natgillin/translations-raw huggingface dataset:
Der var ikke tegn på øget risiko for særlig malignitet over tid bort set fra non-melanom hudcancer (0,3 vs.
There was no evidence of an increased risk of any particular malignancy over time with the exception of non-melanoma skin cancer (0.3 vs.
Der var ikke tilknyttet biverkninger til disse indberetninger.
No adverse reactions have been associated with these reports.
Der var ikke tilknyttet bivirkninger til disse indberetninger.
No adverse reactions have been associated with these reports.
Der var ikke tilstrækkelige data for samlet overlevelse (OS) på tidspunktet for PFS-analysen.
Overall Survival (OS) data were not mature at the time of the PFS analysis.
Der var ikke tilstrækkeligt bevis på udbyttet af denne parameter ved tidlig behandling.
Robust evidence for benefit on this outcome parameter could not be demonstrated for ‘immediate’ treatment.
Der var imidlertid for få patienter under seks år til at kunne understøtte anvendelsen af Telzir i denne aldersgruppe.
However, there were too few patients aged below six years to support the use of Telzir in this age group.
Der var imidlertid ingen evidens af klinisk signifikante bivirkninger i PLATO-studiet efter samtidig administration af ét eller flere lægemidler, kendt for at inducere bradykardi (f.eks.
However, no evidence of clinically significant adverse reactions was observed in the PLATO trial after concomitant administration with one or more medicinal products known to induce bradycardia (e.g.
Der var imidlertid ingen forskel i arbejdsvarighed mellem de to doser (24 sekunder sammenlignet med placebo; p  0,03.
However, there was no difference in exercise duration between the two doses (24 seconds compared to placebo; p  0.03).
Der var imidlertid ingen forskel mellem grupperne i den samlede kræftforekomst, og denne risiko viste sig ikke i de prækliniske under- søgelser af kræftrisikoen med Forxiga.
However, there was no difference between the groups when cancer overall was considered and preclinical studies investigating the risk of developing cancer with Forxiga did not show this risk.
Der var imidlertid ingen forskel mellem grupperne i samlet kræftforekomst, og risikoen sås ikke i de ikke-kliniske undersøgelser for udvikling af kræft med Edistride.
However, there was no difference between the groups when cancer overall was considered and preclinical studies investigating the risk of developing cancer with Edistride did not show this risk.
Der var imidlertid ingen indvirkninger på fertilitets- og forplantningsindekserne eller på embryoudviklingen.
A greater percentage of patients achieved HbA1c targets of
Der var ingen afvigende resultater ved brystpalpation i placebogruppen ved baseline eller ved forsøgsafslutning.
There were no abnormal breast palpation findings in the placebo group at baseline or at study end.
Der var ingen albiglutid- relaterede fund i thyreoidea hos aber, som fik op til 50 mg/kg/uge i op til 52 uger (75 gange den kliniske eksponering baseret på AUC).
There were no albiglutide related findings in thyroids of monkeys given up to 50 mg/kg/week for up to 52 weeks (75 times clinical exposure based on AUC).
Der var ingen andre forsøgspersoner i de to grupper, der havde mere end infusion med bivirkninger.
There were no other subjects with more than infusion with adverse reactions in both groups.
Der var ingen andre klinisk relevante forskelle mellem to samtidige injektioner af Xiapex i den samme hånd og op til tre enkelte injektioner af Xiapex med hensyn til typen af rapporterede uønskede hændelser (dvs. de fleste uønskede hændelser var lokale i forhold til den behandlede ekstremitet, og lette til moderate i intensitet).
There were no other clinically relevant differences between two concurrent injections of Xiapex in the same hand and up to three single injections of Xiapex in the types of adverse events reported (ie, most adverse events were local to the treated extremity and of mild or moderate intensity).
Der var ingen behandlingsrelaterede effekt på afkommets udvikling, opførsel, reproduktion eller fertilitet.
There were no treatment- related effects on developmental signs, behaviour, reproductive performance, or fertility of the offspring.
Der var ingen behandlingsrelaterede malformationer hos rotter.
There were no treatment- related malformations in rats.
Der var ingen behandlingsrelaterede testikulære fund hos mus eller rotter ved doser op til 600 eller 1.000 mg/kg dagligt i to år, og ingen testikulære fund hos hunde, der blev behandlet med avanafil i ni måneder med en eksponering svarende til 110 gange den humane eksponering ved den anbefalede maksimale dosis til mennesker (MRHD).
There were no treatment-related testicular findings in mice or rats treated with doses up to 600 or 1000 mg/kg/day for 2 years, and no testicular findings in dogs treated with avanafil for 9 months at exposures 110 times human exposure at the Maximum Recommended Human Dose (MRHD).
