FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose of MVASI is 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Slovenian: Priporočeni odmerek zdravila MVASI je 10 mg/kg telesne mase v enkratnem odmerku vsaka 2 tedna ali 15 mg/kg telesne mase v enkratnem odmerku vsake 3 tedne, v obliki intravenske infuzije.
English: Topotecan + Paclitaxel vs. Cisplatin + Paclitaxel
Slovenian: Topotekan + paklitaksel proti cisplatin + paklitaksel
English: • MO22224 evaluated the efficacy and safety of bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Slovenian: • Preskušanje MO22224 je ocenjevalo učinkovitost in varnost bevacizumaba v kombinaciji s paklitakselom, topotekanom ali pegiliranim liposomalnim doksorubicinom pri bolnicah s ponovitvijo epitelijskega raka jajčnikov, karcinoma jajcevodov ali primarnega peritonealnega karcinoma, rezistentnega na platino.
English: An increased incidence of CHF has been observed in a clinical trial of patients with diffuse large B-cell lymphoma when receiving bevacizumab with a cumulative doxorubicin dose greater than 300 mg/m2.
Slovenian: V kliničnem preskušanju, ki je vključevalo bolnike z difuznim velikoceličnim B limfomom, ki so prejemali bevacizumab skupaj s kumulativnim odmerkom doksorubicina, ki je presegal 300 mg/m2, so opazili večjo incidenco kongestivnega srčnega popuščanja.
English: This was a phase II randomised, active-controlled, open-labelled clinical trial investigating bevacizumab in combination with 5-FU/FA as first-line treatment of metastatic colorectal cancer.
Slovenian: To je bilo randomizirano, aktivno kontrolirano, odprto klinično preskušanje faze II, v katerem so proučevali kombinacijo bevacizumaba s 5-FU/FA kot prvo linijo zdravljenja metastatskega raka debelega črevesa in danke.
English: MVASI is also used for the treatment of adult patients with advanced non-small cell lung cancer.
Slovenian: Zdravilo MVASI uporabljamo tudi za zdravljenje odraslih bolnikov z napredovalim nedrobnoceličnim rakom pljuč.
English: In a randomised phase II study (BO25041) a total of 121 patients aged ≥ 3 years to < 18 years with newly diagnosed supratentorial or infratentorial cerebellar or peduncular high-grade glioma (HGG) were treated with post-operative radiation therapy (RT) and adjuvant temozolomide (T) with and without bevacizumab: 10 mg/kg every 2 weeks IV.
Slovenian: V randomizirani študiji faze II (BO25041) so s pooperativno radioterapijo in adjuvantnim temozolomidom v kombinaciji z intravenskim bevacizumabom (v odmerku 10 mg/kg vsaka dva tedna) ali brez njega zdravili skupno 121 bolnikov, starih od ≥ 3 do < 18 let, z novo diagnosticiranim supratentorialnim ali infratentorialnim cerebralnim ali pedunkularnim gliomom visoke stopnje.
English: The addition of bevacizumab 5 mg/kg every two weeks to 5-FU/FA resulted in higher objective response rates, significantly longer progression-free survival, and a trend in longer survival as compared to 5-FU/FA chemotherapy alone.
Slovenian: Dodatek 5 mg bevacizumaba/kg telesne mase vsake dva tedna h kemoterapiji po shemi 5-FU/FA je povečal objektivni odgovor na zdravljenje in značilno podaljšal preživetje brez napredovanja bolezni.
English: 95% CI
Slovenian: 95-% interval zaupanja
English: Secondary endpoints Progression-free survival - Primary analysis6 Median PFS (months)1 Hazard ratio [95% CI]
Slovenian: (vrednost p5,8 = 0,0126) Sekundarni opazovani dogodki Preživetje brez napredovanja bolezni - primarna analiza6 Mediana preživetja brez napredovanja (meseci)1 Razmerje ogroženosti [95-% IZ]
English: (14.9 vs. 17.5 months; p = 0.4146)
Slovenian: (14,9 proti 17,5 meseca; p =
English: Cisplatin + Paclitaxel
Slovenian: Cisplatin + paklitaksel
English: Clear to slightly opalescent, colourless to slightly yellow liquid.
Slovenian: FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje Bistra do rahlo motna, brezbarvna do rahlo rumena tekočina.
