FrancophonIA/ELRC3.0 huggingface dataset:
English: Following multiple doses of tezacaftor and ivacaftor for 10 days, subjects with moderately impaired hepatic function (Child-Pugh Class B, score 7 to 9) had an approximately 36% increase in AUC and a 10% increase in Cmax for tezacaftor, and a 50% increase in ivacaftor AUC compared with healthy subjects matched for demographics.
Danish: Efter flere doser af tezacaftor og ivacaftor i 10 dage havde personer med moderat nedsat leverfunktion (Child-Pugh klasse B, score 7 til 9) en ca. 36 % stigning i AUC og en 10 % stigning i Cmax for tezacaftor og en 50 % stigning i AUC for ivacaftor sammenlignet med raske personer med en matchende demografi.
English: • Inner ear disorder (feeling dizzy or spinning)
Danish: • sygdom i det indre øre (svimmelhed eller følelse af at snurre rundt)
English: tacrolimus, sirolimus and everolimus.
Danish: Disse omfatter ciclosporin, tacrolimus, sirolimus og everolimus.
English: Long-term safety and efficacy rollover study (Study 3) An ongoing, Phase 3, open-label, multicenter, rollover, 96-week study to evaluate the safety and efficacy of long-term treatment with Symkevi in combination with ivacaftor is being conducted with patients from Studies 1 (n=459) and 2 (n=226).
Danish: Langtidsrolloverstudie af sikkerhed og virkning (studie 3) Et igangværende fase III, åbent, 96-ugers rollover-multicenterstudie til evaluering af sikkerhed og virkning af langvarig behandling med Symkevi i kombination med ivacaftor udføres aktuelt med patienter fra studie 1 (n=459) og 2 (n=226).
English: Table 6: Primary and key secondary efficacy analyses, full analysis set (Study 2) Analysis
Danish: Tabel 6: Primære og vigtigste sekundære virkningsanalyser, fuldstændigt analysesæt (studie 2)
English: M1-IVA has approximately one-sixth the potency of ivacaftor and is considered pharmacologically active.
Danish: M1-IVA har ca. en sjettedel af ivacaftors styrke og anses for at være farmakologisk aktiv.
English: for patients from Study 1 and Week 16 for patients from Study 2.
Danish: Der blev udført en interimanalyse til og med uge 24 for patienter i studie 1 og til og med uge 16 for patienter i studie 2.
English: There are no data available on the effect of ivacaftor on fertility in humans.
Danish: Der foreligger ingen data for den mulige påvirkning af ivacaftor på fertiliteten hos mennesker.
English: • Medicines for diabetes.
Danish: • Medicin mod sukkersyge.
English: The pharmacokinetics of tezacaftor and ivacaftor are similar between healthy adult volunteers and patients with CF.
Danish: Tezacaftors og ivacaftors farmakokinetik er sammenlignelig for raske voksne frivillige og for patienter med CF.
English: Symkevi in combination with ivacaftor has been studied with an estrogen/progesterone oral contraceptive and was found to have no significant effect on the exposures of the hormonal contraceptive.
Danish: Symkevi i kombination med ivacaftor er blevet undersøgt med oral kontraception indeholdende østrogen/progesteron, og der blev ikke fundet nogen signifikant virkning på eksponeringen for hormonel kontraception.
English: Symkevi in combination with ivacaftor has been studied with pitavastatin, an OATP1B1 substrate, and was found to have no clinically relevant effect on the exposure of pitavastatin (1.24 fold increased exposure based on AUC).
Danish: Symkevi i kombination med ivacaftor er blevet undersøgt med pitavastatin, et OATP1B1-substrat, og der blev ikke fundet nogen klinisk relevant virkning på eksponeringen for pitavastatin (1,24 gange forøget eksponering baseret på AUC).
English: As presented in Table 8, the pharmacokinetic parameters of tezacaftor and ivacaftor in adolescents (12 to 17 years) are comparable to those in adults when given in combination.
Danish: Som det kan ses i tabel 8 er de farmakokinetiske parametre for tezacaftor og ivacaftor hos unge (12 til 17 år) sammenlignelige med parametrene hos voksne, når de gives i kombination.