Der var ingen behandlingsrelateret effekt på embryoets/fostrets udvikling.
There was no treatment-related effect on embryo- fetal development.
Der var ingen bivirkninger, der forekom med markant højere frekvens hos patienter på 65 år eller derover.
No toxicities occurred notably more frequently among patients at least 65 years of age who received Abraxane.
Der var ingen detaljerede oplysninger om de øvrige fire tilfælde.
Of the other 4 cases, detailed information was missing.
Der var ingen dosisrespons indflydelse på undersøgelsens effektivitet (sensitivitet eller specificitet) for antistofdoser mellem 01. og 1.0 mg.
There was no dose- response effect for imaging efficacy (sensitivity or specificity) over antibody doses ranging from 0.1 mg to 1.0 mg.
Der var ingen dødsfald i forbindelse med disse hændelser, og respiratorbehandling eller indlæggelse på intensivafdeling var ikke nødvendig for nogen af de indlagte børn.
No deaths resulted from these events, and none of the hospitalized children required mechanical ventilation or admission to an intensive care unit.
Der var ingen dødsfald på grund af alvorlige infektioner i RA- eller CAPS-undersøgelserne.
There were no deaths due to serious infections in RA or CAPS studies.
Der var ingen dødsfald på grund af alvorlige infektioner i RA-undersøgelserne.
There were no deaths due to serious infections in RA studies.
Der var ingen effekt på clearance af safinamid hos patienter med PD, som fik safinamid som supplement til kronisk L-dopa og/eller DA-agonister, og behandling med safinamid ændrede ikke den farmakokinetiske profil af samtidigt administreret L-dopa.
There was no effect on the clearance of safinamide in patients with PD receiving safinamide as adjunct to chronic L-dopa and/or DA-agonists and safinamide treatment did not change the pharmacokinetic profile of co-administered L-dopa.
Der var ingen effekt på fertiliteten hos rotter, der blev behandlet peroralt med amlodipinmaleat (hanner i 64 dage og hunner i 14 dage før parring) i doser på op til 10 mg amlodipin/kg/dag (ca.
There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses of up to
Der var ingen effekt på QT-intervallet (korrigeret ved Fridericia- eller Bazett-metoden eller individuelt korrigeret), når aclidiniumbromid (200 µg eller 800 µg) blev givet 1 gang dagligt i 3 dage til raske forsøgspersoner i et omhyggeligt QT-studie.
No effects on QT interval (corrected using either the Fridericia or Bazett method or individually- corrected) were observed when aclidinium bromide (200 µg or 800 µg) was administered once daily for 3 days to healthy subjects in a thorough QT study.
Der var ingen effekt på sovetiden induceret af halothan og methohexitalnatrium.
There was no effect on sleep time induced by halothane or methohexital sodium.
Der var ingen effekt på spermiemotilitet eller –morfologi efter indgift af en enkelt oral dosis sildenafil 100 mg hos raske forsøgspersoner (se pkt.
There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 4.6).
Der var ingen eller kun minimal påvirkning af lever- og nyrefunktion.
Effects on hepatic or renal function were minimal or nonexistent.
Der var ingen evidens for ændringer i clearance ved gentagen dosering, baseret på den farmakokinetiske populationsanalyse, og den estimerede akkumulering ved steady state var 19 gange uanset dosis.
There was no evidence of clearance change with repeated dosing based on the population pharmacokinetic analysis and estimated accumulation at steady state was 19-fold irrespective of dose.
Der var ingen farmakokinetiske lægemiddelinteraktioner mellem apremilast og methotrexat hos patienter med psoriatisk artritis.
There was no pharmacokinetic drug-drug interaction between apremilast and methotrexate in psoriatic arthritis patients.
Der var ingen farmakokinetiske lægemiddelinteraktioner mellem apremilast og oral kontraception, der indeholdt ethinyløstradiol og norgestimat.
There was no pharmacokinetic drug-drug interaction between apremilast and oral contraceptives containing ethinyl estradiol and norgestimate.
Der var ingen forbedring med den højere dosis (80 mg/kg/dag).
No improvement was seen with the higher dose (80 mg/kg/day).
Der var ingen forskel behandlingsgrupperne imellem med hensyn til hyppigheden af andre tromboemboliske hændelser.
There was no difference between the treatment groups in the incidence of other thromboembolic events.
Der var ingen forskel i Cmax- værdier.
There were no differences in Cmax.
