natgillin/translations-raw huggingface dataset:
In the Phase III studies MEK115306 (n=209) and MEK116513 (n=350) with dabrafenib in combination with trametinib in patients with unresectable or metastatic melanoma, 56 patients (27%) and 77 patients (22%) respectively were ≥65 years of age, 11 patients (5%) and 21 patients (6%) respectively were ≥75 years of age.
U ispitivanjima faze III MEK115306 (n=209) i MEK116513 (n=350) s dabrafenibom u kombinaciji s trametinibom u bolesnika s neoperabilnim ili metastatskim melanomom, 56 bolesnika (27%) odnosno 77 bolesnika (22%) bilo je u dobi ≥ 65 godina; 11 bolesnika (5%) odnosno 21 bolesnik (6%) bio je u dobi ≥ 75 godina.
In the phase III studies, injection site related reactions (e.g. injection site pain, injection site discomfort) were all grade 1 or 2 in severity and were comparable between pasireotide intramuscular use and octreotide intramuscular use treated patients.
U ispitivanjima faze III, reakcije na mjestu primjene injekcije (npr. bol na mjestu primjene injekcije, nelagoda na mjestu primjene injekcije) bile su po težini stupnja 1 ili 2 te su bile usporedive između bolesnika liječenih pasireotidom primijenjenim intramuskularno i onih liječenih oktreotidom primijenjenim intramuskularno.
In the Phase III study (HPV-015) in women 26 years and older, at the 48-month time point, i.e.
U ispitivanju faze III (HPV-015) u žena u dobi od 26 godina i više, u 48. mjesecu kao vremenskoj točci, tj.
In the Phase III study comparing bortezomib administered intravenously versus subcutaneously, the incidence of Grade  2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
U ispitivanju faze III uspoređena je intravenska primjena bortezomiba u odnosu na supkutanu primjenu, incidencija periferne neuropatije stupnja  2 bila je 24% u skupini sa supkutanom primjenom injekcije i 41% u intravenskoj skupini (p=0,0124).
In the Phase III study comparing VELCADE administered intravenously versus subcutaneously, the incidence of Grade  2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
U ispitivanju faze III uspoređena je intravenska primjena VELCADEa u odnosu na supkutanu primjenu, incidencija periferne neuropatije stupnja ≥ 2 bila je 24% u skupini sa supkutanom primjenom injekcije i 41% u intravenskoj skupini (p = 0,0124).
In the Phase III study in patients with newly diagnosed chronic phase CML with a minimum of 5 years of follow up, the median duration of therapy was approximately 60 months for both SPRYCEL (range 0.03-72.7 months) and for imatinib (range 0.3-74.6 months).
U ispitivanju faze III u bolesnika s novodijagnosticiranom KML u kroničnoj fazi, kod kojega je praćenje trajalo najmanje 5 godina, medijan trajanja liječenja iznosio je približno 60 mjeseci i za SPRYCEL (raspon 0,03-72,7 mjeseci) i za imatinib (raspon 0,3-74,6 mjeseci).
In the Phase III study in patients with newly diagnosed chronic phase CML, treatment was discontinued for adverse reactions in 5% of SPRYCEL-treated patients and 4% of imatinib-treated patients with a minimum of 12 months follow-up.
U ispitivanju faze III u bolesnika s novodijagnosticiranom KML u kroničnoj fazi, nakon najmanje 12 mjeseci praćenja, liječenje je bilo obustavljeno zbog nuspojava u 5% bolesnika liječenih lijekom SPRYCEL i 4% bolesnika liječenih imatinibom.
In the Phase III study in patients with newly diagnosed CML in chronic phase receiving 300 mg nilotinib twice daily, the change from baseline in mean time-averaged QTcF interval at steady state was 6 msec.
U ispitivanju faze III u bolesnika s novodijagnosticiranim KML-om u kroničnoj fazi koji su primali 300 mg nilotiniba dva puta na dan, promjena srednjeg prosječnog vremena QTcF intervala u stanju dinamičke ravnoteže bila je 6 msek u odnosu na početnu vrijednost.
In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with Bortezomib+Melphalan+Prednisone compared with Melphalan+Prednisone (14% versus 4% respectively).
U ispitivanju faze III kod bolesnika s prethodno neliječenim multiplim mijelomom, ukupna incidencija reaktivacije virusa herpes zoster bila je češća u bolesnika koji su primali bortezomib + melfalan + prednizon nego u onih koji su primali melfalan + prednizon (14 % naspram 4 %).
