FrancophonIA/ELRC3.0 huggingface dataset:
English: In the clinical study conducted, the development of antibodies against the PEG moiety of peginterferon beta-1a had no discernible impact on safety, or clinical efficacy (including annualised relapse rate, MRI lesions, and disability progression).
Danish: I det udførte kliniske studie, havde udvikling af antistoffer mod PEG-fraktionen af peginterferon beta-1a ingen påviselig indvirkning på sikkerhed eller klinisk virkning (herunder attakfrekvens på årsbasis, MR-læsioner og udvikling af handicap).
English: Choose the correct syringe from a pack.
Danish: Vælg den korrekte sprøjte fra pakken.
English: Dose 1
Danish: Dosis 1
English: Precautions to be taken before handling or administering the medicinal product Once removed from the refrigerator, Plegridy should be allowed to warm to room temperature (up to 25°C) for about 30 minutes prior to injection.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Når Plegridy tages ud af køleskabet, skal det stå, indtil det har nået stuetemperatur (op til 25 °C) i ca. 30 minutter, før det indgives.
English: Upon repeated dosing with peginterferon beta-1a of sexually mature female monkeys, effects on menstrual cycle length and progesterone levels were observed.
Danish: Efter gentagen dosering med peginterferon beta-1a hos kønsmodne hunaber blev der observeret virkninger på menstruationscyklussens længde og progesteronniveauerne.
English: • Let the injection site dry before injecting the dose.
Danish: • Lad injektionsstedet tørre, før du injicerer dosen.
English: Injection site reactions, including injection site necrosis, have been reported with the use of subcutaneous interferon beta.
Danish: Der er rapporteret reaktioner på injektionsstedet, herunder nekrose på injektionsstedet, i forbindelse med anvendelse af subkutan interferon beta.
English: In both patients, cell counts recovered after discontinuation of Plegridy.
Danish: Hos begge patienter normaliseredes celletallene efter seponering af Plegridy.
English: Do not inject directly into your belly button.
Danish: Du må ikke injicere direkte i navlen.
English: • Let the Plegridy pre-filled syringe warm to room temperature for at least 30 minutes.
Danish: • Lad den fyldte Plegridy-sprøjte varme op til stuetemperatur i mindst 30 minutter.
English: Giving your injection Step 5: Remove the Plegridy pen cap a. Pull the pen cap straight off and set it aside (see Figure E).
Danish: Foretag injektionen Trin 5: Tag hætten af Plegridy-pennen a. Træk hætten lige af, og læg den til side (se figur E).
English: Subcutaneous peginterferon beta-1a resulted in approximately 4-, 9-, and 13-fold higher exposure (AUC168h) values and approximately 2-, 3.5- and 5-fold higher Cmax, following single doses of 63 (6 MIU), 125 (12 MIU), and 188 (18 MIU) micrograms respectively, compared to intramuscular administration of 30 (6 MIU) micrograms non-pegylated beta-1a.
Danish: Subkutan peginterferon beta-1a resulterede i ca. 4, 9 og 13 gange højere eksponeringsværdier (AUC168h) og ca. 2, 3,5 og 5 gange højere Cmax efter enkeltdoser på henholdsvis 63 (6 MIU), 125 (12 MIU) og 188 (18 MIU) mikrogram sammenlignet med intramuskulær administration af 30 (6 MIU) mikrogram non-pegyleret beta-1a.
English: Following subcutaneous administration of peginterferon beta-1a in multiple sclerosis patients, the peak concentration was reached between 1 to 1.5 days post-dose.
Danish: Efter subkutan administration af peginterferon beta-1a hos patienter med MS blev den maksimale koncentration nået 1-1,5 dage efter dosering.
English: Initiation Pack
Danish: Startpakke
English: Patients should be advised to rotate sites for subcutaneous injections.
Danish: Patienten bør rådes til at skifte imellem injektionssteder for de subkutane injektioner.
English: Component of a multipack, cannot be sold separately.
Danish: Må ikke sælges separat.
English: Direct comparative data for Plegridy versus non-pegylated interferon beta or data on efficacy of Plegridy after switching from a non-pegylated interferon beta are not available.
