natgillin/translations-raw huggingface dataset:
Cerebral haemorrhage*, Haemorrhage intracranial (inc subarachnoid)*, Brain oedema, Transient ischaemic attack, Coma, Autonomic nervous system imbalance, Autonomic neuropathy, Cranial palsy*, Paralysis*, Paresis*, Presyncope, Brain stem syndrome, Cerebrovascular disorder, Nerve root lesion, Psychomotor hyperactivity, Spinal cord compression, Cognitive disorder NOS, Motor dysfunction, Nervous system disorder NOS, Radiculitis, Drooling, Hypotonia
Redki možganska krvavitev*, znotrajlobanjska krvavitev (vključno z subarahnoidalno)*, možganski edem, tranzitorna ishemična ataka, koma, neravnovesje v delovanju avtonomnega živčevja, avtonomna nevropatija, kranialna paraliza*, paraliza*, pareza*, presinkopa, sindrom možganskega debla, možgansko-žilne bolezni, lezija živčnih korenov, psihomotorična hiperaktivnost, kompresija hrbtenjače, kognitivna motnja NOS, motorične motnje, bolezni živčevja NOS, radikulitis, slinjenje, hipotonija
This 4-week period is considered a treatment cycle.
To 4-tedensko obdobje predstavlja en cikel zdravljenja.
#, Bronchospasm, Chronic obstructive pulmonary disease*, Hypoxaemia*, Respiratory tract congestion*, Hypoxia, Pleurisy*, Hiccups, Rhinorrhoea, Dysphonia, Wheezing
#, bronhospazem, kronična obstruktivna pljučna bolezen*, hipoksemija*, kongestija dihal*, hipoksija, plevritis*, kolcanje, izcedek iz nosu, disfonija, piskanje v pljučih
The reconstituted solution should be used immediately after preparation.
Rekonstituirano raztopino je treba uporabiti takoj po pripravi.
1.2 Before administration, visually inspect the solution for particulate matter and discolouration.
Pred dajanjem raztopino preverite glede prisotnosti trdnih delcev in obarvanosti.
• Inflammation or haemorrhage of the blood vessels that can appear as small red or purple dots (usually on the legs) to large bruise-like patches under the skin or tissue
• vnetje ali krvavitev krvnih žil, ki se lahko kaže kot majhne rdeče ali vijolične pike
Clinical efficacy with subcutaneous administration of bortezomib in patients with relapsed/refractory multiple myeloma
Klinična učinkovitost subkutanega dajanja bortezomiba bolnikom pri ponovitvi/diseminiranem plazmocitomu, odpornem na zdravljenje
Oedema (inc peripheral), Chills, Injection site reaction*, Malaise*
Pogosti edem (vključno s perifernim), mrazenje, reakcija na mestu injiciranja*, splošno slabo počutje*
In a drug-drug interaction study assessing the effect of omeprazole, a potent CYP2C19 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), there was no significant effect on the pharmacokinetics of bortezomib based on data from 17 patients.
V študiji medsebojnega delovanja zdravil, ki je ocenjevala učinek omeprazola, močnega zaviralca encima CYP2C19, na farmakokinetiko bortezomiba (danega intravensko), na osnovi podatkov 17 bolnikov, ni bilo pomembnega vpliva na farmakokinetiko bortezomiba.
Corneal lesion*, Exophthalmos, Retinitis, Scotoma, Eye disorder (inc. eyelid) NOS, Dacryoadenitis acquired, Photophobia, Photopsia, Optic neuropathy
Redki poškodba roženice*, eksoftalmus, retinitis, skotom, očesne bolezni (vključno z vekami) NOS, pridobljen dakrioadenitis, fotofobija, fotopsija, optična nevropatija
If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive bortezomib intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.
Če pri vas diseminiranega plazmocitoma še niso zdravili in je presaditev krvotvornih matičnih celic za vas primerna, boste kot uvajalno zdravljenje prejeli bortezomib v veno ali v podkožje v kombinaciji z deksametazonom ali z deksametazonom in talidomidom.
Intravenous reconstitution: After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib.
