natgillin/translations-raw huggingface dataset:
Studie ENB-006-09/ENB-008-10 var et åbent, ikke-randomiseret studie.
Study ENB-006-09/ENB-008-10 was an open-label, non-randomised study.
Studie G2301 var et randomiseret, dobbelblindet, placebokontrolleret seponeringsstudie til forebyggelse af udbrud med Ilaris.
Study G2301 was a randomised, double-blind, placebo-controlled withdrawal study of flare prevention by Ilaris.
Studie GS-US-236-0102
Baseline disease characteristicsa
Studie hos børn/unge i alderen 1 – 18 år med de novo ALL
Study in children/adolescents aged 1 – 18 years with de novo ALL
Studie hos patienter med CF, som er heterozygote med hensyn til F508del-mutationen i CFTR-genet
Trial in patients with CF who are heterozygous for the F508del mutation in the CFTR gene
Studie hos patienter, der skifter fra agalsidase beta til Replagal (agalsidase alfa)
Study in patients switching from agalsidase beta to Replagal (agalsidase alfa)
Studie hos unge med skizofreni: R076477-PSZ-3001: 6-ugers, fast dosis, placebo-kontrolleret Intent-to- Treat-analysesæt.
Adolescent Schizophrenia Study: R076477-PSZ-3001: 6-week, fixed-dose, placebo-controlled Intent-to-Treat Analysis Set.
Studie hos unge med skizofreni: R076477-PSZ-3003: 26-ugers, fleksibel dosis, aktivt kontrolleret Intent-to- Treat-analysesæt.
Adolescent Schizophrenia Study: R076477-PSZ-3003: 26-week, flexible-dose, active-controlled Intent-to-Treat Analysis Set.
Studie HPC3008
Study HPC3008
Studie I sammenlignede virkningen af hvert af de to profylaktiske behandlingsprogrammer (individualiseret og ugentligt) med behovsbehandling.
Study I compared the efficacy of each of 2 prophylactic treatment regimens (individualised and weekly) to on demand treatment.
Studie I sammenlignede virkningen af to profylaktiske behandlingsprogrammer (fast ugentligt interval og individuelt interval) med behovsbehandling.
Study I compared the efficacy of each of 2 prophylactic treatment regimens (fixed weekly interval and individualised interval) to on demand treatment.
Studie I, II, III, IV, V, VI, SC-I, SC-II og SC-III evaluerede henholdsvis 339, 638, 389, 1.441, 431, 509, 1.371, 646 og 351 voksne patienter.
Studies I, II, III, IV, V, VI, SC-I, SC-II, and SC-III evaluated 339, 638, 389, 1441, 431, 509 1371, 646, and 351 adult patients, respectively.
Studie I-V inkluderede patienter  18 år med aktiv reumatoid artrit, som var diagnosticerede i henhold til American College of Rheumatology (ACR)- kriterierne, og som havde mindst otte ømme led og seks hævede led ved baseline.
Studies I-V enrolled patients  18 years of age with active RA diagnosed according to the American College of Rheumatology (ACR) criteria and who had at least eight tender and six swollen joints at baseline.
Studie II inkluderede i alt 30 tidligere behandlede drenge med svær hæmofili B (≤2 % endogen FIX- aktivitet).
Study II enrolled a total of 30 previously treated male pediatric patients with severe hemophilia B (≤ 2% endogenous FIX activity).
Studie II og VI vurderede strukturel ledskade radiografisk over en periode på 2 år.
Structural joint damage was assessed radiographically over a two-year period in Studies II, and VI.
Studie II, VI og SC-II vurderede strukturel ledskade radiografisk over en periode på 2 år.
Structural joint damage was assessed radiographically over a two-year period in Studies II, VI, and SC-II.
Studie III og V havde yderligere primære endepunkter i uge 52 med forsinket sygdomsprogression (bestemt ud fra røntgenresultater).
RA studies III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
Studie III vurderede effekt og sikkerhed af abatacept hos patienter med utilstrækkeligt respons på en TNF- hæmmer, hvor TNF-hæmmeren seponeredes inden randomisering; andre DMARDs var tilladt.
In Study III the efficacy and safety of abatacept were assessed in patients with an inadequate response to a TNF-inhibitor, with the TNF-inhibitor discontinued prior to randomization; other DMARDs were permitted.
