natgillin/translations-raw huggingface dataset:
I studie 1 var den CMH-vægtede middelforskel (Omidria - placebo) i middel-AUC -5,20 mm [95 % konfidensinterval: -7,31, -3,09] (P < 0,001).
In Study 1, the CMH weighted mean difference (Omidria – placebo) in the mean AUC was -5.20 mm [95% confidence interval: -7.31, -3.09] (P < 0.001).
I studie 1 ved år 3 var gennemsnitligt beregnet GFR 21 ml/min/1,73 m2 højere med belatacept og henholdsvis 10% og 20% af patienterne nåede CKD-stadium 4/5 (GFR < 30 ml/min/1,73 m2 ) med belatacept versus ciclosporin.
In Study 1 by Year 3, mean calculated GFR was 21 ml/min/1.73 m2 higher with belatacept, and 10% and 20% of patients reached CKD stage 4/5 (GFR < 30 ml/min/1.73 m2) with belatacept versus ciclosporin, respectively.
I studie 1, et randomiseret, placebokontrolleret fase 2-studie af MCD, blev 53 patienter randomiseret til armen med siltuximab-behandling, hvor de fik den anbefalede dosering på 11 mg/kg hver 3. uge, og 26 patienter blev randomiseret til placeboarmen.
In Study 1, a randomised, placebo-controlled Phase 2 study in MCD, 53 patients were randomised to the siltuximab treatment arm and treated at the recommended dose of 11 mg/kg every 3 weeks and 26 patients were randomised to the placebo arm.
I studie 1100.1090 blev bivirkningen granolucytopeni (n=28) rapporteret hyppigere i placebogruppen (3,3%) end i nevirapingruppen (2,5%).
In study 1100.1090, from which the majority of related adverse events (n=28) were received, patients on placebo had a higher incidence of events of granulocytopenia (3.3%) than patients on nevirapine (2.5%).
I studie 1100.1486 (VERxVE) med antiretroviralnaive patienter var optrapningsdosis af Viramune 200 mg én gang dagligt i 14 dage (n=1068), hvorefter patienterne blev randomiseret til enten Viramune 200 mg tabletter to gange dagligt eller Viramune 400 mg i depotform én gang dagligt.
In study 1100.1486 (VERxVE) antiretroviral-naïve patients received a lead-in dose of Viramune 200 mg immediate-release once daily for 14 days (n=1,068) and then were randomised to receive either Viramune 200 mg immediate-release twice daily or Viramune 400 mg prolonged-release once daily.
I studie 1100.1518. undersøgtes farmakokinetikken for Viramune i depotform i kombination med andre antiretrovirale lægemidler, hos 85 patienter (3 til < 18 år), som fik vægt- eller legemsoverfladearealjusteret Viramune 200 mg i mindst 18 uger og skiftede derefter over til Viramune depottabletter (2 x 100 mg, 3 x 100 mg eller 1 x 400 mg én gang dagligt) i 10 dage.
The pharmacokinetics of Viramune prolonged-release was assessed in study 1100.1518. Eighty-five patients (3 to < 18 years) received weight or body surface area dose-adjusted Viramune immediate- release for a minimum of 18 weeks and then were switched to Viramune prolonged-release tablets (2 x 100 mg, 3 x 100 mg or 1 x 400 mg once daily) in combination with other antiretrovirals for 10 days.
I studie 1100.1526 (TRANxITION) blev patienterne efter minimum 18 ugers behandling med Viramune 200 mg tabletter to gange dagligt, randomiseret til enten Viramune 400 mg depottabletter én gang dagligt (n = 295) eller fortsætte behandling med Viramune 200 mg tabletter to gange dagligt (n = 148).
In study 1100.1526 (TRANxITION) patients on Viramune 200 mg immediate-release twice daily treatment for at least 18 weeks were randomised to either receive Viramune 400 mg prolonged-release once daily (n=295) or remain on their Viramune immediate-release treatment (n=148).
