natgillin/translations-raw huggingface dataset:
I FALCON-studiet var antallet af patienter, som rapporterede en bivirkning i form af smerter i led, muskler og knogler, henholdsvis 65 (31,2%) og 48 (24,1%) for fulvestrant-armen og anastrozolarmen. 
In the FALCON study, the number of patients who reported an adverse reaction of joint and musculoskeletal pain was 65 (31.2%) and 48 (24.1%) for fulvestrant and anastrozole arms, respectively.
En dosis indeholder 500 mg benzylakohol og op til 1.000 mg ethanol, vandfri. 
One dose contains 500 mg benzyl alcohol, and up to 1000 mg ethanol anhydrous.
Dosisjustering anbefales ikke til patienter med let til moderat nedsat nyrefunktion (kreatinin-clearance ≥30 ml/min). 
No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance ≥30 ml/min).
Patienter, der potentielt kan blive gravide, skal anbefales at bruge effektiv prævention under behandlingen. 
Women of childbearing potential Patients of child-bearing potential should be advised to use effective contraception while on treatment.
Ikke almindelig Leversvigtc,f, hepatitisf, forhøjet gamma-GTf 
Hepatic failurec,f, hepatitis f, elevated gamma-GT f
Opbevares i køleskab og transporteres nedkølet (2°C - 8°C). 
Store and transport refrigerated (2°C - 8°C).
f Thrombocytopeni inkluderer de følgende PTs: thrombocytopeni, nedsat trombocyttal. 
f Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
Tabel 6 Effektresultater i visceral og ikke-visceral sygdom fra PALOMA-3-studiet (intent-to-treat-population) 
Table 6 Efficacy results in visceral and non-visceral disease from PALOMA3 study (intentto-treat population)
• Allergiske reaktioner (overfølsomhed), der kan omfatte hævelser i ansigt, læber, tunge og/eller svælg, som kan være tegn på en anafylaktisk reaktion 
• Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat that may be signs of anaphylactic reactions
Venøs thromboembolismea, hedeture 
Venous thromboembolisma
166 patienter i fulvestrant plus placebo-armen udfyldte spørgeskemaet ved baseline og ved mindst et besøg efterfølgende. 
A total of 335 patients in the fulvestrant plus palbociclib arm and 166 patients in the fulvestrant plus placebo arm completed the questionnaire at baseline and at least 1 post-baseline visit.
Fulvestrant Myaln leveres i 2 forskellige pakninger, enten en pakning indeholdende 1 fyldt glasinjektionssprøjte eller en pakning med 2 fyldte glas-injektionssprøjter. 
Fulvestrant Mylan has 2 pack presentations, either a pack containing 1 glass pre-filled syringe or a pack containing 2 glass pre-filled syringes.
• Reaktion ved injektionsstedet som smerte og eller betændelseslignende tilstand (inflammation) 
• Injection site reactions, such as pain and/or inflammation
Fulvestrant Mylan indeholder 10 vol % ethanol (alkohol), dvs. op til 1.000 mg pr. dosis, svarende til 20 ml øl eller 8 ml vin pr. dosis. 
Fulvestrant Mylan contains 10% w/v ethanol (alcohol) i.e. up to 1000 mg per dose, equivalent to 20 ml beer or 8 ml wine per dose.
• Tykt, hvidligt udflåd fra skeden og svamp (candidainfektion) 
• Thick, whitish vaginal discharge and candidiasis (infection)
Meget almindelig Overfølsomhedsreaktionere Ikke almindelig Anafylaktiske reaktioner 
Very common Hypersensitivity reactionse Uncommon
Den geometriske, gennemsnitlige steady-state-(ss)dalkoncentration af fulvestrant (Cmin,ss) og AUCss var henholdsvis 4,2 (0,9) ng/ml og 3.680 (1.020) ng*t/ml (standardafvigelse). 
The geometric mean (standard deviation) steady state trough concentration (Cmin,ss) and AUCss was 4.2 (0.9) ng/mL and 3680 (1020) ng*hr/mL, respectively.
