Table 3.
Efficacy Outcomes (Efficacy Analysis Set)
| Moderate Renal Impairment (CLCR 30–59 mL/min) n=30 |
Severe Renal Impairment (CLCR 15–29 mL/min) n=5 |
Total N=35 |
|
|---|---|---|---|
| ADPS, baseline, mean (SD) | 5.7 (1.0) | 6.0 (1.3) | 5.7 (1.1) |
| Week 14 change from baseline (imputed), LS mean [95% CI] | −1.8 [−2.5, −1.1] | −2.1 [−3.8, −0.4] | −1.9 [−2.8, −1.0] |
| ADPS responder ratea | |||
| ≥30% reduction in ADPS at Week 14, n (%) [95% CI] | 13 (43.3) [27.4, 60.8] | 2 (40.0) [11.8, 76.9] | 15 (42.9) [28.0, 59.1] |
| ≥50% reduction in ADPS at Week 14, n (%) [95% CI] | 8 (26.7) [14.2, 44.4] | 2 (40.0) [11.8, 76.9] | 10 (28.6) [16.3, 45.1] |
| SF-MPQ, baseline, mean (SD) | |||
| Sensory score | 7.7 (4.3) | 8.6 (8.8) | 7.8 (5.0) |
| Week 14/LOCF change from baseline | −5.1 (4.4) | −1.8 (2.5) | −4.6 (4.3) |
| Affective score | 1.3 (1.5) | 2.6 (2.7) | 1.5 (1.7) |
| Week 14/LOCF change from baseline | −1.0 (1.6) | −0.8 (0.5) | −1.0 (1.5) |
| Total score | 9 (5.3) | 11.2 (11.4) | 9.3 (6.3) |
| Week 14/LOCF change from baseline | −6.1 (5.4) | −2.6 (2.7) | −5.6 (5.2) |
| VAS (mm) | 59.1 (9.1) | 62.8 (13.4) | 59.6 (9.6) |
| Week 14/LOCF change from baseline | −20.8 (17.7) | −26.0 (22.8) | −21.5 (18.2) |
| Present pain intensity | 1.9 (1.0) | 2 (0.7) | 1.9 (0.9) |
| Week 14/LOCF change from baseline | −0.8 (0.8) | −0.2 (0.8) | −0.7 (0.8) |
| PGICa,b | |||
| Much improved or better (≤2) at Week 14, n (%) [95% CI] | 11 (36.7) [21.9, 54.5] | 1 (20.0) [3.6, 62.4] | 12 (34.3) [20.8, 50.8] |
| Minimally improved or better (≤3) at Week 14, n (%) [95% CI] | 23 (76.7) [59.1, 88.2] | 4 (80.0) [37.6, 96.4] | 27 (77.1) [61.0, 87.9] |
| ADSIS, baselinec, mean (SD) | 3.5 (1.8) | 3.8 (3.4) | 3.5 (2.1) |
| Week 14/LOCF change from baseline | −1.4 (1.6) | −0.5 (0.7) | −1.3 (1.5) |
Notes: aThe 95% CI was calculated using the Wilson score method without continuity correction. bFor patients who were missing PGIC data at Week 14 but who had data prior to Week 14, the LOCF approach was used. Patients who had no PGIC data throughout the study were regarded as non-responders. cBaseline ADSIS was defined as the average of up to 7 available sleep interference scores in the previous 7 days at or before first study treatment.
Abbreviations: ADPS, average daily pain score; ADSIS, average daily sleep interference score; CI, confidence interval; CLCR, creatinine clearance; LOCF, last observation carried forward; LS, least squares; PGIC, patient global impression of change; SD, standard deviation; SF-MPQ, short-form McGill Pain Questionnaire; VAS, visual analog scale.