natgillin/translations-raw huggingface dataset:
In the Phase IIIb trial in Crohn’s disease, SONIC, placebo patients received AZA 2.5 mg/kg/day as active control in addition to placebo infliximab infusions.
V preskušanju IIIb faze SONIC pri bolnikih s Crohnovo boleznijo, so bolniki iz placebo skupine, poleg placebo infuzij infliksimaba, prejemali kot kontrolno zdravilno učinkovino AZA v odmerku 2,5 mg/kg na dan.
In the pitolisant group, ESS decreased significantly between baseline and the end of treatment compared to placebo with an observed mean change of -1.9 ± 4.3 and -5.4 ± 4.3 (mean ± sd) for placebo and pitolisant respectively, (p<0.0001) (Figure 3).
V skupini s pitolizantom se je ČDZ od izhodišča do konca zdravljenja znatno zmanjšala v primerjavi s skupino s placebom, pri čemer je bila zabeležena povprečna sprememba –1,9 ± 4,3 pri placebu in –5,4 ± 4,3 pri pitolizantu (povprečje ± standardni odklon), (p < 0,0001) (slika 3).
In the pivotal clinical study (N = 189), 27.5% of patients reported elevated liver enzymes.
V ključni klinični študiji (n = 189) so pri 27,5 % bolnikov poročali o zvišanju jetrnih encimov.
In the pivotal clinical study (N = 189), 51.9% of patients experienced one or more neurologic adverse reactions (including psychiatric disorders), primarily involving the central nervous system.
V ključni klinični študiji (n = 189) je 51,9 % bolnikov imelo enega ali več nevroloških neželenih učinkov (vključno s psihiatričnimi motnjami), predvsem na osrednjem živčevju.
In the pivotal clinical study (N = 189), less than 1.4% of patients treated with blinatumomab tested positive for binding and neutralising anti-blinatumomab antibodies.
V ključni klinični študiji (n = 189) je imelo pozitiven izvid vezavnih in nevtralizacijskih protiteles proti blinatumomabu manj kot 1,4 % bolnikov, ki so prejemali blinatumomab.
In the pivotal clinical study (N = 189), serious CRS reactions were reported in 0.5% of patients with a median time to onset of 2 days.
V ključni klinični študiji (n = 189) so pri 0,5 % bolnikov poročali o resnih reakcijah sindroma sproščanja citokinov z mediana časom do njihovega pojava 2 dni.
In the pivotal clinical study BO21004/CLL11, 91% (40 out of 44) of evaluable patients treated with Gazyvaro were B-cell depleted (defined as CD19+ B cell counts < 0.07 x 109/L) at the end of treatment period and remained depleted during the first 6 months of follow up.
V ključni klinični študiji BO21004/CLL11 je imelo 91 % (40 od 44) ocenljivih bolnikov, zdravljenih z zdravilom Gazyvaro, na koncu obdobja zdravljenja odsotnost celic B (opredeljeno kot število celic B CD19+ < 0,07 x 109/l); ta odsotnost se je ohranila v prvih 6 mesecih spremljanja.
In the pivotal clinical trial CLEOPATRA, 408 patients received at least one dose of Perjeta in combination with trastuzumab and docetaxel.
V ključnem kliničnem preskušanju CLEOPATRA je 408 bolnikov prejelo vsaj en odmerek zdravila Perjeta v kombinaciji s trastuzumabom in docetakselom.
In the pivotal clinical trials for Kuvan, the following adverse reactions have been identified.
V ključnih kliničnih preizkušanjih za zdravilo Kuvan so opazili naslednje neželene učinke.
In the pivotal controlled trials in adults and children, 12.9% of patients treated with Humira developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 7.2% of patients receiving placebo or active control.
V ključnih kontroliranih preskušanjih pri odraslih in otrocih je reakcije na mestu injiciranja (eritem in/ali srbenje, krvavitve, bolečine ali oteklost) imelo 12,9 % bolnikov, ki so dobivali zdravilo Humira, in 7,1 % bolnikov, ki so dobivali placebo ali kontrolno učinkovino.
In the pivotal controlled trials in adults and children, 12.9% of patients treated with Humira developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 7.2% of patients receiving placebo or active control.
V kontroliranih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet, pri odraslih in otrocih je reakcije na mestu injiciranja (eritem in/ali srbenje, krvavitve, bolečine ali oteklost) imelo 12,9 % bolnikov, ki so dobivali zdravilo Humira, in 7,1 % bolnikov, ki so dobivali placebo ali kontrolno učinkovino.