I dette studie blev virkning og sikkerhed af fulvestrant 500 mg (n=362) sammenlignet med fulvestrant 250 mg (n=374). 
This study compared the efficacy and safety of fulvestrant 500 mg (n=362) with fulvestrant 250 mg (n=374).
De pædiatriske patienter var i alderen 1 til 8 år og fik en intramuskulær dosis på 4 mg fulvestrant/kg hver måned. 
The paediatric patients were aged 1 to 8 years and received 4 mg/kg monthly intramuscular dose of fulvestrant.
Når fulvestrant gives i kombination med palbociclib er det vigtigt, at du også læser indlægssedlen for palbociclib. 
When fulvestrant is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib.
Fulvestrant Mylan indeholder benzylalkohol 
Fulvestrant Mylan contains benzyl alcohol
Et studie på 2 uger med raske postmenopausale frivillige forsøgspersoner, behandlet med 20 μg ethinylestradiol dagligt, viste, at præmedicinering med fulvestrant 250 mg resulterede i en signifikant reduceret stimulation af det postmenopausale endometrium, sammenlignet med placebo, vurderet via ultralydsmålinger af endometriets tykkelse. 
A 2-week study in healthy postmenopausal volunteers treated with 20 μg per day ethinylestradiol showed that pre-treatment with fulvestrant 250 mg resulted in significantly reduced stimulation of the postmenopausal endometrium, compared to pre-treatment with placebo, as judged by ultrasound measurement of endometrium thickness.
• Følelsesløshed, snurrende fornemmelse og smerter 
• Numbness, tingling and pain
Infektioner og parasitære sygdomme Meget almindelig Infektionerb Blod og lymfesystem Meget almindelig Neutropenic Leukopenid Anæmie Thrombocytopenif Ikke almindelig Febril neutropeni Metabolisme og ernæring Meget almindelig Nedsat appetit Nervesystemet Almindelig Dysgeusi Øjne Almindelig Øget tåresekretion Sløret syn Tørre øjne Luftveje, thorax og mediastinum Almindelig Epistaxis Mave-tarm-kanalen Meget almindelig Kvalme 
Infections and infestations Very common Infectionsb Blood and lymphatic system disorders Very common Neutropeniac Leukopeniad Anaemiae Thrombocytopeniaf Uncommon Febrile neutropenia Metabolism and nutrition disorders Very common Decreased appetite Nervous system disorders Common Dysgeusia Eye disorders Common Lacrimation increased Vision blurred Dry eye Respiratory, thoracic and mediastinal disorders Common Epistaxis Gastrointestinal disorders Very common Nausea
Amning skal ophøre under behandling med fulvestrant. 
Breast-feeding must be discontinued during treatment with fulvestrant.
Sammenligning mellem grupper (Fulvestrant 500 mg/ Fulvestrant 250 mg) Hazard ratio 
Comparison between groups (Fulvestrant 500 mg/ Fulvestrant 250 mg) Hazard ratio
DOR (målbar sygdom) [måneder (95 % CI)] 
DOR (measurable disease) [months (95% CI)]
Hvis du føler dig træt efter behandling med Fulvestrant Mylan, bør du ikke køre bil eller betjene maskiner. 
However, if you feel tired after treatment do not drive or use machines.
d Leukopeni inkluderer de følgende PTs: leukopeni, nedsat antal hvide blodlegemer. 
d Leukopenia includes the following PTs: Leukopenia, White blood cell count decreased.
slimhindeinflammation, mundsmerter, orofaryngealt ubehag, orofaryngeale smerter, stomatitis. 
Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
• Tag glassprøjten ud af bakken og undersøg, om den er 
• Remove glass syringe barrel from tray and check that it is not damaged.
for livstruende komplikationer på kort sigt (herunder patienter med massivt ukontrolleret ekssudat [pleural, perikardiel, peritoneal], pulmonal lymfangitis samt mere end 50 % leverpåvirkning), var ikke egnede til deltagelse i studiet. 
massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement), were not eligible for enrolment into the study.
