natgillin/translations-raw huggingface dataset:
a Medianværdi angivet for TG og Lp(a). p-værdi baseret på gennemsnitlig procentuel ændring b p-værdi beregnet for den gennemsnitlige procentuelle ændring fra baseline og baseret på parret t-test
a Median presented for TG and Lp(a). p-value is based on the mean percent change b p-value on the mean percent change from baseline based on paired t-test
a Meget almindelig = Indberettet for  1 patient, der fik KANUMA
a Very common = Reported in  1 patient receiving KANUMA
a Metacarpofalangeale led b Proksimal interfalangeale led c 2 primære led blev ekskluderet fra virkningsanalysen (1 led fra placebogruppen blev ikke evalueret og 1 led fra den Xiapexbehandlede gruppe havde en kontraktur ved baseline på 0 grader før behandling).
a Metacarpophalangeal joint; b Proximal interphalangeal joint; c 2 primary joints were excluded from the efficacy analysis (1 joint from the placebo group was not evaluated and 1 joint from the Xiapex treated group had a baseline contracture of 0 degrees before treatment).
a MTX = methotrexat b P=0,027, Humira 0,8 mg/kg versus MTX
a MTX = methotrexate b P=0.027, Humira 0.8 mg/kg versus MTX
a Muskuloskeletale smerter er en sammensat term, der omfatter rygsmerter, knoglesmerter, muskuloskeletale brystsmerter, muskuloskeletale gener, myalgi, nakkesmerter, smerter i arme og ben, smerter i kæben, smerter i rygsøjlen. b Hyppighederne afspejler den andel af patienter, som i laboratoriemålinger oplevede forværring i forhold til baseline.
a Musculoskeletal pain is a composite term which includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, myalgia, neck pain, pain in extremity, pain in jaw, spinal pain. b Frequencies reflect the proportion of patients who experienced a worsening from baseline in laboratory measurements.
a Målt ved at nedsænke diffusoren i kuvetten i effektmåleren og langsomt øge lasereffekten.
a As measured by immersing the diffuser into the cuvette in the power meter and slowly increasing the laser power.
a n = 9 for AUC12t
a n = 9 for AUC12h
a n afspejler antal randomiserede patienter; det reelle antal patienter til vurdering ved hvert endepunkt kan variere med tidspunkterne.
a n reflects randomised patients; actual number of patients evaluable for each endpoint may vary by timepoint.
a n angiver antal randomiserede patienter
a n reflects randomised patients
a n angiver antal randomiserede patienter
n reflects randomised and treated patients
a n=12 for post partum, n=15 for andet trimester og n=14 for tredje trimester
a n=12 for postpartum, n=15 for second trimester and n=14 for third trimester
a National Cancer Institute Common Toxicity Criteria (CTC v 2.0; NCI 1998)
a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
a National Cancer Institute Common Toxicity Criteria (CTC v 2.0; NCI 1998) b Undtagen neurotoksicitet
a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity
a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Eksklusive neurotoksicitet
a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity
a National Cancer Institute Common Toxicity Criteria (CTC) (v2.0; NCI 1998) b Undtagen neurotoksicitet
a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity
a NC = F, non-completer = failure b C.I., konfidensinterval. c S.E.M. Standard afvigelse på middelværdi d EFV, efavirenz; ZDV, zidovudin, 3TC, lamivudin; IDV, indinavir.
a NC = F, noncompleter = failure. b C.I., confidence interval. c S.E.M., standard error of the mean. d EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir.
a NC = F, noncompleter = failure b C.I., konfidensinterval. c S.E.M. Standard afvigelse på middelværdi d EFV, efavirenz; ZDV, zidovudin, 3TC, lamivudin; IDV, indinavir.
a NC = F, noncompleter = failure. b C.I., confidence interval. c S.E.M., standard error of the mean. d EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir.
