natgillin/translations-raw huggingface dataset:
I TRYPHAENA-studiet forekom diarré hos 72,3 % af patienterne behandlet med neoadjuverende Perjeta plus docetaxel, carboplatin og trastuzumab og hos 61,4 % af patienterne behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel efter 5-fluoruracil, epirubicin og cyclophosphamid.
In the TRYPHAENA trial, diarrhoea occurred in 72.3% of patients treated with neoadjuvant Perjeta+TCH and 61.4% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC.
I TRYPHAENA-studiet forekom udslæt hos 36,8 % af patienterne behandlet med neoadjuverende Perjeta plus docetaxel, carboplatin og trastuzumab og hos 20,0 % af patienterne behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel efter behandling med 5-fluoruracil, epirubicin og cyclophosphamid.
In the TRYPHAENA trial, rash occurred in 36.8% of patients treated with neoadjuvant Perjeta + TCH and 20.0% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC.
I TRYPHAENA-studiet opstod der febril neutropeni hos 17,1 % af patienterne behandlet med neoadjuverende Perjeta plus docetaxel, carboplatin og trastuzumab og hos 9,3 % af patienterne behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel efter 5- fluoruracil, epirubicin og cyclophosphamid.
In the TRYPHAENA trial, febrile neutropenia occurred in 17.1% of patients treated with neoadjuvant Perjeta + TCH, and 9.3% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC.
I TRYPHAENA-studiet var hyppigheden af NCI-CTCAE (version 3) grad 3-4 neutropeni 85,3 % hos patienter behandlet med neoadjuverende Perjeta plus docetaxel, carboplatin og trastuzumab og 77,0 % hos patienter behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel efter behandling med 5-fluoruracil, epirubicin og cyclophosphamid, inklusive henholdsvis 66,7 % og 59,5 % grad 4 neutropeni.
In the TRYPHAENA trial, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was 85.3% in patients treated with neoadjuvantPerjeta + TCH and 77.0% in patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC, including 66.7% and 59.5% Grade 4 neutropenia, respectively.
I tråd med de kriterier, som CHMP har fastlagt, viste dette, at vaccinen gav et passende beskyttelsesniveau.
In line with the criteria laid down by the CHMP, this demonstrated that the vaccine brought about an appropriate level of protection.
I tråd med disse observationer viste relaterede studie-endepunkter, som f.eks. sygdomskontrol og ændring i tumorstørrelse, signifikante forbedringer.
In line with these observations, related study endpoints such as disease control and change in tumour size showed significant improvements.
I TURQUOISE I var SVR12-raterne hos HCV-forsøgspersoner med samtidig HIV-I-infektion konsistente med SVR12-raterne hos forsøgspersonerne i fase 3-studier, der kun var inficeret med HCV.
In TURQUOISE-I, the SVR12 rates in HCV/HIV-1 co-infected subjects were consistent with SVR12 rates in the phase 3 trials of HCV mono-infected subjects.
I tvivlstilfælde bør yderligere undersøgelser overvejes, fx MR-scanning, helst med kontrast, cerebrospinalvæske-test (CSF-test) for JC-viral DNA og gentagne neurologiske vurderinger.
If any doubt exists, further evaluation, including MRI scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC Viral DNA and repeat neurological assessments, should be considered.
I tæver hvor brunsten er udeblevet i en periode på 12 måneder, kan en yderligere behandling gives for at fortsætte udsættelsen af brunst.
In bitches where gonadal function has been successsfully prevented for a period of 12 months, then a second treatment may be administered at that time for continued prevention of oestrus.
I tørstof: urea, natriumchlorid, polysorbat 20, natriumdihydrogenphosphat, dinatriumhydrogenphosphat, calciumchlorid, glycin, L-Leucin, L-Isoleucin, L-Threonin, L- Glutaminsyre og L-Phenylalanin.
In the lyophilisate: urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate, disodium hydrogen phospate, calcium chloride, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, and L-Phenylalanine.
