natgillin/translations-raw huggingface dataset:
In study 302 patients with atrial fibrillation, or other cardiac arrhythmia requiring medical therapy were excluded.
Iz ispitivanja 302 isključeni su bolesnici s atrijskom fibrilacijom ili drugim srčanim aritmijama, koji zahtijevaju medicinsko liječenje.
In study 302 the most frequent clinical sign or symptom reported during the MTT was cough (7.9%).
U ispitivanju 302, najučestalija klinička pojava ili simptom zabilježena tijekom MTT-a bio je kašalj (7,9%).
In study 302 the relative change (95% CI) for rhDNase users and non-users was 3.21 (-0.61, 7.03) and 4.73 (-1.93, 11.40), respectively.
U ispitivanju 302, relativna promjena (95% CI) za osobe koje uzimaju rhDNase iznosila je 3,21 (-0,61, 7,03) te 4,73 (- 1,93, 11,40) za osobe koje ne uzimaju rhDNase.
In Study 309, a statistically significant improvement in OS was observed in patients randomized to the eribulin arm compared to the control arm.
U Ispitivanju 309, u bolesnika randomiziranih u skupinu koja je primala eribulin bilo je opaženo statistički značajno poboljšanje ukupnog preživljenja u usporedbi s kontrolnom skupinom.
In Study 332, in patients with PGTC seizures who also had concomitant myoclonic seizures, freedom from seizures was achieved in 16.7 % (4/24) on perampanel compared to 13.0 % (3/23) in those on placebo.
U ispitivanju 332, u bolesnika s primarno generaliziranim toničko-kloničkim napadajima koji su istovremeno imali miokloničke napadaje, potpuni prestanak napadaja postignut je u 16,7% (4/24) bolesnika koji su uzimali perampanel u usporedbi s 13,0% (3/23) bolesnika koji su uzimali placebo.
In study 4, the Enbrel-treated group had a higher proportion of patients with PASI 75 at week 12 (38%) compared to the placebo-treated group (2%) (p<0.0001).
U ispitivanju 4 skupina liječena Enbrelom imala je veći udio bolesnika s PASI 75 u12. tjednu (38%) u usporedbi sa skupinom liječenom placebom (2%) (p<0,0001).
In study 5, part 1 in patients who had a non-G551D gating mutation in the CFTR gene, treatment with ivacaftor led to a rapid (15 days) and substantial mean change from baseline in sweat chloride of -49 mmol/L (95% CI -57, -41) through 8 weeks of treatment.
U ispitivanju 5, 1. dio, proveden u bolesnika s mutacijom gena CFTR koja nije bila mutacija G551D, liječenje ivakaftorom dovelo je u 8 tjedana liječenja do brze (15 dana) i znatne prosječne promjene u odnosu na početne vrijednosti u koncentraciji klorida u znoju od -49 mmol/l (95% CI -57; -41).
In Study 5, XGEVA has been evaluated in a subset of 18 adolescent patients (aged 13-17 years) with giant cell tumour of bone who had reached skeletal maturity defined by at least 1 mature long bone (e.g., closed epiphyseal growth plate of the humerus) and body weight ≥ 45 kg.
Lijek XGEVA je bio ispitivan u Ispitivanju 5 na podskupini od 18 adolescentnih bolesnika (13-17 godina starosti) s gigantocelularnim tumorom kosti, a koji su dosegli zrelost koštanog sustava što je definirano s barem jednom zrelom dugom kosti (primjerice zatvorena epifizna ploča rasta humerusa) i tjelesnom težinom ≥ 45 kg.
In Study 58, RET mutation testing was performed by using the polymerase chain reaction (PCR) based Amplification Refractory Mutation System (ARMS) assay for the M918T mutation, and direct sequencing of DNA for mutations in exons 10, 11, 13, 14, 15 and 16 (site of M918T mutation) on all sporadic patients where DNA was available (297/298).
