natgillin/translations-raw huggingface dataset:
Der var ingen signifikant forskel mellem 0,5 mg og 1,25 mg på nogen af endepunkterne.
There were no significant differences between the 0.5 mg and the
Der var ingen signifikant forskel mellem placebo og infliximab i andelen af patienter med forlæ nget lukning af alle fistler til og med uge 54, med symptomer som proctalgia, abscesser og urinrørsinfektion eller i antallet af nyudviklede fistler under behandlingen.
There was no significant difference between placebo and infliximab for the proportion of patients with sustained closure of all fistulas through week 54, for symptoms such as proctalgia, abscesses and urinary tract infection or for number of newly developed fistulas during treatment.
Der var ingen signifikante forskelle i AUC for 5-FU, tegafur, gimeracil eller oteracil efter indgift af enten enkelt- eller flerdosis Teysuno 30 mg/m2 to gange dagligt hos patienter med mildt, moderat eller svært nedsat leverfunktion sammenlignet med patienter med normal leverfunktion.
There were no significant differences in AUCs of 5-FU, tegafur, gimeracil, or oteracil after either single or multiple dose administration of Teysuno 30 mg/m2 twice daily in patients with mild, moderate, or severe hepatic impairment compared to those with normal hepatic function.
Der var ingen signifikante forskelle i demografiske og baseline karakteristiska mellem behandlingsgrupperne.
There were no significant differences in demographic and baseline characteristics between the treatment groups.
Der var ingen sikkerhedsmæssig forskel hos disse forsøgspersoner med hensyn til incidens og sværhedsgrad af uønskede hændelser, ændring i varighed eller volumen af menstruationen eller incidens af intermenstruel blødning.
There were no safety differences in these subjects in terms of incidence and severity of adverse events, change in duration or volume of menses or incidence of intermenstrual bleeding.
Der var ingen skadelig påvirkning af nyrefunktionen, som blev fastlagt ved en estimeret glomerulær filtrationshastighed eller CrCL i uge 12 og uge 52.
There was no adverse effect on renal function as determined by estimated glomerular filtration rate or CrCL at Week 12 and Week 52.
Der var ingen statistisk forskel på 200 mg og 400 mg caffein i forbindelse med Rapiscan.
There was no statistical difference between 200 mg and 400 mg caffeine with Rapiscan.
Der var ingen statistisk signifikant forskel i antallet af dødelige blødninger (1,1 % i clopidogrel + ASA-gruppen og
There was no statistically significant difference in the rates of fatal bleeding (1.1% in the clopidogrel +
Der var ingen statistisk signifikant forskel i antallet af dødelige blødninger (1,1% i clopidogrel + ASA-gruppen og
There was no statistically significant difference in the rates of fatal bleeding (1.1% in the clopidogrel + ASA
Der var ingen statistisk signifikant forskel i det primære endepunkt af IRC-vurderet PFS (5,4 vs.
There was no statistically significant difference in the primary endpoint of IRC assessed PFS (5.4 vs.
Der var ingen statistisk signifikant forskel i OS (HR 0,73; 95 % CI 0,45-1,17; p=0,19; gennemsnitligt 34,9 måneder versus 31,9 måneder).
There was no statistically significant difference in OS (HR 0.73; 95% CI 0.45-1.17; p=0.19; median 34.9 months versus 31.9 months).
Der var ingen statistisk signifikant forskel i samlet overlevelse mellem behandlingsgrupperne på tidspunktet for den primære virkningsanalyse (HR=0,73, 95 % CI: 0,50; 1,07, p=0,1032).
There was no statistically significant difference in overall survival between the treatment groups at the time of the primary efficacy analysis (HR=0.73; 95%CI: 0.50, 1.07, p=0.1032).
Der var ingen statistisk signifikant forskel mellem nivolumab og kemoterapi i den foreløbige OS-analyse, som ikke var blevet justeret for eventuel konfunderende virkning af efterfølgende behandling.
