natgillin/translations-raw huggingface dataset:
In the pivotal study for untreated CLL (OMB110911), prolonged neutropenia (defined as Grade 3 or 4 neutropenia not resolved between 24 and 42 days of last treatment) was reported in 41 patients (23 patients treated with ofatumumab and chlorambucil, 18 patients treated with chlorambucil alone).
U ključnom ispitivanju u bolesnika s neliječenim KLL-om (OMB110911), dugotrajna neutropenija (definirana kao neutropenija 3. ili 4. stupnja koja se nije povukla između 24. i 42. dana nakon posljednje doze) prijavljena je u 41 bolesnika (23 bolesnika liječena ofatumumabom i klorambucilom te 18 bolesnika liječenih samo klorambucilom).
In the pivotal study GAO4753g 1% of patients experienced gastrointestinal perforation.
U ključnom ispitivanju GAO4753g, 1% bolesnika doživjelo je gastrointestinalnu perforaciju.
In the pivotal study in iNHL, 44% (85 out of 194) of patients treated with Gazyvaro plus bendamustine were 65 years or older.
U ključnom ispitivanju kod iNHL-a, 44% (85/194) bolesnika liječenih lijekom Gazyvaro plus bendamustinom bilo je u dobi od 65 ili više godina.
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).
U ključnom ispitivanju kod iNHL-a, mala podskupina od 8% (15/194) bolesnika liječenih lijekom Gazyvaro plus bendamustinom imala je umjereno oštećenje funkcije bubrega (CrCl < 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.
U ključnom ispitivanju prevencije moždanog udara i SE-a u bolesnika s fibrilacijom atrija, ukupno je 12 042 bolesnika liječeno dabigatraneteksilata.
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.
U ključnom ispitivanju prevencije moždanog udara i SE-a u bolesnika s fibrilacijom atrija, ukupno je 12 042 bolesnika liječeno dabigatraneteksilatom.
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.
U pivotalnom ispitivanju implantata MACI nisu bili uključeni bolesnici koji su u anamnezi imali osteoartritis (stupnja 3 ili 4 prema Kellgren-Lawrenceovoj ljestvici) u ciljnome koljenu ili istodobnu upalnu bolest.
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.
U pivotalnom ispitivanju u bolesnika s MKRK-om venski tromboembolijski događaji svih stupnjeva javili su se u 9,3% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 7,3% bolesnika koji su primali protokol 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.
U pivotalnom ispitivanju u bolesnika s MKRK-om arterijski tromboembolijski događaji (uključujući tranzitornu ishemijsku ataku, cerebrovaskularni incident, anginu pektoris, intrakardijalni tromb, infarkt miokarda, arterijsku emboliju i ishemijski kolitis) prijavljeni su u 2,6% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 1,5% bolesnika koji su primali protokol 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.
U pivotalnom ispitivanju u bolesnika s MKRK-om proljev (svih stupnjeva) je primijećen u 69,2% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 56,5% bolesnika koji su primali protokol 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.
U pivotalnom ispitivanju u bolesnika s MKRK-om epizode krvarenja (svih stupnjeva) bile su prijavljene u 37,8% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 19,0% bolesnika koji su primali protokol 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.
U pivotalnom ispitivanju u bolesnika s MKRK-om fistule (analne, enterovezikalne, enterokutane, kolovaginalne i crijevne) su prijavljene u 9 od 611 bolesnika (1,5%) liječenih protokolom ZALTRAP/FOLFIRI i u 3 od 605 bolesnika (0,5%) koji su primali protokol 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.
U pivotalnom ispitivanju u bolesnika s MKRK-om gastrointestinalna perforacija (svih stupnjeva) bila je prijavljena u 3 od 611 bolesnika (0,5%) liječenih protokolom ZALTRAP/FOLFIRI i u 3 od 605 bolesnika (0,5%) koji su primali protokol 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.
U pivotalnom ispitivanju u bolesnika s MKRK-om hipertenzija (svih stupnjeva) je prijavljena u 41,2% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 10,7% bolesnika koji su primali protokol 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.
U pivotalnom ispitivanju u bolesnika s MKRK-om neutropenija (svih stupnjeva) je prijavljena u 67,8% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 56,3% bolesnika koji su primali protokol 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.
U pivotalnom ispitivanju u bolesnika s MKRK-om proteinurija (prikupljeno iz kliničkih i laboratorijskih podataka) je prijavljena u 62,2% bolesnika liječenih protokolom ZALTRAP/FOLFIRI i u 40,7% bolesnika koji su primali protokol placebo/FOLFIRI.