English: This finding has not been observed in fetuses derived from rat dams treated with ivacaftor on gestation Days 7 to 17, in rat pups exposed to ivacaftor through milk ingestion up to postnatal Day 20, in 7-week-old rats, nor in 3.5- to 5-month-old dogs treated with ivacaftor.
Danish: Dette fund er ikke blevet observeret hos fostre fra hunrotter behandlet med ivacaftor på gestationsdag 7 til 17, hos rotteafkom eksponeret for ivacaftor via diegivning op til postnataldag 20, hos 7 uger gamle rotter eller hos 3,5 til 5 måneder gamle hunde behandlet med ivacaftor.
English: Therefore, caution should be used when P-gp inhibitors are used with Symkevi.
Danish: Derfor skal der udvises forsigtighed, når der anvendes P-gp-hæmmere sammen med Symkevi.
English: Symkevi in combination with Ivacaftor N=248
Danish: Symkevi i kombination med ivacaftor N=248
English: Based on these results, a modified regimen of Symkevi is recommended for patients with moderate hepatic impairment (see Table 2 in section 4.2).
Danish: Baseret på disse resultater anbefales et modificeret program med Symkevi for patienter med moderat nedsat leverfunktion (se tabel 2, pkt.
English: • rifampicin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John's wort (Hypericum perforatum)
Danish: • rifampicin, rifabutin, phenobarbital, carbamazepin, phenytoin og prikbladet perikon (Hypericum perforatum)
English: Subgroup analysis of patients with severe lung dysfunction (ppFEV1 <40) Study 1 and Study 2 included a total of 39 patients treated with Symkevi in combination with ivacaftor with ppFEV1 <40.
Danish: Undergruppeanalyse af patienter med svær lungedysfunktion (ppFEV1<40) Studie 1 og studie 2 inkluderede i alt 39 patienter i behandling med Symkevi i kombination med ivacaftor med ppFEV1<40.
English: For ivacaftor to function CFTR protein must be present at the cell surface.
Danish: For at ivacaftor kan fungere, skal CFTR-proteinet være til stede på celleoverfladen.
English: As a precautionary measure, it is preferable to avoid the use of therapy during pregnancy.
Danish: For en sikkerheds skyld bør behandling undgås under graviditet.
English: In vitro studies showed that ivacaftor is not a substrate for OATP1B1, OATP1B3, or P-gp.
Danish: In vitro-studier viste, at ivacaftor ikke er et substrat for OATP1B1, OATP1B3 eller P-gp.
English: Patients with a history of colonization with organisms associated with a more rapid decline in pulmonary status such as Burkholderia cenocepacia, Burkholderia dolosa, or Mycobacterium abscessus, or who had two or more abnormal liver function tests at screening (ALT, AST, AP, GGT
Danish: Patienter med tidligere kolonisering med organismer forbundet med et stejlere fald i lungestatus, såsom Burkholderia cenocepacia, Burkholderia dolosa eller Mycobacterium abscessus, eller som havde to eller flere unormale leverfunktionstests ved screening (ALAT, ASAT, AP, GGT ≥3 x ULN
English: • The active substances are tezacaftor and ivacaftor.
Danish: • Aktive stoffer: tezacaftor og ivacaftor.
English: BMI increased in both treatment groups (Symkevi in combination with ivacaftor: 0.18 kg/m2, placebo: 0.12 kg/m2).
Danish: BMI steg i begge behandlingsgrupper (Symkevi i kombination med ivacaftor: 0,18 kg/m2, placebo: 0,12 kg/m2).
English: Co-administration of ivacaftor with rifampicin, a strong CYP3A inducer, significantly decreased ivacaftor exposure [area under the curve (AUC)] by 89%.
Danish: Samtidig administration af ivacaftor og rifampicin, en potent CYP3A-induktor, nedsatte eksponeringen for ivacaftor signifikant [arealet under kurven (AUC)] med 89 %.
English: Tezacaftor facilitates the cellular processing and trafficking of normal or multiple mutant forms of CFTR (including F508del-CFTR) to increase the amount of CFTR protein delivered to the cell surface, resulting in increased chloride transport in vitro.
Danish: Tezacaftor letter den cellulære behandling og strømning af normale og multiple mutante former af CFTR (herunder F508del-CFTR) for at forøge mængden af CFTR-protein, der fremføres til celleoverfladen, hvilket fører til en øget chloridtransport in vitro.