U Ispitivanju 58 u svih je bolesnika sa sporadičnim medularnim karcinomom štitnjače u kojih je bila dostupna DNK (297/298) istražena mutacija protoonkogena RET, i to testom Amplification Refractory Mutation System (ARMS) koji se temelji na lančanoj reakciji polimerazom (PCR) za mutaciju M918T, te izravnim sekvenciranjem DNK za mutacije na eksonima 10, 11, 13, 14, 15 i 16 (mjesto mutacije M918T).
In study 6 in patients aged 6 years or older with CF who had an R117H mutation in the CFTR gene, the treatment difference in mean change in sweat chloride from baseline through 24 weeks of treatment was -24 mmol/L (95% CI -28, -20).
U ispitivanju 6 u bolesnika s cističnom fibrozom u dobi od 6 i više godina koji su imali mutaciju R117H gena CFTR, terapijska razlika prosječne promjene u koncentraciji klorida u znoju od početne vrijednosti do 24. tjedna iznosila je -24 mmol/l (95% CI -28; -20).
In study 7 in patients aged 2 to less than 6 years with a gating mutation on at least 1 allele of the CFTR gene administered either 50 mg or 75 mg of ivacaftor twice daily, the mean absolute change from baseline in sweat chloride was -47 mmol/L (95% CI -58, -36) at week 24.
U ispitivanju 7 u bolesnika u dobi od 2 do manje od 6 godina koji su imali mutaciju na barem 1 alelu gena CFTR zbog koje dolazi do nepravilne regulacije kanala i primali su 50 mg ili 75 mg ivakaftora dvaput na dan, prosječna apsolutna promjena u koncentraciji klorida u znoju od početne vrijednosti iznosila je -47 mmol/l (95% CI -58; -36) u 24. tjednu.
In study AC-052-365 [FUTURE 1] dispersible tablets were administered in 36 PAH children aged from 2 to 11 years.
U studiji AC-052-365 [FUTURE 1] 36 djece s PAH-om u dobi od 2 do 11 godina primalo je tablete za oralnu suspenziju.
In study AC-052-365 [FUTURE 1], dispersible tablets were administered in 36 PAH children aged from 2 to 11 years.
U studiji (AC-052-365 [FUTURE 1] 36 djece s PAH-om u dobi od 2 do 11 godina primalo je tablete za oralnu suspenziju.
In study AC-052-373 [FUTURE 3], using dispersible tablets, the exposure to bosentan in the patients treated with 2 mg/kg twice daily was comparable to that in the FUTURE 1 study.
U studiji AC-052-373 [FUTURE 3] uz primjenu tableta za oralnu suspenziju, izloženost bolesnika liječenih s 2 mg/kg bosentana dvaput dnevno bila je usporediva onoj u studiji FUTURE 1.
In study AC-052-391 [FUTURE 4] conducted in neonates, bosentan concentrations increased slowly and continuously over the first dosing interval, resulting in low exposure (AUC0-12 in whole blood: 164 ng·h/mL, n = 11).
U studiji AC-052-391 [FUTURE 4] provedenoj na novorođenčadi, koncentracije bosentana rasle su polako i neprekidno tijekom prvog intervala doziranja dovodeći do niske izloženosti (AUC0-12 u punoj krvi: 164 ng•h/mL, n = 11).
In study AI455-094, performed in South-Africa, 362 mother-infant pairs were included in a prevention of mother-to-child-transmission study.
Ispitivanje AI455-094, koje je provedeno u Južnoafričkoj Republici, uključilo je 362 para majka- dojenče u ispitivanje prevencije prijenosa s majke na dijete.
In study ALLY-1, the regimen of daclatasvir, sofosbuvir, and ribavirin administered for 12 weeks was evaluated in 113 adults with chronic hepatitis C and Child-Pugh A, B or C cirrhosis (n=60) or HCV recurrence after liver transplantation (n=53).