I u- blindede forsøg og erfaring efter markedsføring, har nogle patienter med en anamnese for længerevarende tidligere eller samtidig brug af intravenøse aminoglycosider oplevet høretab.
In open label studies and post-marketing experience, some patients with a history of prolonged previous or concomitant use of intravenous aminoglycosides have experienced hearing loss.
I uge 104 var den justerede gennemsnitlige ændring i HbA1c fra baseline -0,32 % for dapagliflozin og
At Week 104, adjusted mean change from baseline in HbA1c was -0.32% for dapagliflozin and -0.14% for glipizide.
I uge 104 var HbA1c-reduktionen med 25 mg alogliptin plus metformin (-0,72 %, tabel 6) større end den, som blev opnået med glipizid plus metformin (-0,59 %).
At Week 104, the HbA1c reduction by 25 mg alogliptin plus metformin (- 0.72%, Table 6) was greater than that produced by glipizide plus metformin (-0.59%).
I uge 104 var reduktionen i HbA1c med 25 mg alogliptin plus metformin (-0,72 %, tabel 4) større end den, som blev opnået med glipizid plus metformin (-
At Week 104, the HbA1c reduction by 25 mg alogliptin plus metformin (- 0.72%, Table 4) was greater than that produced by glipizide plus metformin (-0.59%).
I uge 104 var reduktionen i HbA1c med 25 mg alogliptin plus metformin (-0,72 %, tabel 4) større end den, som blev opnået med glipizid plus metformin (-
At Week 104, the HbA1c reduction by 25 mg alogliptin plus metformin (-0.72%, Table 4) was greater than that produced by glipizide plus metformin (-0.59%).
I uge 104 var reduktionen i HbA1c med 25 mg alogliptin plus metformin (-0,72 %, tabel 6) større end den, som blev opnået med glipizid plus metformin (-
At Week 104, the HbA1c reduction by 25 mg alogliptin plus metformin (- 0.72%, Table 6) was greater than that produced by glipizide plus metformin (-0.59%).
I uge 12 var den gennemsnitlige procentvise ændring fra baseline med 300 mg alirocumab Q4W i LDL-C (ITT undersøgelse) -58,4% sammenlignet med +0,3% for placebo.
At week 12, the mean percent change from baseline with alirocumab 300 mg Q4W in LDL-C (ITT analysis) was -58.4% compared to +0.3% for placebo.
I uge 12 var det virologiske respons større i PI-kontrolgruppen (-2,2 log10 kopier/ml fra baseline, n = 53) end i INTELENCE-gruppen (-1,4 log10 kopier/ml fra baseline, n = 40).
At week 12, virologic response was greater in the control-PI arm (-2.2 log10 copies/ml from baseline; n = 53) compared to the INTELENCE arm (-1.4 log10 copies/ml from baseline; n = 40).
I uge 144 af behandlingen forblev den gennemsnitlige ændring fra baseline næsten ens i begge behandlingsgrupper (-3,07 og
At 144 weeks of treatment, the average change from baseline remained similar in both treatment groups (-3.07 and
I uge 144 var procentdelen af patienter med hiv 1-rna under 400 kopier/ml og 50 kopier/ml henholdsvis 71% og 68% i 245 mg tenofovirdisoproxil (som fumarat)-armen sammenlignet med 64% og 63% i stavudinarmen.
At 144 weeks, the proportion of patients with HIV-1 RNA below 400 copies/ml and 50 copies/ml was 71% and 68% respectively in the tenofovir disoproxil 245 mg (as fumarate) arm, compared to 64% and 63% in the stavudine arm.
I uge 16 blev 47 placebopatienter med < 10 % forbedring fra udgangspunktet i både hæ vede og ømme led flyttet til infliximab induktion (tidlig overflytning).
At week 16, 47 placebo patients with < 10% improvement from baseline in both swollen and tender joint counts were switched to infliximab induction (early escape).