Studie JP19959, et substudie i BO18255 (ToGA), blev udført hos japanske mænd og kvinder med fremskreden ventrikelkræft for at undersøge capecitabins og cisplatins farmakokinetik, når de blev anvendt med eller udenHerceptin.
Study JP19959 was a substudy of BO18255 (ToGA) performed in male and female Japanese patients with advanced gastric cancer to study the pharmacokinetics of capecitabine and cisplatin when used with or without Herceptin.
Studie LA16-0102 sammenlignede Ferriprox’ virkning med deferoxamins virkning mht. reduktion af kardial jernophobning og forbedring af hjertefunktionen (som målt med LVEF) hos transfusionsafhængige talassæmi-patienter.
Study LA16-0102 compared the efficacy of Ferriprox with that of deferoxamine in decreasing cardiac iron overload and in improving cardiac function (as measured by LVEF) in transfusion-dependent thalassaemia patients.
Studie LAL-CL02 – børn og voksne 1 mg/kg én gang hver anden uge
Study LAL-CL02 – Children and Adults 1 mg/kg once every other week
Studie LYM-3002 var et åbent, randomiseret fase III-studie, som sammenlignede effekt og sikkerhed af kombinationen af bortezomib, rituximab, cyclophosphamid, doxorubicin og prednison (BzmbR- CAP; n=243) i forhold til rituximab, cyclophosphamid, doxorubicin, vincristin og prednison (R- CHOP; n=244) hos voksne patienter med tidligere ubehandlet MCL (stadie II, III eller IV).
Study LYM-3002 was a Phase III, randomised, open-label study comparing the efficacy and safety of the combination of bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP; n=243) to that of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; n=244) in adult patients with previously untreated MCL (Stage II, III or IV).
Studie LYM-3002 var et åbent, randomiseret fase III-studie, som sammenlignede effekt og sikkerhed af kombinationen af bortezomib, rituximab, cyclophosphamid, doxorubicin og prednison (BzR-CAP; n=243) i forhold til rituximab, cyclophosphamid, doxorubicin, vincristin og prednison (R-CHOP; n=244) hos voksne patienter med tidligere ubehandlet MCL (stadie II, III eller IV).
Study LYM-3002 was a Phase III, randomised, open-label study comparing the efficacy and safety of the combination of bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (BzR-CAP; n=243) to that of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; n=244) in adult patients with previously untreated MCL (Stage II, III or IV).
Studie M05-730 var et randomiseret, åbent, multicenter studie, som sammenlignede behandling med Kaletra 800/200 mg en gang daglig plus tenofovir DF og emtricitabin mod Kaletra 400/100 mg to gange daglig plus tenofovir DF og emtricitabin hos 664 antiretroviral-behandlingsnaive patienter.
Study M05-730 was a randomised, open-label, multicentre trial comparing treatment with Kaletra 800/200 mg once daily plus tenofovir DF and emtricitabine versus Kaletra 400/100 mg twice daily plus tenofovir DF and emtricitabine in 664 antiretroviral treatment-naïve patients.
Studie M98-863 er en randomiseret, dobbeltblindet undersøgelse med 653 antiretroviral- behandlingsnaive patienter, hvor lopinavir/ritonavir (400/100 mg to gange daglig, n=326) blev sammenlignet med nelfinavir (750 mg tre gange daglig, n=327), begge i kombination med lamivudin (150 mg to gange daglig) og stavudin (40 mg to gange daglig).
Study M98-863 is a randomised, double blind trial of 653 antiretroviral-naïve patients investigating lopinavir/ritonavir (400/100 mg BID n=326) compared to nelfinavir (750 mg TID n=327), each in combination with lamivudine (150 mg twice daily) and stavudine (40 mg twice daily).
Studie M98-863 var en randomiseret, dobbeltblind afprøvning af Kaletra (400/100 mg to gange dagligt) hos 653 antiretrovial-naive patienter sammenlignet med nelfinavir (750 mg tre gange dagligt), og alle patienter fik samtidig stavudin og lamivudin.
Study M98-863 was a randomised, double-blind trial of 653 antiretroviral treatment naïve patients investigating Kaletra (400/100 mg twice daily) compared to nelfinavir (750 mg three times daily) plus stavudine and lamivudine.