In the pivotal controlled trials in adults and children, 12.9% of patients treated with Humira developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 7.2% of patients receiving placebo or active control.
V kontroliranih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet, pri odraslih in otrocih je reakcije na mestu injiciranja (eritem in/ali srbenje, krvavitve, bolečine ali oteklost) imelo 12,9 % bolnikov, ki so dobivali zdravilo Humira, in 7,2 % bolnikov, ki so dobivali placebo ali kontrolno učinkovino.
In the pivotal controlled trials in adults and children, the rate of infection was 1.51 per patient year in the Humira treated patients and 1.46 per patient year in the placebo and active control-treated patients.
V kontroliranih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet, pri odraslih in otrocih je bil delež okužb 1,51 na bolnikov-let med bolniki, ki so dobivali zdravilo Humira, in 1,46 na bolnikov-let med bolniki, ki so dobivali placebo oziroma kontrolno učinkovino.
In the pivotal double-blind ATLAS ACS 2 TIMI 51 trial, 15,526 patients were randomly assigned in a 1:1:1 fashion to one of three treatment groups: Xarelto 2.5 mg orally twice daily, 5 mg orally twice daily or to placebo twice daily co-administered with ASA alone or with ASA plus a thienopyridine (clopidogrel or ticlopidine).
V ključnem dvojno slepem preskušanju ATLAS ACS 2 TIMI 51 so 15.526 bolnikov naključno razdelili po shemi 1:1:1 v eno od treh skupin zdravljenja: zdravljenje z zdravilom Xarelto 2,5 mg peroralno dvakrat na dan, 5 mg peroralno dvakrat na dan ali skupino, ki je prejemala placebo dvakrat na dan sočasno samo z acetilsalicilno kislino ali z acetilsalicilno kislino in tienopiridinom (klopidogrel ali tiklopidin).
In the pivotal European multicenter 64-week clinical trial including 12 week randomised, double- blind, double-dummy, 2-arm, parallel study period, 248 high vascular risk patients with mixed dyslipidaemia were randomised to one of the two treatment groups: Pravafenix 40 mg/160 mg or pravastatin 40 mg.
12-tedensko randomizirano, dvojno slepo in dvojno zakrito paralelno študijo z dvema skupinama, je bilo 248 bolnikov z visokim tveganjem za vaskularne bolezni, ki so imeli mešano dislipidemijo, randomiziranih v eno od dveh skupin zdravljenja: zdravilo Pravafenix 40 mg/160 mg ali pravastatin 40 mg.
In the pivotal MCRC study, anaemia, nausea, vomiting, constipation, alopecia, increased alkaline phosphatase, and hyperbilirubinaemia occurred in ≥20% of patients.
V ključni študiji mKRR so se anemija, navzea, bruhanje, zaprtost, alopecija, zvišanje alkalne fosfataze in hiperbilirubinemija pojavili pri ≥ 20 % bolnikov.
In the pivotal metastatic trials of intravenous Herceptin, the incidence of cardiac dysfunction varied between 9 % and 12 % when it was combined with paclitaxel compared with 1 % – 4 % for paclitaxel alone.
V ključnih preskušanjih z intravensko danim zdravilom Herceptin pri metastatski bolezni je bila incidenca motenj v delovanju srca pri bolnikih, ki so zdravilo prejemali sočasno s paklitakselom, v razponu od 9 do 12 % v primerjavi z 1 do 4 % pri samostojnem jemanju paklitaksela.
In the pivotal phase 3 GIST study (n = 312), treatment-related fatal cardiac reactions occurred in 1% of patients on each arm of the study (i.e. sunitinib and placebo arms).
Z zdravljenjem povezani smrtni srčni dogodki so se v ključni študiji 3. faze pri GIST (n = 312) v obeh skupinah (tj. skupini s sunitinibom in skupini s placebom) pojavili pri 1 % bolnikov.
In the pivotal Phase 3 SELECT trial (see section 5.1), hypertension (including hypertension, hypertensive crisis, blood pressure diastolic increased, and blood pressure increased) was reported in 72.8% of lenvatinib-treated patients and 16.0% of patients in the placebo-treated group.
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o hipertenziji (vključno s hipertenzijo, hipertenzivno krizo, zvišanim diastoličnim krvnim tlakom in zvišanim krvnim tlakom) pri 72,8 % bolnikov, zdravljenih z lenvatinibom, in pri 16,0 % bolnikov, ki so prejemali placebo.