U ispitivanju ALLY-1 ocjenjivao se 12-tjedni režim liječenja daklatazvirom, sofosbuvirom i ribavirinom u 113 odraslih bolesnika s kroničnim hepatitisom C i cirozom Child-Pugh stadija A, B ili C (n=60) ili povratom HCV-a nakon presađivanja jetre (n=53).
In study AMD3100-3101, 62 patients (10 in the Mozobil + G-CSF group and 52 in the placebo + G- CSF group), who could not mobilise sufficient numbers of CD34+ cells and thus could not proceed to transplantation, entered into an open-label Rescue procedure with Mozobil and G-CSF.
U ispitivanju AMD3100-3101 62 bolesnika (10 u skupini koja je primala Mozobil + G-CSF i 52 u skupini koja je primala placebo + G-CSF) u kojih nije bilo moguće mobilizirati dovoljan broj CD34+ stanica i tako omogućiti postupak transplantacije, uključeno je u otvoreni postupak “spašavanja” lijekom Mozobil i G-CSF-om.
In study AUGMENT, Brimica Genuair showed improvements in FEV1 at 1 hour post-dose relative to placebo and aclidinium of 284 ml and 108 ml (both p<0.0001), respectively, and improvements in trough FEV1 relative to placebo and formoterol of 130 ml (p<0.0001) and 45 ml (p=0.01), respectively.
U ispitivanju AUGMENT, Brimica Genuair je pokazao poboljšanja u FEV1 jedan sat nakon doze u odnosu na placebo od 284 ml, i u odnosu na aklidinij od 108 ml (oba p < 0,0001), te poboljšanja najnižeg FEV1 u odnosu na placebo od 130 ml i u odnosu na formoterol od 45 ml (oba p < 0,0001).
In study AUGMENT, Duaklir Genuair showed improvements in FEV1 at 1 hour post-dose relative to placebo and aclidinium of 284 ml and 108 ml (both p<0.0001), respectively, and improvements in trough FEV1 relative to placebo and formoterol of 130 ml (p<0.0001) and 45 ml (p=0.01), respectively.
U ispitivanju AUGMENT, Duaklir Genuair je pokazao poboljšanja u FEV1 jedan sat nakon doze u odnosu na placebo od 284 ml, i u odnosu na aklidinij od 108 ml (oba p < 0,0001), te poboljšanja najnižeg FEV1 u odnosu na placebo od 130 ml i u odnosu na formoterol od 45 ml (oba p < 0,0001).
In Study AUX- CC-867, most (85%) subjects received local anesthesia prior to the finger extension procedure.
U ispitivanju AUX-CC- 867, većina ispitanika (85%) je primila lokalnu anesteziju prije postupka ekstenzije prsta.
In Study B, the median age was 51 years (range: 29-80 years); 87.1% of patients were younger than 65 years.
U ispitivanju B medijan dobi bio je 51 godina (raspon: 29-80 godina); 87,1% bolesnika bilo je mlađe od 65 godina.
In study BCIRG 006, 213/1075 patients in the DCarbH (TCH) arm, 221/1074 patients in the ACDH (ACTH) arm, and 217/1073 in the AC→D (ACT) arm had a Karnofsky performance status ≤90 (either 80 or 90).
U ispitivanju BCIRG 006 je 213/1075 bolesnica u skupini DCarbH (TCH), 221/1074 bolesnica u skupini AC→DH (AC→TH) i 217/1073 bolesnica u skupini AC→D (AC→T) imalo Karnofsky status ≤ 90 (bilo 80 ili 90).
In study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA Class III & IV) in the Herceptin 1 year treatment arm was 0.8 %, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6 %.
U ispitivanju BO16348, nakon medijana praćenja od 8 godina, incidencija teškog kongestivnog zatajenja srca (NYHA klase III i IV) u skupini liječenoj 1 godinu lijekom Herceptin iznosila je 0,8%, dok je stopa blage simptomatske i asimptomatske disfunkcije lijeve klijetke iznosila 4,6%.
