natgillin/translations-raw huggingface dataset:
• Changes in or abnormal bowel function
• spremembe v delovanju ali nenormalno delovanje črevesja
In the unlikely event of an overdose, your doctor will monitor you for side effects.
V primeru prevelikega odmerjanja vas bo vaš zdravnik spremljal glede pojava neželenih učinkov.
• Haemoglobin ≥ 8 g/dL
• Koncentracija hemoglobina ≥ 8 g/dl (80 g/l).
Overall, VELCADE was administered for the treatment of multiple myeloma in 3,974 patients.
Za zdravljenje diseminiranega plazmocitoma je zdravilo VELCADE prejelo skupno 3.974 bolnikov.
Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, the CYP2D6 poor metaboliser phenotype is not expected to affect the overall disposition of bortezomib.
Na osnovi majhnega deleža (7%) encima CYP2D6 pri presnovi bortezomiba ni pričakovati, da bi fenotip slabe presnove s CYP2D6 vplival na skupno izločanje bortezomiba.
• The reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
• Rekonstituirano raztopino injiciramo subkutano v stegno (desno ali levo) ali trebuh (desno ali levo).
• Facial blushing or tiny broken capillaries
• rdečica obraza ali pokanje drobnih kapilar
• Inject the solution subcutaneously, under a 45-90°angle.
• Raztopino injicirajte subkutano, pod kotom 45-90 °.
The duration of overall response was 21.4 months longer in the VcR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
Trajanje celokupnega odgovora je bilo 21,4 mesecev daljše v skupini VcR-CAP (mediana 36,5 mesecev proti 15,1 meseca v skupini R-CHOP).
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Če ste prejeli večji odmerek zdravila VELCADE, kot bi smeli To zdravilo vam bo injiciral vaš zdravnik ali medicinska sestra zato ni verjetno, da bi ga lahko prejeli preveč.
VELCADE therapy should be withheld for up to 2 weeks until the patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL.
Zdravljenje z zdravilomVELCADE je treba prekiniti za največ 2 tedna, dokler nima bolnik ANC ≥ 750 celic/μl in število trombocitov ≥ 25.000 celic/μl.
What VELCADE is and what it is used for What you need to know before you use VELCADE How to use VELCADE
Kaj je zdravilo VELCADE in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo VELCADE Kako uporabljati zdravilo VELCADE Možni neželeni učinki
Patients should be instructed to seek medical advice if they experience symptoms of dizziness, light-headedness or fainting spells.
Bolnikom morate naročiti, naj se posvetujejo z zdravnikom, če imajo simptome omotice, vrtoglavice ali napade nezavesti.
Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma Prior to initiating a new cycle of therapy:
Prilagajanje odmerkov med zdravljenjem pri bolnikih z nezdravljenim limfomom plaščnih celic Pred začetkom novega kroga zdravljenja:
(CrCL=20-39 ml/min/1.73 m 2, n=9), and Severe (CrCL < 20 ml/min/1.73 m 2, n=3).
(CrCL = 40-59 ml/min/1,73 m 2, n = 10), zmerna okvara ledvic (CrCL = 20-39 ml/min/1,73 m 2, n = 9),
• Swelling of body, to include eyes and other parts of the body
• otekanje telesa, vključno z očmi in drugimi deli telesa
Patients with previously treated light-chain (AL) Amyloidosis An open label non randomised Phase I/II study was conducted to determine the safety and efficacy of VELCADE in patients with previously treated light-chain (AL) Amyloidosis.
Bolniki, s predhodno zdravljeno amiloidozo lahkih verig (AL amiloidoza) V odprti, ne-randomizirani študiji faze I/II so ugotavljali varnost in učinkovitost zdravila VELCADE pri bolnikih, s predhodno zdravljeno AL amiloidozo.
Macrophage activation
Redki aktivacija makrofagov
Fertility Fertility studies were not conducted with VELCADE (see section 5.3).
Plodnost Študije plodnosti pri uporabi zdravila VELCADE niso bile izvedene (glejte poglavje 5.3).
