FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with Kisqali in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Kisqali i alle undergrupper af den pædiatriske population ved brystkræft (se pkt.
English: Following repeated once-daily dosing, steady state was generally achieved after 8 days and ribociclib accumulated with a geometric mean accumulation ratio of 2.51 (range: 0.97 to 6.40).
Danish: Efter gentagne orale doseringer én gang daglig blev steady state generelt nået efter 8 dage, og ribociclib blev akkumuleret med et akkumuleringsforhold med en geometrisk middelværdi på 2,51 (interval: 0,97 til 6,40).
English: Dose interruption until recovery to grade ≤2.
Danish: Afbryd doseringen indtil bedring til grad ≤2.
English: • St. John's Wort (also known as Hypericum perforatum) - a herbal product used to treat depression and other conditions.
Danish: • Prikbladet perikon (også kendt som Hypericum perforatum) - et naturlægemiddel til behandling af depression og andre tilstande.
English: Clinical activity (pharmacological and safety) of ribociclib was due primarily to parent drug, with negligible contribution from circulating metabolites.
Danish: Den kliniske aktivitet (farmakologisk og sikkerhed) af ribociclib kunne primært tilskrives moderstoffet, med et ubetydeligt bidrag fra cirkulerende metabolitter.
English: The concomitant use of strong CYP3A4 inducers may therefore lead to decreased exposure and consequently a risk for lack of efficacy.
Danish: Samtidig anvendelse af potente CYP3A4-induktorer kan derfor føre til en nedsat eksponering og dermed en risiko for manglende effekt.
English: The median duration of exposure to Kisqali treatment across the pooled phase III studies dataset was 16.5 months, with 61.7% patients exposed ≥12 months.
Danish: Medianvarigheden af eksponering for behandling med Kisqali på tværs af de sammenlagte fase IIIstudiers datasæt var 16,5 måneder, hvoraf 61,7 % af patienterne blev eksponeret i ≥12 måneder.
English: • Tiredness, pale skin (potential sign of a low level of red blood cells, anaemia)
Danish: • Træthed, bleg hud (muligt tegn på et lavt niveau af røde blodlegemer, anæmi)
English: a p-value is obtained from the one-sided stratified log-rank test.
Danish: p-værdien stammer fra den ensidede stratificerede log rank-test.
English: It is not known if ribociclib is present in human milk.
Danish: Det vides ikke, om ribociclib er til stede i human modermælk.
English: The major circulating metabolites included metabolite M13 (CCI284, N-hydroxylation), M4 (LEQ803, N-demethylation), and M1 (secondary glucuronide).
Danish: De primære cirkulerende metabolitter omfattede metabolit M13 (CCI284, Nhydroxylering), M4 (LEQ803, N-demethylering) og M1 (sekundært glukuronid).
English: Caution and monitoring for toxicity are advised during concomitant treatment with sensitive substrates of these transporters which exhibit a narrow therapeutic index, including but not limited to digoxin, pitavastatin, pravastatin, rosuvastatin and metformin.
Danish: Det anbefales at udvise forsigtighed og monitorere for toksicitet under samtidig behandling med følsomme substrater af disse transportører, som har et snævert terapeutisk indeks, herunder, men ikke begrænset til digoxin, pitavastatin, pravastatin, rosuvastatin og metformin.
English: Metabolite LEQ803 was a significant metabolite in excreta and represented approximately 13.9% and 3.74% of the administered dose in faeces and urine, respectively.
Danish: Metabolit LEQ803 var en signifikant metabolit i ekskreter og tegnede sig for ca. 13,9 % og 3,74 % af den administrerede dosis i henholdsvis fæces og urin.
English: Make sure you tell your doctor of all medicines and supplements, including herbal medicines, that you are taking before you start treatment with Kisqali and if you are prescribed a new medicine after you have started treatment with Kisqali.
Danish: Husk at fortælle lægen om alle de lægemidler og kosttilskud, herunder naturlægemidler, du tager, før du starter behandling med Kisqali, og hvis du får ordineret et nyt lægemiddel, efter du er startet behandling med Kisqali.