In study BO20924 of Avastin with current standard of care in metastatic rhabdomyosarcoma and non- rhabdomyosarcoma soft tissue sarcoma, the safety profile of Avastin treated children was comparable with that observed in adults treated with Avastin.
U ispitivanju BO20924, u kojem se ispitivao Avastin s trenutnom standardnom terapijom u liječenju metastatskog rabdomiosarkoma i sarkoma mekog tkiva koji nije rabdomiosarkom, sigurnosni profil lijeka u djece liječene lijekom Avastin bio je usporediv s onim primijećenim u odraslih osoba liječenih lijekom Avastin.
In Study BO20924, the pharmacokinetics of bevacizumab was well characterized by the pediatric population PK model in 70 paediatric patients (1.4 to 17.6 years; 11.6 to 77.5 kg).
U ispitivanju BO20924, farmakokinetika bevacizumaba dobro je okarakterizirana uz pomoć pedijatrijskog populacijskog farmakokinetičkog modela u 70 pedijatrijskih bolesnika (1,4 do 17,6 godina; 11,6 do 77,5 kg).
In study C04-001 (TRIUMPH) PNH patients with at least 4 transfusions in the prior 12 months, flow cytometric confirmation of at least 10% PNH cells and platelet counts of at least 100,000/microliter were randomized to either Soliris (n = 43) or placebo (n = 44).
U ispitivanju C04-001 (TRIUMPH), bolesnici s PNH i najmanje 4 transfuzije u prethodnih 12 mjeseci, s najmanje 10% PNH stanica utvrđenim pomoću protočne citometrije i brojem trombocita od najmanje 100 000/mikrolitar bili su randomizirani u skupinu koja je primala Soliris (N = 43) ili u skupinu koja je primala placebo (N = 44).
In study C208 (stage 1 and 2), aminotransferase elevations of at least 3 x ULN developed more frequently in the SIRTURO treatment group (11/102 [10.8%] versus 6/105 [5.7%]) in the placebo treatment group.
U ispitivanju C208 (stadij 1 i 2) porasti aminotransferaza, od najmanje 3 x GGN razvili su se češće u skupini liječenoj lijekom SIRTURO (11/102 [10,8%] naspram 6/105 [5,7%]) u skupini liječenoj placebom.
In study C209 (n = 690), the BR was emtricitabine/tenofovir disoproxil fumarate.
U ispitivanju C209 (n = 690), osnovni terapijski režim sastojao se od emtricitabina/tenofovirdizoproksilfumarata.
In study C212, patients with HIV-1 co-infection who were treatment-naïve or failed prior peg-IFN/RBV therapy received simeprevir (150 mg once daily) + peginterferon alfa-2a + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
U ispitivanju C212, bolesnici s koinfekcijom HIVom-1 koji prethodno nisu bili liječeni ili su doživjeli neuspjeh prethodne terapije s peg-IFN/RBV, primali su simeprevir (150 mg jedanput dnevno) + peginterferon alfa-2a + ribavirin tijekom 12 tjedana, nakon čega je slijedilo 12 ili 36 dodatnih tjedana peginterferona alfa-2a + ribavirin (vidjeti tablice 17 i 18).
In study C215 (n = 678), the BR consisted of 2 investigator selected N(t)RTIs: emtricitabine/tenofovir disoproxil fumarate (60%, n = 406) or lamivudine/zidovudine (30%, n = 204) or abacavir plus lamivudine (10%, n = 68).
U ispitivanju C215 (n = 678), osnovni terapijski režim sastojao se od 2 N(t)RTI po izboru ispitivača: emtricitabin/tenofovirdizoproksilfumarat (60%, n = 406) ili lamivudin/zidovudin (30%, n = 204) ili abakavir plus lamivudin (10%, n = 68).
In study C2305 the proportion of patients with newly occurring notable QT/QTc intervals was comparable between pasireotide intramuscular use and octreotide intramuscular use groups up to crossover, with few notable outlying values.
