FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the 31-May-2017 data cutoff date, this reduction in risk continued to be observed in the following subgroups: (1) patients with either visceral metastases (HR of 0.62 [95% CI: 0.47, 0.81], median progression-free survival [mPFS] 19.3 months versus 12.3 months) or without visceral metastases (HR of 0.50 [95% CI: 0.37, 0.67], mPFS 35.9 months versus 17.0 months) and (2) patients with either bone only disease (HR of 0.41 [95% CI: 0.26, 0.63], mPFS 36.2 months versus 11.2 months) or without bone-only disease (HR of 0.62 [95% CI: 0.50, 0.78], mPFS 24.2 months versus 14.5 months).
Danish: Ved skæringsdatoen for data 31. maj 2017 sås reduktion i risiko i følgende undergrupper fortsat: (1) patienter med enten viscerale metastaser (HR 0,62 [95 % CI: 0,47; 0,81], median progressionsfri overlevelse [mPFS] 19,3 måneder versus 12,3 måneder) eller uden viscerale metastaser (HR 0,50 [95 % CI: 0,37; 0,67], mPFS 35,9 måneder versus 17,0 måneder) og (2) patienter med enten kun knoglesygdom (HR 0,41 [95 % CI: 0,26; 0,63], mPFS 36,2 måneder versus 11,2 måneder) eller uden kun-knoglesygdom (HR 0,62 [95 % CI: 0,50; 0,78], mPFS 24,2 måneder versus 14,5 måneder).
English: Permanently discontinue IBRANCE in patients with severe interstitial lung disease (ILD)/pneumonitis (see section 4.4).
Danish: Seponer IBRANCE permanent hos patienter med alvorlig interstitiel lungesygdom (ILS)/pneumonitis (se pkt.
English: There were no effects on oestrous cycle (female rats) or mating and fertility in rats (male or female) in nonclinical reproductive studies.
Danish: Der var ingen indvirkning på brunstcyklus (hunrotter) eller parring og fertilitet hos rotter (han- og hunrotter) i ikke-kliniske reproduktionsstudier, men der er ikke tilgængelige fertilitetsdata for mennesker.
English: Progression-Free Survival by Independent Assessment Number of events (%) Median PFS [months (95% CI)]
Danish: Progressionsfri overlevelse baseret på uafhængig vurdering Antal hændelser (%) Median PFS (måneder (95 % CI))
English: In particular, the following may increase the risk of side effects with IBRANCE:
Danish: Det er navnlig følgende lægemidler, som kan øge risikoen for bivirkninger med IBRANCE:
English: DDI studies of palbociclib with oral contraceptives have not been conducted (see section 4.6).
Danish: Der er ikke udført interaktionsstudier med palbociclib og orale kontraceptiva (se pkt.
English: - The other ingredients are: Capsule content: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate type A, colloidal anhydrous silica, magnesium stearate.
Danish: Kapselindhold: mikrokrystallinsk cellulose, lactosemonohydrat, natriumstivelsesglykolat type A, vandfri kolloid silica, magnesiumstearat.
English: Data from a clinical study in patients with breast cancer showed that there was no clinically relevant drug interaction between palbociclib and fulvestrant when the two medicinal products were coadministered.
Danish: Data fra lægemiddelinteraktionsdelen af et klinisk studie med patienter med brystkræft viste, at der ikke var nogen klinisk relevant interaktion mellem palbociclib og fulvestrant, når disse to lægemidler blev administreret samtidigt.
English: Haematological disorders
Danish: Hæmatologiske forstyrrelser
English: The efficacy of palbociclib in combination with fulvestrant versus fulvestrant plus placebo was evaluated in an international, randomised, double-blind, parallel-group, multicentre study conducted in women with HR-positive, HER2-negative locally advanced breast cancer not amenable to resection or radiation therapy with curative intent or metastatic breast cancer, regardless of their menopausal status, whose disease progressed after prior endocrine therapy in the (neo)adjuvant or metastatic setting.
