natgillin/translations-raw huggingface dataset:
Neutropenia may require temporary or permanent dose reduction.
Neutropenija bi mogla zahtijevati privremeno ili trajno smanjenje doze.
Ask your doctor or pharmacist if you are not sure whether your medicine is one of the medicines listed above.
Upitajte svog liječnika ili ljekarnika ako niste sigurni je li Vaš lijek jedan od gore navedenih lijekova.
OTHER SPECIAL WARNING(S), IF NECESSARY
DRUGO(A) POSBENO(A) UPOZORENJE(A), AKO JE POTREBNO
Neutropenia was frequently reported on the basis of laboratory findings determined during the study (all grades: 75%).
Neutropenija je bila učestalo prijavljena na temelju laboratorijskih rezultata utvrđenih tijekom ispitivanja (svi stupnjevi: 75%).
Five patients (1.3%) died of events associated with haemorrhage.
Pet bolesnika (1,3%) umrlo je od događaja povezanih s krvarenjem.
The median OS was 17.5 months.
Medijan OS-a bio je 17,5 mjeseci.
Check with your doctor or your pharmacist if you are not sure.
Provjerite s liječnikom ili ljekarnikom ako niste sigurni.
The majority of patients had received prior transplant (63.6%).
Većina bolesnika primila je prethodno transplantat (63,6%).
The capsules should be swallowed whole with water, with or without food (see section 5.2), and they should not be opened, crushed or chewed.
Kapsule treba progutati cijele s vodom, uz obrok ili bez njega (vidjeti dio 5.2), a ne smiju se otvarati, drobiti ili žvakati.
Patients should be treated initially for eight cycles.
Bolesnici se u početku trebaju liječiti kroz osam ciklusa.
These patients had a median of 3 prior therapies.
Ti su bolesnici imali medijan od 3 prethodne terapije.
A total of 53.0% of patients were male.
Ukupno 53,0% bolesnika bili su muškarci.
- Farydak is taken over 21 days (2 weeks on and 1 week off) - this is called a treatment cycle.
• Farydak se uzima tijekom 21 dana (2 tjedna uzimanja i 1 tjedan bez uzimanja) - to se naziva ciklusom liječenja.
• uncontrolled shaking of the body
• nekontrolirano drhtanje tijela
Your doctor will tell you exactly how many capsules of Farydak you need to take.
Liječnik će Vam reći koliko točno kapsula Farydaka morate uzeti.
The list of associated symptoms is provided in section 4, Possible side effects.
Popis povezanih simptoma naveden je u dijelu 4, Moguće nuspojave.
In the event of QT prolongation during treatment:
U slučaju produljenja QT-a tijekom liječenja:
Overall survival (OS) was the key secondary endpoint.
Ukupno preživljenje (eng. overall survival, OS) bilo je ključni sekundarni ishod.
An increase in early resorptions was observed in female rats (doses ≥30 mg/kg).
Povećanje u ranoj resorpciji bilo je uočeno u ženki štakora (doze ≥30 mg/kg).
Modification of the treatment dose and/or schedule may be required based on individual tolerability.
Modifikacija terapijske doze i/ili rasporeda mogla bi biti potrebna na temelju individualne podnošljivosti.
- Do not throw away any medicines via wastewater.
Nikada nemojte nikakve lijekove bacati u otpadne vode.
Follow all your doctor's instructions carefully.
Upozorenja i mjere opreza Pažljivo slijedite sve upute liječnika.
Its fraction in the erythrocyte is 0.60 in vitro, independent of the concentration.
Njegova frakcija u eritrocitu je 0,60 in vitro, neovisno o koncentraciji.
If you are pregnant, think you might be pregnant or plan to become pregnant, ask your doctor for advice.
Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet.
- Do not store above 30°C.
- Ne čuvati na temperaturi iznad 30°C.
Overall response [95% CI]
Ukupni odgovor [95% CI]
Farydak is not to be used in children or adolescents under 18 years of age.
Djeca i adolescenti Farydak se ne smije koristiti u djece i adolescenata mlađih od 18 godina.
ECOG performance status was 0-1 in 93% of patients.
