Examples of using Efficacy data in English and their translations into German
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Iv efficacy data.
This is the only in vivo approach that takesinto account all physiological processes in living skin and provides efficacy data with the greatest possible relevance for the in-use situation.
Ii efficacy data; and.
Due to the known efficacy and safety profile of risperidone,this additional dose is approvable without its own efficacy data and can be based solely on the PK data. .
Limited efficacy data are available in elderly patients.
Table 1 summarizes efficacy data from this study.
Efficacy data from Studies 1001 and 1005 are provided in Table 6.
However, limited efficacy data are available at this dose.
Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.
Placebo-controlled efficacy data were collected and analysed through week 16.
Efficacy data on combination with other corticosteroids and 5-HT3 antagonists are limited.
In addition to Study 1, efficacy data are available in patients with CD from a single arm Phase 1 study Study 2.
Efficacy data from clinical trials in paediatric patients 6 months to 2 years of age with persistent asthma are limited.
In view of limited safety and efficacy data in patients with secondary acute myelogenous leukaemia(AML), filgrastim should be administered with caution.
Efficacy data are available which demonstrate that this vaccine can be administered at least 14 days before or after the administration of MERIAL non-adjuvanted vaccine against feline leukaemia.
This indication is based on safety and efficacy data from two double-blind, placebo-controlled trials of 48 weeks duration in treatment-experienced patients see section 5.1.
The efficacy data from study GS-US-264-0111(see section 5.1) indicates that the brief period of lower rilpivirine exposure does not impact antiviral efficacy of Eviplera.
Table 10 Efficacy data in patients with brain metastases BREAK-MB Study.
The efficacy data from this pivotal study are supported and confirmed with data from a dose-finding study(25 mg/kg arm) and the interim analysis of an ongoing Treatment IND study(severe VOD subset), as presented in Table 1 and 2.
In conclusion, the efficacy data are considered too weak to support a paediatric indication of oesophagitis in children and adolescents.
All efficacy data is based on 84 patients who completed the study with the exception of patient diary data which is based on 83.
Most recent analysis included available safety and efficacy data from the SCRIPT Phase III study in patients with previous inadequate response(IR) to TNF-inhibitors and safety data from the Phase III FILM study in patients who were methotrexate(MTX) naïve.
The efficacy data generated in this study are summarised in the table below.
Clinical efficacy data in patients with complicated lower urinary tract infection are limited.
Limited efficacy data supports this indication, a summary of the relevant studies is shown in section 5.1.
Additional efficacy data are available from 3 single-arm Phase II trials with similar populations treated with the same regimen.
No safety and efficacy data are available on re-treatment with crizotinib of patients who received crizotinib in previous lines of therapy.
Antiviral efficacy data from randomised controlled studies is available for cobicistat-boosted atazanavir, but not for cobicistat-boosted darunavir see sections 4.4 and 5.2.
The table below shows the efficacy data of the 48-week analyses on the recommended 600 mg dose of PREZISTA co-administered with 100 mg ritonavir b. i. d. from the pooled POWER 1 and POWER 2 trials as well as from the POWER 3 trial.
The CHMP considered that while the efficacy data showed statistically significant difference in favour of Rapinyl versus placebo on SPID 30, the CHMP considered that the primary endpoints should include the assessment of pain intensity difference by simple scale and to define responder.