Danish: Virkningen af palbociclib i kombination med fulvestrant versus fulvestrant plus placebo blev evalueret i et internationalt, randomiseret, dobbeltblind multicenterstudie med parallelle grupper hos kvinder med HR-positiv, HER2-negativ lokalt fremskreden brystkræft, hvor kurativ resektion eller strålebehandling ikke var muligt, eller metastatisk brystkræft, uanset deres menopausale status, hvor sygdommen havde progredieret efter forudgående endokrin terapi i det (neo)-adjuverende eller metastatiske scenario.
English: A reduction in the risk of disease progression or death in the palbociclib plus fulvestrant arm was observed in all individual patient subgroups defined by stratification factors and baseline characteristics.
Danish: Der blev observeret en reduktion i risikoen for sygdomsprogression eller død i palbociclib plus fulvestrant-armen i alle patientundergrupper defineret iht.
English: IBRANCE 100 mg hard capsules EU/1/16/1147/003
Danish: IBRANCE 100 mg hårde kapsler EU/1/16/1147/003
English: 4.5 Interaction with other medicinal products and other forms of interaction Palbociclib is primarily metabolised by CYP3A and sulphotransferase (SULT) enzyme SULT2A1.
Danish: Palbociclib metaboliseres primært af CYP3A og sulfotransferase (SULT) enzymet SULT2A1.
English: Grade 3: ANC 500 - <1000/mm3; Grade 4: ANC <500/mm3.
Danish: < 1.000/mm 3, grad 4: ANC < 500/mm
English: IBRANCE 125 mg hard capsules EU/1/16/1147/005
Danish: IBRANCE 125 mg hårde kapsler EU/1/16/1147/005
English: Impairment of fertility
Danish: Forringelse af fertilitet
English: Drug-drug interaction between palbociclib and fulvestrant
Danish: Interaktion mellem palbociclib og fulvestrant
English: Do not take IBRANCE:
Danish: Tag ikke IBRANCE
English: The concomitant use of strong CYP3A inducers including, but not limited to: carbamazepine, enzalutamide, phenytoin, rifampin, and St. John's Wort should be avoided (see sections 4.3 and 4.4).
Danish: Samtidig brug af potente CYP3A-induktorer, herunder, men ikke begrænset til carbamazepin, enzalutamid, phenytoin, rifampicin og perikon bør undgås (se pkt.
English: Benefit was also observed regardless of lines of prior therapy in the metastatic setting, whether 0 (HR of 0.59 [95% CI: 0.37, 0.93]), 1 (HR of 0.46 [95% CI: 0.32, 0.64]), 2 (HR of 0.48 [95% CI: 0.30, 0.76]), or ≥3 lines (HR of 0.59 [95% CI: 0.28, 1.22]).
Danish: Ved metastatisk sygdom blev der også observeret en fordel, uanset om antallet af forudgående behandlingslinjer var 0 (HR 0,59 [95 % CI: 0,37-0,93]), 1 (HR 0,46 [95 % CI: 0,320,64]), 2 (HR 0,48 [95 % CI: 0,30-0,76]), eller ≥ 3 (HR 0,59 [95 % CI: 0,28-1,22]).
English: Data from the drug-drug interaction (DDI) evaluation portion of a clinical study in patients with breast cancer showed that there was no drug interaction between palbociclib and letrozole when the 2 medicinal products were coadministered.
Danish: Data fra lægemiddelinteraktionsdelen af et klinisk studie med patienter med brystkræft viste, at der ikke var nogen interaktion mellem palbociclib og letrozol, når disse to lægemidler blev administreret samtidigt.
English: d Leukopenia includes the following PTs: Leukopenia, White blood cell count decreased.
Danish: d. Leukopeni omfatter følgende foretrukne termer: Leukopeni, nedsat antal leukocytter.
English: e Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
Danish: e. Anæmi omfatter følgende foretrukne termer: Anæmi, nedsat hæmoglobin, nedsat hæmatokrit.
English: b ANC: Grade 1: ANC < LLN - 1500/mm3; Grade 2: ANC 1000 - <1500/mm3;
Danish: 3, grad 2: ANC 1.000 - < 1.500/mm
English: Peak palbociclib unbound exposure (unbound Cmax) was increased by 7%, 38% and 72% for mild, moderate and severe hepatic impairment, respectively, relative to subjects with normal hepatic function.
Danish: Maksimalværdi for palbociclib ubundet eksponering (ubundet Cmax) blev forøget med henholdsvis 7 %, 38 % og 72 % for let, moderat og svært nedsat leverfunktion i forhold til personer med normal leverfunktion.