English: Marketing Authorisation Holder: Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper Dublin 2, D02 EK84
Danish: Indehaver af markedsføringstilladelsen: Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper Dublin 2, D02 EK84
English: Tezacaftor is a selective CFTR corrector that binds to the first Membrane Spanning Domain (MSD-1) of CFTR.
Danish: Tezacaftor er et selektivt CFTR-korrigerende stof, der binder til det første membranspændende domæne (MSD-1) for CFTR.
English: Safety data from an interim safety analysis performed on 867 patients in a long-term safety and efficacy rollover study (Study 3), including 326 patients with ≥48 weeks of cumulative treatment with Symkevi given in combination with ivacaftor, were consistent with the safety data from the placebo-controlled Phase 3 studies.
Danish: Sikkerhedsdata fra en interim-sikkerhedsanalyse udført på 867 patienter i et langtids-rolloverstudie af sikkerhed og virkning (studie 3), som omfattede 326 patienter med ≥48 ugers kumulativ behandling med Symkevi givet i kombination med ivacaftor, var i overensstemmelse med sikkerhedsdata fra de placebokontrollerede fase III-studier.
English: In a human pharmacokinetic study with tezacaftor alone, there was minimal elimination of tezacaftor and its metabolites in urine (only 13.7% of total radioactivity was recovered in the urine with 0.79% as unchanged medicinal product).
Danish: I et farmakokinetisk studie hos mennesker med tezacaftor alene var der minimal elimination af tezacaftor og dets metabolitter i urinen (kun 13,7 % af den totale radioaktivitet blev genfundet i urinen med 0,79 % som uændret lægemiddel).
English: *Nominal p-value, based on hierarchical testing procedure.
Danish: *Nominel p-værdi, baseret på en hierarkisk testprocedure.
English: Tezacaftor is metabolized extensively in humans.
Danish: Tezacaftor metaboliseres i udtalt grad hos mennesker.
English: Symkevi taken with ivacaftor is for long-term treatment of patients aged 12 and over who have CF with certain genetic mutations that result in reduced amount and/or function of the CFTR protein.
Danish: Symkevi, der tages sammen med ivacaftor, er til langvarig behandling af patienter i alderen 12 år og ældre, som har CF med bestemte genetiske mutationer, der fører til en nedsat mængde og/eller funktion af CFTR-proteinet.
English: In Study 3, the change in BMI z-value in the Symkevi in combination with ivacaftor group was maintained and patients previously treated with placebo showed an increase of 0.10 (0.05) kg/m2.
Danish: I studie 3 blev ændringen i BMI z-værdi i gruppen med Symkevi i kombination med ivacaftor opretholdt, og patienter, der tidligere blev behandlet med placebo, viste en stigning på 0,10 (0,05) kg/m2.
English: Placental transfer of tezacaftor was observed in pregnant rats.
Danish: Der blev observeret placental overførsel hos drægtige rotter.
English: The mean ppFEV1 at baseline was 62.3% (range: 34.6% to 93.5%).
Danish: Den gennemsnitlige ppFEV1 ved baseline var 62,3 % (interval: 34,6 % til 93,5 %).
English: Ivacaftor is a CFTR potentiator that potentiates the channel-open probability (or gating) of CFTR at the cell surface to increase chloride transport.
Danish: Ivacaftor er en CFTR-potentiator, der potenserer kanal-åben sandsynlighed (eller gating) i CFTRproteinet på celleoverfladen til forøgelse af chloridtransporten.
English: itraconazole, posaconazole, voriconazole and fluconazole.
Danish: itraconazol, posaconazol, voriconazol og fluconazol.
English: If you stop taking Symkevi
Danish: Hvis du holder op med at tage Symkevi
English: Co-administration with digoxin, a sensitive P-gp substrate, increased digoxin exposure by 1.3-fold, consistent with weak inhibition of P-gp by ivacaftor.
Danish: Administration sammen med digoxin, et følsomt P-gp-substrat, øgede digoxineksponeringen med 1,3 gange i overensstemmelse med svag hæmning af P-gp pga. ivacaftor.