There was no statistically significant difference between nivolumab and chemotherapy in the preliminary OS analysis that was not adjusted for the potentially confounding effects of subsequent therapy.
Der var ingen statistisk signifikant forskel mellem pembrolizumab og kemoterapi i den præliminære OS-analyse, som ikke var korrigeret for den potentielt konfunderende effekt af overkrydsningen.
There was no statistically significant difference between pembrolizumab and chemotherapy in the preliminary OS analysis that was not adjusted for the potentially confounding effects of crossover.
Der var ingen stigning i den samlede hyppighed af infektioner eller af alvorlige infektioner hos patienter med lavt IgA, IgG eller IgM.
There was no increased rate in overall infections or serious infections in patients with low IgA, IgG or IgM.
Der var ingen tegn på forringet fertilitet eller nedsat forplantningsevne hos rotter, som fik perorale doser af emedastindifumerat på op til 30 mg/kg/dag
There was no evidence of impaired fertility or decreased reproductive capacity in rats administered oral dosages of Emedastine difumarate of up to 30 mg/kg/day.
Der var ingen tegn på karcinogenicitet i livstidsstudier med rotter og mus.
There was no evidence of any carcinogenicity in life long studies in mice and rats.
Der var ingen tegn på mutagenicitet eller clastogenicitet med irbesartan/hydrochlorthiazid- kombinationen.
There was no evidence of mutagenicity or clastogenicity with the irbesartan/hydrochlorothiazide combination.
Der var ingen tegn på mutagenicitet eller klastogenicitet med irbesartan/hydrochlorthiazid- kombinationen.
There was no evidence of mutagenicity or clastogenicity with the irbesartan/hydrochlorothiazide combination.
Der var ingen tegn på overfølsomheds- reaktioner, allergiske reaktioner, effekt på serumcalcium eller effekt på knoglemineraltætheden (BMD).
There was no evidence of hypersensitivity reactions, allergic reactions, effects on serum calcium, or effects on Bone Mineral Density (BMD) response.
Der var ingen tegn på takyfylaksi for effekten af Anoro over tid.
There was no evidence for tachyphylaxis in the effect of ANORO over time.
Der var ingen tegn på takyfylaksi for effekten af Incruse over tid.
There was no evidence for tachyphylaxis in the effect of Incruse over time.
Der var ingen tegn på takyfylaksi for effekten af Laventair over tid.
There was no evidence for tachyphylaxis in the effect of LAVENTAIR over time.
Der var ingen tegn på utilsigtede virkninger i endometriet hos brystcancerpatienterne i forsøget.
There is no evidence of adverse endometrial effects in the breast cancer patients studied.
Der var ingen tegn på, at de påviste antistoffer repræsenterede et specifikt immunrespons til drotrecogin alfa (aktiveret)-behandling.
There was no evidence that the antibodies detected represented a specific immune response to drotrecogin alfa (activated) therapy.
Der var ingen teratogenicitet med rilpivirin hos rotter og kaniner.
There was no teratogenicity with rilpivirine in rats and rabbits.
Der var ingen tilfælde af alvorlig hypoglykæmi med Trulicity eller placebo.
No cases of severe hypoglycaemia were observed
Der var ingen tilgængelige data for en patient (2%) i uge 48-perioden; studielægemidlet blev seponeret pga. protokolovertrædelse (dvs. en anden årsag end bivirkninger eller død); i den sidst tilgængelige analyse var hiv 1-rna
One patient (2%) did not have data available in the week 48 window; study drug was discontinued due to a protocol violation (i.e. reason other than AE or death) and the last available HIV-1 RNA was
Der var ingen tydelig evidens for en karcinogen virkning efter eksponeringer ved inhalation op til den anbefalede dosis (20 ppm) hos rotter i 20 t/dag i op til to år.
No evidence of a carcinogenic effect was apparent, at inhalation exposures up to the recommended dose (20 ppm), in rats for 20 h/day for up to two years.
Der var ingen tydelig ophobning af elosulfase alfa i plasma efter den ugentlige dosering.