In the pivotal Phase 3 SELECT trial (see section 5.1), proteinuria was reported in 33.7% of lenvatinib- treated patients and 3.1% of patients in the placebo-treated group.
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o proteinuriji pri 33,7 % bolnikov, zdravljenih z lenvatinibom, in pri 3,1 % bolnikov v skupini, ki je prejemala placebo.
In the pivotal Phase III NSCLC trial, current smokers achieved erlotinib steady state trough plasma concentration of 0.65 µg/mL (n=16) which was approximately 2-fold less than the former smokers or patients who had never smoked (1.28 µg/mL, n=108).
V ključni študiji faze III pri nedrobnoceličnem raku pljuč je bila najmanjša koncentracija erlotiniba v stanju dinamičnega ravnovesja pri bolnikih, ki so med zdravljenjem kadili, 0,65 µg/ml (n = 16), kar je bilo približno 2-krat manj, kot pri nekdanjih kadilcih ali bolnikih, ki niso nikoli kadili (1,28 µg/ml, n =
In the pivotal placebo-controlled study of ADCIRCA for the treatment of PAH, a total of 323 patients were treated with ADCIRCA at doses ranging from 2.5 mg to 40 mg once daily and 82 patients were treated with placebo.
V ključni, s placebom kontrolirani študiji zdravila ADCIRCA za zdravljenje PAH je zdravilo ADCIRCA v odmerkih od 2,5 mg do 40 mg enkrat dnevno dobivalo skupno 323 bolnikov, 82 bolnikov je dobivalo placebo.
In the pivotal SCCHN studies patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 6-15) in all subsequent cycles.
V ključnem preskušanju pri bolnikih s skvamoznoceličnim karcinomom glave in vratu, pri katerih se je pojavila zapletena nevtropenija (ki vključuje dolgotrajno nevtropenijo, febrilno nevtropenijo ali okužbo), je bilo priporočeno, naj se v vseh naslednjih ciklih za profilaktično kritje (na primer med 6. in 15. dnem) uporablja G-CSF.
In the pivotal SCCHN studies patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 6-15) in all subsequent cycles.
V ključnih SCCHN študijah pri bolnikih, pri katerih se je pojavila komplicirana nevtropenija (ki vključuje dolgotrajno nevtropenijo, fibrilno nevtropenijo ali okužbo), je bilo priporočeno, naj se v vseh naslednjih ciklih za profilaktično kritje (na primer med 6. in 15. dnem) uporablja G-CSF.
In the pivotal SCCHN studies patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 6-15) in all subsequent cycles.
V ključnih študijah SCCHN preskušanju pri bolnikih, pri katerih se je pojavila komplicirana nevtropenija (ki vključuje dolgotrajno nevtropenijo, fibrilno nevtropenijo ali okužbo), je bilo priporočeno, naj se v vseh naslednjih ciklih za profilaktično kritje (na primer med 6. in 15. dnem) uporablja G-CSF.
In the pivotal studies, the negative predictive value for NeoSpect in association with CT for solitary pulmonary nodules (SPNs) was 90–96% at a disease prevalence of 30-50%.
V študijah je bila negativna napovedna vrednost za NeoSpect v povezavi z CT za posamezne pljučne vozliče(SPN) 90-96% pri 30- 50% prevalenci bolezni.
In the pivotal study 1199.13, 85 patients (12.9 % of the patients with adenocarcinoma histology) were ≥ 70 years of age (median age: 72 years, range: 70 - 80 years) (see section 5.1).
V osrednji študiji 1199.13 je bilo 85 bolnikov (12,9 % je imelo histologijo adenokarcinoma) starih ≥ 70 let (mediana starost: 72 let, razpon: 70 do 80 let) (glejte poglavje 5.1).
In the pivotal study for MCRC, compromised wound healing was reported in 3 patients (0.5%) treated with the ZALTRAP/FOLFIRI regimen and 5 patients (0.8%) treated with the placebo/FOLFIRI regimen.
V ključni študiji pri bolnikih z mKRR so slabše celjenje ran zabeležili pri 3 (0,5 %) prejemnikih sheme ZALTRAP/FOLFIRI in pri 5 (0,8 %) prejemnikih sheme placebo/FOLFIRI.
In the pivotal study GAO4753g 1% of patients experienced gastrointestinal perforation.
V ključni študiji GAO4753g je imelo gastro-intestinalne perforacije 1 % bolnikov.
In the pivotal study in iNHL, 44% (85 out of 194) of patients treated with Gazyvaro plus bendamustine were 65 years or older.
