Eksempler på bruk av Open-label extension study på Engelsk og deres oversettelse til Norsk
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The immunogenicity of NeuroBloc has been evaluated in two clinical studies and an open-label extension study.
Open-label Extension Study in the Treatment of Postmenopausal Osteoporosis.
Ten patients who completed Study 025 enrolled in an open-label extension study(025EXT), 8 of whom completed the study. .
In an open-label extension study, one patient developed bacterial meningitis and died.
Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg Humira was administered every other week.
An open-label extension study(CHEST-2) included 237 patients who had completed CHEST-1.
At the end of the double-blind study, patients could enter a long-term open-label extension study for a total duration of up to 2 years.
An open-label extension study(PATENT-2) included 363 patients who had completed PATENT-1 at the cut-off-date.
No new safety signals have been identified in patients exposed to 0.05 mg/kg/day of Revestive for up to 30 months in a long-term open-label extension study.
In this open-label extension study, clinical remission and clinical response were observed in patients for up to 124 weeks.
Patients in both prospective studies were treated with Solirisfor 26 weeks and most patients enrolled into a long-term, open-label extension study.
Among the 250 subjects who completed the open-label extension study, improvements in physical function were maintained through 10 years of treatment.
Of the 783 patients initially randomised to active treatment in RA-I,508 completed 52 weeks of placebo- controlled treatment and entered the open-label extension study.
Patients participating in Studies HS-I and HS-II were eligible to enroll into an open-label extension study in which Humira 40mg was administered every week.
In this open-label extension study, the benefits of vedolizumab treatment as assessed by partial Mayo score, clinical remission, and clinical response were shown for up to 124 weeks.
Patients from the group treated with epoetin alfa were also enrolled in an open-label extension study which demonstrated improvements in their quality of life that were maintained for an additional 12 months.
Efficacy and safety of Fabrazyme was evaluated in one study with children, one dose-finding study, two double-blind placebo-controlled studies, and one open-label extension study in both male and female patients.
Of 342 subjects originally randomized to Humira monotherapy orHumira/methotrexate combination therapy who entered the open-label extension study, 171 subjects completed 10 years of Humira treatment.
Eltrombopag was administered to 302 ITP patients in the open-label extension study EXTEND(TRA105325), 218 patients completed 1 year, 180 completed 2 years, 107 completed 3 years, 75 completed 4 years, 34 completed 5 years and 18 completed 6 years.
Sustained inhibition of progression of structural damage was demonstrated in a subset of 449 of these patients who completed at least 2 years of treatment with Cimzia(RA-I and open-label extension study) and had evaluable data at the 2-year timepoint.
In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50%, 26.4%(92/349) and 37.8%(132/349) of patients achieved PASI 75 response at Week 12 and 24, respectively.
In the open-label extension study, the rate of change in the NIS-LL during the 12 months of treatment was similar to that observed in those patients randomised and treated with tafamidis in the previous double blind 18 month period.
In a pooled analysis of two five-year open-label extension studies(586 patients total) the combined graft and patient survival rates were not statistically different for the basiliximab and placebo groups.
One hundred patients(n=100)from the Paediatric CD Study continued in an open-label long-term extension study.