I uge 18 var der et statistisk signifikant fald i HbA1c med empagliflozin sammenlignet med placebo (Tabel 5).
At Week 18, empagliflozin provided statistically significant improvement in HbA1c compared with placebo (Table 5).
I uge 2 blev alle patienter bedømt til klinisk respons og randomiseret til en af 3 behandlingsgrupper; en placebo- vedligeholdelsesgruppe, en 5 mg/kg vedligeholdelsesgruppe og en 10 mg/kg vedligeholdelsesgruppe.
At week 2, all patients were assessed for clinical response and randomised to one of 3 treatment groups; a placebo maintenance group, 5 mg/kg maintenance group and 10 mg/kg maintenance group.
I uge 208 var den justerede gennemsnitlige ændring i HbA1c i forhold til baseline
At Week 208, adjusted mean change from baseline in HbA1c was -0.10% for dapagliflozin and 0.20% for glipizide.
I uge 22 steg middel-AUC0-t og -Cmax med henholdsvis 181 % og 192 % i forhold til uge 0.
At Week 22, the mean AUC0-t and Cmax increased by 181% and 192%, respectively, when compared to Week 0.
I uge 24 havde 203 HBeAg-positive og 177 HBeAg-negative forsøgspersoner opnået ikke- detekterbare HBV-DNA-niveauer.
At week 24, 203 HBeAg-positive and 177 HBeAg-negative subjects achieved non-detectable HBV DNA levels.
I uge 24 var antallet af ASAS 20 respondere 15/78 (19 %) i placebogruppen og 123/201 (61 %) i gruppen, der fik 5 mg/kg infliximab (p < 0,001).
In SPIRIT, the proportion of patients achieving PASI 75 at week 10 was 71.7% in the 3 mg/kg infliximab group, 87.9% in the 5 mg/kg infliximab group, and 5.9% in the placebo group (p<0.001).
I uge 24 var den gennemsnitlige behandlingsforskel for 300 mg alirocumabQ4W/150 mg Q2W fra placebo i LDL-C procetvise ændring fra baseline -58,7%. (97,5% CI: -65,0%, -52,4%; p-værdi: <0,0001).
At week 24, the mean treatment difference for alirocumab 300 mg Q4W/150 mg Q2W from placebo in LDL-C percent change from baseline was -58.7.% (97.5% CI: -65.0%, -52.4%; p-value: ˂ 0.0001).
I uge 4 efter indgivelse af en enkelt dosis opnåede 22/27 (81 %) af de infliximab-behandlede patienter, der fik 5 mg/kg dosen en klinisk virkning mod 4/25 (16 %) af placebopatienterne (p < 0,001).
Sixty eight percent (21/31) of infliximab-treated patients receiving a 5 mg/kg dose regimen achieved a clinical response vs.
I uge 48 af behandlingen udviste 70% og 64% af patienterne hiv 1-RNA < 50 kopier/ml med henholdsvis en og to gange daglig behandling med lopinavir/ritonavir.
At 48 weeks, 70% and 64% of patients demonstrated HIV-1 RNA < 50 copies/ml with the once and twice daily regimens of lopinavir/ritonavir, respectively.
I uge 48 blev der set en markant forbedring i CD4+-celle- procenten hos begge doseringsgrupper.
A marked improvement in the CD4+ cell percent was observed through Week 48 for both dose groups.
I uge 48 og 104 forblev insulindosen stabil sammenlignet med baseline hos forsøgspersoner, der fik dapagliflozin 10 mg med en gennemsnits dosis på 76 IE dagligt.
At Weeks 48 and 104, the insulin dose remained stable compared to baseline in subjects treated with dapagliflozin 10 mg at an average dose of 76 IU/day.
I uge 52 svarede reduktionen i HbA1c med 25 mg alogliptin plus metformin (-0,76 %, tabel 4) til den, som blev opnået med glipizid (gennemsnitsdosis = 5,2 mg) plus metforminhydrochloridbehandling (gennemsnitsdosis = 1.824 mg, -0,73 %).