English: If patients develop ALT and/or AST >3 x ULN along with total bilirubin >2 x ULN irrespective of baseline grade, discontinue Kisqali.
Danish: Hvis patienter udvikler et ALAT- og/eller ASAT-niveau >3 x ULN sideløbende med et totalbilirubin-niveau >2 x ULN uanset graden ved baseline, skal Kisqali seponeres.
English: The effect of a moderate CYP3A4 inducer on ribociclib exposure has not been studied.
Danish: Virkningen af en moderat CYP3A4-induktor på ribociclibs eksponering er ikke undersøgt.
English: Ribociclib showed foetotoxicity and teratogenicity at doses which did not show maternal toxicity in the rats or rabbits.
Danish: Ribociclib viste føtotoksicitet og teratogenicitet ved doser, der ikke viste maternel toksicitet i hverken rotter eller kaniner.
English: 21 film-coated tablets 42 film-coated tablets 63 film-coated tablets
Danish: 21 filmovertrukne tabletter 42 filmovertrukne tabletter 63 filmovertrukne tabletter
English: What Kisqali is
Danish: Hvad Kisqali er
English: Ribociclib exhibits high solubility at or below pH 4.5 and in bio-relevant media (at pH 5.0 and 6.5).
Danish: Ribociclib har høj opløselighed ved eller under pH 4,5 og i biorelevant medie (ved pH 5,0 og 6,5).
English: Genotoxicity studies in bacterial in vitro systems and in mammalian in vitro and in vivo systems with and without metabolic activation did not reveal any evidence for a genotoxic potential of ribociclib.
Danish: Studier af genotoksicitet i bakterielle in vitro-systemer og i in vitro- og in vivo-pattedyrssystemer med og uden metabolisk aktivering viste ingen tegn på, at ribociclib har genotoksisk potentiale.
English: Simulations using physiologically-based pharmacokinetic models suggested that Kisqali given at the clinically relevant dose of 600 mg is expected to increase the midazolam AUC by 5.2-fold.
Danish: Simuleringer, hvor der blev anvendt fysiologisk baserede farmakokinetiske modeller, tydede på, at Kisqali givet i den klinisk relevante dosis 600 mg forventes at øge midazolams AUC med 5,2 gange.
English: Ribociclib is a substrate for P-gp in vitro, but based on mass balance data inhibition of P-gp or BCRP is unlikely to affect ribociclib exposure at therapeutic doses.
Danish: Ribociclib er et substrat for P-gp in vitro, men baseret på massebalancedata er det ikke sandsynligt, at P-gp- eller BCRP-hæmning påvirker eksponering for ribociclib ved terapeutiske doser.
English: • Painful and frequent urination (signs of a urinary tract infection)
Danish: • Smertefuld og hyppig vandladning (tegn på urinvejsinfektion)
English: • Methadone, used to treat pain or addiction to opioids.
Danish: • Methadon, der anvendes til at behandle smerter eller afhængighed af opioider.
English: In the event of ribociclib-related toxicity, the dose should be modified or treatment should be interrupted until toxicity is resolved (see sections 4.2 and 5.2).
Danish: I tilfælde af toksicitet, som er relateret til ribociclib, bør dosis ændres eller behandling afbrydes indtil toksiciteten er bedret (se pkt.
English: Amongst the patients who had QTcF prolongation >480 msec, the median time to onset was 15 days regardless of the combination and these changes were reversible with dose interruption and/or dose reduction (see sections 4.2, 4.4 and 5.2).
Danish: Blandt patienter, der havde QTcF-forlængelse >480 ms, var mediantiden til fremkomst 15 dage uanset kombination, og disse ændringer var reversible ved afbrydelse af doseringen og/eller dosisreduktion (se pkt.
English: No tablet should be ingested if it is broken, cracked or otherwise not intact.
Danish: En tablet må ikke indtages, hvis den er knækket, revnet eller på anden måde ikke er intakt.
English: If you are a woman of childbearing potential you should have a negative pregnancy test before starting treatment with Kisqali.
Danish: Hvis du er en kvinde, der kan blive gravid, skal du have en negativ graviditetstest, før du starter på behandling med Kisqali.