Der var ingen forskel i den samlede bivirkningsprofil hos patienterne, uanset antistofstatus, med undtagelse af en øget forekomst af reaktioner på injektionsstedet (4,7 % hos antistofpositive patienter sammenlignet med 2,5 % hos antistofnegative patienter under hele behandlingsperioden).
There was no difference in the overall safety profile in patients regardless of the antibody status with the exception of an increase of the incidence of injection site reactions (4.7% in antibody-positive patients compared to 2.5% in antibody-negative patients during the entire treatment period).
Der var ingen forskel i den samlede bivirkningsprofil hos patienterne, uanset antistofstatus, med undtagelse af en øget forekomst af reaktioner på injektionsstedet (4,7 % hos antistofpositive patienter sammenlignet med 2,5 % hos antistofnegative patienter under hele behandlingsperioden).
There was no difference in the overall safety profile in patients regardless of the antibody status with the exception of an increase of the incidence of injection site reactions (4.7%in antibody positive patients compared to 2.5% in antibody negative patients during the entire treatment period).
Der var ingen forskel i middel serumcalcium, phosphat eller 24 timers urincalcium mellem behandlingsgrupperne.
There were no differences in mean serum calcium, phosphate, or 24-hour urine calcium between treatment groups.
Der var ingen forskel i sikkerhedsprofilen mellem behandlingsgrupperne.
There were no other differences in safety profile between the treatment arms.
Der var ingen forskel i virkningen af rivaroxaban ved forskellige center-niveauer for TTR (Time in Target INR Range (tid i terapeutisk område) på 2,0-3,0) i de lige store kvartiler (p = 0,74 for interaktion).
The effect of rivaroxaban did not differ across the level of centre TTR (Time in Target INR Range of 2.0 - 3.0) in the equally sized quartiles (P=0.74 for interaction).
Der var ingen forskel i ændringen fra baseline af helkrops-BMD eller -BMC for rilpivirin sammenlignet med kontrollen, for den samlede population, eller hos de patienter, der behandles med et baggrundsprogram, der omfatter tenofovirdisoproxilfumarat.
There was no difference in the change from baseline in whole body BMD or BMC for rilpivirine compared with control, in the overall population or in those patients treated with a backbone regimen including tenofovir disoproxil fumarate.
Der var ingen forskel mellem atosiban og beta-memetika gruppen med hensyn til denne parameter.
There was no difference between the atosiban and beta- mimetic groups with regard to this parameter.
Der var ingen forskel mellem behandlingerne midt på dagen.
0.2 mmol/l) and evening meal (- 1.6 versus + 0.1 mmol/l), there was no difference between treatments at midday.
Der var ingen forskel mellem behandlingsgrupperne mht. forekomst af nye ikke-vertebrale frakturer.
There was no difference between treatment groups in the incidence of new nonvertebral fractures.
Der var ingen forskel mellem insulin glarin og standardbehandling for de to sammensatte primære effektmål, for enkeltkomponenterne af disse effektmål, for mortalitet af alle årsager eller for det sammensatte mikrovaskulære effektmål.
There were no differences between insulin glargine and standard care for the two co-primary outcomes; for any component endpoint comprising these outcomes; for all-cause mortality; or for the composite microvascular outcome.
Der var ingen forskel mellem kombinationen og de enkelte komponenter i sværhedsgraden af nogen af de observerede bivirkninger.
There was no difference between the combination and the individual components in severity for any observed adverse reactions.
Der var ingen forskel mellem kønnene med hensyn til sværhedsgrad eller behandlingsophør på grund af udslæt.
There was no gender difference in severity or treatment discontinuation due to rash.
Der var ingen forskel på 20, 20, 40 mg/kg ataluren og placebo.
There was no difference between ataluren 20-, 20-, 40 mg/kg and placebo.
Der var ingen forskel på ataluren 20, 20, 40 mg/kg og placebo.
There was no difference between ataluren 20-, 20-, 40 mg/kg and placebo.
Der var ingen forskel på den farmakokinetiske profil for alglucosidase alfa hos disse unge patienter med sent sygdomsdebut sammenlignet med patienter med sygdom, der debuterede i spædbørnsalderen.
There was no difference in the pharmacokinetic profile of alglucosidase alfa in these juvenile late- onset patients compared to infantile-onset patients.
Der var ingen forskel på den primære effektivitets variable – HbA1c efter 16 ugers behandling – hos patienter der var behandlet med NovoMix 30 kombineret med metformin og patienter behandlet med metformin og sulfonylurea.
The primary efficacy variable - HbA1c after 16 weeks of treatment - did not differ between patients with NovoMix 30 combined with metformin and patients with metformin plus sulfonylurea.
Der var ingen forskelle i hæmoglobin, neutrofiler eller trombocytter i de 2 behandlingsgrupper.