Studie M98-863 var en randomiseret, dobbeltblind afprøvning af Kaletra (400/100 mg to gange dagligt) hos 653 antiretroviral-naive patienter sammenlignet med nelfinavir (750 mg tre gange dagligt), og alle patienter fik samtidig stavudin og lamivudin.
Study M98-863 was a randomised, double-blind trial of 653 antiretroviral treatment naïve patients investigating Kaletra (400/100 mg twice daily) compared to nelfinavir (750 mg three times daily) plus stavudine and lamivudine.
Studie MCL-002: I lenalidomidarmen seponerede 11/81 (14 %) patienter med stor tumorbyrde behandlingen i løbet af behandlingscyklus 1 vs.
In study MCL-002, during treatment cycle 1, 11/81 (14%) patients with high tumour burden were withdrawn from therapy in the lenalidomide arm vs.
Studie med aktiv komparator (n=2569) Evaluerbare patienter
Active Comparator Trials (n=2569) Evaluable Patients
Studie med behandlingserfarne patienter
Studies in treatment-experienced patients
Studie med forsøgspersoner, der genbehandles med CHAMPIX
Study in subjects re-treated with CHAMPIX
Studie med patienter, der skifter fra imiglucerase-behandling til VPRIV
Study in patients switching from imiglucerase treatment to VPRIV
Studie MenACWY-TT-039(1)
Study MenACWY-TT-039(1)
Studie MenACWY-TT-039(1)*
Study MenACWY-TT-039(1)
Studie MenACWY-TT-040(2)
Study MenACWY-TT-040(2)
Studie MenACWY-TT-104(1)
Study MenACWY-TT-104(1)
Studie MO16982: støddosis 6 mg/kg ugentlig x 3 efterfulgt af 6 mg/kg med 3-ugers intervaller
Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule
Studie MO22982 undersøgte skift mellem Herceptin intravenøs og Herceptin subkutan formulering med det primære formål at evaluere patientpræferencen for enten intravenøs eller subkutan administration af trastuzumab.
Study MO22982 investigated switching between the Herceptin intravenous and Herceptin subcutaneous formulation with a primary objective to evaluate patient preference for either intravenous or the subcutaneous route of trastuzumab administration.
Studie OMB110911 (randomiseret, open-label, parallel-arm, multicenter) evaluerede effekten af Arzerra i kombination med chlorambucil sammenlignet med chlorambucil alene i 447 patienter med tidligere ubehandlet CLL, som var vurderet uegnet til fludarabinbaseret behandling (f.eks. på grund af fremskreden alder eller forekomst af komorbiditeter), med aktiv sygdom og indiceret til behandling.
Study OMB110911 (randomised, open-label, parallel-arm, multicentre) evaluated the efficacy of Arzerra in combination with chlorambucil compared with chlorambucil alone in 447 patients with previously untreated CLL considered inappropriate for fludarabine-based treatment (e.g. due to advanced age or presence of co-morbidities), with active disease and indicated for treatment.
Studie OMB115991 vurderede effekten af Arzerra i kombination med bendamustin hos 44 patienter med tidligere ubehandlet CLL, der er vurderet uegnet til fludarabinbaseret behandling.
Study OMB115991 evaluated the efficacy of Arzerra in combination with bendamustine in 44 patients with previously untreated CLL considered inappropriate for fludarabine-based treatment.
Studie PACTG 1021 var et ikke-blindet studie til evaluering af SUSTIVAs farmakokinetik, sikkerhed, tolerabilitet og antivirale aktivitet i kombination med didanosin og emtricitabin hos antiretroviral- naive pædiatriske patienter.
Study PACTG 1021 was an open-label study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of SUSTIVA in combination with didanosine and emtricitabine in paediatric patients who were antiretroviral therapy naive.
Studie RA-I Methotrexat kombination (24 og 52 uger)
Study RA-I Methotrexate combination (24 and 52 weeks)
Studie SC-I: Fyldt pen (ClickJect) sub-studie
Study SC-I: Pre-filled pen (ClickJect) sub-study
Studie SC-II vurderede strukturel ledskade radiografisk udtrykt som ændringen i forhold til baseline i van der Heijde modificeret total Sharp score (mTSS) og dets komponenter.
In Study SC-II, structural joint damage was assessed radiographically and expressed as a change from baseline in the van der Heijde-modified Total Sharp Score (mTSS) and its components.