In the pivotal study of patients with a single clinical event suggestive of multiple sclerosis an autoinjector was used in the majority of patients.
U pivotalnim ispitivanjima bolesnika s pojedinačnim kliničkim događajem koji ukazuje na multiplu sklerozu autoinjektor je korišten u većine bolesnika.
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).
U pivotalnom ispitivanju Protokol 001, djelotvornost cjepiva Gardasil 9 protiv tipova 31, 33, 45, 52 i 58 HPV-a ocijenjena je u usporedbi s cjepivom qHPV u žena u dobi od 16 do 26 godina (N=14 204: 7099 primilo je Gardasil 9; 7105 primilo je cjepivo qHPV).
In the pivotal study the initial docetaxel infusion was started the day following the first dose of trastuzumab.
U pivotalnom kliničkom pokusu inicijalna infuzija docetaksela započela se primjenjivati dan nakon prve doze trastuzumaba.
In the pivotal study with patients inadequately controlled on another somatostatin analogue, the proportion of patients not previously treated with anti-diabetic agents who required commencement of anti-diabetic therapy during the study was 17.5% and 16.1% in the Signifor 40 mg and 60 mg arms compared to 1.5% in the active control arm; in the pivotal study with patients who did not receive prior medical treatment, the proportion of patients who required commencement of anti-diabetic therapy during the study was 36% in the Signifor arm compared to 4.4% in the active control arm.
U ključnom ispitivanju s bolesnicima čije je stanje bilo neodgovarajuće kontrolirano drugim analogom somatostatina, udio bolesnika koji prethodno nisu bili liječeni antidijabeticima i u kojih je bilo potrebno započeti terapiju antidijabetikom tijekom ispitivanja bio je 17,5% odnosno 16,1% u skupinama koje su primale Signifor 40 mg odnosno 60 mg, u usporedbi s 1,5% u skupini s aktivnom kontrolom; u ključnom ispitivanju s bolesnicima koji prethodno nisu primali terapiju lijekovima, udio bolesnika u kojih je bilo potrebno započeti terapiju antidijabetikom tijekom ispitivanja bio je 36% u skupini koja je primala Signifor u usporedbi s 4,4% u skupini s aktivnom kontrolom.
In the pivotal study, 27.8% of patients discontinued due to adverse events, which were mostly mild or moderate (see section 4.8).
U ključnom ispitivanju 27,8% bolesnika prekinulo je liječenje zbog štetnih događaja, koji su uglavnom bili blagi ili umjereni (vidjeti dio 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).
U ključnom je ispitivanju 46% (156 od 336) bolesnika s KLL-om liječenih lijekom Gazyvaro i klorambucilom bilo u dobi od 75 ili više godina (medijan dobi iznosio je 74 godine).
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.
U pivotalnom istraživanju, CARISA, Ranexa je bila dodatni lijek, uz atenolol 50 mg jednom dnevno, amlodipin 5 mg jednom dnevno i diltiazem 180 mg jednom dnevno.
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).
Prema pivotalnom ispitivanju, Preotact povećava BMD u lumbalnoj kralježnici za 6,5% nakon 18 mjeseci liječenja u usporedbi sa -0,3% za placebo (p<0,001).
In the pivotal trial (BO16216) Herceptin and anastrozole were administered from day 1.
U pivotalnom kliničkom ispitivanju (BO16216) Herceptin i anastrozol primjenjivani su od prvoga dana.
In the pivotal trial BO22227, Herceptin was administered concurrently with neoadjuvant chemotherapy that contained four cycles of epirubicin (cumulative dose 300 mg/m2); at a median follow-up of 40 months, the incidence of congestive cardiac failure was 0.0% in the Herceptin intravenous arm and 0.7% in the Herceptin subcutaneous arm.
U pivotalnom ispitivanju BO22227, Herceptin se primjenjivao istodobno s neoadjuvantnom kemoterapijom koja se sastojala od četiri ciklusa epirubicina (kumulativna doza: 300 mg/m2); nakon medijana praćenja od 40 mjeseci, incidencija kongestivnog zatajenja srca iznosila je 0,0% u skupini koja je primala lijek Herceptin za intravensku primjenu te 0,7% u skupini koja je primala lijek Herceptin za supkutanu primjenu.