English: Secondary endpoint results are based on confirmed and unconfirmed responses according to RECIST 1.1.
Danish: Sekundære endepunktsresultater er baseret på bekræftet og ubekræftet respons iht.
English: • St. John's Wort, an herbal product used to treat mild depression and anxiety.
Danish: • Perikon, som er et naturlægemiddel, der anvendes til behandling af let depression og angst.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Meget almindelig Udslæt
English: Dry eye
Danish: Tør hud
English: No dose adjustments are required for coadministration of palbociclib with moderate CYP3A inducers (see section 4.5).
Danish: Dosisjustering er ikkenødvendig ved samtidig administration af palbociclib og moderate CYP3A-induktorer (se pkt.
English: f Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
Danish: f. Trombocytopeni omfatter følgende foretrukne termer: Trombocytopeni, nedsat trombocyttal.
English: IBRANCE 100 mg hard capsules
Danish: IBRANCE 100 mg hårde kapsler
English: How to take IBRANCE
Danish: Sådan skal du tage IBRANCE
English: Stomatitisg
Danish: stomatitis.
English: All Grades n (%)
Danish: Foretrukken term n (%)
English: Under fed conditions (intake of a moderate-fat meal), coadministration of multiple doses of the proton pump inhibitor (PPI) rabeprazole with a single dose of 125 mg IBRANCE decreased palbociclib Cmax by 41%, but had limited impact on AUCinf (13% decrease) compared with a single dose of 125 mg IBRANCE administered alone.
Danish: I ikke-fastende tilstand (efter indtagelse af et måltid med moderat fedtindhold) medførte samtidig administration af flere doser af protonpumpehæmmeren (PPI) rabeprazol og en enkelt dosis IBRANCE 125 mg nedsættelse af palbociclib Cmax med 41 %, men havde begrænset indvirkning på AUCinf (13 % nedsættelse) sammenlignet med en enkelt dosis palbociclib 125 mg givet alene.
English: Coadministration should only be considered after careful evaluation of the potential benefits and risks.
Danish: Risk/benefit skal overvejes nøje inden samtidig administration.
English: The study met its primary endpoint of prolonging investigator-assessed PFS at the interim analysis conducted on 82% of the planned PFS events; the results crossed the prespecified Haybittle-Peto efficacy boundary (α=0.00135), demonstrating a statistically significant prolongation in PFS and a clinically meaningful treatment effect.
Danish: Resultaterne krydsede den præspecificerede Haybittle-Peto-effektgrænse (α = 0,00135) og viste en statistisk signifikant forlængelse af PFS og en klinisk relevant virkning af behandlingen.
English: IBRANCE dose modification and management - Haematological toxicities CTCAE Grade
Danish: Anbefalet dosisjustering og håndtering af IBRANCE- Hæmatologiske bivirkninger CTCAE-grad
English: Drug-drug interaction between palbociclib and letrozole
Danish: Interaktion mellem palbociclib og letrozol
English: Ovarian ablation or suppression with an LHRH agonist is mandatory when pre/perimenopausal women are administered IBRANCE in combination with an aromatase inhibitor, due to the mechanism of action of aromatase inhibitors.
Danish: På grund af aromatase-hæmmerens virkningsmekanisme er ablation eller suppression af ovarierne med en LHRH-agonist et krav, når præ-/perimenopausale kvinder gives palbociclib i kombination med en aromatasehæmmer.
English: IBRANCE 75 mg hard capsules IBRANCE 100 mg hard capsules IBRANCE 125 mg hard capsules
Danish: IBRANCE 75 mg hårde kapsler IBRANCE 100 mg hårde kapsler IBRANCE 125 mg hårde kapsler
English: WBC decreased Neutrophils decreased Anaemia
Danish: Fald i leukocytter Fald i neutrofile Anæmi
English: Each hard capsule contains 93 mg of lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver hård kapsel indeholder 93 mg lactose (som monohydrat).
English: In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.
Danish: Endokrinterapi skal kombineres med en luteiniserende hormon-frigivende hormon (LHRH)-agonist hos præ- og perimenopausale kvinder.
