natgillin/translations-raw huggingface dataset:
In the overall patient population of the study MF4411, no reduction was observed for non-vertebral fractures, however daily ibandronic acid appeared to be effective in a high-risk subpopulation (femoral neck BMD T-score < -3.0), where a non-vertebral fracture risk reduction of 69% was observed.
U ukupnoj populaciji bolesnika ispitivanja MF4411 nije uočeno smanjenje broja nevertebralnih prijeloma, no čini se da je dnevna doza ibandronata djelotvorna u visokorizičnoj populacijskoj podskupini (T-vrijednost BMD za vrat bedrene kosti < -3,0), u kojoj je primijećeno smanjenje rizika od nevertebralnih prijeloma za 69%.
In the overall pool of guanfacine-treated patients, somnolence occurred in 40.6% and sedation in 10.2% of guanfacine-treated patients.
U cjelokupnom objedinjenom skupu bolesnika liječenih gvanfacinom, somnolencija je nastala u 40,6%, a sedacija u 10,2% bolesnika liječenih gvanfacinom.
In the overall population (n = 31), 2 mg/kg twice daily resulted in a daily exposure of 8,535 ng·h/mL; AUC was 4,268 ng·h/mL (CV: 61%).
U sveukupnoj populaciji (n = 31) primjena doze od 2 mg/kg dvaput dnevno rezultirala je dnevnom izloženošću od 8535 ng•h/mL; AUCτ je bila 4268 ng•h/mL (CV: 61%).
In the overall population of 2,712 SPRYCEL treated patients, 520 (19%) experienced adverse reactions leading to treatment discontinuation.
U cjelokupnoj populaciji od 2712 bolesnika liječenih lijekom SPRYCEL, u njih 520 (19%) nastupile su nuspojave koje su dovele do prekida liječenja.
In the overall population, 86% (227/263) had documentation of response at the time of the first scan (6 weeks); 96% (253/263) had documentation of response at the time of the second scan (12 weeks).
U sveukupnoj populaciji, 86% (227/263) bolesnika je imalo zabilježen odgovor u trenutku prvog pregleda (6 tjedana); 96% (253/263) je imalo zabilježen odgovor u trenutku drugog pregleda (12 tjedana).
In the overall SJIA program, high ALT and/or AST > 3 x upper limit of normal (ULN) were reported in 19 patients (9.5%).
U cjelokupnom programu za SJIA-u zabilježene su visoke razine ALT-a i/ili AST-a > 3 x gornja granica normale (GGN) u 19 bolesnika (9,5%).
In the overall SJIA program, transient decreased white blood cell (WBC) counts ≤ 0.8 x LLN were reported in 33 patients (16.5%).
U cjelokupnom programu za SJIA-u prolazno snižene razine broja leukocita (Lkc) ≤ 0,8 x DGN bile su zabilježene u 33 bolesnika (16,5%).
In the overall SJIA program, transient decreases in absolute neutrophil count (ANC) to less than 1 x 109/l were reported in 12 patients (6.0%).
U cjelokupnom programu za SJIA-u zabilježena su prolazna smanjenja apsolutnog broja neutrofila (ABN) na manje od 1 x 109/l u 12 bolesnika (6,0%).
In the overall SJIA program, transient decreases in platelet counts (< LLN) were observed in 19 patients (9.5%).
U cjelokupnom programu za SJIA-u zabilježena su prolazna smanjenja broja trombocita (< DGN) u 19 bolesnika (9,5%).
In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or gastrointestinal origin (vomiting and diarrhoea).
U slučajevima predoziranja s dozom manjom od 140 mg ili nepoznatom dozom, bolesnici su opisivali simptome središnjeg živčanog sustava (konfuziju, omamljenost, somnolenciju, vrtoglavicu, agitaciju, agresiju, halucinacije i poremećaj hoda) i/ili gastrointestinalne simptome (povraćanje i proljev).
In the paediatric bipolar population (10-17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 28.0% and 53.3%, respectively.
U pedijatrijskoj populaciji s bipolarnim poremećajem (10-17 godina), koja je lijeku bila izložena tijekom najviše 30 tjedana, incidencija niskih vrijednosti prolaktina u serumu iznosila je 28,0 % u djevojčica (< 3 ng/ml) i 53,3 % u dječaka (< 2 ng/ml).
