Primjeri korištenja Controlled phase na Engleski i njihovi prijevodi na Hrvatskom
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Efficacy Results: FAST-3; Controlled Phase-- ITT population.
In the 12 week controlled phase, the rate of serious infections in the tocilizumab group was 11.5 per 100 patient years.
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In the 12 week controlled phase, 4% of patients from the tocilizumab group experienced events occurring during infusion.
Table 1: Adverse reactions observed during the 12 week controlled phase of study AEGIS 1/2 and the 52 week extension phase. .
In the 12 week controlled phase, 16% of patients in the tocilizumab group and 5.4% of patients in the placebo group experienced an event within 24 hours of infusion.
This study consisted of two phases, a placebo- controlled phase followed by a pre-planned follow-up phase. .
In the 12 week controlled phase, the rate of all infections in the tocilizumab group was 344.7 per 100 patient years and 287.0 per 100 patient years in the placebo group.
Less than 1% of patients who received Plegridy during the placebo controlled phase of the ADVANCE study discontinued treatment due to flu-like symptoms.
During the double-blind, controlled phases of the two long-term trials, injection site reactions were observed; those seen were generally mild to moderate in severity, and resolved over time.
Table 1 presents all adverse reactions occurring during the 12 week controlled phase and during the 52 week extension phase in subjects treated with Feraccru.
In the ongoing open label extension phase, the pattern andincidence of elevations in lipid parameters remained consistent with the 12 week controlled phase data.
In total, 128 patients received somatropin over the 24 month controlled phase of the 2 studies, and 139 patients were treated with somatropin in the open extension phases. .
Injection site reactions were observed more frequently in prolonged-release exenatide treated patients versus comparator-treated patients(16% versus range of 2-7%)during the 6-month controlled phase of studies.
Long-term data were generated from all 173 patients who were treated with bosentan in the controlled phase and/or were switched from placebo to bosentan in the open-label extension phase of the EARLY study.
During routine laboratory monitoring in the 12 week controlled phase, a decrease in neutrophil counts below 1 x 109/l occurred in 7% of patients in the tocilizumab group, and no decreases in the placebo group.
During routine laboratory monitoring in the 12 week controlled phase, elevation in ALT or AST≥ 3 x ULN occurred in 5% and 3% of patients, respectively, in the tocilizumab group, and 0% in the placebo group.
(c) the identification number of the notified body, where that body is involved in the production control phase, has been affixed in violation of Article 20 or has not been affixed;
(c) the identification number of the notified body involved in the production control phase has been affixed in violation of Article 17 or has not been affixed;
(d) the identification number of the notified body,where that body is involved in the production control phase, has been affixed in violation of Article 17 or has not been affixed;
The identification number of the notified body involved in the production control phase shall be affixed on the fitting.
The CE marking andthe supplementary metrology marking shall be followed by the identification number of the notified body, where that body is involved in the production control phase.
The CE marking shall be followed by the identification number of the notified body,where that body is involved in the production control phase or in the post-construction assessment.
The CE marking and the supplementary metrology marking shallbe followed by the identification number of the notified body, where that body is involved in the production control phase as set out in Annex II.
The CE marking shall be followed by the identification number of the notified body,where that body is involved in the production control phase.
The CE marking shall be followed by the identification number of the notified body involved in the production control phase of the appliance.
The CE marking and the supplementary metrology marking shall be followed by the identification number(s) of the notified body orbodies involved in the production control phase as set out in Annex II.
The CE marking and the supplementary metrology marking shall be followed by theidentification number of the notified body, where that body is involved in the production control phase as set out in Annex II. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.