natgillin/translations-raw huggingface dataset:
Er du i tvivl, så spørg lægen eller på apoteket. 
In case of any doubt, ask your doctor or pharmacist.
PHEBURANE skal imidlertid bruges sammen med en lavproteindiæt, som udarbejdes specielt til dig af en læge eller en kostvejleder. 
However PHEBURANE must be used along with a diet reduced in proteins, designed especially for you by the doctor and the dietician.
Plasma og urinkoncentrationer af phenylbutyrat og dets metabolitter er blevet målt på fastende raske voksne, efter at de havde fået en enkelt dosis på 5 g natriumphenylbutyrat og fra patienter med urinstofcyklusdefekter, hæmoglobinopatier og levercirrhose, som fik enkelte og gentagne doser peroralt på op til 20 g/dag (ukontrollerede forsøg). 
Plasma and urine concentrations of phenylbutyrate and its metabolites have been obtained from fasting normal adults who received a single dose of 5 g of sodium phenylbutyrate and from patients with urea cycle disorders, haemoglobinopathies and cirrhosis receiving single and repeated oral doses up to 20 g/day (uncontrolled studies).
Phenylacetat er en metabolisk aktiv substans, som konjugeres med glutamin ved acetylering for at danne phenylacetylglutamin, som derefter udskilles af nyrerne. 
Phenylacetate is a metabolically active compound that conjugates with glutamine via acetylation to form phenylacetylglutamine which is then excreted by the kidneys.
Hvert gram natriumfenylbutyrat indeholder 124 mg (5,4 mmol) natrium og 768 mg saccharose. 
Each gram of sodium phenylbutyrate contains 124 mg (5.4 mmol) of sodium and 768 mg of sucrose.
PHEBURANE 483 mg/g {Kun karton} 
PHEBURANE 483 mg/g {For carton only}
PHEBURANE indeholder natrium og saccharose. 
PHEBURANE contains sodium and sucrose
Patienternes kognitive præstationer forblev relativt uændrede under behandlingen med phenylbutyrat. 
Their cognitive performance remained relatively stable during phenylbutyrate therapy.
Hver flaske indeholder 174 g granulat. 
Each bottle contains 174g of granules.
Kvinder i den fertile alder skal bruge en effektiv antikonception. 
Women of childbearing potential must use effective contraception during treatment.
Hvis du har glemt at tage PHEBURANE: 
If you forget to take PHEBURANE
Blod og lymfesystem Almindelig anæmi, trombocytopeni, leukopeni, leukocytose, trombocytose 
Common anaemia, thrombocytopenia, leukopenia, leukocytosis, thrombocytosis
Efter en enkelt oral dosis på 5 g natriumphenylbutyrat i form af granulat blev der påvist målbare koncentrationer i plasma af phenylbutyrat 15 minutter efter indgift. 
After a single oral dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylbutyrate were detected 15 minutes after dosing.
Karton: 1 flaske med 174 g granulat. 
Carton: One bottle with 174 g granules.
Efter en enkelt dosis på 5 g natriumphenylbutyrat i granulatform blev der påvist målelige plasmakoncentrationer af phenylacetat og phenylacetylglutamin henholdsvis 30 og 60 minutter efter indgift. 
After a single dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylacetate and phenylacetylglutamine were detected 30 and 60 minutes respectively after dosing.
Der medfølger en måleske, som afmåler op til 3 g natriumphenylbutyrat med en graduering på 250 mg. 
A calibrated dosing spoon is provided which dispenses up to 3g of sodium phenylbutyrate by graduation of 250 mg.
Man ved, at phenylbutyrat bliver oxyderet til phenylacetat, som enzymatisk konjugeres med glutamin for at danne phenylacetylglutamin i leveren og nyren. 
Phenylbutyrate is known to be oxidised to phenylacetate which is enzymatically conjugated with glutamine to form phenylacetylglutamine in the liver and kidney.
Saccharosekugler (saccharose og majsstivelse), hypromellose, ethylcellulose N7, macrogol 1500, povidon K25. 
