natgillin/translations-raw huggingface dataset:
I fase III-forsøgene DUET-1 og DUET-2 var de mutationer, som oftest blev udviklet hos patienter med virologisk svigt over for INTELENCE-regimet V108I, V179F, V179I, Y181C og Y181I, som normalt opstod sammen med flere andre NNRTI-resistensassocierede mutationer (RAM).
In the Phase III trials DUET-1 and DUET-2, mutations that developed most commonly in patients with virologic failure to the INTELENCE containing regimen were V108I, V179F, V179I, Y181C and Y181I, which usually emerged in a background of multiple other NNRTI resistance-associated mutations (RAMs).
I fase III-forsøget med aktiv kontrol var formindskelsens størrelse i iltmætning sammenlignelig mellem Zalviso and i.v.-patientkontrollerede morfingrupper.
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.
I fase III-IM-pact-RSV- studiet med præmature børn og børn med bronkopulmonal dysplasi- var andelen af børn, som fik de sædvanlige børnevaccinationer, influenzavaccination, bronkodilatatorer eller kortikosteroider, ens i placebo- og palivizumabgrupperne, og der blev ikke observeret en merstigning i bivirkninger hos børn, der fik disse lægemidler.
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.
I fase III-studier blev der set klinisk relevante bronkodilaterende effekt inden for 5 minutter efter den første dosis, og denne blev opretholdt i hele doseringsintervallet.
In Phase III studies, clinically meaningful bronchodilator effects were seen within 5 minutes of the first dose and were maintained over the dosing interval.
I fase III-studier med korttarmssyndrompatienter, behandlet med Revestive i ≥ 2 år, udviklede 39 % af patienterne antistoffer mod teduglutid, og 21 % af patienterne udviklede antistoffer mod E.coli-protein (residuelt værtscelleprotein fra fremstillingen af Revestive).
In phase 3 studies with SBS patients who received Revestive for ≥2 years, 39% of patients developed anti-teduglutide antibodies and 21% of patients developed antibodies against E.coli protein (residual host cell protein from the manufacture).
I fase III-studierne af RA, PsA, AS og UC er der ikke observeret overordnede forskelle i bivirkninger, alvorlige bivirkninger og alvorlige infektioner hos patienter på 65 år eller derover som fik Simponi, sammenlignet med yngre patienter.
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.
I fase III-studierne var antallet af hvide blodlegemer100 x 109/L eller derover dagen inden eller dagen for aferese hos 7 % af de patienter, der fik Mozobil, og hos 1 % af de patienter, der fik placebo.
White blood cell counts of 100 x 109/L or greater were observed, on the day prior to or any day of apheresis, in 7% patients receiving Mozobil and in 1% patients receiving placebo in the Phase III studies.
I fase III-studierne var reaktioner relateret til injektionsstedet (fx smerte på injektionsstedet, ubehag på injektionsstedet) alle af sværhedsgrad 1 eller 2 og var sammenlignelige for pasireotid til intramuskulær anvendelse og octreotid til intramuskulær anvendelse.
In the phase III studies, injection site related reactions (e.g. injection site pain, injection site discomfort) were all grade 1 or 2 in severity and were comparable between pasireotide intramuscular use and octreotide intramuscular use treated patients.
I fase III-studiet førte behandlingen med bortezomib til signifikant længere tid indtil progression, en signifikant længere overlevelse og en signifikant højere responsrate sammenlignet med behandling med dexametason (se tabel 14) hos alle patienter samt hos patienter, som tidligere havde fået én behandling.
In the Phase III study, treatment with bortezomib led to a significantly longer time to progression, a significantly prolonged survival and a significantly higher response rate, compared to treatment with dexamethasone (see Table 14), in all patients as well as in patients who have received 1 prior line of therapy.
I fase III-studiet førte behandlingen med VELCADE til signifikant længere tid indtil progression, en signifikant længere overlevelse og en signifikant højere responsrate sammenlignet med behandling med dexametason (se tabel 14) hos alle patienter samt hos patienter, som tidligere havde fået én behandling.
