natgillin/translations-raw huggingface dataset:
Uncommon: hyperkalaemia, cachexia, hypercalcaemia, hypocalcaemia, hypernatraemia, hyponatraemia, hypoglycaemia, hyperuricaemia, vitamin B12 deficiency, appetite increased, hypomagnesaemia, hypophosphataemia.
dehidracija, hipokaliemija, hiperglikemija. hiperkaliemija, kaheksija, hiperkalciemija, hipokalciemija, hipernatriemija, hipoglikemija, hiperurikemija, pomanjkanje vitamina B12, zvečan apetit,
Psychiatric disorders Common: confusion, depression, insomnia, anxiety.
Občasni:
Uncommon: agitation, delirium, hallucinations, restlessness, mood swings, mental status changes, sleep disorder, irritability, abnormal dreams.
zmedenost, depresija, nespečnost, anksioznost. vznemirjenost, delirij, halucinacije, nemir, nihanje razpoloženja, spremembe
Nervous system disorders (see sections 4.4 and 4.7) Very common:
Pogosti:
peripheral neuropathy, peripheral sensory neuropathy (see section 4.4),
polinevropatija, poslabšanje periferne nevropatije, omotica (z izjemo vrtoglavice),
paraesthesia, headache.
motnje okusa, disestezija, hipoestezija, tremor.
Common: polyneuropathy, peripheral neuropathy aggravated, dizziness (excluding vertigo), dysgeusia, dysaesthesia, hypoaesthesia, tremor.
paraplegija, možganska krvavitev, subarahnoidna krvavitev, krči (glejte poglavje 4. 4),
Uncommon: paraplegia, intracranial haemorrhage, subarachnoid haemorrhage convulsions (see section 4.4), peripheral motor neuropathy, syncope, paresis, disturbance in attention, increased activity, ageusia, somnolence, migraine, cognitive disorder, jerky movements, dizziness postural, sciatica, mononeuropathy, speech disorder, restless leg syndrome.
Občasni:
Eye disorders Common: vision blurred (see section 4.7), eye pain.
zameglen vid (glejte poglavje 4. 7), bolečina v očesu. krvavitve v očesu, nenormalen vid, suho oko, konjunktivitis, izcedek iz očesa,
Uncommon: eye haemorrhage, vision abnormal, dry eye, conjunctivitis, eye discharge, photophobia, eye irritation, lacrimation increased, conjunctival hyperaemia, eye swelling.
Občasni:
9 Ear and labyrinth disorders Common: vertigo.
9 Srčne bolezni Občasni:
Uncommon: deafness, tinnitus, hypoacusis, hearing impaired.
srčni zastoj, kardiogeni šok, miokardni infarkt, angina pektoris, nestabilna angina
Cardiac disorders Uncommon: cardiac arrest, cardiogenic shock, myocardial infarction, angina pectoris, angina unstable, development or exacerbation of congestive heart failure (see section 4.4), cardiac failure, ventricular hypokinesia, pulmonary oedema and acute pulmonary oedema, sinus arrest, atrioventricular block complete, tachycardia, sinus tachycardia, supraventricular tachycardia, arrhythmia, atrial fibrillation, palpitations.
Žilne bolezni
Rare: new onset of decreased left ventricular ejection fraction.
nov pojav zmanjšanja iztisne frakcije levega prekata.
Vascular disorders Common: hypotension, orthostatic and postural hypotension (see sections 4.4 and 4.7), phlebitis, haematoma, hypertension.
hipotenzija, ortostatska in posturalna hipotenzija (glejte poglavji 4. 4 in 4. 7), flebitis,
Uncommon: cerebral hemorrhage, vasculitis, cerebrovascular accident, pulmonary hypertension, petechiae, ecchymosis, purpura, vein discolouration, vein distended, wound hemorrhage, flushing, hot flushes.
možganska krvavitev, vaskulitis, cerebrovaskularni dogodki, pljučna hipertenzija,
Respiratory, thoracic and mediastinal disorders Very common:
Pogosti:
dyspnoea.