U ispitivanju C2305 udio bolesnika s novonastalim zamjetnim QT/QTc intervalima bio je usporediv između skupina koje su primale pasireotid primijenjen intramuskularno i onih koje su primale oktreotid primijenjen intramuskularno sve do ukrižene zamjene ispitivanog lijeka, uz vrlo malo zamjetnih stršećih vrijednosti.
In study C2402, the only notable outlier was a QTcF value
U ispitivanju C2402, jedina zamjetna stršeća vrijednost bila je vrijednost QTcF-a
In Study CAC-002-01, the mean age of patients at baseline was 9.0 years, with ages ranging from 0.3 to 35 years.
U ispitivanju CAC-002-01, prosječna dob bolesnika na početku iznosila je 9,0 godina, pri čemu je raspon godina iznosio od 0,3 do 35 godina.
In Study CAC-91-10-10 the efficacy analysis showed that treatment with cholic acid significantly improved, i.e. decreased, urinary bile acid excretion in patients with single enzyme defects.
U ispitivanju CAC-91-10-10, analizom djelotvornosti utvrđeno je da je liječenje kolatnom kiselinom značajno poboljšalo, odnosno smanjilo, izlučivanje žučne kiseline u urinu kod bolesnika s defektima pojedinačnog enzima.
In study CAL30001, 182 treatment-experienced patients with virologic failure were randomised and received treatment with either the fixed-dose combination of abacavir/lamivudine (FDC) once daily or abacavir 300 mg twice daily plus lamivudine 300 mg once daily, both in combination with tenofovir and a PI or an NNRTI for 48 weeks.
U studiji CAL30001, 182 bolesnika koji pri prethodnom liječenju nisu imali virološki odgovor, randomizirani su tako da su tijekom 48 tjedana dobivali ili fiksnu kombinaciju abakavira i lamivudina jedanput na dan ili abakavir u dozi od 300 mg dvaput na dan uz lamivudin 300 mg jedanput na dan, u oba slučaja u kombinaciji s tenofovirom i nekim inhibitorom proteaze ili nekim nenukleozidnim inhibitorom reverzne transkriptaze.
In study CLDT600ACN04E1, 57 patients with available paired liver biopsies at baseline and after mean treatment of 260.8 weeks were evaluated for changes in liver histology (38 HBeAg-positive and 19 HBeAg-negative patients).
Ispitivanje CLDT600ACN04E1 uključivalo je 57 bolesnika s dostupnim usporednim biopsijama na početku i nakon prosječnog liječenja tijekom 260,8 tjedana, pri čemu su određene histološke promjene u jetri (38 HBeAg-pozitivni and 19 HBeAg-negativni bolesnici).
In study DPM-CF-301 64.4 % of the patient population were adults while in study DPM-CF-302 this figure was 49.5%.
U ispitivanju DPM-CF-301, 64,4 % populacije pacijenata činile su odrasle osobe, dok je ista brojka u ispitivanju DPM-CF-302 bila 49,5%.
In study ESS30008, 260 patients with virologic suppression on a first line therapy regimen containing abacavir 300 mg plus lamivudine 150 mg, both given twice daily and a PI or NNRTI, were randomised to continue this regimen or switch to Kivexa plus a PI or NNRTI for 48 weeks.
U studiji ESS30008, 260 bolesnika u kojih je pri prethodnom liječenju abakavirom u dozi od 300 mg dvaput na dan i lamivudinom u dozi od 150 mg dvaput na dan uz inhibitor proteaze (IP) ili nenukleozidni inhibitor reverzne transkriptaze došlo do supresije virusa, randomizirani su tako da su 48 tjedana ili nastavili s tim režimom ili prešli na liječenje lijekom Kivexa i nekim inhibitorom proteaze ili nenukleozidnim inhibitorom reverzne transkriptaze.