In the paediatric patients included in the studies HLSTM01 (age 13, 14 and 16 years) and HLSTM02 (age 8 and 14 years) the profile of adverse reactions was not different from the adult population.
U pedijatrijskih bolesnika uključenih u ispitivanja HLSTM01 (u dobi od 13, 14 i 16 godina) i HLSTM02 (u dobi od 8 i 14 godina) profil nuspojava nije bio različit od onoga u odrasloj populaciji.
In the paediatric population 5 µg/kg i.v. glycopyrronium has low central bioavailability, except in the case where the blood brain barrier has been compromised (e.g. a shunt infection).
U pedijatrijskih bolesnika intravenska doza glikopironija od 5 µg/kg ima nisku središnju bioraspoloživost, osim u slučajevima u kojima je oštećena krvno-moždana barijera (primjerice, kod infekcije shunta).
In the Paget's disease trials, symptomatic hypocalcaemia was observed in approximately 1% of patients, in all of whom it resolved.
U kliničkim ispitivanjima Pagetove bolesti opažena je simptomatska hipokalcemija kod otprilike 1% bolesnika od koje su se svi oporavili.
In the Paget’s disease trials, symptomatic hypocalcaemia was observed in approximately 1% of patients, in all of whom it resolved.
U kliničkim ispitivanjima Pagetove bolesti opažena je simptomatska hipokalcijemija kod otprilike 1% bolesnika, koja se kod svih povukla.
In the Paget’s disease trials, symptomatic hypocalcaemia was observed in approximately 1% of patients, in all of whom it resolved.
U kliničkim ispitivanjima Pagetove bolesti u otprilike 1% bolesnika opažena je simptomatska hipokalcijemija, koja se kod svih povukla.
In the palonosetron 10 µg/kg, 20 µg/kg and ondansetron groups, the proportion of patients with CR0-24h was 54.2%, 59.4% and 58.6%.
U skupinama koje su primale palonosetron 10 µg/kg i 20 µg/kg te u skupini koja je primala ondansetron, udio bolesnika s potpunim odgovorom CR0-24h bio je 54,2%, 59,4% i 58,6%.
In the pancreatic neuroendocrine study, patients who took Afinitor lived for an average of 11 months without the disease getting worse, compared with 4.6 months for the patients who took placebo.
U ispitivanju bolesnika s neuroendokrinim rakom gušterače, bolesnici koji su uzimali lijek Afinitor živjeli su prosječno 11 mjeseci bez pogoršanja bolesti u usporedbi s 4,6 mjeseci u slučaju bolesnika koji su uzimali placebo.
In the paper by Besouw et al (2011), the authors provided description of 6 male paediatric patients (age at onset ranged 3-15 years) with cystinosis who experienced adverse effects while receiving cysteamine.
U svom radu Besouw et al. (2011.) opisuju 6 muških pedijatrijskih bolesnika (početak bolesti u dobi od 3 do 15 godina) s cistinozom koji su imali nuspojave dok su primali cisteamin.
In the patients above 2 years (n = 22) the daily exposure was 8,820 ng·h/mL; AUC was 4,410 ng·h/mL (CV: 58%).
U bolesnika starijih od 2 godine (n = 22) dnevna izloženost bila je 8820 ng•h/mL; AUCτ je bila 4410 ng•h/mL (CV: 58%).
In the patients with Child-Pugh class B liver impairment, the mean (95% CI) steady-state AUC of bosentan was 360 (212-613) ng.h/mL, i.e., 4.7 times higher, and the mean (95% CI) AUC of the active metabolite Ro 48-5033 was 106 (58.4-192) ng.h/mL, i.e., 12.4 times higher than in the patients with normal liver function (bosentan: mean [95% CI] AUC: 76.1 [9.07-638] ng.h/mL; Ro 48-5033: mean [95% CI] AUC
Kod bolesnika s oštećenjem jetre Child-Pugh stadij B, srednja vrijednost (95% CI) AUC-a za bosentan u stanju dinamičke ravnoteže bila je 360 (212-613) ng.h/ml, tj., 4,7 puta viša, a srednji (95% CI) AUC aktivnog metabolita Ro 48-5033 bio je 106 (58,4-192) ng.h/ml, tj., 12,4 puta viši nego kod bolesnika s normalnom funkcijom jetre (bosentan: srednji [95% CI] AUC: 76,1 [9,07-638] ng.h/ml; Ro 48-5033: srednji [95% CI] AUC 8,57 [1,28-57,2] ng.h/ml).