English: Transaminase elevations very common
Danish: Transaminaseforhøjelser meget almindelig
English: Following oral administration of a single dose of 100 mg 14C-tezacaftor to healthy male subjects, M1-TEZ, M2-TEZ, and M5-TEZ were the three major circulating metabolites of tezacaftor in humans, contributing to 15%, 31%, and 33% of total radioactivity, respectively.
Danish: Efter en oral administration af en enkelt dosis på 100 mg 14C-tezacaftor hos raske, frivillige mænd var M1-TEZ, M2-TEZ og M5-TEZ de tre primære tezacaftor-metabolitter i kredsløbet hos mennesker med en andel på hhv. 15 %, 31 % og 33 % af den totale radioaktivitet.
English: The combination targets the abnormal CFTR protein by increasing the quantity and function of CFTR at the cell surface and subsequently increasing airway surface liquid height, and ciliary beat frequency in vitro in human bronchial epithelial (HBE) cells from homozygous F508del CF patients.
Danish: Kombinationen retter sig mod det unormale CFTR-protein ved at forøge CFTRs mængde og virkning på celleoverfladen og dermed øge væskehøjden på luftvejsoverfladerne og den ciliære slagfrekvens in vitro i humane bronkiale epitelceller (HBE) fra homozygote F508del CF-patienter.
English: Symkevi is usually taken with ivacaftor.
Danish: Symkevi tages normalt sammen med ivacaftor.
English: • Antibiotic medicines (used for the treatment of bacterial infections).
Danish: • Antibiotika (anvendes til behandling af bakterieinfektioner).
English: Physiologically based pharmacokinetic modeling suggested co-administration with fluconazole, a moderate CYP3A inhibitor, may increase tezacaftor exposure (AUC) by approximately 2-fold.
Danish: Fysiologisk baserede farmakokinetiske modeller tydede på, at administration sammen med fluconazol, en moderat CYP3A-hæmmer, kan øge tezacaftor-eksponeringen (AUC) ca. 2 gange.
English: Symkevi in combination with ivacaftor was associated with a lower event rate per year of severe pulmonary exacerbations requiring hospitalization or IV antibiotic therapy (0.29) compared to placebo (0.54).
Danish: Symkevi i kombination med ivacaftor blev forbundet med en mindre hyppighed af hændelser pr. år af svære lungeeksacerbationer, der krævede indlæggelse eller i.v.-antibiotika (0,29), sammenlignet med placebo (0,54).
English: Following once daily dosing of tezacaftor and twice-daily dosing of ivacaftor in patients with CF, plasma concentrations of tezacaftor and ivacaftor reach steady-state within 8 days and within 3 to 5 days, respectively, after starting treatment.
Danish: Efter dosering en gang dagligt af tezacaftor og to gange dagligt af ivacaftor til patienter med CF når plasmakoncentrationerne af tezacaftor og ivacaftor steady-state i løbet af hhv. 8 dage og i løbet af 3 til 5 dage efter behandlingsstart.
English: Symkevi in combination with ivacaftor has not been studied in patients with moderate or severe renal impairment (creatinine clearance ≤30 mL/min) or in patients with end-stage renal disease.
Danish: Symkevi i kombination med ivacaftor er ikke blevet undersøgt hos patienter med moderat til svært nedsat nyrefunktion (kreatininclearance ≤30 ml/min) eller hos patienter med nyresygdom i slutstadiet (ESRD).
English: The efficacy of Symkevi in combination with ivacaftor 150 mg tablet in patients with CF was demonstrated in two Phase 3, double-blind, controlled studies (Study 1 and Study 2), and one Phase 3, open-label extension study (Study 3).
Danish: Symkevis virkning i kombination med ivacaftor 150 mg tablet hos patienter med CF blev vist i to fase III dobbeltblindede, kontrollerede studier (studie 1 og studie 2) og i ét fase III, åbent forlængelsesstudie (studie 3).
English: The mean ppFEV1 at baseline was 60.0% (range: 27.8% to 96.2%).
Danish: Den gennemsnitlige ppFEV1 ved baseline var 60,0 % (interval: 27,8 % til 96,2 %).
English: Mean improvement in ppFEV1 was observed at the first assessment on Day 15 and sustained throughout the 24-week treatment period.