PHARMACEUTICAL PARTICULARS 6.1 List of excipients sugar spheres (sucrose and maize starch), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25.
Flaske: 174 g granulat. 
Bottle: 174 g granules.
Den daglige dosis PHEBURANE beregnes på baggrund af din legemsvægt eller legemsoverflade og justeres efter din proteinbalance og kost. 
The daily dose of PHEBURANE will be based on your body weight or body surface and adjusted according to your protein tolerance and diet. You will need regular blood tests to determine the correct daily dose.
Dette lægemiddel indeholder 124 mg (5,4 mmol) natrium pr. g natriumphenylbutyrat. 
This medicine contains 124 mg (5.4 mmol) of sodium per 1 g of sodium phenylbutyrate.
• hovedpine 
• headache,
Indlægsseddel: Information til brugeren PHEBURANE granulat, 483 mg/g 
Package leaflet: Information for the patient PHEBURANE 483 mg/g granules
Brug af anden medicin sammen med PHEBURANE 
Other medicines and PHEBURANE
Ikke almindelig arytmi 
Uncommon arrhythmia
og den gennemsnitlige maksimumkoncentration var 195 µg/ml. 
The mean time to peak concentration was 1 hour and the mean peak concentration 195 μg/ml.
Baseret på undersøgelser af udskillelsen af phenylacetylglutamin hos patienter med urinstofcyklusdefekter er det muligt at skønne, at der dannes mellem 0,12 og 0,15 g phenylacetylglutaminkvælstof, for hvert gram natriumphenylbutyrat, der er indgivet. 
Clinical efficacy and safety Based on studies of phenylacetylglutamine excretion in patients with urea cycle disorders it is possible to estimate that, for each gram of sodium phenylbutyrate administered, between 0.12 and 0.15 g of phenylacetylglutamine nitrogen are produced.
Pheburane er kontraindiceret under amning (se pkt. 
Pheburane is contra-indicated during breast-feeding (see section 4.3).
Der medfølger en inddelt måleske. 
A calibrated measuring spoon is provided.
Dette lægemiddel indeholder 768 mg saccharose pr. g natriumphenylbutyrat. 
This medicine contains 768 mg of sucrose per 1 g of sodium phenylbutyrate.
På molær basis er natriumphenylbutyrat sammenlignelig med urinstof (indeholder begge 2 mol nitrogen). 
On a molar basis, phenylacetylglutamine is comparable to urea (each containing 2 moles of nitrogen) and therefore provides an alternate vehicle for waste nitrogen excretion.
Granulat Hvidt til let gulligt granulat. 
White to off-white granules.
Almindelig nedsat indhold i blodet af kalium, albumin, total protein og fosfat, forhøjet indhold i blodet af alkalisk fosfatase, transaminaser, bilirubin, urinsyre, chlorid, fosfat og natrium, vægtøgning 
Increased blood alkaline phosphatase, transaminases, bilirubin, uric acid, chloride, phosphate and sodium.
• hvis du er overfølsom (allergisk) over for phenylbutyrat eller et af de øvrige indholdsstoffer 
• are allergic to sodium phenylbutyrate or any of the other ingredients of this medicine (listed in section 6).
Hvert gram af granulatet indeholder 483 mg natriumphenylbutyrat. 
Each gram of granules contains 483 mg of sodium phenylbutyrate.
Sådan skal du tage PHEBURANE 
How to take PHEBURANE
EXP Skal anvendes inden for 45 dage efter anbrud af emballagen. 
EXP After the first opening, to be used within 45 days.
Ikke almindelig aplastisk anæmi, ekkymose Metabolisme og ernæring Almindelig metabolisk acidose, alkalose, nedsat appetit Psykiske lidelser 
Common metabolic acidosis, alkalosis, decreased appetite
Navn og adresse på fremstilleren (fremstillerne) ansvarlig(e) for batchfrigivelse 
Name and address of the manufacturer(s) responsible for batch release Lucane Pharma
• svækket hukommelse 
• impaired memory,
Tabel over uønskede hændelser 
Tabulated list of adverse reactions
Uønsket hændelse 
Adverse reaction
Skal anvendes inden 45 dage efter anbrud af emballagen. 