Et åben-label fase-2-studie undersøgte sikkerhed og virkning samt farmakokinetiske egenskaber ved fulvestrant hos 30 piger i alderen 1 til 8 år med progressiv pubertas præcox i forbindelse med McCune Albright-syndrom (MAS). 
An open-label phase 2 study investigated the safety, efficacy and pharmacokinetics of fulvestrant in 30 girls aged 1 to 8 years with Progressive Precocious Puberty associated with McCune Albright Syndrome (MAS).
• Forhøjet mængde bilirubin (galdefarvestof, der dannes i leveren) 
• Increase of bilirubin (bile pigment produced by the liver)
Hos rotter sås reversibel nedsat kvindelig fertilitet og embryo-overlevelse, dyctocia samt en øget forekomst af fosterabnormaliteter inkl. 
In rats, a reversible reduction in female fertility and embryonic survival, dystocia and an increased incidence of foetal abnormalities including tarsal flexure were observed.
Fulvestrant Mylan 500 mg (2 x 250 mg/5 ml injektionsvæske, opløsning) skal administreres med 2 fyldte injektionssprøjter, se afsnit 3. 
Fulvestrant Mylan 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3.
Fulvestrant Mylan anvendes enten 
Fulvestrant Mylan is used either:
Perifer neuropatie, iskiase 
Neuropathy peripherale, sciaticae
Hazard ratio for fulvestrant 250 mg i forhold til anastrozol for tid til død, var 1,01 (95% konfidensinterval, 0,86 til 1,19). 
The hazard ratio of fulvestrant 250 mg to anastrozole for time to death was 1.01 (95% CI 0.86 to 1.19).
Anvend kun dette lægemiddel til børn, gravide eller ammende kvinder og patienter i højrisikogruppe såsom patienter med epilepsi og leversygdomme efter aftale med lægen. 
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Temperaturer under 2°C vil ikke beskadige produktet, forudsat at det ikke opbevares ved temperaturer under -20°C. 
Exposure to temperatures below 2°C will not damage the product providing it is not stored below -20°C.
Fulvestrant skal anvendes med forsigtighed til patienter med meget nedsat nyrefunktion (kreatininclearance < 30 ml/min). 
Fulvestrant should be used with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min).
Fulvestrant Mylan indeholder: - Aktivt stof: fulvestrant. 
What Fulvestrant Mylan contains - The active substance is fulvestrant.
6.6 Regler for bortskaffelse og anden håndtering Administrationsinstruktion 
6.6 Special precautions for disposal and other handling
- Øvrige indholdsstoffer (hjælpestoffer): benzylbenzoat, benzylalkohol, vandfri ethanol, renset ricinusolie. 
- The other ingredients (excipients) are benzyl benzoate, benzyl alcohol, ethanol, anhydrous, castor oil, refined.
I alt 521 præ-/peri- og postmenopausale kvinder, som havde progredieret under eller inden for 12 måneder efter fuldførelse af adjuverende endokrin behandling, under eller inden for 1 måned efter tidligere endokrin behandling mod fremskreden sygdom, blev randomiseret 2:1 til fulvestrant plus palbociclib eller fulvestrant plus placebo og stratificeret efter dokumenteret følsomhed over for tidligere hormonbehandling, menopausalstatus ved studiets start (præ-/peri- versus postmenopausal) og forekomst af viscerale metastaser. 
A total of 521 pre/peri- and postmenopausal women who had progressed on or within 12 months from completion of adjuvant endocrine therapy on or within 1 month from prior endocrine therapy for advanced disease, were randomised 2:1 to fulvestrant plus palbociclib or fulvestrant plus placebo and stratified by documented sensitivity to prior hormonal therapy, menopausal status at study entry (pre/peri- versus postmenopausal), and presence of visceral metastases.
Der bør udvises forsigtighed, hvis Fulvestrant Mylan injiceres i det dorsogluteale område på grund af den nært underliggende iskiasnerve. 
Caution should be taken if injecting Fulvestrant Mylan at the dorsogluteal site due to the proximity of the underlying sciatic nerve.