Danish: En gennemsnitlig forbedring i ppFEV1 blev observeret ved den første vurdering på dag 15, som var vedvarende i hele den 24-ugers behandlingsperiode.
English: Co-administration with itraconazole, a strong CYP3A inhibitor, increased tezacaftor exposure (measured as AUC) by 4-fold and increased ivacaftor AUC by 15.6-fold.
Danish: Administration sammen med itraconazol, en potent CYP3A-hæmmer, øgede eksponeringen af tezacaftor (målt som AUC) 4 gange og øgede ivacaftor-AUC 15,6 gange.
English: Improvements in ppFEV1 were observed regardless of age, disease severity, sex, mutation class, colonization with Pseudomonas, concomitant use of standard-of-care medications for CF, and geographic region.
Danish: Der blev observeret forbedringer i ppFEV1 uanset alder, sygdommens sværhedsgrad, køn, mutationsklasse, kolonisering med Pseudomonas, samtidig anvendelse af standardbehandling for CF og geografisk region.
English: • Redness in the throat
Danish: • rødme i halsen
English: • If you are allergic to tezacaftor, ivacaftor, or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis du er allergisk over for tezacaftor, ivacaftor eller et af de øvrige indholdsstoffer i Symkevi
English: Baseline value
Danish: Baseline-værdi
English: Table 3 reflects adverse reaction observed with Symkevi in combination with ivacaftor in patients aged 12 years and older based on pooled data from three double-blind, placebo-controlled Phase 3 clinical studies.
Danish: Tabel 3 viser bivirkninger observeret med Symkevi i kombination med ivacaftor hos patienter i alderen 12 år og ældre baseret på samlede data fra tre dobbeltblindede, placebokontrollerede fase III kliniske studier.
English: Key pharmacokinetic parameters for tezacaftor and ivacaftor at steady-state are shown in Table 7.
Danish: Farmakokinetiske nøgleparametre for tezacaftor og ivacaftor ved steady-state er vist i tabel 7.
English: Both Symkevi and ivacaftor tablets should be taken with fat-containing food, such as food recommended in standard nutritional guidelines (see section 5.2).
Danish: Både tabletterne med Symkevi og ivacaftor skal tages sammen med fedtholdig mad, såsom mad der er anbefalet i standard-kostanbefalinger (se pkt.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BLISTER CARD
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE BLISTERKORT
English: Table 7: Mean (SD) pharmacokinetic parameters of tezacaftor and ivacaftor at steady state in patients with CF
Danish: Tabel 7: Gennemsnitlige (SD) farmakokinetiske parametre for tezacaftor og ivacaftor ved steady-state hos patienter med CF
English: • Anticoagulant medicines (used to prevent blood clots).
Danish: • Antikoagulantia (anvendes til at forhindre blodpropper).
English: Improvements in ppFEV1 were observed regardless of age, sex, baseline ppFEV1, colonization with Pseudomonas, concomitant use of standard-of-care medications for CF, and geographic region.
Danish: Der blev observeret forbedringer i ppFEV1 uanset alder, køn, baseline ppFEV1, kolonisering med Pseudomonas, samtidig anvendelse af standardbehandling for CF og geografisk region.
English: Concomitant use of CYP3A inducers may result in reduced exposures and thus reduced efficacy of Symkevi and ivacaftor.
Danish: Samtidig anvendelse af CYP3A-induktorer kan føre til nedsatte eksponeringer og dermed en nedsat virkning af Symkevi og ivacaftor.
English: Food or drink containing grapefruit or Seville oranges should be avoided during treatment (see section 4.5).
Danish: Mad eller drikkevarer, der indeholder grapefrugt eller Sevilla-appelsiner, bør undgås under behandlingen (se pkt.
English: Mean improvement in ppFEV1 was observed at the first assessment on Day 15 and sustained throughout the 8-week treatment period.
Danish: En gennemsnitlig forbedring i ppFEV1 blev observeret ved den første vurdering på dag 15, som var vedvarende i hele den 8-ugers behandlingsperiode.
English: Side effects seen with Symkevi in combination with ivacaftor: Very common side effects
Danish: Bivirkninger observeret med Symkevi i kombination med ivacaftor: Meget almindelige bivirkninger
English: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Danish: Bivirkningerne er anført i henhold til MedDRA-systemorganklasse og hyppighed: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1,000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: In vitro data suggested that tezacaftor is metabolized mainly by CYP3A4 and CYP3A5.