In the pivotal trial BO22227, Herceptin was administered concurrently with neoadjuvant chemotherapy that contained four cycles of epirubicin (cumulative dose 300 mg/m2); at a median follow-up of 40 months, the incidence of congestive cardiac failure was 0.0% in the Herceptin intravenous arm.
U pivotalnom ispitivanju BO22227, Herceptin se primjenjivao istodobno s neoadjuvantnom kemoterapijom koja se sastojala od četiri ciklusa epirubicina (kumulativna doza: 300 mg/m2); nakon medijana praćenja od 40 mjeseci, incidencija kongestivnog zatajenja srca iznosila je 0,0% u skupini koja je primala Herceptin za intravensku primjenu.
In the pivotal trial BO22227, the rate of all grade ARRs was 37.2 % with the Herceptin intravenous formulation and 47.8 % with the Herceptin subcutaneous formulation; severe grade 3 reactions were reported in 2.0 % and 1.7 % of the patients, respectively during the treatment phase; no severe grade 4 or 5 reactions were observed.
U pivotalnom je ispitivanju BO22227 stopa reakcija povezanih s primjenom lijeka svih stupnjeva iznosila 37,2% za intravensku formulaciju lijeka Herceptin te 47,8% za Herceptin u supkutanoj formulaciji; teški događaji stupnja 3 tijekom razdoblja liječenja prijavljeni su u 2,0% odnosno 1,7% bolesnika; nisu zabilježeni teški događaji stupnja 4 ili 5.
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.
U pivotalnom ispitivanju BO22227 hipertenziju je prijavio više nego dvostruko veći broj bolesnica koje su primale Herceptin u supkutanoj formulaciji (4,7% uz intravensku formulaciju naspram 9,8% uz supkutanu formulaciju), a pritom je i veći udio bolesnica prijavio teške događaje (NCI CTCAE stupnja ≥ 3), < 1% uz intravensku formulaciju naspram 2,0% uz supkutanu formulaciju.
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.
U pivotalnom ispitivanju CLEOPATRA u metastatskom raku dojke, proljev se javio u 68,4% bolesnika liječenih lijekom Perjeta te u 48,7% bolesnika koji su primali 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.
U pivotalnom ispitivanju CLEOPATRA u metastatskom raku dojke, ukupna učestalost slučajeva preosjetljivosti/anafilaksije koje su prijavili ispitivači tijekom cijelog razdoblja liječenja iznosila je 9,3% u skupini koja je primala placebo i 11,3% u skupini liječenoj lijekom Perjeta, od kojih je njih 2,5% odnosno 2,0% bilo NCI-CTCAE stupnja 3-4.
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).
U pivotalnom ispitivanju CLEOPATRA u bolesnika s metastatskim rakom dojke, Perjeta u kombinaciji s trastuzumabom i docetakselom nije bila povezana s povećanom incidencijom simptomatske sistoličke disfunkcije lijeve klijetke niti smanjene ejekcijske frakcije lijeve klijetke u usporedbi s primjenom placeba u kombinaciji s trastuzumabom i docetakselom (vidjeti dio 4.8).
In the pivotal trial CLEOPATRA, ADRs were reported less frequently after discontinuation of docetaxel treatment.
U pivotalnom ispitivanju CLEOPATRA, nuspojave su se rjeđe prijavljivale nakon prekida primjene docetaksela.
In the pivotal trial CLEOPATRA, the initial dose of Perjeta was given the day before trastuzumab and docetaxel to allow for the examination of Perjeta-associated reactions.
U pivotalnom ispitivanju CLEOPATRA početna doza lijeka Perjeta primijenjena je dan prije trastuzumaba i docetaksela kako bi se mogle istražiti reakcije povezane s lijekom Perjeta.
In the pivotal trial CLEOPATRA, the majority of patients in both treatment groups experienced at least one leucopenic event (63.0% of patients in the Perjeta-treated group and 58.3% of patients in the placebo-treated group), of which the majority were neutropenic events.
U pivotalnom ispitivanju CLEOPATRA u većine se bolesnika u obje ispitivane skupine javila najmanje jedna epizoda leukopenije (u 63,0% bolesnika liječenih lijekom Perjeta i 58,3% bolesnika koji su primali placebo), od kojih je većina bila neutropenija.
In the pivotal trial in patients with ovarian cancer treated at a dose of 50 mg/m2, myelosuppression was generally mild to moderate, reversible, and was not associated with episodes of neutropaenic infection or sepsis.