English: Gall bladder perforation (not known)
Slovenian: Bolezni prebavil razjeda v prebavilih (ni znana)
English: • The protocol-specified analysis of investigator assessed PFS (without censoring for CA-125 progression or non-protocol therapy [NPT]) shows a stratified hazard ratio of 0.71 (95% CI: 0.61-0.83, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 10.4 months in the CPP arm and 14.1 months in the CPB15+ arm.
Slovenian: • S protokolom opredeljena analiza preživetja brez napredovanja bolezni, ocenjena s strani raziskovalca (brez krnjenih podatkov za napredovanje bolezni glede na CA 125 ali zdravljenja, ki ni bilo v skladu s protokolom) kaže stratificirano razmerje ogroženosti 0,71 (95-% interval zaupanja: 0,61-0,83; p-vrednost za enostranski log rank test < 0,0001) ko primerjamo CPB15+ s CPP, z mediano preživetja brez napredovanja bolezni 10,4 meseca v CPP skupini in 14,1 meseca v CPB15+ skupini.
English: In patients developing PRES, treatment of specific symptoms including control of hypertension is recommended along with discontinuation of MVASI.
Slovenian: Če se pri bolniku pojavi sindrom posteriorne reverzibilne encefalopatije, je poleg prekinitve zdravljenja z zdravilom MVASI priporočljivo zdravljenje specifičnih simptomov, vključno z uravnavo hipertenzije.
English: The number of infusions that you receive will depend on how you are responding to treatment; you should continue to receive this medicine until MVASI fails to stop your tumour growing.
Slovenian: Število infuzij, ki jih boste prejeli, je odvisno od vašega odziva na zdravljenje.
English: • MVASI can increase the risk of developing a weak heart.
Slovenian: • zdravilo MVASI lahko poveča tveganje za opešanje srca.
English: This was a phase III randomised, controlled, open-label trial investigating bevacizumab 5.0 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks in combination with fluoropyrimidine-based chemotherapy versus fluoropyrimidine-based chemotherapy alone in patients with mCRC who have progressed on a first-line bevacizumab-containing regimen.
Slovenian: To je bilo randomizirano, kontrolirano, odprto preskušanje faze III, s katerim so pri bolnikih z metastatskim rakom debelega črevesa in danke, pri katerih je po prvi liniji zdravljenja z bevacizumabom prišlo do napredovanja bolezni, proučevali bevacizumab v odmerku 5,0 mg/kg telesne mase vsaka 2 tedna ali v odmerku 7,5 mg/kg telesne mase vsake 3 tedne v kombinaciji s kemoterapijo, osnovano na fluoropirimidinu, v primerjavi s samostojno kemoterapijo na osnovi fluoropirimidina.
English: The recommended dose of MVASI is 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Slovenian: Priporočeni odmerek zdravila MVASI je 7,5 mg/kg telesne mase ali 15 mg/kg telesne mase v enkratnem odmerku na 3 tedne, v obliki intravenske infuzije.
English: Paclitaxel (n = 354)
Slovenian: paklitaksel (n = 354)
English: • The analysis of PFS as determined by the independent review committee (censoring for NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.50-0.77, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 13.1 in the CPP arm and 19.1 months in the CPB15+ arm.
Slovenian: • Analiza preživetja brez napredovanja bolezni, kot jo je določil odbor za neodvisni pregled (s krnjenimi podatki za zdravljenje, ki ni bilo v skladu s protokolom) kaže stratificirano razmerje ogroženosti 0,62 (95-% interval zaupanja: 0,50-0,77; p-vrednost za enostranski log rank test < 0,0001) ko primerjamo CPB15+ s CPP, z mediano preživetja brez napredovanja bolezni 13,1 v CPP skupini in 19,1 meseca v CPB15+ skupini.
English: You may be advised to have a dental check-up before you start treatment with MVASI.
Slovenian: Pred začetkom zdravljenja z zdravilom MVASI boste morda morali opraviti pregled zob.
English: Overall survival - Primary analysis1 Hazard ratio (95% CI)
Slovenian: Drugi faktor Celokupno preživetjeprimarna analiza1 Razmerje ogroženosti (95-% IZ)
English: Grade 3-5 reactions have been observed in up to 2.3% of patients treated with bevacizumab plus chemotherapy as compared with < 1% with chemotherapy alone (NCI-CTCAE v.3).