I studie 1100.1526 (TRANxITION) blev patienterne efter minimum 18 ugers behandling medViramune 200 mg tabletter to gange dagligt , randomiseret til enten Viramune 400 mg depottabletter én gang dagligt (n = 295) eller fortsætte behandling med Viramune 200 mg tabletter to gange dagligt (n = 148).
In study 1100.1526 (TRANxITION) patients on Viramune 200 mg immediate-release twice daily treatment for at least 18 weeks were randomised to either receive Viramune 400 mg prolonged-release once daily (n=295) or remain on their Viramune immediate-release treatment (n=148).
I studie 1182.14, et åbent, randomiseret, multicenter-studie blev hiv-positive, pædiatriske patienter i alderen fra 2 til 18 år undersøgt.
HIV-positive, paediatric patients, aged 2 through 18 years, were studied in a randomized, open-label, multicenter study (trial 1182.14).
I studie 1199.13 (LUME-Lung 1) var hyppigheden af alvorlige hændelser (SAEs) hos de patienter, der blev behandlet med nintedanib plus docetaxel, større hos patienter der vejede under 50 kg end hos patienter der vejede ≥ 50 kg.
In study 1199.13 (LUME-Lung 1), there was a higher frequency of SAEs in patients treated with nintedanib plus docetaxel with a body weight of less than 50 kg compared to patients with a weight
I studie 19 blev der identificeret 18 patienter med en somatisk tumor-BRCA-mutation (en mutation i tumoren, men vildtype i kimcellen).
In Study 19, 18 patients were identified with a somatic tumour BRCA mutation (a mutation in the tumour but wildtype in the germline).
I studie 2 havde patienterne følgende mediane baseline-værdier: Alder 37 år, sygdomsvarighed 6,0 år, EDSS-score 2,5.
In Study 2, patients had the following median baseline characteristics: age 37 years, disease duration 6.0 years, EDSS score 2.5. In addition, 17% of patients had an EDSS score >3.5, 32% had
I studie 2 var den CMH-vægtede middelforskel (Omidria - placebo) i middel-AUC -4,58 mm [95 % konfidensinterval: - 6,92, -2,24] (P < 0,001).
In Study 2, the CMH weighted mean difference (Omidria – placebo) in the mean AUC was -4.58 mm [95% confidence interval: -6.92, -2.24] (P < 0.001).
I studie 2 var den CMH-vægtede middelforskel (Omidria - placebo) i middel-AUC 0,59 mm [95 % konfidensinterval: 0,49, 0,69] (P < 0,0001).
In Study 2, the CMH weighted mean difference (Omidria – placebo) in the mean AUC was 0.59 mm [95% confidence interval: 0.49, 0.69] (P < 0.0001).
I studie 2, et fase 1-studie, blev 16 af 37 patienter med CD behandlet med siltuximab i den anbefalede dosering på 11 mg/kg hver 3. uge.
In Study 2, a Phase 1 study, 16 of 37 patients with CD were treated with siltuximab, at the recommended dose of 11 mg/kg every 3 weeks
I studie 2011-003 var forekomsten af venøse tromboemboliske hændelser 10,6 % i Kd-armen og 3,1 % i bortezomib- plus dexamethason-armen (Vd).
In study 2011 003 the incidence of venous thromboembolic events was 10.6% in the Kd arm and 3.1% in the bortezomib plus dexamethasone (Vd) arm.
I studie 3 opretholdt hovedparten af de patienter (77 %), som initialt blev randomiseret til 50 mg to gange om ugen og som fik nedsat deres Enbrel dosis til 25 mg to gange om ugen efter 12 uger, deres PASI 75- respons til uge 36.
In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their Enbrel dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
I studie 312-0116/0117 og 312-0119 forekom udslæt (rapporteret som eksfoliativ dermatitis, udslæt, erytematøst udslæt, generaliseret udslæt, makuløst udslæt, makulopapuløst udslæt, papuløst udslæt, pruritisk udslæt og hudsygdom) hos 28,3 % af de patienter, der fik idelalisib + et anti-CD20 monoklonalt antistof (rituximab eller ofatumumab), og hos 7,7 % af de patienter, der kun fik et anti-CD20 monoklonalt antistof (rituximab eller ofatumumab).
