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Table 6 Adverse drug reactions

From: Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study

Adverse Drug Reactions

HMWHA

XLHA

P-value

N = 146

N = 139

Injection site pruritus

1 (1)

1 (1)A

1.00

Pain

0 (0)

1 (2)A

0.49

Swelling

0 (0)

1 (1)

0.49

Injection site hemorrhage

0 (0)

1 (1)

0.49

Joint swelling

0 (0)

1 (1)

0.49

Erythema

0 (0)

2 (2)A

0.24

Total number

1 (1)

7 (8)

0.03

  1. Data are number of patients experiencing adverse drug reaction and the numbers in parenthesis are number of events
  2. A, In XLHA group, 3 adverse drug reactions (each event of injection site pruritus, pain, and erythema) occurred after placebo injection, which preceded XLHA injection