natgillin/translations-raw huggingface dataset:
Congestive heart failure (CHF) (see section 4.8)
Kongestivno srčno popuščanje (glejte poglavje 4.8)
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.
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.
Topotecan + Paclitaxel vs. Cisplatin + Paclitaxel
Topotekan + paklitaksel proti cisplatin + paklitaksel
• 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.
• 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.
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.
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.
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.
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.
MVASI is also used for the treatment of adult patients with advanced non-small cell lung cancer.
Zdravilo MVASI uporabljamo tudi za zdravljenje odraslih bolnikov z napredovalim nedrobnoceličnim rakom pljuč.
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.
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.
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.
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.
95% CI
95-% interval zaupanja
Secondary endpoints Progression-free survival - Primary analysis6 Median PFS (months)1 Hazard ratio [95% CI]
(vrednost p5,8 = 0,0126) Sekundarni opazovani dogodki Preživetje brez napredovanja bolezni - primarna analiza6 Mediana preživetja brez napredovanja (meseci)1 Razmerje ogroženosti [95-% IZ]
(14.9 vs. 17.5 months; p = 0.4146)
(14,9 proti 17,5 meseca; p =
Cisplatin + Paclitaxel
Cisplatin + paklitaksel
Clear to slightly opalescent, colourless to slightly yellow liquid.
FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje Bistra do rahlo motna, brezbarvna do rahlo rumena tekočina.
Gall bladder perforation (not known)
Bolezni prebavil razjeda v prebavilih (ni znana)
• 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.
• 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.
In patients developing PRES, treatment of specific symptoms including control of hypertension is recommended along with discontinuation of MVASI.
Če se pri bolniku pojavi sindrom posteriorne reverzibilne encefalopatije, je poleg prekinitve zdravljenja z zdravilom MVASI priporočljivo zdravljenje specifičnih simptomov, vključno z uravnavo hipertenzije.
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.
Število infuzij, ki jih boste prejeli, je odvisno od vašega odziva na zdravljenje.
• MVASI can increase the risk of developing a weak heart.
• zdravilo MVASI lahko poveča tveganje za opešanje srca.
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.
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.
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.
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.
Paclitaxel (n = 354)
paklitaksel (n = 354)
• 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.
• 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.
You may be advised to have a dental check-up before you start treatment with MVASI.
Pred začetkom zdravljenja z zdravilom MVASI boste morda morali opraviti pregled zob.
Overall survival - Primary analysis1 Hazard ratio (95% CI)
Drugi faktor Celokupno preživetjeprimarna analiza1 Razmerje ogroženosti (95-% IZ)
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).
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).
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.
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.
Progression-free survival1
Preživetje brez napredovanja bolezni1
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.
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.
(17.5 vs.15.0 months; p = 0.0584)
(17,5 proti 15,0 meseca; p =
,b
,d,
• CP arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks duration.
• CP skupina: 6 tritedenskih ciklov karboplatina (AUC 6) in paklitaksela (175 mg/m2).
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.
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.
• 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
• 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.
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.
Poleg tega je bila opravljena vnaprej določena analiza v kateri niso uporabili podatkov za dogodke napredovanja bolezni glede na CA 125.
Relative to the control arm.
b glede na kontrolno skupino.
• CP arm: Carboplatin (AUC5) and paclitaxel (175 mg/m2 IV) every 3 weeks for 6 and up to
• skupina CP: karboplatin (AUC5) in paklitaksel (175 mg/m2 intravensko) vsake 3 tedne, od 6 do največ 8 ciklov.
• 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)
• 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).
Paclitaxel/ bevacizumab (n = 252)
paklitaksel/ bevacizumab (n = 252)
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.
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.
• a blood clot in the blood vessels of your lungs,
• krvni strdek v krvnih žilah pljuč,
CT (n = 144)
kemoterapija (n = 144)
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.
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.
Venous thromboembolism (see section 4.8)
Venska trombembolija (glejte poglavje 4.8)
The recommended dose of MVASI is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
Priporočeni odmerek zdravila MVASI je 10 mg/kg telesne mase v enkratnem odmerku vsaka 2 tedna, v obliki intravenske infuzije.
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.
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.
Paclitaxel/ bevacizumab (n = 229)
paklitaksel/ bevacizumab (n = 229)
130 mg/m2 IV 2 h
Oksaliplatin 130 mg/m2 i.v.
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)
• 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);
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.
Zdravilo MVASI dodajamo h kemoterapiji, osnovani na platini, do 6 ciklov, nato pa zdravilo MVASI dajemo samostojno do napredovanja bolezni.
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).
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).
MVASI is also used for treatment of adult patients with advanced kidney cancer.
Zdravilo MVASI uporabljamo tudi za zdravljenje odraslih bolnikov z napredovalim rakom ledvičnih celic.
Progression-free survival Median (months) Hazard ratio (95% confidence interval)
Preživetje brez napredovanja bolezni mediana (meseci) razmerje ogroženosti 95-% interval zaupanja
• 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.
• 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.
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.
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.
EGFR monoclonal antibodies in combination with bevacizumab chemotherapy regimens
Monoklonska protitelesa z delovanjem na EGFR, v kombinaciji s kemoterapevtskimi shemami, ki vključujejo bevacizumab
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.
V študiji BO25041 z bevacizumabom, dodanim pooperativni radioterapiji s sočasno in adjuvantno uporabo temozolomida pri pediatričnih bolnikih z novo diagnosticiranim supratentorialnim,
Median (months) Hazard ratio [95% CI]
Mediana (meseci)1 Razmerje ogroženosti [95-% IZ]
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).
