natgillin/translations-raw huggingface dataset:
Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each bortezomib treatment cycle.
Melfalan in prednizon je treba dati peroralno na 1., 2., 3. in 4. dan v prvem tednu vsakega cikla zdravljenja z bortezomibom.
Inhibition of the proteasome results in cell cycle arrest and apoptosis.
Zavora proteasoma povzroči ustavitev celičnega cikla in apoptozo.
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 ciklih zdravljenja dosežejo odgovor ali so stabilni, lahko prejmejo enako zdravljenje še največ 4 dodatne cikle.
Patients in the BTDx 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 BTDx oziroma TDx je bila mediana starost bolnikov 57 let oziroma 56 let, 99 % oziroma 98 % je bilo belcev, moških je bilo 58 % oziroma 54 %.
Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the BR-CAP arm and with at least a possible or probable causal relationship to the components of the BR-CAP arm, are listed in table 8 below.
V preglednici 8 so navedeni ugotovljeni neželeni učinki s pogostnostjo ≥ 1%, ki je bila podobna ali večja v skupini BR-CAP in z najmanj verjetno ali možno vzročno povezanostjo s komponentami v skupini BR-CAP.
Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib
Preglednica 15: Povzetek analize učinkovitosti subkutanega in intravenskega dajanja bortezomiba Bortezomib intravensko Bortezomib subkutano
In study IFM-2005-01 bortezomib combined with dexamethasone [BDx, n=240] was compared to vincristine-doxorubicin-dexamethasone [VDDx, n=242].
V študiji IFM-2005-01 so primerjali kombinacijo bortezomiba in deksametazona [BDx, n = 240] s kombinacijo vinkristin-doksorubicin-deksametazon VDDx, n = 242].
• Irritated or inflamed eyes, excessively wet eyes, painful eyes, dry eyes, eye infections, lump in the eyelid (chalazion) and red and swollen eyelids, discharge from the eyes, abnormal vision, bleeding of the eye
• draženje ali vnetje oči, prekomerno solzne oči, boleče oči, suhe oči, okužbe oči, zatrdlina na veki (halazij), rdeče in otekle veke, izcedek iz oči, motnje vida, krvavitve v očesu
Table 16: Efficacy results from study LYM-3002 Efficacy endpoint
Preglednica 16: Rezultati učinkovitosti zdravila v študiji LYM-3002
If you are given bortezomib 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, tiredness, fainting - coughing and breathing difficulties or tightness in the chest.
Če prejemate bortezomib 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,
Median PFS by investigator assessment was 30.7 months in the BR-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 BR-CAP in 16,1 meseca v skupini R-CHOP (razmerje tveganja [HR] = 0,51; p < 0,001).
• a dose-calculation tool that enables prescribers to input a patient's height and weight in order to calculate the body surface area (BSA) and thereby to determine the appropriate bortezomib dose.
• Model izračuna odmerka, s katerim lahko zdravnik, ki predpisuje zdravilo, izračuna telesno površino na podlagi izbire bolnikove višine in telesne mase, ter tako določil ustrezen odmerek bortezomiba.
Fertility Fertility studies were not conducted with bortezomib (see section 5.3).
Plodnost Študije plodnosti pri uporabi bortezomiba niso bile izvedene (glejte poglavje 5.3).
In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m dose and 89 to 120 ng/ml for the 1.3 mg/m dose.
Pri ponovljenih odmerkih so bile povprečne vrednosti najvišjih plazemskih koncentracij v razponu 67 do 106 ng/ml pri odmerku 1,0 mg/m in 89 do 120 ng/ml pri odmerku 1,3 mg/m
Median OS was 90.7 months for the BR-CAP group compared with 55.7 months for the R-CHOP group (HR=0.66; p=0.001).
V skupini BR-CAP je bilo mediano OS 90,7 mesecev v primerjavi s 55,7 meseci v skupini R-CHOP (HR=0,66; p=0,001).
B=bortezomib; Dex=dexamethasone
B = bortezomib; Dex = deksametazon
In study LYM-3002, colony stimulating factor support was given to 78% of patients in the BR-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 BR-CAP in 61 % bolnikov v skupini R-CHOP.
• Injection sites must be rotated for successive injections.