If you are given VELCADE for multiple myeloma or mantle cell lymphoma, tell your doctor straight away if you notice any of the following symptoms: - muscle cramping, muscle weakness - confusion, visual loss or disturbances, blindness, seizures, headaches - shortness of breath, swelling of your feet or changes in your heart beat, high blood pressure,
Če prejemate zdravilo VELCADE za zdravljenje diseminiranega plazmocitoma ali limfoma plaščnih celic, takoj obvestite svojega zdravnika, če se pri vas pojavi kateri koli od naslednjih simptomov: - mišični krči, mišična šibkost - zmedenost, izguba ali motnje vida, slepota, epileptični napadi, glavoboli - težko dihanje, otekanje nog ali spremembe srčnega utripa, visok krvni tlak, utrujenost,
The median duration of complete response was 42.1 months in the VcR-CAP group compared with 18 months in the R-CHOP group.
Mediana trajanja popolnega odgovora je bila 42,1 meseca v skupini VcR-CAP in 18 mesecev v skupini R-CHOP.
Progressive multifocal leukoencephalopathy (PML) Very rare cases with unknown causality of John Cunningham (JC) virus infection, resulting in PML and death, have been reported in patients treated with VELCADE.
Progresivna multifokalna levkoencefalopatija (PML) Pri bolnikih, zdravljenih z zdravilom VELCADE, so poročali o zelo redkih primerih okužbe z JC virusom (John Cunningham virus), z neznano vzročno povezavo, ki je vodila v PML in smrt.
A hazard ratio < 1 indicates an advantage for VcR-CAP.
Stopnja tveganja < 1 predstavlja prednost za skupino VcR-CAP.
Mannitol (E 421) Nitrogen
manitol (E 421), dušik
Geometric mean (%CV) clearance was 7.79 (25%) L/hr/m2, volume of distribution at steady-state was 834 (39%) L/m2, and the elimination half-life was 100 (44%) hours.
Geometrični povprečni očistek (%CV) je bil 7,79 l/h/m (25%), volumen porazdelitve v dinamičnem ravnovesju 834 l/m2 (39%), razpolovni čas izločanja pa
Grade 4 (life-threatening consequences; urgent intervention indicated) and/or severe autonomic neuropathy
Stopnja 4 (posledice, ki ogrožajo življenje;potrebno je nujno ukrepanje ) in/ali huda avtonomna nevropatija ukinite zdravilo VELCADE
Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy VcR-CAP (N=240)
Preglednica 10: Pojavnost periferne nevropatije v študiji LYM-3002 glede na stopnjo toksičnosti in prekinitev zdravljenja zaradi periferne nevropatije VcR-CAP (n = 240)
Intravenous use only.
Samo za intravensko uporabo.
• Redness and pain at injection site
• pordelost in bolečina na mestu injiciranja
No clinical data are available for bortezomib with regard to exposure during pregnancy.
Za bortezomib ni na voljo kliničnih podatkov nosečnic, ki so bile izpostavljene zdravilu.
Based on a population pharmacokinetic analysis, clearance of bortezomib increased with increasing body surface area (BSA).
Analiza populacijske farmakokinetike je pokazala, da se očistek bortezomiba zveča z zvečanjem telesne površine (BSA- Body Surface Area).
The usual starting dose of VELCADE is 1.3 mg/m2 body surface area twice a week.
Običajni začetni odmerek zdravila VELCADE je 1,3 mg/m2 telesne površine dvakrat na teden.
Patients who had received 2 to 3 prior therapeutic regimens had a response rate of 32% (10/32) and patients who received greater than 7 prior therapeutic regimens had a response rate of 31% (21/67).
Bolniki, ki so prejeli 2 do 3 predhodne vrste zdravljenj, so imeli stopnjo odziva 32% (10/32).
Patients on oral antidiabetic agents receiving VELCADE treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetics.
Pri bolnikih, ki so prejemali peroralne antidiabetike in zdravilo VELCADE, je potrebno skrbno spremljanje koncentracije glukoze v krvi in prilagoditi odmerek antidiabetika.
The median TTP was 6.5 months for the VELCADE monotherapy patients compared with 9.3 months for the VELCADE plus pegylated liposomal doxorubicin combination therapy patients.
Mediana vrednost TTP je znašala 6,5 mesecev pri bolnikih, ki so prejemali samo zdravilo VELCADE, v primerjavi z 9,3 meseci pri tistih, ki so prejemali kombinirano zdravljenje z zdravilom VELCADE in pegiliranim liposomskim doksorubicinom.
