natgillin/translations-raw huggingface dataset:
Virkningen blev etableret gennem det primære endepunkt samlet remissionsrate (ORR) inden for 3 måneder efter infusion, vurderet af en uafhængig komite til gennemgang af data (IRC), varighed af remission (DOR) og andel af patienter, der opnåede komplet remission (CR) eller komplet remission med ufuldstændig normalisering af blodtal (CRi) med minimal residualsygdom (MRD) på &lt; 0,01 % bestemt ved flowcytometri (MRD-negativ).
Efficacy was established through the primary endpoint of overall remission rate (ORR) within 3 months post infusion, as determined by Independent Review Committee (IRC) assessment, duration of remission (DOR) and the proportion of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) with minimal residual disease (MRD) &lt; 0.01% by flow cytometry (MRD-negative).
MRD (minimal residualsygdom)-negativ var defineret som MRD bestemt ved flowcytometri på
MRD (minimal residual disease) negative was defined as MRD by flow cytometry &lt; 0.01%.
CRi (komplet remission med ufuldstændig normalisering af blodtal) var defineret som &lt; 5 % blaster i knoglemarven, cirkulerende blaster i blodet skal være &lt; 1 %, ingen påvisning af ekstramedullær sygdom og uden fuldstændig normalisering af antallet af perifere blodceller med eller uden blodtransfusion.
CRi (complete remission with incomplete blood count recovery) was defined as &lt; 5% of blasts in the bone marrow, circulating blasts in blood should be &lt; 1%, no evidence of extramedullary disease, and without full recovery of peripheral blood counts with or without blood transfusion.
Infusionsposerne skal undersÃ¸ges for eventuelle brud eller revner inden optÃ¸ning.
The infusion bag(s) should be examined for any breaks or cracks prior to thawing.
Infektioner vides at komplicere forlÃ¸bet og hÃ¥ndteringen af sidelÃ¸bende cytokinfrigivelsessyndrom.
Infections are known to complicate the course and management of concurrent cytokine release syndrome.
Infektioner og parasitÃ¦re sygdommea)
Infections and infestationsa)
InfusionsvÃ¦ske, dispersion.
Dispersion for infusion.
CR (komplet remission) var defineret som &lt; 5 % blaster i knoglemarven, cirkulerende blaster i blodet skulle være &lt; 1 %, ingen påvisning af ekstramedullær sygdom og fuldstændig normalisering af antallet af perifere blodceller (trombocyttal &gt; 100.000/μl og absolut neutrofiltal [ANC] &gt; 1.000/μl) uden blodtransfusion.
Nominal one-sided exact p-value based on H0: ORR ≤20% vs. Ha: ORR &gt; 20% CR (complete remission) was defined as &lt; 5% of blasts in the bone marrow, circulating blasts in blood should be &lt; 1%, no evidence of extramedullary disease, and full recovery of peripheral blood counts (platelets &gt; 100,000/μL and absolute neutrophil counts [ANC] &gt; 1,000/μL) without blood transfusion.
De mest almindelige ( &gt; 25 %) hæmatologiske laboratorieanomalier af grad 3 og 4 var fald i lymfocyttal (95 %), fald i neutrofiltal (81 %), fald i antal hvide blodceller (77 %), fald i hæmoglobinniveau (59 %) og fald i trombocyttal (55 %).
The most common ( &gt; 25%) Grade 3 and 4 haematological laboratory abnormalities were lymphocyte count decreased (95%), neutrophil count decreased (81%), white blood cell count decreased (77%), haemoglobin decreased (59%) and platelet count decreased (55%).
Hyppigheden af uønskede hændelser er klassificeret som meget almindelig (≥1/10), almindelig (≥1/100 til &lt; 1/10) og ikke almindelig (≥1/1.000 til &lt; 1/100) .
The frequency of adverse events are classified as very common (≥1/10), common (≥1/100 to &lt; 1/10), and uncommon (≥1/1,000 to &lt; 1/100).
Influenza kan vÃ¦re forbundet med en rÃ¦kke neurologiske og adfÃ¦rdsmÃ¦ssige symptomer.
Influenza can be associated with a variety of neurological and behavioural symptoms.
Egnede patienter måtte ikke have fået &gt; 3 dages forudgående antiviral behandling.
Eligible patients were not to have had &gt; 3 days of prior antiviral treatment.
