natgillin/translations-raw huggingface dataset:
You should continue to drink at least 1.5 to 2 litres of water on the day you start Venclyxto. 
1,5 - 2 litre vode na dan kada počnete uzimati Venclyxto.
In rabbits, venetoclax produced maternal toxicity, but no foetal toxicity at exposures of 0.1 times the human AUC exposure at the recommended dose. 
U kunića je venetoklaks uzrokovao toksičnost za majku, ali ne i toksičnost za fetus pri razinama izloženosti 0,1 x izloženost[AUC] koja se postiže u ljudi kod primjene preporučene doze.
What Venclyxto is and what it is used for What Venclyxto is 
Što je Venclyxto i za što se koristi Što je Venclyxto
• If you are not sure talk to your doctor, pharmacist or nurse. 
• Ako niste sigurni, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
Substrates of P-gp, BCRP, and OATP1B1 
Supstrati P-gp-a, BCRP-a i prijenosnika OATP1B1
Venclyxto monotherapy is indicated for the treatment of CLL: 
Venclyxto je indiciran kao monoterapija za liječenje KLL-a:
Venclyxto tablets are provided in blisters which are packed in cartons as follows: 
Venclyxto tablete dolaze u blisterima zapakiranima u kutije sa:
• itraconazole ketoconazole, posaconazole, or voriconazole for fungal infections 
• itrakonazolom, ketokonazolom, posakonazolom ili vorikonazolom, za liječenje gljivičnih infekcija
The most frequently reported serious adverse reactions (≥2%) in patients receiving venetoclax in combination with rituximab were pneumonia, febrile neutropenia, and TLS. 
Najčešće prijavljene ozbiljne nuspojave (≥ 2%) u bolesnika koji su primali venetoklaks u kombinaciji s rituksimabom bile su pneumonija, febrilna neutropenija i TLS.
If a moderate CYP3A inhibitor must be used, the initiation and titration doses of venetoclax should be reduced by at least 50%. 
Ako se mora primijeniti umjeren inhibitor CYP3A, početnu dozu i doze venetoklaksa tijekom titracije treba smanjiti za najmanje 50%.
Forest plot of Investigator-Assessed PFS in Subgroups from MURANO 
Slika 3. Grafikon raspona pouzdanosti (engl. forest plot) za PFS prema ocjeni ispitivača u podskupinama iz ispitivanja MURANO
The median time since diagnosis was 8.3 years (range: 0.3 to 18.5 years; N=96). 
Medijan vremena od dijagnoze iznosio je 8,3 godine (raspon: 0,3 do 18,5 godina; N=96).
Table 4: Investigator-assessed progression-free survival in patients with previously treated CLL in MURANO 
Tablica 4: Preživljenje bez progresije bolesti prema ocjeni ispitivača među bolesnicima s prethodno liječenim KLL-om u ispitivanju MURANO
Concomitant use of venetoclax with strong CYP3A inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, ritonavir) at initiation and during the dose-titration phase is contraindicated due to increased risk for TLS (see section 4.3). 
Istodobna primjena venetoklaksa sa snažnim inhibitorima CYP3A (npr. itrakonazolom, ketokonazolom, posakonazolom, vorikonazolom, klaritromicinom, ritonavirom) pri uvođenju liječenja i tijekom faze titracije doze kontraindicirana je zbog povećanog rizika od TLS-a (vidjeti dio 4.3).
Neutropenia is an identified risk with Venclyxto treatment. 
Neutropenija je poznat rizik liječenja lijekom Venclyxto.
The primary efficacy endpoint was ORR according to IWCLL updated NCI-WG guidelines. 
Primarna mjera ishoda za djelotvornost bio je ORR prema NCI-WG smjernicama koje je ažurirao IWCLL.
Of the 107 patients who were evaluated for efficacy from M13-982 study, 57% were 65 years or older. 
Među 107 bolesnika kod kojih se ocjenjivala djelotvornost u ispitivanju M13-982, njih 57% bilo je u dobi od 65 ili više godina.
Patients should be monitored more closely for signs of toxicities (see sections 4.4 and 4.5). 
Bolesnike treba pažljivije nadzirati zbog mogućih znakova toksičnosti (vidjeti dijelove 4.4 i 4.5).
Median age was 65 years (range: 22 to 85); 74% were male, and 97% were white. 
Medijan dobi iznosio je 65 godina (raspon: 22 do 85); 74% bili su muškarci, a 97% bijelci.