Regardless of 2-microglobulin levels at baseline, all efficacy parameters (time to progression and overall survival, as well as response rate) were significantly improved on the VELCADE arm.
Ne glede na koncentracijo 2-mikroglobulina ob začetku zdravljenja, so se tudi vsi parametri učinkovitosti (čas do napredovanja bolezni in celokupno preživetje, kot tudi odziv na zdravljenje) v delu preskušanja z zdravilom VELCADE statistično značilno izboljšali.
Caution is advised when treating patients with a history of syncope receiving medicinal products known to be associated with hypotension; or who are dehydrated due to recurrent diarrhoea or vomiting.
Pri zdravljenju bolnikov s sinkopami v anamnezi, ki prejemajo zdravila, za katera je znano, da so povezana s pojavom hipotenzije, ali pri tistih, ki so dehidrirani zaradi ponavljajoče driske ali bruhanja, svetujemo previdnost.
• moderate to severe liver problems
• imate zmerne do hude težave z jetri,
Orthostatic/postural hypotension was not acutely related to bolus infusion of VELCADE.
Ortostatska oz. posturalna hipotenzija ni bila akutno povezana z infuzijo zdravila VELCADE.
• Tiredness, feeling weak
• utrujenost, občutek šibkosti
Bortezomib is a proteasome inhibitor.
Bortezomib je zaviralec proteasoma.
• Feeling sick (nausea) or vomiting, loss of appetite
• slabost (navzea) ali bruhanje, izguba apetita
** Instrumental ADL: refers to preparing meals, shopping for groceries or clothes, using telephone, managing money, etc; ***Self care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medicinal products, and not bedridden.
Instrumentalna ADL: zajema pripravo obrokov, nakup živil ali oblačil, uporabo telefona, upravljanje z denarjem, itd; Fizična ADL: zajema kopanje, oblačenje in slačenje, hranjenje, uporabo stranišča, jemanje zdravil, ne zajema pa bolnikov priklenjenih na posteljo zaradi bolezni.
Dose adjustments during treatment and re-initiation of treatment for combination therapy with melphalan and prednisone
Prilagajanje odmerka med zdravljenjem in ob ponovni uvedbi kombiniranega zdravljenja z melfalanom in prednizonom
Confirm concentration on vial to ensure that the correct dose is being given for the intravenous route of administration (1 mg/ml).
Na viali preverite koncentracijo, da zagotovite pravilni odmerek za intravensko dajanje zdravila (1 mg/ml).
When compared to patients with normal hepatic function, mild hepatic impairment did not alter dose-normalised bortezomib AUC.
Ob primerjavi z bolniki z normalnim delovanjem jeter, pri bolnikih z blago jetrno okvaro ni bilo sprememb v povprečnem, na odmerek normaliziranem AUC bortezomiba.
This 21-day period (3 weeks) corresponds to one treatment cycle.
To 21dnevno obdobje (3 tedni) je en krog zdravljenja.
• Lump in the eyelid (chalazion), red and swollen eyelids
• zatrdlina na veki (halazij), rdeče in otekle veke
• Altered levels of consciousness, confusion, memory impairment or loss
• spremenjena stopnja zavesti, zmedenost, poslabšanje ali izguba spomina
A total of 74 evaluable patients were administered dexamethasone in combination with VELCADE.
Odziv na zdravljenje so ocenili pri skupaj 74 bolnikih, ki so prejeli deksametazon v kombinaciji z zdravilom VELCADE.
The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the VcR-CAP group and 5.0% in the R-CHOP group) as well as Grade 3 and higher bleeding events (VcR-CAP: 4 patients [1.7%]; R-CHOP: 3 patients [1.2%]).
V obeh skupinah pa je bila podobna celokupna pojavnost krvavitev vseh stopenj (6,3% v VcR-CAP in 5,0% v R-CHOP) in krvavitev stopnje 3 ali več (VcR-CAP: 4 bolniki [1,7%]; R-CHOP: 3 bolniki [1.2%]).
Undesirable effects in Table 7 were considered by the investigators to have at least a possible or probable causal relationship to VELCADE.