Danish: Direkte sammenlignelige data for Plegridy og non-pegyleret interferon beta eller effekten af Plegridy efter skift fra non-pegyleret interferon beta foreligger ikke.
English: Do not inject into an area of the body where the skin is irritated, tender, red, bruised, tattooed, infected, or scarred.
Danish: Du må ikke injicere et sted på kroppen, hvor huden er irriteret, øm, rød, har blå mærker, er tatoveret, inficeret eller arret.
English: the annual relapse rate at 1 year was 0.39 for placebo, 0.29 for Plegridy every 4 weeks and 0.25 for Plegridy every 2 weeks.
Danish: (n=1.401) var den årlige attakfrekvens ved 1 år 0,39 for placebo, 0,29 for Plegridy hver 4. uge og 0,25 for Plegridy hver 2. uge.
English: Increased concentrations of neopterin were observed in both healthy subjects and multiple sclerosis patients treated with Plegridy, with a sustained and prolonged elevation over 10 days compared to 5 days observed for non-pegylated interferon beta-1a.
Danish: Der blev observeret forhøjede koncentrationer af neopterin hos både raske studiespersoner og MS-patienter, som blev behandlet med Plegridy, med en vedvarende og langvarig forhøjelse over 10 dage sammenlignet med 5 dage for non-pegyleret interferon beta-1a.
English: The most common adverse drug reactions (ADR) (at a higher incidence than placebo) for Plegridy 125 micrograms subcutaneously every 2 weeks were injection site erythema, influenza like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia.
Danish: De hyppigste bivirkninger (højere incidens end placebo) for Plegridy 125 mikrogram subkutant hver 2. uge var erytem på injektionsstedet, influenzalignende sygdom, pyreksi, hovedpine, myalgi, kulderystelser, smerter på injektionsstedet, asteni, pruritus på injektionsstedet og artralgi.
English: What you need to know before you use Plegridy Do not use Plegridy
Danish: Det skal du vide, før du begynder at bruge Plegridy Brug ikke Plegridy
English: Preparing for your injection Step 1: Remove your pen from the fridge.
Danish: Klargøring af injektionen Trin 1: Tag pennen ud af køleskabet.
English: Injection site reactions (e.g. injection site erythema, pain, pruritus, or oedema) were reported by 66% of patients who received Plegridy 125 micrograms every 2 weeks compared to 11% of patients receiving placebo.
Danish: Reaktioner på injektionsstedet (f.eks. erytem, smerter, pruritus eller ødem på injektionsstedet) blev rapporteret af 66 % af de patienter, som fik Plegridy 125 mikrogram hver 2. uge, kontra 11 % af de patienter, som fik placebo.
English: Do not use the pen if it has been dropped or is visibly damaged.
Danish: Du må ikke bruge pennen, hvis du har tabt den, eller der er synlige skader på den.
English: Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or light-headedness.
Danish: Symptomerne kan være flere blå mærker end normalt, blødning, feber, følelse af ekstrem svaghed, hovedpine, svimmelhed eller uklarhed.
English: Plegridy is to be injected under the skin (subcutaneous injection).
Danish: Plegridy skal injiceres under huden (subkutan injektion).
English: The duration of this response was sustained and prolonged for Plegridy, with elevations detected up to 15 days compared to 4 days for non-pegylated interferon beta-1a.
Danish: Varigheden af dette respons var vedvarende og langvarigt for Plegridy, idet der blev påvist forhøjelser i op til 15 dage sammenlignet med 4 dage for non-pegyleret interferon beta-1a.
English: Each haemodialysis reduced peginterferon beta-1a concentration by approximately 24%, suggesting that haemodialysis partially removes peginterferon beta-1a from systemic circulation.
Danish: Hver hæmodialyse reducerede peginterferon beta-1a-koncentrationen med ca. 24 %, hvilket indikerer, at hæmodialyse delvist fjerner peginterferon beta-1a fra det systemiske kredsløb.
English: You must only inject Plegridy once every 2 weeks.
Danish: Du må kun injicere Plegridy én gang hver 2. uge.
English: Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
Danish: Det har været rapporteret, at interferoner reducerer aktiviteten af de leverenzymer, der er afhængige af CYP, hos mennesker og dyr.