If you are at risk of TLS you may be treated in hospital so that you can be given fluids into the vein if needed, have blood tests done more often and to check for side effects. 
Ako kod Vas postoji rizik od TLS-a, možda ćete se morati liječiti u bolnici kako bi se po potrebi omogućila primjena tekućina u venu, češće provođenje krvnih pretraga i praćenje zbog mogućih nuspojava.
Additional efficacy results in MURANO Investigator assessed 
Tablica 5. Dodatni rezultati za djelotvornost u ispitivanju MURANO
Your doctor may also give you medicines to help prevent the build up of uric acid in your body before you start treatment with Venclyxto. 
Liječnik će Vam prije početka liječenja lijekom Venclyxto možda dati i lijekove koji će pomoći spriječiti nakupljanje mokraćne kiseline u tijelu.
In subjects with severe (Child-Pugh C; n=5) hepatic impairment, the mean venetoclax Cmax was similar to subjects with normal hepatic function but venetoclax AUCinf was on average 2.7-fold higher (range: no change to 5-fold higher) than venetoclax AUCinf in the subjects with normal hepatic function (see section 4.2). 
U ispitanika s teškim (Child-Pugh C; n=5) oštećenjem jetrene funkcije, srednja vrijednost Cmax za venetoklaks bila je slična onoj u ispitanika s normalnom jetrenom funkcijom, ali je vrijednost AUCinf za venetoklaks bila u prosjeku 2,7 puta veća (raspon: od bez promjene do 5 puta veća) u odnosu na vrijednost AUCinf za venetoklaks u ispitanika s normalnom jetrenom funkcijom (vidjeti dio 4.2).
Agents that may have their plasma concentrations altered by venetoclax 
Lijekovi čija se plazmatska koncentracija može promijeniti uslijed djelovanja venetoklaksa
Preparations containing St. John's wort are contraindicated during treatment with venetoclax, as efficacy may be reduced (see section 4.3). 
Primjena pripravaka koji sadrže gospinu travu kontraindicirana je tijekom liječenja venetoklaksom jer može smanjiti njegovu djelotvornost (vidjeti dio 4.3).
In a dedicated hepatic impairment study, venetoclax Cmax and AUC in subjects with mild (Child-Pugh A; n=6) or moderate (Child-Pugh B; n=6) hepatic impairment were similar to subjects with normal hepatic function, after receiving a 50 mg single dose of venetoclax. 
U ispitivanju oštećenja jetrene funkcije, vrijednosti Cmax i AUC za venetoklaks u ispitanika s blagim (Child-Pugh A; n=6) ili umjerenim (Child-Pugh B; n=6) oštećenjem jetrene funkcije bile su slične onim u ispitanika s normalnom jetrenom funkcijom, nakon primanja jedne doze venetoklaksa od 50 mg.
Agents that may alter venetoclax plasma concentrations 
Lijekovi koji mogu promijeniti plazmatske koncentracije venetoklaksa
If a patient vomits following dosing, no additional dose should be taken that day. 
Ako bolesnik povrati nakon uzimanja doze, ne smije uzeti dodatnu dozu taj dan.
Venclyxto film-coated tablets are for oral use. 
Venclyxto filmom obložene tablete namijenjene su za peroralnu primjenu.
25 (19.6, NR) 
25 (19,6; NP)
Table 6: Efficacy results in patients with previously treated CLL with 17p deletion (study M13-982) Endpoint 
Tablica 6: Rezultati za djelotvornost u bolesnika s prethodno liječenim KLL-om i delecijom 17p (ispitivanje M13-982)
In non-clinical studies, venetoclax has demonstrated cytotoxic activity in tumour cells that overexpress BCL-2. 
U nekliničkim je ispitivanjima venetoklaks pokazao citotoksičnu aktivnost u tumorskim stanicama koje prekomjerno eksprimiraju
For patients who have had a dosing interruption lasting more than 1 week during the first 5 weeks of dose titration or more than 2 weeks after completing the dose-titration phase, TLS risk should be reassessed to determine if restarting at a reduced dose is necessary (e.g., all or some levels of the dose titration; see Table 
U bolesnika kojima je primjena bila prekinuta tijekom više od tjedan dana u prvih 5 tjedana titracije ili tijekom više od 2 tjedna nakon završetka faze titracije doze, potrebno je ponovno ocijeniti rizik od
Table 3: Adverse drug reactions reported in patients with CLL treated with venetoclax 
Tablica 3: Nuspojave prijavljene u bolesnika s KLL-om liječenih venetoklaksom
Co administration with transporter substrates/inhibitors Venetoclax is a P-gp and BCRP substrate as well as a P-gp and BCRP inhibitor and a weak OATP1B1 inhibitor in vitro (see section 4.5). 