English: Palbociclib was the major circulating drug-derived entity in plasma.
Danish: Palbociclib cirkulerede primært som uomdannet lægemiddel i plasma.
English: Peak palbociclib exposure (Cmax) was increased by 17%, 12%, and 15% for mild, moderate, and severe renal impairment, respectively, relative to subjects with normal renal function.
Danish: Maksimal (Cmax) eksponering for palbociclib blev forøget med henholdsvis 17 %, 12 % og 15 % for let, moderat og svært nedsat nyrefunktion.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Danish: Dette lægemiddel indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Appropriate monitoring should be performed (see sections 4.2 and 4.8).
Danish: Passende monitorering er nødvendig (se pkt.
English: Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis (see section 4.2).
Danish: Seponer IBRANCE permanent hos patienter med alvorlig ILS eller pneumonitis (se pkt.
English: IBRANCE plus Letrozole (N = 444)
Danish: IBRANCE plus letrozol (N = 444)
English: IBRANCE 75 mg hard capsules
Danish: IBRANCE 75 mg hårde kapsler
English: Coadministration of multiple 400 mg daily doses of modafinil, a moderate CYP3A inducer, with a single 125 mg IBRANCE dose decreased palbociclib AUCinf and Cmax by 32% and 11%, respectively, relative to a single 125 mg IBRANCE dose given alone.
Danish: Samtidig administration af multiple doser på 400 mg modafinil daglig, en moderat CYP3A-induktor, og en enkelt dosis IBRANCE 125 mg reducerede AUCinf og Cmax af palbociclib med henholdsvis 32 % og 11 % i forhold til en enkelt dosis IBRANCE 125 mg givet alene.
English: IBRANCE 125 mg hard capsules
Danish: IBRANCE 125 mg hårde kapsler
English: Administer IBRANCE with caution to patients with moderate or severe renal impairment, with close monitoring of signs of toxicity (see sections 4.2 and 5.2).
Danish: IBRANCE skal anvendes med forsigtighed hos patienter med moderat eller svært nedsat leverfunktion, og der skal overvåges nøje for tegn på toksicitet (se pkt.
English: Under fasting conditions, the coadministration of multiple doses of the proton pump inhibitor (PPI) rabeprazole with a single dose of 125 mg IBRANCE decreased palbociclib AUCinf and Cmax by 62% and 80%, respectively.
Danish: I fastende tilstand medførte samtidig administration af flere doser af protonpumpehæmmeren (PPI) rabeprazol og en enkelt dosis IBRANCE 125 mg nedsættelse af palbociclib AUCinf og Cmax med henholdsvis 62 % og 80 %.
English: Permanent discontinuation due to an adverse reaction occurred in 5.2% of patients receiving IBRANCE in randomised clinical studies regardless of the combination.
Danish: 5,2 % af patienter, som fik IBRANCE i randomiserede kliniske studier, seponerede permanent på grund af en bivirkning uafhængigt af kombinationen.
English: A 6.9-month difference in median OS in the palbociclib plus fulvestrant arm compared with the placebo plus fulvestrant arm was observed; this result was not statistically significant at the prespecified significance level of 0.0235 (1-sided).
Danish: Der blev observeret en 6,9 måneders forskel i median OS i palbociclib plus fulvestrant-armen sammenlignet med placebo plus fulvestrant-armen.
English: The NOEL for palbociclib-related carcinogenicity effects was 10 mg/kg/day (approximately 2 times the human clinical exposure based on AUC) and
Danish: Det observerede NOEL for palbociclib-relateret karcinogenecitet var på henholdsvis 10 mg/kg/dag (ca. 2 gange den kliniske humane eksponering baseret på AUC) og 200 mg/kg/dag (ca. 4 gange den kliniske humane eksponering baseret på AUC) hos hanner og hunner.
English: What IBRANCE looks like and contents of the pack - IBRANCE 75 mg is supplied as opaque, hard capsules, with a light orange body (printed “PBC 75” in white) and a light orange cap (printed “Pfizer” in white).
Danish: Udseende og pakningstørrelser - IBRANCE 75 mg leveres som uigennemsigtige, hårde kapsler med en lys orange underdel (mærket ”PBC 75” med hvid skrift) og en lys orange overdel (mærket ”Pfizer” med hvid skrift).