English: After your injection Step 9: Disposing of the used Plegridy pre-filled syringe
Danish: Efter injektionen Trin 9: Bortskaffelse af den brugte fyldte Plegridy-sprøjte
English: One patient out of 1468 patients who received Plegridy in clinical studies experienced an injection site necrosis which resolved with standard medical treatment.
Danish: En patient ud af 1.468 patienter, der fik Plegridy i et klinisk studie, havde nekrose på injektionsstedet, som forsvandt efter standardbehandling.
English: - If you have trouble handling the pen, ask your doctor or nurse who may be able to help.
Danish: - Hvis du har svært ved at håndtere pennen, så spørg din læge eller sygeplejerske til råds, de kan sikkert hjælpe dig.
English: The most commonly reported adverse reaction leading to discontinuation in patients treated with Plegridy 125 micrograms subcutaneously every 2 weeks was influenza-like illness (<1%).
Danish: Den hyppigst indberettede bivirkning, som medførte seponering hos patienter, der var i behandling med Plegridy 125 mikrogram subkutant hver 2. uge, var influenzalignende sygdom (<1 %).
English: MRI endpoints
Danish: MR-endepunkter
English: Dosage schedule
Danish: Doseringsskema
English: You could get a needle injury or the pen may lock.
Danish: Du kan stikke dig på kanylen, eller pennen kan låse.
English: Do not remove the cap until you are ready to inject.
Danish: Du må ikke tage hætten af, før du er klar til at injicere.
English: Step 7: Inject medicine
Danish: Trin 7: Injicér medicin
English: - Serious liver or kidney problems
Danish: - Alvorlige lever- eller nyreproblemer
English: Laboratory findings suggestive of TMA include decreased platelet counts, increased serum lactate dehydrogenase (LDH) due to haemolysis and schistocytes (erythrocyte fragmentation) on a blood film.
Danish: Laboratoriefund, som tyder på TMA, kan være nedsat antal trombocytter, forhøjet laktatdehydrogenase (LDH) (forårsaget af hæmolyse) i serum og skistocytter (erytrocytfragmentering) på en blodfilm.
English: Treatment with Plegridy should not be restarted (see section
Danish: Behandlingen med Plegridy må ikke genstartes (se pkt.
English: The incidence of potentially clinically significant decreases in lymphocyte counts (<0.5 x 109/L) (<1%), neutrophil counts (≤1.0 x 109/L) (<1%) and platelet counts (≤100 x 109/L) (≤1%) was similar in Plegridy-treated patients compared to placebotreated patients.
Danish: Incidensen af potentielt klinisk signifikante fald i lymfocyttal (<0,5 x 109/l) (<1 %), neutrofiltal (≤1,0 x 109/l) (<1 %) og trombocyttal (≤100 x 109/l) (≤1 %) var sammenlignelig mellem patienter, som fik Plegridy, og patienter, som fik placebo.
English: The incidence of potentially clinically significant decreases in RBC counts (<3.3 x 1012/L) was similar in Plegridy-treated patients compared to placebo-treated patients.
Danish: Incidensen af potentielt klinisk signifikante fald i RBC-tal (<3,3 x 1012/l) var sammenlignelig mellem patienter, som fik Plegridy, og patienter, som fik placebo.
English: Accordingly, the half-life (t1/2) of peginterferon beta-1a is approximately 2-fold longer than non-pegylated interferon beta-1a in healthy volunteers.
Danish: Derfor er halveringstiden (t1/2) for peginterferon beta-1a ca. 2 gange længere end non-pegyleret interferon beta1a hos raske frivillige.
English: The mean steady state clearance of peginterferon beta-1a was 4.1 ± 0.4 L/hr.
Danish: Den gennemsnitlige steady state-clearance af peginterferon beta-1a var 4,1 ± 0,4 l/time.
English: You need to inject Plegridy once every 2 weeks.
Danish: Du skal injicere Plegridy én gang hver 2. uge.
English: Cytopenias, including rare severe neutropenia and thrombocytopenia, have been observed in patients treated with Plegridy.