No accumulation of elosulfase alfa in plasma was evident following weekly dosing.
Der var ingen tydelig påvirkning af fertilitets-og reproduktionsparametre hos moderdyrene og den følgende generation.
No effects on fertility or reproductive parameters were evident in the dams or in the subsequent generation.
Der var ingen umiddelbar forskel mellem atosiban- og β-agonistgruppen mht. udfaldet for moder og foster, men de kliniske afprøvninger havde ikke statistisk styrke nok til at udelukke en mulig forskel.
Fetal and maternal outcome did apparently not differ between the atosiban and the β-agonist group, but the clinical studies were not powered enough to rule out a possible difference.
Der var ingen virkning på gonadefunktion hos han- eller hunrotter, parring eller fertilitet ved doser på op til 120 mg/kg/døgn (hunrotter) og op til 180 mg/kg/døgn (hanrotter) (hhv.
There were no effects on male or female rat gonadal function, mating, or fertility at doses up to
Der var ingen væsentlig forskel i procentdelen af patienter i alderen 65 år eller derover i lenalidomid/dexamethason- og placebo/dexamethason-grupperne.
The percentage of patients aged 65 or over was not significantly different between the lenalidomide/dexamethasone and placebo/dexamethasone groups.
Der var ingen væsentlige sikkerhedsproblemer.
There were no major safety concerns.
Der var ingen ændringer i fostervægt og –udvikling i rotter eller aber.
There were no adverse effects on fetal growth or development in rats or monkeys.
Der var ingen ændringer i imatinibs kinetik ved gentagen dosering, og akkumulering var 1,5–2,5 gange ved steady-state ved dosering 1 gang daglig.
There was no change in the kinetics of imatinib on repeated dosing, and accumulation was 1.5–2.5-fold at steady state when dosed once daily.
Der var ingen øget blødning hos nogen af disse patienter, selv om der er indberettet et tilfælde af moderat blødning under en CABG- operation.
There was no excessive bleeding in any of these patients, although one patient undergoing CABG surgery was reported as having had a moderate bleed.
Der var ingen øget forekomst af alvorlige infektioner hos patienter med lymfocyttal <0,8x109
There was no increased incidence of serious infections observed in patients with lymphocyte counts
Der var intet mønster i blødningstilfældene og ingen forskel i koagulationsparametrene mellem behandlingsgrupperne.
There was no pattern for the bleeding events and no difference between treatment groups in coagulation parameters.
Der var intet tumorfremkaldende respons hos hverken han- eller hunmus.
There was no tumourigenic response in mice of either sex.
Der var intet tumorfremkaldende respons hos mus af begge køn.
There was no tumorigenic response in mice of either sex.
Der var intet tumorfremkaldende respons hos mus af begge køn.
There was no tumourigenic response in mice of either sex.
Der var klinisk og statistisk signifikant flere patienter på depotformulering af exenatid end på exenatid opløsning til injektion, som opnåede et fald i HbA1c på ≤ 7 % eller < 7 % i de to studier (henholdsvis p < 0,05 og p ≤ 0,0001).
Clinically and statistically significantly more subjects on prolonged-release compared to immediate-release exenatide patients achieved an HbA1c reduction of ≤ 7 % or < 7 % in the two studies (p < 0.05 and p ≤ 0.0001 respectively).
Der var mindre brug af smertestillende morfika (p < 0,01), smertestillende ikke-morfika (p < 0,01), anden ikke-sygdomsrelateret medicin (p = 0,06) og strålebehandling (p < 0,01) hos de patienter, der fik behandling med docetaxel ved doseringen 75 mg/m2 end hos patienterne, der fik bedste palliative behandling.
There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medications (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Der var mindre brug af smertestillende morfika (p < 0,01), smertestillende ikke-morfika (p < 0,01), anden ikke-sygdomsrelateret medicin (p = 0,06) og strålebehandling (p < 0,01) hos de patienter, der fik behandling med docetaxel ved doseringen 75 mg/m2 end hos patienterne, der fik bedste palliative behandling.