Občasni:
Common: dyspnoea exertional, epistaxis, cough, rhinorrhoea.
dispneja pri naporu, epistaksa, kašelj, rinoreja. respiratorna odpoved, hipoksija, pljučna kongestija, plevralni izliv, astma, respiratorna
Uncommon: respiratory arrest, hypoxia, pulmonary congestion, pleural effusion, asthma, respiratory alkalosis, tachypnoea, wheezing, nasal congestion, hoarseness, rhinitis, hyperventilation, orthopnoea, chest wall pain, sinus pain, throat tightness, productive cough.
Pogosti:
Gastrointestinal disorders (see section 4.4) Very common:
bolečina v trebuhu, stomatitis, dispepsija, mehko blato, bolečina v zgornjem delu
vomiting, diarrhoea, nausea, constipation.
Občasni:
Common: abdominal pain, stomatitis, dyspepsia, loose stools, abdominal pain upper, flatulence, abdominal distension, hiccups, mouth ulceration, pharyngolaryngeal pain, dry mouth.
akutni pankreatitis, paralitični ileus, kolitis povzročen z antibiotiki, kolitis,
Uncommon: acute pancreatitis, ileus paralytic, antibiotic associated colitis, colitis, haematemesis, diarrhoea haemorrhagic, gastrointestinal haemorrhage, rectal haemorrhage, enteritis, dysphagia, abdominal discomfort, eructation, gastrointestinal motility disorder, oral pain, retching, change in bowel habit, spleen pain, oesophagitis, gastritis, gastro-oesophageal reflux disease, gastrointestinal pain, gingival bleeding, gingival pain, hiatus hernia, irritable bowel syndrome, oral mucosal petechiae, salivary hypersecretion, tongue coated, tongue discolouration, faecal impaction.
Bolezni jeter, žolčnika in žolčevodov (glejte poglavje 4. 4) Občasni:
Hepato-biliary disorders (see section 4.4) Uncommon: hepatitis, hepatic haemorrhage, hypoproteinaemia, hyperbilirubinaemia.
hepatitis, krvavitev v jetrih, hipoproteinemija, hiperbilirubinemija.
Skin and subcutaneous tissue disorders Very common:
Bolezni kože in podkožja Zelo pogosti: izpuščaj.
Common: periorbital skin, eczema.
Pogosti: koža, ekcem.
rash. oedema, urticaria, rash pruritic, pruritus, erythema, sweating increased, dry
periorbitalni edem, urtikarija, srbeč izpuščaj, pruritus, eritem, povečano znojenje, suha
Uncommon: vasculitic rash, rash erythematous, photosensitivity reaction, contusion, pruritus generalised, rash macular, rash papular, psoriasis, rash generalized, eyelid oedema, face oedema, dermatitis, alopecia, nail disorder, skin discolouration, dermatitis atopic, hair texture abnormal, heat rash, night sweats, pressure sore, ichthyosis, skin nodule.
Pogosti:
Musculoskeletal, connective tissue and bone disorders Very common:
oslabelost mišic, kostno- mišična bolečina, bolečine v udih, mišični krči, bolečina v
myalgia.
Občasni:
Common: muscle weakness, musculoskeletal pain, pain in limb, muscle cramps, arthralgia, bone pain, back pain, peripheral swelling.
mišični spazmi, trzanje mišic ali občutek teže, mišična okorelost, otekanje sklepov,
Uncommon: muscle spasms, muscle twitching or sensation of heaviness, muscle stiffness, joint swelling, joint stiffness, buttock pain, swelling, pain in jaw.
Občasni:
10 Renal and urinary disorders Common: renal impairment, dysuria.
ledvična okvara, disurija. akutna ledvična odpoved, ledvična odpoved, oligurija, ledvična kolika, hematurija,
Uncommon: renal failure acute, renal failure, oliguria, renal colic, haematuria, proteinuria, urinary retention, urinary frequency, difficulty in micturition, loin pain, urinary incontinence, micturition urgency.