Za neželene učinke, navedene v preglednici 7, so raziskovalci menili, da imajo vsaj možno do verjetno vzročno povezavo z zdravilom VELCADE.
• Bleeding in the brain
• krvavitve v možganih
The European Medicines Agency has waived the obligation to submit the results of studies with VELCADE in all subsets of the paediatric population in multiple myeloma and in mantle cell lymphoma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom VELCADE za vse skupine pediatrične populacije za indikacijo diseminirani plazmocitom in limfom plaščnih celic (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
• Hearing loss, deafness or ringing in the ears, ear discomfort
• poslabšanje sluha, gluhost ali zvonjenje v ušesih, nelagodje v ušesu
Patients achieving a response or a stable disease after 4 cycles of this combination therapy can continue to receive the same combination for a maximum of 4 additional cycles.
Bolniki, ki prejemajo kombinirano zdravljenje in po 4 krogih zdravljenja dosežejo odgovor ali so stabilni, lahko prejmejo enako zdravljenje še največ 4 dodatne kroge.
In the Phase II study, patients who did not obtain an optimal response to therapy with VELCADE alone were able to receive high-dose dexamethasone in conjunction with VELCADE.
Bolniki v študiji faze II, ki niso dosegli optimalnega odziva na zdravljenje z zdravilom VELCADE v monoterapiji, so poleg zdravila VELCADE lahko prejemali tudi deksametazon v velikih odmerkih.
VELCADE should not be administered intrathecally.
Zdravila VELCADE se ne sme dajati intratekalno.
It is recommended that patients be carefully monitored for symptoms of neuropathy such as a burning sensation, hyperesthesia, hypoesthesia, paraesthesia, discomfort, neuropathic pain or weakness.
Priporočamo, da bolnike skrbno spremljate in ugotavljate simptome nevropatije, npr. občutek pečenja, hiperestezijo, hipoestezijo, parestezijo, neprijeten občutek, nevropatično bolečino ali oslabelost.
Grade ≥ 3 non-haematological toxicities considered to be related to VELCADE
Ne-hematološka toksičnost stopnje ≥ 3 povezana z uporabo zdravila VELCADE
Grading based on NCI Common Toxicity Criteria CTCAE v 4.0.
Razvrstitev po 4. različici enotnih meril toksičnosti za vrednotenje neželenih učinkov nacionalnega onkološkega inštituta (NCI Common Toxicity Criteria CTCAE v 4.0).
• different reconstitution requirements for VELCADE 3.5 mg IV or SC use
• Različne zahteve za rekonstitucijo zdravila VELCADE 3,5 mg pri i.v.
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.
Dodatno je bila pri subkutani skupini incidenca perifernih nevropatij stopnje 3 ali več za 10% manjša in za 8% manjša pogostnost prekinitve zdravljenja zaradi perifernih nevropatij, v primerjavi s skupino, ki je zdravilo prejemala intravensko.
• Redness or pain at the injection site
• pordelost ali bolečina na mestu injiciranja
Therefore, you will have to take regular blood tests before and during your treatment with VELCADE, to check your blood cell counts regularly.
Zato vam bodo pred in med zdravljenjem z zdravilom VELCADE, redno pregledovali kri in tako preverjali število vaših krvnih celic.
• Movement disorders, paralysis, twitching
• motnje gibanja, paraliza, trzanje
• Genital pain, problem having an erection
• bolečina v spolovilih, motnje pri doseganju erekcije
• Infection or inflammation of the stomach and intentines
• okužba ali vnetje trebuha in črevesja
Following intravenous bolus administration of a 1.0 mg/m2 and 1.3 mg/m2 dose to 11 patients with multiple myeloma and creatinine clearance values greater than 50 ml/min, the mean first-dose maximum plasma concentrations of bortezomib were 57 and 112 ng/ml, respectively.
Absorpcija Po intravenski aplikaciji bolusnega odmerka 1,0 mg/m2 in 1,3 mg/m2 11 bolnikom z diseminiranim plazmocitomom in očistkom kreatinina večjim kot 50 ml/min, sta bili povprečni vrednosti najvišjih plazemskih koncentracij bortezomiba po prvem odmerku 57 in 112 ng/ml.