There was less use of morphinic analgesic (p<0.01), non-morphinic analgesics (p<0.01), other disease-related medications (p=0.06) and radiotherapy (p<0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Der var mindre sandsynlighed for, at patienter behandlet med Jetrea havde gennemgået vitrektomi ved studiets afslutning (6. måned) sammenlignet med patienter behandlet med placebo (integrerede data: 17,7 % vs.
JETREA treated patients were less likely to have had a vitrectomy by the end of the study (Month 6) compared with placebo treated patients (integrated data: 17.7% vs.
Der var mindre, men ikke klinisk signifikante stigninger i LDL- kolesterolniveauer.
HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
Der var nogle tilfælde af mere alvorlig neutropeni hos patienter behandlet med Ribavirin Teva Pharma B.V. i kombination med peginterferon alfa-2b (WHO grad 3: 39 af 186 [21 %] og WHO grad 4: 13 af 186 [7 %]); WHO grad 3 leukopeni blev også rapporteret hos 7 % af denne behandlingsgruppe.
There were some cases of more severe neutropenia in patients treated with Ribavirin Teva Pharma B.V. in combination with peginterferon alfa-2b (WHO grade 3: 39 of 186 [21 %]; and WHO grade 4: 13 of 186 [7 %]); WHO grade 3 leukopenia was also reported in 7 % of this treatment group.
Der var også en fordel for patienter med genotype 1, 4, 5 og 6 med eller uden cirrose og/eller for dem, der havde fået foretaget en levertransplantation.
Benefit was also shown for patients with genotype 1, 4, 5 and 6 with or without cirrhosis and/or for those who had received a liver transplant.
Der var også en stimulatorisk effekt på leukocyt- produktionen, da de perifere blodtal for neutrofiler, lymfocytter, monocytter og eosinofiler steg en anelse.
There was also a stimulatory effect on leukocyte production, as peripheral blood counts for neutrophils, lymphocytes, monocytes, and eosinophils were mildly increased.
Der var også en øget forekomst af pneumonier, der krævede hospitalsindlæggelse.
There was also an increased incidence of pneumonias resulting in hospitalisation.
Der var også inkluderet separate behandlingsarme i fase II-studiet for at undersøge Tasigna på en gruppe CP- og AP-patienter, som havde fået ekstensiv tidligere behandling, inkl. et tyrosinkinasehæmmende stof, ud over imatinib.
Separate treatment arms were also included in the Phase II study to investigate Tasigna in a group of CP and AP patients who had been extensively pre-treated with multiple therapies including a tyrosine kinase inhibitor agent in addition to imatinib.
Der var også omklassificeringer i den primære analyse i uge 48, hvor den mest almindelige omklassificering var fra virologisk svigt til afbrydelse af behandlingen af andre årsager end AE. f.eks. manglende opfølgning, manglende compliance, samtykke trukket tilbage.
There were also reclassifications in the Week 48 primary analysis with the most common being reclassification from virologic failure to discontinued for non-AE reasons. e.g. lost to follow up, non-compliance, withdrew consent.
Der var også reklassifikationer i den primære analyse ved uge 48, hvor den hyppigste reklassifikation var fra virologisk svigt til seponering af andre årsager end AE’er.
There were also reclassifications in the week 48 primary analysis with the most common being reclassification from virologic failure to discontinued for non-AE reasons.
Der var også signifikant forskel mellem grupperne med hensyn til ændring i kropsvægt ved baseline (sitagliptin - 0,6 kg; glipizid +1,2 kg).
There was also a significant difference between groups with respect to change from baseline body weight (sitagliptin -0.6 kg; glipizide +1.2 kg).
Der var også tilfælde af lokale allergiske reaktioner efter markedsføringen.
Post- marketing reports of local allergic reactions were also received.
Der var overensstemmelse mellem estimater af racens og kønnets virkning på eltrombopags plasma-CL/F hos pædiatriske og voksne patienter.
The effects of race and sex on plasma eltrombopag CL/F estimates were consistent between pediatric and adult patients.