Danish: Der er observeret cytopenier, herunder sjælden svær neutropeni og trombocytopeni, hos patienter i behandling med Plegridy.
English: Sodium acetate trihydrate Acetic acid, glacial Arginine hydrochloride Polysorbate 20
Danish: Natriumacetattrihydrat Krystalliseret eddikesyre Argininhydrochlorid Polysorbat 20
English: The needle cover will extend to cover the needle and will lock (see Figure I).
Danish: Kanylehætten skydes automatisk frem, så den dækker kanylen og låser (se figur I).
English: Pre-Filled Pen Initiation Pack
Danish: Fyldt pen, startpakke
English: Mean white blood cell counts remained within normal limits in patients treated with Plegridy.
Danish: De gennemsnitlige leukocyttal lå inden for normalgrænserne hos patienter, der blev behandlet med Plegridy.
English: b. Firmly press and hold down the pen on your injection site.
Danish: b. Tryk ned med et fast tryk, og hold pennen på injektionsstedet.
English: Step 3: Check your Plegridy pen (see Figure C)
Danish: Trin 3: Kontrollér Plegridy-pennen (se figur C)
English: Plegridy should be administered with caution to patients with previous depressive disorders (see section 4.3).
Danish: Plegridy bør administreres med forsigtighed til patienter med tidligere depressive lidelser (se pkt.
English: Thrombotic microangiopathy including thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome*
Danish: trombotisk trombocytopenisk purpura/hæmolytisk-uræmisk syndrom*
English: Do not reuse your Plegridy pen.
Danish: Du må ikke genbruge din Plegridy-pen.
English: Note: After the pen has been removed from the injection site, the needle cover will lock to protect against needle injury.
Danish: Bemærk: Når pennen er fjernet fra injektionsstedet, låser kanylehætten, så du ikke stikker dig på kanylen.
English: Patients exposed to Plegridy every 2 weeks showed statistically significant reductions compared to patients exposed to Plegridy every 4 weeks over 2 years in a post-hoc analysis for endpoints including ARR (24%, p=0.0209), the risk of relapse (24%, p=0.0212), the risk of disability progression with 24 week confirmation (36%, p=0.0459), and MRI endpoints (new/enlarging T2 60%, Gd+ 71%, and new T1 hypointense lesions 53%; p<0.0001 for all).
Danish: Patienter, som blev eksponeret for Plegridy hver 2. uge, viste statistisk signifikante reduktioner sammenlignet med patienter, som blev eksponeret for Plegridy hver 4. uge over 2 år i en post hoc-analyse for endepunkter, herunder ARR (24 %, p=0,0209), risikoen for attak (24 %, p=0,0212), risikoen for udvikling af handicap med 24 ugers bekræftelse (36 %, p=0,0459) og MRendepunkter (nye/voksende T2 60 %, Gd+ 71 % og nye hypointense T1-læsioner 53 %; p<0,0001 for alle).
English: - Hypersensitivity to natural or recombinant interferon beta or peginterferon or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for naturligt eller rekombinant interferon beta eller peginterferon eller over for et eller flere af hjælpestofferne anført i pkt.
English: • Keep Plegridy pen and all medicines out of reach of children.
Danish: • Plegridy-pennen og al medicin skal opbevares utilgængeligt for børn.
English: The incidence of hepatic transaminase increases was greater in patients receiving Plegridy compared to placebo.
Danish: Incidensen af forhøjede levertransaminaser var større hos patienter, som fik Plegridy, end hos patienter, som fik placebo.
English: Plegridy also significantly reduced the risk of relapse by 39% (p=0.0003), the risk of sustained disability progression confirmed at 12 weeks by 38% (p=0.0383) and at 24 weeks (post-hoc analysis) by 54% (p=0.0069), the number of new or newly enlarging T2 lesions by 67% (p<0.0001), the number of Gd-enhancing lesions by 86% (p<0.0001) and the number of new T1 hypointense lesions compared to placebo by 53% (p<0.0001).
