Examples of using Laboratory abnormalities in English and their translations into Polish
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Laboratory abnormalities.
Adverse Event and Laboratory Abnormalities.
Identify and communicate subject safety issues to appropriate staff(e.g., laboratory abnormalities);
Dose adjustments due to laboratory abnormalities see section 4.4.
Laboratory abnormalities included increased amylase and lipase, decreased haematocrit and occult blood in the stool.
For patients who develop haematologic laboratory abnormalities, see section 4.2.
No grade 3-4 laboratory abnormalities for AST/ALT or grade 3-4 ADRs of transaminase increased were reported.
Table 5 Incidence of clinically relevant grade 3/4* laboratory abnormalities in≥2% of patients in any disease group.
All symptoms and laboratory abnormalities resolved without treatment after discontinuation of the study medicinal product.
The incidence of grade≥3 anaemia, increased AST, ALT, andbilirubin based on laboratory abnormalities were 10.5%, 0.7%, 0.9%, and 0.6%, respectively.
Incidence of laboratory abnormalities(all patients) in TT01 and TT02.
Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities.
The adverse reactions and laboratory abnormalities presented below are not exposure adjusted.
Events(grade 2-4) reported by study investigators as attributable to study medication and occurring in> 1% of patients,are included as well as grade 3-4 treatment emergent laboratory abnormalities.
The list also includes marked laboratory abnormalities that have been observed with nelfinavir at 48 weeks.
The placebo-controlled Phase 2 and Phase 3 Studies(pooled data)included 1,346 HCV-infected patients incidence rates are based on adverse event reporting rates additionally, see Laboratory abnormalities below.
One patient experienced drug related laboratory abnormalities, Grade 4 AST and Grade 3 ALT, which were considered serious.
Laboratory abnormalities were reported as adverse events less frequently by investigators than as indicated by laboratory value tables.
A higher frequency of adverse events(eg, dizziness, nausea,paraesthesia) and laboratory abnormalities(elevated liver enzymes) have been observed when efavirenz is co-administered with ritonavir dosed as an antiretroviral agent.
When laboratory abnormalities and adverse events were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic events were observed in 8% of the patients.
Adverse drug reactions, excluding laboratory abnormalities, that were reported in≥ 5% of patients in SPRYCEL clinical trials are shown in Table 3.
When laboratory abnormalities and adverse events were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic events were observed in 8% of the patients.
The investigator shall report to the sponsor adverse events or laboratory abnormalities identified in the protocol as critical to the safety evaluation in accordance with the reporting requirements and within the time periods specified in the protocol.
Laboratory abnormalities The most frequently reported laboratory abnormality in patients receiving regimens containing REYATAZ and one or more NRTIs was elevated total bilirubin reported predominantly as elevated indirect[unconjugated] bilirubin 84% Grade 1, 2, 3, or 4.
The incidence of adverse events and laboratory abnormalities(with the exception of elevations of ALT and CPK, see below) were similar between placebo and lamivudine treated patients.
Once symptoms or laboratory abnormalities are controlled and overall patient improvement is evident, treatment with ipilimumab may be resumed and initiation of corticosteroid taper should be based on clinical judgment.
The three most frequent non-haematological laboratory abnormalities(any CTCAE grade) were hypercholesterolaemia(30.0%), raised alanine aminotransferase(22.7%) and raised aspartate aminotransferase 20.9.
Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations shall be reported to the sponsor according to the reporting requirements and within the time periods specified in the protocol.
Adolescents, children and infants:adverse reactions and serious laboratory abnormalities reported to occur in paediatric patients ranging in age from birth through adolescence who received stavudine in clinical studies were generally similar in type and frequency to those seen in adults.
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.