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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