Patienternes median alder var 57 år og 35% (218/615) af patienterne var ≥65 år, hvoraf 17% (n = 103) var 65 til &lt; 75; 14% (n = 84) var 75 til &lt; 85, og 5% (n = 31) var ≥85 år.
The median patient age was 57 years and 35% (218/615) of patients were ≥65 years, of which 17% (n=103) were 65 to &lt; 75; 14% (n=84) were 75 to &lt; 85, and 5% (n=31) were ≥85 years of age.
Den vigtigste alvorlige bivirkning var hepatocellulær skade, der blev set hos to patienter ( &lt; 1%).
The most important serious adverse reaction was hepatocellular injury, observed in two patients ( &lt; 1%).
6 måneder til &lt; 6 år
6 months to &lt; 6 years
≥ 6 år til &lt; 18 år
 6 years to &lt; 18 years
Zanamivirs serumhalveringstid stiger til ca. 12-20 timer hos patienter med svær nedsat nyrefunktion (kreatininclearance &lt; 30 ml/min.).
The serum half-life of zanamivir increases to approximately 12-20 hours in patients with severe renal impairment (creatinine clearance &lt; 30 mL/min).
Bivirkningernes hyppighed er defineret ved hjælp af følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000 til &lt;
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000) and not known (cannot be estimated from available data).
måneder - &lt; 1 år mg/kg
6 months - &lt; 1 year mg/kg
Zanamivir havde en signifikant profylaktisk effekt mod en forsøgsprovokation med influenza A-virus, der blev påvist af den lave infektionsrate (14 % vs. 100 % positiv serologi i placebogruppen, p &lt; 0,005) og isolation af virus via viruskultur (0 % vs. 100 % i placebogruppen, p &lt; 0,005) samt reduktioner i feber (14 % vs. 88 % i placebogruppen, p &lt; 0,05), sygdom i de øvre luftveje (0 % vs. 100 % i placebogruppen, p &lt; 0,005) og den samlede symptomscore (1 vs. 44 medianscore i placebogruppen, p &lt; 0,001).
Zanamivir had a significant prophylactic effect against an experimental challenge with influenza A virus as demonstrated by the low infection rate (14% vs. 100% positive serology in placebo group, p &lt; 0.005), isolation of virus by viral culture (0% vs. 100% in placebo group, p &lt; 0.005), as well as reductions in fever (14% vs. 88% in placebo group, p &lt; 0.05), upper respiratory tract illness (0% versus 100% in placebo group, p &lt; 0.005) and total symptom scores (1 vs. 44 median score in placebo group, p &lt; 0.001).
Se sidst i &lt; afsnit &gt; &lt; punkt &gt; 4, hvordan &lt; De &gt; &lt; du &gt; indberetter bivirkninger.
See the end of section 4 for how to report side effects.
Bivirkningsprofilen i den pædiatriske population er baseret på 71 patienter i alderen ≥6 måneder til
The adverse reaction profile in the paediatric population is based on 71 patients aged ≥6 months to &lt; 18 years in the Phase II study.
50 til &lt; 80
50 to &lt; 80
15 til &lt; 30
15 to &lt; 30
Zanamivirs farmakokinetik efter en intravenøs dosis på 14 mg/kg to gange dagligt til pædiatriske patienter mellem 6 måneder og &lt; 6 år og 12 mg/kg til pædiatriske patienter mellem 6 år og &lt; 18 år var den samme, som blev observeret hos voksne, der fik 600 mg intravenøst to gange dagligt.
The pharmacokinetics of zanamivir following a twice daily intravenous dose of 14 mg/kg for paediatric patients between 6 months and &lt; 6 years and 12 mg/kg for those between 6 years and &lt; 18 years of age were similar to those seen in adults who received 600 mg twice daily intravenously.
30 til &lt; 50
30 to &lt; 50
Zanamivirs farmakokinetik hos forsøgspersoner i alderen 6 måneder til &lt; 18 år (administreret standarddosis på 12 mg/kg, 14 mg/kg eller 600 mg efter alder og legemsvægt) og hos voksne forsøgspersoner (administreret standarddosis på 600 mg) var den samme (tabel 7).
The pharmacokinetics of zanamivir in subjects 6 months to &lt; 18 years of age (administered standard dose of 12 mg/kg, 14 mg/kg or 600 mg according to age and body weight) and in adult subjects (administered standard dose of 600 mg) was similar (Table 7).
