Skip to main content

Table 1 Demographic and other baseline characteristics in the full analysis 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

Characteristics   Knee joint
N = 126
Other joint
N = 40
Total
N = 166
Age (years), n (%) Mean ± SD 67.0 ± 10.2 62.1 ± 13.4 65.9 ± 11.2
< 65 51 (40.5) 19 (47.5) 70 (42.2)
≥65–75 45 (35.7) 14 (35.0) 59 (35.5)
> 75 30 (23.8) 7 (17.5) 37 (22.3)
Sex, n (%) Male 33 (26.2) 17 (42.5) 50 (30.1)
Female 93 (73.8) 23 (57.5) 116 (69.9)
BMI (kg/m2), n (%) Mean ± SD 26.06 ± 4.92 25.33 ± 4.49 25.88 ± 4.82
< 25.0 54 (42.9) 20 (50.0) 74 (44.6)
≥25.0 72 (57.1) 20 (50.0) 92 (55.4)
Duration of current joint pain (years), n (%) Mean ± SD 5.7 ± 6.4 4.1 ± 5.3 5.3 ± 6.2
< 1 31 (24.6) 13 (32.5) 44 (26.5)
≥1 95 (75.4) 27 (67.5) 122 (73.5)
Classification of OA, n (%) Primary 122 (96.8) 30 (75.0) 152 (91.6)
Secondary 4 (3.2) 10 (25.0) 14 (8.4)
Causea, n (%)b Injury 2 (50.0) 1 (10.0) 3 (21.4)
Cuff tear   2 (20.0) 2 (14.3)
Meniscus injury 2 (50.0)   2 (14.3)
Acetabular dysplasia   6 (60.0) 6 (42.9)
Other 0 1 (10.0) 1 (7.1)
Stage of OAc
 Knee, shoulder and elbow OA, n (%) Grade 1 18 (14.3) 13 (32.5) 31 (18.7)
Grade 2 52 (41.3) 5 (12.5) 57 (34.3)
Grade 3 43 (34.1) 4 (10.0) 47 (28.3)
Grade 4 13 (10.3) 1 (2.5) 14 (8.4)
 Hip OA, n (%) Early stage   5 (12.5) 5 (3.0)
Advanced stage   3 (7.5) 3 (1.8)
End stage   1 (2.5) 1 (0.6)
 Ankle OA, n (%) Stage 1   3 (7.5) 3 (1.8)
Stage 2   1 (2.5) 1 (0.6)
Stage 3   3 (7.5) 3 (1.8)
Stage 4   1 (2.5) 1 (0.6)
 Joint pain scored, n (%) Mean ± SD 6.0 ± 1.1 5.7 ± 1.3 5.9 ± 1.2
< 5 15 (11.9) 12 (30.0) 27 (16.3)
≥5–7 71 (56.3) 19 (47.5) 90 (54.2)
≥7 40 (31.7) 9 (22.5) 49 (29.5)
  1. SD standard deviation, BMI body mass index, OA osteoarthritis, K-L Kellgren and Lawrence
  2. aThis assessment was conducted for patients with secondary OA
  3. bPercentages are based on the number of patients with secondary OA
  4. cIn knee, shoulder, and elbow joints, Stage of OA is indicated by K-L grading score. In hip and ankle joints, Stage of OA is indicated by stage of each joint
  5. dFor the 0 to 10 numerical rating scale for pain intensity, 0 indicates no pain and 10 indicates worst pain