Slovenian: Neželene učinke stopnje 3 do 5 so opazili pri do 2,3 % bolnikov, ki so bili zdravljeni z bevacizumabom in kemoterapijo (NCI-CTCAE v.3).
English: In the FOLFOX treatment subgroup, the median PFS was 8.6 months in placebo and 9.4 months in bevacizumab-treated patients, HR = 0.89, 97.5% CI = [0.73; 1.08]; p-value = 0.1871, the corresponding results in the XELOX treatment subgroup being 7.4 vs. 9.3 months, HR = 0.77, 97.5% CI = [0.63; 0.94]; p-value = 0.0026.
Slovenian: V podskupini, ki je prejemala zdravljenje po shemi FOLFOX, je bila mediana preživetja brez napredovanja bolezni 8,6 meseca pri bolnikih, ki so prejemali placebo, ter 9,4 meseca pri bolnikih, ki so se zdravili z bevacizumabom; razmerje ogroženosti = 0,89, 97,5-% interval zaupanja = [0,73; 1,08]; p-vrednost = 0,1871.
English: Progression-free survival1
Slovenian: Preživetje brez napredovanja bolezni1
English: This was a randomised, double-blind, phase II clinical trial investigating bevacizumab 10 mg/kg in a 2 weekly schedule with the same dose of bevacizumab in combination with 150 mg daily erlotinib, in patients with metastatic clear cell RCC. A total of 104 patients were randomised to treatment in this trial, 53 to bevacizumab 10 mg/kg every 2 weeks plus placebo and 51 to bevacizumab 10 mg/kg every 2 weeks plus erlotinib 150 mg daily.
Slovenian: Skupno so v zdravljenje v tem preskušanju randomizirali 104 bolnike; 53 v skupino, ki je prejemala bevacizumab 10 mg/kg vsake 2 tedna in placebo, ter 51 v skupino, ki je prejemala bevacizumab 10 mg/kg vsake 2 tedna in 150 mg erlotiniba na dan.
English: (17.5 vs.15.0 months; p = 0.0584)
Slovenian: (17,5 proti 15,0 meseca; p =
English: ,b
Slovenian: ,d,
English: • CP arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks duration.
Slovenian: • CP skupina: 6 tritedenskih ciklov karboplatina (AUC 6) in paklitaksela (175 mg/m2).
English: Severe reactions are defined as adverse events with at least a 2% difference compared to the control arm in clinical studies for NCI-CTCAE grade 3-5 reactions.
Slovenian: Hudi neželeni učinki so tisti neželeni učinki stopnje 3 do 5 po lestvici NCI-CTCAE, ki so se pojavili z najmanj 2-% razliko v primerjavi s kontrolno skupino v kliničnih preskušanjih.
English: • CPB15 arm: Five cycles of bevacizumab (15 mg/kg q3w started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by placebo alone, for a total of up to 15 months of therapy
Slovenian: • CPB15 skupina: pet ciklov bevacizumaba (15 mg/kg telesne mase enkrat na 3 tedne, z začetkom v ciklu 2) v kombinaciji s karboplatinom (AUC 6) in 6 cikli paklitaksela (175 mg/m2), katerim je sledil samo placebo do skupno 15 mesecev zdravljenja.
English: In addition, a pre-specified analysis of the data censoring for CA-125 progression events was conducted, as well as an independent review of PFS as determined by radiological scans.
Slovenian: Poleg tega je bila opravljena vnaprej določena analiza v kateri niso uporabili podatkov za dogodke napredovanja bolezni glede na CA 125.
English: Relative to the control arm.
Slovenian: b glede na kontrolno skupino.
English: • CP arm: Carboplatin (AUC5) and paclitaxel (175 mg/m2 IV) every 3 weeks for 6 and up to
Slovenian: • skupina CP: karboplatin (AUC5) in paklitaksel (175 mg/m2 intravensko) vsake 3 tedne, od 6 do največ 8 ciklov.
English: • Paclitaxel 175 mg/m2 IV over 3 hours on day 1 and topotecan 0.75 mg/m2 IV over 30 minutes on days 1-3 plus bevacizumab 15 mg/kg IV on day 1 (q3w)
Slovenian: • paklitaksel 175 mg/m2 intravensko v 3-urni infuziji 1. dan in topotekan 0,75 mg/m2 intravensko v 30 minutah od 1. do 3. dne (na 3 tedne) ter bevacizumab 15 mg/kg intravensko 1. dan (na 3 tedne).