a NC = F, noncompleter = failure b EFV, efavirenz; ZDV, zidovudin; 3TC, lamivudin; IDV, indinavir; NRTI, nucleoside reverse transkriptasehæmmer; NFV, nelfinavir c C.I., konfidensinterval for antal patienter med respons d S.E.M., Standard afvigelse på middelværdi
a NC = F, noncompleter = failure. b EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir; NRTI, nucleoside reverse transcriptase inhibitor; NFV, nelfinavir. c C.I., confidence interval for proportion of patients in response. d S.E.M., standard error of the mean.
a Non-inferioritet blev defineret som den laveste grænse af det 2-sidede 95 % CI for GMR større end 0,5. b Statistisk signifikant større respons blev defineret som den laveste grænse af det 2-sidede 95 % CI for GMR større end 1. c For serotype 6A†, som er unik for Prevenar 13, blev et statistisk signifikant større respons defineret som den laveste grænse af det 2-sidede 95 % CI for GMR større end 2.
a Non-inferiority was defined as the lower limit of the 2-sided 95% CI for GMR was greater than 0.5. b Statistically significantly greater response was defined as the lower bound of the 2-sided 95% CI for the GMR was greater than 1. c For serotype 6A†, which is unique to Prevenar 13, a statistically significantly greater response was defined as the lower bound of the 2-sided 95% CI for the GMR being greater than 2.
a Non-inferioritet blev defineret som den laveste grænse af det 2-sidede 95 % CI for GMR større end 0,5. b Statistisk signifikant større respons blev defineret som den laveste grænse af det 2-sidede 95 % CI for GMR større end 1. c For serotype 6A†, som er unik for Prevenar 13, blev et statistisk signifikant større respons defineret som den laveste grænse af det 2-sidede 95 % CI for GMR større end 2.
a Non-inferiority was defined as the lower limit of the 2-sided 95% CI for GMR was greater than 0.5. b Statistically significantly greater response was defined as the lower bound of the 2-sided 95% CI for the GMR was greater than 1. c For serotype 6A†, which is unique to Prevenar 13, a statistically significantly greater response was defined as the lower bound of the 2-sided 95% CI for the GMR greater than 2.
a Non-inferioritet blev defineret som den laveste grænse af det tosidede 95 % CI for GMR større end 0,5. b Statistisk signifikant større respons blev defineret som den laveste grænse af det tosidede 95 % CI for GMR større end 1. c Konfidensintervaller (CI) for ratioen er transformeret tilbage, af et konfidensinterval baseret på t-fordelingen for middeldifferensen af logaritmerne for målingerne.
a Non-inferiority was defined as the lower limit of the 2-sided 95% CI for GMR was greater than 0.5. b Statistically significantly greater response was defined as the lower bound of the 2-sided 95% CI for the GMR was greater than 1. c Confidence intervals (CIs) for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
a Note: Intensiteten af kliniske bivirkninger klassificeret af National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
a Note: The intensity of clinical adverse events graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
a Når der er opnået et absolut neutrofiltal på ≥ 1,0 x 109/l (1.000 celler/mm3) og et trombocyttal på ≥ 50 x 109/l (50.000 celler/mm3), skal dosis reduceres til det næstfølgende dosisniveau i henhold til tabellen ovenfor.
a Upon recovery to ANC 1.0 x 109/l (1000 cells/mm3) and platelets to 50 x 109/l (50,000 cells/mm3), the doses should be modified to the next lower dose level according to the table above.
a Når det er muligt, skal det BO-segment, der er valgt til behandling, indbefatte normale vævskanter på nogle få millimeter i proksimale og distale ende.
a Whenever possible, the BO segment selected for treatment should include normal tissue margins of a few millimetres at the proximal and distal ends.
a OJ nr.