In studies 312-0116/0117 and 312-0119, rash (reported as dermatitis exfoliative, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, and skin disorder) occurred in 28.3% of subjects who received idelalisib + an anti-CD20 monoclonal antibody (rituximab or ofatumumab) and 7.7% who received an anti-CD20 monoclonal antibody only (rituximab or ofatumumab).
I studie 4 blev patienter, der gennemførte behandlingen i studie 1 og 2 med placebo, skiftet til ivacaftor, mens patienterne, der fik ivacaftor, fortsatte med at få det i mindst 96 uger, dvs. behandlingsvarigheden med ivacaftor var mindst 96 uger for patienter i placebo/ivacaftor-gruppen, og mindst 144 uger for patienter i ivacaftor/ivacaftor-gruppen.
In study 4 patients who completed treatment in studies 1 and 2 with placebo were switched to ivacaftor while patients on ivacaftor continued to receive it for a minimum of 96 weeks, i.e., the length of treatment with ivacaftor was at least 96 weeks for patients in the placebo/ivacaftor group and at least 144 weeks for patients in the ivacaftor/ivacaftor group.
I studie 4 deltog 37 voksne patienter med histologisk bekræftede, ikke-resekterbare eller recidiverende kæmpecelletumorer i knogle.
Study 4 enrolled 37 adult patients with histologically confirmed unresectable or recurrent giant cell tumour of bone.
I studie 5 deltog 507 voksne eller knoglemæssigt fuldt udviklede unge med kæmpecelletumorer i knogle og evidens for målbar aktiv sygdom.
Study 5 enrolled 507 adult or skeletally mature adolescents with giant cell tumour of bone and evidence of measurable active disease.
I studie 7 hos patienter i alderen 2 til under 6 år med en gating-mutation på mindst 1 allel i CFTR- genet, der enten fik administreret 50 mg eller 75 mg ivacaftor to gange dagligt, var den gennemsnitlige absolutte ændring fra baseline i sved-chlorid -47 mmol/l (95 % CI -58; -36) ved uge 24.
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.
I Studie A og B sås hjernemetastaser hos henholdsvis 60,1 % og 71,4 % af patienterne.
In Studies A and B, brain metastases were seen in 60.1% and 71.4% of patients, respectively.
I studie AC-052-356 [BREATHE-3] blev farmakokinetikken af oral enkeltdosis og gentagne doser bosentan som filmovertrukne tabletter undersøgt hos 19 børn i alderen fra 2 til 15 år med pulmonal arteriel hypertension (PAH), som fik en vægtbaseret dosis på 2 mg/kg to gange dagligt.
Study AC-052-356 [BREATHE-3]) evaluated the pharmacokinetics of single and multiple oral doses of the film-coated tablet formulation of bosentan in 19 children aged from 3 to 15 years with pulmonary arterial hypertension (PAH) who were dosed on the basis of body weight with 2 mg/kg twice daily.
I studie AC-052-356 [BREATHE-3] blev farmakokinetikken af oral enkeltdosis og gentagne doser bosentan som filmovertrukne tabletter undersøgt hos 19 børn i alderen fra 3 til 15 år med pulmonal arteriel hypertension (PAH), som fick en vægtbaseret dosis på 2 mg/kg to gange dagligt.
Study AC-052-356 [BREATHE-3]) evaluated the pharmacokinetics of single and multiple oral doses of the film-coated tablet formulation of bosentan in 19 children aged from 3 to 15 years with pulmonary arterial hypertension (PAH) who were dosed on the basis of body weight with 2 mg/kg twice daily.
I studie AC-052-356 [BREATHE-3] blev farmakokinetikken af oral enkeltdosis og gentagne doser bosentan som filmovertrukne tabletter undersøgt hos 19 børn i alderen fra 3 til 15 år med pulmonal arteriel hypertension (PAH), som fik en vægtbaseret dosis på 2 mg/kg to gange dagligt.