In Study ESTEEM 1, approximately 61% of patients re-randomized to apremilast at Week 32 had a PASI-75 response at Week 52.
U ispitivanju ESTEEM 1, približno 61% bolesnika ponovno randomiziranih na apremilast u 32. tjednu imalo je odgovor PASI-75 u 52. tjednu.
In Study ESTEEM 1, patients randomized to apremilast at the start of the study who did not achieve a PASI- 75 response at Week 32 were permitted to use concomitant topical therapies and/or UVB phototherapy between Weeks 32 to 52.
U ispitivanju ESTEEM 1, bolesnicima randomiziranim na apremilast na početku ispitivanja koji nisu postigli odgovor PASI-75 u 32. tjednu bile su dopuštene primjena istodobne topikalne terapije i/ili UVB fototerapija između 32. i 52. tjedna.
In Study ESTEEM 2, approximately 80.3% of patients re-randomized to apremilast at Week 32 had a PASI- 50 response at Week 52.
U ispitivanju ESTEEM 2, približno 80,3% bolesnika ponovno randomiziranih na apremilast u 32. tjednu imalo je odgovor PASI-50 u 52. tjednu.
In study GAO4753g, patients in the bendamustine (B) arm received 6 months of induction treatment only, whereas after the induction period, patients in the Gazyvaro plus bendamustine (G+B) arm continued with Gazyvaro maintenance treatment.
U ispitivanju GAO4753g, bolesnici u skupini liječenoj bendamustinom (B) primili su samo 6 mjeseci uvodnog liječenja, dok su bolesnici liječeni lijekom Gazyvaro plus bendamustinom (G+B) nakon razdoblja uvodnog liječenja nastavili primati Gazyvaro kao terapiju održavanja.
In study GEICAM 9805, lymphoedema was observed to be ongoing in 4 of the 5 patients in TAC arm and in 1 of the 2 patients in FAC arm at the end of the chemotherapy and did not resolve during the follow-up period (median follow-up of 10 years and 5 months).
U GEICAM 9805 studiji limfedem je i dalje bio prisutan u 4 od 5 bolesnika u TAC skupini i u 1 od 2 bolesnika u FAC skupini na kraju kemoterapije i nije se povukao tijekom perioda praćenja (medijan vremena praćenja od 10 godina i 5 mjeseci).
In study GEICAM 9805, lymphoedema was observed to be ongoing in 4 of the 5 patients in TAC arm and in 1 of the 2 patients in FAC arm at the end of the chemotherapy and did not resolve during the follow-up period (median follow-up time of 10 years and 5 months).
U GEICAM 9805 studiji limfedem je i dalje bio prisutan u 4 od 5 bolesnika u TAC skupini i u 1 od 2 bolesnika u FAC skupini na kraju kemoterapije i nije se povukao tijekom perioda praćenja (medijan vremena praćenja od 10 godina i 5 mjeseci).
In study GEICAM 9805, lymphoedema was observed to be ongoing in 4 of the 5 patients in TAC arm and in 1 of the 2 patients in FAC arm at the end of the chemotherapy, and did not resolve during the follow-up period (median follow-up time of 10 years and 5 months).
U GEICAM 9805 studiji limfedem je i dalje bio prisutan u 4 od 5 bolesnika u TAC skupini i u 1 od 2 bolesnika u FAC skupini, na kraju kemoterapije i nije se povukao tijekom perioda praćenja (medijan vremena praćenja od 10 godina i 5 mjeseci).
In study GEICAM 9805, lymphoedema was observed to be ongoing in 4 of the 5 patients in TAC arm and in 1 of the 2 patients in FAC armat the end of the chemotherapy, , and did not resolve during the follow-up period (median follow-up time of 10 years and 5 months).
U GEICAM 9805 studiji limfedem je i dalje bio prisutan u 4 od 5 bolesnika u TAC skupini i u 1 od 2 bolesnika u FAC skupini na kraju kemoterapije i nije se povukao tijekom perioda praćenja (medijan vremena praćenja od 10 godina i 5 mjeseci).