Danish: In vitro-data indikerer, at tezacaftor primært metaboliseres af CYP3A4 og CYP3A5.
English: If you forget to take Symkevi
Danish: Hvis du har glemt at tage Symkevi
English: Ivacaftor can potentiate the CFTR protein delivered to the cell surface by tezacaftor, leading to a further enhancement of chloride transport than either active substance alone.
Danish: Ivacaftor kan potensere fremføringen af CFTRprotein til celleoverfladen ved hjælp af tezacaftor, hvilket fører til en yderligere forøgelse af chloridtransport end sker med det ene eller det andet af de aktive stoffer alene.
English: The treatment difference of 0.06 kg/m2 for mean change in BMI from baseline to Week 24 (95% CI: -0.08, 0.19) was not statistically significant (P=0.4127).
Danish: Behandlingsforskellen på 0,06 kg/m2 for den gennemsnitlige ændring i BMI fra baseline til uge 24 (95 % CI: -0,08; 0,19) var ikke statistisk signifikant (P=0,4127).
English: Symkevi 100 mg tezacaftor/150 mg ivacaftor film-coated tablets are yellow, oval-shaped tablets stamped with “V100” on one side and plain on the other.
Danish: Symkevi 100 mg tezacaftor/150 mg ivacaftor filmovertrukne tabletter er gule, ovale tabletter præget med ”V100” på den ene side og glatte på den anden side.
English: The mean (SD) elimination half-lives for M1-TEZ, M2-TEZ and M5-TEZ were similar to that of the parent compound.
Danish: De gennemsnitlige (SD) eliminationshalveringstider for M1-TEZ, M2-TEZ og M5-TEZ svarede til halveringstiden for moderstoffet.
English: Other medicines and Symkevi
Danish: Brug af anden medicin sammen med Symkevi
English: ppFEV1: percent predicted forced expiratory volume in 1 second; SD: Standard Deviation; LS mean: least squares mean; CI: confidence interval; BMI: body mass index; CFQ-R: Cystic Fibrosis Questionnaire-Revised.
Danish: ppFEV1: procent forventet forceret eksspiratorisk volumen i løbet af 1 sekund, SD: standarddeviation, LS-gennemsnit: mindste kvadraters (least squares) gennemsnit, CI: konfidensinterval, BMI: kropsmasseindeks, CFQ-R: Cystic Fibrosis Questionnaire-Revised.
English: No dose adjustment is recommended for patients with mild or moderate renal impairment.
Danish: En dosisjustering for patienter med let eller moderat nedsat nyrefunktion anbefales ikke.
English: However, exposure to M2-TEZ (tezacaftor metabolite) may be increased by inhibitors of P-gp.
Danish: Eksponeringen for M2-TEZ (en tezacaftor-metabolit) kan imidlertid øges af
English: • Stomach (abdominal) ache
Danish: • mavepine (abdominalsmerter)
English: Co-administration of fluconazole increased ivacaftor AUC by 3-fold.
Danish: Administration sammen med fluconazol øgede ivacaftor-AUC 3 gange.
English: In such cases, Symkevi should be used at a reduced dose (see sections 4.4 and 5.2).
Danish: I sådanne tilfælde bør Symkevi anvendes med en nedsat dosis (se pkt.
English: • Talk to your doctor if you have kidney problems, or you have previously had them.
Danish: • Kontakt lægen, hvis du har nyreproblemer, eller du har haft det tidligere.
English: Study 2 was a randomized, double-blind, placebo-controlled, 2-period, 3-treatment, 8-week crossover study.
Danish: Studie 2 var et randomiseret, dobbeltblindet, placebokontrolleret overkrydsningsstudie med 2 perioder og 3 behandlinger, der varede i 8 uger.
English: One patient (0.2%) on therapy and two patients (0.4%) on placebo permanently discontinued treatment for elevated transaminases.
Danish: Én patient (0,2 %) der fik Symkevi i kombination med ivacaftor og to patienter (0,4 %), der fik placebo, seponerede behandlingen permanent på grund af forhøjede transaminaser.