English: Paclitaxel/ bevacizumab (n = 252)
Slovenian: paklitaksel/ bevacizumab (n = 252)
English: As bevacizumab may adversely impact wound healing, patients who had major surgery within the last 28 days were excluded from participation in phase III clinical trials.
Slovenian: Bolniki, ki so imeli večjo operacijo v zadnjih 28 dneh pred pričetkom zdravljenja, niso bili vključeni v klinična preskušanja faze III, saj lahko bevacizumab negativno vpliva na celjenje ran.
English: • a blood clot in the blood vessels of your lungs,
Slovenian: • krvni strdek v krvnih žilah pljuč,
English: CT (n = 144)
Slovenian: kemoterapija (n = 144)
English: Prior radiation is a major risk factor for the development of GI-vaginal fistulae and all patients with GI-vaginal fistulae had a history of prior radiation.
Slovenian: Predhodno obsevanje je velik dejavnik tveganja za nastanek fistule med prebavili in nožnico; vse bolnice s fistulo med prebavili in nožnico so bile predhodno obsevane.
English: Venous thromboembolism (see section 4.8)
Slovenian: Venska trombembolija (glejte poglavje 4.8)
English: The recommended dose of MVASI is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
Slovenian: Priporočeni odmerek zdravila MVASI je 10 mg/kg telesne mase v enkratnem odmerku vsaka 2 tedna, v obliki intravenske infuzije.
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (GOG-0240), 1.8% of bevacizumab-treated patients and 1.4% of control patients were reported to have had nongastrointestinal vaginal, vesical, or female genital tract fistulae.
Slovenian: V kliničnem preskušanju pri bolnicah z rakom materničnega vratu, pri katerih je bila bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je bila metastatska (študija GOG-240), je imelo fistule med nožnico, mehurjem ali ženskimi spolovili in organi izven prebavil 1,8 % prejemnic bevacizumaba in 1,4 % bolnic v kontrolni skupini.
English: Paclitaxel/ bevacizumab (n = 229)
Slovenian: paklitaksel/ bevacizumab (n = 229)
English: 130 mg/m2 IV 2 h
Slovenian: Oksaliplatin 130 mg/m2 i.v.
English: Paclitaxel 175 mg/m2 IV over 3 hours on day 1 and cisplatin 50 mg/m2 IV on day 2 (q3w); or Paclitaxel 175 mg/m2 IV over 3 hours on day 1 and cisplatin 50 mg/m2 IV on day 1 (q3w)
Slovenian: • paklitaksel 135 mg/m2 intravensko v 24-urni infuziji 1. dan in cisplatin 50 mg/m2 intravensko 2. dan na 3 tedne, ali paklitaksel 175 mg/m2 intravensko v 3-urni infuziji 1. dan in cisplatin 50 mg/m2 intravensko 2. dan (na 3 tedne), ali paklitaksel 175 mg/m2 intravensko v 3-urni infuziji 1. dan in cisplatin 50 mg/m2 intravensko 1. dan (na 3 tedne);
English: First-line treatment of non-squamous NSCLC in combination with platinum-based chemotherapy MVASI is administered in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by MVASI as a single agent until disease progression.
Slovenian: Zdravilo MVASI dodajamo h kemoterapiji, osnovani na platini, do 6 ciklov, nato pa zdravilo MVASI dajemo samostojno do napredovanja bolezni.
English: Patients treated for persistent, recurrent, or metastatic cervical cancer with bevacizumab are at increased risk of fistulae between the vagina and any part of the GI tract (Gastrointestinal-vaginal fistulae).
Slovenian: Bolnice z rakom materničnega vratu, pri katerih je bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je metastatska, in se zdravijo z bevacizumabom, imajo večje tveganje za nastanek fistule med nožnico in katerim koli delom prebavil (fistule med prebavili in nožnico).
English: MVASI is also used for treatment of adult patients with advanced kidney cancer.
Slovenian: Zdravilo MVASI uporabljamo tudi za zdravljenje odraslih bolnikov z napredovalim rakom ledvičnih celic.
English: Progression-free survival Median (months) Hazard ratio (95% confidence interval)
Slovenian: Preživetje brez napredovanja bolezni mediana (meseci) razmerje ogroženosti 95-% interval zaupanja
English: • CPB15+ arm: Five cycles of bevacizumab (15 mg/kg q3w started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by continued use of bevacizumab (15 mg/kg q3w) as single agent for a total of up to 15 months of therapy.