U pivotalnom kliničkom ispitivanju u bolesnica s karcinomom jajnika liječenih dozom od 50 mg/m2 mijelosupresija je općenito bila blaga do umjerena, reverzibilna i nije bila povezana s epizodama neutropenijske infekcije ili sepse.
In the pivotal trial MO16432, Herceptin was administered concurrently with neoadjuvant chemotherapy containing three cycles of doxorubicin (cumulative dose 180 mg/m2 ) .
U pivotalnom ispitivanju MO16432, Herceptin se primjenjivao istodobno s neoadjuvantnom kemoterapijom koja se sastojala od tri ciklusa doksorubicina (kumulativna doza 180 mg/m2).
In the pivotal trial MO16432, Herceptin was administered concurrently with neoadjuvant chemotherapy containing three cycles of doxorubicin (cumulative dose 180 mg/m2 ).
U pivotalnom ispitivanju MO16432, Herceptin se primjenjivao istodobno s neoadjuvantnom kemoterapijom koja se sastojala od tri ciklusa doksorubicina (kumulativna doza 180 mg/m2).
In the pivotal trial, 166 patients with relapsed or chemoresistant low-grade or follicular B cell NHL received 375 mg/m2 of MabThera as an intravenous infusion once weekly for four weeks.
U pivotalnom je ispitivanju 166 bolesnika s relapsirajućim ili kemorezistentnim, nisko malignim ili folikularnim B-staničnim ne-Hodgkinovim limfomom primilo lijek MabThera u dozi od 375 mg/m2 putem intravenske infuzije jedanput tjedno tijekom četiri tjedna.
In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of Herceptin (for dose, see the Summary of Product Characteristics (SmPC) for paclitaxel or docetaxel) and immediately after the subsequent doses of Herceptin if the preceding dose of Herceptin was well tolerated.
U pivotalnim kliničkim ispitivanjima (H0648g, M77001) paklitaksel ili docetaksel primjenjivan je dan nakon prve doze lijeka Herceptin (za dozu vidjeti Sažetak opisa svojstava lijeka za paklitaksel ili docetaksel) i neposredno nakon sljedećih doza lijeka Herceptin ako je bolesnik prethodnu dozu lijeka Herceptin dobro podnio.
In the pivotal trials Grade 3 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations were observed in 2.4% (LUX- Lung-3) and 1.6% (LUX-Lung 8) of patients with normal baseline liver tests treated with 40 mg/day.
U ključnim ispitivanjima porast alanin aminotransferaze (ALT) i aspartat aminotransferaze (AST) stupnja 3 primijećen je kod 2,4% (LUX-Lung 3) i 1,6% (LUX-Lung 8) bolesnika s urednim početnim vrijednostima jetrenih enzima koji su bili liječeni s 40 mg/dan.
In the pivotal trials with 3 times a week dosing, the most frequently reported adverse drug reactions judged to be probably or possibly related to imiquimod cream treatment were application site reactions at the wart treatment site (33.7% of imiquimod treated patients).
U ključnim ispitivanjima primjene kreme 3 puta tjedno najčešće prijavljene nuspojave vjerojatno ili moguće povezane s liječenjem imikvimod kremom bile su reakcije na liječenom području s bradavicama (33,7% bolesnika liječenih imikvimodom).
In the pivotal trials with 3 times per week dosing for up to 2 courses each of 4 weeks, 56% of imiquimod patients reported at least one adverse event.
U ključnim ispitivanjima primjene kreme 3 puta tjedno tijekom 2 ciklusa liječenja u pojedinačnom trajanju od 4 tjedna, 56% bolesnika liječenih imikvimodom prijavilo je najmanje jednu nuspojavu.
In the pivotal two-year study in postmenopausal women with osteoporosis (BM16550), the overall safety of intravenous injection of ibandronic acid 3 mg every 3 months and oral ibandronic acid 2.5 mg daily were shown to be similar.
Dvogodišnje pivotalno ispitivanje provedeno u žena s osteoporozom u postmenopauzi (BM 16550) pokazalo je sličnu sveukupnu sigurnost primjene intravenske injekcije ibandronatne kiseline od 3mg svaka tri mjeseca i peroralno primijenjene ibandronatne kiseline 2,5mg jedanput dnevno.
