Examples of using Were generally consistent in English and their translations into Croatian
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The studies were large,well-designed and the results were generally consistent across the studies.
Adverse reactions were generally consistent with those seen in previous studies of the individual components.
Results of the BRAFi naïve population from Study NO25395 were generally consistent with those from Study GO28141.
Results were generally consistent in subgroups according to age, gender, PAH aetiology and baseline WHO functional class and 6MWD.
Overall, the adverse reactions reported in the paediatric ulcerative colitis trial(C0168T72) and adult ulcerative colitis(ACT 1 and ACT 2)studies were generally consistent.
Supporting data from a study on adult-onset GHD patients were generally consistent with those of the pivotal studies, with some improvements in BMD.
Results were generally consistent in subgroups according to aetiology(primary and connective tissue disease-associated PAH), WHO functional class, gender, race, location, mean PAP and PVRI.
The safety findings observed with long-term ambrisentan exposure in this study were generally consistent with those observed in the 12 week placebo-controlled studies.
Changes in exposures of the metabolite were generally consistent with that observed with dasabuvir except for studies with CYP2C8 inhibitor, gemfibrozil, where the metabolite exposures decreased by up to 95% and CYP3A inducer, carbamazepine, where the metabolite exposures decreased by only up to 39.
The tolerability profile of a fosaprepitant-based regimen was typical of that in patients receiving emetogenic chemotherapy, andadverse events were generally consistent with those observed with an aprepitant-based regimen.
The overall safety results from this study were generally consistent with the known safety profile of tadalafil and with adverse events(AEs) expected in a paediatric DMD population receiving corticosteroids.
Treatment effects in evaluable subgroups(e.g., age, gender, race, baseline HbA1c, baseline visual acuity, prior anti-VEGF therapy) in each study andin the combined analysis were generally consistent with the results in the overall populations.
The objective response rates measured in these subgroups were generally consistent with the PFS results, with the RET mutation positive, negative, and unknown subgroups showing tumour response rates of 32%, 22%, and 25%, respectively.
The adverse reactions observed for the combination of dolutegravir+ abacavir/lamivudine in an analysis of pooled data from Phase IIb to Phase IIIb clinical trials were generally consistent with the adverse reaction profiles for the individual components dolutegravir, abacavir and lamivudine.
OS of ipilimumab 3 mg/kg monotherapy in chemotherapy-naive patients pooled across Phase 2 and 3 clinical trials(N= 78;randomised) and in treatment-naive patients in two retrospective observational studies(N= 273 and N= 157) were generally consistent.
Pendarovski: The most accurate judgment was given by the OSCE Office for Democratic Institutions and Human Rights(ODIHR),which determined that the elections were generally consistent with international standards, which means they produced a legal and legitimate winner.
Safety data profiles from individual pivotal studies(including studies in moderately renally impaired patients; older patients[≥ 55 years ofage to≤ 80 years of age]; patients with increased CV-risk) were generally consistent with the adverse reactions identified in this table.
The efficacy results for pre-specified major subgroups(with dose reduction as required), including age, body weight, gender, status of renal function, prior stroke or TIA, diabetes andP-gp inhibitors were generally consistent with the primary efficacy results for the overall population studied in the trial.
In relation to the broader set of EU policies,the INSPIRE Directive is generally consistent with the objectives of the European Interoperability Framework and the broader objectives of the EU Digital Single Market.
Regardless of the subgroup evaluated,PFS was generally consistent with that observed in the ITT population for both treatment groups.
The adverse reactions profile seen in this paediatric study was generally consistent with that in adults see table above.
Where a specific mention of on-call work is made in national rules, this is generally consistent with the Court's interpretation.
Efficacy across subgroups, including age, gender, body mass index(BMI), renal function, extent of index PE, location of DVT thrombus, andprior parenteral heparin use was generally consistent.
Post-marketing reports of post-injection syndrome since the marketing authorization of ZYPADHERA are generally consistent with the experience seen in clinical studies.
The adverse reaction profile of tigecycline in these 25 subjects was generally consistent with that in adults.
The safety information that became available in this reporting period is generally consistent with the known safety profile of vinflunine.
Although the study was too small for a meaningful assessment of the pharmacokinetics of children under 12 years of age,the results are generally consistent with the findings in adults and confirm the non-linearity of telmisartan, particularly for Cmax.
The adverse reaction profile of tigecycline in these 58 subjects was generally consistent with that in adults, with the exception of nausea(48.3%), vomiting(46.6%) and elevated lipase in serum(6.9%) which were seen at greater frequencies in children than in adults.
Although the study was too small for a meaningful assessment of the pharmacokinetics of children under 12 years of age,the results are generally consistent with the findings in adults and confirm the non-linearity of telmisartan, particularly for Cmax.
In patients, the median apparent volume of distribution(Vz/F)of the first dose ranged from 50.5 L to 92 L and was generally consistent across the dose groups from 3.2 mg to 32 mg.