In the Phase III study MEK115306, cuSCC occurred in 3% (6/209) of patients receiving trametinib in combination with dabrafenib and 10% (22/211) of patients receiving dabrafenib as a single agent.
U ispitivanju faze III MEK115306, cuSCC se pojavio u 3% (6/209) bolesnika koji su primali trametinib u kombinaciji s dabrafenibom i 10% (22/211) bolesnika koji su primali samo dabrafenib.
In the Phase III study MEK116513, cuSCC occurred in 1% (5/350) of patients receiving trametinib in combination with dabrafenib and 18% (63/349) of patients receiving vemurafenib as a single agent.
U ispitivanju faze III MEK116513, cuSCC se pojavio u 1% (5/350) bolesnika koji su primali trametinib u kombinaciji s dabrafenibom i 18% (63/349) bolesnika koji su primali samo vemurafenib.
In the Phase III study patients who received VELCADE subcutaneously compared to intravenous administration had 13% lower overall incidence of treatment emergent adverse reactions that were Grade 3 or higher in toxicity, and a 5% lower incidence of discontinuation of VELCADE.
U ispitivanju faze III bolesnici koji su primili VELCADE supkutano u odnosu na intravensku primjenu, ukupno su imali 13% manju incidenciju nuspojava stupnja toksičnosti 3 ili više, koje su proizašle iz liječenja i 5% manju incidenciju prekida primjene VELCADEa.
In the phase III study RE-LY (see section 5.1.) the overall rate of myocardial infarction (MI) was 0.82, 0.81, and 0.64 % / year for dabigatran etexilate 110 mg twice daily, dabigatran etexilate 150 mg twice daily and warfarin, respectively, an increase in relative risk for dabigatran of 29 % and 27 % compared to warfarin.
U studiji faze III pod nazivom RE-LY (vidi dio 5.1), ukupna godišnja stopa infarkta miokarda (IM) bila je 0,82, 0,81 i 0,64 % / godina za dabigatraneteksilat 110 mg dvaput dnevno, dabigatraneteksilat 150 mg dvaput dnevno i varfarin, povećanje relativnog rizika uz dabigatran od 29 % i 27 % u usporedbi s varfarinom.
In the Phase III study, 69 patients were on lenalidomide 5 mg, 69 patients on lenalidomide 10 mg and 67 patients were on placebo during the double-blind phase of the study.
Tijekom dvostruko slijepe faze ispitivanja faze III, 69 bolesnika primalo je lenalidomid 5 mg, 69 lenalidomid 10 mg a 67 bolesnika primalo je placebo.
In the Phase III study, treatment with VELCADE led to a significantly longer time to progression, a significantly prolonged survival and a significantly higher response rate, compared to treatment with dexamethasone (see Table 14), in all patients as well as in patients who have received 1 prior line of therapy.
U ispitivanju faze III, liječenje VELCADEom značajno je produljilo vrijeme do progresije bolesti i dovelo do značajno produljenog preživljenja te značajno veće stope odgovora u usporedbi s liječenjem deksametazonom (vidjeti tablicu 14) u svih bolesnika, kao i u bolesnika koji su prethodno primili 1 liniju terapije.
In the Phase III trials DUET-1 and DUET-2, mutations that developed most commonly in patients with virologic failure to the INTELENCE containing regimen were V108I, V179F, V179I, Y181C and Y181I, which usually emerged in a background of multiple other NNRTI resistance-associated mutations (RAMs).
U kliničkim ispitivanjima faze III DUET-1 i DUET-2 mutacije koje su se najčešće razvile u bolesnika s neuspjelim virološkim odgovorom na način liječenja INTELENCEom bile su V108I, V179F, V179I, Y181C i Y181I i obično su se pojavljivale u pozadini višestrukih drugih NNRTI mutacija povezanih s rezistencijom (RAM).
In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% versus 28.6% (study MN301), and 49.4% versus 26.3% (study US301).After
U ispitivanjima faze III terapijske stope prema ACR-u bile su 54,6% za leflunomid 20 mg/dan naspram 28,6% za placebo (ispitivanje MN301), odnosno 49,4% naspram 26,3% (ispitivanje US301).