There were no differences in haemoglobin, neutrophils or platelets between both treatment groups.
Der var ingen forskelle i tigecyclins clearance i forhold til etnisk baggrund.
There were no differences in the clearance of tigecycline based on race.
Der var ingen indberetninger om anafylaksi på grund af belatacept.
There were no reports of anaphylaxis on belatacept.
Der var ingen indikationer på en kraftig inflammatorisk reaktion.
There were no indications of gross inflammatory reaction.
Der var ingen klinisk betydningsfulde farmakokinetiske forskelle mellem patienter med svært nedsat nyrefunktion og raske forsøgspersoner.
There were no clinically important pharmacokinetic differences between patients with severe renal insufficiency and healthy subjects.
Der var ingen klinisk betydningsfulde farmakokinetiske forskelle på grund af køn, race eller BMI (Body Mass Index) for raltegravir hos voksne.
There were no clinically important pharmacokinetic differences due to gender, race or body mass index (BMI) for raltegravir in adults.
Der var ingen klinisk meningsfyldte lægemiddelinteraktioner mellem ketoconazol og apremilast.
There was no clinically meaningful drug-drug interaction between ketoconazole and apremilast.
Der var ingen klinisk relevant farmakokinetisk ændring af ruxolitinib efter administration sammen med indtagelse af et måltid med højt fedtindhold.
There was no clinically relevant change in the pharmacokinetics of ruxolitinib upon administration with a high-fat meal.
Der var ingen klinisk relevant forskel i systemiske eksponering mellem hvid, sort eller asiatisk race.
There were no clinically relevant differences in systemic exposures between White, Black or Asian races.
Der var ingen klinisk relevant gennemsnitlig stigning i C-reaktivt protein i forhold til baseline efter langvarig behandling med Revestive i op til 30 måneder.
There were no clinically relevant mean increases of C-reactive protein from baseline following long-term treatment with Revestive for up to 30 months.
Der var ingen klinisk relevante forskelle mellem naloxegol 12,5 mg, 25 mg og placebo i de gennemsnitlige scorer for smerteintensitet, daglig opioiddosis eller opioidabstinenser over det 12- ugers studie.
There were no clinically relevant differences between naloxegol 12.5 mg, 25 mg, and placebo in average pain intensity, daily opioid dose or in opioid withdrawal scores over the 12-week study.
Der var ingen klinisk relevante ændringer fra baseline i smertescore hverken hos patienter behandlet med methylnaltrexonbromid eller med placebo.
There were no clinically relevant changes in pain scores from baseline in either the methylnaltrexone bromide or placebo-treated patients.
Der var ingen klinisk relevante ændringer fra baseline i smertescore, hverken hos patienter behandlet med methylnaltrexonbromid eller med placebo
There were no clinically relevant changes from baseline in pain scores in either the methylnaltrexone bromide or placebo-treated patients.
Der var ingen klinisk relevante ændringer i laboratorieværdier eller i puls og blodtryk i nogen af grupperne i studiets forløb.
There were no clinically relevant changes in the laboratory values or vital signs in either treatment group throughout the study.
Der var ingen klinisk signifikant forskel mellem nateglinids systemiske tilgængelighed og halveringstid hos diabetikere med let, moderat (kreatininclearance 31–50 ml/min) og svært (kreatininclearance 15–30 ml/min) nedsat nyrefunktion (ikke i dialyse) og hos raske personer.
The systemic availability and half-life of nateglinide in diabetic patients with mild, moderate (creatinine clearance 31–50 ml/min) and severe (creatinine clearance 15–30 ml/min) renal impairment (not undergoing dialysis) did not differ to a clinically significant degree from those in healthy subjects.
Der var ingen klinisk signifikante farmakokinetiske interaktioner, når tenofovirdisoproxilfumarat blev administreret sammen med emtricitabin, lamivudin, indinavir, efavirenz, nelfinavir, saquinavir (ritonavir-boostet), methadon, ribavirin, rifampicin, tacrolimus eller hormonantikonceptionsmidlet norgestimat/ethinylestradiol.
There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil fumarate was co-administered with emtricitabine, lamivudine, indinavir, efavirenz, nelfinavir, saquinavir (ritonavir boosted), methadone, ribavirin, rifampicin, tacrolimus, or the hormonal contraceptive norgestimate/ethinyl oestradiol.
Der var ingen klinisk signifikante farmakokinetiske interaktioner, når tenofovirdisoproxilfumarat blev administreret sammen med emtricitabin, nelfinavir eller ribavirin.
There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil fumarate was co-administered with emtricitabine, nelfinavir or ribavirin.