Intravenska rekonstitucija: Po rekonstituciji 1 ml raztopine za intravensko injiciranje vsebuje 1 mg bortezomiba.
If any discolouration or particulate matter is observed, the solution should be discarded.
Če opazite kakršnokoli obarvanost ali prisotnost trdnih delcev, raztopino zavrzite.
1, 4, 8, and 11), and oral dexamethasone (40 mg/day on days 1 to 4 and days 9 to 12, in Cycles 1 and 2, and on days 1 to 4 in Cycles 3 and 4).
V vsakem ciklu so prejeli bortezomib (1,3 mg/m2 intravensko dvakrat na teden na 1., 4., 8. in 11. dan) in deksametazon (40 mg/dan, peroralno, 1. do 4. in 9. do 12. dan v 1. in 2. ciklu in 1. do 4. dan v 3. in 4. ciklu).
Deboronated-bortezomib metabolites are inactive as 26S proteasome inhibitors.
Presnovka, ki nastaneta po odcepitvi bora, ne delujeta kot zaviralca 26S proteasoma.
A 6-week period is considered a treatment cycle.
Šesttedensko obdobje predstavlja en cikel zdravljenja.
The incidence of herpes zoster among patients in the B+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
V skupini, zdravljeni z B+M+P, je pri 17 % bolnikov, ki niso prejemali protivirusnih zdravil, prišlo do reaktivacije virusa herpes zoster, pri bolnikih, ki so prejemali protivirusna zdravila, pa je prišlo do reaktivacije virusa pri 3 % bolnikov.
Time to progression Events n (%) Median a (95% CI)
Čas do napredovanja bolezni dogodki n (%) mediana a (95 % IZ)
• Weight increase
• povečan tek
performance status, chromosome 13 deletion status, or the number or type of previous therapies.
Pri multivariantni analizi stopnja odziva ni bila odvisna od vrste plazmocitoma, stanja fizične zmogljivosti bolnika, napak na kromosomu 13 in števila ali vrste predhodnih zdravljenj.
• Muscle cramps, muscle spasms, muscle weakness, pain in your limbs
• mišični krči, oslabelost mišic, bolečina v udih
Sepsis (inc septic shock)*, Herpes zoster (inc disseminated & ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex*
Zelo pogosti pljučnica* Pogosti sepsa (vključno s septičnim šokom)*, herpes zoster (vključno z diseminiranim in očesnim), okužba s herpes virusom, bakterijske okužbe *, okužba zgornjih/spodnjih dihal*, glivična okužba *, herpes simpleks*
N=240 (ITT population)
n = 240 (ITT populacija) n = 242 (ITT populacija)
A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone and thalidomide group.
Opazili so statistično pomembno razliko v prid kombinaciji bortezomiba z deksametazonom in talidomidom.
When bortezomib is given together with dexamethasone, you will receive bortezomib intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib 21-day treatment cycle.
Če boste prejeli bortezomib skupaj z deksametazonom, boste prejeli bortezomib v veno ali v podkožje v 21-dnevnem ciklu zdravljenja in 40 mg deksametazona peroralno na 1., 2., 3., 4., 8., 9., 10. in 11. dan cikla zdravljenja z bortezomibom.
- in combination with the medicines melphalan and prednisone, for patients whose disease has not been previously treated and are unsuitable for high-dose chemotherapy with blood stem cell transplantation.