In the patients with IHC-p53 positivity, a lower rate of progression to AML was observed amongst patients who achieved a transfusion independence (TI) response (11.1%) compared to a non-responder (34.8%).
U bolesnika s pozitivnim nalazom IHC-p53, niža stopa napredovanja bolesti u AML opažena je među bolesnicima u kojih je postignut odgovor u odnosu na neovisnost o transfuziji (11,1%) u usporedbi s onima u kojih odgovor nije postignut (34,8%).
In the PegIntron combination trial, 1,530 naïve patients were treated for one year with one of the following combination regimens:
U ispitivanju lijeka PegIntron u kombinaciji s ribavirinom, 1530 bolesnika koji prethodno nisu bili liječeni primalo je tijekom godine dana jedan od sljedeća tri režima kombinirane terapije:
In the per protocol population there was a significantly larger observed reduction in GHb in the pre-meal glulisine group compared with the regular insulin group.
U populaciji prema protokolu zabilježeno je značajno veće smanjenje vrijednosti glikiranog hemoglobina (GHb) u skupini koja je prije obroka dobivala glulizin u odnosu na skupinu koja je dobivala obični inzulin.
In the performed safety pharmacology and repeated dose toxicity studies with dogs, fosaprepitant Cmax and aprepitant AUC values were up to 3 times and 40 times, respectively, higher than clinical values.
U provedenim ispitivanjima sigurnosne farmakologije i toksičnosti ponovljenih doza na psima, Cmax fosaprepitanta bio je do 3 puta viši , a AUC aprepitanta 40 puta viši od kliničkih vrijednosti.
In the peri-post natal development study, high doses of histamine dihydrochloride caused maternal toxicity, and the offspring showed toxicity during lactation (fewer live pups at day 21 compared to lactation at day 4) but not after weaning.
U peri- postnatalnim ispitivanjima razvoja, visoke doze histamin dihidroklorida uzrokovale su maternalnu toksičnost, a potomci su pokazali blagu toksičnost tijekom laktacije (manje žive mladunčadi 21. dana u usporedbi s 4. danom laktacije), no ne i nakon odbijanja od sise.
In the Peyronie’s disease clinical studies, at 6 weeks after the first treatment cycle of Xiapex, approximately 75% of patients had antibodies against AUX-I and approximately 55% of patients had antibodies against AUX-II.
U kliničkim ispitivanjima u Peyronijevoj bolesti 6 tjedana nakon prvog ciklusa liječenja Xiapexom, približno 75% bolesnika imalo je protutijela protiv AUX-I i približno 55% bolesnika imalo je protutijela protiv AUX-II.
In the phase 1 study MDX1106-03, pneumonitis, including a Grade 4 case in 1 patient, was reported in 3/37 patients (8.1%) with NSCLC receiving nivolumab 3 mg/kg.
U ispitivanju faze 1 MDX1106-03, pneumonitis je prijavljen je u 3/37 bolesnika (8,1%) s NSCLC-om koji su primali nivolumab u dozi od 3 mg/kg, uključujući jedan slučaj 4. stupnja u 1 bolesnika.
In the Phase 1/2 clinical study in patients with previously treated Ph+ leukaemias, QTcF interval changes >60 ms from baseline were observed 6 (1.1%) of 562 patients.
U kliničkom ispitivanju u fazi 1/2 u bolesnika s prethodno liječenim Ph+ leukemijama promjene QTcF intervala > 60 ms u odnosu na početne vrijednosti zapažene su u 6 (1,1%) od 562 bolesnika.
In the Phase 2 and 3 studies (3 studies), the incidence of PTLD was higher in belatacept-treated patients than in ciclosporin-treated patients (see section 4.8).
U ispitivanjima Faze II i III (3 ispitivanja), incidencija PTLD-a bila je viša u bolesnika liječenih belataceptom nego u bolesnika liječenih ciklosporinom (vidjeti dio 4.8).
In the Phase 2 clinical trial of adult patients with previously treated Ph+ leukaemia, dose escalation to 600 mg once daily with food was allowed in patients who did not experience severe or persistent moderate-adverse reactions, under any of the following circumstances.