In the phase IIIb study D2304 (RETAIN), 372 patients were randomised in 1:1:1 ratio to receive: ranibizumab 0.5 mg with concomitant laser photocoagulation on a treat-and-extend (TE) regimen, ranibizumab 0.5 mg monotherapy on a TE regimen, ranibizumab 0.5 mg monotherapy on a PRN regimen.
U ispitivanju faze IIIb D2304 (RETAIN), 372 bolesnika bilo je randomizirano u omjeru 1:1:1 na primanje: ranibizumaba 0,5 mg s konkomitantnom laserskom fotokoagulacijom po režimu „liječi i produži“ (LIP), ranibizumaba 0,5 mg kao monoterapije po LIP režimu, ranibizumaba 0,5 mg kao monoterapije po režimu p.p..
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.
U kliničkom ispitivanju faze IIIb u Crohnovoj bolesti, pod nazivom SONIC, bolesnici u placebo skupini primali su AZA u dozi od 2,5 mg/kg/dan kao aktivnu kontrolu uz placebo infuzije infliksimaba.
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).
U skupini koja je primala pitolizant, ESS se značajno smanjio od početka do kraja liječenja u odnosu na skupinu koja je primala placebo, uz opaženu srednju vrijednost promjene od -1,9 ± 4,3 za placebo i -5,4 ± 4,3 (srednja vrijednost ± SD) za pitolizant (p<0,0001) (slika 3).
In the pivotal clinical studies about 30% of the patients received penile block before injection.
U ključnim kliničkim ispitivanjima oko 30% bolesnika dobilo je penilni blok prije injekcije.
In the pivotal clinical study (N = 189), 27.5% of patients reported elevated liver enzymes.
U pivotalnom kliničkom ispitivanju (N = 189), u 27,5% bolesnika prijavljeni su povišeni jetreni enzimi.
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.
U pivotalnom kliničkom ispitivanju (N = 189), 51,9% bolesnika imalo je jednu ili više neuroloških nuspojava (uključujući psihijatrijske poremećaje), primarno uključujući središnji živčani sustav.
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.
U pivotalnom kliničkom ispitivanju (N = 189), manje od 1,4% bolesnika liječenih blinatumomabom bilo je pozitivno na vezujuća i neutralizirajuća anti-blinatumomab antitijela.
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.
U pivotalnom kliničkom ispitivanju (N = 189), ozbiljne reakcije CRS-a prijavljene su u 0,5% bolesnika, uz medijan vremena do pojave od 2 dana.
In the pivotal clinical study (study 1), the primary endpoint was the average sum of differences in pain intensity scores from dosing to 60 minutes, inclusive (SPID60), which was statistically significant compared to placebo (p<0.0001).
U pivotalnom kliničkom ispitivanju (ispitivanje 1) primarni ishod bio je prosječni zbroj razlika u rezultatima intenziteta boli od doziranja do 60 minuta uključivo (SPID60) koja je bili statistički značajna u usporedbi s placebom (p<0,0001).
In the pivotal clinical trial CLEOPATRA, 408 patients received at least one dose of Perjeta in combination with trastuzumab and docetaxel.
U pivotalnom ispitivanju CLEOPATRA 408 bolesnika primilo je barem jednu dozu lijeka Perjeta u kombinaciji s trastuzumabom i docetakselom.
In the pivotal clinical trials for Kuvan, the following adverse reactions have been identified.
U ključnim kliničkim ispitivanjima lijeka Kuvan uočene su sljedeće nuspojave.
In the pivotal clinical trials, a greater proportion of patients using lipid lowering or anti- hypertensive medicines that were CYP3A substrates required concomitant medicinal product change when treated with Zurampic 200 mg in combination with a xanthine oxidase inhibitor, compared with patients treated with placebo in combination with a xanthine oxidase inhibitor (35% versus 28%, respectively).
U pivotalnim je kliničkim ispitivanjima bio veći udio bolesnika u kojih je bila potrebna promjena istodobno primjenjivanog lijeka za sniženje lipida ili antihipertenzivnog lijeka koji su supstrati CYP3A kada se Zurampic primjenjivao u dozi od 200 mg u kombinaciji s inhibitorom ksantin oksidaze nego u bolesnika liječenih placebom u kombinaciji s inhibitorom ksantin oksidaze (35% naspram 28%).
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.