At Week 52, the HbA1c reduction by 25 mg alogliptin plus metformin (-0.76%, Table 4) was similar to that produced by glipizide (mean dose = 5.2 mg) plus metformin hydrochloride therapy (mean dose = 1,824 mg, -0.73%).
I uge 52 svarede reduktionen i HbA1c med 25 mg alogliptin plus metformin (-0,76 %, tabel 6) til den, som blev opnået med glipizid (gennemsnitlig dosis = 5,2 mg) plus metforminhydrochloridbehandling (gennemsnitsdosis = 1.824 mg, -0,73 %).
At Week 52, the HbA1c reduction by 25 mg alogliptin plus metformin (-0.76%, Table 6) was similar to that produced by glipizide (mean dose = 5.2 mg) plus metformin hydrochloride therapy (mean dose = 1,824 mg, -0.73%).
I uge 52 svarede reduktionen i HbA1c med 25 mg alogliptin samt metformin (-0,76 %, tabel 6) til den, som blev opnået med glipizid (gennemsnitsdosis = 5,2 mg) plus metforminhydrochloridbehandling (gennemsnitsdosis = 1.824 mg, -0,73 %).
At Week 52, the HbA1c reduction by 25 mg alogliptin plus metformin (-0.76%, Table 6) was similar to that produced by glipizide (mean dose = 5.2 mg) plus metformin hydrochloride therapy (mean dose = 1,824 mg, -0.73%).
I uge 72 sås der et fald fra udgangspunktet i procent forventet FVC på ≥10 % (en tærskel, der indikerer risiko for mortalitet ved ILF) hos 20 % af patienterne, som fik Esbriet, sammenlignet med 35 % af dem, som fik placebo (tabel 2).
At Week 72, a decline from baseline in percent predicted FVC of ≥10% (a threshold indicative of the risk of mortality in IPF) was seen in 20% of patients receiving Esbriet compared to 35% receiving placebo (Table 2).
I uge 96 var den gennemsnitlige ændring fra baseline i CD4+ celletal +228 x 106 celler/l i rilpivirin- gruppen og +219 x 106 celler/l i efavirenz-gruppen i den poolede analyse af studierne ECHO og THRIVE [estimeret behandlingsforskel (95 % CI): 11,3 (-6,8; 29,4)].
At week 96, the mean change from baseline in CD4+ cell count was +228 x 106 cells/l in the rilpivirine arm and +219 x 106 cells/l in the efavirenz arm in the pooled analysis of the ECHO and THRIVE trials [estimated treatment difference (95% CI): 11.3 (-6.8; 29.4)].
I uge 96 var den gennemsnitlige ændring i forhold til baseline i niveauerne af ACTH-stimuleret cortisol lavere i rilpivirin-armen (+18,4 ± 8,36 nmol/l) end i efavirenz-armen (+54,1 ± 7,24 nmol/l).
At Week 96, the mean change from baseline in ACTH-stimulated cortisol levels was lower in the rilpivirine arm (+18.4 ± 8.36 nmol/L) than in the efavirenz arm (+54.1 ± 7.24 nmol/L).
I undergruppeanalyser for personer i behandlingsgruppen med 60 mg, hvor dosis blev reduceret til 30 mg i ENGAGE-AF-TIMI 48 for legemsvægt ≤ 60 kg, moderat nedsat nyrefunktion eller samtidig anvendelse af P-gp-hæmmere, havde 104 (3,05 % pr. år) af de personer, der fik dosisreduceret edoxaban 30 mg, og 166 (4,85 % pr. år) af de personer, der fik dosisreduceret warfarin, en svær blødningshændelse [HR (95 %): 0,63 (0,50; 0,81)].