Børn og unge (6 år til under 18 år med en legemsvægt på mindre end 50 kg) samt spædbørn og børn (6 måneder til under 6 år) med kreatininclearance (CLcr) eller clearance via kontinuerlig nyresubstitutionsterapi (CLCRRT) &lt; 80 ml/min skal have en initialdosis efterfulgt af en passende vedligeholdelsesdosis to gange dagligt som vist i tabel 3, 4 og 5.
Children and adolescents (6 years to less than 18 years with a body weight less than 50 kg), and infants and children (6 months to less than 6 years) with creatinine clearance (CLcr) or clearance by continual renal replacement therapy (CLCRRT) &lt; 80 mL/min should receive an initial dose followed by an appropriate twice-daily maintenance dose as shown in Tables 3, 4 and 5.
Fase III-studie hos patienter med kompliceret influenza Der er udført et dobbeltblindet fase III-studie til vurdering af virkning, antiviral aktivitet og sikkerhed af zanamivir 600 mg intravenøst to gange dagligt sammenlignet med oral oseltamivir 75 mg to gange dagligt og 300 mg zanamivir intravenøst to gange dagligt hos indlagte patienter ( &gt; 16 år) med influenza.
A Phase III, double-blind, study was conducted to evaluate the efficacy, antiviral activity and safety of zanamivir 600 mg twice daily intravenously compared to oral oseltamivir 75 mg twice daily and 300 mg zanamivir twice daily intravenously in hospitalised patients ( &gt; 16 years of age) with influenza.
Voksne og børn (i alderen 6 år og derover med en legemsvægt på 50 kg eller mere) med kreatininclearance (CLcr) eller clearance via kontinuerlig nyresubstitutionsterapi (CLCRRT) &lt; 80 ml/min skal have en initialdosis på 600 mg efterfulgt af en vedligeholdelsesdosis to gange dagligt i henhold til deres nyrefunktion (tabel 2).
Adults and children (aged 6 years and over with a body weight of 50 kg or above) with creatinine clearance (CLcr) or clearance by continual renal replacement therapy (CLCRRT) &lt; 80 mL/min should receive an initial 600 mg dose followed by twice-daily maintenance dosing according to their renal function (Table 2).
&lt; De &gt; &lt; Du &gt; kan hjælpe ved at indberette alle de bivirkninger, &lt; De &gt; &lt; du &gt; får.
You can help by reporting any side effects you may get.
Influenzapositiv population, N Median-TTCR, dage Medianforskel mellem behandlinger, dage (95 % CI) p-vÃ¦rdi fra Wilcoxons tosidede rangsumtest Intensivafdeling/mekanisk ventilationundergruppe, N Median-TTCR, dage Medianforskel mellem behandlinger, dage (95 % CI) p-vÃ¦rdi fra Wilcoxons tosidede rangsumtest Symptomdebut â¤ 4 dage-undergruppe, N Median-TTCR, dage Medianforskel mellem behandlinger, dage (95 % CI) p-vÃ¦rdi fra Wilcoxons tosidede rangsumtest
Median difference between treatments, days (95% CI) p-value from Wilcoxon rank-sum 2-sided test Symptom onset 4 days subgroup, N Median TTCR, days
1 - &lt; 2 år 14 mg/kg
14 mg/kg
Neutrofiltal &lt; 1.000/µl eller hæmoglobin &lt; 8 g/dl
Neutrophil &lt; 1,000/µL or Haemoglobin &lt; 8 g/dL
CA-125-niveauet bør være normalt (eller udvise et fald på &gt; 90 % fra baseline) efter den sidste platin-behandling og bør være stabilt i mindst 7 dage.
The CA-125 levels should be normal (or a &gt; 90 % decrease in CA-125 from baseline) following their last platinum treatment, and be stable for at least 7 days.
Pancytopeni er set hos &lt; 1 % af de patienter, som fik niraparib.
Pancytopenia has been observed in &lt; 1 % of patients receiving niraparib.
De mest almindelige alvorlige bivirkninger hos &gt; 1 % (hyppigheder under behandling) var trombocytopeni og anæmi.
The most common serious adverse reactions &gt; 1 % (treatment-emergent frequencies) were thrombocytopenia and anaemia.
Varigheden af Zejula-behandlingen hos patienter, før de udviklede myelodysplastisk syndrom/akut myeloid leukæmi, varierede fra 1 måned til &gt; 2 år.
