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Table 3 Subgroup analysis of TEAEs by concomitant medication

From: Open-label phase 3 study of diclofenac conjugated to hyaluronate (diclofenac etalhyaluronate: ONO-5704/SI-613) for treatment of osteoarthritis: 1-year follow-up

 

N

TEAEs

Treatment-related TEAEs

Gastrointestinal disordersa

Without NSAIDs

72

46 (63.9%)

5 (6.9%)

1 (1.4%)

With NSAIDs

94

80 (85.1%)

10 (10.6%)

1 (1.1%)

 

N

TEAEs

Treatment-related TEAEs

Events at injection site

Without HA

112

83 (74.1%)

12 (10.7%)

14 (12.5%)

With HA for ≤24 weeks

30

23 (76.7%)

2 (6.7%)

1 (3.3%)

With HA for > 24 weeks

24

20 (83.3%)

1 (4.2%)

3 (12.5%)

  1. TEAEs treatment-emergent adverse events, HA hyaluronan, NSAIDs nonsteroidal anti-inflammatory drugs
  2. aStandardised MedDRA Queries (Broad Scope)