• Mesta injiciranja je treba med zaporednimi injiciranji menjavati.
• to remind that patients receiving bortezomib in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide, with reference to the SmPC of thalidomide for additional information.
• Bolnike, ki prejemajo bortezomib v kombinaciji s talidomidom je treba opozoriti, da morajo upoštevati program preprečevanja nosečnosti za talidomid, s sklicem na povzetek glavnih značilnosti zdravila za talidomid za pridobitev dodatnih informacij.
In the BR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
V skupini BR-CAP je prejelo infuzijo trombocitov 22,5 % bolnikov, v skupini RCHOP pa 2,9% bolnikov.
Hepatitis B virus (HBV) reactivation and infection Mantle cell lymphoma
Reaktivacija in okužba z virusom hepatitisa B (HBV) Limfom plaščnih celic
• different reconstitution requirements for bortezomib 3.5 mg IV or SC use
• Različne zahteve za rekonstitucijo bortezomiba 3,5 mg pri i.v.
At least 6 months after prior therapy, bortezomib was started at the last tolerated dose of 1.3 mg/m
Po najmanj 6 mesecih po predhodnem zdravljenju, so bortezomib uvedli v odmerku, ki ga je bolnik pri predhodnem zdravljenju še prenašal, 1,3 mg/m
You may also be given bortezomib together with the medicines pegylated liposomal doxorubicin or dexamethasone.
Lahko pa boste bortezomib prejeli skupaj z zdraviloma pegilirani liposomski doksorubicin ali deksametazon.
In the Phase II study, patients who did not obtain an optimal response to therapy with bortezomib alone were able to receive high-dose dexamethasone in conjunction with bortezomib.
Bolniki v študiji faze II, ki niso dosegli optimalnega odziva na zdravljenje z bortezomibom v monoterapiji, so poleg bortezomiba lahko prejemali tudi deksametazon v velikih odmerkih.
The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m 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).
In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with Bortezomib+Melphalan+Prednisone compared with Melphalan+Prednisone (14% versus 4% respectively).
V študiji faze III, pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom, je bila splošna pojavnost reaktivacije virusa herpes zoster pri bolnikih zdravljenih z zdravili bortezomib+melfalan+prednizon pogostejša, kot pri bolnikih zdravljenih z melfalanom+prednizonom (14 % v primerjavi s 4 %).
Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BR-CAP arm.
V BR-CAP kraku študije je protivirusna zdravila prejelo 137 od 240 bolnikov (57 %).
Meningitis (inc bacterial), Epstein-Barr virus infection, Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue syndrome
Redki meningitis (vključno z bakterijskim), okužba z virusom Epstein- Barr, genitalni herpes, tonzilitis, mastoiditis, post virusni sindrom utrujenosti
- 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).
You must not breast-feed while using bortezomib.
Med uporabo bortezomiba ne smete dojiti.
There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS) in patients receiving bortezomib (see section 4.8).
Pri bolnikih, ki so prejemali bortezomib so redko poročali o akutni difuzni infiltracijski pljučni bolezni neznane etiologije, kot je pnevmonitis, intersticijska pljučnica, infiltracija pljuč in sindrom akutne respiratorne stiske (SARS) (glejte poglavje 4.8).
Bortezomib should not be administered intrathecally.
Bortezomiba se ne sme dajati intratekalno.
Dexamethasone was administered in combination with bortezomib to 83 patients in cycle 1 with an additional 11 patients receiving dexamethasone during the course of bortezomib retreatment cycles.
V 1. ciklu zdravljenja je skupaj z bortezomibom prejemalo deksametazon 83 bolnikov, v nadaljnjih ciklih zdravljenja z bortezomibom pa še dodatnih 11 bolnikov.
If any discolouration or particulate matter is observed, the solution must be discarded.
Če opazite kakršno koli spremembo barve ali delce v raztopini, jo morate zavreči.
Bortezomib treatment must be withheld at the onset of any ≥ grade 3 bortezomib -related non-haematological toxicities (excluding neuropathy) or ≥ grade 3 haematological toxicities (see also section 4.4).
