Table 4.
Safety Summary (Safety Analysis Set)
| TEAEs | Total (n=130) | Osteoarthritis (n=56) | Diabetic Neuropathic Pain (n=11) | Post-Herpetic Neuralgia (n=28) | Other Chronic Pain Conditions (n=35) |
|---|---|---|---|---|---|
| TEAEs | |||||
| Overall, n (%) | 122 (93.8) | 53 (94.6) | 10 (90.9) | 27 (96.4) | 32 (91.4) |
| Number of events | 672 | 278 | 53 | 119 | 222 |
| Serious TEAEs | |||||
| Overall, n (%) | 12 (9.2) | 5 (8.9) | 3 (27.3) | 1 (3.6) | 3 (8.6) |
| Number of events | 14 | 6 | 4 | 1 | 3 |
| Significant TEAEs | |||||
| Overall, n (%) | 25 (19.2) | 13 (23.2) | 1 (9.1) | 4 (14.3) | 7 (20.0) |
| Number of events | 36 | 20 | 1 | 4 | 11 |
| TEAEs leading to study drug discontinuation | |||||
| Overall, n (%) | 29 (22.3) | 15 (26.8) | 2 (18.2) | 4 (14.3) | 8 (22.9) |
| Number of events | 43 | 24 | 2 | 5 | 12 |
Abbreviation: TEAE, treatment-emergent adverse event.