U fazi 2 kliničkog ispitivanja u odraslih bolesnika s prethodno liječenom Ph+ leukemijom, postupno povećanje doze na 600 mg jedanput dnevno s hranom bilo je dopušteno u bolesnika koji nisu imali teške ili uporne umjerene nuspojave ni pod jednom od sljedećih okolnosti.
In the phase 3 clinical trial these patients were at greater risk of bleeding, including fatal bleeding, compared to patients <75 years of age.
U faze III kliničkog ispitivanja ti su bolesnici bili izloženi većem riziku od krvarenja, uključujući i ona sa smrtnim ishodom, u usporedbi s bolesnicima mlađima od 75 godina.
In the phase 3 pivotal studies in MF bleeding events (including intracranial and gastrointestinal, bruising and other bleeding events) were reported in 32.6% of patients exposed to Jakavi and 23.2% of patients exposed to the reference treatments (placebo or best available therapy).
U ključnim ispitivanjima MF-a faze 3 događaji krvarenja (uključujući intrakranijalno i gastrointestinalno, modrice i druge događaje krvarenja) bili su prijavljeni u 32,6% bolesnika koji su bili izloženi Jakaviju te u 23,2% bolesnika koji su bili izloženi referentnim terapijama (placebu ili najboljoj dostupnoj terapiji).
In the Phase 3 pivotal treatment study (2005-01 Study), the overall incidence of adverse events was similar in the defibrotide treatment group and in the control group (historical).
U pivotalnom ispitivanju lijeka faze 3 (ispitivanje 2005-01), sveukupna incidencija štetnih događaja bila je slična u skupini liječenoj defibrotidom i u kontrolnoj skupini (na temelju povijesnih kontrola).
In the Phase 3 placebo-controlled study in patients with PAH, a transient increase in mean heart rate of 3–4 bpm at 2–4 hours post-dose was observed.
U placebom kontroliranom ispitivanju faze 3 u bolesnika s PAH-om uočen je prolazan porast srednje vrijednosti frekvencije srca od 3–4 otkucaja/minuti 2–4 sata poslije uzimanja doze.
In the Phase 3 placebo-controlled study in patients with PAH, no increased risk of bleeding was detected with selexipag compared to placebo, including when selexipag was administered with anticoagulants (such as heparin, coumarin-type anticoagulants) or inhibitors of platelet aggregation.
U placebom kontroliranom ispitivanju faze 3 u bolesnika s PAH-om nije zabilježen povećan rizik od krvarenja uz seleksipag u usporedbi s placebom, uključujući i pri primjeni seleksipaga s antikoagulansima (kao što su heparinski i kumarinski antikoagulansi) ili inhibitorima agregacije trombocita.
In the phase 3 pNET study hypothyroidism was reported in 6 patients (7.2%) receiving sunitinib and in one patient (1.2%) on placebo.
U ispitivanju pNET-a faze III hipotireoza je zabilježena u 6 bolesnika (7,2%) koji su primali sunitinib i u jednog bolesnika (1,2%) koji je primao placebo.
In the phase 3 pNET study, one (1%) patient who received sunitinib had treatment-related fatal cardiac failure.
U ispitivanju pNET-a faze III je u jednog (1%) bolesnika koji je primao sunitinib zabilježeno s liječenjem povezano zatajenje srca sa smrtnim ishodom.
In the Phase 3 studies GS-US-236-0102 and GS-US-236-0103, bone fractures occurred in 27 subjects (3.9%) in the Stribild group, 8 subjects (2.3%) in the efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) group, and 19 subjects (5.4%) in the ATV/r+FTC/TDF group.
U fazi 3 ispitivanja GS-US-236-0102 i GS-US-236-0103, prijelomi kostiju dogodili su se u 27 ispitanika (3,9%) u skupini koja je primila Stribild, u 8 ispitanika (2,3%) u skupini koja je primala efavirenz / emtricitabin / tenofovirdizoproksilfumarat (EFV/FTC/TDF) i u 19 ispitanika (5,4%) u skupini ATV/r+FTC/TDF.
In the Phase 3 study GS-US-236-0103, bone mineral density (BMD) was assessed in a non-random subset of 120 subjects (Stribild group n = 54; ritonavir-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) group n = 66).