Zdravljenje z bortezomibom je treba prekiniti ob pojavu katere koli z uporabo bortezomiba povezane ne-hematološke toksičnosti stopnje ≥ 3 (razen nevropatije) ali hematološke toksičnosti stopnje ≥ 3 (glejte tudi poglavje 4.4).
a Intent to Treat (ITT) population b p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p < 0.0001
b p-vrednost iz stratificiranega testa log-rank; v analizi po vrsti terapije ni bila vključena stratifikacija po terapevtski anamnezi, p < 0,0001
Dose adjustments during treatment and re-initiation of treatment for monotherapy Bortezomib treatment must be withheld at the onset of any grade 3 non-haematological or any grade 4 haematological toxicities, excluding neuropathy as discussed below (see also section 4.4).
Prilagoditev odmerjanja med zdravljenjem in pri ponovni uvedbi zdravljenja v obliki monoterapije Zdravljenje z bortezomibom morate prekiniti ob pojavu katere koli nehematološke toksičnosti 3. stopnje ali katere koli hematološke toksičnosti 4. stopnje, z izjemo nevropatije, kot je opisano v nadaljevanju (glejte tudi poglavje 4.4).
Grade ≥ 3 non-haematological toxicities considered to be related to bortezomib
Ne-hematološka toksičnost stopnje ≥ 3 povezana z uporabo bortezomiba
* Survival update based on a median duration of follow-up at 60.1 months mo: months
* Preživetje na osnovi podatkov po 60,1 mesecih spremljanja.
Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2 g/m per day)
Zato ta režim dajanja s sočasnim velikim odmerkom citarabina v 24 urni kontinuirani infuziji (2 g/m na dan) ni priporočljiv.
T 100 mg a
T 100 mg a na dan na dan
The MAH shall ensure that all healthcare professionals involved in the prescribing, dispensing, handling or administration of bortezomib are provided with educational material.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo vsi zdravstveni delavci, ki bodo predpisovali, izdajali ali uporabljali zdravilo, prejeli izobraževalno gradivo.
Table 2: Recommended posology for bortezomib in combination with melphalan and prednisone Twice weekly bortezomib (cycles 1-4) Week B (1.3 mg/m
Preglednica 2: Priporočeno odmerjanje bortezomiba v kombinaciji z melfalanom in prednizonom Odmerjanje bortezomiba dvakrat na teden (cikli 1-4)
- If toxicity resolves i.e. patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL, bortezomib may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m to 1 mg/m 2, or from
• Če toksičnost mine oz. ima bolnik ANC ≥ 750 celic/μl in število trombocitov ≥ 25.000 celic/μl, lahko ponovno uvedete bortezomib v odmerku, ki je eno stopnjo manjši od prejšnjega (z 1,3 mg/m na
Therefore, you will have to take regular blood tests before and during your treatment with bortezomib, to check your blood cell counts regularly.
Zato vam bodo pred in med zdravljenjem z bortezomibom, redno pregledovali kri in tako preverjali število vaših krvnih celic.
Bortezomib therapy should be withheld until symptoms of the toxicity have resolved to grade 2 or better.
Zdravljenje z bortezomibom je treba prekiniti dokler se simptomi toksičnosti ne povrnejo na 2. stopnjo ali še izboljšajo.
In a clinical trial, two patients (out of 2) given high-dose cytarabine (2 g/m per day) by continuous infusion over 24 hours with daunorubicin and bortezomib for relapsed acute myelogenous leukaemia died of ARDS early in the course of therapy, and the study was terminated.
V kliničnem preskušanju, sta dva bolnika (od dveh), pri katerih so ponovni pojav akutne mielogene levkemije zdravili z velikim odmerkom citarabina v 24 urni kontinuirani infuziji (2 g/m na dan) skupaj z daunorubicinom in bortezomibom, umrla zaradi SARS na začetku zdravljenja in študijo so zaključili.
Marketing Authorisation Holder Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Germany
Imetnik dovoljenja za promet Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Nemčija
The effect of hepatic impairment on the pharmacokinetics of bortezomib was assessed in a Phase I study during the first treatment cycle, including 61 patients primarily with solid tumors and varying degrees of hepatic impairment at bortezomib doses ranging from 0.5 to 1.3 mg/m
Vpliv jetrne okvare na farmakokinetiko bortezomiba v odmerkih od 0,5 do 1,3 mg/m so ocenjevali v študiji faze I med prvim ciklom zdravljenja, ki je vključevala 61 bolnikov s primarno solidnimi tumorji in različnimi stopnjami jetrne okvare.
