Примери за използване на Uncontrolled clinical на Английски и техните преводи на Български
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Uncontrolled clinical studies in paediatric patients.
In the paediatric studies, 282 paediatric ITP subjects were treated with romiplostim in 2 controlled and 3 uncontrolled clinical trials.
Experience from controlled and uncontrolled clinical studies involving approximately 10,000 patients who received the combination of loratadine;
Severe penile haematoma was also reported as an adverse reaction in39 of 1044 patients(3.7%) in the controlled and uncontrolled clinical studies in Peyronie's disease.
Study reports of uncontrolled clinical studies reports of analyses of data from more than one study and other clinical study reports.
Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, 3 events of thrombocytosis were reported, n= 271.
In the controlled and uncontrolled clinical studies of Xiapex in Peyronie's disease corporal rupture and other serious penile injury were reported uncommonly(see section 4.4).
The results observed in a population of 211 newly diagnosed Ph+ ALL patients in four uncontrolled clinical studies(AAU02, ADE04, AJP01 and AUS01) are consistent with the results described above.
In an uncontrolled clinical trial(study MC-ASP.6/INF), 12 infants(median age[range] at time of first infusion: 6 months[0.5- 12.2 months]) with de novo ALL were treated with Spectrila within the.
The evidence of efficacy of unboosted Agenerase was based on two uncontrolled clinical studies involving 288 HIV infected children aged between 2 and 18 years, 152 of whom were PI experienced.
Severe vision decrease, equivalent to 4 lines or more, within seven days after treatment was reported in 2.1% of the verteporfin-treated patients in the placebo-controlled ocular Phase III clinical studies andin less than 1% of patients in uncontrolled clinical studies.
The safety of Ixiaro was assessed in controlled and uncontrolled clinical studies in 5,021 healthy adults(from non-endemic countries) and 1,559 children and adolescents(mostly from endemic countries).
Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, 4 events of thrombocytopenia after cessation of treatment were reported, n= 271(see section 4.4).
In 3 controlled and 2 uncontrolled clinical studies among adult ITP patients receiving eltrombopag(n=446), 17 patients experienced a total of 19 TEEs, which included(in descending order of occurrence) deep vein thrombosis(n=6), pulmonary embolism(n=6), acute myocardial infarction(n=2), cerebral infarction(n=2), embolism(n=1)(see section 4.4).
Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, the overall subject incidence of all adverse reactions for romiplostim-treated subjects was 91.5%(248/271).
Apart from data on IBS, no controlled or uncontrolled clinical study or literature data are available to assess the efficacy and safety of Symbioflor 2 in the treatment of these diseases.
Adverse reactions from these studies(299 patients), from uncontrolled clinical trials(384 patients), and that were spontaneously reported from post-marketing experience are listed by frequency in the table below.
Patients with hypertension uncontrolled by medication were excluded from participation in premarketing clinical trials and special care is indicated if patients with uncontrolled hypertension are treated with Gilenya.
The clinical study was open-labelled and uncontrolled.
No conclusion can be drawn with regard to clinical efficacy in this uncontrolled study.
Clinical algorithm for distinguishing between uncontrolled and severe refractory asthma.
Apply clinical strategies to differentiate between uncontrolled and severe asthma.
Patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies.
Patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies.
A clinical algorithm for distinguishing between uncontrolled asthma and severe refractory asthma.
In a phase III, uncontrolled, open-label clinical study(Zoster-033), 96 adults≥ 50 years of age with a physician-documented history of HZ received 2 doses of Shingrix 2 months apart.
In addition, patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies.
Antibody persistence was evaluated for three years after the primary vaccination with IXIARO in an uncontrolled, open-label follow-up clinical trial conducted in the United States, Europe and Australia.
The safety and immunogenicity of IXIARO was evaluated in an uncontrolled, open-label clinical trial conducted in the United States, Europe and Australia in healthy male and female subjects with planned travel to JEV-endemic areas.
In an additional long term(24 month), uncontrolled, open-label clinical study the safety of RAVICTI has been evaluated in 16 UCD patients less than 2 months of age and 10 pediatric patients with UCDs aged 2 months to less than 2 years.