• v kombinaciji z melfalanom in prednizonom pri bolnikih, pri katerih bolezni še niso zdravili in pri njih kemoterapija v velikih odmerkih s presaditvijo krvotvornih matičnih celic ni primerna;
#, Deep vein thrombosis*, Haemorrhage*, Thrombophlebitis (inc superficial), Circulatory collapse (inc hypovolaemic shock), Phlebitis, Flushing*, Haematoma (inc perirenal)*, Poor peripheral circulation*, Vasculitis, Hyperaemia (inc ocular)*
#, globoka venska tromboza*, krvavitev*, tromboflebitis (vključno s površinskim), cirkulatorni kolaps (vključno s hipovolemičnim šokom), flebitis, pordelost*, hematom (vključno s perirenalnim)*, slaba periferna prekrvavitev*, vaskulitis, hiperemija (vključno z očesno)*
Bortezomib Hospira 1 mg powder for solution for injection Bortezomib Hospira 2.5 mg powder for solution for injection Bortezomib Hospira 3 mg powder for solution for injection Bortezomib Hospira 3.5 mg powder for solution for injection bortezomib
Bortezomib Hospira 1 mg prašek za raztopino za injiciranje Bortezomib Hospira 2,5 mg prašek za raztopino za injiciranje Bortezomib Hospira 3 mg prašek za raztopino za injiciranje Bortezomib Hospira 3,5 mg prašek za raztopino za injiciranje bortezomib
If local injection site reactions occur following Bortezomib Hospira subcutaneous injection, either a less concentrated Bortezomib Hospira solution (Bortezomib Hospira to be reconstituted to 1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Če se po subkutanem injiciranju zdravila Bortezomib Hospira na mestu injiciranja pojavijo lokalne reakcije, se priporoča, da subkutano injicirate manj koncentrirano raztopino zdravila Bortezomib Hospira (1 mg/ml namesto 2,5 mg/ml) ali pa preidete na intravensko dajanje zdravila.
Dexamethasone is administered orally at 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 of the Bortezomib Hospira treatment cycle.
Deksametazon se jemlje peroralno v odmerku 20 mg na 1., 2., 4., 5., 8., 9., 11. in 12. dan v ciklu zdravljenja z zdravilom Bortezomib Hospira.
Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction*
Pogosti fibrilacija srca (vključno z atrijsko), aritmija*, srčno popuščanje (vključno s popuščanjem levega in desnega prekata)*, ishemija miokarda, motnja delovanja prekatov*
Common Renal impairment* Uncommon Renal failure acute, Renal failure chronic*, Urinary tract infection*, Urinary tract signs and symptoms*, Haematuria*, Urinary retention, Micturition disorder*, Proteinuria, Azotaemia, Oliguria*, Pollakisuria
Občasni akutna odpoved ledvic, kronična odpoved ledvic*, okužba sečil*, znaki in simptomi bolezni sečil*, hematurija*, retenca urina, težave pri uriniranju*, proteinurija, azotemija, oligurija*, polakiurija
Each carton of 2.5 mg, 3 mg or 3.5 mg Bortezomib Hospira contains a glass 10 ml vial with a rubber stopper and an aluminium seal.
Ena škatla zdravila Bortezomib Hospira 2,5 mg, 3 mg ali 3,5 mg vsebuje stekleno 10 ml vialo z gumijastim zamaškom in aluminijasto zaporko.
Thalidomide is administered orally at 50 mg daily on days 1-14 and if tolerated the dose is increased to 100 mg on days 15-28, and thereafter may be further increased to 200 mg daily from cycle 2 (see Table 4).
Če odmerek dobro prenaša, se ga lahko poveča na 100 mg od 15. do 28. dneva in nato od 2. cikla zdravljenja naprej na 200 mg na dan (glejte preglednico 4).
When bortezomib is given together with dexamethasone, you will receive bortezomib intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the bortezomib, 21-day treatment cycle.
Če boste prejeli bortezomib skupaj z deksametazonom, boste prejeli bortezomib v veno ali v podkožje v 21-dnevnem ciklu zdravljenja in 20 mg deksametazona peroralno na 1., 2., 4., 5., 8., 9., 11. in 12. dan cikla zdravljenja z bortezomibom.
A drug-drug interaction study assessing the effect of melphalan-prednisone on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC increase of 17% based on data from 21 patients.
Študija medsebojnega delovanja zdravil za učinkovine melfalan, prednizon na farmakokinetiko bortezomiba (danega intravensko) je pokazala 17 % zvečanje srednje vrednosti AUC bortezomiba (na osnovi podatkov 21 bolnikov).
The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration.
Rekonstituirano raztopino je treba pred uporabo pregledati glede prisotnost trdnih delcev in obarvanosti.
