Table 5.
Summary of treatment-emergent AEs (all-causality) by baseline pain severity in neuropathic pain
| Baseline paina | ||||
|---|---|---|---|---|
| Moderate | Severe | |||
| Subjects with AEsb, n (%) | Pregabalin (n=333) | Placebo (n=180) | Pregabalin (n=150) | Placebo (n=79) |
| Subjects with ≥1 AE | 282 (84.7) | 127 (70.6) | 131 (87.3) | 52 (65.8) |
| Common AEsc | ||||
| Dizziness | 99 (29.7) | 11 (6.1) | 39 (26.0) | 6 (7.6) |
| Somnolence | 98 (29.4) | 20 (11.1) | 43 (28.7) | 2 (2.5) |
| Weight gain | 44 (13.2) | 3 (1.7) | 15 (10.0) | 3 (3.8) |
| Constipation | 32 (9.6) | 6 (3.3) | 13 (8.7) | 3 (3.8) |
| Peripheral edema | 44 (13.2) | 6 (3.3) | 15 (10.0) | 2 (2.5) |
Notes: Subjects with baseline pain <4 and missing baseline pain scores are excluded.
a
Baseline pain scores defined as moderate (≥4–<7) or severe (≥7–10).
b
Defined by Medical Dictionary of Regulatory Activities preferred terms.
c
Reported in ≥5% of subjects and at twice the rate of placebo within a disease cohort.
Abbreviation: AE, adverse event.