Atri ONE Adverse Reactions

There were no serious adverse events related to this product.
In a clinical trial (YY_YYD302_003) of this product in patients with osteoarthritis of the knee, using Synovian Injection as a control group, the occurrence rate of adverse events at injection site following injection into articular cavity was 48.42% (46/95 subjects) and 47.27% (26/55 subject) after the first injection and re-injection of this product, respectively. The reported adverse events at injection site are shown in the following Table 1. The severe adverse events were reported in the decreasing order of swelling (9.47% and 7.27% after the first injection and re-injection of this product, respectively), redness (erythema) (6.32% and 3.64% after the first injection and re-injection of this product, respectively), and pain (3.16% and 12.73% after the first injection and re-injection of this product, respectively). Adverse events at injection site lasting for 7 days or more after injection of this product were pain 5.26%, warmth 3.16%, and swelling 1.05%, yet all of them resolved within 14 days without any special treatment. After re-injection, adverse event at injection site lasting for 7 days or more were pain 10.91%, swelling 5.45%, warmth 3.64%, and redness (erythema) 1.82%, yet all of them resolved without any special treatment. (See Table 1.)

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In the clinical trial (YY_YYD302_003) of this product in patients with osteoarthritis of the knee, using Synovian as a control group, the occurrence rate of adverse events excluding ones occurred at the injection site was 9.47% (9/95 subjects, 19 cases) during 12 weeks after the first injection of this product, 29.09% (16/55 subjects, 35 cases) during 36 weeks after the first injection of this product, and 14.55% (8/55 subjects, 13 cases) during 12 weeks after re injection of this product. Most of them were mild to moderate. Table 2 indicates the adverse events reported to be occurred in 1% or more after injection of this product. (See Table 2.)

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