V ključni študiji pri iNHL je bilo 44 % (85 od 194) bolnikov, zdravljenih z zdravilom Gazyvaro in bendamustinom, starih 65 let ali več.
In the pivotal study in iNHL, a small subset of 8% (15 out of 194) of patients treated with Gazyvaro plus bendamustine, had moderate renal impairment (CrCL < 50 mL/min).
V ključni študiji pri iNHL je manjši delež 8 % bolnikov (15 od 194), zdravljenih z zdravilom Gazyvaro in bendamustinom, imel zmerno ledvično okvaro (očistek kreatinina < 50 ml/min).
In the pivotal study investigating the prevention of stroke and SEE in patients with atrial fibrillation, a total of 12,042 patients were treated with dabigatran etexilate.
V ključni raziskavi, v kateri so proučevali preprečevanje možganske kapi in sistemskih emboličnih dogodkov pri bolnikih z atrijsko fibrilacijo, je bilo 12.042 bolnikov zdravljenih z dabigatran eteksilatom.
In the pivotal study of MACI, patients were excluded if they had a history of osteoarthritis (Kellgren-Lawrence Grade 3 or 4) in the target knee, or concomitant inflammatory disease.
V osrednji študiji z zdravilom MACI so bili bolniki izključeni, če so imeli v anamnezi osteoartritis (3. ali 4. stopnje po lestvici Kellgren–Lawrence) v ciljnem kolenu ali sočasno vnetno bolezen.
In the pivotal study of MCRC patients, all grades VTE occurred in 9.3% of patients treated with the ZALTRAP/FOLFIRI regimen and 7.3% of patients treated with the placebo/FOLFIRI regimen.
V ključni študiji pri bolnikih z mKRR so se VTE vseh stopenj pojavili pri 9,3 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 7,3 % prejemnikov sheme placebo/FOLFIRI.
In the pivotal study of MCRC patients, ATE (including transient ischaemic attack, cerebrovascular accident, angina pectoris, intracardiac thrombus, myocardial infarction, arterial embolism, and ischaemic colitis) were reported in 2.6% of patients treated with the ZALTRAP/FOLFIRI regimen and 1.5% of patients treated with the placebo/FOLFIRI regimen.
V ključni študiji pri bolnikih z mKRR so arterijske trombembolične dogodke (vključno s tranzitorno ishemično atako, cerebrovaskularnim inzultom, angino pektoris, intrakardialnim trombom, miokardnim infarktom, arterijsko embolijo in ishemičnim kolitisom) zabeležili pri 2,6 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 1,5 % prejemnikov sheme placebo/FOLFIRI.
In the pivotal study of MCRC patients, diarrhoea (all grades) has been observed in 69.2% of patients treated with ZALTRAP/FOLFIRI and 56.5% of patients treated with placebo/FOLFIRI.
V ključni študiji pri bolnikih z mKRR so drisko (vseh stopenj) zabeležili pri 69,2 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 56,5 % prejemnikov sheme placebo/FOLFIRI.
In the pivotal study of MCRC patients, episodes of bleeding/haemorrhage (all grades) was reported in 37.8% of patients treated with the ZALTRAP/FOLFIRI regimen compared to 19.0% of patients treated with the placebo/FOLFIRI regimen.
V ključni študiji pri bolnikih z mKRR so krvavitve (vseh stopenj) zabeležili pri 37,8 % prejemnikov sheme ZALTRAP/FOLFIRI in 19,0 % prejemnikov sheme placebo/FOLFIRI.
In the pivotal study of MCRC patients, fistulas (anal, enterovesical, enterocutaneous, colovaginal, intestinal sites) were reported in 9 of 611 patients (1.5%) treated with the ZALTRAP/FOLFIRI regimen and 3 of 605 patients (0.5%) treated with the placebo/FOLFIRI regimen.
V ključni študiji pri bolnikih z mKRR so fistule (analne, enterovezikalne, enterokutane, kolovaginalne, intestinalne) zabeležili pri 9 od 611 (1,5 %) prejemnikov sheme ZALTRAP/FOLFIRI in pri 3 od 605 (0,5 %) prejemnikov sheme placebo/FOLFIRI.
In the pivotal study of MCRC patients, GI perforation (all grades) was reported in 3 of 611 patients (0.5%) treated with the ZALTRAP/FOLFIRI regimen and 3 of 605 patients (0.5%) treated with the placebo/FOLFIRI regimen.