After the first opening, to be used within 45 days.
Hvis du har taget for meget PHEBURANE 
If you take more PHEBURANE than you should
PHEBURANE granulat, 483 mg/g 
PHEBURANE 483 mg/g granules
• smagsforstyrrelser 
• changes in taste (taste disturbances),
Der medfølger en inddelt måleske, som kan afmåle op til 3 gram natriumphenylbutyrat. 
A calibrating measuring spoon which dispenses up to 3 g of sodium phenylbutyrate is provided with the medicine.
• PHEBURANE anses for at have et højt natrium-indhold, Dette bør især tages i betragtning hos patienter på en diæt med lavt saltindhold. 
• PHEBURANE is considered high in sodium.
• Spørg lægen eller på apoteketspersonalet, hvis der er mere, du vil vide. 
• If you have any further questions, ask your doctor or pharmacist.
Spørg din læge eller på apoteket, hvis du er usikker på, om din medicin indeholder disse stoffer. 
If you are uncertain if your medicines contain these substances, you should check with your doctor or pharmacist.
Mave-tarmkanalen 
Common oedema
Relevansen for mennesker er dog ukendt. 
However, the relevance to humans is unknown.
*Repræsenterer en sammenlægning af foretrukne termer 
*Represents a pooling of preferred terms
Responsen blev vurderet hver 4. uge indtil sygdomsprogression. 
Response was assessed every 4 weeks until disease progression.
Lægen undersøger dig, og du vil blive overvåget nøje under behandlingen. 
Your doctor will examine you and you will be monitored closely during treatment.
Lægen kan også justere dosis af de to andre lægemidler. 
The doctor may also adjust the doses of the other medicines.
• Lad ikke indholdet i kapslen komme i kontakt med din hud. 
• Do not let the contents of the capsule come into contact with your skin.
Alder, køn og race 
Age, gender, race
Resultaterne for PFS er opsummeret i tabel 4 og figur 1. 
PFS results are summarised in Table 4 and Figure 1.
Den gennemsnitlige absolutte orale biotilgængelighed er 58%. 
The mean absolute oral bioavailability is 58%.
Anden reduktion til 
Second reduction to
‡ORR = CR+VGPR+PR §Baseret på responders i den respons-evaluerbare population 
‡ORR = CR+VGPR+PR §Based on responders in the response-evaluable population
Transportørbaserede interaktioner 
Transporter-based interactions
Lenalidomid er strukturelt beslægtet med thalidomid. 
Lenalidomide is structurally related to thalidomide.
Tid til respons, måneder Median 
Time to Response, months Median
En risiko for nyfødte/spædbørn kan ikke udelukkes, og derfor skal amning ophøre. 
A risk to newborns/infants cannot be excluded and therefore breast-feeding should be discontinued.
85% af populationen var hvide, 9% asiater og 2% sorte. 
Eighty five percent of the population was White, 9% Asian and 2% Black.
NINLARO tages én gang om ugen (på samme ugedag) i de første 3 uger i denne cyklus. 
NINLARO is taken once a week (on the same day of the week) for the first 3 weeks of this cycle.
Hvert blisterkort indeholder én kapsel). 
Each blister contains one capsule).
Primær refraktær, defineret som bedste respons af stabil sygdom eller sygdomsprogression på alle tidligere behandlinger, blev dokumenteret hos 6% af patienterne. 
Primary refractory, defined as best response of stable disease or disease progression on all prior therapies, was documented in 6% of patients.
Medianalderen var 66 år (38-91 år); 58% af patienterne var over 65 år. 
The median age was 66 years, range 38-91 years; 58% of patients were older than 65 years.
Medianen for samlet overlevelse (OS) blev ikke nået i nogen af grupperne. 
Median overall survival was not reached in either regimen.
