5%). Tabulated list of adverse reactions Adverse reactions are listed according to MedDRA system organ class. Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first. In addition, the corresponding frequency category for each adverse reaction is defined as: 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 available data).
7 Table 1 Adverse reactions* System organ class Adverse reaction Frequency Infections and infestations Upper respiratory tract infections1 Very common Herpes virus infections2 Common Nervous system disorders Headache Common Vascular disorders Bruising Common Petechiae Common Contusion3 Common Ecchymosis Common Purpura Uncommon Bleeding Common Haematuria Common Epistaxis Uncommon Conjunctival bleeding Uncommon Gingival bleeding Uncommon Gastrointestinal disorders Nausea Common Abdominal pain Common Musculoskeletal and connective tissue disorders Back pain Common General disorders and administration site conditions Pyrexia Common * 24-week placebo-controlled phase III studies in CSU 1 Upper respiratory tract infections include preferred terms: upper respiratory tract infection, acute sinusitis, chronic sinusitis, H1N1 influenza, influenza, laryngitis, nasopharyngitis, pharyngitis, pharyngitis streptococcal, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, tonsillitis bacterial, upper respiratory tract infection bacterial, upper respiratory tract infection viral 2 Herpes virus infections include preferred terms: herpes simplex, herpes zoster, oral herpes 3 Contusion includes preferred terms: contusion, increased tendency to bruise, haematoma The safety profile of remibrutinib in patients treated for up to 52 weeks in REMIX-1 and REMIX-2 remained consistent with the adverse reactions reported in Table 1.
8% of patients treated with remibrutinib. 3%). 0% were moderate in severity. The median time to onset was 25 days and the median duration was 22 days. All cases resolved spontaneously without additional treatment. No association between mucocutaneous bleeding events and low platelet counts was observed.
5). 5). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
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