Et to-årigt onkogenicitetsstudie med rotter (intramuskulær administration af fulvestrant) viste øget forekomst af godartede ovarietumorer i granulosa-celler hos hunrotter ved den høje dosis på 10 mg/rotte/15 dage og en øget forekomst af Leydigs tumorer i testiklerne hos hanrotter. 
A two-year oncogenicity study in rats (intramuscular administration of fulvestrant) showed increased incidence of ovarian benign granulosa cell tumours in female rats at the high dose, 10 mg/rat/15 days and an increased incidence of testicular Leydig cell tumours in males.
For brugervenlighed vendes kanylens skråspids opad mod vippearmen (se figur 4). 
For user convenience, the needle bevel- up position is oriented to the lever arm (see Figure 4).
Benzylbenzoat Benzylalkohol Ethanol, vandfri Ricinusolie, renset 
Benzyl benzoate Benzyl alcohol Ethanol, anhydrous Castor oil, refined
-AI-undergruppe (n=313)a 
-AI subgroup (n=313)a
Benzylbenzoat 
Benzyl benzoate
Studiet omfattede 423 patienter med recidiverende eller progredierende sygdom under antiøstrogen-behandlingen (AE-undergruppe), og 313 patienter med recidiverende eller progredierende sygdom under aromatasehæmmer-behandlingen (AI-undergruppe). 
The study included 423 patients whose disease had recurred or progressed during anti-estrogen therapy (AE subgroup) and 313 patients whose disease had recurred or progressed during aromatase inhibitor therapy (AI subgroup).
Ved niveauet ”ingen effekt” for disse fund var den systemiske eksponering (AUC) cirka 1,5 gange niveauet af den forventede humane eksponeringer hos hunrotter og 0,8 gange hos hanrotter. 
At the no-effect level for these findings, systemic exposure levels (AUC) were, in rats, approximately 1.5-fold the expected human exposure levels in females and 0.8-fold in males, and in mice, approximately 0.8fold the expected human exposure levels in both males and females.
Sammenligning melle grupper (Fulvestrant 500 mg/Fulvestrant 250 mg) 
Comparison between groups (Fulvestrant 500 mg/Fulvestrant 250 mg)
Du må ikke amme, mens du behandles med Fulvestrant Mylan. 
You must not breast-feed while on treatment with Fulvestrant Mylan.
Interferens med estradiol-antistofanalyser 
Interference with estradiol antibody assays
Meget almindelig Astenia, reaktioner ved injektionsstedetb 
Very common Astheniaa, injection site reactionsb Common
Fulvestrant er indiceret til patienter med recidiverende eller progredierende sygdom under antiøstrogenbehandling. 
Fulvestrant is indicated in patients whose disease had recurred or progressed on an anti-estrogen therapy.
4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Fulvestrant skal anvendes med forsigtighed til patienter med let til moderat nedsat leverfunktion (se pkt. 
4.4 Special warnings and precautions for use Fulvestrant should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
• som monoterapi til behandling af østrogen-receptor-positiv, lokal fremskreden eller metastatisk brystkræft hos postmenopausale kvinder: - der ikke tidligere har modtaget endokrin behandling, eller - med sygdomstilbagefald under eller efter adjuverende behandling med antiøstrogen, eller sygdomsprogression under antiøstrogenbehandling. 
• as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.
Opbevar den fyldte sprøjte i den originale pakning for at beskytte mod lys. 
Keep the pre-filled syringe in the original package in order to protect from light.
Temperaturudsving har en kumulativ virkning på produktkvaliteten, og perioden på 28 dage må ikke overskrides i løbet af Fulvestrant Mylans opbevaringstid (se pkt. 
Temperature excursions have a cumulative effect on the product quality and the 28 day time period must not be exceeded over the duration of the shelf life of Fulvestrant Mylan (see section 6.3).
55% af patienterne havde viscerale metastaser ved studiets udgangspunkt. 
Fifty-five percent (55.0%) of patients had visceral metastasis at baseline.