In study GEICAM 9805, lymphoedema was observed to be ongoing in 4 of the 5 patients in TAC arm and in 1 of the 2 patients in FAC armat the end of the chemotherapy, and did not resolve during the follow-up period (median follow-up time of 10 years and 5 months).
U GEICAM 9805 studiji limfedem je i dalje bio prisutan u 4 od 5 bolesnika u TAC skupini i u 1 od 2 bolesnika u FAC skupini na kraju kemoterapije i nije se povukao tijekom perioda praćenja (medijan vremena praćenja od 10 godina i 5 mjeseci).
In Study GEN501, 42 patients with relapsed and refractory multiple myeloma received 16 mg/kg DARZALEX until disease progression.
U ispitivanju GEN501, 42 bolesnika s relapsnim i refraktornim multiplim mijelomom primala su DARZALEX u dozi od 16 mg/kg do progresije bolesti.
In Study GO28141, the most common adverse reactions (>20%) observed with a higher frequency in the Cotellic plus vemurafenib arm were diarrhoea, rash, nausea, pyrexia, photosensitivity reaction, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood creatine phosphokinase, and vomiting.
U ispitivanju GO28141, najčešće nuspojave (> 20%) primijećene s većom učestalošću u skupini koja je primala Cotellic plus vemurafenib bile su proljev, osip, mučnina, pireksija, reakcija fotoosjetljivosti, povišene vrijednosti alanin aminotransferaze, povišene vrijednosti aspartat aminotransferaze, povišene vrijednosti kreatin fosfokinaze u krvi i povraćanje.
In study GS-99-907, 550 treatment-experienced adult patients were treated with placebo or tenofovir disoproxil 245 mg (as fumarate) for 24 weeks.
U ispitivanju GS-99-907 sudjelovalo je 550 prethodno liječenih odraslih pacijenata koji su primali placebo ili tenofovirdizoproksil u dozi od 245 mg (u obliku tenofovirdizoproksilfumarata) u trajanju od 24 tjedna.
In study GS-US-104-0321, 87 HIV-1 infected treatment-experienced patients 12 to < 18 years of age were treated with tenofovir disoproxil fumarate (n = 45) or placebo (n = 42) in combination with an optimised background regimen (OBR) for 48 weeks.
U ispitivanju GS-US-104-0321, 87 prethodno liječenih pacijenata zaraženih virusom HIV-1, u dobi od 12 do 18 godina starosti, primali su tenofovirdizoproksilfumarat (n = 45) ili placebo (n = 42) u kombinaciji s optimiziranim pozadinskim režimom (OBR) tijekom 48 tjedana.
In study GS-US-104-0352, 4 out of 89 paediatric patients exposed to tenofovir disoproxil fumarate (median tenofovir disoproxil fumarate exposure 312 weeks) discontinued due to adverse reactions consistent with proximal renal tubulopathy.
U ispitivanju GS-US-104-0352, 4 od 89 pedijatrijskih pacijenata izloženih tenofovirdizoproksilfumaratu (medijan izloženosti tenofovirdizoproksilfumaratu: 312 tjedana) prekinulo je liječenje zbog nuspojava sukladnih proksimalnoj bubrežnoj tubulopatiji.
In study GS-US-104-0352, 4 out of 89 paediatric patients exposed to tenofovir disoproxil fumarate discontinued due to adverse reactions consistent with proximal renal tubulopathy (median tenofovir disoproxil fumarate exposure 104 weeks).
U ispitivanju GS-US-104-0352, 4 od 89 pedijatrijskih pacijenata izloženih tenofovirdizoproksilfumaratu prekinulo je ispitivanje zbog nuspojava sukladnih proksimalnoj bubrežnoj tubulopatiji (medijan izloženosti tenofovirdizoproksilfumaratu iznosio je 104 tjedna).