Table 3.
Summary of secondary oximetry endpoint analysis in the per-protocol population
| Treatment group | Time (min) at SpO2 < 90% Mean (SD) |
Percent of TST at SpO2 < 90% Mean (SD) |
||||
|---|---|---|---|---|---|---|
| Baseline | Day 14 | Day 28 | Baseline | Day 14 | Day 28 | |
| Placebo/Placebo (N = 7) | 85.9 (85.67) | 104.2 (100.33) | 96.4 (101.85) | 19.2 (18.80) | 25.1 (22.82) | 23.4 (24.10) |
| Placebo / Ond 24 mg (N = 9) | 13.2 (17.44) | 20.0 (26.66) | 51.8 (69.61) | 2.9 (3.63) | 4.4 (5.76) | 11.2 (14.47) |
| Fl 5 mg / Ond 24 mg (N = 9) | 38.5 (41.34) | 66.5 (84.43) | 77.6 (91.29) | 10.1 (9.26) | 18.7 (22.29) | 18.7 (22.03) |
| Fl 10 mg / Ond 24 mg (N = 10) | 53.6 (71.18) | 36.6 (45.74) | 46.3 (58.49) | 12.9 (16.78) | 9.6 (13.15) | 11.7 (15.11) |
TST, total sleep time; SpO2, oxygen saturation by pulse oximetry; Ond, ondansetron; Fl, fluoxetine.
Dunnett adjusted P-values were not significant for all group and time comparisons.