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.
Reported adverse events in clinical investigations: In a pivotal clinical trial of Hyruan ONE in patients with knee osteoarthritis (a total of 285 subjects), the occurrence rate of local reaction at the injection site after injection into the 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 (5.0% of the study group, 2.1% of the control group), and so on. 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 knee osteoarthritis (285 subjects), the occurrence rate of the adverse events excluding ones that 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 that occurred in more than 1% of the study group. (See Table 2.)


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