Slovenian: • CPB15+ skupina: pet ciklov bevacizumaba (15 mg/kg telesne mase enkrat na 3 tedne, z začetkom v ciklu 2) v kombinaciji s karboplatinom (AUC 6) in 6 cikli paklitaksela (175 mg/m2), katerim je sledilo zdravljenje samo z bevacizumabom (15 mg/kg telesne mase enkrat na 3 tedne) do skupno 15 mesecev zdravljenja.
English: In one clinical trial evaluating bevacizumab in combination with 5-fluorouracil/folinic acid, AVF2192g, patients with metastatic colorectal cancer who were not candidates for treatment with irinotecan were included.
Slovenian: Bolniki z metastatskim rakom debelega črevesa in danke, ki niso bili primerni za zdravljenje z irinotekanom, so bili vključeni v klinično preskušanje AVF2192g, ki je ocenjevalo bevacizumab v kombinaciji s 5-fluorouracilom oziroma folinsko kislino.
English: EGFR monoclonal antibodies in combination with bevacizumab chemotherapy regimens
Slovenian: Monoklonska protitelesa z delovanjem na EGFR, v kombinaciji s kemoterapevtskimi shemami, ki vključujejo bevacizumab
English: In study BO25041 of bevacizumab added to post-operative radiation therapy (RT) with concomitant and adjuvant temozolomide in paediatric patients with newly diagnosed supratentorial, infratentorial, cerebellar, or peduncular high-grade glioma, the safety profile was comparable with that observed in other tumour types in adults treated with bevacizumab.
Slovenian: V študiji BO25041 z bevacizumabom, dodanim pooperativni radioterapiji s sočasno in adjuvantno uporabo temozolomida pri pediatričnih bolnikih z novo diagnosticiranim supratentorialnim,
English: Median (months) Hazard ratio [95% CI]
Slovenian: Mediana (meseci)1 Razmerje ogroženosti [95-% IZ]
English: Patients were randomised to paclitaxel alone (90 mg/m2 / IV over 1-hour once weekly for three out of four weeks) or in combination with bevacizumab (10 mg/kg IV infusion every two weeks).
Slovenian: v 1 uri enkrat tedensko tri od štirih tednov) ali v skupino, ki je prejemala kombinacijo paklitaksela in bevacizumaba (10 mg/kg z intravensko infuzijo vsaka dva tedna).
English: Median PFS (months) Hazard ratio (95% CI)4 Randomised patients with stage IV disease CPP (n = 153)
Slovenian: Randomizirane bolnice z boleznijo stadija IV CPP (n = 153)
English: Cervical cancer
Slovenian: Rak materničnega vratu
English: Median PFS (months) Hazard ratio (95% CI)4 Randomised patients with stage III suboptimally debulked disease3 CP (n = 154)
Slovenian: Randomizirane bolnice s suboptimalno citoredukcijo, stadija III3 CP (n = 154)
English: • The primary analysis of investigator assessed PFS (censoring for CA-125 progressions and NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.52-0.75, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 12.0 months in the CPP arm and 18.2 months in the CPB15+ arm.
Slovenian: • Primarna analiza preživetja brez napredovanja bolezni, ocenjena s strani raziskovalca (s krnjenimi podatki za napredovanje bolezni glede na CA 125 in zdravljenja, ki ni bilo v skladu s protokolom) kaže stratificirano razmerje ogroženosti 0,62 (95-% interval zaupanja: 0,52-0,75; p-vrednost za enostranski log rank test < 0,0001) ko primerjamo CPB15+ s CPP, z mediano preživetja brez napredovanja bolezni 12,0 mesecev v CPP skupini in 18,2 meseca v CPB15+ skupini.
English: Fistulab,d, Muscular weakness, Back pain
Slovenian: fistulab,d, mišična oslabelost, bolečine v hrbtu osteonekroza čeljustnica,b, osteonekroza izven spodnje čeljustnicea,f
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Celokupni odgovor delež (n) p-vrednost
English: Overall survival - Follow-up analysis2 Hazard ratio (95% CI)
Slovenian: Celokupno preživetjeanaliza po spremljanju2 Razmerje ogroženosti (95-% IZ)
English: • GOG-0213 evaluated the efficacy and safety of bevacizumab in combination with carboplatin and paclitaxel, followed by bevacizumab as a single agent in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Slovenian: • Preskušanje GOG-0213 je ocenjevalo učinkovitost in varnost bevacizumaba v kombinaciji s karboplatinom in paklitakselom, ki jim je sledil bevacizumab samostojno, pri bolnicah s ponovitvijo epitelijskega raka jajčnikov, karcinoma jajcevodov ali primarnega peritonealnega karcinoma, občutljivega na platino.