Der var ingen klinisk signifikante farmakokinetiske interaktioner, når tenofovirdisoproxilfumarat blev administreret sammen med entecavir.
No clinically significant pharmacokinetic interactions when tenofovir disoproxil fumarate was co-administered with entecavir.
Der var ingen klinisk signifikante farmakokinetiske interaktioner, når tenofovirdisoproxilfumarat blev administreret samtidig med saquinavir forstærket med ritonavir.
There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil fumarate was co-administered with ritonavir boosted saquinavir.
Der var ingen knogleændringer hos mus eller rotter efter livslang eksponering (2 år) ved 4 eller 2 gange den humane kliniske eksponering hos voksne eller pædriatriske ITP-patienter ved doser på 75 mg/dag og 2 gange den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC.
There were no bone changes observed in mice or rats after lifetime exposure (2 years) at 4 times or 2 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 2 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Der var ingen ledsagende kliniske symptomer, og hændelsen blev afhjulpet.
There were no accompanying clinical symptoms and the event resolved.
Der var ingen målelig plasmaproteinbinding efter administration af [14C]-migalastathydrochlorid i koncentrationsområdet 1- 100 M.
There was no detectable plasma protein binding following administration of [14C]-migalastat hydrochloride in the concentration range between 1 and 100 M.
Der var ingen patienter i alderen 45 år eller derover i nr- aksial SpA-studiet.
There were no patients age 45 and over in the nr-Axial SpA study.
Der var ingen patienter med genotype 1-HCV, der havde virologisk svigt under behandlingen.
No patients with genotype 1 HCV had on-treatment virologic failure.
Der var ingen patienter på 85 år eller ældre i RECOURSE-studiet og i det japanske fase 2-studie.
There were no patients 85 years or older in the RECOURSE study and the Japanese phase 2 study.
Der var ingen primær eller sekundær transplantationsafstødning.
There is no primary nor secondary graft rejection.
Der var ingen proteinbindingsfortrængning mellem enzalutamid og andre stærkt bundne lægemidler (warfarin, ibuprofen og salicylsyre) in vitro.
There was no protein binding displacement between enzalutamide and other highly bound drugs (warfarin, ibuprofen and salicylic acid) in vitro.
Der var ingen relevant forskel i bivirkningshyppigheden hos patienter over og under 2 år, men dette er imidlertid baseret på bare 21 børn under 2 år, herunder 6 patienter i alderen 3 måneder til 1 år.
There was no relevant difference in adverse event frequencies between patients above and below the age of 2 years, however this is based on only 21 children less than 2 years including 6 patients between 3 months to 1 year of age.
Der var ingen relevant forskel i bivirkningshyppigheden hos patienter over og under 2 år, men dette er imidlertid baseret på bare 21 børn under 2 år, herunder 6 patienter i alderen 3 måneder til 1 år.
There was no relevant difference in adverse event frequencies between patients above and below the age of 2 years, however this is based on only 21 children less than 2 years, including 6 patients between 3 months to 1 year of age.
Der var ingen relevant stigning i eksponeringen for nilotinib, når dosisblev øget fra 400 mg 2 gange dagligt til 600 mg 2 gange dagligt.
There was no relevant increase in exposure to nilotinib when the dose was increased from 400 mg twice daily to 600 mg twice daily.
Der var ingen relevante forskelle mellem Nivestim og referencepræparatet med hensyn til varighed af svær neutropeni og hyppighed af febril neutropeni.
There were no relevant differences between Nivestim and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Der var ingen sammenhæng mellem tilstedeværelse af anti-alemtuzumab eller hæmmende anti-alemtuzumab- antistoffer og reduktion i effektivitet, ændring i farmakodynamiske egenskaber eller forekomst af bivirkninger, herunder IAR'er.
There was no association of the presence of anti-alemtuzumab or inhibitory anti-alemtuzumab antibodies with a reduction in efficacy, change in pharmacodynamics, or the occurrence of adverse reactions, including infusion associated reactions.
Der var ingen samtidige eller efterfølgende klinisk betydningsfulde stigninger i serumbilirubin, INR eller alkalisk fosfatase.
There were no concomitant or subsequent clinically meaningful elevations in serum bilirubin, INR, or alkaline phosphatase.
Der var ingen signifikant forskel i effekten mellem sildenafildoserne.
There was no significant difference in effect between sildenafil doses.
Der var ingen signifikant forskel i procentdelen af patienter med kardial dysfunktion ved første vurdering (13% for Ferriprox vs.
There was no significant difference in percentage of patients with cardiac dysfunction at first assessment (13% for Ferriprox vs.