In subgroup analyses, for subjects in the 60 mg treatment group who were dose reduced to 30 mg in the ENGAGE AF-TIMI 48 study for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors, 104 (3.05% per year) of edoxaban 30 mg dose reduced subjects and 166 (4.85% per year) of warfarin dose reduced subjects had a major bleeding event [HR (95% CI): 0.63 (0.50, 0.81)].
I undergruppen af forsøgspersoner i alderen 19-55 år, der var seronegative ved baseline, var forholdet af forsøgspersoner, der opnåede en hSBA ≥ 1:8 efter 1 dosis af Menveo, som følger: Serogruppe A 67 % (582/875), serogruppe C 71 % (401/563), serogruppe W135 82 % (131/160) og serogruppe Y 66 % (173/263).
In the subset of subjects aged 19-55 years who were seronegative at baseline, the proportion of subjects who achieved a hSBA ≥ 1:8 after a dose of Menveo were as follows: serogroup A 67% (582/875); serogroup C 71% (401/563); serogroup W135 82% (131/160); serogroup Y 66% (173/263).
I undergruppen af patienter med forhøjede aminotransferaser i anamnesen blev ALAT eller ASAT rapporteret hyppigere hos patienter, der fik ivacaftor, sammenlignet med placebo.
In the subset of patients with a medical history of elevated transaminases, increased ALT or AST have been reported more frequently in patients receiving ivacaftor compared to placebo.
I undergruppen af patienter med genotype 1 og lav virusmængde (< 600.000 IE/ml) som bliver hcv-RNA-negative ved behandlingsuge 4, og som stadig er hcv-RNA-negative ved uge 24, kan behandlingen enten stoppes efter denne 24 ugers behandlingsperiode eller fortsættes i yderligere 24 uger (dvs. en samlet 48 ugers behandlingsperiode).
In the subset of patients with genotype 1 infection and low viral load (< 600,000 IU/ml) who become HCV-RNA negative at treatment week 4 and remain HCV-RNA negative at week 24, the treatment could either be stopped after this 24 week treatment course or pursued for an additional 24 weeks (i.e. overall 48 weeks treatment duration).
I undergruppen af patienter med genotype 1 og lav virusmængde (< 600.000 IE/ml), som bliver hcv-RNA-negative ved behandlingsuge 4, og som stadig er hcv-RNA negative ved uge 24, kan behandlingen enten stoppes efter denne 24 ugers behandlingsperiode eller fortsættes i yderligere 24 uger (dvs. en samlet 48 ugers behandlingsperiode).
In the subset of patients with genotype 1 infection and low viral load (< 600,000 IU/ml) who become HCV-RNA negative at treatment week 4 and remain HCV-RNA negative at week 24, the treatment could either be stopped after this 24 week treatment course or pursued for an additional 24 weeks (i.e. overall 48 weeks treatment duration).
I undergruppen af patienter med genotype 1 og lav virusmængde (< 600.000 IE/ml), som bliver hcv-RNA-negative ved behandlingsuge 4, og som stadig er hcv-RNA-negative ved uge 24, kan behandlingen enten stoppes efter denne 24 ugers behandlingsperiode eller fortsættes i yderligere 24 uger (dvs. en samlet 48 ugers behandlingsperiode).
In the subset of patients with genotype 1 infection and low viral load (< 600,000 IU/ml) who become HCV-RNA negative at treatment week 4 and remain HCV-RNA negative at week 24, the treatment could either be stopped after this 24 week treatment course or pursued for an additional 24 weeks (i.e. overall 48 weeks treatment duration).
I undergruppen af patienter, der blev optitreret ved uge 12, blev der opnået en yderligere gennemsnitlig reduktion i LDL-C ved uge 24.
Among the subgroup of patients up-titrated at week 12, an additional 15.7% mean reduction in LDL-C was achieved at week 24.
I undergruppen af patienter, der var indiceret til behandling af hurtigt udviklende relapsing- remitterende MS (patienter med 2 eller flere attakker eller 1 eller flere Gd+ læsioner), var den årlige attakhyppighed 0,282 i den TYSABRI behandlede gruppe (n= 148) og 1,455 i placebo-gruppen (n= 61) (p <0,001).