The duration of Zejula treatment in patients prior to developing MDS/AML varied from 1 month to &gt; 2 years.
til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000 til &lt; 1/1.000) og meget sjælden
Frequencies of occurrence of undesirable effects are defined as: very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000).
Randomiseringen inden for hver kohorte blev stratificeret efter tid til progression efter den næstsidste platinbehandling før inklusion i studiet (6 til &lt; 12 måneder og ≥ 12 måneder), brug eller ingen brug af bevacizumab sammen med det næstsidste eller sidste platinregime samt bedste respons i det seneste platinregime (komplet respons og delvis respons).
Randomisation within each cohort was stratified by time to progression after the penultimate platinum therapy before study enrollment (6 to &lt; 12 months and ≥ 12 months); use or not of bevacizumab in conjunction with the penultimate or last platinum regimen; and best response during the most recent platinum regimen (complete response and partial response).
Afbrydelse på grund af hypertension forekom hos &lt; 1 % af patienterne.
Discontinuation due to hypertension occurred in &lt; 1 % of patients.
Trombocyttal &lt; 100.000/μl
Platelet count &lt; 100,000/μL
I den farmakokinetiske populationsanalyse af data fra kliniske studier hos patienter havde eksisterende let nedsat nyrefunktion (ClCr &lt; 90 - ≥ 60 ml/min) og moderat nedsat nyrefunktion (ClCr &lt; 60 - ≥ 30 ml/min) ingen indflydelse på clearance af niraparib.
In the population pharmacokinetic analysis of data from clinical studies in patients, pre-existing mild (CLCr &lt; 90 - ≥ 60 ml/min) and moderate (CLCr &lt; 60 - ≥ 30 mL/min) renal impairment did not influence the clearance of niraparib.
En følsomhedsanalyse af investigator-PFS viste følgende resultater for gBRCA-mut-kohorten: HR 0,27 (95 %-KI*, 0,182-0,401; p &lt; 0,0001); median PFS 14,8 måneder (95 %-KI*, 12,0-16,6) for niraparib og median PFS 5,5 måneder (95 %-KI*, 4,9-7,2) for placebo, og for ikke-gBRCA-mutkohorten: HR 0,53 (95 %-KI*, 0,405-0,683; p &lt; 0,0001); median PFS 8,7 måneder (95 %-KI*, 7,3-10,0) for niraparib og median PFS 4,3 måneder (95 %-KI*, 3,7-5,5) for placebo.
A sensitivity analysis of investigator PFS showed the following results for the gBRCAmut cohort: HR 0.27 (95 % CI*, 0.182, 0.401; p &lt; 0.0001); median PFS 14.8 months (95% CI*, 12.0, 16.6) for niraparib and median PFS 5.5 months (95% CI*, 4.9, 7.2) for placebo, and for the non-gBRCAmut cohort: HR 0.53 (95 % CI*, 0.405, 0.683; p &lt; 0.0001); median PFS 8.7 months (95 % CI*, 7.3, 10.0) for niraparib and median PFS 4.3 months (95% CI*, 3.7, 5.5) for placebo.
Hvis trombocyttallet på noget tidspunkt er &lt; 75.000/μl,
• If platelet count is &lt; 75,000/μL at any time, resume at a reduced dose.
Studiet opfyldte sit primære formål med statistisk signifikant forbedret PFS ved vedligeholdelsesmonoterapi med niraparib sammenlignet med placebo i gBRCAmut-kohorten (HR 0,27, 95 %-KI* 0,173-0,410, p &lt; 0,0001) samt i ikke-gBRCAmut-kohorten overordnet set (HR 0,45, 95 %-KI* 0,338-0,607, p &lt; 0,0001).
The study met its primary objective of statistically significantly improved PFS for niraparib maintenance monotherapy compared with placebo in the gBRCAmut cohort (HR 0.27; 95 % CI* 0.173, 0.410; p &lt; 0.0001) as well as in the overall non-gBRCAmut cohort (HR 0.45; 95 % CI* 0.338, 0.607; p &lt; 0.0001).
I HRDneg-gruppen var hazard ratio 0,58 (95 %-KI, 0,361-0,922, p &lt; 0,0226).
In the HRDneg group, the hazard ratio was 0.58 (95 % CI, 0.361, 0.922; p = 0.0226).
Det primære tumorsted hos de fleste patienter ( &gt; 80 %) i hver kohorte var ovarierne.