U pivotalnim kontroliranim ispitivanjima u odraslih i djece, stopa infekcija bila je 1,51 po bolesnik- godini u bolesnika liječenih lijekom Humira, odnosno 1,46 po bolesnik-godini u bolesnika koji su primali placebo ili aktivni kontrolni lijek.
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).
U osnovnom dvostruko slijepom ispitivanju ATLAS ACS 2 TIMI 51, 15 526 bolesnika bilo je nasumično raspodijeljeno u omjeru 1:1:1 u jednu od tri terapijske skupine: Xarelto 2,5 mg peroralno dvaput na dan, 5 mg peroralno dvaput na dan ili placebo dvaput na dan primijenjen istodobno s ASA samom ili s ASA uz dodatak tienopiridina (klopidogrel ili tiklopidin).
In the pivotal double-blind ROCKET AF study, 14,264 patients were assigned either to Xarelto 20 mg once daily (15 mg once daily in patients with creatinine clearance 30 - 49 ml/min) or to warfarin titrated to a target INR of 2.5 (therapeutic range 2.0 to 3.0).
U osnovnom dvostruko slijepom ispitivanju ROCKET AF 14 264 bolesnika dobilo je dozu od 20 mg lijeka Xarelto jedanput na dan (15 mg jedanput na dan kod bolesnika s klirensom kreatinina 30-49 ml/min) ili dozu varfarina titriranog na ciljni INR od 2,5 (terapeutski raspon od 2,0 do 3,0).
In the pivotal double-blind ROCKET AF study, 14,264 patients were assigned either to Xarelto 20 mg once daily (15 mg once daily in patients with creatinine clearance 30 - 49 ml/min) or to warfarin titrated to a target INR of 2.5 (therapeutic range 2.0 to 3.0).
U osnovnom dvostruko slijepom ispitivanju ROCKET AF, 14 264 bolesnika dobilo je dozu od 20 mg lijeka Xarelto jedanput na dan (15 mg jedanput na dan kod bolesnika s klirensom kreatinina 30-49 ml/min) ili dozu varfarina titriranog na ciljni INR od 2,5 (terapeutski raspon od 2,0 do 3,0).
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.
U ključnom multicentričnom europskom kliničkom ispitivanju u trajanju od 64 tjedna, a uključivalo je 12-tjedno randomizirano, dvostruko slijepo, dvostrukim placebom kontrolirano, paralelno ispitivanje 2 ispitnih skupina, 248 bolesnika s visokim vaskularnim rizikom s miješanom dislipidemijom bilo je randomizirano u jednu ili dvije liječene skupine: skupinu koja je primala Pravafenix 40 mg/160 mg ili skupinu koja je primala pravastatin 40 mg.
In the pivotal MCRC study, anaemia, nausea, vomiting, constipation, alopecia, increased alkaline phosphatase, and hyperbilirubinaemia occurred in ≥20% of patients.
U pivotalnom ispitivanju MKRK-a u ≥ 20% bolesnika pojavili su se anemija, mučnina, povraćanje, konstipacija, alopecija, povišene vrijednosti alkalne fosfataze i hiperbilirubinemija.
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.
U pivotalnim ispitivanjima intravenske formulacije lijeka Herceptin u metastatskoj bolesti, incidencija srčane disfunkcije kretala se između 9% i 12% kod primjene u kombinaciji s paklitakselom, u usporedbi s 1% - 4% kod primjene samo paklitaksela.
In the pivotal non-dialysis study 204, a total of 148 CKD ND patients with hyperphosphatemia and iron deficiency anaemia received treatment with study drug; there were 141 patients in the intent-to- treat population (Fexeric: 72 patients; Placebo: 69 patients).
U pivotalnom ispitivanju 204 na bolesnicima koji se ne liječe dijalizom ukupno je 148 bolesnika s KBB ND, hiperfosfatemijom i anemijom zbog manjka željeza primilo liječenje ispitivanim lijekom; populacija koju se namjeravalo liječiti (ITT, engl. intent-to-treat) obuhvaćala je 141 bolesnika (Fexeric: 72 bolesnika; placebo: 69 bolesnika).
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).
U pivotalnom ispitivanju faze III u indikaciji GIST-a (n = 312) smrtonosni srčani događaji povezani s liječenjem javili su se u 1% bolesnika u svakoj terapijskoj skupini (tj. u skupinama koje su primale sunitinib odnosno placebo).
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.
