Vám neznámý uživateli, doporučuji, abyste si pečlivě přečetli výsledky studií v angličtině (pokud na to jejich schopnosti stačí).
:-))))
Safety
Assessor’s note: the solicited and unsolicited symptoms are described in the Clinical Study Report for study HPV-058 up to Month 12 and not represented here.
The percentage of subjects for whom at least one unsolicited symptom was reported during the 30 day post-vaccination follow-up period was 37.2% (95% CI: 32.3%; 42.3%) of subjects in the HPV group and 33.2% (95% CI: 28.5%; 38.3%) of subjects in the control group. No fatal SAEs were reported throughout the study period (Month 0 to Month 12). The percentage of subjects for whom at least one SAE was reported during the entire study period (Month 0 to Month 12) was 1.3% (95% CI: 0.4%; 3.1%) of subjects in the HPV group and 0.5% (95% CI: 0.1%; 1.9%) of subjects in the control group. None of these SAEs were considered by the investigator to be related to vaccination
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