English: Continue Kisqali treatment for as long as your doctor tells you to.
Danish: Fortsæt Kisqalibehandlingen, så længe lægen siger, at du skal gøre det.
English: Hepatotoxicity: hepatocellular injury, drug-induced liver injury (<1%), hepatotoxicity, hepatic failure, autoimmune hepatitis (single case).
Danish: Hepatotoksicitet: hepatocellulær skade, lægemiddelinduceret leverskade (<1 %), hepatotoksicitet, leversvigt, autoimmun hepatitis (enkelt tilfælde).
English: Titanium dioxide (E171) Xanthan gum
Danish: Titandioxid (E 171) Xanthangummi
English: There are no data on the effects of ribociclib on the breast-fed infant or the effects of ribociclib on milk production.
Danish: Der foreligger ingen data om virkningen af ribociclib på det ammede spædbarn eller virkningen af ribociclib på mælkeproduktion.
English: Please refer to the SmPC of fulvestrant for additional details.
Danish: Der henvises til SmPC'et for fulvestrant for yderligere oplysninger.
English: Healthy subjects received single oral doses ranging from 400 mg to 600 mg or repeated daily doses (8 days) at 400 mg.
Danish: Raske forsøgspersoner fik orale enkeltdoser i intervallet 400 mg til 600 mg eller gentagne daglige doser (8 dage) på 400 mg.
English: ECG should be assessed before initiating treatment.
Danish: EKG skal vurderes, før behandling indledes.
English: Population pharmacokinetic analysis showed that there are no clinically relevant effects of age, body weight or gender on the systemic exposure of ribociclib that would require a dose adjustment.
Danish: Populationsfarmakokinetisk analyse viste, at der ikke er nogen klinisk relevant effekt af alder, legemsvægt eller køn på den systemiske eksponering for ribociclib, der kræver dosisjustering.
English: • Antibiotics such as clarithromycin, telithromycin, moxifloxacin, rifampicin, ciprofloxacin,
Danish: • Antibiotika, fx clarithromycin, telithromycin, moxifloxacin, rifampicin, ciprofloxacin,
English: If QTcF interval prolongation to greater than 500 msec or greater than 60 msec change from baseline occurs in combination with torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia, permanently discontinue Kisqali.
Danish: Hvis der opstår en forlængelse af QTcF-intervallet, der er større end 500 ms eller en ændring fra baseline på mere end 60 ms i kombination med torsade de pointes eller polymorf ventrikulær takykardi eller tegn/symptomer på alvorlig arytmi, skal Kisqali seponeres permanent.
English: The film-coated tablets are light greyish violet in colour, unscored, round, debossed with “RIC” on one side and “NVR” on the other side.
Danish: De filmovertrukne tabletter har en lys gråviolet farve, er runde, uden delekærv og præget med “RIC” på den ene side og “NVR” på den anden side.
English: There were no such cases reported in Study E2301 (MONALEESA-7).
Danish: Der blev ikke rapporteret sådanne tilfælde i studie E2301 (MONALEESA-7).
English: Ribociclib was the major circulating drug-derived entity in plasma.
Danish: Ribociclib var den primære lægemiddel-afledte entitet, der cirkulerede i plasma.
English: Lymphopenia, thrombocytopenia, febrile neutropenia
Danish: Lymfopeni, trombocytopeni, febril neutropeni
English: Treatment discontinuation due to neutropenia was low (0.8%) (see sections 4.2 and
Danish: Andelen af seponeringer af behandlingen som følge af neutropeni var lav (0,8 %) (se pkt.
English: Clinical benefit rate (CBR)
Danish: Rate for klinisk fordel (CBR)
English: The effect at the 200 mg once-daily dose was predicted to be a 1.7- and 2.8-fold increase, respectively.
Danish: Effekten ved en dosis på 200 mg én gang daglig blev forudsagt til at være øget med henholdsvis 1,7 og 2,8 gange.
English: At the clinically relevant dose of 600 mg, simulations using PBPK models predicted only weak inhibitory effects of ribociclib on CYP1A2 substrates (<2-fold increase in AUC).