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), hipertenzija (koja uključuje hipertenziju, hipertenzivnu krizu, povišen dijastolički krvni tlak i povišen krvni tlak) zabilježena je u 72,8% bolesnika liječenih lenvatinibom i 16,0% bolesnika u skupini koja je primala 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.
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), proteinurija je bila zabilježena u 33,7% bolesnika liječenih lenvatinibom i 3,1% bolesnika u skupini koja je primala placebo.
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.
U pivotalnom placebom kontroliranom ispitivanju lijeka ADCIRCA u liječenju PAH-a ukupno su 323 bolesnika liječena lijekom ADCIRCA u dozama od 2,5 mg do 40 mg jedanput na dan, dok su 82 bolesnika primala 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 (e.g., day 6-15) in all subsequent cycles.
U pivotalnim SCCHN ispitivanjima bolesnicima kod kojih se javila komplicirana neutropenija (uključujući produljenu neutropeniju, febrilnu neutropeniju ili infekciju), preporučeno je primijeniti GCSF u svim sljedećim ciklusima (npr. dani 6-15), kako bi se osigurala profilaktička zaštita.
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.
U pivotalnim SCCHN ispitivanjima bolesnicima kod kojih se javila komplicirana neutropenija (uključujući produljenu neutropeniju, febrilnu neutropeniju ili infekciju), preporučeno je primijeniti G- CSF u svim sljedećim ciklusima (npr. dani 6-15) kako bi se osigurala profilaktička zaštita.
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.
U pivotalnim SCCHN ispitivanjima bolesnicima kod kojih se javila komplicirana neutropenija (uključujući produljenu neutropeniju, febrilnu neutropeniju ili infekciju), preporučeno je primijeniti G- CSF u svim sljedećim ciklusima (npr. dani 6-15), kako bi se osigurala profilaktička zaštita.
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.
U pivotalnim SCCHN ispitivanjima bolesnicima kod kojih se javila komplicirana neutropenija (uključujući produljenu neutropeniju, febrilnu neutropeniju ili infekciju), preporučeno je primijeniti G-CSF u svim sljedećim ciklusima (npr. dani 6-15), kako bi se osigurala profilaktička zaštita.
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.
U pivotalnim SCCHN ispitivanjima, bolesnicima kod kojih se javila komplicirana neutropenija (uključujući produljenu neutropeniju, febrilnu neutropeniju ili infekciju), preporučeno je primijeniti G- CSF u svim sljedećim ciklusima (npr. dani 6-15) kako bi se osigurala profilaktička zaštita.
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.
U pivotalnim SCCHN kliničkim ispitivanjima bolesnicima kod kojih se javila komplicirana neutropenija (uključujući produljenu neutropeniju, febrilnu neutropeniju ili infekciju), preporučeno je primijeniti G-CSF u svim sljedećim ciklusima (npr. dani 6-15), kako bi se osigurala profilaktička zaštita.
In the pivotal studies of treatment-experienced patients coronary heart disease events was more common in patients treated with maraviroc than with placebo (11 during 609 PY vs 0 during 111 PY of follow-up).
U pivotalnim studijama prethodno liječenih bolesnika događaji koronarne bolesti srca bili su češći u bolesnika liječenih maravirokom nego u bolesnika na placebu (11 slučajeva tijekom 609 PY naspram 0 slučajeva tijekom 111 PY ili tijekom razdoblja praćenja).
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).
U pivotalnoj studiji 1199.13, 85 bolesnika (12,9 % bolesnika s histološkim nalazom adenokarcinoma) bili su u dobi ≥ 70 godina (medijan dobi: 72 godine, raspon: od 70 do 80 godina) (vidjeti dio 5.1).
In the pivotal study BR.21 in NSCLC, the incidence of ILD (0.8%) was the same in both the placebo and Tarceva groups.
U kliničkom ispitivanju BR.21 za rak pluća nemalih stanica incidencija pojave intersticijske bolesti pluća (0,8%) bila je jednaka u skupinama koje su primale placebo i skupinama koje su primale lijek Tarceva.
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.
U pivotalnom ispitivanju u bolesnika s MKRK-om otežano zacjeljivanje rana bilo je prijavljeno u 3 bolesnika (0,5%) liječena protokolom ZALTRAP/FOLFIRI i u 5 bolesnika (0,8%) koji su primali protokol placebo/FOLFIRI.