Examples of using Frequency categories in English and their translations into Croatian
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The frequency categories used are.
Adverse reactions reported are listed according to the following frequency categories.
Table 4 shows the frequency categories of adverse reactions observed in clinical trials.
Adverse reactions are listed in Table 1 according to MedDRA system organ class and frequency categories.
The adverse reactions are assigned frequency categories using the following convention: Very Common(≥1/10);
Frequency categories for the reactions below have been based on clinical trials and postmarketing data.
However, percentages with one decimal precision are used to identify terms with a frequency of at least 5% andto classify terms according to frequency categories.
Frequency categories are based on information available from the metformin Summary of Product Characteristics.
Table 1 presents adverse reactions listed by system organ class and frequency categories, using the following convention: very common(≥1/10), common(≥1/100 to< 1/10), and uncommon≥1/1,000 to.
Frequency categories below reflect combined data for the 2 doses of Eperzan, 30 mg or 50 mg weekly subcutaneously.
In the table below, since the majority of the studies wereof an open nature, all causality adverse reactions and their frequency categories in 1,873 adults from pooled therapeutic(1,603) and prophylaxis(270) studies, by system organ class.
Frequency categories are only assigned to those adverse reactions considered to be at least possibly causally related to lamivudine.
Adverse reactions and laboratory abnormalities reported in patients treated with the ZALTRAP/FOLFIRI regimen compared to patients treated with the placebo/FOLFIRI regimen are listed in Table 1 according to MedDRA system organ class and frequency categories.
Table 4 shows the frequency categories of adverse reactions observed in clinical trials for RCC and DTC.
The ADRs in the pJIA and sJIA patients treated with tocilizumab are described below and are presented in the Table 2 by system organ class and frequency categories, defined using the following convention: very common(≥ 1/10); common(≥ 1/100 to< 1/10) or uncommon≥ 1/1,000 to< 1/100.
Frequency categories are based on information available from metformin Summary of Product Characteristics available in the EU.
AThe table shows adverse reactions identified from up to 24-week(short-term) data regardless of glycaemic rescue, except those marked with§,for which adverse reaction and frequency categories are based on information from the metformin Summary of Product Characteristics available in the European Union.
Frequency categories are based on information available from pravastatin and fenofibrate Summary of Product characteristics available in the EU.
Presented in Table 2, by system organ classification and frequency categories, is the list of adverse reactions with at least a suspected causal relationship, reported in clinical trials cumulatively up to Year 3 and pooled for both belatacept regimens MI and LI.
Frequency categories are defined as follows: very common(≥ 1/10), common(≥ 1/100 to< 1/10) and uncommon≥ 1/1,000 to< 1/100.
Adverse reactions have been assigned to the frequency categories in Table 1 where possible based on the incidence of comparable adverse event reports in a pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials 2462 IRESSA-treated patients.
Frequency categories are based on information available from metformin Summary of Product Characteristics available in the European Union.
The changes do not impact on the frequency categories for the listed ADRs apart from“peripheral sensory neuropathy” which is upgraded from common to very common and“tumour pain”, which is now categorised as uncommon previously its frequency was not known.
Frequency categories were determined from the crude incidence rate reported for each adverse reaction in the pivotal clinical study N 189.
Frequency categories are derived according to the following conventions: common(≥ 1/100 to< 1/10), uncommon(≥ 1/1,000 to< 1/100) see Table 3.
Frequency categories are based on information available from simvastatin and fenofibrate Summary of Product Characteristics available in the EU.
Frequency categories were determined from the crude incidence rate reported for each adverse reaction in a dataset of pooled clinical studies n 2,044.
Frequency categories do not account for other factors including varying study duration, pre-existing conditions and baseline patient characteristics.
Frequency categories are derived from adverse reactions and/or potentially clinically significant laboratory abnormalities, and are defined according to the following conventions.
The frequency categories given in the table are based on the studies in adults; the observed frequencies in the paediatric studies were similar or lower, unless shown in the table.