• Feeling sick (nausea) or vomiting, loss of appetite
• slabost (navzea) ali bruhanje, izguba teka
Very Common Pyrexia*, Fatigue, Asthenia Common
Zelo pogosti pireksija*, utrujenost, astenija
Bortezomib Hospira IS FOR SUBCUTANEOUS OR INTRAVENOUS USE.
Zdravilo Bortezomib Hospira je ZA SUBKUTANO ALI INTRAVENSKO UPORABO.
Bortezomib Hospira 1 mg powder for solution for injection Bortezomib Hospira 2.5 mg powder for solution for injection Bortezomib Hospira 3 mg powder for solution for injection Bortezomib Hospira 3.5 mg powder for solution for injection
Bortezomib Hospira 1 mg prašek za raztopino za injiciranje Bortezomib Hospira 2,5 mg prašek za raztopino za injiciranje Bortezomib Hospira 3 mg prašek za raztopino za injiciranje Bortezomib Hospira 3,5 mg prašek za raztopino za injiciranje
Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
b Ocena razmerja ogroženosti na osnovi Coxovega modela, stratificirani z IPI tveganjem in stopnjo bolezni.
Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration (see section
Če se zakasnitve ciklov zdravljenja ponavljajo, je treba razmisliti o profilaktični uporabi granulocitne kolonije spodbujajočih faktorjev (glejte poglavje 4.2).
Median c (95% CI) (months)
mediana c (95 % IZ) (meseci) 24,7 (19,8; 31,8) 14,4 (12; 16,9)
• advice on how to reduce the risk of mix-up of IV and SC reconstituted syringes
• Navodilo za zmanjšanje možnost zamenjave pripravljenih injekcijskih brizg za i.v.
Progression Free Survival, months (95% CI)
Preživetje brez napredovanja bolezni, meseci (95 % IZ) razmerje ogroženosti (95 % IZ) vrednost p
• Injection sites should be rotated for successive injections.
• Za uspešno injiciranje je treba mesta injiciranja menjati.
Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration.
Če se zakasnitve ciklov zdravljenja ponavljajo, je treba razmisliti o profilaktični uporabi granulocitne kolonije spodbujajočih faktorjev.
Bortezomib Hospira dose should be reduced by 1 dose level (from 1.3 mg/m to 1 mg/m 2, or from 1 mg/m 2 to
Odmerek zdravila Bortezomib Hospira je treba zmanjšati za 1 stopnjo (z 1,3 mg/m2 na
Pigmentation disorder*
Občasni pancitopenija*
Common Oedema (inc peripheral), Chills, Pain*, Malaise* Uncommon General physical health deterioration*, Face oedema*, Injection site reaction*, Mucosal disorder*, Chest pain, Gait disturbance, Feeling cold, Extravasation*, Catheter related complication*, Change in thirst*, Chest discomfort, Feeling of body temperature change*, Injection site pain*
Občasni poslabšanje splošnega zdravstvenega stanja*, edem obraza*, reakcija na mestu injiciranja*, bolezni sluznice*, bolečina v prsih, motnje hoje, občutek mrazenja, ekstravazacija*, s katetrom povezani zapleti*, spremembe občutka žeje*, občutek nelagodja v prsih, občutek spremembe telesne temperature*, bolečina na mestu injiciranja*
This 3-week period is considered a treatment cycle.
To 3-tedensko obdobje predstavlja en cikel zdravljenja.
• shingles (localised including around the eyes or spread across the body)
• pasasti izpuščaj (lokaliziran, vključno s področjem okoli oči ali razširjen po telesu)
• Severe allergic reaction (anaphylactic reaction) signs of which may include difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and /or throat, which may cause difficulty in swallowing,
bolečino ali tiščanje v prsih, in/ali omotico/omedlevico, hudo srbenje kože ali dvignjene bulice na koži, otekanje obraza, ustnic, jezika in/ali grla, kar lahko povzroči oteženo požiranje,
An open label, randomised, Phase III non-inferiority study compared the efficacy and safety of the subcutaneous administration of bortezomib versus the intravenous administration.
V odprtem, randomiziranem preskušanju faze III pri dveh enakovrednih skupinah so primerjali učinkovitost in varnost subkutanega in intravenskega dajanja bortezomiba.