The primary tumour site in most patients ( &gt; 80 %) within each cohort was the ovary; most patients ( &gt; 84 %) had tumours with serous histology.
I HRDpos-gruppen var hazard ratio 0,38 (95 %-KI, 0,243-0,586, p &lt; 0,0001).
In the HRDpos group, the hazard ratio was 0.38 (95 % CI, 0.243, 0.586; p &lt; 0.0001).
Ca. 76 % af patienterne med en lav blodpladeværdi ved baseline ( &lt; 180 × 109/l), som fik Zejula, oplevede trombocytopeni (alle grader), og 45 % af patienterne oplevede trombocytopeni af grad 3-4.
Approximately 76 % of patients with lower baseline platelets ( &lt; 180 × 109/L) who received Zejula experienced thrombocytopenia of any grade, and 45 % of the patients experienced Grade 3/4 thrombocytopenia.
Følgende definitioner gælder for den herefter anvendte terminologi for hyppighed: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000).
The following definitions apply to the frequency terminology used hereafter: very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100), rare (≥ 1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000).
Hvis der opstår tegn på hyperstimulation af ovariet, f.eks. serumestradiol &gt; 5.500 picog/ml eller &gt; 20.200 picomol/l og/eller ≥ 40 follikler i alt, bør hCG seponeres og patienten tilrådes at afstå fra coitus eller bruge en sikker præventionsmetode i mindst 4 dage.
Therefore, if signs of ovarian hyperstimulation occur such as serum oestradiol level &gt; 5,500 pg/mL or &gt; 20,200 pmol/L and/or ≥ 40 follicles in total, it is recommended that hCG be withheld and the patient be advised to refrain from coitus or to use barrier contraceptive methods for at least 4 days.
Agranulocytose (≥ 1/1.000 til &lt; 1/100) og neutropeni er rapporteret; derfor tilrådes regelmæssig monitorering af patienter i behandling med Mycophenolate mofetil Teva (se pkt.
Agranulocytosis (≥1/1000 to &lt; 1/100) and neutropenia have been reported; therefore regular monitoring of patients taking Mycophenolate mofetil Teva is advised (see section 4.4).
Gingival hyperplasi (≥ 1/100 til &lt; 1/10), colitis inklusive cytomegalovirus colitis (≥ 1/100 til &lt; 1/10),
Gingival hyperplasia (≥1/100 to &lt; 1/10), colitis including cytomegalovirus colitis (≥1/100 to &lt; 1/10),
I den tidlige posttransplantationsperiode ( &lt; 40 dage efter transplantationen) var den gennemsnitlige MPA AUC hos nyre-, hjerte- og levertransplanterede patienter ca. 30 % lavere og Cmax ca. 40 % lavere sammenlignet med den sene posttransplantationsperiode (3-6 måneder efter transplantationen).
In the early post-transplant period ( &lt; °40 days post-transplant), renal, cardiac and hepatic transplant patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower compared to the late post-transplant period (3 - 6°months post-transplant).
Hvis der optræder neutropeni (det absolutte neutrofillocyttal &lt; 1,3 x 103/µl), skal behandlingen med Mycophenolate mofetil Teva måske afbrydes eller stoppes.
If neutropenia develops (absolute neutrophil count &lt; °1.3°x 103/°µl) it may be appropriate to interrupt or discontinue Mycophenolate mofetil Teva.
pancreatitis (≥ 1/100 til &lt; 1/10) og intestinal villøs atrofi.
pancreatitis (≥1/100 to &lt; 1/10) and intestinal villous atrophy.
Gingival hyperplasi (≥ 1/100 til &lt; 1/10), colitis inklusive cytomegalovirus colitis (≥ 1/100 til &lt; 1/10), pancreatitis (≥ 1/100 til &lt; 1/10) og intestinal villøs atrofi.
Gingival hyperplasia (≥1/100 to &lt; 1/10), colitis including cytomegalovirus colitis (≥1/100 to &lt; 1/10), pancreatitis (≥1/100 to &lt; 1/10) and intestinal villous atrophy.
Hos nyretransplanterede patienter med svær, kronisk nedsat nyrefunktion (glomerulær filtration &lt; 25 ml/min1,73 m2), bortset fra perioden umiddelbart efter transplantionen, bør doser på mere end 1 g administreret to gange dagligt undgås.
In renal transplant patients with severe chronic renal impairment (glomerular filtration rate &lt; 25 mL/min/1.73°m2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided.