In the sub-group of patients indicated for treatment of rapidly evolving relapsing remitting MS (patients with 2 or more relapses and 1 or more Gd+ lesion), the annualised relapse rate was 0.282 in the TYSABRI treated group (n = 148) and 1.455 in the placebo group (n = 61) (p <0.001).
I undergruppen med patienter med hjertefrekvens ≥ 75 slag i minuttet (n=4.150) sås en større risikoreduktion for det primære sammensatte endepunkt på 24 % (hazard ratio: 0,76; 95 % KI [0,68;0,85]; p<0,0001) og for de sekundære endepunkter inklusive død uanset årsag (hazard ratio: 0,83; 95 % KI [0,72;0,96]; p=0,0109) og kardiovaskulær død (hazard ratio: 0,83; 95 % KI [0,71;0,97]; p=0,0166).
In the subgroup of patients with HR ≥ 75 bpm (n=4150), a greater reduction was observed in the primary composite endpoint of 24 % (hazard ratio: 0.76, 95%CI [0.68;0.85] – p<0.0001) and for other secondary endpoints, including all cause death (hazard ratio: 0.83, 95%CI [0.72;0.96] – p=0.0109) and CV death (hazard ratio: 0.83, 95%CI [0.71;0.97] – p=0.0166).
I undergruppen med personer i alderen > 65 år varierede procentdelen af vaccinerede med rSBA-titer ≥ 128 en måned efter vaccination fra 90 % gruppe A til 97 % gruppe Y.
In the subgroup aged > 65 years the percentage of vaccinees with rSBA titres ≥ 128 at one month post- vaccination ranged from 90% (group A) to 97% (group Y).
I undergruppen med personer i alderen > 65 år varierede procentdelen af vaccinerede med rSBA-titer ≥ 128 en måned efter vaccination fra 90 % gruppe A til 97 % gruppe Y.
In the subgroup aged > 65 years the percentage of vaccinees with rSBA titres ≥ 128 at one month post-vaccination ranged from 90% (group A) to 97% (group Y).
I undergruppen med utilstrækkeligt respons på laksantia resulterede naloxegol 25 mg-dosen i en større forbedring (ændring i forhold til baseline) end placebo i patienternes totalscore ifm. vurdering af obstipationssymptomer (PAC-SYM) i begge studier efter 12 uger (Kodiac 4 p=0,023, Kodiac 5 p=0,002).
Naloxegol 25 mg dose in the LIR subgroup resulted in a greater improvement (change from baseline) of patient assessment of constipation symptoms (PAC-SYM) total scores compared with placebo in both studies at 12 weeks (Kodiac 4 p=0.023, Kodiac 5 p=0.002).
I understøttende analyser er der observeret positiv behandlingseffekt i alle undergrupper med undtagelse af undergruppen af patienter med primærtumor udgået fra ileum (ileum: HR=1,22 [95 % CI: 0,56-2,65]; ikke-ileum: HR=0,34 [95 % CI: 0,22-0,54]; lunge: HR=0,43 [95 % CI: 0,24-0,79]) (se figur 4).
In supportive analyses, positive treatment effect has been observed in all subgroups with the exception of the subgroup of patients with ileum as primary site of tumour origin (Ileum: HR=1.22 [95% CI: 0.56 to 2.65]; Non-ileum: HR=0.34 [95% CI: 0.22 to 0.54]; Lung: HR=0.43 [95% CI: 0.24 to 0.79]) (see Figure 4).
I undersøgelse 1899 blev et signifikant fald i alle årsager til dødelighed til fordel for posaconazol observeret [POS 49/304 (16 %) vs.
In Study 1899, a significant decrease in all cause mortality in favour of posaconazole was observed [POS 49/304 (16 %) vs.