Patients with moderate or severe hepatic impairment should be started on Bortezomib Hospira at a reduced dose of 0.7 mg/m2 per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m 2 or further dose reduction to 0.5 mg/m 2 may be considered based on patient tolerability (see Table 6 and sections 4.4 and 5.2).
Na osnovi bolnikovega prenašanja zdravljenja je treba pretehtati možnost povečanja odmerka na 1,0 mg/m 2 ali zmanjšanja odmerka na 0,5 mg/m 2 (glejte preglednico 6 ter poglavji 4.4 in 5.2).
9/l or ANC ≤ 0.75 x Bortezomib Hospira therapy should be withheld • If platelet counts ≤ 30 x 10
9/l ali ANC ≤ 0,75 x 10
CR+nCR+PR 121 (38)b 56 (18)
CR+ nCR + PR 121
Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (including Thrombocytopenic purpura)
Redki diseminirana intravaskularna koagulacija, trombocitoza*, hiperviskozni sindrom, bolezni trombocitov NOS, trombotična mikroangiopatija (vključno s trombocitopenično purpuro) bolezni krvi NOS, hemoragična diateza, limfocitna infiltracija
Bortezomib will be administered by a health care professional experienced in the use of cytotoxic medicines.
Zdravilo Bortezomib Hospira pa lahko aplicira tudi zdravstveno osebje, ki ima izkušnje z zdravljenjem s kemoterapevtskimi učinkovinami.
• Lump in the eyelid (chalazion), red and swollen eyelids
• zatrdlina na veki (halazij), pordele in otekle veke
CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate;
CR = popoln odziv; nCR = skoraj popoln odziv; PR = delni odziv; MR = minimalni odziv
Day 1, 2, 3, 4
Dan 1 Dan 2 Dan 3 Dan 4 -
OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p values by Cochran Mantel-Haenszel test.
* Primarni opazovani dogodek a OR za stopnje odziva na osnovi Mantel-Haenszelove ocene razmerja obetov za stratificirane preglednice;
In addition, the incidence of Grade 3 or higher peripheral neuropathies was 10% lower, and the discontinuation rate due to peripheral neuropathies 8% lower for the subcutaneous group as compared to the intravenous group.
manjša, delež prekinitev zdravljenja zaradi perifernih nevropatij pa za 8 % manjši kot v skupini, ki je zdravilo prejemala intravensko.
Retreatment of patients with relapsed multiple myeloma In a study in which bortezomib retreatment was administered in 130 patients with relapsed multiple myeloma, who previously had at least partial response on a bortezomib-containing regimen, the most common all-grade adverse events occurring in at least 25% of patients were thrombocytopenia (55%),
Ponovno zdravljenje bolnikov s ponovitvijo diseminiranega plazmocitoma V preskušanju, v katerem so z bortezomibom ponovno zdravili 130 bolnikov s ponovitvijo diseminiranega plazmocitoma, ki so imeli vsaj delni odziv na predhodno zdravljenje, ki je vključevalo bortezomib, so bili najpogostejši neželeni učinki vseh stopenj, ki so se pojavili pri najmanj 25 % bolnikov, trombocitopenija (55 %), nevropatija (40 %), anemija (37 %), diareja (35 %) in zaprtje (28 %).
If you are given Bortezomib for the treatment of multiple myeloma the side effects you may get are listed below:
Če prejemate zdravilo Bortezomib Hospira za zdravljenje diseminiranega plazmocitoma, se lahko pri vas pojavijo naslednji neželeni učinki:
• Non-haematological toxicities should have resolved to Grade 1 or baseline.
• se morajo nehematološke toksičnosti povrniti na 1. stopnjo ali na stanje pred začetkom zdravljenja.
Sleep disorders and disturbances*
Psihiatrične motnje Pogosti motnje spanja*
Dose adjustments during treatment and re-initiation of treatment for combination therapy with melphalan and prednisone Prior to initiating a new cycle of therapy:
Prilagajanje odmerka med zdravljenjem in ob ponovni uvedbi kombiniranega zdravljenja z melfalanom in prednizonom
BTDx=bortezomib, thalidomide, dexamethasone; PN=peripheral neuropathy Note: Peripheral neuropathy included the preferred terms: neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy.