In the pJIA study, children who received golimumab 30 mg/m2 (maximum 50 mg) subcutaneously every 4 weeks, had median steady-state trough golimumab concentrations which were similar across different age groups, and which were also similar to or slightly higher than those seen in adult RA patients who received 50 mg golimumab every 4 weeks.
U ispitivanju pJIA, medijan najnižih koncentracija golimumaba u stanju dinamičke ravnoteže u djece koja su primala golimumab supkutano u dozi od 30 mg/m2 (maksimalno 50 mg) svaka 4 tjedna bio je sličan u svim dobnim skupinama te je bio sličan ili nešto viši od onog primijećenog u odraslih bolesnika s RA koji su primali 50 mg golimumaba svaka 4 tjedna.
In the placebo arm, a total of 51 (51%) of patients had progressed: 46 (46%) by RECIST progression and 5 (5%) by death in the absence of progression.
U skupini na placebu, ukupno je u 51 bolesnika (51%) došlo do progresije: U 46 bolesnika (46%) progresija je utvrđena prema RECIST-u, a 5 bolesnika (5%) je umrlo, a da nije došlo do progresije.
In the placebo controlled study, patients were aged 6 - ≤22 years with an FEV1 at screening of between 25% and 84% of predicted normal values for their age, sex and height based upon Knudson criteria.
U placebom kontroliranom ispitivanju bolesnici su imali 6 - ≤22 godina uz FEV1 na probiru između 25% i 84% od predviđenih normalnih vrijednosti za svoju dob, spol i visinu na temelju Knudsonovih kriterija.
In the placebo group, there were 4 cases of 6-month persistent infection and 1 case of 12-month persistent infection.
U placebo skupini bila su 4 slučaja 6-mjesečne perzistentne infekcije i 1 slučaj 12-mjesečne perzistentne infekcije.
In the placebo- controlled clinical trials, abatacept treatment did not lead to increased autoantibody formation, such as antinuclear and anti-dsDNA antibodies, relative to placebo treatment (see sections 4.8 and 5.3).
U placebom kontroliranim kliničkim ispitivanjima liječenje abataceptom nije dovelo do povećanog stvaranja autoantitijela, poput antinuklearnih i anti-dsDNK antitijela, u usporedbi s primjenom placeba (vidjeti dijelove 4.8 i 5.3).
In the placebo- controlled trials of lacosamide in epilepsy patients, atrial fibrillation or flutter were not reported; however both have been reported in open-label epilepsy trials and in post-marketing experience (see section 4.8).
U placebom kontroliranim istraživanjima lakozamida u bolesnika s epilepsijom, fibrilacija ili undulacija atrija nisu zabilježene; međutim, oboje je zabilježeno u otvorenim istraživanjima epilepsije te tijekom razdoblja nakon stavljanja lijeka u promet (vidjeti dio 4.8).
In the placebo-controlled clinical trials with intravenous abatacept, infections at least possibly related to treatment were reported in 23.1% of abatacept-treated patients and 20.7% of placebo-treated patients.
U placebom kontroliranim kliničkim ispitivanjima intravenski primijenjenog abatacepta, infekcije koje su bile barem moguće povezane s liječenjem prijavljene su u 23,1% bolesnika liječenih abataceptom i 20,7% bolesnika koji su primali placebo.
In the placebo-controlled clinical trials, infections at least possibly related to treatment were reported in 23.1% of abatacept-treated patients and 20.7% of placebo-treated patients.
U placebom kontroliranim kliničkim ispitivanjima infekcije koje su bile barem moguće povezane s liječenjem prijavljene su u 23,1% bolesnika liječenih abataceptom i 20,7% bolesnika koji su primali placebo.
In the placebo-controlled clinical trials, the frequencies of malignancies in abatacept- and placebo- treated patients were 1.4% and 1.1%, respectively (see section 4.8).
U placebom kontroliranim kliničkim ispitivanjima učestalost zloćudnih bolesti iznosila je 1,4% u bolesnika liječenih abataceptom, a 1,1% u bolesnika koji su primali placebo (vidjeti dio 4.8).
In the placebo-controlled GIST phase III trial, the overall incidence of hand-foot skin reaction was 66.7% in patients treated with Stivarga as compared to 15.2% in patients receiving placebo.
U placebom kontroliranom ispitivanju faze III u bolesnika s GIST- om, ukupna incidencija kožne reakcije na šakama i stopalima bila je 66,7% u bolesnika liječenih lijekom Stivarga u usporedbi s 15,2% u bolesnika koji su primali placebo.