Studie TMC278-C204 var et randomiseret, aktivt kontrolleret, fase IIb-studie antiretroviralnaive hiv 1-inficerede voksne patienter bestående af 2 dele: en indledende delvist blindet dosisbestemmende del [doserne af (rilpivirin) er blindede] på op til 96 uger, efterfulgt af en langvarig, åben del.
Study TMC278-C204 was a randomised, active-controlled, Phase IIb trial in antiretroviral treatment-naïve HIV-1 infected adult patients consisting of 2 parts: an initial partially blinded dose-finding part [(rilpivirine) doses blinded] up to 96 weeks, followed by a long-term, open label part.
Studie TMX-01-005 (FOCUS) var et femårigt åbent, forlænget fase 2-multicenterstudie til evaluering af sikkerheden hos patienter, som havde gennemført studie TMX-00-004 med 4 ugers febuxostat- behandling i et dobbeltblindt design.
FOCUS Study (TMX-01-005) was a 5 years Phase 2, open-label, multicenter, safety extension study for patients who had completed the febuxostat 4 weeks of double blind dosing in study TMX-00-004.
Studie udført hos patienter med kronisk HCV-infektion
Study conducted in patients with chronic HCV infection
Studie udført med hiv-inficerede
Study conducted in HIV infected
Studie UV I Behandling
Study UV I Treatment  Placebo  Adalimumab
Studie UV II Behandling  Placebo  Adalimumab
Study UV II Treatment  Placebo  Adalimumab
Studie V72P16 2, 3 og 4 måneder
Study V72P16 2, 3, 4 months
Studie V87P1
Study V87P1
Studie V87P11 21 dage efter 2. dosis
21 days after 2nd dose N=132
Studie V87P11 21 dage efter 2. dosis
21 days after 2nd dose N=182
Studie V87P12 21 dage efter 2. dosis
Study V87P12 21 days after 2nd dose
Studie V87P13 21 dage efter 2. dosis
21 days after 2nd dose N=128
Studie V87P13 21 dage efter 2. dosis
21 days after 2nd dose N=143
Studie V87P3
Study V87P3
Studie vedrørende forskellige vaccinationsprogrammer:
Trial on different vaccination schedules:
Studie WO16229: støddosis 8 mg/kg efterfulgt af 6 mg/kg med 3-ugers intervaller
Study WO16229: loading dose 8 mg/kg, followed by 6 mg/kg 3 weekly schedule
STUDIE*
STUDY
Studie- gruppe
Study group
Studiearme og behandlingsvarighed (antal behandlede forsøgspersoner)
Study Arms and Duration (Number of Subjects Treated)
Studiebehandlingen fortsatte indtil sygdomsprogression (evidens for radiografisk progression, en skeletrelateret hændelse eller klinisk progression) og initiering af cytotoksisk kemoterapi eller et forsøgsmiddel eller indtil uacceptabel toksicitet.
Study treatment continued until disease progression (evidence of radiographic progression, a skeletal- related event, or clinical progression) and the initiation of either a cytotoxic chemotherapy or an investigational agent, or until unacceptable toxicity.
Studiedesign/demografi og resultater for studie 1 og 2 fremgår af henholdsvis tabel 2 og 3.
For studies 1 and 2, Study design/demographics and results are shown in Table 2 and Table 3 respectively.
Studiekohorter
Study Cohorts
Studiemåned
0.0071
Studien opfyldte ikke det primære formål med påvisning af en reduktion af risikoen for all-cause-mortalitet eller kardiovaskulære hændelser, herunder myokardieinfarkt, hospitalsindlæggelse på grund af ustabil angina, hjerteinsufficiens eller perifer vaskulær hændelse (HR 0,93; 95% CI: 0,85; 1,02; p = 0,112).
The study did not meet its primary objective of demonstrating a reduction in risk of all-cause mortality or cardiovascular events including myocardial infarction, hospitalisation for unstable angina, heart failure or peripheral vascular event (HR 0.93; 95% CI: 0.85, 1.02; p = 0.112).
Studien opfyldte ikke det primære formål med påvisning af en reduktion af risikoen for all-cause-mortalitet eller kardiovaskulære hændelser, herunder myokardieinfarkt, hospitalsindlæggelse på grund af ustabil angina, hjerteinsufficiens eller perifer vaskulær hændelse (HR 0,93; 95% CI: 0,85; 1,02; p = 0,112).
