Table 2.
Reasons for treatment discontinuation [intent-to-treat (ITT) population]
| Reason for discontinuation, n (%) | OL titration | DB maintenance | |
|---|---|---|---|
| Tapentadol ER (n = 1,040) | Placebo (n = 343) | Tapentadol ER (n = 360) | |
| Total discontinuations for any reason | 296 (28.5) | 103 (30.0) | 104 (28.9) |
| Adverse event | 169 (16.3) | 28 (8.2) | 51 (14.2) |
| Withdrawal of consent | 32 (3.1) | 16 (4.7) | 21 (5.8) |
| Ineligible for DB maintenance | 26 (2.5) | – | – |
| Lack of efficacy | 22 (2.1) | 38 (11.1) | 11 (3.1) |
| Study drug noncompliance | 22 (2.1) | 8 (2.3) | 6 (1.7) |
| Lost to follow-up | 5 (0.5) | 2 (0.6) | 2 (0.6) |
| Physician decision | 1 (0.1) | 1 (0.3) | 2 (0.6) |
| Protocol violation | 1 (0.1) | 2 (0.6) | 1 (0.3) |
| Other | 18 (1.7) | 8 (2.3) | 10 (2.8) |
DB double-blind, ER extended release, OL open-label