V ključni študiji bolnikov z mKRR so perforacije prebavil (vseh stopenj) zabeležili pri 3 od 611 (0,5 %) prejemnikov sheme ZALTRAP/FOLFIRI in pri 3 od 605 (0,5 %) prejemnikov sheme placebo/FOLFIRI.
In the pivotal study of MCRC patients, hypertension (all grades) has been reported in 41.2% of patients treated with ZALTRAP/FOLFIRI and 10.7% of patients treated with placebo/FOLFIRI.
V ključni študiji bolnikov z mKRR se je hipertenzija (vseh stopenj) pojavila pri 41,2 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 10,7 % prejemnikov sheme placebo/FOLFIRI.
In the pivotal study of MCRC patients, neutropenia (all grades) has been reported in 67.8% of patients treated with ZALTRAP/FOLFIRI and 56.3% of patients treated with placebo/FOLFIRI.
V ključni študiji pri bolnikih z mKRR so nevtropenijo (vseh stopenj) zabeležili pri 67,8 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 56,3 % prejemnikov sheme placebo/FOLFIRI.
In the pivotal study of MCRC patients, proteinuria (compiled from clinical and laboratory data) was reported in 62.2% patients treated with the ZALTRAP/FOLFIRI regimen compared to 40.7% patients treated with the placebo/FOLFIRI regimen.
V ključni študiji pri bolnikih z mKRR so proteinurijo (na podlagi kliničnih in laboratorijskih podatkov skupaj) zabeležili pri 62,2 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 40,7 % prejemnikov sheme placebo/FOLFIRI.
In the pivotal study of MCRC patients, severe hypersensitivity reactions have been reported in 0.3% of patients treated with the ZALTRAP/FOLFIRI regimen and 0.5% of patients treated with the placebo/FOLFIRI regimen (see section 4.4).
V ključni študiji pri bolnikih z mKRR so hude preobčutljivostne reakcije zabeležili pri 0,3 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 0,5 % prejemnikov sheme placebo/FOLFIRI (glejte poglavje 4.4).
In the pivotal study Protocol 001, the efficacy of Gardasil 9 against HPV Types 31, 33, 45, 52, and 58 was evaluated compared to qHPV vaccine in women 16 through 26 years of age (N=14,204: 7,099 receiving Gardasil 9; 7,105 receiving qHPV vaccine).
V ključni študiji Protokol 001 so učinkovitost cepiva Gardasil 9 proti tipom HPV 31, 33, 45, 52 in 58 ovrednotili v primerjavi s qHPV cepivom pri ženskah, starih od 16 do 26 let (N = 14.204: 7.099 jih je prejelo cepivo Gardasil 9 in 7.105 qHPV cepivo).
In the pivotal study, 27.8% of patients discontinued due to adverse events, which were mostly mild or moderate (see section 4.8).
V ključni študiji je 27,8 % bolnikov prekinilo zdravljenje zaradi neželenih dogodkov, ki so bili večinoma blago ali zmerno izraženi (glejte poglavje 4.8).
In the pivotal study, 46% (156 out of 336) of patients with CLL treated with Gazyvaro plus chlorambucil were 75 years or older (median age was 74 years).
V ključni študiji je bilo 46 % (156 od 336) bolnikov s KLL, zdravljenih s kombinacijo zdravila Gazyvaro in klorambucila, starih 75 let ali več (mediana starosti je bila 74 let).
In the pivotal study, CARISA, Ranexa was added to treatment with atenolol 50 mg once daily, amlodipine 5 mg once daily, or diltiazem 180 mg once daily.
V osrednji študiji CARISA so zdravilo Ranexa dodali zdravljenju z atenololom v odmerku 50 mg enkrat na dan, amlodipinom v odmerku 5 mg enkrat na dan ali diltiazemom v odmerku 180 mg enkrat na dan.
In the pivotal study, Preotact increased BMD in the lumbar spine after 18 months treatment by 6.5 compared with -0.3 for placebo (p0.001).
V osrednji študiji je zdravilo Preotact po 18 mesecih zdravljenja povečalo BMD ledvenega predela za 6,5% v primerjavi z -0,3% pri bolnicah, ki so prejemale placebo (p<0,001).
In the pivotal trial (BO16216) Herceptin and anastrozole were administered from day 1.
V ključni študiji (BO16216) so zdravilo Herceptin in anastrozol dajali od 1. dne dalje.