Danish: Ved den klinisk relevante dosis 600 mg, forudsagde simuleringer med anvendelse af PBPK modeller kun svag hæmmende effekt af ribociclib på CYP1A2-substrater (<2 gange øgning af AUC).
English: • Medicines like intravenous ondansetron, used to prevent nausea and vomiting caused by chemotherapy (treatment with cancer medicines).
Danish: • Lægemidler, som intravenøs ondansetron til forebyggelse af kvalme og opkastning forårsaget af kemoterapi (behandling med kræftmedicin).
English: The concomitant use of moderate CYP3A4 inducers may therefore lead to decreased exposure and consequently a risk for impaired efficacy, in particular in patients treated with ribociclib at 400 mg or 200 mg once daily.
Danish: Samtidig brug af moderate CYP3A4-induktorer kan derfor medføre nedsat eksponering og dermed risiko for nedsat effekt særligt hos patienter i behandling med 400 mg eller 200 mg ribociclib én gang daglig.
English: Hazard ratio (95% CI) CI=confidence interval; N=number of patients; NE = Not estimable.
Danish: Hazard ratio (95 % CI) CI = konfidensinterval, N = antal patienter, NE = kan ikke estimeres.
English: Time (months) Ribociclib Placebo
Danish: Tid (måneder) Ribociclib Placebo
English: The clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment (see section 4.4).
Danish: Planen for håndtering af bivirkninger hos den enkelte patient bør tilpasses ud fra den behandlende læges kliniske vurdering på baggrund af en individuel vurdering af benefit/risk-forholdet (se pkt.
English: When Kisqali is used in combination with fulvestrant, fulvestrant is administered intramuscularly on days 1, 15 and 29, and once monthly thereafter.
Danish: Når Kisqali anvendes i kombination med fulvestrant, administreres fulvestrant intramuskulært på dag 1, 15 og 29 og herefter én gang om måneden.
English: The efficacy and safety of ribociclib have not been studied in patients with critical visceral disease.
Danish: Virkningen og sikkerheden af ribociclib er ikke undersøgt hos patienter med kritisk visceral sygdom.
English: LEQ803 Cmax increased 1.7-fold and AUCinf decreased by 27%, respectively.
Danish: LEQ803's Cmax blev øget med 1,7 gange og AUCinf blev reduceret med 27 %.
English: In vitro data are not sufficient to exclude a potential of ribociclib to induce CYP2B6 via CAR.
Danish: In vitro data er ikke tilstrækkelige til at udelukke, at ribociclib potentielt kan inducere CYP2B6 via CAR.
English: Management of severe or intolerable adverse drug reactions (ADRs) may require temporary dose interruption, reduction or discontinuation of Kisqali.
Danish: Håndtering af svære eller ikke-tolerable bivirkninger kan kræve midlertidig afbrydelse, dosisreduktion eller seponering af Kisqali.
English: Table 3 Dose modification and management - Hepatobiliary toxicity
Danish: Tabel 3 Dosisændring og håndtering - hepatobiliær toksicitet
English: There are no clinical data available regarding effects of ribociclib on fertility.
Danish: Der er ingen tilgængelige kliniske data vedrørende virkningen af ribociclib på fertilitet.
English: Show the Kisqali packet.
Danish: Vis pakningen med Kisqali.
English: In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
Danish: Hos præ- eller perimenopausale kvinder skal den endokrine behandling kombineres med en luteiniserende hormonfrigivende hormon (LHRH)-agonist.
English: The median time to resolution of grade ≥3 (to normalisation or grade <3) was 12 days in the Kisqali plus any combination arms following treatment interruption and/or reduction and/or discontinuation.
Danish: Mediantiden til bedring af grad ≥3 (til normalisering eller grad <3) var 12 dage i armene med Kisqali plus enhver kombination efter afbrydelse og/eller reduktion og/eller seponering.
English: In study E2301 (MONALEESA-7), the observed mean QTcF increase from baseline was approximately 10 msec higher in the tamoxifen plus placebo subgroup compared with the NSAI plus placebo subgroup, suggesting that tamoxifen alone had a QTcF prolongation effect which can contribute to the QTcF values observed in the Kisqali plus tamoxifen group.