Danish: Plegridy reducerede også signifikant risikoen for attakker med 39 % (p=0,0003), risikoen for vedvarende udvikling af handicap bekræftet ved 12 uger med 38 % (p=0,0383) og ved 24 uger (post hoc-analyse) med 54 % (p=0,0069), antallet af nye eller nyligt voksende T2-læsioner med 67 % (p<0,0001), antallet af Gd-forstærkende læsioner med 86 % (p<0,0001) og antallet af nye hypointense T1-læsioner i forhold til placebo med 53 % (p<0,0001).
English: Talk to your doctor, pharmacist or nurse before injecting Plegridy if you have any of the conditions listed below.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før Plegridy injiceres, hvis du har en af nedenstående sygdomme.
English: Plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis (see section 5.1).
Danish: Plegridy er indiceret til behandling af voksne patienter med attakvis multipel sklerose (MS) (se pkt.
English: Caution should be used and close monitoring considered when administering Plegridy to patients with severe hepatic impairment.
Danish: Der bør udvises forsigtighed og tæt overvågning bør overvejes ved administration af Plegridy til patienter med svært nedsat leverfunktion.
English: (may affect more than 1 in 10 people) - Flu-like symptoms.
Danish: (kan forekomme hos op til 1 ud af 10 patienter) - Influenzalignende symptomer.
English: - Injection site damage
Danish: - Skader på injektionsstedet
English: Pulmonary arterial hypertension has been seen at various time points during treatment, including several years after starting treatment with interferon beta-products.
Danish: Pulmonal arteriel hypertension er observeret på forskellige tidspunkter under behandlingen herunder op til flere år efter påbegyndelse af behandling med interferon beta-produkter.
English: Step 7: Remove the Plegridy pen from your injection site a. After the clicking sound has stopped, lift the pen from your injection site.
Danish: Trin 7: Fjern Plegridy-pennen fra injektionsstedet a. Løft pennen fra injektionsstedet, når kliklydene er stoppet.
English: • For the Initiation Pack injections, you can use the record table printed on the inside of the lid of the Initiation Pack.
Danish: • Til injektionerne i startpakken kan du bruge registreringsskemaet på indersiden af låget på startpakken.
English: Step 9: Dispose of used Plegridy pen
Danish: Trin 9: Bortskaffelse af den brugte Plegridy-pen
English: *The active substance, peginterferon beta-1a, is a covalent conjugate of interferon beta-1a, produced in Chinese Hamster Ovary cells, with 20,000 Dalton (20 kDa) methoxy poly(ethyleneglycol) using an O-2-methylpropionaldehyde linker.
Danish: *Det aktive stof, peginterferon beta-1a, er et kovalent konjugat af interferon beta-1a, som fremstilles af kinesiske hamsterovarieceller med 20.000 Dalton (20 kDa) methoxy poly(etylenglykol) med en O-2-metylpropionaldehydkobling.
English: Early clinical features include thrombocytopenia, new onset hypertension, fever, central nervous system symptoms (e.g. confusion, paresis) and impaired renal function.
Danish: Tidlige kliniske manifestationer kan være trombocytopeni, nyindtrådt hypertension, feber, symptomer fra centralnervesystemet (f.eks. forvirring, parese) og nedsat nyrefunktion.
English: If you get some or all of these symptoms: - Increased bruising or bleeding - Extreme weakness - Headache, dizziness or light-headedness
Danish: Hvis du får nogle af eller alle disse symptomer: - Flere blå mærker eller blødninger end normalt - Følelse af ekstrem svaghed - Hovedpine eller svimmelhed
English: - Throw away any pen that is kept out of the fridge for more than 30 days.
Danish: Kassér penne, som har været opbevaret uden for køleskab i mere end 30 dage.
English: One injection of Plegridy 125 micrograms every 14 days (every two weeks).
Danish: Én injektion med Plegridy 125 mikrogram hver 14. dag (hver 2. uge).
English: The dose indicates the quantity of the interferon beta-1a moiety of peginterferon beta-1a without consideration of the PEG moiety attached.
Danish: Dosis angiver mængden af interferon beta-1a-fraktionen af peginterferon beta-1a uden hensyntagen til den tilkoblede PEG-fraktion.