• Confirm the dose and concentration in the syringe prior to use (check that the syringe is marked as intravenous administration).
• Pred dajanjem zdravila preverite odmerek in koncentracijo v brizgi (prepričajte se, da je na brizgi oznaka za intravensko dajanje).
Uncommon Colitis (inc clostridium difficile)*
Občasni kolitis (vključno s kolitisom, povzročenim s Clostridium difficile)*
Median PFS by investigator assessment was 30.7 months in the VcR-CAP group and 16.1 months in the R-CHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
Mediana PFS po oceni raziskovalca je bila 30,7 mesecev v skupini VcR-CAP in 16,1 meseca v skupini R-CHOP (razmerje tveganja [HR] = 0,51; p < 0,001).
Overall survival* Events (deaths) n (%) Median (95% CI)
Celokupno preživetje* dogodki (smrti) n (%) Mediana (95% CI)
Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise,
Nekatere vključujejo oteženo dihanje, zasoplost, zasoplost brez telesnega napora, dihanje postane plitvo,
• Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.
• Raztopino injicirajte v obliki 3-5 sekund trajajoče bolusne intravenske injekcije skozi periferno ali centralno intravensko cevko v veno.
The overall best response rate (CR + PR), to retreatment in 130 patients was 38.5% (95% CI: 30.1, 47.4).
Pri 130 bolnikih je bila celokupna stopnja odgovora (CR+PR) 38,5% (95% CI: 30,1;
How to use VELCADE
Kako uporabljati zdravilo VELCADE
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
p-vrednost iz stratificiranega testa log-rank; v analizi po vrsti terapije ni bila vključena stratifikacija po terapevtski anamnezi, p < 0,0001
The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m2 doses to 104 pediatric patients (2-16 years old) with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Farmakokinetiko bortozomiba so ovrednotili po intravenski aplikaciji bolusnega odmerka 1,3 mg/m dvakrat na teden 104 pediatričnim bolnikom (starim 2-16 let) z akutno limfoblastno levkemijo (ALLAcute Lymphoblastic Leukemia) ali z akutno mieloično levkemijo (AML - Acute Myeloid Leukemia).
One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the VcTDx and TDx groups, respectively.
Eno avtologno presaditev krvotvornih matičnih celic so opravili pri 105 (81%) bolnikih v skupini VcTDx in 78 (61%) bolnikih v skupini TDx.
CR+nCR+ PR+MR Median duration Days (months) Time to response CR+PR (days)
CR+nCR+ PR+MR Mediana trajanja odziva dnevi (meseci) Čas do odziva CR+PR (dnevi)
• bleeding problems and/or low number of platelets in your blood
• imate težave s strjevanjem krvi in/ali majhno število krvnih ploščic (trombocitov),
The demographic and baseline disease characteristics were generally well balanced between the two treatment arms: median patient age was 66 years, 74% were male, 66% were Caucasian and 32% Asian, 69% of patients had a positive bone marrow aspirate and/or a positive bone marrow biopsy for MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV disease.
Bolniki v obeh skupinah so na splošno imeli podobne demografske in bolezenske značilnosti: mediana starost bolnikov je bila 66 let, 74% je bilo moških, 66% je bilo belcev in 32% azijcev, 69% bolnikov je imelo pozitivno aspiracijo kostnega mozga in/ali pozitivno biopsijo kostnega mozga za MCL, 54% bolnikov je imelo vrednost mednarodnega prognostičnega indeksa (International Prognostic Index-IPI) ≥ 3 in 76% bolnikov je bilo v IV. stadiju bolezni.
In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the VcR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
Pri bolnikih z MCL (študija LYM-3002) je bila pojavnost okužbe z virusom herpes zoster v skupini VcR-CAP 6,7% in v skupini R-CHOP 1,2% (glejte poglavje 4.8).
Median OS was 90.7 months for the VcR-CAP group compared with 55.7 months for the R-CHOP group (HR=0.66; p=0.001).
V skupini VcR-CAP je bilo mediano OS 90,7 mesecev v primerjavi s 55,7 meseci v skupini R-CHOP (HR=0,66; p=0,001).
The MAH shall ensure thatall healthcare professionals involved in the prescribing, dispensing, handling or administration of VELCADE are provided with educational material.
