Summary of the safety profile: Safety data obtained from clinical studies revealed that PIASCLEDINE safety profile did not differ from that of a placebo. For both treatments, the body system with the higher incidence of adverse events is digestive system. Safety data obtained from pharmacovigilance evidenced a very low incidence of adverse events, that is lower than 0.08 cases per million treatment-days. Out of the whole events reported, digestive events were the most frequent (around 20% of all events). Other events with relative proportions >5% included those in the body systems: skin and subcutaneous tissue disorders, investigations, general disorders and administration site conditions, vascular disorders and nervous system disorders.
Tabulated list of adverse reactions: The frequency of undesirable effects is consistent with the MedDRA frequency convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1 000 to <1/100); Rare (≥1/10 000 to <1/1 000); Very rare (<1/10 000), not known (cannot be estimated from the available data). (See table.)
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Description of selected adverse reactions: Not applicable.
Safety in paediatric population: Not applicable.
Safety in other special populations: There was no specific assessment of safety in special populations such as elderly or patients with renal/liver function impairment.