I undersøgelse 301 var de totalt set hyppigst rapporterede bivirkninger under MTT hoste hos 18 (4,8 %) forsøgspersoner, hvæsende vejrtrækning/bronkospasme hos otte (2,1 %) forsøgspersoner og ubehag i brystet hos seks (1,6 %) forsøgspersoner.
In study 301, overall the most frequently reported events during the MTT were cough in 18 (4.8%) subjects, wheezing/bronchospasm in eight (2.1%) subjects and chest discomfort in six (1.6%) subjects.
I undersøgelse 302 var det hyppigst rapporterede kliniske tegn eller symptom under MTT hoste (7,9 %).
In study 302 the most frequent clinical sign or symptom reported during the MTT was cough (7.9%).
I undersøgelse CAC-002-01 var patienternes gennemsnitsalder ved baseline 9,0 år med variationsbredde 0,3 til 35 år.
In Study CAC-002-01, the mean age of patients at baseline was 9.0 years, with ages ranging from 0.3 to 35 years.
I undersøgelse CAC-91-10-10 viste analysen af virkning, at cholsyre medførte væsentlig bedring i form af nedsat galdesyreudskillelse i urinen hos patienter med enkeltenzymdefekter.
In Study CAC-91-10-10 the efficacy analysis showed that treatment with cholic acid significantly improved, i.e. decreased, urinary bile acid excretion in patients with single enzyme defects.
I undersøgelse DPM-CF-301 og 302 blev den relative % forventet FEV1 sammenlignet med kontrolgruppen hos børn (6-11 år) forbedret med henholdsvis 0,44 % (95 % CI -5,90, 6,77, N=43) og 6,1 % (95 % CI -1,28, 13,54, N=59) over 26 uger (p=0,892 og 0,104).
In studies DPM-CF-301 and 302 relative % predicted FEV1 compared to control in children (6-11 years) was improved by 0.44% (95% CI -5.90, 6.77, N=43) and 6.1% (95% CI -1.28, 13.54, N=59) over 26 weeks (p=0.892 and 0.104) respectively.
I undersøgelse DPM-CF-301 var 64,4 % af patientpopulationen voksne, mens dette tal var 49,5 % i undersøgelse DPM-CF-302.
In study DPM-CF-301 64.4 % of the patient population were adults while in study DPM-CF-302 this figure was 49.5%.
I undersøgelse II blev patienterne randomiseret til behandling i 18 uger med enten placebo (229 patienter) eller rasagilin 1 mg dagligt (231 patienter) eller til behandling med 200 mg entakapon, en katekol-O-metyltransferase (COMT) hæmmer (227 patienter), i kombination med levodopa (LD)/decarboxylasehæmmer.
In study II, patients were randomly assigned to receive placebo (229 patients), or rasagiline 1 mg/day (231 patients) or the catechol-O–methyl transferase (COMT) inhibitor, entacapone, 200 mg taken along with scheduled doses of levodopa (LD)/decarboxylase inhibitor (227 patients), and were treated for 18 weeks.
I undersøgelse II var den gennemsnitlige forskel i antallet af timer tilbragt i ”off” tilstand sammenlignet med placebo 0.78 timer, 95% CI [1,18; 0,39], p=0,0001.
In study II, the mean difference in the number of hours spent in the “OFF” state compared to placebo was
I undersøgelse III var den gennemsnitlige forskel sammenlignet med placebo 0,94 timer, 95% CI [1,36; 0,51], p<0,0001.
In study III, the mean difference compared to placebo was -0.94h, 95% CI
I undersøgelsen af 160 patienter faldt HbA1c-koncentrationen hos patienter, der fik saxagliptin sammen med metformin, med 0,6 % sammenlignet med en reduktion på 0,2 % hos patienter, der fik et placebo sammen med metformin.
In the study of 160 patients, patients taking saxagliptin with metformin had a reduction of 0.6% in their HbA1c levels, compared with a reduction of 0.2% in patients taking placebo with metformin.