Hyruan One Adverse Reactions

Serious adverse events: Shock: Since symptoms of shock (frequency unknown) may occur, careful observation should be made. In case abnormalities are noticed, administration should be discontinued and proper measures should be taken.
In pivotal trial of Hyruan ONE in patients with the knee osteoarthritis (a total of 285 subjects), the occurrence rate of local reaction at injection site after injection into articular cavity was 48.9% (68/139 subjects) in the study group and 49.3% (72/146 subjects) in the control group. The reported adverse events are shown in Table 1. The serious adverse events were reported in the decreasing order of pain (7.2% of the study group, 6.2% of the control group), redness (erythema) (5.0% of the study group, 2.1% of the control group) and swelling (1.4% of the study group, 2.1% of the control group). Adverse events lasting over a week were pain 5.3%, redness 1.4%, swelling and warmth each accounting for 1.0%, yet all of them completely resolved in two weeks without any special treatment. (See Table 1.)

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Of the patients with the knee osteoarthritis (285 subjects), the occurrence rate of the adverse events excluding ones occurred at the injection site is 34.5% (48/139, 73 cases) for the study group and 28.8% (42/146, 63 cases) for the control group. Most of them were mild to moderate. Table 2 indicates the adverse events occurred in more than 1% of the study group. (See Table 2.)

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