Varighed af behandlingen med NINLARO Du skal fortsætte behandlingen, indtil lægen siger, du skal stoppe. 
Duration of the treatment with NINLARO You should continue treatment until your doctor tells you to stop.
Der foreligger ingen data fra dyrestudier. 
No animal data are available.
Patienten skal vurderes med henblik på underliggende årsager og eventuelt gives understøttende pleje. 
The patient should be evaluated for underlying causes and provide supportive care, as necessary.
Du skal læse indlægssedlerne for de to andre lægemidler for at få yderligere oplysninger om deres anvendelse og virkning. 
You should read the Package Leaflets of these other medicines for further information on their use and effects.
Bemærk: De bivirkninger, der er angivet som foretrukne termer, er baseret på MedDRA-version 16.0. 
Note: ADRs included as preferred terms are based on MedDRA version 16.0.
Før du begynder at tage NINLARO og under behandlingen, vil der blive taget blodprøver for at sikre, at du har blodceller nok. 
Before starting NINLARO and during treatment, you will have blood tests to check that you have enough blood cells.
Du kan føle dig træt og svimmel, mens du tager NINLARO. 
You may feel tired and dizzy while taking NINLARO.
Ixazomibs indvirkning på andre lægemidler 
Effect of ixazomib on other medicinal products
Anbefalede handlinger 
Recommended actions
Undgå direkte kontakt med kapslens indhold. 
Direct contact with the capsule contents should be avoided.
En hazard ratio under 1 indikerer en fordel for ixazomib-regimet. 
A hazard ratio less than 1 indicates an advantage for the ixazomib regimen.
Reproduktiv og embryo-føtal udvikling 
Reproductive and embryo-foetal development
De kliniske data er begrænsede, men der er rapporteret om doser på op til 12 mg i det randomiserede kontrollerede studie. 
Clinical data is limited but doses up to 12 mg have been reported in the randomised controlled trial.
Overvej at tilføje G-CSF i henhold til de kliniske retningslinjer. 
Consider adding G-CSF as per clinical guidelines.
Da der foreligger begrænsede data for disse patienter, anbefales en omhyggelig risk/benefit-vurdering, før et ixazomib-regime påbegyndes. 
As data are limited in these patients, a careful risk-benefit assessment is recommended before initiating the ixazomib regimen.
Disse lægemidler skal undgås, da de kan nedsætte virkningen af NINLARO. 
These medicines should be avoided as they may reduce the effectiveness of NINLARO.
• Slug kapslen hel sammen med vand. 
• Swallow the capsule whole with water.
Figur 2: Forest-plot af progressionsfri overlevelse i alle undergrupper 
Figure 2: Forest plot of progression-free survival in subgroups
Tag ikke NINLARO hvis du er allergisk over for ixazomib eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6). 
Do not take NINLARO if you are allergic to ixazomib or to any of the other any of the other ingredients of this medicine (listed in section 6).
Børn og unge NINLARO anbefales ikke til børn og unge på under 18 år. 
Children and adolescents NINLARO is not recommended for use in children and adolescents aged under 18 years.
Af de 5 patienter i placebogruppen havde 2 bekræftet meget god delvis respons. 
Of the 5 patients in the placebo regimen, 2 had a confirmed very good partial response.
I dette studie blev refraktær sygdom defineret som sygdomsprogression under behandling eller progression inden for 60 dage efter den sidste dosis af lenalidomid eller en proteasomhæmmer. 
For the purposes of this study, refractory disease was defined as disease progression on treatment or progression within 60 days after the last dose of lenalidomide or a proteasome inhibitor.
Den anbefalede dosis er én 4 mg kapsel, der skal indtages gennem munden. 
The recommended dose is one 4 mg capsule taken by mouth.
Forbedringen i PFS i ixazomib-gruppen blev understøttet af forbedringer i den samlede responsrate. 
The improvement in PFS in the ixazomib regimen was supported by improvements in overall response rate.
Det skyldes, at anden medicin kan påvirke den måde, NINLARO fungerer på. 
This is because other medicines can affect the way NINLARO works.
Det er ukendt, om ixazomib eller dets metabolitter udskilles i human mælk. 
It is unknown whether ixazomib or its metabolites are excreted in human milk.
De demografiske data og sygdomskarakteristika ved baseline var afbalancerede og sammenlignelige mellem de to forsøgsgrupper. 
The baseline demographics and disease characteristics were balanced and comparable between the study regimens.
Patienten skal overvåges for symptomer på perifer neuropati. 
The patient should be monitored for symptoms of peripheral neuropathy.
En plasmacelle er en blodcelle, der normalt danner proteiner for at bekæmpe infektioner. 
A plasma cell is a blood cell that normally produces proteins to fight infections.
Fortæl straks lægen, hvis du eller din partner bliver gravid under behandlingen med NINLARO. 
Tell doctor right away if you or your partner becomes pregnant while receiving NINLARO.
Betingelserne i graviditetsforebyggelsesprogrammet for lenalidomid skal overholdes hos alle patienter, medmindre der er pålidelig evidens for, at patienten ikke er fertil. 
The conditions of the Pregnancy Prevention Programme for lenalidomide must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential.
I tilfælde af alvorlige gastrointestinale bivirkninger anbefales monitorering af serum-kalium. 
In case of severe gastrointestinal events, monitoring of serum potassium level is recommended.
Hvis pulveret ved et uheld kommer i kontakt med din hud, skal du vaske huden grundigt med vand og sæbe. 
If the powder accidentally comes into contact with your skin, wash it off thoroughly with soap and water.
Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14a, stk. 4, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger: 
FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Hvis du kaster op efter at have taget en dosis, skal du ikke tage en ekstra dosis. 
If you vomit after taking a dose, do not take an extra dose.
I fase 3-studiet (C16010) havde 10 patienter (5 i hver behandlingsgruppe) svært nedsat nyrefunktion ved baseline. 
In the Phase 3 study (C16010), 10 patients (5 in each treatment regimen) had severe renal impairment at baseline.
• manglende lyst til at spise (appetitløshed) 
• not feeling like eating (decreased appetite)
† Standardiserede MedDRA-retningslinjer (SMQ'er) 
† Standardised MedDRA Queries (SMQs)
• lavt blodtryk (hypotension) 
• lowered blood pressure (hypotension)
Før en ny behandlingscyklus påbegyndes: 
Prior to initiating a new cycle of therapy:
• Tag NINLARO mindst én time før eller mindst to timer efter indtagelse af føde. 
• Take NINLARO at least one hour before or at least two hours after food.
Af de 5 patienter i ixazomib-gruppen havde én patient bekræftet delvis respons og 3 bekræftet stabil sygdom (2 havde dog ikke-bekræftet delvis respons, og 1 havde ikke-bekræftet meget god delvis respons). 
Of the 5 patients in the ixazomib regimen, one patient had a confirmed partial response and 3 confirmed stable disease (however 2 were unconfirmed partial response and 1 was an unconfirmed very good partial response).
*p-værdien er baseret på den stratificerede log rank test. †Hazard ratio er baseret på den stratificerede Cox-regressionsmodel. 
*P-value is based on the stratified log-rank test. †Hazard ratio is based on a stratified Cox's proportional hazard regression model.
Patienterne skal informeres om ikke at føre motorkøretøj og betjene maskiner, hvis de oplever nogen af disse -bivirkninger. 
Patients should be advised not to drive or operate machines if they experience any of these symptoms.
Der anvendes følgende konventioner til klassificering af hyppigheden af bivirkninger (ADR): 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). 
The following convention is used for the classification of the frequency of an adverse drug reaction (ADR): very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 21. november 2016 Dato for seneste fornyelse: 16. september 2019 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 November 2016
57% af patienterne var mænd. 
Fifty seven percent of patients were male.
Den terminale halveringstid (t1/2) for ixazomib er 9,5 dage. 
The terminal half-life (t1/2) of ixazomib was 9.5 days.