Der var potentielt bidragende faktorer til stede hos flere af disse patienter, som uafhængigt kan have øget deres risiko for krampeanfald.
Potentially contributing factors were present in several of these patients that may have independently increased their risk of seizure.
Der var reduktionen af den relative risiko for recidiverende myokardieinfarkt 35 % sammenlignet med behandling med ufraktioneret heparin (p < 0,001).
There was the reduction of relative risk of recurrent myocardial infarction by 35% compared to treatment with unfractionated heparin (p <0.001).
Der var sammenhæng mellem cellulær respons og antistofreaktioner på PAP og PAP-GM-CSF i Provenge- gruppen og forbedret overlevelse.
There was a correlation between cellular or antibody responses to PAP or PAP-GM-CSF in the Provenge group and improved survival.
Der var signifikant flere bivirkninger (99,2 % vs.
There were more adverse events (99.2% vs.
Der var signifikant flere patienter i ciclosporingruppen (n=13), som måtte overføres til tacrolimus end tacrolimusbehandlede patienter, der måtte overføres til ciclosporin (n=2) (p=0,02) (Keenan et al.; Ann Thoracic Surg 1995; 60:580).
Significantly more ciclosporin- treated patients (n = 13) required a switch to tacrolimus than tacrolimus-treated patients to ciclosporin (n = 2) (p = 0.02) (Keenan et al., Ann Thoracic Surg 1995;60:580).
Der var signifikant forbedring af DAS i studie II, III, V og VI sammenlignet med placebo eller komparator.
There was a significant improvement of DAS in Studies II, III, V, and VI as compared to placebo or comparator.
Der var signifikant klinisk respons og remission så tidligt som i uge 3 hos patienter behandlet med ustekinumab, og dette respons blev fortsat bedre til uge 8.
Clinical response and remission were significant as early as week 3 in ustekinumab treated patients and continued to improve through week 8.
Der var signifikant klinisk respons og remission så tidligt som i uge 3 hos patienter behandlet med ustekinumab, og dette respons forsatte til og med uge 8.
Clinical response and remission were significant as early as week 3 in ustekinumab treated patients and continued to improve through week 8.
Der var små, men ikke klinisk signifikante stigninger i LDL-kolesterolniveauer.
HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
Der var stor variabilitet patienterne i mellem i plasmaimatinib AUC efter en oral dosis.
There was high between- patient variability in plasma imatinib AUC levels after an oral dose.
Der var større hyppighed af Grad 4-neutropeni (ANC < 0,5 x 109/l), 12 % vs.
There were higher rates of Grade 4 neutropenia (ANC
Der var tendens til bedre resultater hos patienter med nedsat nyrefunktion end med normal nyrefunktion.
There was a trend for better results in patients with reduced kidney function than those whose kidney function was normal.
Der var tilmeldt 77 forsøgspersoner i den første undersøgelse og 109 i den anden.
There were 77 subjects enrolled into the first study and 109 into the second.
Der var tilsyneladende ingen tydelig sammenhæng med forekomsten af bivirkninger i kliniske undersøgelser med patienter, som samtidig blev behandlet med forskellige typer af de mest almindelige lægemidler.
There was no apparent relationship with respect to occurrence of adverse events in the clinical studies for patients receiving various categories of the most common concomitant medications.
Der var tydelig forsinket fosterudvikling ved dyreforsøg med pioglitazon.
Foetal growth restriction was apparent in animal studies with pioglitazone.
Der var tydelig forsinket fosterudvikling ved dyrestudie med pioglitazon.
Foetal growth restriction was apparent in animal studies with pioglitazone.
Der var tydelig variation og signifikant overlap i eksponeringen mellem patienter med nedsat leverfunktion og raske frivillige.
There was substantial variability and significant overlap in exposures between patients with hepatic impairment and healthy volunteers.
