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Table 2 Adverse events by study group

From: Phase 1 safety and tolerability study of BMP-7 in symptomatic knee osteoarthritis

 

0.03 mg

(N = 7)

0.1 mg

(N = 6)

0.3 mg

(N = 6)

1 mg

(N = 6)

Placebo

(N = 8)

Number of Patients with at least one AE

7 (100%)

5 (83.3%)

5 (83.3%)

6 (100%)

7 (87.5%)

Number of Patients with no AE

0 (0%)

1 (16.7%)

1 (16.7%)

0 (0%)

1 (12.5%)

Arthralagia

4 (57.1%)

1 (16.7%)

5 (83.3%)

5 (83.3%)

6 (75%)

Nasopharyngitis

2 (28.6%)

2 (33.3%)

1 (16.7%)

0 (0%)

1 (12.5%)

Upper Respiratory Tract Infection

1 (14.3%)

0 (0%)

3 (50%)

1 (16.7%)

1 (12.5%)

Headache

1 (14.3%)

2 (33.3%)

2 (33.3%)

0 (0%)

1 (12.5%)

Influenza

0 (0%)

2 (33.3%)

0 (0%)

0 (0%)

2 (25%)

Joint Stiffness

2 (28.6%)

1 (16.7%)

1 (16.7%)

0 (0%)

1 (12.5%)

Joint Swelling

2 (28.6%)

0 (0%)

0 (0%)

1 (16.7%)

0 (0%)

Lymphadenopathy

0 (0%)

1 (16.7%)

0 (0%)

1 (16.7%)

0 (0%)

Injection Site Bruising

0 (0%)

2 (33.3%)

0 (0%)

0 (0%)

0 (0%)

Injection Site Pain

1 (14.3%)

0 (0%)

0 (0%)

4 (66.7%)

1 (12.5%)

Injection Site Mass

0 (0%)

1 (16.7%)

0 (0%)

1 (16.7%)

0 (0%)

Injection Site Swelling

1 (14.3%)

0 (0%)

1 (16.7%)

1 (16.7%)

0 (0%)