Motnje reprodukcije in dojk Občasni:
Reproductive system and breast disorders Uncommon: testicular pain, erectile dysfunction.
bolečina v modih, erektilna disfunkcija.
General disorders and administration site conditions Very common:
Pogosti:
fatigue (see section 4.7), pyrexia.
bolečine v prsih, bolečina, edem.
Common: asthenia, weakness, lethargy, rigors, malaise, influenza like illness, oedema peripheral, chest pain, pain, oedema.
padec, krvavitev iz sluznice, vnetje sluznice, nevralgija, flebitis na mestu injiciranja,
Uncommon: fall, mucosal haemorrhage, mucosal inflammation, neuralgia, injection site phlebitis, extravasation inflammation tenderness, injection site erythema, feeling cold, chest pressure sensation, chest discomfort, groin pain, chest tightness.
Občasni:
Investigations Common: weight decreased, blood lactate dehydrogenase increased.
zmanjšanje telesne mase, povečanje koncentracije laktat dehidrogenaze v krvi. povečanje koncentracije alanin aminotransferaze, povečanje koncentracije aspartat
Uncommon: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, blood alkaline phosphatase increased, blood creatinine increased, blood urea increased, gamma-glutamyltransferase increased, blood amylase increased, liver function tests abnormal, red blood cell count decreased, white blood cell count decreased, blood bicarbonate decreased, heart rate irregular, C-reactive protein increased, blood phosphate decreased, weight increased.
Poškodbe, zastrupitve in zapleti pri posegih Občasni: opekline.
Injury and poisoning Uncommon: catheter related complications, post procedural pain, post procedural haemorrhage, burns.
zapleti, povezani z uporabo katetra, bolečina po posegu, krvavitev po posegu,
Summary of safety data in patients with previously untreated multiple myeloma:
Povzetek podatkov o varnosti zdravila pri bolnikih z diseminiranim plazmocitomom, ki ga predhodno še niso zdravili:
The following table 5 describes safety data from 340 patients with previously untreated multiple myeloma who received VELCADE (1.3 mg/ m2) in combination with melphalan (9 mg/ m2) and prednisone (60 mg/ m2) in a prospective Phase III study.
V prospektivni študiji III. faze so prejemali zdravilo VELCADE (1, 3 mg/ m2) v kombinaciji z melfalanom (9 mg/ m2) in prednizolonom (60 mg/ m2).
Overall, the safety profile of patients treated with VELCADE in monotherapy was similar to that observed in patients treated with VELCADE in combination with melphalan and prednisone.
Celokupno je bil varnostni profil bolnikov zdravljenih z zdravilom VELCADE v monoterapiji podoben profilu opaženem pri bolnikih zdravljenih z zdravilom VELCADE v kombinaciji z melfalanom in prednizolonom.