ECOG status bio je 0-1 u 93% bolesnika.
Treatment discontinuation due to infections was reported in 5% of patients.
Prekid liječenja uzrokovan infekcijama bio je prijavljen u 5% bolesnika.
Replacement intravenous fluids and electrolytes may be used as appropriate.
Nadomjesne intravenske tekućine i elektroliti mogu se koristiti prema potrebi.
In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from available data).
Uz to, odgovarajuća kategorija učestalosti za svaku nuspojavu temelji se na sljedećoj konvenciji (CIOMS III): vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); i nepoznato (ne može se procijeniti iz dostupnih podataka).
• dry mouth or changes to your sense of taste
• suha usta ili promjene u osjetu okusa
It is recommended that patients with clinical benefit continue the treatment for eight additional cycles.
Preporučuje se da bolesnici u kojih postoji klinička korist nastave liječenje kroz još osam dodatnih ciklusa.
• with uncontrolled or significant cardiac disease, including recent myocardial infarction,
• s nekontroliranom ili značajnom srčanom bolesti, uključujući nedavni infarkt miokarda,
- Swallow the capsules whole with a glass of water.
Uzimanje ovog lijeka - Progutajte kapsule cijele uz čašu vode.
Since food did not alter overall bioavailability (AUC), panobinostat can be administered regardless of food in cancer patients.
Budući da hrana nije promijenila ukupnu bioraspoloživost (AUC), panobinostat se može primjenjivati bez obzira na hranu u bolesnika s rakom.
The days of the cycle are numbered on the blister.
Dani ciklusa su numerirani na blisteru.
Studies in animals have shown reproductive and embryo-foetal toxicity (see section 5.3).
Ispitivanja na životinjama pokazala su reproduktivnu i embriofetalnu toksičnost (vidjeti dio 5.3).
Never take a missed dose of Farydak on one of the “off” days when no Farydak dose is planned.
Nikada nemojte uzeti propuštenu dozu Farydaka u jedan od dana „bez lijeka“ kada nije planirana doza Farydaka.
Patients over 65 years of age had a higher frequency of selected adverse events and of discontinuation of treatment because of adverse events.
Bolesnici stariji od 65 godina imali su veću učestalost odabranih štetnih događaja i prekida liječenja zbog štetnih događaja.
Most newly occurring severe neutropenia was grade 3 (28%), with considerably fewer cases of grade 4 (6.6%).
Većina novih slučajeva teške neutropenije bila je 3. stupnja (28%), uz znatno manje slučajeva 4. stupnja (6,6%).
Your heart rate will also be checked using a machine that measures the electrical activity of the heart (called an ECG).
Provjeravat će Vam se i srčana frekvencija pomoću uređaja koji mjeri električnu aktivnost srca (a zove se EKG).
STOP taking Farydak and seek medical help immediately if you experience any of the following:
PRESTANITE uzimati Farydak i odmah zatražite liječničku pomoć ako primijetite bilo što od sljedećeg:
If it is used during pregnancy or if the patient becomes pregnant while using it, the patient must be informed of the potential risk to the foetus.
Ako se koristi tijekom trudnoće ili ako bolesnica zatrudni dok ga koristi, bolesnica mora biti obaviještena o potencijalnom riziku za fetus.
Electrocardiographic changes
Elektrokardiografske promjene
During Farydak treatment, you should also tell your doctor or your pharmacist if you are prescribed another medicine that you have not already been taking.
Tijekom liječenja Farydakom morate također obavijestiti svog liječnika ili ljekarnika ako Vam bude propisan neki drugi lijek koji još niste uzimali.
Then continue taking the medicine as normal.
Zatim nastavite uzimati lijek kao inače.
No patient had an absolute QTcF >500 msec.
Nijedan bolesnik nije imao apsolutni QTcF >500 msec.
15.7% of patients were exposed to study treatment for ≥48 weeks.
15,7% bolesnika bilo je izloženo ispitivanoj terapiji ≥48 tjedana.
Panobinostat represented 6 to 9% of the drug-related exposure in plasma.
Panobinostat je predstavljao 6 do 9% s lijekom povezane izloženosti u plazmi.
If vomiting occurs the patient should not take an additional dose, but should take the next usual prescribed dose.
Ako dođe do povraćanja, bolesnik ne smije uzeti dodatnu dozu već uzeti sljedeću uobičajenu propisanu dozu.
Discontinuation due to adverse events, regardless of causality, was observed in 36.2% of patients.
Prekid primjene zbog štetnih događaja, bez obzira na uzročnu vezu, bio je uočen u 36,2% bolesnika.
Physicians and patients should be aware of the increased risk of infection with panobinostat.
Liječnici i bolesnici moraju biti svjesni povećanog rizika od infekcije uz panobinostat.
Caucasians comprised 65.0% of the study population, Asians 30.2% and blacks 2.9%.
Bijelci su sačinjavali 65,0% ispitivane populacije, Azijati 30,2%, crnci 2,9%.
If you have to vomit after you swallow the Farydak capsules, do not take any more capsules until your next scheduled dose.
Ako morate povraćati nakon što progutate Farydak kapsule, ne uzimajte više kapsula do sljedeće doze po rasporedu.
• being unable to control the flow of urine because of loss of or weak bladder control
• nesposobnost kontroliranja toka mokraće zbog gubitka ili slabe kontrole mjehura
Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX42
Farmakoterapijska skupina: Ostali antineoplastici, ATK oznaka: L01XX42
Cycle:Day
Ciklus:Dan
Farydak blocks the growth of cancerous plasma cells and reduces the number of cancer cells.
Farydak blokira rast kanceroznih plazma stanica i smanjuje broj stanica raka.
Progression-free survival Probability
Vjerojatnost preživljenja bez progresije
- if you have blood clotting problems (coagulation disorder).
- ako imate problema sa zgrušavanjem krvi (poremećaj koagulacije).
What Farydak looks like and contents of the pack
Kako Farydak izgleda i sadržaj pakiranja
Farydak may have a minor influence on the ability to drive and use machines.
Farydak može malo utjecati na sposobnost upravljanja vozilima i strojevima.
Your doctor will discuss with you the possible risks of taking Farydak during pregnancy.
Liječnik će razgovarati s Vama o mogućim rizicima uzimanja Farydaka tijekom trudnoće.
Metabolism via CYP2D6 and 2C19 was minor.
Metabolizam putem CYP2D6 i 2C19 bio je malog razmjera.
Treatment was administered for a maximum of 16 cycles (see Tables 1 and 2).
Terapija se primjenjivala u najviše 16 ciklusa (vidjeti Tablice 1 i 2).
o A table describing the treatment regimen for each day of the cycle with space for the patient to note what medication they took.
o Tablica koja opisuje režim liječenja za svaki dan ciklusa s praznim prostorom u koji bolesnik može upisati lijek koji je uzeo.
The median time to response was 1.4 months and the median duration of response was 6.0 months.
Medijan vremena do odgovora bio je 1,4 mjeseci, a medijan trajanja odgovora bio je 6,0 mjeseci.
• decreased appetite or weight loss
• smanjeni apetit ili gubitak tjelesne težine
In the phase III clinical study 162 out of 387 patients were aged 65 years or over.
U kliničkom ispitivanju faze III, 162 od 387 bolesnika bilo je u dobi od 65 ili više godina.
The median age was 63 years, range 28-84; 42.1% of patients were older than 65 years.
Medijan dobi bio je 63 godine, raspon 28-84; 42,1% bolesnika bilo je starije od 65 godina.
More than 1 dose omitted
Više od 1 doze propušteno
Take Farydak once a day at the same time each day only on the scheduled days.
Uzimajte Farydak jedanput na dan u isto vrijeme svakoga dana, samo u dane određene rasporedom.
• with long QT syndrome.
• sa sindromom dugog QT-a.
• difficulty falling or staying asleep (insomnia)
• poteškoće prilikom usnivanja ili spavanja (nesanica)
Other medicines and Farydak
Drugi lijekovi i Farydak
Farydak should not be taken during pregnancy, unless the potential benefit to the mother is greater than the potential risk to the baby.
Farydak se ne smije uzimati tijekom trudnoće, osim ako je potencijalna korist za majku veća od potencijalnog rizika za dijete.
Your doctor will monitor your condition to see if the treatment is working.
Vaše stanje kako bi vidio funkcionira li liječenje.
Oxidative metabolism of panobinostat played a less prominent role, with approximately 40% of the dose eliminated by this pathway.
Oksidativni metabolizam panobinostata igrao je manje istaknutu ulogu, s otprilike 40% doze eliminirane ovim putem.
If a dose reduction is required, the dose of panobinostat should be reduced by decrements of 5 mg (i.e. from 20 mg to 15 mg or from 15 mg to 10 mg).
Ako je potrebno smanjenje doze, dozu panobinostata treba smanjivati za po 5 mg (tj. s 20 mg na 15 mg ili s 15 mg na 10 mg).
QTcF >500 msec was not reported in any patient.
QTcF >500 msec nije bio prijavljen ni u jednog bolesnika.
Patients achieved an ORR (≥PR (partial response)) of 34.5% and 52.7% (≥MR (minimal response)).
Bolesnici su postigli ORR (≥PR (eng. partial response, djelomični odgovor)) od 34,5% i 52,7% (≥MR (eng. minimal response, minimalni odgovor)).
Prior to launch of Farydak in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Prije stavljanja lijeka Farydak u promet u svakoj državi članici nositelj odobrenja mora s nacionalnim nadležnim tijelom dogovoriti sadržaj i oblik edukativnog programa, uključujući komunikaciju s medijima, načine distribucije i bilo koji drugi aspekt programa.
The median duration of exposure to study treatment was 4.6 months (range: 0.1-24.1 months).
Medijan trajanja izloženosti ispitivanoj terapiji bio je 4,6 mjeseci (raspon: 0,1-24,1 mjesec).
congestive heart failure, unstable angina or clinically significant bradycardia.
kongestivno zatajenje srca, nestabilnu anginu ili klinički značajnu bradikardiju.
Refractoriness to bortezomib was defined as disease progression on or within 60 days of the last bortezomib-containing line of therapy.
Refraktornost na bortezomib bila je definirana kao progresija bolesti tijekom ili u roku od 60 dana od posljednje linije terapije koja je sadržavala bortezomib.
The absolute oral bioavailability of panobinostat was approximately 21%.
Apsolutna oralna bioraspoloživost panobinostata bila je otprilike 21%.
Pre-existing infections should be treated prior to initiation of the therapy.
Već postojeće infekcije moraju se liječiti prije početka terapije.
Contents of the pack and other information What Farydak contains
Sadržaj pakiranja i druge informacije Što Farydak sadrži
Additional analysis suggests that the risk of QTc prolongation does not increase over time (see section 4.2).
Dodatna analiza upućuje na to da se rizik od produljenja QTc-a ne povećava tijekom vremena (vidjeti dio 4.2).
Anticipated pharmacodynamic interactions
Očekivane farmakodinamičke interakcije
Strong CYP3A4 inhibitors
Snažni CYP3A4 inhibitori
You should not eat star fruit, pomegranate or grapefruit or drink pomegranate or grapefruit juice during your treatment with Farydak, as they may increase the amount of the medicine that passes into your blood.
Ne smijete jesti karambolu (zvjezdano voće), šipak ili grejp ili piti sok od šipka ili grejpa tijekom liječenja Farydakom, budući da oni mogu povećati količinu lijeka koja prelazi u Vašu krv.
Farydak is used to treat adult patients with a rare type of blood cancer called multiple myeloma.
Farydak se koristi za liječenje odraslih bolesnika s rijetkom vrstom raka krvi koji se naziva multipli mijelom.
The primary endpoint was progression free survival (PFS) as per modified European Bone Marrow Transplant Group (mEBMT) criteria and as assessed by the investigator.
Primarni ishod bio je preživljenje bez progresije (eng. progression free survival, PFS) prema modificiranim kriterijima Europske skupine za transplantaciju koštane srži (mEBMT) i procjeni ispitivača.
The following pack sizes are available: blister packs containing 6, 12 or 24 capsules.
Dostupne su sljedeće veličine pakiranja: blister pakiranja koja sadrže 6, 12 ili 24 kapsule.
• reduced level of calcium in the blood, sometimes leading to cramps
• smanjena razina kalcija u krvi koja ponekad dovodi do grčeva
This is a long-term treatment with 16 cycles (48 weeks).
Ovo je dugoročno liječenje sa 16 ciklusa (48 tjedana).
Patients were heavily pre-treated and had received multiple prior regimens (median: 4; range: 2-11).
Bolesnici su ranije primali puno terapija i višestruke prethodne režime (medijan: 4; raspon: 2-11).
Cytochrome P450 3A4 (CYP3A4) is the main oxidation enzyme, with potential minor involvement of CYP2D6 and 2C19.
Citokrom P450 3A4 (CYP3A4) glavni je oksidacijski enzim, s potencijalnom manjom uključenošću CYP2D6 i 2C19.
Therefore, physicians and patients should be aware of the increased risk of thrombocytopenia and the potential for haemorrhage, especially in patients with coagulation disorders or in those who are receiving chronic anti-coagulation therapy.
Stoga liječnici i bolesnici moraju biti svjesni povećanog rizika od trombocitopenije i mogućnosti krvarenja, osobito u bolesnika s poremećajima koagulacije ili u onih koji primaju kroničnu antikoagulacijsku terapiju.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, such as vitamins or herbal supplements, because they might interact with Farydak.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove koji se dobivaju bez recepta, kao što su vitamini ili biljni dodaci, zato što bi oni mogli imati međudjelovanje s Farydakom.
No pharmacokinetic data are available for patients with severe hepatic impairment.
Nema dostupnih farmakokinetičkih podataka za bolesnike s teškim oštećenjem jetre.
None
Nikakva
What Farydak is and what it is used for What you need to know before you take Farydak How to take Farydak
Što je Farydak i za što se koristi Što morate znati prije nego počnete uzimati Farydak Kako uzimati Farydak
On days when you do not have to take Farydak, including the rest period in week 3, scratch the relevant empty cavities with your finger nail to help you keep track of your medication schedule.
Za dane kada ne morate uzeti Farydak, uključujući stanku u 3. tjednu, noktom postružite odgovarajuće prazne šupljine kako biste lakše pratili raspored svog liječenja.
Pneumonia fungal, hepatitis B, aspergillosis
Gljivična pneumonija, hepatitis B, aspergiloza
The MAH shall ensure that in each Member State where Farydak is marketed, all patients/carers who are expected to use Farydak have access to/are provided with the following educational package:
Nositelj odobrenja mora osigurati da u svakoj državi članici u kojoj se Farydak nalazi u prometu, svi bolesnici/skrbnici za koje se očekuje da primjenjuju Farydak imaju pristup, odnosno da im je dan sljedeći edukativni paket:
• If QT prolongation is unresolved within 7 days, treatment should be discontinued.
• Ako se produljenje QT-a ne riješi unutar 7 dana, liječenje treba prekinuti.
Adverse drug reactions from the phase III study (Panorama 1) are shown in Table 7.
Nuspojave na lijek iz ispitivanja faze III (Panorama 1) prikazane su u Tablici 7.
Only 0.3% of the patients were discontinued from the treatment due to neutropenia.
Samo 0,3% bolesnika prekinulo je liječenje zbog neutropenije.
• If any QTcF value is above 500 msec, Farydak therapy should be permanently discontinued.
• Ako je bilo koja vrijednost QTcF-a iznad 500 msec, terapiju Farydakom treba trajno prekinuti.
It is currently unknown whether panobinostat may reduce the effectiveness of hormonal contraceptives.
Trenutačno nije poznato može li panobinostat smanjiti djelotvornost hormonskih kontraceptiva.
Therefore an ECG should be recorded prior to the start of therapy and repeated periodically before each treatment cycle.
Stoga treba napraviti EKG prije početka terapije te ponoviti periodički prije svakog ciklusa terapije.
More than one third (35.8%) of the patients were relapsed and refractory to prior treatment.
Više od jedne trećine (35,8%) bolesnika imalo je relaps i bilo refraktorno na prethodnu terapiju.
Packs containing 6, 12 or 24 capsules.
Pakiranja koja sadrže 6, 12 ili 24 kapsule.
1 Hazard ratio obtained from stratified Cox model
1 Omjer hazarda dobiven iz stratificiranog Coxovog modela
Response rates are summarised in Table 9.
Stope odgovora sažete su u Tablici 9.
Discontinuation of treatment may be considered if neutropenia does not improve despite the dose modifications and/or despite the addition of granulocyte colony stimulating factor therapy according to local medical practice and treatment guidelines, and/or in the event of severe secondary infections.
Prekid liječenja može se razmotriti ako se neutropenija ne popravi usprkos modifikacijama doze i/ili usprkos dodavanju terapije čimbenikom stimulacije kolonije granulocita u skladu s lokalnom medicinskom praksom i smjernicama za liječenje, i/ili u slučaju teških sekundarnih infekcija.
Panobinostat is a P-gp substrate.
Panobinostat je supstrat P-gp-a.
Panobinostat is moderately (approximately 90%) bound to human plasma proteins.
Panobinostat se umjereno (otprilike 90%) veže za proteine u ljudskoj plazmi.
The median duration of exposure in the study was 5.0 months.
Medijan trajanja izloženosti u ispitivanju bio je 5,0 mjeseci.
If your partner is able to become pregnant she should also use a highly effective method of contraception during your treatment and for six months after.
Ako Vaša partnerica može zatrudnjeti, također mora koristiti vrlo učinkovitu metodu kontracepcije tijekom Vašeg liječenja te šest mjeseci nakon njega.
The total duration of treatment is up to 16 cycles (48 weeks).
Ukupno trajanje liječenja je do 16 ciklusa (48 tjedana).
Therefore, medicinal products that can influence CYP3A4 enzyme activity may alter the pharmacokinetics of panobinostat.
Stoga lijekovi koji mogu utjecati na aktivnosti enzima CYP3A4 mogu promijeniti farmakokinetiku panobinostata.
Farydak should be administered orally once daily on scheduled days only, at the same time each day.
Farydak treba primjenjivati peroralno jedanput na dan samo u dane određene rasporedom, svaki put u isto vrijeme.
Panobinostat has a terminal elimination half-life of approximately 37 hours based on final parameters estimate in the population PK analysis.
Panobinostat je imao terminalni poluživot eliminacije od otprilike 37 sati na temelju konačne procjene parametara u populaciji PK
Thrombocytopenia rarely leads to treatment discontinuation (1.6% of patients).
Trombocitopenija rijetko dovodi do trajnog prekida liječenja (1,6% bolesnika).
If you have questions about how long to take Farydak, talk to your doctor or pharmacist.
Ako imate pitanja o tome koliko dugo uzimati Farydak, obratite se svom liječniku ili ljekarniku.
After oral administration, panobinostat pharmacokinetics appear to be linear in the dose range 10-30 mg, but AUC increases less than proportionally with dose at higher doses.
Nakon peroralne primjene, čini se da je farmakokinetika panobinostata linearna u rasponu doza od 10-30 mg, ali AUC se povećava manje nego proporcionalno s dozom pri višim dozama.
The incidence of deaths not related to study indication was 8.8% in patients ≥65 years of age compared to 5.4% in patients <65 years of age.
Incidencija smrti koje nisu bile povezane s ispitivanom indikacijom bila je 8,8% u bolesnika u dobi ≥65 godina, u usporedbi s 5,4% u bolesnika u dobi <65 godina.
The parent substance is deemed to be responsible for the overall pharmacological activity of panobinostat.
Smatra se da je matična tvar odgovorna za cjelokupnu farmakološku aktivnost panobinostata.
Panobinostat should not be administered in patients with severe hepatic impairment due to lack of experience and safety data in this population.
Panobinostat se ne smije primjenjivati u bolesnika s teškim oštećenjem jetre zbog nedostatka iskustva i sigurnosnih podataka u ovoj populaciji.
Patients had to be exposed to an IMiD (lenalidomide or thalidomide).
Bolesnici su morali biti izloženi imunomodulacijskom lijeku (lenalidomidu ili talidomidu).