Bivirkninger, som var ”sandsynligt relateret” eller ”muligt relateret” til mycophenolatmofetil, og som rapporteredes hos ≥ 1/10 og hos ≥ 1/100 til &lt; 1/10 af de patienter, der blev behandlet med mycophenolatmofetil i de kontrollerede kliniske studier med nyre- (2 g data), hjerte- og levertransplanterede patienter er anført i den følgende tabel.
Adverse reactions, probably or possibly related to mycophenolate mofetil, reported in ≥1/10 and in ≥1/100 to &lt; 1/10 of patients treated with mycophenolate mofetil in the controlled clinical trials of renal (2°g data), cardiac and hepatic transplant patients are listed in the following table.
Til patienter med en legemsoverflade &gt; 1,5 m2 kan der ordineres Mycophenolate mofetil Teva-kapsler i en dosis på 1 g to gange daglig (daglig dosis: 2 g).
Patients with a body surface area greater than 1.5 m2 may be prescribed Mycophenolate mofetil Teva capsules at a dose of 1 g twice daily (2 g daily dose).
Hyppighederne defineres som: meget almindelig ( &gt; 1/10), almindelig ( &gt; 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100), rare (≥ 1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000) and not known (cannot be estimated from the available data).
Behandling med OCALIVA 10 mg eller OCALIVA-titrering (5 mg til 10 mg) resulterede i klinisk og statistisk signifikant stigning (p &lt; 0,0001) i antallet af patienter, som nåede det primære endepunkt, på alle tidspunkter i studiet (se tabel 3).
Treatment with OCALIVA 10 mg or OCALIVA titration (5 mg to 10 mg) resulted in clinically and statistically significant increases (p &lt; 0.0001) relative to placebo in the number of patients achieving the primary composite endpoint at all study time points (see Table 3).
ALP &lt; 1,67 gange ULN, n
ALP less than 1.67-times ULN, n (%)
Patienterne blev inkluderet i studiet, hvis alkalisk fosfatase (ALP) var ≥ 1,67 gange den øvre normalgrænse (ULN), og/eller hvis total-bilirubin (TB) var &gt; 1 x ULN, men &lt; 2 x ULN.
Patients were included in the trial if the alkaline phosphatase (ALP) was greater than or equal to 1.67 times upper limit of normal (ULN) and/or if total bilirubin was greater than 1 x ULN but less 2 x ULN.
51 PBC-patienter med baseline-ALP ≥ 1,67 gange ULN og/eller total-bilirubin &gt; ULN blev evalueret for biokemisk respons på OCALIVA som monoterapi (24 patienter fik OCALIVA 10 mg én gang dagligt, og 27 patienter fik placebo) i en puljet analyse af data fra det randomiserede, dobbeltblinde, placebokontrollerede 12-måneders fase III-studie og fra et randomiseret, dobbeltblindt, placebokontrolleret 3-måneders studie.
Fifty-one PBC patients with baseline ALP 1.67-times ULN or greater and/or total bilirubin greater than ULN were evaluated for a biochemical response to OCALIVA as monotherapy (24 patients received OCALIVA 10 mg once daily and 27 patients received placebo) in a pooled analysis of data from the phase III randomised, double-blind, placebo-controlled 12 month study (POISE) and from a randomised, double-blind, placebo-controlled, 3- month study.
OCALIVA-titrering (5 mg én gang dagligt i de første 6 måneder med mulighed for stigning til 10 mg én gang dagligt i de sidste 6 måneder, hvis patienten tolererede OCALIVA, men havde ALP ≥ 1,67 gange ULN og/eller total-bilirubin &gt; ULN eller &lt; 15 % reduktion i ALP) eller placebo.
or OCALIVA titration (5 mg once daily for the initial 6 months, with the option to increase to 10 mg once daily for the last 6 months, if the patient was tolerating OCALIVA but had ALP 1.67-times the ULN or greater, and/or total bilirubin above the ULN, or less than 15% ALP reduction) or placebo.
Mantel-Haenszel General Association test stratificeret efter intolerans over for UDCA og ALP &gt; 3 gange ULN og/eller ASAT &gt; 2 gange ULN og/eller total-bilirubin &gt; ULN før behandling.
P-values are obtained using the Cochran-Mantel-Haenszel General Association test stratified by intolerance to UDCA and pretreatment ALP greater than 3-times ULN and/or AST greater than 2-times ULN and/or total bilirubin greater than ULN.