Other provisions
a Omfatter hypertensiv kardiomyopati. b Foretrukket term i MedDRA omfattede anal blødning, blodig diarré, gastrisk blødning, gastrointestinal blødning, hæmatemese, hæmatochezi, hæmorideblødning, Mallory-Weiss-syndrom, melæna, øsofageal blødning, rektal blødning og øvre gastrointestinal blødning.
a Includes hypertensive cardiomyopathy. b MedDRA preferred terms included anal haemorrhage, diarrhoea haemorrhage, gastric haemorrhage, gastrointestinal haemorrhage, haematemesis, haematochezia, haemorrhoidal haemorrhage, Mallory-Weiss syndrome, melaena, oesophageal haemorrhage, rectal haemorrhage, and upper gastrointestinal haemorrhage.
a Omfatter personer, der igen blev randomiseret til APR 30 to gange dagligt efter uge 32 med en baseline-værdi og en post-baseline-værdi ved den evaluerede studieuge. bN er baseret på personer med moderat eller større psoriasis i hårbunden ved baseline, der igen blev randomiseret til APR 30 to gange dagligt efter uge 32.
a Includes subjects re-randomized to APR 30 BID at Week 32 with a baseline value and a post-baseline value at the evaluated study week. bN is based on subjects with moderate or greater scalp psoriasis at baseline who were re-randomized to APR 30 BID at Week 32.
a Omfatter: hæmatom ved injektionsstedet og penilt hæmatom, blev rapporteret med beskrivelsen blå mærker på penis eller injektionsstedet hos 87 % af patienterne.
Includes: injection site haematoma and penile haematoma were reported with the verbatim term of penile bruising or injection site bruising in 87% of patients.
a p < 0,001 b CDLQI: CDLQI er et dermatologisk redskab til vurdering af et hudproblems indvirkning på den helbredsrelaterede livskvalitet i den pædiatriske population.
a p < 0.001 b CDLQI: The CDLQI is a dermatology instrument to assess the effect of a skin problem on the health-related quality of life in the paediatric population.
a p < 0,001 for hver infliximab-behandlingsgruppe mod placebo.
a p < 0.001, for each infliximab treatment group vs. placebo
a p < 0,001, etanercept vs. placebo b p = 0,002, etanercept vs. placebo
a p < 0.001, etanercept vs. placebo b p = 0.002, etanercept vs. placebo
a p < 0,001, for hver infliximab-behandlingsgruppe mod kontrol b højere værdier indikerer mere ledskade.
a p <0.001, for each infliximab treatment group vs control b greater values indicate more joint damage.
a p < 0,001, for hver infliximab-behandlingsgruppe mod kontrol. b højere væ rdier indikerer mere ledskade.
a p < 0.001, for each infliximab treatment group vs control
a p < 0,001, for hver infliximab-behandlingsgruppe mod placebo.
a p < 0.001, for each infliximab treatment group vs. placebo.
a p < 0,001, for hver infliximab-behandlingsgruppe versus kontrol b N = 292 c Analysen var baseret på patienter med neglepsoriasis ved baseline (81,8 % af patienterne).
a p <0.001, for each infliximab treatment group vs. control b n = 292 c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
a p < 0,001, for hver infliximab-behandlingsgruppe versus kontrol. b N = 292. c Analysen var baseret på patienter med neglepsoriasis ved baseline (81,8 % af patienterne).
a p <0.001, for each infliximab treatment group vs. control. b n = 292. c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
a p-værdi beregnet med anvendelse af Pearsons chi-kvadrattest bStatistisk signifikant flere patienter opnåede ≥ 5 x 106 celler/kg inden for ≤ 4 aferesedage med Mozobil og G-CSF (n=89; 59,3 %) end med placebo og G-CSF (n=29; 19,6 %), p < 0,001; statistisk signifikant flere patienter opnåede
a p-value calculated using Pearson’s Chi-Squared test bStatistically significantly more patients achieved ≥ 5 x 106 cells/kg in ≤ 4 apheresis days with Mozobil and G-CSF (n=89; 59.3%) than with placebo and G-CSF (n=29; 19.6%), p<0.001; statistically significantly more patients achieved
a p-værdi ved sammenligning af de kombinerede tenofovirindeholdende arme versus entecavirarmen = 0,622, b p-værdi ved sammenligning af de kombinerede tenofovirindeholdende arme versus entecavirarmen = 1,000.
