Table 3.

Summary of final neurologic examinations and neurologic consultations. Neurological examinations were performed per protocol by study investigators. Data are n (%).

Placebo, n = 208Tanezumab 5 mg, n = 206Study 1015 Tanezumab 10 mg, 500 n = 208Naproxen mg BID, n = 206Placebo, n = 209Tanezumab 5 mg, n = 211Study 1018 Tanezumab 10 mg, n = 209Naproxen 500 mg BID, n = 211
Final neurological examination assessments
New or worsened abnormality
  Clinically significant01 (0.5)1 (0.5)1 (0.5)01 (0.5)1 (0.5)1 (0.5)
  Not clinically significant27 (13.0)24 (11.8)23 (11.2)14 (6.8)14 (6.9)17 (8.2)19 (9.3)20 (9.9)
  No new or worsened abnormality180 (87.0)179 (87.7)181 (88.3)191 (92.7)189 (93.1)190 (91.3)184 (90.2)181 (89.6)
Final neurological consultation categorization
  Subjects referred for consultation10 (4.8)20 (9.7)38 (18.3)10 (4.9)3 (1.4)20 (9.5)25 (12.0)9 (4. 3)
  Symptoms, clinically significant signs, or diagnostic tests suggestive of new or worsened peripheral neuropathy1 (0.5)6 (2.9)19 (9.1)2 (1.0)2 (1.0)4 (1.9)7 (3.3)3 (1.4)
  Other neurological symptoms or signs3 (1.4)4 (1.9)8 (3.8)3 (1.5)1 (0.4)11 (5.2)9 (4.3)2 (0.9)
  No neurological symptoms or signs6 (2.9)10 (4.9)11 (5.3)5 (2.4)05 (2.4)9 (4.3)4 (1.9)
  • Administered intravenously on Day 1 and Day 57 (Week 8).

  • Neurological consultations were performed by neurologists following a neurological adverse event report or after significant neurological examination abnormalities were detected by investigators.