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).
Median PFS (months) Hazard ratio (95% CI)4 Randomised patients with stage IV disease CPP (n = 153)
Randomizirane bolnice z boleznijo stadija IV CPP (n = 153)
Cervical cancer
Rak materničnega vratu
Median PFS (months) Hazard ratio (95% CI)4 Randomised patients with stage III suboptimally debulked disease3 CP (n = 154)
Randomizirane bolnice s suboptimalno citoredukcijo, stadija III3 CP (n = 154)
• 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.
• 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.
Fistulab,d, Muscular weakness, Back pain
fistulab,d, mišična oslabelost, bolečine v hrbtu osteonekroza čeljustnica,b, osteonekroza izven spodnje čeljustnicea,f
STATEMENT OF ACTIVE SUBSTANCE(S)
Celokupni odgovor delež (n) p-vrednost
Overall survival - Follow-up analysis2 Hazard ratio (95% CI)
Celokupno preživetjeanaliza po spremljanju2 Razmerje ogroženosti (95-% IZ)
• 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.
• 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.
5-FU/FA + bevacizumabb
5-FU/FA + bevacizumab a
Patients may be at risk of developing venous thromboembolic reactions, including pulmonary embolism under bevacizumab treatment.
Med zdravljenjem z bevacizumabom so bolniki lahko podvrženi povečanemu tveganju za razvoj venskih trombemboličnih neželenih učinkov, vključno s pljučno embolijo.
Dehydration, Hyponatraemia
Presnovne in prehranske motnje dehidracija, hiponatriemija
Median PFS (months) Hazard ratio (95% CI) Median OS (months) Hazard ratio (95% CI) Topotecan n = 120
Razmerje ogroženosti (95-% interval zaupanja) Mediana celokupnega preživetja (meseci) Razmerje ogroženosti (95-% interval zaupanja) topotekan n = 120
Paclitaxel (n = 243)
paklitaksel (n = 243)
MVASI is also used for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer.
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.
Cisplatin/Gemcitabine + bevacizumab 15 mg/kg q 3 weeks
Skupina 2 karboplatin, paklitaksel in bevacizumab 15 mg/kg na 3 tedne
difference compared to the control arm for NCI-CTCAE grade 1-5 reactions or at least a 2%
• 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),
PFS1 results by disease stage and debulking status from study BO17707 (ICON7) Randomised patients stage III optimally debulked disease2,3 CP (n = 368)
Rezultati preživetja brez napredovanja bolezni1, glede na stadij bolezni in stopnjo citoredukcije iz študije BO17707 (ICON7)
(17.5 vs.14.3 months; p = 0.0609)
(17,5 proti 14,3 meseca; p =
Across all clinical trials, mucocutaneous haemorrhage has been seen in up to 50% of bevacizumabtreated patients.
Pri do 50 % bolnikov, ki so bili zdravljeni z bevacizumabom v vseh kliničnih preskušanjih, je prišlo do krvavitev iz kože in sluznic.
Hazard ratio (95% CI) > 12 months (n = 282) Median
6 - 12 mesecev (n = 202) mediana razmerje ogroženosti (95 % interval zaupanja) > 12 mesecev (n = 282) mediana razmerje ogroženosti (95 % interval zaupanja)
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.
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.
Fistulaa,b, Myalgia, Arthralgia, Muscular weakness, Back pain
Bolezni mišično-skeletnega sistema in vezivnega tkiva fistulaa,b, mialgija, artralgija, mišična oslabelost, bolečine v hrbtu osteonekroza čeljustnicb,c
Posterior Reversible Encephalopathy Syndrome (PRES) (see section 4.8)
Sindrom posteriorne reverzibilne encefalopatije (glejte poglavje 4.8)
• blocking of the veins by a blood clot,
• zamašitev ven s krvnim strdkom,
Treatment with bevacizumab at 15 mg/kg every 3 weeks in combination with chemotherapy (carboplatin and paclitaxel) for 6 and up to 8 cycles, followed by bevacizumab until disease progression or unacceptable toxicity resulted, when data were derived from eCRF, in a clinically meaningful and statistically significant improvement in OS compared to treatment with carboplatin and paclitaxel alone.
Izsledki (po zbranih podatkih iz eCRF) so pokazali klinično pomembno in statistično značilno podaljšanje celokupnega preživetja pri skupini, ki je prejemala bevacizumab v odmerku 15 mg/kg vsake 3 tedne v kombinaciji s kemoterapijo (karboplatinom in paklitakselom) od 6 do največ 8 ciklov, ki mu je sledil bevacizumab do napredovanja bolezni ali nesprejemljive toksičnosti, v primerjavi z dajanjem samo karboplatina in paklitaksela.
Median PFS (months) HR (95% CI) p-value Response rates (for patients with measurable disease) Investigator assessment
Odgovor bolnikov na zdravljenje (pri bolnikih z merljivo boleznijo) Ocena raziskovalca
(16.2 vs. 17.5 months; p = 0.3769)
(16,2 proti 17,5 meseca; p =
From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 venous thromboembolic events have been reported in up to 15.6% of patients treated with bevacizumab in combination with paclitaxel and cisplatin compared with up to 7.0% of patients treated with paclitaxel and cisplatin.
so o venskih trombemboličnih dogodkih stopnje 3 do 5 poročali pri do 15,6 % bolnic, ki so prejemale bevacizumab v kombinaciji s paklitakselom in cisplatinom, in pri do 7,0 % bolnic, ki so prejemale paklitaksel in cisplatin.