mammary tumour induction, RANK-Fc reduced hormone-induced proliferation in mammary epithelium and delayed tumour formation.
V mišjem modelu indukcije mamarnih tumorjev je RANK-Fc zmanjšal hormonsko izzvano proliferacijo mamarnega epitelija in je zakasnil nastanek tumorjev.
A post-hoc analysis in study 2 (patients with other solid tumours or multiple myeloma) examined overall survival for the 3 tumour types used for stratification (non-small cell lung cancer, multiple myeloma, and other).
Post hoc analiza v študiji 2 (bolniki z drugimi solidnimi tumorji ali diseminiranim plazmocitomom) je raziskala celokupno preživetje pri 3 vrstah tumorjev, uporabljenih za stratifikacijo (nedrobnocelični pljučni rak, diseminirani plazmocitom in drugi).
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.
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.
Patients being treated with XGEVA should not be treated concomitantly with other denosumab containing medicinal products (for osteoporosis indications).
Bolniki, zdravljeni z zdravilom XGEVA, sočasno ne smejo prejemati drugih zdravil, ki vsebujejo denosumab (za indikacije pri osteoporozi).
It may contain trace amounts of clear to white particles.
Vsebuje lahko sledove prosojnih do belih delcev.
Clear, colourless to slightly yellow solution and may contain trace amounts of translucent to white proteinaceous particles.
Bistra, brezbarvna do rahlo rumena raztopina, ki lahko vsebuje sledove prosojnih do belih beljakovinskih delcev.
In patients with giant cell tumour of bone, denosumab binds to RANK ligand, significantly reducing or eliminating osteoclast-like giant cells.
Pri bolnikih z gigantocelularnim kostnim tumorjem se denosumab veže na RANK-ligand in znatno zmanjša ali odstrani osteoklastom podobne gigantske celice.
Low calcium levels in the blood
Nizka koncentracija kalcija v krvi
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.
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.
HR (95% CI) / RRR (%)
HR (95 % IZ) / RRR (%)
• 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.
• 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.
Clinical efficacy and safety in adults and skeletally mature adolescents with giant cell tumour of bone
Klinična učinkovitost in varnost pri odraslih in skeletno dozorelih mladostnikih z gigantocelularnim kostnim tumorjem
Your doctor should delay the start of your treatment if you have unhealed wounds in your mouth from dental procedures or oral surgery.
Zdravnik bo zakasnil začetek zdravljenja, če imate v ustih nezaceljene rane po zobnih posegih ali ustnih kirurških posegih.
Giant cell tumours of bone are characterised by neoplastic stromal cells expressing RANK ligand and osteoclast-like giant cells expressing RANK.
Za gigantocelularne kostne tumorje so značilne neoplastične celice strome z izraženim RANK-ligandom in osteoklastom podobne gigantske celice z izraženim RANK.
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).
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).
• another medicine containing denosumab
• s kakšnim drugim zdravilom, ki vsebuje denosumab,
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.
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.
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.
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.
Hypocalcaemia has very commonly been reported following XGEVA administration, mostly within the first 2 weeks.
Zelo pogosto so poročali o hipokalciemiji po aplikaciji zdravila XGEVA, predvsem v prvih 2 tednih po aplikaciji.
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.
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.
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.
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.
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).
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).
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]).
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]).
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).
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).
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).
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).
In clinical trials, musculoskeletal pain was very common in both the denosumab and zoledronic acid treatment groups.
V kliničnih preskušanjih je bila mišično-skeletna bolečina zelo pogosta tako v skupini z denosumabom kot v skupini z zoledronsko kislino.
It is unknown whether denosumab is excreted in human milk.
Ni znano, ali se denosumab izloča v materino mleko.
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.
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.
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.
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.
Clinical efficacy and safety in patients with bone metastases from solid tumours
Klinična učinkovitost in varnost pri bolnikih s kostnimi metastazami solidnih tumorjev
What XGEVA looks like and contents of the pack
Izgled zdravila XGEVA in vsebina pakiranja
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).
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).
Available clinical data does not suggest an increased risk of malignancy in giant cell tumour of bone patients treated with XGEVA.
Razpoložljivi klinični podatki ne kažejo povečanega tveganja za malignost pri bolnikih z gigantocelularnim kostnim tumorjem, zdravljenih z zdravilom XGEVA.
First and subsequent SRE* Mean number/patient Rate ratio (95% CI) /
Prvi in nadaljnji SRE* Povprečno število/bolnika Razmerje deležev (95 % IZ) /