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Table 2 Treatment-emergent adverse events in the safety set

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

  TEAEs Treatment-related TEAEs
  Knee joint Other joint Total Knee joint Other joint Total
  N = 126 N = 40 N = 166 N = 126 N = 40 N = 166
Any events 94 (74.6) 32 (80.0) 126 (75.9) 9 (7.1) 6 (15.0) 15 (9.0)
Common events (≥5%)
 Nasopharyngitis 30 (23.8) 11 (27.5) 41 (24.7) 0 0 0
 Eczema 6 (4.8) 4 (10) 10 (6.0) 0 0 0
 Osteoarthritis 11 (8.7) 2 (5.0) 13 (7.8) 0 0 0
 Injection site joint pain 9 (7.1) 5 (12.5) 14 (8.4) 8 (6.3) 5 (12.5) 13 (7.8)
 Contusion 13 (10.3) 4 (10.0) 17 (10.2) 0 0 0
Serious TEAEs 10 (7.9) 0 10 (6.0) 0 0 0
Significant TEAEsa 0 1 (2.5) 1 (0.6) 0 1 (2.5) 1 (0.6)
Special interest events
 Events at injection site 12 (9.5) 6 (15.0) 18 (10.8) 8 (6.3) 5 (12.5) 13 (7.8)
 Gastrointestinal disorders 2 (1.6) 0 2 (1.2) 0 0 0
 Anaphylactic reaction 4 (3.2) 3 (7.5) 7 (4.2) 0 0 0
 Hypersensitivity 16 (12.7) 7 (17.5) 23 (13.9) 0 0 0
  1. TEAEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) ver.22.0. OA = osteoarthritis; knee joint = patients with knee OA; Other joint = patients with OA at joints other than knee; NSAIDs =  Nonsteroidal anti-inflammatory drugs; total = whole patients treated concomitantly with or without systemic NSAIDs
  2. aTreatment-emergent adverse events (TEAEs) leading to study drug withdrawal are defined as significant TEAEs