VDDx = vinkristin, doksorubicin, deksametazon; BDx = bortezomib, deksametazon; TDx = talidomid, deksametazon; BTDx = bortezomib, talidomid, deksametazon; PN = periferna nevropatija Opomba: periferna nevropatija vključuje priporočene termine: periferna nevropatija, periferna motorična nevropatija, periferna senzorična nevropatija in polinevropatija.
During clinical trials, hypoglycaemia and hyperglycaemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycaemics.
Med kliničnimi preskušanji so pri bolnikih z diabetesom, ki prejemajo peroralne antidiabetike, občasno poročali o hipoglikemiji in pogosto o hiperglikemiji.
Patients in the BTDx group received six 4-week cycles, each consisting of bortezomib (1.3 mg/m2 administered twice weekly days
Bolniki v skupini BR-CAP so prejeli bortezomib (1,3 mg/m2 na
Pancreatitis acute, Peritonitis*, Tongue oedema*, Ascites, Oesophagitis, Cheilitis, Faecal incontinence, Anal sphincter atony, Faecaloma*, Gastrointestinal ulceration and perforation*, Gingival hypertrophy, Megacolon, Rectal discharge, Oropharyngeal blistering*, Lip pain, Periodontitis, Anal fissure, Change of bowel habit, Proctalgia, Abnormal faeces
Redki akutni pankreatitis, peritonitis*, edem jezika*, ascites, ezofagitis, heilitis, inkontinenca blata, atonija analnega sfinktra, fekalom*, razjede in perforacije v prebavilih*, hipertrofija dlesni, megakolon, izcedek iz rektuma, orofaringealni mehurji*, bolečina v ustnicah, periodontitis, analna fisura, spremembe pri odvajanju blata, proktalgija, nenormalno blato
Mean total body clearances were 102 and 112 l/h following the first dose for doses of 1.0 mg/m2 and 1.3 mg/m respectively, and ranged from 15 to 32 l/h and 18 to 32 l/h following subsequent doses for doses of 1.0 mg/m2 and 1.3 mg/m2, respectively.
Po odmerku 1,0 mg/m je srednji celotni očistek telesa po prvem odmerku znašal 102 l/h in 112 l/h po odmerku 1,3 mg/m 2.
• advice on method of administration for both IV and SC use, including the need to rotate injection sites for SC use
in s.c. in da je pri s.c. uporabi potrebno menjati mesta injiciranja.
Injection sites should be rotated for successive injections.
Za uspešna injiciranja je treba mesta injiciranja menjati.
Intent to Treat (ITT) population p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p < 0.0001 Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product.
a populacija z namenom zdravljenja (ITT - Intent To Treat) b vrednost p iz stratificiranega testa log-rang; v analizi po vrsti zdravljenja ni bila vključena stratifikacija po terapevtski anamnezi, p < 0,0001 c Populacija, pri kateri so ovrednotili odziv na zdravljenje, vključuje bolnike, ki so imeli merljivo bolezen na začetku in so prejeli najmanj en odmerek preskušanega zdravila d vrednost p iz Cochran-Mantel-Haenszelovega hi-kvadrat testa, korigiranega s faktorji stratifikacije; v analizi po vrsti zdravljenja ni bila vključena stratifikacija po terapevtski anamnezi * CR+PR+MR; **CR=CR, (IF-); nCR=CR (IF+)
Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether bortezomib (1.3 mg/m2 injected intravenously) in combination with melphalan (9 mg/m 2) and prednisone (60 mg/m 2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m2) and prednisone (60 mg/m2) in patients with previously untreated multiple myeloma.
mg/m2) in prednizonom (60 mg/m2) vodi v podaljšanje časa do napredovanja bolezni (TTP - Time To Progression) v primerjavi z zdravljenjem samo z melfalanom (9 mg/m2) in prednizonom (60 mg/m pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom, so izvedli prospektivno, mednarodno, randomizirano (1:1), odprto klinično preskušanje faze III (MMY-3002 VISTA) s 682 bolniki.