In the Phase III study, treatment with VELCADE led to a significantly longer time to progression, a significantly prolonged survival and a significantly higher response rate, compared to treatment with dexamethasone (see Table 14), in all patients as well as in patients who have received 1 prior line of therapy.
I fase III-studiet havde patienter, der fik bortezomib subkutant, sammenlignet med patienter, der fik bortezomib intravenøst, en 13 % lavere samlet forekomst af bivirkninger i forbindelse med behandlingen i form af ≥ grad 3-toksicitet og en 5 % lavere forekomst af seponering af behandling med bortezomib.
In the Phase III study patients who received bortezomib subcutaneously compared to intravenous administration had 13% lower overall incidence of treatment emergent adverse reactions that were Grade 3 or higher in toxicity, and a 5% lower incidence of discontinuation of bortezomib.
I fase III-studiet med hidtil ubehandlede myelomatosepatienter var den samlede forekomst af herpes zoster- reaktivering større hos patienter behandlet med bortezomib+melphalan+prednison sammenlignet med melphalan+prednison (14 % versus 4 %).
In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with Bortezomib+Melphalan+Prednisone compared with Melphalan+Prednisone (14% versus 4% respectively).
I fase III-studiet med patienter med nyligt diagnosticeret CML i kronisk fase med mindst 12 måneders opfølgning, seponeredes behandlingen på grund af bivirkninger hos 5% af de patienter, der blev behandlet med SPRYCEL, og hos 4% af de patienter, der blev behandlet med imatinib.
In the Phase III study in patients with newly diagnosed chronic phase CML, treatment was discontinued for adverse reactions in 5% of SPRYCEL-treated patients and 4% of imatinib-treated patients with a minimum of 12 months follow-up.
I fase III-studiet med pJIA blev der til og med uge 48 ved hjælp af den lægemiddel-tolerante EIA-metode fundet antistoffer mod golimumab hos 40% (69/172) af de golimumab-behandlede børn, hvoraf størstedelen havde en titer under 1:1000.
In the Phase III pJIA study through week 48, antibodies to golimumab were detected by the drug-tolerant EIA method in 40% (69/172) of golimumab treated children of which a majority had a titre lower than 1:1000.
I fase III-studiet med trametinib hos patienter med inoperabelt eller metastatisk melanom (n = 211) var 49 patienter (23 %) ≥ 65 år, og 9 patienter (4 %) var ≥ 75 år.
In the phase III study with trametinib in patients with unresectable or metastatic melanoma (n = 211), 49 patients (23%) were ≥65 years of age, and 9 patients (4%) were ≥75 years of age.
I fase III-studiet MEK115306 forekom cuSCC hos 3 % (6/209) af de patienter, der fik trametinib i kombination med dabrafenib, og hos 10 % (22/211) af de patienter, der fik dabrafenib som monoterapi.
In the Phase III study MEK115306, cuSCC occurred in 3% (6/209) of patients receiving trametinib in combination with dabrafenib and 10% (22/211) of patients receiving dabrafenib as a single agent.
I fase III-studiet MEK116513 forekom cuSCC hos 1 % (5/350) af de patienter, der fik trametinib i kombination med dabrafenib, og hos 18 % (63/349) af de patienter, der fik vemurafenib som monoterapi.
In the Phase III study MEK116513, cuSCC occurred in 1% (5/350) of patients receiving trametinib in combination with dabrafenib and 18% (63/349) of patients receiving vemurafenib as a single agent.
I fase III-studiet SABRINA (BO22334) blev lokale hudreaktioner rapporteret hos op til 20 % af de patienter, der fik subkutan MabThera.
In the NHL phase 3 trial SABRINA (BO22334), local cutaneous reactions were reported in up to 20% of patients receiving subcutaneous MabThera.
I fase III-studiet til sammenligning af bortezomib administreret intravenøst versus subkutant var forekomsten af hændelser med  grad 2 perifer neuropati 24 % i gruppen, der fik subkutane injektioner, og 41 % i gruppen, der fik intravenøse injektioner (p=0,0124).