a p-value comparing the combined tenofovir-containing arms versus the entecavir arm = 0.622, b p-value comparing the combined tenofovir-containing arms versus the entecavir arm = 1.000.
a P-værdien er afledt fra en ikke-stratificeret log-rank-test b Hazard ratio er afledt fra en ikke-stratificeret, proportional hazards-model.
a P-value is derived from an unstratified log-rank test b Hazard Ratio is derived from an unstratified proportional hazards model.
a P-værdien er baseret på en log-rank-test stratificeret efter ECOG-funktionsscore (0-1 ift.
a P-value is derived from a log-rank test stratified by ECOG performance status score (0-1 vs.
a p-værdien er beregnet med anvendelse af Cochran-Mantel-Haenszel-statistik med blokke af trombocytter ved baseline b Statistisk signifikant flere patienter opnåede ≥ 6 x 106 celler/kg inden for ≤ 2 aferesedage med Mozobil og G-CSF (n=106; 71,6 %) end med placebo og G-CSF (n=53; 34,4 %), p < 0,001; statistisk signifikant flere patienter opnåede
ap-value calculated using Cochran-Mantel-Haenszel statistic blocked by baseline platelet count bStatistically significantly more patients achieved ≥ 6 x 106 cells/kg in ≤ 2 apheresis days with Mozobil and G-CSF (n=106; 71.6%) than with placebo and G-CSF (n=53; 34.4%), p<0.001; statistically significantly more patients achieved
a p-værdien for den non-inferiority-hypotese er, at den subkutane gruppe bibeholder mindst 60 % af responsraten i den intravenøse gruppe. b Der indgik 222 forsøgspersoner i studiet, og 221 af disse blev behandlet med VELCADE
a p-value is for the non-inferiority hypothesis that the SC arm retains at least 60% of the response rate in the IV arm. b 222 subjects were enrolled into the study; 221 subjects were treated with VELCADE
a p-værdien for non-inferiority-hypotesen er, at den subkutane gruppe bibeholder mindst 60 % af responsraten i den intravenøse gruppe. b Der indgik 222 forsøgspersoner i studiet, og 221 af disse blev behandlet med bortezomib. c Estimatet af hazard-ratio er baseret på en Cox-model justeret for stratifikationsfaktorer: ISS-score og antal tidligere linjer. d Log-rank-test justeret for stratifikationsfaktorer: ISS-score og antal tidligere linjer. e Median varighed af opfølgning er 11,8 måneder.
a p-value is for the non-inferiority hypothesis that the SC arm retains at least 60% of the response rate in the IV arm. b 222 subjects were enrolled into the study; 221 subjects were treated with bortezomib c Hazards ratio estimate is based on a Cox model adjusted for stratification factors: ISS staging and number of prior lines. d Log rank test adjusted for stratification factors: ISS staging and number of prior lines. e Median duration of follow up is 11.8 months
a p-værdier baseret på Chi-square-test.
a p-values based on Chi-squared test.
a P-værdier efter logrank test.
a P-values by logrank test.
a p-værdier, der sammenligner efalizumab med placebo ved hjælp af logistisk regression, hvor baseline PASI score, tidligere behandling af psoriasis og geografisk område indgik som kovariater.
a p-values compared efalizumab with placebo using logistic regression including baseline PASI score, prior treatment for psoriasis and geographical region as covariates.
a p<0,00001, sammenligning med vPDT-kontrol b Sammenlignelig kontrol op til måned 3.
a p<0.00001 comparison with vPDT control b Comparative control up to Month 3.