2 years
27 mesecev
Note: An OR > 1 indicates an advantage for B-containing induction therapy.
Opomba: OR > 1 kaže na prednost uvajalnega zdravljenja z B.
When toxicity resolves re-initiate bortezomib treatment and reduce dose to 0.7 mg/m once per week
Nato ponovno uvedite zdravljenje z bortezomibom in zmanjšajte odmerek na 0,7 mg/m enkrat na teden.
Efficacy results are presented in table 11:
Podatki o učinkovitosti so navedeni v preglednici 11:
In a study in previously untreated mantle cell lymphoma patients, 42.9% and 10.4% of patients exposed to bortezomib were in the range 65-74 years and ≥ 75 years of age, respectively.
V študiji z bortezomibom pri bolnikih, pri katerih limfom plaščnih celic še ni bil zdravljen, je bilo 42,9 % bolnikov starih 65-74 let in 10,4 % bolnikov starih ≥ 75 let.
CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio; OR=Odds Ratio; ITT=Intent to Treat
CR = popolni odgovor; CRu = nepotrjen popolni odgovor; PR = delni odgovor; CI = interval zaupanja; HR = razmerje tveganja; OR = razmerje verjetnosti; ITT = populacija, ki so jo nameravali zdraviti
Table 6: Recommended starting dose modification for bortezomib in patients with hepatic impairment
Preglednica 6: Priporočena prilagoditev začetnega odmerka bortezomiba pri bolnikih z boleznijo jeter Stopnja jetrne okvare*
How bortezomib is given
Kako boste prejeli bortezomib
For patients with a response first documented at cycle 6, two additional treatment cycles were given.
Bolniki, ki so dosegli odgovor šele v 6. ciklu, so prejeli dva dodatna cikla zdravljenja.
N=240 (ITT population) N=242 (ITT population)
n = 240 (ITT populacija)
Main efficacy results are presented in table 13.
Glavni rezultati so zbrani v preglednici 13.
Patients with baseline grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/µl were excluded.
Bolniki, ki so imeli na začetku študije stopnjo periferne nevropatije ≥ 2 ali število trombocitov < 50,000/µl, so bili izključeni.
Therefore, patients must be cautious when driving or using machines and should be advised not to drive or operate machinery if they experience these symptoms (see section 4.8).
Bolnike je treba opozoriti naj v primeru pojava teh simptomov ne vozijo ali upravljajo strojev.
A Phase II, single arm activity, safety, and pharmacokinetic trial conducted by the Children's Oncology Group assessed the activity of the addition of bortezomib to multi agent re induction chemotherapy in paediatric and young adult patients with lymphoid malignancies (pre-B cell acute lymphoblastic leukemia [ALL], T-cell ALL, and T-cell lymphoblastic lymphoma [LL]).
V farmakokinetični študiji varnosti in učinkovitosti faze II, z enim krakom, ki jo je izvedla Skupina za otroško onkologijo (COG - Children's Oncology Group) so ocenili delovanje bortezomiba, ki so ga dodali k ponovno uvedeni indukcijski kemoterapiji z več zdravili pri pediatričnih in mladih odraslih bolnikih z limfatičnimi malignomi (s pre-B-celično akutno limfoblastno levkemijo [ALL], T-celično ALL in T-celičnim limfoblastnim limfomom [LL]).
A pharmacokinetic study was conducted in patients with various degrees of renal impairment who were classified according to their creatinine clearance values (CrCL) into the following groups: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate
Bolnike so glede na vrednost očistka kreatinina (CrCL) razdelili v naslednje skupine: normalno delovanje ledvic (CrCL ≥ 60 ml/min/1,73 m2, n = 12), blaga okvara ledvic (CrCL = 40
This medicine is for intravenous or subcutaneous use.
Za subkutano ali intravensko uporabo.
Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m and doxorubicin at 50 mg/m
375 mg/m rituksimaba, 750 mg/m ciklofosfamida in 50 mg/m 2doksorubicina.
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/m
Main efficacy results are presented in table 12.