Treatment emergent drug-related adverse reactions reported in ≥ 10% of patients treated with VELCADE in combination with melphalan and prednisone -------------- Vc+M+P ------------ ---------------- M+P ---------------
Neželeni učinki, ki so se pojavili med zdravljenjem in so povezani z zdravilom, poročani pri ≥ 10% bolnikov zdravljenih z zdravilom VELCADE v kombinaciji z melfalanom in prednizolonom
(n=340)
-------------- Vc+M+P -------------- (n=340)
MedDRA System Organ Class
celokupno stopnja toksičnosti, n (%) celokupno stopnja toksičnosti, n (%) Organski sistemi po MedDRA
Total Toxicity
število
Grade, n
število
Preferred Term Infections and Infestations
termin Infekcijske in parazitske bolezni
Herpes Zoster Blood and lymphatic system disorders
herpes zoster Bolezni krvi in limfatičnega sistema
-------------- Vc+M+P ------------ ---------------- M+P ---------------
9 (3)
(n=340)
4 (1)
(n=337)
57 (17) 33 (10)
MedDRA System Organ Class
140 (42) 143 (42)
Total Toxicity
48 (14) 77 (23)
Grade, n
(12) (12)
(%) Total Toxicity Grade, n (%)
anemija levkopenija
Preferred Term
109 (32) 108 (32)
n (%)
4 (1) 8 (2)
3
(5) (3)
≥ 4 n (%) 3
51 (15)
≥ 4
26 (8)
Anorexia Psychiatric disorders
anoreksija Psihiatrične motnje
Insomnia Nervous system disorders
nespečnost Bolezni živčevja
Peripheral Neuropathy
periferna nevropatija nevralgija
156 (46)
156 (46) 117 (34)
42 (12)
42 (12) 27 (8)
2 (1)
2 (1) 2 (1)
4 (1)
4 (1) 1 (< 1)
Neuralgia Paraesthesia Gastrointestinal disorders
---------------- M+P --------------- (n=337)
117 (34) 42 (12)
število
27 (8) 6 (2)
število
2
6 (2)
(1) 0
4 (1) 0
1 (< 1) 4 (1)
1
0 0
0 (3) 19 (6)
Nausea
0 2 (1)
134 (39)
70 (21) 20 (6)
1
1 (< 1) 1 (< 1)
2 (1)
0 0
Vomiting Constipation Abdominal Pain Upper Skin and subcutaneous tissue disorders
bruhanje zaprtje bolečina v zgornjem delu trebuha Bolezni kože in podkožja
87 (26) 77 (23) 34 (10)
87 (26) 77 (23) 34 (10)
13 (4) 2 (1) 1 (< 1)
13 (4) 2 (1) 1 (< 1)
41 (12) 14 (4) 20 (6)
41 (12) 14 (4) 20 (6)
2 (1) 0 0
2 (1) 0 0
Rash General disorders and administration site conditions
izpuščaj Splošne težave in spremembe na mestu aplikacije
7 (2)
2 (1)
Pyrexia
zvišana telesna temperatura
In the Phase III study in patients with previously untreated multiple myeloma, 27% of patients received prophylactic antivirals in the Vc+M+P arm.
V študiji III. faze, pri bolnikih s predhodno ne- zdravljenim diseminiranim plazmocitomom, je 27% bolnikov (v Vc+M+P kraku študije) preventivno prejelo protivirusna zdravila.
In this study, herpes zoster reactivation was more common in patients treated with Vc+M+P compared with M+P (11% vs 3% respectively).
V tej študiji je bila reaktivacija virusa herpes zoster pri bolnikih zdravljenih z Vc+M+P pogostejša, kot pri bolnikih zdravljenih z M+P (11% v primerjavi s 3%).
Three (3%) of the 91 patients in the Vc+M+P treatment group who received prophylactic antivirals developed herpes zoster reactivation.
Med 91 bolniki, v skupini zdravljeni z Vc+M+P, ki so preventivno prejeli protivirusna zdravila je pri treh (3%) prišlo do reaktivacije virusa herpes zoster.
Post-marketing experience Clinically significant adverse reactions are listed in Table 6, if they have been reported during post approval use of VELCADE and may or may not have been reported in clinical trials.
Izkušnje po pridobitvi dovoljenja za promet z zdravilom V preglednici 6 so navedeni klinično pomembni neželeni učinki o katerih so poročali po pridobitvi dovoljenja za promet z zdravilom, o nekaterih so poročali v kliničnih preskušanjih o drugih pa ne.
Their frequency is not known.
Njihova pogostnost ni znana.