U fazi 3 ispitivanja GS-US-236-0103, mineralna gustoća kostiju (BMD) procijenjena je u podskupini od 120 ispitanika (skupina koja je primala Stribild, n = 54; skupina koja je primala ritonavirom pojačan atazanavir (ATV/r) plus emtricitabin/tenofovirdizoproksilfumarat (FTC/TDF), n = 66) koji nisu bili nasumično odabrani.
In the Phase 3 trial of Humira in patients with paediatric Crohn’s disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6% (5/192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
U ispitivanju faze III lijeka Humira u pedijatrijskih bolesnika s Chronovom bolešću, koje je ocijenilo djelotvornost i sigurnost dvaju režima terapije održavanja dozom prilagođenom tjelesnoj težini nakon indukcijske terapije prilagođene tjelesnoj težini do 52 tjedna liječenja, povišenje ALT-a ≥ 3 x GGN javilo se u 2,6% (5/192) bolesnika, od kojih je njih četvero na početku liječenja bilo izloženo istodobnoj terapiji imunosupresivima.
In the Phase 3 trial, 3 of 4 patients with ALT elevations >5x ULN reported alcohol consumption beyond the limits recommended in the protocol.
U ispitivanju faze 3, u 3 od 4 bolesnika s povišenjem vrijednosti ALT > 5 x GGN zabilježena je konzumacija alkohola iznad ograničenja preporučenog protokolom.
In the Phase 3 trial, patients were provided daily dietary supplements of vitamin E, linoleic acid, ALA, EPA and DHA.
U ispitivanju faze 3 bolesnici su svakodnevno primali dodatke prehrani vitamina E, linolne kiseline, alfa linolenske kiseline, eikosapentaenoične kiseline i dokosaheksaenoične kiseline.
In the Phase I study (BO25532), the Herceptin 600 mg solution for injection in administration system was shown to be comparable (using a standard bioequivalence confidence interval of 0.8-1.25) with Herceptin 600 mg solution for injection in vial administered by syringe.
U ispitivanju faze I (BO25532), Herceptin 600 mg otopina za injekciju u sustavu za primjenu bila je usporediva s Herceptin 600 mg otopinom za injekciju u bočici primijenjena štrcaljkom (korišten je standardni interval pouzdanosti za bioekvivalenciju od 0,8-1,25).
In the Phase I/II study, treatment with Ilaris had a rapid onset of action, with disappearance or clinically significant improvement of symptoms within one day after dosing.
U ispitivanju faze I/II liječenje Ilarisom imalo je brzi nastup djelovanja, uz nestanak ili klinički značajno poboljšanje simptoma u roku od jednog dana od primitka doze.
In the phase II SAA clinical study with eltrombopag, the incidence of new cytogenetic abnormalities was observed in 19% of patients [8/43 (where 5 of them had changes in chromosome 7)].
U kliničkom ispitivanju faze II teške aplastične anemije s eltrombopagom, incidencija novih citogenetskih abnormalnosti bila je uočena u 19% bolesnika [8/43 (pri čemu je 5 od njih imalo promjene u kromosomu 7)].
In the Phase II studies, the incidence of ILD was 6.2% in patients of Japanese ethnicity, 1.2% in patients of non-Japanese Asian ethnicity and 2.4% in non-Asian patients.
U ispitivanjima faze II, incidencija IBP-a bila je 6,2% u bolesnika japanskog porijekla, 1,2% u bolesnika ne-japanskog azijskog porijekla i 2,4% u ne-azijskih bolesnika.
In the phase II study, AUC0-8h and Cmax at day 1 were 22.1 ± 12.7 µgh/mL and 4.1 ± 2.3 µg/mL.
U ispitivanju faze II, AUC0-8h je prvoga dana primjene iznosio 22,1 ± 12,7 µgh/ml, a Cmax 4,1 ± 2,3 µg/ml.
In the Phase II study, patients who did not obtain an optimal response to therapy with VELCADE alone were able to receive high-dose dexamethasone in conjunction with VELCADE.
U ispitivanju faze II, bolesnici koji nisu postigli optimalni terapijski odgovor kod liječenja samo VELCADEom mogli su primiti visoku dozu deksametazona zajedno s VELCADEom.
In the Phase II, all 148 patients were on lenalidomide treatment.
U fazi II svih 148 bolesnika liječeno je lenalidomidom.