In the Phase III study comparing bortezomib administered intravenously versus subcutaneously, the incidence of Grade  2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
I fase III-studiet TRANxITION (studie 1100.1526) blev sikkerhed og antiviral aktivitet hos patienter, der skifter fra Viramune 200 mg til Viramune i depotform evalueret.
TRANxITION (study 1100.1526) is a Phase 3 study to evaluate safety and antiviral activity in patients switching from Viramune immediate-release to Viramune prolonged-release.
I fase III-studiet var 69 patienter i behandling med lenalidomid 5 mg, 69 patienter i behandling med 10 mg, og 67 patienter fik placebo i løbet af den dobbeltblinde fase af studiet.
In the Phase III study, 69 patients were on lenalidomide 5 mg, 69 patients on lenalidomide 10 mg and 67 patients were on placebo during the double-blind phase of the study.
I fase III-studiet var 94 (28 %) ud af 336 patienter med ikke-operabelt eller metastatisk melanom behandlet med vemurafenib ≥ 65 år.
In the phase III study, ninety-four (28%) of 336 patients with unresectable or metastatic melanoma treated with vemurafenib were ≥ 65 years.
I fase IIIb-studiet D2304 (RETAIN) blev 372 patienter randomiseret i forholdet 1:1:1 til at få: ranibizumab 0,5 mg med samtidig laserbehandling på et treat-and-extend (TE)-regime, ranibizumab 0,5 mg som monoterapi på et TE-regime, ranibizumab 0,5 mg som monoterapi på et p.n.-regime.
In the phase IIIb study D2304 (RETAIN), 372 patients were randomised in 1:1:1 ratio to receive: ranibizumab 0.5 mg with concomitant laser photocoagulation on a treat-and-extend (TE) regimen, ranibizumab 0.5 mg monotherapy on a TE regimen, ranibizumab 0.5 mg monotherapy on a PRN regimen.
I fase IIIb-studiet med Crohns sygdom, SONIC, fik placebo-patienterne AZA 2,5 mg/kg/dag som aktiv kontrol i tillæ g til placebo- infliximab-infusioner.
In the Phase IIIb trial in Crohn’s disease, SONIC, placebo patients received AZA 2.5 mg/kg/day as active control in addition to placebo infliximab infusions.
I fase IIIb-studiet med Crohns sygdom, SONIC, fik placebo-patienterne AZA 2,5 mg/kg/dag som aktiv kontrol i tillæg til placebo-infliximab-infusioner.
In the Phase IIIb trial in Crohn’s disease, SONIC, placebo patients received AZA 2.5 mg/kg/day as active control in addition to placebo infliximab infusions.
I fase undersøgelsen opgav 3 ud af 4 patienter med ALAT > 5 x ULN at have et alkoholforbrug, der oversteg de anbefalede grænser i protokollen.
In the Phase 3 trial, 3 of 4 patients with ALT elevations >5x ULN reported alcohol consumption beyond the limits recommended in the protocol.
I Fase-I flerdosisstudier blev der ikke observeret dosisrelaterede kliniske bivirkninger med sitagliptin ved doser op til 600 mg/dag i perioder op til 10 dage og 400 mg/dag i perioder op til 28 dage.
In Phase I multiple-dose studies, there were no dose-related clinical adverse reactions observed with sitagliptin with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for periods of up to 28 days.
I fase-III studier hos Parkinsons patienter blev det ikke observeret, at kropsvægt har nogen klinisk relevant påvirkning på den terapeutiske virkning og tolerabiliteten af Mirapexin depottabletter.
However, in Phase III trials in Parkinson’s disease patients no clinically meaningful influence of body weight on the therapeutic effect and tolerability of MIRAPEXIN prolonged-release tablets was detected.
I fase-III studier hos Parkinsons patienter blev det ikke observeret, at kropsvægt har nogen klinisk relevant påvirkning på den terapeutiske virkning og tolerabiliteten af pramipexol depottabletter.