Glavni rezultati so zbrani v preglednici 12.
PRES is a rare, often reversible, rapidly evolving neurological condition, which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances.
Pri bolnikih, ki so prejemali bortezomib so poročali o PRES. PRES je redka, pogosto reverzibilna nevrološka motnja, ki se razvije hitro in se lahko kaže z epileptičnimi napadi, hipertenzijo, glavoboli, letargijo, zmedenostjo, slepoto in drugimi motnjami vida ter nevrološkimi motnjami.
In the Phase III study comparing bortezomib administered intravenously versus subcutaneously, the incidence of grade ≥ 2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
V študiji faze III z bortezomibom, ki je primerjala intravensko in subkutano dajanje zdravila, je bila pogostnost dogodkov periferne nevropatije ≥ 2. stopnje v skupini, ki je prejemala zdravilo subkutano 24 %, v skupini, ki je prejemala zdravilo intravensko pa 41 % (p = 0,0124).
VDDx=vincristine, doxorubicin, dexamethasone; BDx=bortezomib, dexamethasone; TDx=thalidomide, dexamethasone; 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.
• different reconstitution requirements for intravenous (IV) or subcutaneous (SC) use
• Različne zahteve za rekonstitucijo pri intravenski (i.v.)
In multi-cycle general toxicity studies conducted in the rat and monkey, the principal target organs included the gastrointestinal tract, resulting in vomiting and/or diarrhoea; haematopoietic and lymphatic tissues, resulting in peripheral blood cytopenias, lymphoid tissue atrophy and haematopoietic bone marrow hypocellularity; peripheral neuropathy (observed in monkeys, mice and dogs) involving sensory nerve axons; and mild changes in the kidneys.
V raziskavah splošne toksičnosti z več cikli zdravljenja na podganah in opicah so bili poglavitni tarčni organi prebavila s posledičnim bruhanjem in/ali drisko, ter krvotvorni organi s posledičnim zmanjšanjem števila krvnih celic v periferni krvi, zmanjšanjem limfatičnega tkiva ter hipocelularnostjo kostnega mozga, periferno nevropatijo (ki so jo opažali pri opicah, miših in psih) s prizadetostjo senzoričnih živčnih končičev in blagimi spremembami ledvic.
BR-CAP
BR-CAP R-CHOP
A drug-drug interaction study assessing the effect of ketoconazole, a potent CYP3A4 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC increase of 35% (CI90% [1.032 to 1.772]) based on data from 12 patients.
Študija medsebojnega delovanja zdravil, ki je ocenjevala učinek ketokonazola, močnega inhibitorja CYP3A4, na famakokinetiko bortezomiba (danega intravensko), je na osnovi podatkov 12 bolnikov pokazala povprečen dvig AUC bortezomiba za 35 % (CI90% (1,032 do 1,772).
At least 72 hours should elapse between consecutive doses of bortezomib.
Med zaporednimi odmerki bortezomiba mora preteči vsaj 72 ur.
The matched-pair analysis is a statistical method in which patients in the treatment group (e.g. bortezomib in combination with dexamethasone) and patients in the comparison group (e.g. bortezomib) 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. bortezomib v kombinaciji z deksametazonom) in bolnike v primerjalni skupini (npr. samo bortezomib) po parih tako, da na osnovi nerandomiziranih podatkov izločimo moteče dejavnike, ki lahko vplivajo na oceno učinkov zdravljenja.
Table 3: Posology modifications during subsequent cycles of bortezomib therapy in combination with melphalan and prednisone Toxicity
Preglednica 3: Prilagajanje odmerkov med kasnejšimi cikli zdravljenja z bortezomibom v kombinaciji z melfalanom in prednizonom
CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; B=bortezomib; BDx=bortezomib, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
CI = interval zaupanja; CR = popoln odgovor; nCR = skoraj popoln odgovor; ITT = populacija, ki so jo nameravali zdraviti; RR = stopnja odgovora; B = bortezomib; BDx = bortezomib in deksametazon; VDDx = vinkristin, doksorubicin in deksametazon; VGPR = zelo dober delni odgovor; PR = delni odgovor; OR = razmerje verjetnosti.
(95% CI)=1.428
(95 % CI) = 1,428 p-vrednost g a