In the Phase IIb, open label study (C209), where patients with no treatment options received other QT- prolonging medicinal products used to treat tuberculosis, including clofazimine, concurrent use with SIRTURO resulted in additive QT prolongation, proportional to the number of QT prolonging medicinal products in the treatment regimen.
U otvorenom ispitivanju faze IIb, (C209), u kojem su bolesnici bez opcija za liječenje primili druge lijekove za liječenje tuberkuloze koji produljuju QT, uključujući klofazimin, istovremena primjena s lijekom SIRTURO rezultirala je aditivnim QT produljenjem, proporcionalnom broju lijekova u režimu liječenja koji produljuju QT.
In the Phase IIb, open-label study (C209), 6.9% (16/233) patients died.
U otvorenom ispitivanju faze IIb (C209), 6,9% (16/233) bolesnika je umrlo.
In the Phase III (FLAGS) study, tegafur AUC was significantly higher in patients with the CYP2A6*4 allele, however, no significant difference was found for 5-FU AUC and for the incidence of adverse reactions.
U (FLAGS) studiji faze III, AUC tegafura je bila značajno viša u bolesnika s alelom CYP2A6*4, no nije pronađena značajna razlika AUC 5-FU-a i učestalosti nuspojava.
In the Phase III (RECOURSE) clinical trial, treatment-related infections occurred more frequently in Lonsurf-treated patients (5.6%) compared to those receiving placebo (1.9%).
U kliničkom ispitivanju faze III (RECOURSE), infekcije povezane s liječenjem češće su zabilježene kod bolesnika liječenih Lonsurfom (5,6%) u usporedbi s placebom (1,9%).
In the Phase III active-controlled trial, the magnitude of decrease in oxygen saturation was comparable between Zalviso and i.v. patient-controlled morphine groups.
U aktivno kontroliranom ispitivanju faze III veličina smanjenja saturacije kisikom bila je usporediva između skupine liječene Zalvisom i bolesnika koji su kontrolirali bol intravenskim morfinom.
In the phase III clinical trials, median reductions of approximately 80% were maintained in uNTx/Cr after 3 months of treatment in 2075 XGEVA-treated advanced cancer patients’ naïve to IV- bisphosphonate.
U kliničkim ispitivanjima faze III, medijan smanjenja uNTx/Cr od otprilike 80% zadržan je nakon 3 mjeseca liječenja u 2075 bolesnika s uznapredovalim rakom liječenima lijekom XGEVA koji nisu ranije primali intravenski bisfosfonat.
In the Phase III FLAGS study, there was no apparent relationship between 5-FU AUC (Teysuno/cisplatin arm) and 5-FU concentration (5-FU/cisplatin arm) during Cycle 1 and efficacy outcomes of overall survival (OS) or progression-free survival (PFS).
U studiji faze III FLAGS nije bilo vidljive povezanosti između AUC 5-FU-a (Teysuno/cisplatin skupina) i koncentracije 5-FU-a (5-FU/cisplatin skupina) tijekom 1. ciklusa i ishoda učinkovitosti ukupnog preživljenja ili preživljenja bez progresije bolesti.
In the phase III IMpact-RSV study in the premature and bronchopulmonary dysplasia paediatric populations, the proportions of patients in the placebo and palivizumab groups who received routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents.
U ispitivanju faze III IMpact- RSV u nedonoščadi i djece s bronhopulmonalnom displazijom, postotak bolesnika koji su dobivali uobičajena dječja cjepiva, cjepivo protiv gripe, bronhodilatatore ili kortikosteroide bio je sličan u skupinama liječenim placebom i palivizumabom i nije zabilježeno povećanje učestalosti nuspojava u bolesnika koji su uzimali navedene lijekove.
In the Phase III studies in RA, PsA, AS, and UC, no overall differences in adverse events (AEs), serious adverse events (SAEs), and serious infections in patients age 65 or older who received Simponi were observed compared with younger patients.
U ispitivanjima faze III u bolesnika s RA, PsA, AS i UC općenito nije bilo razlika što se tiče ukupnih štetnih događaja, ozbiljnih štetnih događaja i ozbiljnih infekcija između bolesnika starih 65 godina ili starijih koji su primali Simponi, u odnosu na mlađe bolesnike.
In the phase III studies MEK115306 (n = 209) and MEK116513 (n = 350) with trametinib in combination with dabrafenib 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 trametinibom u kombinaciji s dabrafenibom 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.