Study AC-052-356 [BREATHE-3]) evaluated the pharmacokinetics of single and multiple oral doses of the film-coated tablet formulation of bosentan in 19 children aged from 3 to 15 years with pulmonary arterial hypertension (PAH) who were dosed on the basis of body weight with 2 mg/kg twice daily.
I studie AC-052-365 [FUTURE 1] blev der administreret dispergible tabletter til 36 PAH-børn i alderen fra 2 til 11 år.
In study AC-052-365 [FUTURE 1], dispersible tablets were administered in 36 PAH children aged from 2 to 11 years.
I studie AC-052-365 [FUTURE 1]) blev der administreret dispergible tabletter til 36 PAH-børn i alderen fra 2 til 11 år.
In study AC-052-365 [FUTURE 1] dispersible tablets were administered in 36 PAH children aged from 2 to 11 years.
I studie AC-052-365 [FUTURE 1]) blev der administreret dispergible tabletter til36 PAH-børn i alderen fra 2 til11 år.
In study AC-052-365 [FUTURE 1] dispersible tablets were administered in 36 PAH children aged from 2 to 11 years.
I studie AC-052-373 [FUTURE 3], hvor der blev anvendt dispergible tabletter, var eksponeringen for bosentan hos de patienter, der blev behandlet med 2 mg/kg to gange dagligt, sammenlignelig med den eksponering, der blev set i FUTURE 1-studiet.
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.
I studie AC-052-391 [FUTURE 4] udført hos nyfødte steg bosentankoncentrationerne langsomt og kontinuerligt i løbet af det første doseringsinterval, hvilket resulterede i lav eksponering (AUC0-12 i helblod: 164 ng·t/ml, n=11).
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:
I studie AC-052-391 [FUTURE 4] udført hos nyfødte steg bosentankoncentrationerne langsomt og kontinuerligt i løbet af det første doseringsinterval, hvilket resulterede i lav eksponering (AUC0-12 i helblod: 164 ng·t/ml, n=11).
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).
I studie ACLIFORM-COPD observeredes der kun et lille fald i total SGRQ-score sammenlignet med placebo på grund af et uventet stort placebo-respons (p=0,598) og den procentvise andel af patienter, der opnåede klinisk betydningsfulde forbedringer i forhold til baseline var 55,3 % med Brimica Genuair og 53,2% med placebo (p=0,669).
In study ACLIFORM-COPD, only a small decrease in SGRQ total score compared to placebo was observed due to an unexpectedly large placebo response (p=0.598) and the percentages of patients who achieved clinically meaningful improvements from baseline were 55.3% with Brimica Genuair and 53.2% with placebo (p=0.669).
I studie ACLIFORM-COPD observeredes der kun et lille fald i total SGRQ-score sammenlignet med placebo på grund af et uventet stort placebo-respons (p=0,598) og den procentvise andel af patienter, der opnåede klinisk betydningsfulde forbedringer i forhold til baseline var 55,3 % med Duaklir Genuair og 53,2% med placebo (p=0,669).
In study ACLIFORM-COPD, only a small decrease in SGRQ total score compared to placebo was observed due to an unexpectedly large placebo response (p=0.598) and the percentages of patients who achieved clinically meaningful improvements from baseline were 55.3% with Duaklir Genuair and 53.2% with placebo (p=0.669).
I studie AI455-094, udført i Sydafrika, blev 362 par af moder-spædbarn inkluderet i et studie om forebyggelse af moder-til-barn overførsel.
In study AI455-094, performed in South-Africa, 362 mother-infant pairs were included in a prevention of mother-to-child-transmission study.
I studie BO16348 var incidensen af svær kongestiv hjerteinsufficiens (NYHA III & IV) efter 1 års Herceptin-behandling 0,8 % efter en median opfølgning på 8 år, og hyppigheden af let symptomatisk og asymptomatisk dysfunktion af venstre ventrikel var 4,6 %.
