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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)