Table 2

Results for key secondary end points

Placebo
(n=282)
Tanezumab 2.5 mg
(n=283)
Tanezumab 5 mg
(n=284)
Treatment response: ≥50% reduction from baseline in WOMAC Pain at week 24*Number of patients with treatment response95 (33.8%)128 (45.4%)136 (47.9%)
Odds ratio vs placebo1.721.87
P value†0.00220.0004
WOMAC Pain: change from baseline to week 2‡LS mean (SE)–1.35 (0.14)–2.02 (0.14)–1.69 (0.14)
LS mean difference vs placebo (SE)–0.67 (0.14)–0.34 (0.14)
P value†<0.00010.0149
Average pain score: change from baseline to week 1‡LS mean (SE)–0.57 (0.11)–1.06 (0.11)–0.93 (0.11)
LS mean difference vs placebo (SE)–0.49 (0.11)–0.36 (0.11)
P value†<0.00010.0009
  • *Mixed baseline/last observation carried forward.

  • †Nominal, unadjusted p value. In line with the predefined gatekeeping strategy, hypothesis testing of the three key secondary end points could not be performed: no key secondary end points can be declared as statistically significantly better than placebo treatment.

  • ‡Multiple imputation.

  • LS, least squares; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.