However, in Phase III trials in Parkinson’s disease patients no clinically meaningful influence of body weight on the therapeutic effect and tolerability of pramipexole prolonged-release tablets was detected.
I fase-III studier hos Parkinsons patienter blev det ikke observeret, at kropsvægt har nogen klinisk relevant påvirkning på den terapeutiske virkning og tolerabiliteten af Sifrol depottabletter.
However, in Phase III trials in Parkinson’s disease patients no clinically meaningful influence of body weight on the therapeutic effect and tolerability of SIFROL prolonged-release tablets was detected.
I fasen efter markedsføring fik flere patienter en overdosis af Rienso fra 1 g på 1 dag til 2,5 g over
During the post-marketing phase, several patients received an overdose of Rienso ranging from 1 g in 1 day to
I fasen før antiviral behandling fik patienterne ublindet eltrombopag med henblik på at øge trombocyttallet til ≥ 90.000 pr. µl i ENABLE 1 og til ≥ 100.000 pr. µl i ENABLE 2.
In the pre-antiviral treatment phase, subjects received open-label eltrombopag to increase the platelet count to ≥ 90,000/µl for ENABLE 1 and ≥ 100,000/µl for ENABLE 2.
I fastdosiskombinationen er PritorPlus (80 mg telmisartan/25 mg hydrochlorthiazid) indiceret til voksne, hvis blodtryk ikke kan reguleres tilfredsstillende med PritorPlus 80 mg/12,5 mg (80 mg telmisartan/12,5 mg hydrochlorothiazid) eller til patienter, som tidligere er stabiliseret på telmisartan og hydrochlorothiazid givet hver for sig.
PritorPlus fixed dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on PritorPlus 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
I fastende raske forsøgspersoner gav en opdeling af den totale daglige dosis (800 mg) på 200 mg fire gange dagligt sammenlignet med 400 mg to gange dagligt en 58 % øget eksponering for posaconazol over 48 timer.
daily dose (800 mg) into 200 mg four times daily compared to 400 mg twice daily, was shown to increase posaconazole exposure by 58 % over 48 hours.
I feltstudier viste 10% af seronegative hunde dog ikke serokonvertion (> 0,1 IE/ml) 3-4 uger efter en enkelt basisvaccination mod rabies.
However, in field studies 10% of sero-negative dogs did not show seroconversion (>0.1 IU/ml) 3–4 weeks after single primary vaccination against rabies.
I feltstudier viste 10% af seronegative hunde dog ikke serokonvertion (>0,1 IE/ml) 3-4 uger efter en enkelt basisvaccination mod rabies.
However, in field studies 10% of sero-negative dogs did not show seroconversion (> 0.1 IU/ml) 3–4 weeks after single primary vaccination against rabies.
I feltstudier viste 10% af seronegative hunde dog ikke serokonvertion (>0,1 IE/ml) 3-4 uger efter en enkelt basisvaccination mod rabies.
However, in field studies 10% of sero-negative dogs did not show seroconversion (>0.1 IU/ml) 3–4 weeks after single primary vaccination against rabies.
I feltstudier viste 10% af seronegative hunde dog ikke serokonvertion (≥ 0,1 IE/ml) 3-4 uger efter en enkelt basisvaccination mod rabies.
However, in field studies 10% of seronegative dogs did not show seroconversion (>0.1 IU/ml) 3–4 weeks after single primary vaccination against rabies.
I feltstudier viste 10% af seronegative hunde dog ikke serokonvertion (≥0,1 IE/ml) 3-4 uger efter en enkelt basisvaccination mod rabies.
However, in field studies 10% of seronegative dogs did not show seroconversion (>0.1 IU/ml) 3–4 weeks after single primary vaccination against rabies.
I feltundersøgelsen af basisvaccinationen fandt man en stigning i mængden af antistoffer mod felin rhinotracheitis herpesvirus, calicivirus-infektion og felin panleukopeni-virus.