Neoadjuverende behandling af brystkræftpatienter i op til 16 uger, med enten fulvestrant 500 mg eller fulvestrant 250 mg, viste ingen klinisk signifikante ændringer i endometriets tykkelse, hvilket indikerer manglende agonistvirkning. 
Neoadjuvant treatment for up to 16 weeks in breast cancer patients treated with either fulvestrant 500 mg or fulvestrant 250 mg did not result in clinically significant changes in endometrial thickness, indicating a lack of agonist effect.
Det skal du vide, før du begynder at bruge Fulvestrant Mylan 
What you need to know before you use Fulvestrant Mylan
Hold fast i låget (A) med den anden hånd og vip forsigtigt frem og tilbage, indtil låget brækkes af og kan trækkes af. 
With the other hand, take hold of the cap (A) and carefully tilt back and forth until the cap disconnects and can be pulled off, do not twist (see Figure 1).
I de poolede datasæt med fulvestrant som monoterapi var de hyppigst rapporterede bivirkninger reaktioner ved injektionsstedet, asteni, kvalme og forhøjede leverenzymer (ALAT, ASAT, ALP). 
In the pooled dataset of fulvestrant monotherapy, the most frequently reported adverse reactions were injection site reactions, asthenia, nausea, and increased hepatic enzymes (ALT, AST, ALP).
Stomatitisg Diarré Opkastning Hud og subkutane væv Meget almindelig Alopeci Udslæth Almindelig Tør hud Almene symptomer og reaktioner på administrationsstedet Meget almindelig Træthed Feber Almindelig Asteni Undersøgelser Almindelig Forhøjet ASAT Forhøjet ALAT 
Stomatitisg Diarrhoea Vomiting Skin and subcutaneous tissue disorders Very common Alopecia Rashh Common Dry skin General disorders and administration site conditions Very common Fatigue Pyrexia Common Asthenia Investigations Common AST increased ALT increased
Efter temperaturudsving skal produktet straks igen opbevares ved de anbefalede opbevaringsforhold (opbevares i køleskab og transporteres nedkølet ved 2°C - 8°C). 
After temperature excursions, the product should be returned immediately to the recommended storage conditions (store and transport in a refrigerator 2°C - 8°C).
Der blev udført et randomiseret, dobbeltblindet, dobbelt-dummy, fase 3-multicenterstudie med fulvestrant 500 mg versus anastrozol 1 mg med postmenopausale kvinder med ER-positiv og/eller PgR-positiv lokalt fremskreden eller metastatisk brystkræft, som ikke tidligere havde fået hormonbehandling. 
A Phase 3, randomised, double-blind, double-dummy, multicentre study of fulvestrant 500 mg versus anastrozole 1 mg was conducted in postmenopausal women with ER-positive and/or PgR-positive locally advanced or metastatic breast cancer who had not previously been treated with any hormonal therapy.
Patienter med fremskreden/metastatisk, symptomatisk, visceral spredning, som havde risiko 
Patients with advanced/metastatic, symptomatic, visceral spread, that were at risk of life-threatening complications in the short term (including patients with
Der blev udført et internationalt, randomiseret, dobbeltblindet, fase 3-multicenterstudie med parallelgrupper med fulvestrant 500 mg plus palbociclib 125 mg versus fulvestrant 500 mg plus placebo med kvinder med HR-positiv, HER2-negativ lokalt fremskreden brystkræft, der ikke var modtagelig for resektion eller strålebehandling med henblik på helbredelse, eller metastatisk brystkræft, uanset menopausalstatus, hvis sygdom progredierede efter tidligere endokrin behandling i (neo)adjuverende eller metastatisk regi. 
A Phase 3, international, randomised, double-blind, parallel-group, multicentre study of fulvestrant 500 mg plus palbociclib 125 mg versus fulvestrant 500 mg plus placebo was 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.