English: g Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
Danish: g. Stomatitis omfatter følgende foretrukne termer: Aftøs stomatitis, cheilitis, glossitis, glossalgi,
English: The primary endpoint of the study was progression-free survival (PFS) evaluated according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as assessed by investigator.
Danish: Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
English: • chest pain
Danish: • Tør hoste
English: Grade 3 n (%)
Danish: n (%)
English: IBRANCE 75 mg hard capsules IBRANCE 100 mg hard capsules IBRANCE 125 mg hard capsules palbociclib
Danish: IBRANCE 75 mg hårde kapsler IBRANCE 100 mg hårde kapsler IBRANCE 125 mg hårde kapsler palbociclib
English: Infections have been reported at a higher rate in patients treated with IBRANCE in randomised clinical studies compared to patients treated in the respective comparator arm. Grade 3 and Grade 4 infections occurred respectively in 4.5% and 0.7% of patients treated with IBRANCE in any combination (see section 4.8).
Danish: Grad 3 og grad 4 infektioner forekom hos henholdsvis 4,5 % og 0,7 % af patienterne behandlet med IBRANCE i alle kombinationer (se pkt.
English: AST increased
Danish: Forhøjet ASAT
English: N=number of patients; CI=confidence interval; OR=objective response based on confirmed and unconfirmed responses according to RECIST 1.1; TTR=time to first tumour response.
Danish: N = antal patienter; CI = konfidensinterval; OR = objektiv respons baseret på bekræftet og ubekræftet respons iht.
English: Placebo plus Letrozole (N = 222)
Danish: Placebo plus letrozoll (N = 222)
English: - IBRANCE 125 mg is supplied as opaque, hard capsules, with a caramel body (printed “PBC 125” in white) and a caramel cap (printed “Pfizer” in white).
Danish: - IBRANCE 125 mg leveres som uigennemsigtige, hårde kapsler, med en karamelfarvet underdel (mærket ”PBC 125” med hvid skrift) og en karamelfarvet overdel (mærket ”Pfizer” med hvid skrift).
English: • Sulfasalazine used to treat rheumatoid arthritis.
Danish: • Sulfasalazin, som anvendes til behandling af leddegigt.
English: Dysgeusia Eye disorders
Danish: Smagsforstyrrelser (dysgeusi)
English: Infectionsb Blood and lymphatic system disorders
Danish: Unormale leverblodprøver
English: Addition of palbociclib to fulvestrant resulted in a symptom benefit by significantly delaying time-to-deterioration in pain symptom compared with placebo plus fulvestrant (median 8.0 months versus 2.8 months; HR of 0.64 [95% CI: 0.49, 0.85]; p<0.001).
Danish: Tillæg af palbociclib til fulvestrant resulterede i en symptomfordel ved væsentligt at forsinke tiden til forværring af smertesymptomer sammenlignet med placebo plus fulvestrant (median 8,0 måneder versus 2,8 måneder.
English: IBRANCE recommended dose modifications for adverse reactions Dose level
Danish: Anbefalede dosisjusteringer af IBRANCE ved bivirkninger
English: A reduction in the risk of disease progression or death in favour of the palbociclib plus letrozole arm was observed in all individual patient subgroups defined by stratification factors and baseline characteristics in the primary and in the updated analysis.
Danish: Der blev observeret en reduktion i risikoen for sygdomsprogression eller død til fordel for palbociclib plus letrozol-armen i alle patientundergrupper, defineret iht.
English: Coadministration of multiple 200 mg doses of itraconazole with a single 125 mg palbociclib dose increased palbociclib total exposure (AUCinf) and the peak concentration (Cmax) by approximately 87% and 34%, respectively, relative to a single 125 mg palbociclib dose given alone.
Danish: Samtidig administration af flere doser itraconazol 200 mg og en enkelt dosis palbociclib 125 mg øgede den samlede eksponering (AUCinf) og peak-koncentration (Cmax) af palbociclib med henholdsvis ca. 87 % og 34 % i forhold til en enkelt dosis palbociclib 125 mg givet alene.