a p<0,0001 for begge sammenligninger i BRIGHTER ved måned 6: Lucentis 0,5 mg vs laser og
a p<0.0001for both comparisons in BRIGHTER at Month 6: Lucentis 0.5 mg vs Laser and
a p<0,001 Humira versus placebo b p<0,001 Humira versus methotrexat c p<0,01 Humira versus placebo d p<0,05 Humira versus methotrexat
a p < 0.001 Humira vs. placebo b p < 0.001 Humira vs. methotrexate c p < 0.01 Humira vs. placebo d p < 0.05 Humira vs. methotrexate
a p<0,001 Humira versus placebo b p<0,001 Humira versus methotrexat c p<0,01 Humira versus placebo d p<0,05 Humira versus methotrexat
a p<0.001 Humira vs. placebo b p<0.001 Humira vs. methotrexate c p<0.01 Humira vs. placebo d p<0.05 Humira vs. methotrexate
a p<0,001 versus placebo
a p<0.001 versus placebo
a Parret t-test
a Paired t-test
a Patienter med minimum et delvist respons på Humira 40 mg ugentlig efter 12 ugers behandling. b Patienter, som opfylder protokol-specifikke kriterier for tab af respons eller ingen forbedring, var forpligtet til at udgå af studierne og blev optalt som non-respondere.
a Patients with at least a partial response to Humira 40 mg weekly after 12 weeks of treatment. b Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as nonresponders.
a Patienter, som ikke gennemførte 12 måneder af studiet, blev betragtet som ikke-responderende. b Værdier for sygdomsaktivitetsscore (Disease Activity Score, DAS) er middelværdier. c Remission er defineret som DAS <1,6.
a Patients who did not complete 12 months in the study were considered to be non-responders. b Values for Disease Activity Score (DAS) are means. c Remission is defined as DAS <1.6.
a Patienter, som opnår klinisk success (klinisk respons ”heldbredt” eller ”forbedret”) og mikrobiologisk success (niveau af patogen ”udryddet” eller ”formodet udryddet”) er klassificeret som overordnet terapeutisk success.
a Subjects achieving clinical success (Clinical Response of “Cure” or “Improved”) and microbiological success (pathogen–level response of “Eradicated” or “Presumed Eradicated”) are classified as overall therapeutic success.
a Personerne var fra ITT-populationen og fik mindst en dosis studielægemiddel i studie 1 eller 2 b Hver vurdering af PDQ krævede, at personerne havde haft et vaginalt samleje i de sidste 3 måneder før studiets gennemførelse c Højere scorer afspejler værre symptomer
a Subjects were from ITT population and received at least one dose of study drug in Study 1 or 2 b Each PDQ assessment required subjects to have had vaginal intercourse in the 3 months prior to completion c Higher scores represent worse symptoms
A petición de la Agencia Europea de Medicamentos.
At the request of the European Medicines Agency;
a Plus baggrundsbehandling med emtricitabin 200 mg og tenofovirdisoproxilfumarat 300 mg i fastdosis-kombination b Manglende = ekskluderet analyse
a Plus background regimen of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg fixed-dose combination b Missing = excluded analysis
a Populationen, som blev analyseret histologisk, inkluderede kun patienter med tilgængelige data fra leverbiopsi (manglende = ekskluderet) ved uge 240.
a The population used for analysis of histology included only patients with available liver biopsy data (Missing = Excluded) by week 240.
a Post-hoc-analyse; Resultaterne skal fortolkes med forsigtighed, da populationsstørrelsen i undergrupperne er lille, og da PD-L1 IHC 28-8 pharmDx-analysen ikke var blevet valideret analytisk ved 10% og 50% ekspressionsniveauerne på analysetidspunktet.
a Post-hoc analysis; results should be interpreted with caution as the subgroup samples sizes are small and, at the time of the analysis, the PD-L1 IHC 28-8 pharmDx assay was not analytically validated at the 10% or 50% expression levels.