Figur 1 Kaplan-Meier-diagram over progressionsfri overlevelse (investigatorvurdering, intentto-treat-population) ─ FALCON-studiet 
Figure 1 Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment, Intent-To-Treat Population) ─ FALCON Study
• Anafylaktisk reaktion 
• Anaphylactic reactions
Det reproduktive system og mammae 
Reproductive system and breast disorders Common
Neoadjuverende behandling med enten fulvestrant 500 mg eller fulvestrant 250 mg til brystkræftpatienter i op til 16 uger resulterede ikke i klinisk signifikante ændringer af knogle-turnover-markører i serum. 
Neoadjuvant treatment for up to 16 weeks in breast cancer patients with either fulvestrant 500 mg or fulvestrant 250 mg did not result in clinically significant changes in serum bone-turnover markers.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING En fyldt injektionssprøjte indeholder 250 mg fulvestrant i 5 ml opløsning. 
QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
Sådan skal du bruge Fulvestrant Mylan 
How to use Fulvestrant Mylan
To kliniske fase 3-studier blev gennemført med i alt 851 postmenopausale kvinder med fremskreden brystkræft, som havde sygdomstilbagefald under, eller efter, adjuvant endokrin behandling, eller progression efter endokrin behandling for fremskreden sygdom. 
Two phase-3 clinical studies were completed in a total of 851 postmenopausal women with advanced breast cancer who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.
En fyldt injektionssprøjte (5 ml) indeholder 250 mg fulvestrant. 
Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.
ORR-odds ratio (95% CI) og pværdi 
ORR Odds Ratio (95% CI) and p-value
To klare type 1 fyldte glas-injektionssprøjter med et polystyren pumpestempel, der er lukket med sikkerhedsforsegling, hver indeholdende 5 ml Fulvestrant Mylan injektionsvæske, opløsning. 
Two clear type 1 glass pre-filled syringes with polypropylene plunger rod, fitted with a tamper-evident closure, each containing 5 ml Fulvestrant Mylan solution for injection.
For undergruppen af patienter med sygdom, der var begrænset til ikkeviscerale metastaser (n=208), var hazard ratio 0,592 (95% CI: 0,419; 0,837) for fulvestrant-armen sammenlignet med anastrozol-armen. 
For the subgroup of patients with disease limited to non-visceral metastasis (n=208), the HR was 0.592 (95% CI: 0.419, 0.837) for the fulvestrant arm compared to the anastrozole arm. For the subgroup of patients with visceral metastasis (n=254), the HR was 0.993 (95% CI: 0.740, 1.331) for the fulvestrant arm compared to the anastrozole arm.
Kaplan-Meier-diagram over progressionsfri overlevelse (investigatorvurdering, intent-to-treat-population) - PALOMA-3-studiet 
Figure 2 Kaplan-Meier plot of progression-free survival (investigator assessment, intentto-treat population) - PALOMA3 study
-AE-undergruppe (n=423) -AI-undergruppe (n=313)a a 
-AE subgroup (n=423) -AI subgroup (n=313)a a
e Anæmi inkluderer de følgende PTs: anæmi, nedsat hæmoglobin, nedsat hæmatokrit. 
e Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
assisterede vippearm for at aktivere beskyttelsesmekanismen (se figur 5). 
• After injection, immediately apply a single-finger stroke to the activation assisted lever arm to activate the shielding mechanism (see Figure 5).
SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab og transporteres nedkølet. 
Store and transport refrigerated.
I forbindelse med administration af fulvestrant er bivirkninger, relateret til injektionsstedet, herunder iskias, neuralgi, neuropatiske smerter og perifer neuropati, observeret og rapporteret. 
Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with fulvestrant injection.
Progressionsfri overlevelse Antal PFS-hændelser (%) PFS-hazard ratio (95% CI) og pværdi 
Progression-Free Survival Number of PFS Events (%) PFS Hazard Ratio (95% CI) and pvalue
Den fyldte injektionssprøjte opbevares i den originale yderpakning for at beskytte mod lys. 
Store the pre-filled syringe in the original package in order to protect from light.
Blandt de vigtigste sekundære effektendepunkter var objektiv responsrate (ORR), klinisk gevinstrate (CBR) og total overlevelse (OS). 
Progression-free survival (PFS) was the primary endpoint; key secondary efficacy endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS).