What is the translation of " OPEN- LABEL " in English?

• open-label
• open label

Examples of using Open- label in Danish and their translations into English

Sikkerheden for anagrelid er undersøgt i 4 kliniske open- label forsøg.
The safety of anagrelide has been examined in 4 open label clinical studies.

I CHARM modtog 854 patienter open- label 80 mg i uge 0 og 40 mg i uge 2.
In CHARM, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2.

De nedenfor beskrevne data afspejler eksponeringen for Tasigna hos 438 patienter i et open- label-, multicenterstudie.
The data described below reflect exposure to Tasigna in 438 patients in an open-label multicentre study.

Der har været gennemført fem kliniske undersøgelser(4 open- label og 1 dobbeltblind, placebokontrolleret undersøgelse) med INCRELEX.
Five clinical studies(4 open-label and 1 double-blind, placebo-controlled) were conducted with INCRELEX.

M98- 940 er en open- label afprøvning af en flydende formulering af Kaletra med 100 pædiatriske patienter, der enten var antiretroviralt behandlingsnaive(44%) eller med forudgående behandling med antiretrovirale midler 56.
M98-940 is an open-label study of a liquid formulation of Kaletra in 100 antiretroviral naïve(44%) and experienced(56%) paediatric patients.

I CD- forsøg III modtog 854 patienter open- label 80 mg i uge 0 og 40 mg i uge 2.
In CD Study III, 854 patients received open-label 80 mg at Week 0 and 40 mg at Week 2.

Sen debuterende Pompes sygdom En open- label klinisk undersøgelse vurderede sikkerhed og effekt for Myozyme hos 5 patienter med sen debuterende Pompes sygdom, der var fra 5 til 15 år ved behandlingens start.
Late-onset Pompe disease An open-label clinical trial assessed the safety and efficacy of Myozyme in 5 patients with late-onset Pompe disease who ranged in age from 5 to 15 years at initiation of treatment.

Patienterne i dette forsøg(n=1. 927) modtog CHAMPIX open- label 1 mg 2 gange dagligt i 12 uger.
Patients in this study(n=1,927) received open-label CHAMPIX 1 mg twice daily for 12 weeks.

I et internationalt, enkelt arm, open- label fase 3b klinisk forsøg(ENHANCE) modtog i alt 2378 voksne patienter med svær sepsis drotrecogin alfa aktiveret.
A total of 2378 adult patients with severe sepsis received drotrecogin alfa(activated) in a Phase 3b, international, single-arm, open-label clinical trial ENHANCE.

Alle patienter på dosen 400/ 100 mg to gange daglig skiftede til open- label Kaletra mellem uge 48 og uge 72.
All patients converted to open-label Kaletra at the 400/ 100 mg twice daily.

Knoglemanifestationer blev evalueret i 3 open- label kliniske undersøgelser hos patienter med Gauchers sygdom type 1, der blev behandlet med miglustat 100 mg 3 gange dagligt i op til 2 år n=72.
Bone manifestations of type 1 Gaucher disease were evaluated in 3 open-label clinical studies in patients treated with miglustat 100 mg t. i. d. for up to 2 years n 72.

Efter undersøgelsens første år fortsatte 53 patienter i en open- label fortsættelse til uge 102.
After the first year of the study, 53 patients continued into an open-label extension to week 102.

Yderligere klinisk erfaring I et internationalt, enkelt- arm, open- label klinisk fase 3b forsøg(ENHANCE) modtog 2378 voksne patienter med svær sepsis drotrcogin alfa aktiveret.
Further Clinical Experience In a Phase 3b international, single-arm, open-label clinical trial(ENHANCE), 2378 adult patients with severe sepsis received drotrecogin alfa activated.

I dette studie fik patienterne en dosis Enbrel på 50 mg eller placebo én gang om ugen i 12 uger, og derefter fik alle patienterne open- label Enbrel 50 mg én gang om ugen i yderligere 12 uger.
Patients in this study received a dose of 50 mg Enbrel or placebo once weekly for 12 weeks and then all patients received open- label 50 mg Enbrel once weekly for an additional 12 weeks.

Privigens sikkerhed og virkning blev evalueret i to prospektive, open- label, multicenterundersøgelser af enkeltgrupper, der blev foretaget ITP- undersøgelse i Europa og PID- undersøgelse i Europa samt USA.
The safety and efficacy of Privigen was evaluated in two prospective, open-label, single-arm, multicenter studies performed in Europe(ITP study) and Europe and USA PID study.

Patienter, som fuldførte 144 ugers behandling med enten den ene eller den anden af behandlingsarmene i GS- 01- 934, fik mulighed for at fortsætte i en, forlænget open- label fase af undersøgelsen med Atripla på tom mave.
Patients who completed 144 weeks of treatment with either treatment arm in study GS-01-934 were given the option to continue in an open-label extended phase of the study with Atripla on an empty stomach.

IDflus sikkerhed er blevet undersøgt i 2 randomiserede, open- label kliniske undersøgelser, i hvilke 2. 974 personer blev vaccineret med IDflu.
The safety of IDflu has been assessed in 2 open-label randomised clinical trials, 2,974 vaccinees received an injection of IDflu.

I en open- label farmakokinetisk studie oplevede alle 24 raske personer lysfølsomhedsreaktioner, der var karakteristisk repræsenteret ved erythematøst udslet og ødem og var af mild til moderat intensitet.
In an open label pharmacokinetic study, all 24 healthy subjects experienced photosensitivity reactions, which were characteristically represented by erythematous rash and oedema and were mild to moderate in intensity.

I et studie med forebyggelse af tilbagefald blev de patienter, som responderede på 6 måneders akut behandling med open- label CYMBALTA, randomiseret til enten CYMBALTA eller placebo i yderligere 6 måneder.
In a relapse prevention study, patients responding to 6 months of acute treatment with open-label CYMBALTA were randomised to either CYMBALTA or placebo for further 6-months.

Selv om ziconotid er blevet undersøgt i langvarige, open- label kliniske forsøg vedrørende effektivitet og sikkerhed, er der ikke udført kontrollerede studier af mere end 3 ugers varighed se afsnit 5.
Although ziconotide has been studied in long-term, open label efficacy and safety clinical trials, controlled studies of longer than 3 weeks duration have not been conducted see section 5.1.

Vitalstatus over længere tid for alle 235 patienter, som blev behandlet med bosentan, blev imidlertid noteret, i de to pivotale placebo- kontrollerede studier(AC- 052- 351 og AC- 052- 352) og/ eller deres to ukontrollerede, open- label forlængelser.
However, long-term vital status was recorded for all 235 patients who were treated with bosentan in the two pivotal placebo-controlled trials(AC-052-351 and AC-052-352) and/or their two uncontrolled, open- label extensions.

Et klinisk open- label forsøg med en 3 måneders behandlingsperiode gav ikke anledning til bekymring med hensyn til sikkerheden af anagrelid hos 17 børn/ yngre patienter med ET(i alderen 7- 14 år) sammenlignet med 18 voksne patienter.
An open label clinical study with a 3 month treatment period did not raise any safety concerns for anagrelide in 17 children/ adolescent patients with ET(age range 7-14 years) compared to 18 adult patients.

Linje- B- CLL- patienter Sikkerhed og effektivitet for MabCampath blev evalueret i et Fase 3, open- label, randomiseret komparativt forsøg med 1. linje- patienter(tidligere ubehandlede) behandlingskrævende Rai- stadie I- IV B- CLL patienter Undersøgelse 4.
The safety and efficacy of MabCampath were evaluated in a Phase 3, open-label, randomized comparative trial of first line(previously untreated) Rai stage I-IV B-CLL patients requiring therapy Study 4.

Vectibix'effekt hos patienter med metastatisk colorectal cancer(mCRC), der havde sygdomsprogression under eller efter tidligere kemoterapi, blev undersøgt i et randomiseret, kontrolleret forsøg(463 patienter) og open- label, enkeltgruppe- forsøg 384 patienter.
The efficacy of Vectibix in patients with metastatic colorectal cancer(mCRC) who had disease progression during or after prior chemotherapy was studied in a randomised controlled trial(463 patients) and open-label, single-arm trials 384 patients.

I et randomiseret, open- label multicenterforsøg med 1053 patienter evaluerede man effekten af bevacizumab og kemoterapeutiske regimener, der indeholdt oxaliplatin eller irinotecan med og uden Vectibix i førstevalgsbehandlingen af metastatisk colorectal cancer.
A randomized, open-label, multicentre study of 1,053 patients evaluated the efficacy of bevacizumab and oxaliplatin- or irinotecan-containing chemotherapeutic regimens with and without Vectibix in the first-line treatment of metastatic colorectal cancer.

Kliniske undersøgelser af demens, der er associeret med Parkinsons sygdom Effekten af rivastigmin ved demens, der er associeret med Parkinsons sygdom, er demonstreret i et 24- ugers multicenter, dobbelt- blindt, placebo- kontrolleret hovedstudie og dets 24- ugers open- label forlængelsesfase.
Clinical studies in dementia associated with Parkinson' s disease The efficacy of rivastigmine in dementia associated with Parkinson' s disease has been demonstrated in a 24-week multicentre, double-blind, placebo-controlled core study and its 24-week open-label extension phase.

I en randomiseret fase III open- label multicenter- undersøgelse med parallelgruppe, der blev udført hos 646 patienter, blev sikkerhed og effekt af kombinationsbehandling med Caelyx og bortezomib sammenlignet med bortezomib monoterapi hos patienter med multipelt myelom.
A phase III randomized, parallel-group, open-label, multicentre study comparing the safety and efficacy of Caelyx plus bortezomib combination therapy with bortezomib monotherapy in patients with multiple myeloma who have received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy, was conducted in 646 patients.

Induktions kemoterapi efterfulgt af kemostråleterapi(TAX 324) Sikkerheden og effekten af docetaxel i den indledende behandling af patienter med lokalt fremskredent pladecellecarcinom i hoved og hals(SCCHN) blev evalueret i et randomiseret, multicenter, open- label fase III studie TAX 324.
Induction chemotherapy followed by chemoradiotherapy(TAX324) The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck(SCCHN) was evaluated in a randomized, multicenter open-label, phase III, trial TAX324.

M98- 957 er en randomiseret, open- label afprøvning af Kaletra i to dosisniveauer(400/ 100 mg og 533/ 133 mg, begge to gange dagligt) og efavirenz(600 mg en gang dagligt) og nukleosid revers transkriptasehæmmere i 57 patienter, der tidligere er blevet behandlet med flere proteasehæmmere, men ikke med non- nukleosid revers transkriptasehæmmere.
M98-957 is a randomised, open-label study evaluating Kaletra treatment at two dose levels(400/ 100 mg and 533/ 133 mg, both twice daily) plus efavirenz(600 mg once daily) and nucleoside reverse transcriptase inhibitors in 57 multiple protease inhibitor experienced, non-nucleoside reverse transcriptase inhibitor naïve patients.

Effekten af Lantus(en gang dagligt) på diabetisk retinopati blev undersøgt i et 5 års open- label NPH- kontrolleret forsøg(NPH givet 2 gange dagligt) med 1024 patienter med type 2 diabetes, i hvilket progression af retinopati med 3 eller flere trin på Early Treatment Diabetic Retinopathy Study(ETDRS) standarden, blev undersøgt ved hjælp af fundus- fotografering.
Effects of Lantus(once daily) on diabetic retinopathy were evaluated in an open-label 5-year NPH- controlled study(NPH given bid) in 1024 type 2 diabetic patients in which progression of retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study(ETDRS) scale was investigated by fundus photography.