a Primært endepunkt for AP-CML og BP-CML/Ph+ ALL-kohorter var MaHR, som kombinerer
a Primary endpoint for AP-CML and BP-CML/Ph+ ALL Cohorts was MaHR, which combines
a Procent af patienterne, som opnåede PASI 75-respons beregnet med
a Percent of patients achieving PASI75 response was calculated as center
a Procent af patienterne, som opnåede PASI75-respons beregnet med
a Percent of patients achieving PASI75 response was calculated as center
a Procentdele fastlagt efter Kaplan Meier-metoden
aPercents determined by Kaplan Meier method
a Pædiatrisk ACR 30/50/70-responser ved uge 48 er signifikant bedre end responserne for placebo- behandlede patienter
a Ped ACR 30/50/70 responses Week 48 significantly greater than those of placebo treated patients
a Pædiatriske ACR 30/50/70-responser ved uge 48 er signifikant bedre end responserne for placebo- behandlede patienter
a Ped ACR 30/50/70 responses Week 48 significantly greater than those of placebo treated patients
a RA-studie I efter 24 uger, RA-studie II efter 26 uger og RA-studie III efter 24 og 52 uger b 40 mg Humira givet hver anden uge c MTX = methotrexat
a RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks b 40 mg Humira administered every other week c MTX = methotrexate
a Rate for fuldstændig heling er defineret som andelen af patienter med ingen (nul) synlige aktinisk keratose
a Complete clearance rate is defined as the proportion of patients with no (zero) clinically visible actinic
a Recidivrate er Kaplan-Meier (KM) estimatet på studiedagen udtrykt i procent (95% CI).
a The recurrence rate is the Kaplan-Meier (KM) estimate at the target study date of the visit expressed as a percentage (95% CI).
a Relativ risikoreduktion beregnet for hændelsen (post-baseline) serokonvertering fra den dobbeltblinde behandlingsperiode og igennem den otte uger lange opfølgningsperiode.
a Relative risk reduction calculated on incident (post-baseline) seroconversion from the double-blind treatment period and through the 8-week follow-up period.
a Repræsenterer forekomsten af laboratoriefund, ikke af rapporterede bivirkninger. b Faldet var CTCAE grad 2 eller større for hæmoglobin, absolutte neutrofiler, trombocytter og lymfocytter. c Forhøjelse af middelcellevolumen fra baseline til over den øvre normalgrænse.
a Represents the incidence of laboratory findings, not of reported adverse events. b Decreases were CTCAE grade 2 or greater for haemoglobin, absolute neutrophils, platelets and lymphocytes. c Elevation in mean corpuscular volume from baseline to above the ULN (upper limit of normal).
a Respons = CR + PR
a Response = CR + PR
a Resultater afspejler brug af 1-mg dosis af entecavir hos 147 ud af 149 patienter i År 3 og hos alle patienter i År 4 og 5 og i kombinationsbehandling med entecavir-lamivudin (efterfulgt af længerevarende entecavirbehandling) i gennemsnitlig 20 uger hos 130 ud af 149 patienter i År 3 og i 1 uge for 1 ud af 121 patienter i År 4 i et rollover- forsøg. b Inkluderer patienter med mindst én HBV-DNA-måling under behandling ved PCR ved eller efter uge 24 til og med uge 58 (År 1), efter uge 58 til og med uge 102 (År 2) eller efter uge 102 til og med uge 156 (År 3), efter uge 156 til og med uge 204 (År 4) eller efter uge 204 til og med uge 252 (År 5). c Patienterne skal også have LVDr-substitutioner. d ≥ 1 log10 stigning over nadir i HBV-DNA ved PCR, bekræftet ved på hinanden følgende målinger eller ved afslutningen af tidsvinduet.
a Results reflect use of a 1-mg dose of entecavir for 147 of 149 patients in Year 3 and all patients in Years 4 and 5 and of combination entecavir-lamivudine therapy (followed by long-term entecavir therapy) for a median of 20 weeks for 130 of 149 patients in Year 3 and for 1 week for 1 of 121 patients in Year 4 in a rollover study. b Includes patients with at least one on-therapy HBV DNA measurement by PCR at or after week 24 through week 58 (Year 1), after week 58 through week 102 (Year 2), after week 102 through week 156 (Year 3), after week 156 through week 204 (Year 4), or after week 204 through week 252 (Year 5). c Patients also have LVDr substitutions. d 1 log10 increase above nadir in HBV DNA by PCR, confirmed with successive measurements or at the end of the windowed time point.