Immune system disorders
Neželeni učinki o katerih so poročali po pridobitvi dovoljenja za promet Infekcijske in parazitske bolezni herpetični meningoencefalitis, septični šok neznana:
Nervous system disorders
Bolezni imunskega sistema angioedem neznana:
Encephalopathy, autonomic neuropathy
Bolezni živčevja encefalopatija, avtonomna nevropatija neznana:
Ophthalmic herpes
Očesne bolezni herpes na očesu neznana:
Gastrointestinal disorders
Srčne bolezni tamponada srca, perikarditis, kardialna in kardiorestpiratorna odpoved, ventrikularne aritmije, popolni atrioventrikularni blok, neznana: atrijska fibrilacija, tahikardija, sinusna in ventrikularna tahikardija Bolezni dihal, prsnega koša in mediastinalnega prostora (glejte poglavje 4. 4) pnevmonitis, pljučnica, intersticijska pljučnica, sindrom akutne respiratorne stiske (SARS), akutna difuzna infiltracijska pljučna bolezen, pulmonarna hipertenzija, odpoved dihanja, pljučna neznana: alveolarna hemoragija, akutni pljučni edem, pljučni edem, pljučna embolija, periferna embolija.
disease, pulmonary hypertension, respiratory failure, pulmonary alveolar haemorrhage, acute pulmonary oedema, pulmonary oedema, pulmonary embolism, peripheral embolism
12 Bolezni prebavil ishemični kolitis neznana:
Hepatobiliary disorders
Bolezni jeter, žolčnika in žolčevodov odpoved jeter neznana:
Ischemic colitis
4. 9 Preveliko odmerjanje
(For preclinical cardiovascular safety pharmacology studies, see section 5.3.
Pri bolnikih je bilo preveliko odmerjanje (odmerki so bili več kot dvakrat višji od priporočenega) povezano z akutnim pojavom simptomatične hipotenzije in trombocitopenije s smrtnimi izidi (Za preklinična farmakološka preskušanja kardiovaskularne varnosti zdravila glejte poglavje 5. 3).
There is no known specific antidote for bortezomib overdose.
Za bortezomib specifični antidot ni poznan.
In the event of an overdose, the patient ’ s vital signs should be monitored and appropriate supportive care given to maintain blood pressure (such as fluids, pressors, and/ or inotropic agents) and body temperature (see sections 4.2 and 4.4).
V primeru prevelikega odmerjanja zdravila Velcade je treba spremljati bolnikove vitalne znake in uvesti ustrezne podporne ukrepe za vzdrževanje krvnega tlaka (npr.: tekočine, učinkovine, ki zvišujejo krvni tlak, in/ ali inotropne učinkovine) in telesne temperature (glejte poglavji 4. 2 in 4. 4).
Other antineoplastic agents, ATC code:
Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe Oznaka ATC:
This medicinal product has been authorised under “ Exceptional Circumstances”.
Zdravilo je pridobilo tako imenovano "pogojno dovoljenje za promet".
This means that for scientific reasons it has not been possible to obtain complete information on this medicinal product.
To pomeni, da zaradi znanstvenih razlogov ni bilo mogoče pridobiti vseh informacij v povezavi s tem zdravilom.
The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo vsako leto ponovno pregledala nove podatke o zdravilu in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
Mechanism of action Bortezomib is a proteasome inhibitor.
Mehanizem delovanja Bortezomib je zaviralec proteasoma.
The ubiquitin-proteasome pathway plays an essential role in regulating the turnover of specific proteins, thereby maintaining homeostasis within cells.
Pot prek kompleksa ubikvitin- proteasom ima pomembno vlogo pri uravnavanju presnove specifičnih beljakovin in tako ohranja homeostazo v celicah.
At 10 μ M concentrations, bortezomib does not inhibit any of a wide variety of receptors and proteases screened and is more than 1500-fold more selective for the proteasome than for its next preferable enzyme.
Pri koncentraciji 10 μM bortezomib ne zavira nobenega od številnih različnih pregledanih receptorjev in proteaz in je več kot 1500- krat bolj selektiven za proteasom kot za njegov drugouvrščeni prednostni encim.
Bortezomib mediated proteasome inhibition affects cancer cells in a number of ways, including, but not limited to, altering regulatory proteins, which control cell cycle progression and nuclear factor kappa B (NF-kB) activation.
Zaviranje proteasoma z bortezomibom vpliva na rakave celice na več načinov, vključno s spremembo regulatornih proteinov, ki nadzorujejo napredovanje celičnega ciklusa in aktivacijo nuklearnega faktorja kappa B (NF- kB).