The study did not meet its primary objective of demonstrating a reduction in risk of all-cause mortality or cardiovascular events including myocardial infarction, hospitalization for unstable angina, heart failure or peripheral vascular event (HR 0.93; 95% CI: 0.85, 1.02; p = 0.112).
Studien opfyldte ingen af de primære formål påvisning af et fald i risikoen for all-cause-mortalitet eller kardiovaskulær morbiditet (darbepoetin alfa vs. placebo; hazard ratio (HR) 1,05; 95% CI [0,94; 1,17]) eller all-cause-mortalitet eller nyresygdom i slutstadiet (ESRD) (darbepoetin alfa vs. placebo; HR 1,06; 95% CI [0,95; 1,19]).
The study did not meet either primary objective of demonstrating a reduction in risk for all-cause mortality or cardiovascular morbidity (darbepoetin alfa vs placebo; HR 1.05, 95% CI (0.94, 1.17)), or all-cause mortality or end stage renal disease (ESRD) (darbepoetin alfa vs placebo; HR 1.06, 95% CI (0.95, 1.19)).
Studien understøtter antagelsen om, at 500 μg én gang hver tredje uge er sammenlignelig med en ugentlig dosis, når det gælder hyppigheden af forsøgspersonernes modtagelse af mindst én transfusion med røde blodlegemer i perioden fra uge 5 til slutningen af behandlingsforløbet.
This study supports 500 μg once every three weeks being comparable to once weekly administration with respect to the incidence of subjects receiving at least one red blood cell transfusion from week 5 to the end of treatment phase.
Studieperiode
Period of Study
Studiepersoner n (%)
Study subjects n (%)
Studiepopulationen bestod af 2.004 patienter ≥ 75 år og 3.324 patienter med nedsat nyrefunktion (eGFR < 60 ml/min/1,73 m2).
2,004 patients ≥ 75 years of age and 3,324 patients with renal impairment (eGFR < 60 mL/min/1.73 m2).
Studiepopulationen bestod af 2.004 patienter ≥ 75 år og 3.324 patienter med nedsat nyrefunktion (eGFR < 60 ml/min/1,73 m2).
The study population included 2,004 patients ≥ 75 years of age and 3,324 patients with renal impairment (eGFR < 60 mL/min/1.73 m2).
Studiepopulationen bestod af 497 kvinder med osteoporose, defineret ved lav rygsøjle-BMD (T- score ≤ 2,5).
The study population consisted of 497 women with osteoporosis as defined by low vertebral BMD (T-score ≤ 2.5).
Studiepopulationen bestod af 68 (25%) mænd og 209 (75%) kvinder med en gennemsnitsalder på 49 år (alder 18-81 år) og baseline 6 minutters gangtest med en distance på mellem 100 og 450 meter inklusive (gennemsnit: 344 meter).
68 (25 %) men and 209 (75 %) women with a mean age of 49 years (range: 18-81 years) and baseline 6-minute walk test distance between 100 and 450 metres inclusive (mean: 344 metres).
Studiepopulationen bestod af 82% mænd, 39% var kaukasere og 37% asiatere, og gennemsnitsalderen var 49 år; 89% af patienterne havde HBeAg- negativ sygdom på transplantationstidspunktet.
The study population was 82% male, 39% Caucasian, and 37% Asian, with a mean age of 49 years; 89% of patients had HBeAg-negative disease at the time of transplant.
Studiepopulationen bestod af generelt raske, postmenopausale kvinder i alderen 41 til 80 år (gennemsnitsalder = 59 år), som ved baseline havde ≤ 5,0% overfladiske celler i vaginale celleprøver, et vaginalt pH på >5,0, og kvinderne skulle samtidig have mindst et moderat til svært VVA-symptom, hvor patienten skulle vælge det symptom, som var mest generende (MBS, Most Bothersome Symptom).
The study population consisted of generally healthy post-menopausal women between 41 to 80 years of age (mean age = 59 years), who at baseline had ≤ 5.0% superficial cells in the vaginal smear, a vaginal pH >5.0 and were required to have at least one moderate or severe VVA symptom, where patients had to choose the symptom that was the most bothersome (MBS).