In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus, calicivirus infection, and feline panleucopenia viruses.
I feltundersøgelsen af loppeangreb opnåedes 90 % reduktion i antallet af lopper på dag 14 og dag 30 hos henholdsvis 96,7 % og 88,7 % af de hunde, der var behandlet med Trifexis, sammenholdt med 85,9 % og 73,2 % af de hunde, der var behandlet med selamectin.
The flea field study found a 90% reduction in flea count in 96.7% and 88.7% of Trifexis-treated dogs at day 14 and 30 respectively, compared with 85.9% and 73.2% in the selamectin-treated dogs.
I feltundersøgelsen dannede 98,5 % af det undersøgte vaccinerede kvæg (269–274 dyr) antistoffer mod begge typer BVD-virus.
In the field study 98.5% of vaccinated cattle sampled (range 269–274 animals) developed antibodies to both BVD virus types.
I feltundersøgelserne af Purevax RC så forskerne nærmere på planen for basisvaccinationen (2 injektioner med 3-4 ugers mellemrum) og boostervaccinationen (kun én injektion).
In the field, the studies of Purevax RC looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection).
I feltundersøgelserne af Purevax RCP så forskerne nærmere på planen for basisvaccinationen (2 injektioner med 3-4 ugers mellemrum) og boostervaccinationen (kun én injektion).
In the field, the studies of Purevax RCP looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection).
I feltundersøgelserne af Purevax RCPCh så forskerne nærmere på planen for basisvaccinationen (2 injektioner med 3-4 ugers mellemrum) og boostervaccinationen (kun én injektion).
In the field, the studies of Purevax RCPCh looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection).
I fem andre blev virkningerne af saxagliptin alene eller i kombination med metformin sammenlignet med enten placebo (en uvirksom behandling) eller et andet lægemiddel (et sulfonylurinstof eller sitagliptin) hos over 4 000 patienter.
Another five looked at the effects of saxagliptin alone or in combination with metformin, compared either with placebo (a dummy treatment) or another medicine (a sulphonylurea or sitagliptin) in over 4,000 patients.
I fem store, langvarige kliniske studier blev over 2.500 patienter behandlet med Victoza alene eller i kombination med metformin, sulfonylurinstof (med eller uden metformin) eller metformin med rosiglitazon.
In five large long­term clinical trials over 2,500 patients have received treatment with Victoza alone or in combination with metformin, a sulfonylurea (with or without metformin) or metformin plus rosiglitazone.
I Fendrix anvendes det med et adjuverende system (hjælpesystem), der indeholder MPL, som er et renset fedtstof fra bakterier, og en aluminiumsforbindelse.
In Fendrix, it is used with an ‘adjuvant system’ which contains ‘MPL’, a purified fat from bacteria, and an aluminium compound.
I FIELD-studiet, et randomiseret, placebokontrolleret forsøg, der blev udført med 9.795 patienter med type 2-diabetes mellitus, sås der en statistisk signifikant stigning i pancreatitistilfælde hos patienter, der fik fenofibrat, kontra patienter, der fik placebo (0,8 % kontra 0,5 %, p=0,031).
In the FIELD study, a randomised placebo-controlled trial performed in 9795 patients with type 2 diabetes mellitus, a statistically significant increase in pancreatitis cases was observed in patients receiving fenofibrate versus patients receiving placebo (0.8% versus 0.5%; p=0.031).
I fikseret-dosis studier (filmovertrukne tabletter) med en bred sammensat population af mænd med erektil dysfunktion, opnåede 68% (5 mg), 76% (10 mg) og 80% (20 mg) af patienterne succesfuld penetration (SEP 2) sammenlignet med 49% for placebo over en tre måneders periode.
In fixed dose studies (film-coated tablets) in a broad population of men with erectile dysfunction, 68% (5 mg), 76% (10 mg) and 80% (20 mg) of patients experienced successful penetrations (SEP 2) compared to 49% on placebo over a three month study period.