Danish: I studie E2301 (MONALEESA-7) var den observerede gennemsnitlige QTcF-stigning i forhold til baseline ca. 10 ms højere i tamoxifen plus placebo-subgruppen sammenlignet med NSAI plus placebo-subgruppen, hvilket tyder på, at tamoxifen alene havde en QTcF-forlængende effekt, som kan medvirke til de QTcF-værdier, der blev set i Kisqali plus tamoxifen-gruppen.
English: ECGs with QTcF >480 msec
Danish: EKG'er med QTcF >480 ms
English: Patients receiving Kisqali should not breast-feed for at least 21 days after the last dose.
Danish: Patienter, der får Kisqali, bør ikke amme i mindst 21 dage efter den sidste dosis.
English: Ribociclib is primarily metabolised by CYP3A4.
Danish: Ribociclib metaboliseres primært af CYP3A4.
English: • Spontaneous bleeding or bruising (signs of a low level of blood platelets)
Danish: • Spontan blødning eller blå mærker (tegn på et lavt niveau af blodplader)
English: Additionally, in vivo antitumour activity of ribociclib in combination with fulvestrant was assessed in immune-deficient mice bearing the ZR751 ER+ human breast cancer xenografts and the combination with fulvestrant resulted in complete tumour growth inhibition.
Danish: Endvidere blev antitumoraktiviteten af ribociclib i kombination med fulvestrant in vivo vurderet hos immunkompromitterede mus, der bar de ZR751 ER+ humane brystkræft-xenografter, og kombinationen med fulvestrant resulterede i en komplet hæmning af tumorvækst.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Kisqali.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Kisqali.
English: Patients should be advised to be cautious when driving or using machines in case they experience fatigue, dizziness or vertigo during treatment with Kisqali (see section 4.8).
Danish: Patienter skal informeres om at udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner, hvis de oplever træthed, svimmelhed eller vertigo under behandling med Kisqali (se pkt.
English: Therefore, medicinal products that can influence CYP3A4 enzyme activity may alter the pharmacokinetics of ribociclib.
Danish: Lægemidler, som kan påvirke aktiviteten af CYP3A4enzym, kan derfor ændre ribociclibs farmakokinetik.
English: Log rank p-value = 9.83*10^(-8)
Danish: Log rank p-værdi = 9,83*10^(-8)
English: When Kisqali is used in combination with an aromatase inhibitor, the aromatase inhibitor should be taken orally once daily continuously throughout the 28-day cycle.
Danish: Når Kisqali anvendes i kombination med en aromatasehæmmer, skal aromatasehæmmeren tages oralt én gang daglig kontinuerligt i hele serien på 28 dage.
English: Dose interruptions and/or adjustments due to hepatobiliary toxicity events were reported in 10.4% of Kisqali plus any combination treated patients, primarily due to ALT increased (6.9%) and/or AST increased (6.1%).
Danish: Afbrydelser og/eller dosisjusteringer som følge af hændelser med hepatobiliær toksicitet blev rapporteret hos 10,4 % af patienter, der blev behandlet med Kisqali plus enhver kombination, primært på grund af forhøjet ALAT-niveau (6,9 %) og/eller forhøjet ASAT-niveau (6,1 %).
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE42
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, proteinkinasehæmmere, ATC-kode: L01XE42.
English: These findings included reduced/small lung lobes and additional vessel on the aortic arch and diaphragmatic hernia, absent accessory lobe or (partly) fused lung lobes and reduced/small accessory lung lobe (30 and 60 mg/kg), extra/rudimentary thirteenth ribs and misshapen hyoid bone and reduced number of phalanges in the pollex.
Danish: Disse fund omfattede mindre/små lungelapper og ekstra blodkar på aoartabuen og diaphragmahernie, manglende accessorisk lap eller (delvis) sammensmeltede lungelapper og mindre/lille accessorisk lungelap (30 og 60 mg/kg), ekstra/rudimentære trettende ribben og deformt tungeben og reduceret antal phalanges i pollex.
English: A pharmacokinetic-pharmacodynamic analysis included a total of 997 patients treated with ribociclib at doses ranging from 50 to 1200 mg.