English: Ammonium hydroxide (28% solution)
Danish: Titandioxid (E171) Ammoniumhydroxid (28% opløsning) Propylenglykol
English: Platelets decreased
Danish: Nedsat leverfunktion
English: Patients were well matched for baseline demographics and prognostic characteristics between the palbociclib plus letrozole arm and the placebo plus letrozole arm.
Danish: Patienterne var ligeligt fordelt mellem palbociclib plus letrozol-armen og placebo plus letrozol-armen mht. demografiske data ved baseline og prognostiske karakteristika.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG
Danish: Indehaver af markedsføringstilladelsen Pfizer Europe MA EEIG Boulevard de la Plaine 17
English: Each hard capsule contains 74 mg of lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver hård kapsel indeholder 74 mg lactose (som monohydrat).
English: Each hard capsule contains 56 mg of lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver hård kapsel indeholder 56 mg lactose (som monohydrat).
English: EU/1/16/1147/005 (21 hard capsules) EU/1/16/1147/009 (63 hard capsules)
Danish: EU/1/16/1147/005 (21 hårde kapsler) EU/1/16/1147/009 (63 hårde kapsler)
English: * Adverse Drug Reaction (ADR) identified post-marketing.
Danish: Bivirkning identificeret efter markedsføring.
English: - IBRANCE 100 mg is supplied as opaque, hard capsules, with a light orange body (printed “PBC 100” in white) and a caramel cap (printed “Pfizer” in white).
Danish: - IBRANCE 100 mg leveres som uigennemsigtige, hårde kapsler, med en lys orange underdel (mærket ”PBC 100” med hvid skrift) og en karamelfarvet overdel (mærket ”Pfizer” med hvid skrift).
English: EU/1/16/1147/003 (21 hard capsules) EU/1/16/1147/008 (63 hard capsules)
Danish: EU/1/16/1147/003 (21 hårde kapsler) EU/1/16/1147/008 (63 hårde kapsler)
English: Effect of acid reducing agents
Danish: Virkning af syrenedsættende stoffer
English: IBRANCE plus letrozole (N=230)
Danish: IBRANCE plus letrozol (N=230)
English: IBRANCE 125 mg hard capsules Each hard capsule contains 125 mg of palbociclib.
Danish: IBRANCE 125 mg hårde kapsler Hver hård kapsel indeholder 125 mg palbociclib.
English: IBRANCE plus fulvestrant (N=206)
Danish: IBRANCE plus letrozol (N=206)
English: IBRANCE 100 mg hard capsules Each hard capsule contains 100 mg of palbociclib.
Danish: IBRANCE 100 mg hårde kapsler Hver hård kapsel indeholder 100 mg palbociclib.
English: IBRANCE 75 mg hard capsules Each hard capsule contains 75 mg of palbociclib.
Danish: IBRANCE 75 mg hårde kapsler Hver hård kapsel indeholder 75 mg palbociclib.
English: - IBRANCE 125 mg hard capsule: each capsule contains 125 mg palbociclib.
Danish: - IBRANCE 125 mg hård kapsel: Hver kapsel indeholder 125 mg palbociclib.
English: Placebo plus letrozole (N=110)
Danish: Placebo plus letrozol (N=110)
English: - IBRANCE 75 mg hard capsule: each capsule contains 75 mg palbociclib.
Danish: - IBRANCE 75 mg hård kapsel: Hver kapsel indeholder 75 mg palbociclib.
English: Placebo plus letrozole (N=112)
Danish: Placebo plus letrozol (N=112)
English: IBRANCE plus letrozole (N=214)
Danish: IBRANCE plus letrozol (N=214)
English: - IBRANCE 100 mg hard capsule: each capsule contains 100 mg palbociclib.
Danish: - IBRANCE 100 mg hård kapsel: Hver kapsel indeholder 100 mg palbociclib.
English: NAME OF THE MEDICINAL PRODUCT IBRANCE 100 mg hard capsules palbociclib
Danish: IBRANCE 100 mg hårde kapsler palbociclib
English: Patients were well matched for baseline demographics and prognostic characteristics between the palbociclib plus fulvestrant arm and the placebo plus fulvestrant arm.
Danish: Patienterne var ligeligt fordelt mellem palbociclib plus fulvestrant-armen og placebo plus fulvestrantarmen mht. demografiske data ved baseline og prognostiske karakteristika.