13 including cell growth and survival, angiogenesis, cell-cell interactions, and metastasis.
NF- kB je transkripcijski faktor, katerega aktivacija je potrebna za mnoge stopnje nastanka tumorja, npr. za rast in preživetje celic, angiogenezo, interakcije med celicami in metastaziranje.
Experiments have demonstrated that bortezomib is cytotoxic to a variety of cancer cell types and that cancer cells are more sensitive to the pro-apoptotic effects of proteasome inhibition than normal cells.
Bortezomib je
Bortezomib causes reduction of tumour growth in vivo in many preclinical tumour models, including multiple myeloma.
13 povzročil zmanjšanje rasti tumorja in vivo v mnogih predkliničnih tumorskih modelih, vključno z modelom diseminiranega plazmocitoma.
Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (VISTA) of 682 patients was conducted to determine whether VELCADE (1.3 mg/ m2) in combination with melphalan (9 mg/ m2) and prednisone (60 mg/ m2) 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.
Klinična učinkovitost pri bolnikih s predhodno ne- zdravljenim diseminiranim plazmocitomom Za ugotovitev ali uporaba zdravila VELCADE (1, 3 mg/ m2) v kombinaciji z melfalanom (9 mg/ m2) in prednizolonom (60 mg/ m2) prispeva k podaljšanju časa do napredovanja bolezni (Time To Progression- TTP) v primerjavi z zdravljenjem samo z melfalanom (9 mg/ m2) in prednizolonom (60 mg/ m2), pri bolnikih s predhodno ne- zdravljenim diseminiranim plazmocitomom, so izvedli prospektivno, mednarodno, randomizirano (1: 1) odprto klinično študijo III. faze (VISTA) pri 682 bolnikih.
Baseline demographics and patient characteristics are summarized in Table 7.
Demografski podatki bolnikov pred začetkom zdravljenja so podani v Preglednici 7.
Summary of baseline patient and disease characteristics in the VISTA study
Povzetek demografskih podatkov bolnikov in značilnosti bolezni v študiji VISTA
Patient characteristics
Podatki o bolnikih
Median age in years (range) Gender: male/ female
srednja starost v letih (razpon) spol: moški/ ženske
Race: caucasian/ asian/ black/ other Karnofsky performance status score ≤ 70 Hemoglobin < 100 g/ l Platelet count < 75 x 109/ l Disease Characteristics
rasa: belci/ azijci/ temnopolti/ ostalo ocena stanja zmogljivosti po Karnofskem ≤ 70 hemoglobin < 100 g/ l
88% / 10% / 1% / 1% 35% 37% < 1%
/ 1% / 1% 35% 37%
87% / 11% / 2% / 0% 33% 36% 1%
87% / 11% / 2% / 0% 33% 36%
Type of myeloma (%):
< 1%
64% / 24% / 8% 4.2 33.0 20 (6%)
1%
62% / 26% / 8% 4.3 33.0 16 (5%)
26% / 8% 4, 3 33, 0
Survival continued to be followed after the interim analysis.
Po vmesni analizi so še naprej spremljali preživetje.
Median follow-up was 16.3 months.
Srednja vrednost je bila 16, 3 mesecev.