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo vsi zdravstveni delavci, ki bodo predpisovali, izdajali ali uporabljali zdravilo, prejeli izobraževalno gradivo.
VELCADE treatment is very commonly associated with haematological toxicities (thrombocytopenia, neutropenia and anaemia).
Zdravljenje z zdravilom VELCADE je zelo pogosto povezano s toksičnimi učinki na hematološki sistem (trombocitopenija, nevtropenija in anemija).
• heart or blood pressure problems
• imate težave s srcem ali s krvnim tlakom,
9/l and the absolute neutrophils count should be ≥ 1.0 x 10
Neutrophil Count) mora biti ≥ 1,0 x 10
• General ill feeling, pain, vertigo, light-headedness, a feeling of weakness or loss of consciousness
• splošno slabo počutje, bolečina, vrtoglavica, blagi glavoboli, občutek šibkosti ali izguba zavesti
In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m2 dose and 89 to 120 ng/ml for the 1.3 mg/m2 dose.
Pri ponovljenih odmerkih so bile povprečne vrednosti najvišjih plazemskih koncentracij v razponu 67 do 106 ng/ml pri odmerku 1,0 mg/m2 in 89 do 120 ng/ml pri odmerku 1,3 mg/m
Patients in the VcTDx and TDx groups respectively had a median age of 57 versus 56 years, 99% versus 98% patients were Caucasians, and 58% versus 54% were males.
V skupini VcTDx oziroma TDx je bila mediana starost bolnikov 57 let oziroma 56 let, 99% oziroma 98% je bilo belcev, moških je bilo 58% oziroma 54%.
Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each VELCADE treatment cycle.
Melfalan in prednizon je treba dati peroralno na 1., 2., 3. in 4. dan v prvem tednu vsakega kroga zdravljenja z zdravilom VELCADE.
Higher incidences were also noted for infections with Grade ≥ 3 neutropenia (24% versus 19% in Block 1 and 22% versus 11% in Block 2), increased ALT (17% versus 8% in Block 2), hypokalaemia (18% versus 6% in Block 1 and 21% versus 12% in Block 2) and hyponatraemia (12% versus 5% in Block 1 and 4% versus 0 in Block 2).
Večja je bila tudi pojavnost okužb z nevtropenijo stopnje ≥ 3 (24% proti 19% v 1. sklopu in 22% proti 11% v 2. sklopu), povečane koncentracije ALT (17% proti 8% v 2. sklopu), hipokaliemije (18% proti 6% v 1. sklopu in 21% proti 12% v 2. sklopu) in hiponatriemije (12% proti 5% v 1. sklopu in 4% proti 0 v 2. sklopu).
The matched-pair analysis is a statistical method in which patients in the treatment group (e.g. VELCADE in combination with dexamethasone) and patients in the comparison group (e.g. VELCADE) are made comparable with respect to confounding factors by individually pairing study subjects.
Analiza izenačenih parov je statistični postopek v katerem primerjamo bolnike v skupini, ki se zdravi (npr. zdravilo VELCADE v kombinaciji z deksametazonom) in bolnike v primerjalni skupini (npr. samo zdravilo VELCADE) po parih tako, da na osnovi nerandomiziranih podatkov izločimo moteče dejavnike, ki lahko vplivajo na oceno učinkov zdravljenja.
Table 8: Adverse reactions in patients with Mantle Cell Lymphoma treated with VcR-CAP in a clinical trial System Organ Class
Preglednica 8: Neželeni učinki pri bolnikih z limfomom plaščnih celic, zdravljenih z VcR-CAP v kliničnih preskušanjih
(feeling, hearing, tasting, smelling), attention disturbance, trembling, twitching
okus, vonj), motnje pozornosti, tresenje, trzanje
In study LYM-3002, colony stimulating factor support was given to 78% of patients in the VcR-CAP arm and 61% of patients in the R-CHOP arm.
V študiji LYM-3002 je podporno zdravljenje s kolonijami spodbujajočih faktorjev prejelo 78% bolnikov v skupini VcR-CAP in 61% bolnikov v skupini R-CHOP.
TTP, months (95% CI)
TTP, dnevi ([95% CI])