Hyppigere monitorering skal overvejes i de første tre cyklusser i henhold til produktresuméet for lenalidomid. 
More frequent monitoring should be considered during the first three cycles as per the lenalidomide SmPC.
Hver pakning indeholder 3 hårde kapsler (tre enkeltpakninger, som hver indeholder et blisterkort forseglet i en mappe. 
Each pack contains 3 hard capsules (three single cartons, each containing a blister sealed inside a wallet.
Ved disse bivirkninger er første dosisjustering at pausere/reducere lenalidomid. 
For these toxicities, the first dose modification step is to withhold/reduce lenalidomide.
PVC-aluminiums-/aluminiumsblisterkort forseglet i en mappe, der indeholder én kapsel. 
PVC-Aluminium /Aluminium blister sealed inside a wallet pack containing one capsule.
Der er ingen data fra anvendelse af ixazomib til gravide kvinder. 
There are no data for the use of ixazomib in pregnant women.
Ixazomib er en oral, meget selektiv og reversibel proteasomhæmmer. 
Ixazomib is an oral, highly selective and reversible proteasome inhibitor.
Der er observeret træthed og svimmelhed i kliniske studier. 
Fatigue and dizziness have been observed in clinical trials.
Brug ikke lægemidlet, hvis du bemærker eventuelle skader eller tegn på, at emballagen har været åbnet. 
Do not use this medicine if you notice any damage or signs of tampering to medicine packaging.
Dosisjustering af ixazomib er ikke nødvendig for patienter over 65 år. 
No dose adjustment of ixazomib is required for patients over 65 years of age.
NINLARO anbefales ikke under graviditet, da det kan skade dit ufødte barn. 
NINLARO is not recommended during pregnancy as it may harm your unborn baby.
Dag 1 Dag 2 til 7 
Day 1 Days 2 to 7
3 pakker af 1 hård kapsel. 
3 packs of 1 hard capsule.
Det primære endepunkt var progressionsfri overlevelse (PFS) i henhold til de standardiserede responskriterier fra IMWG (International Myeloma Working Group) fra 2011 efter vurdering af et uafhængigt bedømmelsesudvalg (IRC) baseret på centrallaboratorie-resultater. 
The primary endpoint was progression-free survival (PFS) according to the 2011 International Myeloma Working Group (IMWG) Consensus Uniform Response Criteria as assessed by a blinded independent review committee (IRC) based on central laboratory results.
Tag den næste dosis som planlagt, når det er tid. 
Take the next dose, as normal, when it is due.
Farmakoterapeutisk klassifikation: Antineoplastiske midler, andre antineoplastiske midler, ATC-kode: L01XX50 
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX50
Ixazomib-Cmax blev reduceret med 4%, og AUC blev øget med 11%. 
Ixazomib Cmax was decreased by 4% and AUC was increased by 11%.
Baseret på en populationsfarmakokinetisk analyse er den systemiske clearance (CL) ca. 1,86 l/time med en inter-individuel variation på 44%. 
Based on a population PK analysis, systemic clearance (CL) was approximately 1.86 L/hr with inter-individual variability of 44%.
Ixazomib-AUC øges proportionalt med dosis i et dosisområde på 0,2-10,6 mg. 
Ixazomib AUC increases in a dose proportional manner over a dose range of 0.2-10.6 mg.
Tag hver NINLARO-kapsel hel sammen med vand på samme tidspunkt hver uge, mindst én time før eller mindst to timer efter indtagelse af føde. 
Take each NINLARO capsule whole with water at the same time each week, at least one hour before or no sooner than two hours after any food.
Fase 3-studiet udelukkede patienter, der var refraktære over for lenalidomid eller proteasomhæmmere, og patienter, der havde fået mere end tre tidligere behandlinger. 
The Phase 3 study excluded patients who were refractory to lenalidomide or proteasome inhibitors and patients who received more than three prior therapies.
Behandlingen fortsatte indtil sygdomsprogression eller uacceptabel toksicitet. 
Treatment continued until disease progression or unacceptable toxicities.