Istodobna primjena sa supstratima/inhibitorima prijenosnika Venetoklaks je supstrat P-gp-a i BCRP-a, kao i inhibitor P-gp-a i BCRP-a te slab inhibitor prijenosnika OATP1B1 in vitro (vidjeti dio 4.5).
NR (16.4, NR) 
NP (16,4; NP)
Patients with moderate hepatic impairment should be monitored more closely for signs of toxicity at initiation and during the dose-titration phase (see section 4.8). 
Bolesnike s umjerenim oštećenjem jetrene funkcije treba pažljivije nadzirati zbog mogućih znakova toksičnosti pri uvođenju liječenja i tijekom faze titracije doze (vidjeti dio 4.8).
Venetoclax was not genotoxic in bacterial mutagenicity assay, in vitro chromosome aberration assay and in vivo mouse micronucleus assay. 
Venetoklaks nije bio genotoksičan u testu mutagenosti na bakterijama, testu kromosomskih aberacija in vitro i u mikronukleusnom testu na miševima in vivo.
The median age was 66 years (range: 28 to 85 years), 70% were male, and 92% were white. 
Medijan dobi iznosio je 66 godina (raspon: 28 do 85 godina); 70% bolesnika bili su muškarci, a 92% bijelci.
Of the patients, 37% (34/91) were fludarabine refractory, 81% (30/37) harboured the unmutated IgVH gene, and 72% (60/83) had TP53 mutation. 
Među bolesnicima je njih 37% (34/91) bilo refraktorno na fludarabin, 81% (30/37) imalo je nemutiran gen IgVH, dok je njih 72% (60/83) imalo mutaciju gena
Median prior lines of therapy was 1 (range: 1 to 5); and included alkylating agents (94%), anti-CD20 antibodies (77%), B-cell receptor pathway inhibitors (2%) and prior purine analogs (81%, including 55% FCR). 
Medijan broja prethodnih linija liječenja bio je 1 (raspon: 1 do 5), a liječenje je uključivalo alkilirajuće lijekove (94%), protutijela na CD20 (77%), inhibitore signalnih puteva B-staničnih receptora (2%) i purinske analoge (81%, uključujući 55% bolesnika koji su primali protokol FCR).
Table 7: Efficacy results as assessed by investigator in patients who have failed a B-cell receptor pathway inhibitor (study M14-032) 
Tablica 7: Rezultati za djelotvornost prema ocjeni ispitivača u bolesnika koji nisu odgovorili na liječenje inhibitorom signalnih puteva B-staničnih receptora (ispitivanje M14-032).
Peripheral blood, % (95% CI)c 
Periferna krv, % (95% CI)c
Co-administration of narrow therapeutic index P-gp, or BCRP substrates (e.g., digoxin, dabigatran, everolimus, sirolimus) with venetoclax should be avoided. 
Treba izbjegavati istodobnu primjenu supstrata P-gp-a ili BCRP-a uskog terapijskog indeksa (npr. digoksina, dabigatrana, everolimusa, sirolimusa) i venetoklaksa.
In the MURANO study, dose interruptions due to adverse reactions occurred in 71% of patients treated with the combination of venetoclax and rituximab; the most common adverse reaction that led to dose interruption of venetoclax was neutropenia (43%). 
U ispitivanju MURANO, privremeni je prekid primjene zbog nuspojava zabilježen u 71% bolesnika liječenih kombinacijom venetoklaksa i rituksimaba; najčešća nuspojava koja je dovela do privremenog prekida primjene venetoklaksa bila je neutropenija (43%).
The median time since diagnosis was 6.8 years (range: 0.1 to 32 years; N=106). 
Medijan vremena od dijagnoze iznosio je 6,8 godina (raspon: 0,1 do 32 godine; N=106).
For patients who have completed the dose-titration phase and are on a steady daily dose of venetoclax, the venetoclax dose should be reduced by 50% when used concomitantly with moderate CYP3A inhibitors and by 75% when used concomitantly with strong CYP3A inhibitors. 
U bolesnika koji su završili fazu titracije doze i primaju stabilnu dnevnu dozu venetoklaksa, dozu venetoklaksa treba smanjiti za 50% pri istodobnoj primjeni s umjerenim inhibitorima CYP3A te za 75% pri istodobnoj primjeni sa snažnim inhibitorima CYP3A.
At an updated efficacy analysis with all patients off treatment (data cut-off date 8 May 2018 and median follow-up of 36 months) the 36-month PFS estimate in the venetoclax + rituximab arm was 71.4% [95% CI: 64.8, 78.1] and in the bendamustine + rituximab arm was 15.2% [95% CI: 9.1, 21]. 
U trenutku provedbe analize ažuriranih podataka o djelotvornosti u svih bolesnika koji više nisu primali liječenje (završni datum prikupljanja podataka: 8. svibnja 2018.; medijan praćenja od 36 mjeseci), 36-mjesečni procijenjeni PFS u skupini koja je primala venetoklaks + rituksimab iznosio je 71,4% (95% CI: 64,8; 78,1), dok je u skupini koja je primala bendamustin + rituksimab iznosio 15,2% (95% CI: 9,1; 21).
Median time since diagnosis was 6.7 years (range: 0.3 to 29.5). 
Medijan vremena od dijagnoze iznosio je 6,7 godina (raspon: 0,3 do 29,5).
Patients with reduced renal function (CrCl <80 ml/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase (see “Prevention of tumour lysis syndrome” above). 
(CrCl < 80 ml/min) možda će biti potrebna intenzivnija profilaksa i praćenje kako bi se smanjio rizik od TLS-a pri uvođenju liječenja i tijekom faze titracije doze (vidjeti odlomak „Prevencija sindroma lize tumora“ u prethodnom tekstu).
Dosage reductions due to adverse reactions occurred in 15% of patients treated with the combination of venetoclax and rituximab in the MURANO study and 14% of patients treated with venetoclax in the monotherapy studies. 
Do smanjenja doze zbog nuspojava došlo je u 15% bolesnika liječenih kombinacijom venetoklaksa i rituksimaba u ispitivanju MURANO i 14% bolesnika liječenih venetoklaksom u ispitivanjima monoterapije.
For patients who are on a steady daily dose of Venclyxto, the venetoclax dose should be reduced by 50% when used concomitantly with moderate CYP3A inhibitors and by 75% when used concomitantly with strong CYP3A inhibitors. 
U bolesnika koji primaju stabilnu dnevnu dozu lijeka Venclyxto, dozu venetoklaksa treba smanjiti za 50% pri istodobnoj primjeni s umjerenim inhibitorima CYP3A te za 75% pri istodobnoj primjeni sa snažnim inhibitorima CYP3A.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING CARTON multipack (without blue box) 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU KUTIJA - višestruko pakiranje (bez plavog okvira)
Venetoclax is a potent, selective inhibitor of B-cell lymphoma (BCL)-2, an anti-apoptotic protein. 
Venetoklaks je snažan, selektivan inhibitor antiapoptotskog proteina B-staničnog limfoma 2 (engl.
Ask your doctor for advice on sperm storage before starting treatment with Venclyxto. 
Obratite se svom liječniku za savjet o pohrani sperme prije nego započnete liječenje lijekom
Treatment with Venclyxto should be withheld for any grade 3 or 4 non-haematological toxicities, grade 3 or 4 neutropenia with infection or fever, or grade 4 haematological toxicities, except lymphopenia. 
3. ili 4. stupnja, neutropenije 3. ili 4. stupnja praćene infekcijom ili vrućicom, ili hematoloških toksičnosti 4. stupnja, osim limfopenije.
In the initial Phase 1 dose-finding studies, which had a shorter (2 to 3 week) titration phase and higher starting dose, the incidence of TLS was 13% (10/77; 5 laboratory TLS; 5 clinical TLS), including 2 fatal events and 3 events of acute renal failure, 1 requiring dialysis. 
U početnim ispitivanjima faze 1 provedenima radi određivanja doze, koja su imala kraću (2 do 3 tjedna) fazu titracije i višu početnu dozu, incidencija TLS-a iznosila je 13% (10/77; 5 laboratorijski utvrđenih
Post-titration dose for venetoclax in combination with rituximab 
Doza venetoklaksa u kombinaciji s rituksimabom nakon titracije
Concomitant use of preparations containing St. John's wort (see sections 4.4 and 4.5). 
Istodobna primjena pripravaka koji sadrže gospinu travu (vidjeti dijelove 4.4 i 4.5).
Venetoclax as monotherapy for the treatment of patients with CLL harbouring 17p deletion or TP53 mutation - study M13-982 
Venetoklaks u monoterapiji za liječenje bolesnika s KLL-om koji imaju deleciju 17p ili mutaciju gena TP53 - ispitivanje M13-982
Initiation and titration phase 
Uvođenje liječenja i faza titracije
It is not known whether the active substance in Venclyxto passes into breast milk. 
Nije poznato izlučuje li se djelatna tvar lijeka Venclyxto u majčino mlijeko.
In a drug-drug interaction study in 12 healthy subjects, co-administration of 500 mg of azithromycin on the first day followed by 250 mg of azithromycin once daily for 4 days decreased venetoclax Cmax by 25% and AUC∞ by 35%. 
U ispitivanju interakcija s drugim lijekovima provedenom u 12 zdravih ispitanika, istodobna primjena 500 mg azitromicina prvog dana, a zatim 250 mg azitromicina jedanput na dan tijekom 4 dana, snizila je Cmax venetoklaksa za 25%, a njegov AUC∞ za 35%.
The venetoclax dose that was used prior to initiating the CYP3A inhibitor should be resumed 2 to 3 days after discontinuation of the inhibitor (see section 4.2). 
Dozu venetoklaksa koja se koristila prije uvođenja inhibitora CYP3A treba ponovno uvesti 2 do 3 dana nakon prekida primjene inhibitora (vidjeti dio 4.2).
The most commonly occurring adverse reactions (≥20%) of any grade in patients receiving venetoclax in the combination study with rituximab were neutropenia, diarrhoea, and upper respiratory tract infection. 
Najčešće nuspojave (≥ 20%) bilo kojeg stupnja u bolesnika koji su primali venetoklaks u ispitivanju kombinacije s rituksimabom bile su neutropenija, proljev i infekcija gornjih dišnih putova.
MRD negativity rate at end of combination treatmentb 
Stopa negativnog nalaza na MRD na kraju kombiniranog liječenjab
Because venetoclax was not dosed to steady state, it is recommended that the international normalized ratio (INR) be monitored closely in patients receiving warfarin. 
Budući da se venetoklaks nije primjenjivao do postizanja stanja dinamičke ravnoteže, preporučuje se pažljivo pratiti internacionalni normalizirani omjer (engl.
In a drug-drug interaction study, administration of a single 100 mg dose of venetoclax with 0.5 mg digoxin, a P-gp substrate, resulted in a 35% increase in digoxin Cmax and a 9% increase in digoxin AUC∞. 
U ispitivanju interakcija s drugim lijekovima, primjena jednokratne doze venetoklaksa od 100 mg zajedno s 0,5 mg digoksina, supstrata P-gp-a, povećala je Cmax digoksina za 35%, a AUC∞ digoksina za 9%.
In the monotherapy studies with venetoclax, dose interruptions due to adverse reactions occurred in 40% of patients; the most common adverse reaction leading to dose interruption was neutropenia (5%). 
U ispitivanjima monoterapije venetoklaksom, privremeni je prekid primjene zbog nuspojava zabilježen u 40% bolesnika; najčešća nuspojava koja je dovela do privremenog prekida primjene bila je neutropenija (5%).
P-gp and BCRP inhibitors 
Inhibitori P-gp-a i BCRP-a
Blood chemistry (potassium, uric acid, phosphorus, calcium, and creatinine) should be assessed and pre-existing abnormalities corrected. 
mokraćna kiselina, fosfor, kalcij i kreatinin) te korigirati postojeća odstupanja od normalnih vrijednosti.
Arm B: 69%). 
70% (skupina A: 70%; skupina B: 69%).
Dose modifications for use with CYP3A inhibitors 
Prilagodbe doze kod primjene s inhibitorima CYP3A
In the monotherapy studies with venetoclax, 11% of patients discontinued due to adverse reactions. 
U ispitivanjima monoterapije venetoklaksom liječenje je zbog nuspojava prekinulo 11% bolesnika.
Progression-free survival (PFS) was assessed by investigators using the International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008). 
Preživljenje bez progresije bolesti (engl. progression-free survival, PFS) ocjenjivali su ispitivači na temelju smjernica radne skupine koju je sponzorirao Nacionalni institut za rak (engl.
PFS, months, median (95% CI) 
PFS, mjeseci, medijan (95% CI)
Prior to initiating venetoclax, tumour burden assessment, including radiographic evaluation (e.g., CT scan), must be performed for all patients. 