English: 5-FU/FA + bevacizumabb
Slovenian: 5-FU/FA + bevacizumab a
English: Patients may be at risk of developing venous thromboembolic reactions, including pulmonary embolism under bevacizumab treatment.
Slovenian: Med zdravljenjem z bevacizumabom so bolniki lahko podvrženi povečanemu tveganju za razvoj venskih trombemboličnih neželenih učinkov, vključno s pljučno embolijo.
English: Dehydration, Hyponatraemia
Slovenian: Presnovne in prehranske motnje dehidracija, hiponatriemija
English: Median PFS (months) Hazard ratio (95% CI) Median OS (months) Hazard ratio (95% CI) Topotecan n = 120
Slovenian: Razmerje ogroženosti (95-% interval zaupanja) Mediana celokupnega preživetja (meseci) Razmerje ogroženosti (95-% interval zaupanja) topotekan n = 120
English: Paclitaxel (n = 243)
Slovenian: paklitaksel (n = 243)
English: MVASI is also used for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer.
Slovenian: Zdravilo MVASI se uporablja tudi za zdravljenje odraslih bolnic z rakom materničnega vratu, pri katerih je bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je metastatska.
English: Cisplatin/Gemcitabine + bevacizumab 15 mg/kg q 3 weeks
Slovenian: Skupina 2 karboplatin, paklitaksel in bevacizumab 15 mg/kg na 3 tedne
English: difference compared to the control arm for NCI-CTCAE grade 1-5 reactions or at least a 2%
Slovenian: • zaradi primerljive incidence, opažene med preiskovanimi skupinami v kliničnih preskušanjih (z najmanj 10-% razliko v primerjavi s kontrolno skupino za neželene učinke stopnje 1 do 5 po lestvici NCI-CTCAE ali najmanj 2-% razliko v primerjavi s kontrolno skupino za neželene učinke stopnje 3 do 5 po lestvici NCI-CTCAE),
English: PFS1 results by disease stage and debulking status from study BO17707 (ICON7) Randomised patients stage III optimally debulked disease2,3 CP (n = 368)
Slovenian: Rezultati preživetja brez napredovanja bolezni1, glede na stadij bolezni in stopnjo citoredukcije iz študije BO17707 (ICON7)
English: (17.5 vs.14.3 months; p = 0.0609)
Slovenian: (17,5 proti 14,3 meseca; p =
English: Across all clinical trials, mucocutaneous haemorrhage has been seen in up to 50% of bevacizumabtreated patients.
Slovenian: Pri do 50 % bolnikov, ki so bili zdravljeni z bevacizumabom v vseh kliničnih preskušanjih, je prišlo do krvavitev iz kože in sluznic.
English: Hazard ratio (95% CI) > 12 months (n = 282) Median
Slovenian: 6 - 12 mesecev (n = 202) mediana razmerje ogroženosti (95 % interval zaupanja) > 12 mesecev (n = 282) mediana razmerje ogroženosti (95 % interval zaupanja)
English: Overall approximately 50% of patients had a GOG PS of 0 at baseline, 43% a GOG PS score of 1, and 7% a GOG PS score of 2.
Slovenian: Pred začetkom zdravljenja so skupno približno 50 % bolnic, status zmogljivosti (PS, performance status) po GOG (Gynecologic Oncology Group) ocenili z 0; 43 % so ga ocenili z 1, 7 % bolnicam pa z 2.
English: Fistulaa,b, Myalgia, Arthralgia, Muscular weakness, Back pain
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva fistulaa,b, mialgija, artralgija, mišična oslabelost, bolečine v hrbtu osteonekroza čeljustnicb,c
English: Posterior Reversible Encephalopathy Syndrome (PRES) (see section 4.8)
Slovenian: Sindrom posteriorne reverzibilne encefalopatije (glejte poglavje 4.8)
English: • blocking of the veins by a blood clot,
Slovenian: • zamašitev ven s krvnim strdkom,