Studiepopulationen omfattede patienter ≥ 65 år (n=8.561) og ≥ 75 år (n=2.330) med normal eller let nedsat nyrefunktion (n=13.916), moderat (n=2.240) eller svært (n=336) nedsat nyrefunktion.
The study population included those ≥ 65 years (n=8561) and ≥ 75 years (n=2330), with normal or mild renal impairment (n=13,916) as well as moderate (n=2240) or severe (n=336) renal impairment.
Studier
Trial
Studier af 2 års varighed hos mus og rotter til vurdering af ivacaftors karcinogenicitet viste, at ivacaftor ikke var karcinogent for nogen af arterne.
Two-year studies in mice and rats to assess the carcinogenic potential of ivacaftor demonstrated that ivacaftor was not carcinogenic in either species.
Studier af akut toksicitet har ikke givet nogen relevant information om specifik toksicitet af fenofibrat.
Acute toxicity studies have yielded no relevant information about specific toxicity of fenofibrate.
Studier af bimatoprost 0,3 mg/l hos patienter med glaukom eller okulær hypertension har vist, at hyppigere eksponering af øjet for mere end 1 dosis bimatoprost dagligt kan nedsætte den IOP- sænkende virkning.
In studies of bimatoprost 0.3 mg/ml in patients with glaucoma or ocular hypertension, it has been shown that more frequent exposure of the eye to more than 1 dose of bimatoprost daily may decrease the IOP-lowering effect.
Studier af embryo/føtal udviklingstoksicitet hos rotter og kaniner viste ingen stoffremkaldte misdannelser eller udviklingsafvigelser ved indgift i organogeneseperioden.
Embryo-foetal developmental toxicity studies conducted in rats and rabbits revealed no compound- induced malformations or developmental variations when administered during the period of organogenesis.
Studier af exenatid opløsning til injektion i kombination med basal insulin
Studies of immediate-release exenatide in combination with basal insulin
Studier af gentagen dosis-toksicitet hos hunde af op til 4 ugers varighed og hos cynomolgusaber af op til 9 måneders varighed viste leveren som det primære målorgan for nilotinibs toksicitet.
Repeated-dose toxicity studies in dogs of up to 4 weeks’ duration and in cynomolgus monkeys of up to 9 months’ duration revealed the liver as the primary target organ of toxicity of nilotinib.
Studier af lægemiddel-lægemiddel interaktioner med digoxin (P-glycoproteinsubstrat) og warfarin (CYP2C9-substrat) hos raske forsøgspersoner har ikke vist nogen klinisk relevante farmakokinetiske interaktioner efter samtidig administration med vildagliptin.
Drug-drug interaction studies with digoxin (P-glycoprotein substrate) and warfarin (CYP2C9 substrate) in healthy subjects have shown no clinically relevant pharmacokinetic interactions after co- administration with vildagliptin.
Studier af mirabegron ved anvendelse af humane levermikrosomer og rekombinante humane CYP-enzymer har vist, at mirabegron er en moderat og tidsafhængig CYP2D6-hæmmer og en svag CYP3A-hæmmer.
Studies of mirabegron using human liver microsomes and recombinant human CYP enzymes showed that mirabegron is a moderate and time- dependent inhibitor of CYP2D6 and a weak inhibitor of CYP3A.
Studier af Myocets virkning på andre stoffer mangler ligeledes.
Studies of the effect of Myocet on other substances are also lacking.
Studier af patienter, som tidligere har været i behandling med antiretrovirale lægemidler: Fuzeons kliniske aktivitet (i kombination med andre antiretrovirale stoffer) på plasma-hiv-RNA- koncentrationer og CD4-tal er undersøgt i to randomiserede, kontrollerede multicenterstudier (TORO 1 og TORO 2) af 48 ugers varighed.
Studies in Antiretroviral Experienced Patients: The clinical activity of Fuzeon (in combination with other antiretroviral agents) on plasma HIV RNA levels and CD4 counts have been investigated in two randomised, multicentre, controlled studies (TORO 1 and TORO 2) of Fuzeon of 48 weeks duration.
Studier af reproduktionstoksicitet udført hos rotter og kaniner med cobicistat viste ingen virkninger hverken på parrings-, fertilitets-, graviditets- eller fosterparametre.
Reproductive toxicity studies in rats and rabbits with cobicistat showed no effects on mating, fertility, pregnancy or fetal parameters.