Efficacy results are presented in Table 7:
Podatki o učinkovitosti so navedeni v Preglednici 7:
Summary of efficacy analyses in the VISTA study Efficacy endpoint Time to progression –
Povzetek analize učinkovitosti v študiji VISTA Učinkovitost Čas do napredovanja bolezni
Events n (%) Mediana (95% CI)
dogodki n (%)
Hazard ratiob
srednja vrednosta (95% CI) stopnja tveganjab
(17.6, 24,7)
20, 7 mesecev (17, 6, 24, 7)
(14.1, 17.9)
15, 0 mesecev (14, 1, 17, 9)
(95% CI) p-value c Progression-free survival
(95% CI) p- vrednostc Preživetje brez napredovanja bolezni
(16.6, 21.7)
18, 3 mesecev (16, 6, 21, 7)
(11.1, 15.0)
14, 0 mesecev (11, 1, 15, 0)
(95% CI) p-value c Overall survival
(95% CI) p- vrednost c Celokupno preživetje
Events (deaths) n (%) Hazard ratiob (95% CI) c
dogodki (smrti) n (%) stopnja tveganjab (95% CI) p- vrednostc Stopnja odziva populacijae n = 668
p-value
14 Učinkovitost
0.00782
Vc+M+P n=344
n=331
M+P n=338
CR + PRf n (%) p-valued
PRf n (%) nCR n (%) CR + PRf n (%) p- vrednostd Zmanjšanje serumskega M- proteina populacijag n=667
n=331
103 (31) 0 115 (35) n=331
> =90% n (%) Time to first response in CR + PR
> =90% n (%) Čas do prvega odziva pri CR + PR
Median a Median response duration
srednja vrednost Srednja vrednosta trajanja odziva
1.4 mo
1, 4 mesecev
4.2 mo
4, 2 mesecev
CRf CR + PRf Time to next therapy
CRf CR + PRf Čas do naslednjega zdravljenja
24.0 mo 19.9 mo
24, 0 mesecev 19, 9 mesecev
12.8 mo 13.1 mo
12, 8 mesecev 13, 1 mesecev
Events n (%) Mediana
dogodki n (%) srednja vrednosta (95% CI) stopnja tveganjab
(0.39, 0.70)
127 (38) 20, 8 mesecev (18, 3, 28, 5)
p-value a
(95% CI) p- vrednostc a Ocena po metodi Kaplan- Meier. b
0.000009
(0, 39, 0, 70) 0, 000009
Kaplan-Meier estimate. b Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β 2-microglobulin, albumin, and region.
Ocena stopnje tveganja na osnovi Coxovega proporcionalnega modela, prilagojena na osnovi stratifikacijskih dejavnikov: β2- mikroglobulin, albumin in regija.
A hazard ratio less than 1 indicates an advantage for VMP c p-value based on the stratified log-rank test adjusted for stratification factors: beta2-microglobulin, albumin, and region d p-value for Response Rate (CR + PR) from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors e Response population includes patients who had measurable disease at baseline f EBMT criteria g All randomized patients with secretory disease
Stopnja tveganja manjša kot 1 kaže prednost zdravljenja z VcMP. c p- vrednost na osnovi stratificiranega log- rank testa, prilagojena na osnovi stratifikacijskih dejavnikov: β2- mikroglobulin, albumin in regija. d p- vrednost za stopnjo odziva (CR + PR) po Cochran- Mantel- Haenszel hi- kvadratnem testu, prilagojena na osnovi stratifikacijskih dejavnikov e Populacijo, pri kateri je prišlo do odziva, predstavljajo bolniki, pri katerih so lahko ovrednotili bolezen pred začetkom zdravljenja. f EBMT kriteriji g Vsi randomizirani bolniki s sekrecijsko boleznijo NE:
Not estimable
(Not Estimable) ocena ni mogoča
(see Tables 9, 10 and 11).
Klinična učinkovitost pri relapsu ali diseminiranem plazmocitomu, odpornem na zdravljenje Varnost in učinkovitost zdravila VELCADE v priporočenem odmerku (1, 3 mg/ m2) so ovrednotili v dveh preskušanjih: v randomiziranem, primerjalnem (primerjava z deksametazonom (Dex)) preskušanju tretje faze pri 669 bolnikih z relapsom ali z diseminiranim plazmocitomom, odpornim na zdravljenje, ki so pred tem že prejeli 1 do 3 vrste terapije ter v enodelnem preskušanju druge faze pri 202 bolnikih z relapsom ali z diseminiranim plazmocitomom, odpornim na zdravljenje, ki so pred tem že prejeli najmanj 2 vrsti terapije in je bolezen ob zadnji vrsti terapije napredovala (glejte preglednice 9, 10 in 11).