Danish: I en analyse af farmakokinetik og farmakodynamik blev der medtaget i alt 997 patienter, som blev behandlet med ribociclib i doser i intervallet 50 til 1.200 mg.
English: • The recommended starting dose of Kisqali is 600 mg (3 tablets of 200 mg) once daily.
Danish: • Den anbefalede startdosis af Kisqali er 600 mg (3 tabletter på hver 200 mg) én gang daglig.
English: In addition, haematological (e.g. neutropenia, thrombocytopenia) toxicity and possible QTc prolongation may occur.
Danish: Der kan endvidere forekomme hæmatologisk (fx neutropeni, trombocytopeni) toksicitet og eventuelt QTc-forlængelse.
English: No dose adjustments of ribociclib are required at initiation of treatment with mild or moderate CYP3A4 inhibitors.
Danish: Dosisjustering af ribociclib er ikke nødvendig ved initiering af behandling med lette eller moderate CYP3A4-hæmmere.
English: The dose should be interrupted.
Danish: Doseringen bør afbrydes 2.
English: When tested in a panel of breast cancer cell lines with known ER status, ribociclib demonstrated to be more efficacious in ER+ breast cancer cell lines than in the ER- ones.
Danish: Når ribociclib blev afprøvet på et panel af brystkræftcellelinjer med kendt ER-status, demonstrerede ribociclib højere effekt i ER+ brystkræftcellelinjer end i ER- brystkræftcellelinjer.
English: The analysis of ECG data showed 52 patients (4.9%) and 11 patients (1.4%) with at least one >480 msec post-baseline QTcF for the Kisqali plus aromatase inhibitor or fulvestrant arms and the placebo plus aromatase inhibitor or fulvestrant arms, respectively.
Danish: Analysen af EKG-data viste 52 patienter (4,9 %) og 11 patienter (1,4 %) med mindst et tilfælde af post-baseline-QTcF >480 ms for henholdsvis armene med Kisqali plus aromatasehæmmer eller fulvestrant og armene med placebo plus aromatasehæmmer eller fulvestrant.
English: Hypersensitivity to the active substance or to peanut, soya or any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for peanuts, soja eller et eller flere af hjælpestofferne anført i pkt.
English: Time (months) Ribociclib+ Fulvestrant Placebo+Fulvestrant
Danish: Tid (måneder) Ribociclib + fulvestrant Placebo + fulvestrant
English: The patients included were Caucasian (82.2%), Asian (7.6%), and Black (2.5%).
Danish: De inkluderede patienter var kaukasiere (82,2 %), asiater (7,6 %) og sorte (2,5 %).
English: In vitro, ribociclib decreased pRb phosphorylation, leading to arrest in the G1 phase of the cell cycle, and reduced cell proliferation in breast cancer cell lines.
Danish: Ribociclib reducerede fosforylering af pRb in vitro, hvilket førte til bremsning af G1-fasen af cellecyklussen og reducerede celleproliferation i brystkræftcellelinjer.
English: <90 ml/min/1.73 m2) and 35 patients with moderate renal impairment (eGFR 30 to <60 ml/min/1.73 m2), mild and moderate renal impairment had no effect on the exposure of ribociclib (see section 4.2).
Danish: <90 ml/min/1,73 m2) og 35 patienter med moderat nedsat nyrefunktion (eGFR 30 til <60 ml/min/1,73 m2), havde let og moderat nedsat nyrefunktion ingen effekt på eksponeringen for ribociclib (se pkt.
English: If you miss a dose of Kisqali
Danish: Hvis du glemmer en dosis Kisqali
English: Grade 1 or 2**
Danish: Grad 1 eller 2**
English: c p-values are obtained from one-sided Cochran-Mantel-Haenszel chi-square test
Danish: c p-værdierne stammer fra den ensidede Cochran-Mantel-Hänszel chi i anden-test.
English: • Antimalarials such as chloroquine.
Danish: • Lægemidler mod malaria, fx chloroquin.
English: Grade 3* (ANC
Danish: Grad 3* (ANC
English: Median PFS [months] (95% CI)
Danish: Median-PFS [måneder] (95 % CI)