I FinIP var den samlede observerede VE mod kulturbekræftet IPD 100 % (95 % CI 85,6-100; 0 versus 14 tilfælde) for 3+1-vaccinationsprogrammet, 85,8 % (95 % CI 49,1-97,8; 2 versus 14 tilfælde) for 2+1-vaccinationsprogrammet og 93,0 % (95 % CI 74,9-98,9; 2 versus 14 tilfælde) uanset primært vaccinationsprogram.
In FinIP the overall observed VE against culture-confirmed IPD was 100% (95% CI: 85.6-100; 0 versus 14 cases) for the 3+1 schedule, 85.8% (95% CI: 49.1-97.8; 2 versus 14 cases) for the 2+1 schedule and 93.0% (95% CI: 74.9-98.9; 2 versus 14 cases) regardless of the primary vaccination schedule.
I fire af disse undersøgelser blev midazolam indgivet via mundhulen sammenlignet med diazepam indgivet rektalt, og effektmålet var behandlingens evne til at stoppe anfaldet inden for 10 minutter.
In four of these studies, oromucosal midazolam was compared with rectal diazepam and the measure of effectiveness was the treatment’s ability to stop the seizure within 10 minutes.
I fire af undersøgelserne så man på lægemidlets virkning ved behandling af mild til moderat lungebetændelse erhvervet uden for hospital, i to andre så man på akut sinusitis, i to så man på akutte eksacerbationer af kronisk bronchitis, og i to så man på tonsillitis eller pharyngitis.
Four studies looked at its effects in mild to moderate community-acquired pneumonia, two looked at acute sinusitis, two looked at acute exacerbations of chronic bronchitis and two looked at tonsillitis or pharyngitis.
I fire andre undersøgelser blev Edistride sammenlignet med placebo, idet det blev anvendt som tillægsbehandling enten til metformin, et sulfonylurinstof (glimepirid), et thiazolidinedion eller insulin hos 2 370 patienter.
Four other studies compared Edistride with placebo, when used as an add-on to either metformin, a sulphonylurea (glimepiride), a thiazolidinedione or insulin in 2,370 patients.
I fire andre undersøgelser blev Forxiga sammenlignet med placebo hos 2 370 patienter, idet det blev anvendt som tillægsbehandling til enten metformin, et sulfonylurinstof (glimepirid), et thiazolidindion eller insulin.
Four other studies compared Forxiga with placebo, when used as an add-on to either metformin, a sulphonylurea (glimepiride), a thiazolidinedione or insulin in 2,370 patients.
I fire pivotale kliniske forsøg blev 1.305 voksne patienter behandlet med Zinforo (600 mg indgivet over 60 minutter hver 12. time).
In four pivotal clinical trials, 1305 adult patients were treated with Zinforo (600 mg administered over 60 minutes every 12 hours).
I fire placebokontrollerede studier sås middelændringer fra baseline i forhold til placebo i FPG på -20,5 mg/dl [-1,14 mmol/l] for empagliflozin 10 mg og -23,2 mg/dl [–1,29 mmol/l] for empagliflozin 25 mg sammenlignet med placebo (7,4 mg/dl [0,41 mmol/l]), når empagliflozin blev givet som monoterapi eller i kombinationsbehandling til metformin, pioglitazon eller metformin plus et sulfonylurinstof.
In four placebo-controlled studies, treatment with empagliflozin as monotherapy or add-on therapy to metformin, pioglitazone, or metformin plus a sulfonylurea resulted in mean changes from baseline in FPG of -20.5 mg/dl [-1.14 mmol/l] for empagliflozin 10 mg and -23.2 mg/dl [-1.29 mmol/l] for empagliflozin 25 mg compared to placebo (7.4 mg/dl [0.41 mmol/l]).
I fire separate studier (N= 9 til 12) spændte middel steady state trough-plasmakoncentrationerne fra 2,6 til 3,4 g/ml.
In four separate studies (N = 9 to 12) the mean steady state trough plasma concentration ranged from 2.6 to 3.4 g/ml.