In the pivotal trial BO22227, there were more than twice as many patients reporting all grade hypertension with the Herceptin subcutaneous formulation (4.7 % versus 9.8 % in the intravenous and subcutaneous formulations respectively), with a greater proportion of patients with severe events (NCI CTCAE grade ≥3) <1 % versus 2.0 % the intravenous and subcutaneous formulations respectively.
V ključni študiji BO22227 je več kot dvakrat več bolnikov poročalo o vseh stopnjah hipertenzije pri subkutani obliki zdravila Herceptin (pri intravenski obliki 4,7 % v primerjavi z 9,8 % pri subkutani obliki), z večjim deležem bolnikov z resnimi dogodki (NCI CTCAE stopnje ≥ 3), < 1 % pri intravenski obliki v primerjavi z 2 % pri subkutani obliki.
In the pivotal trial CLEOPATRA in metastatic breast cancer, diarrhoea occurred in 68.4% of Perjeta- treated patients and 48.7% of placebo-treated patients.
V ključnem preskušanju CLEOPATRA pri metastatskem raku dojk se je diareja pojavila pri 68,4 % bolnikov v skupini, ki je prejemala zdravilo Perjeta, in pri 48,7 % bolnikov v skupini, ki je prejemala placebo.
In the pivotal trial CLEOPATRA in metastatic breast cancer, rash occurred in 51.7% of Perjeta-treated patients, compared with 38.9% of placebo-treated patients.
V ključnem preskušanju CLEOPATRA pri metastatskem raku dojk se je izpuščaj pojavil pri 51,7 % bolnikov, ki so prejemali zdravilo Perjeta, v primerjavi s 38,9 % bolnikov, ki so prejemali placebo.
In the pivotal trial CLEOPATRA in metastatic breast cancer, the incidence of LVD during study treatment was higher in the placebo-treated group than in the Perjeta-treated group (8.6% and 6.6%, respectively).
V ključnem preskušanju CLEOPATRA pri metastatskem raku dojk je bila incidenca LVD v času zdravljenja v študiji večja v skupini, ki je prejemala placebo (8,6 %), kot v skupini, ki je prejemala zdravilo Perjeta (6,6 %).
In the pivotal trial CLEOPATRA in metastatic breast cancer, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was balanced in the two treatment groups (86.3% of Perjeta-treated patients and 86.6% of placebo-treated patients, including 60.7% and 64.8% Grade 4 neutropenia, respectively).
V ključnem preskušanju CLEOPATRA pri metastatskem raku dojk je bila incidenca nevtropenije 3. do 4. stopnje po merilih NCI-CTCAE (različica 3) med obema terapevtskima skupinama uravnotežena (86,3-% v skupini, ki je prejemala zdravilo Perjeta, in 86,6-% v skupini, ki je prejemala placebo; vključno z nevtropenijo stopnje 4 pri 60,7 % v skupini, ki je prejemala zdravilo Perjeta, in 64,8 % v skupini, ki je prejemala placebo).
In the pivotal trial CLEOPATRA in metastatic breast cancer, the overall frequency of investigator reported hypersensitivity/anaphylaxis events during the entire treatment period was 9.3% in the placebo-treated group and 11.3% in the Perjeta-treated group, of which 2.5% and 2.0% were NCI- CTCAE Grade 3-4, respectively.
V ključnem preskušanju CLEOPATRA pri metastatskem raku dojk je bila skupna pogostnost preobčutljivosti/anafilaktičnih dogodkov, o katerih so poročali raziskovalci, med celotnim obdobjem zdravljenja 9,3-% pri bolnikih, ki so prejemali placebo, in 11,3-% pri bolnikih, ki so prejemali zdravilo Perjeta; od tega je bilo primerov 3. ali 4. stopnje po merilih NCI-CTCAE med prvimi 2,5 % in med drugimi 2,0 %.
In the pivotal trial CLEOPATRA in patients with metastatic breast cancer, Perjeta in combination with trastuzumab and docetaxel was not associated with a greater incidence of symptomatic left ventricular systolic dysfunction (LVD) or LVEF declines compared with placebo and trastuzumab and docetaxel (see section 4.8).
V ključnem preskušanju CLEOPATRA pri bolnikih z metastatskim rakom dojk zdravljenje z zdravilom Perjeta v kombinaciji s trastuzumabom in docetakselom ni bilo povezano z večjo incidenco simptomatske disfunkcije levega prekata (LVD – left ventricular systolic dysfunction) ali večjim upadom LVEF v primerjavi s skupino, zdravljeno s placebom, trastuzumabom in docetakselom (glejte poglavje 4.8).