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 %.
I studie BO20924 hvor Avastin var givet sammen med standardbehandlingen af metastatisk rabdomyosarkom og ikke-rabdomyosarkom bløddelssarkom var sikkerhedsprofilen hos de Avastinbehandlede børn sammenlignelig med den som var observeret hos Avastinbehandlede voksne.
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.
I studie C206 (ASPIRE) fik patienter, der ikke havde opnået effekt af tidligere peg-IFN/RBV- behandling, 12, 24 eller 48 ugers behandling med simeprevir (100 mg eller 150 mg én gang dagligt) i kombination med 48 ugers behandling med peginterferon alfa-2a + ribavirin (se tabel 17 og 18).
In study C206 (ASPIRE), patients who failed prior peg-IFN/RBV therapy received 12, 24 or 48 weeks simeprevir (100 mg or 150 mg once daily) in combination with 48 weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
I studie C209 (n = 690) var BR emtricitabin/tenofovirdisoproxilfumarat.
In study C209 (n = 690), the BR was emtricitabine/tenofovir disoproxil fumarate.
I studie C212 fik patienter med samtidig HIV 1-infektion, der var behandlingsnaive, eller hvor tidligere peg-IFN/RBV-behandling havde fejlet, simeprevir (150 mg én gang dagligt) + peginterferon alfa-2a + ribavirin i 12 uger efterfulgt af yderligere 12 eller 36 ugers behandling med peginterferon alfa-2a + ribavirin (se tabel 17 og 18).
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).
I studie C215 (n = 678) bestod BR af 2 N(t)RTI’er udvalgt af investigatoren: Emtricitabin/tenofovirdisoproxilfumarat (60%, n = 406) eller lamivudin/zidovudin (30%, n = 204) eller abacavir plus lamivudin (10%, n = 68).
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).
I studie CAMMS223 udviklede en forsøgsperson med multipel sklerose, som blev behandlet med alemtuzumab, listeria meningitis, og fire spontane tilfælde af enten systemisk listeriose eller Listeria monocytogenes meningitis blev observeret efter markedsføring.
One alemtuzumab -treated MS clinical trial patient, enrolled in study CAMMS223, developed listeria meningitis and four spontaneous post-marketing cases of either systemic listeriosis or Listeria monocytogenes meningitis.
I studie ESTEEM 1 og ESTEEM 2 blev der observeret signifikante forbedringer i psoriasis i hårbunden af en mindst moderat sværhedsgrad (≥3), målt ved andelen af patienter, der opnåede psoriasis i hårbunden lægens samlede vurdering (scalp psoriasis physician’s global assessment, ScPGA) på klaret op (0) eller minimal (1) efter uge 16, hos patienter, der fik apremilast, sammenlignet med placebobehandlede patienter (p < 0,0001 for begge studier).
In Studies ESTEEM 1 and ESTEEM 2, significant improvements in scalp psoriasis of at least moderate severity (≥3), measured by the proportion of patients achieving Scalp Psoriasis Physician’s Global Assessment (ScPGA) of clear (0) or minimal (1) at Week 16, were observed in patients receiving apremilast compared to placebo-treated patients (p< 0.0001 for both studies).
I studie ESTEEM 1og ESTEEM 2 blev der observeret signifikante forbedringer (reduktioner) i neglepsoriasis, målt ved den gennemsnitlige procentvise ændring i indeks over sværhedsgrad af neglepsoriasis (nail psoriasis severity index, NAPSI) fra baseline hos patienter, der fik apremilast, sammenlignet med placebobehandlede patienter efter uge 16 (p < 0,0001 hhv. p=0,052).
In Studies ESTEEM 1 and ESTEEM 2, significant improvements (reductions) in nail psoriasis, as measured by the mean percent change in Nail Psoriasis Severity Index (NAPSI) from baseline, were observed in patients receiving apremilast compared to placebo-treated patients at Week 16 (p< 0.0001 and p=0.0052, respectively).
