Table 1.
Summary of demographic and baseline characteristics of study patients
| Placebo n = 176* | Alosetron 0.5 mg QD n = 177* | Alosetron 1 mg QD n = 175* | Alosetron 1 mg BID n = 177* | |
|---|---|---|---|---|
| Age (y) (Mean ± s.d.) | 46.6 ± 14.5 | 45.9 ± 13.1 | 46.6 ± 12.3 | 47.0 ± 13.9 |
| Ethnic origin [n (%)] | ||||
| Caucasian | 154 (88) | 163 (92) | 158 (90) | 145 (87) |
| Black | 10 (6) | 8 (5) | 5 (3) | 10 (6) |
| Hispanic | 10 (6) | 6 (3) | 10 (6) | 12 (7) |
| Others | 2 (1) | (0) | 2 (1) | (0) |
| Quality of Life Scores (Mean ± S.E.) | ||||
| Emotional | 37.5 (1.8) | 34.6 (1.7) | 36.4 (1.9) | 36.4 (1.7) |
| Mental health | 57.8 (1.8) | 58.3 (1.8) | 58.9 (2.0) | 58.7 (1.9) |
| Sleep | 59.3 (1.8) | 57.5 (1.8) | 58.6 (1.8) | 59.1 (1.8) |
| Energy | 40.8 (2.0) | 37.5 (2.0) | 38.6 (2.0) | 38.7 (1.8) |
| Physical functioning | 56.3 (1.8) | 55.9 (1.8) | 57.6 (2.1) | 55.5 (2.0) |
| Food/diet | 48.7 (1.7) | 44.9 (1.7) | 46.0 (1.9) | 46.9 (1.7) |
| Social functioning | 32.0 (1.7) | 31.5 (1.7) | 32.1 (1.8) | 32.3 (1.8) |
| Physical role | 29.4 (1.8) | 32.0 (1.8) | 31.3 (1.8) | 30.2 (1.8) |
| Sexual relations | 53.9 (2.8) | 51.8 (2.4) | 52.7 (2.6) | 55.9 (2.5) |
| Lost workplace productivity (h) (Mean ± S.E.) | 31.2 (3.0) | 33.5 (3.0) | 32.2 (3.2) | 34.6 (4.2) |
BID, twice daily; ITT, intent-to-treat; QD, once daily.
*
ITT population (N = 705).