English: What Plegridy is
Danish: Hvad er Plegridy
English: A single-dose study in healthy subjects and subjects with various degrees of renal impairment (mild, moderate, and severe renal impairment as well as subjects with end state renal disease) showed a fractional increase in AUC (13-62%) and Cmax (42-71%) in subjects with mild (estimated glomerular filtration rate 50 to ≤80 mL/min/1.73m2), moderate (estimated glomerular filtration rate 30 to <50 mL/min/1.73m2), and severe (estimated glomerular filtration rate <30 mL/min/1.73m2) renal impairment, compared to subjects with normal renal function (estimated glomerular filtration rate >80 mL/min/1.73m2).
Danish: Et enkeltdosisstudie med raske studiedeltagere og deltagere med forskellige grader af nedsat nyrefunktion (let, moderat og svært nedsat nyrefunktion samt deltagere med terminal nyresygdom) viste en minimal stigning i AUC (13-62 %) og Cmax (42-71 %) hos studiedeltagere med let (estimeret glomerulær filtrationsrate på 50 til ≤80 ml/min./1,73m2), moderat (estimeret glomerulær filtrationsrate på 30 til <50 ml/min./1,73m2) og svært (estimeret glomerulær filtrationsrate på <30 ml/min./1,73m2) nedsat nyrefunktion i forhold til studiedeltagere med normal nyrefunktion (estimeret glomerulær filtrationsrate >80 ml/min./1,73m2).
English: • Close the pack and put pack back in the fridge after removing one pre-filled syringe.
Danish: • Luk pakningen, og læg den tilbage i køleskabet, når du har taget én fyldt sprøjte.
English: Do not use this medicine after the expiry date which is stated on the carton and the label after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Mean [Median] no. of Gd-enhancing lesions (range) % reduction vs placebo P-value p<0.0001
Danish: Gennemsnitligt [Median for] antal Gdforstærkende læsioner (interval) % reduktion kontra placebo P-værdi p<0,0001
English: Supplies needed for your plegridy injection
Danish: Ting, du skal bruge til din Plegridy-injektion
English: Decreased peripheral blood counts in all cell lines, including rare pancytopenia and severe thrombocytopenia, have been reported in patients receiving interferon beta.
Danish: Der er rapporteret nedsatte perifere blodtællinger i alle cellelinjer, herunder sjælden pancytopeni og svær trombocytopeni hos patienter, som fik interferon beta.
English: Dose 3
Danish: Dosis 3
English: With your other hand, firmly grasp needle cover and pull it straight off the needle (See Figure F).
Danish: Tag godt fat om kanylehætten med den anden hånd, og træk den lige af kanylen (se figur F).
English: - Headache - Muscle pain (myalgia) - Pain in your joints, arms, legs or neck (arthralgia) - Chills - Fever - Feeling weak and tired (asthenia) - Redness, itching or pain around the place you have injected
Danish: - Hovedpine - Muskelsmerter (myalgi) - Smerter i led, arme, ben eller hals (artralgi) - Kulderystelser - Feber - Følelse af svaghed og træthed (asteni) - Rødme, kløe eller smerter omkring injektionsstedet
English: Do not use your syringe if it has been dropped or is visibly damaged.
Danish: Du må ikke bruge din sprøjte, hvis du har tabt den, eller der er synlige skader på den.
English: Plegridy is interferon beta-1a conjugated to a single, linear 20 kDa methoxy poly(ethyleneglycol) molecule at the alpha-amino group of the N-terminal amino acid residue.
Danish: Plegridy er interferon beta-1a konjugeret til et enkelt, lineært 20 kDa methoxy poly(etylenglykol) molekyle ved alfa-aminogruppen i N-terminalens aminosyrerest.
English: Worsening of cardiac disease has been reported in patients receiving interferon beta.
Danish: Der er indberetninger om forværring af hjertesygdom hos patienter under behandling med interferon beta.
English: How long to use Plegridy
Danish: Hvor længe skal du bruge Plegridy
English: - If you have trouble handling the syringe, ask your doctor or nurse who may be able to help.
Danish: - Hvis du har svært ved at håndtere sprøjten, så spørg din læge eller sygeplejerske til råds, de kan sikkert hjælpe dig.
English: HR 95% CI P-value p=0.0383
Danish: 95 % CI P-værdi p=0,0383