Der var én bivirkning af grad 4 med hypokaliæmi og én bivirkning med hyponatriæmi. c Se NCI CTCAE-kriterierne (version 4.0) for hver toksicitetsgrad. d Foretrukne termer i MedDRA omfattede: fald i kaliumniveauet i blodet og hypokaliæmi. e Foretrukne termer i MedDRA omfattede: blodtryksstigning og hypertension. f Foretrukne termer i MedDRA omfattede: abdominale smerter, nedre abdominale smerter, øvre abdominale smerter og leversmerter.
There was one Grade 4 ADR of hypokalaemia and one of hyponatraemia. c Refer to NCI CTCAE Criteria (Version 4.0) for each Grade of toxicity. d MedDRA preferred terms included are: blood potassium decreased and hypokalaemia. e MedDRA preferred terms included are: blood pressure increased and hypertension. f MedDRA preferred terms included are: abdominal pain, abdominal pain lower, abdominal pain upper, and hepatic pain.
Der var én patient, der døde i hver gruppe (mindre end 1 %).
There was one death in each group (less than 1%).
Der var ét tilfælde med dødelig udgang, omend dette var ringe dokumenteret.
There was one fatal case, although it was poorly documented.
Der vedlægges også beskyttede kanyler (BD SafetyGlideTM) til montering på hver sprøjte.
Safety needles (BD SafetyGlideTM) for connection to each barrel are also provided.
Der vedlægges også beskyttede kanyler (BD SafetyGlide™) til montering på hver sprøjte.
Safety needles (BD SafetyGlideTM) for connection to each barrel are also provided.
Der vedlægges også en beskyttet kanyle (BD SafetyGlideTM) til montering på sprøjten.
A safety needle (BD SafetyGlideTM) for connection to the barrel is also provided.
Der vil blive anmodet om en erstatningsprøve, hvis en oprindelig prøve mislykkes under PCR kvalitets- eller Sanger sekvenseringstest.
A replacement sample will be requested if an original sample fails during the PCR quality or the Sanger sequencing tests.
Der vil blive gennemført et studie for at undersøge dette.
A study will be conducted to investigate this.
Der vil blive indsamlet data i form af vævstype til assay, dato for vævsbiopsi, testbeskrivelse og de anvendte definitioner af positiv og negativ status for RET-mutation.
Tissue type used for assay, date of tissue biopsy, assay type and definition used for RET mutation positive and negative will be collected.
Der vil blive taget blod- og/eller urinprøver for at måle kalkindholdet i dit blod eller din urin 1, 3 og 6 måneder efter behandlingsstart.
Your doctor will perform blood and/or urine tests to measure the level of calcium in your blood and/or urine at month 1, 3 and 6 after starting your treatment with Preotact.
Der vil blive taget prøver for at kontrollere mængden af kalium, magnesium, calcium og kreatinin i blodet, inden du får din første dosis TRISENOX.
Tests will be performed to check the amount of potassium, magnesium, calcium and creatinine in your blood before your first dose of TRISENOX.
Der vil blive taget små blodprøver før behandlingen og 6 måneder og 12 måneder efter behandlingen for at bestemme, hvordan dit immunforsvar reagerer på behandlingen med Glybera.
Small amounts of blood will be drawn before treatment, 6 months and 12 months after treatment to measure how your body’s immune (defence) system is responding to the treatment with Glybera.
Der vil desuden blive udført en yderligere undersøgelse til fastlæggelse af den mest hensigtsmæssige dosis.
A further study will also be carried out to confirm the most appropriate dose.
Der vil desuden blive udleveret en pjece til patienter, som får ordineret Valdoxan, så de er opmærksomme på risikoen for at få leverskader og vigtigheden af at overvåge leverfunktionen og holde øje med tegn på leverproblemer.
A patient booklet will also be distributed to all patients who are prescribed Valdoxan so that they are aware of the risk to the liver, the importance of monitoring liver function and the signs of liver problems to look out for.
Der vil kunne ses små partikler i opløsningen, men disse vil ikke påvirke lægemidlets effekt.
Small particles may be visible in the solution and will not affect the effectiveness of the medicinal product.