Examples of using Study data in English and their translations into Bulgarian
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Not applicable, as there are no clinical study data available.
There are no clinical study data on the effects of Dovato in the paediatric population.
The frequency category was estimated based on observational study data.
There are no clinical study data to support the use of stiripentol as monotherapy in Dravet's syndrome.
Differences in mobility between the sexes have been a consistent trend from 1650 up until the late 20th century, according to the study data.
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Study data indicate that such patients may benefit less from treatment with rivaroxaban(see section 5.1).
A large-scale, prospective and 3-handed study data suggests that this risk increase is mainly present in the first 3 months.
Study data suggest dosages of 0.5 mg to 1 mg a day reduce serum estradiol by approximately 50% in men, which differs in postmenopausal women.
The CHMP also noted problems with the study data provided by the company, including statistical errors and missing information.
Study data currently suggests that dosages of 0.5mg to 1mg a day reduce serum estradiol by about 50% in men, which differs from the typical reduction in postmenopausal women.
The reduced posology in neonates from 0 to 13 days is based on average study data and may not correspond to invidual variation in kidney maturation.
There are no clinical study data to support the clinical safety of Diacomit administered at daily doses greater than 50mg/ kg/ day.
As incidence of adverse reactions did not increase andno new adverse reaction was identified, COMPASS study data were not included for frequency calculation in this table.
There are no clinical study data to support the clinical safety of stiripentol administered at daily doses greater than 50 mg/kg/day.
Economists work in many fields including academia, government and in the private sector,where they may also"… study data and statistics in order to spot trends in economic activity, economic confidence levels, and consumer attitudes.
Economists study data and statistics in order to spot trends in economic activity, economic confidence levels, and consumer attitudes.
Regarding the treatment of severe hypertension in pregnancy, the CHMP took into account the limited study data, the lack of long-term study data on morbidity and mortality and the recommendations of current guidelines.
Limited clinical study data suggest that the prolonged dose interval is not optimal and could result in increased toxicity and possibly inadequate response.
Therefore, the CHMP considered that the size of the safety database was already satisfactory before provision of the additional clinical study data and that the new information submitted brings the total to well above the minimum suggested in the CHMP guideline.
Based on the available clinical study data, it is not possible to determine a causal relationship between effects on changes in cardiac contractility and lorlatinib.
The inspection, carried out by the German, Swedish and UK medicines agencies, identified a number of critical and major findings which revealed a failure to conduct the studies in compliance with Good Clinical Practice(GCP) andseriously questioned the reliability of the study data.
In pigs appropriate GLP-compliant study data were provided to derive withdrawal periods for edible tissues for two different dosage regimens.
The study data shows some two thirds of kidney transplant recipients are men although the gender difference was less pronounced for donations by deceased men and women.
A statement from Roche said:"Roche has made full clinical study data available to health authorities around the world for their review as part of the licensing process.
Study data indicate that Asian patients may be more susceptible to liver function test abnormalities- 3.2%(194/ 5995) of Asian patients and 1.8%(100/ 5641) of Caucasian patients.
Assessment of adverse reactions from clinical study data is based on experience in three studies in adults(n= 1,479) and three paediatric studies(n= 169).
Study data indicate that Asian patients may be more susceptible to liver function test abnormalities3.2%(194/5995) of Asian patients and 1.8%(100/5641) of Caucasian patients.
In arriving at its conclusions, the CHMP noted that study data showed a beneficial effect in preventing fractures, including in patients at high risk of fracture.
The study data demonstrated that prophylactic ITI prevents or reduces the occurrence of antibodies against alglucosidase alfa over time, which may maintain clinical benefit of ERT and improve survival in CRIM-negative IOPD patients.
The company presented an analysis of the study data, comparing the survival of patients whose tumour cells had high levels of EGFR on their surface, with the survival of patients whose tumours had low levels of EGFR.