I studie FVF2587g (ANCHOR) blev 423 patienter med overvejende klassiske CNV-læsioner randomiseret i forholdet 1:1:1 til at få Lucentis 0,3 mg månedligt, Lucentis 0,5 mg månedligt eller verteporfin-PDT (ved baseline og hver 3. måned derefter, hvis fluoresceinangiografi viste persistens eller recidiv af vaskulær lækage).
In study FVF2587g (ANCHOR), 423 patients with predominantly classic CNV lesions were randomised in a 1:1:1 ratio to receive Lucentis 0.3 mg monthly, Lucentis 0.5 mg monthly or verteporfin PDT (at baseline and every 3 months thereafter if fluorescein angiography showed persistence or recurrence of vascular leakage).
I studie G2305 var forbedringen i henhold til Childhood Health Assessment’s spørgeskema beregnet ved mindste kvadraters metode 0,69 for Ilaris versus placebo, hvilket er 3,6 gange den mindste klinisk vigtige forskel på 0,19 (p=0,0002).
In study G2305, the Childhood Health Assessment Questionnaire Least Squares means improvement was 0.69 for Ilaris vs placebo representing 3.6 times the minimal clinically important difference of 0.19 (p=0.0002).
I studie GAO4753g fik patienterne i bendamustin-armen kun 6 måneder med induktionsbehandling, hvorimod patienterne i Gazyvaro plus bendamustin-armen fortsatte med Gazyvaro vedligeholdelsesbehandling efter induktionsperioden.
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.
I studie GS-01-934 lignede bivirkningsprofilen for emtricitabin og tenofovirdisoproxil hos et begrænset antal hiv-inficerede patienter, der samtidigt var inficerede med HBV (n = 13) eller HCV (n = 26) bivirkningsprofilen hos patienter, som kun er inficeret med hiv.
The adverse reaction profile of emtricitabine and tenofovir disoproxil in a limited number of HIV- infected patients in study GS-01-934 who were co-infected with HBV (n=13) or HCV (n=26) was similar to that observed in patients infected with HIV without co-infection.
I studie GS-99-907 blev 550 behandlingserfarne voksne patienter behandlet med placebo eller 245 mg tenofovirdisoproxil (som fumarat) i 24 uger.
In study GS-99-907, 550 treatment-experienced adult patients were treated with placebo or tenofovir disoproxil 245 mg (as fumarate) for 24 weeks.
I studie GS-US-104-0321 blev 87 hiv 1-inficerede behandlingserfarne patienter i alderen 12 til < 18 år behandlet med tenofovirdisoproxilfumarat (n = 45) eller placebo (n = 42) i kombination med et optimeret baggrundsregime (OBR) i 48 uger.
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.
I studie GS-US-104-0352 blev 97 behandlingserfarne patienter i alderen 2 til < 12 år med stabil, virologisk suppression på stavudin- eller zidovudin-holdige behandlinger randomiseret til enten at erstatte stavudin eller zidovudin med tenofovirdisoproxilfumarat (n = 48) eller at fortsætte med den oprindelige behandling (n = 49) i 48 uger.
In study GS-US-104-0352, 97 treatment-experienced patients 2 to < 12 years of age with stable, virologic suppression on stavudine- or zidovudine-containing regimens were randomised to either replace stavudine or zidovudine with tenofovir disoproxil fumarate (n = 48) or continue on their original regimen (n = 49) for 48 weeks.
I studie GS-US-104-0352 seponerede 4 ud af 89 pædiatriske patienter eksponeret for tenofovirdisoproxilfumarat behandlingen som følge af bivirkninger i overensstemmelse med proximal renal tubulopati (gennemsnitlig eksponering for tenofovirdisoproxilfumarat 104 uger).
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).
I studie GS-US-104-0352 seponerede 4 ud af 89 pædiatriske patienter, der blev eksponeret for tenofovirdisoproxilfumarat (median tenofovirdisoproxilfumarat-eksponering 312 uger), behandlingen på grund af bivirkninger forenelige med proksimal renal tubulopati.
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.