Prije uvođenja venetoklaksa, u svih se bolesnika mora odrediti opterećenje tumorskom masom, što uključuje radiografsku ocjenu (npr. CT oslikavanje).
Adverse reactions are listed below by MedDRA body system organ class and by frequency. 
3. Nuspojave u nastavku navedene su prema MedDRA klasifikaciji organskih sustava i učestalosti.
Efficacy data are presented for 107 patients with data cutoff date 30 April 2015. 
bolesnika za koje su podaci prikupljani do 30. travnja 2015.
PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON (5 day pack) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (5-dnevno pakiranje)
Co-administration of a 600 mg single dose of rifampin, a P-gp inhibitor, in 11 healthy subjects increased venetoclax Cmax by 106% and AUC∞ by 78%. 
Istodobna primjena rifampina, inhibitora P-gp-a, u jednokratnoj dozi od 600 mg u 11 zdravih ispitanika, povećala je Cmax venetoklaksa za 106%, a AUC∞ za 78%.
Venetoclax is a P-gp, BCRP and OATP1B1 inhibitor in vitro. 
Venetoklaks je inhibitor P-gp-a, BCRP-a i prijenosnika OATP1B1 in vitro.
During dose-titration phase, treatment should be interrupted and patients should be monitored carefully for signs and symptoms of TLS (fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, muscle or joint pain, abdominal pain and distension) along with other toxicities (see section 4.2). 
zimice, mučnine, povraćanja, smetenosti, nedostatka zraka, napadaja, nepravilnih otkucaja srca, tamne ili mutne mokraće, neuobičajenog umora, boli u mišićima ili zglobovima, boli u abdomenu i distenzije abdomena), kao i drugih toksičnosti (vidjeti dio 4.2).
aThe discrepancy between IRC- and investigator-assessed CR rate was due to interpretation of residual adenopathy on CT scans. 
aNepodudarnost između stope potpune remisije prema ocjeni neovisnog ocjenjivačkog povjerenstva i stope potpune remisije prema ocjeni ispitivača posljedica je interpretacije rezidualne adenopatije na CT snimcima.
How Venclyxto works 
Kako Venclyxto djeluje
Overall, 65% of patients received prior nucleoside analogue, 86% rituximab, 39% other monoclonal antibodies, and 72% alkylating agent (including 41% with bendamustine). 
Ukupno je 65% bolesnika prethodno primalo nukleozidni analog, 86% rituksimab, 39% druga monoklonska protutijela, a 72% alkilirajući lijek
CR = complete remission; CRi = complete remission with incomplete marrow recovery; IRC = independent review committee; MRD = minimal residual disease; nPR = nodular partial remission; NA = not available; NR = not reached; ORR = overall response rate (CR + CRi + nPR + PR); PR = partial remission. 
CR (engl. complete remission) = potpuna remisija; CRi (engl. complete remission with incomplete marrow recovery) = potpuna remisija uz nepotpun oporavak koštane srži; IRC (engl. independent review committee) = neovisno ocjenjivačko povjerenstvo; MRD (engl. minimal residual disease), minimalna rezidualna bolest; nPR (engl. nodular partial remission) = nodularna djelomična remisija; ND = nije dostupno; NP = nije postignuto; ORR (engl. overall response rate) = stopa ukupnog odgovora (CR + CRi + nPR + PR); PR (engl. partial remission) = djelomična remisija.
The median number of prior anti-CLL treatments was 2 (range: 1 to 10 treatments); 49.5% with a prior nucleoside analogue, 38% with prior rituximab, and 94% with a prior alkylator (including 33% with prior bendamustine). 
1 do 10 terapija); 49,5% prethodno se liječilo nukleozidnim analogom, 38% rituksimabom, a 94% alkilirajućim lijekom (uključujući 33% bolesnika koji su prethodno liječeni bendamustinom).
Concomitant use of venetoclax with moderate CYP3A inhibitors at initiation and during the dose-titration phase should be avoided. 
Istodobnu primjenu venetoklaksa s umjerenim inhibitorima CYP3A pri uvođenju liječenja i tijekom faze titracije doze treba izbjegavati.
Venetoclax as monotherapy for the treatment of patients with CLL who have failed a B-cell receptor pathway inhibitor - study M14-032 
Venetoklaks u monoterapiji za liječenje bolesnika s KLL-om koji nisu odgovorili na liječenje inhibitorom signalnih puteva B-staničnih receptora - ispitivanje M14-032