Efficacy evaluation measurement Day of dose administration
Pre-Admin Day1 Day2 Day3 Day4 Day5 Day6 Day7 Day8 Day9 Day10
Change in number of events during a 24 hour period (events/24 hours) No. 23 23 22 22 21 19 18 18 17 17 17
Mean 14.36 8.76 6.75 7.43 7.70 5.54 4.68 4.22 3.55 4.18 3.54
SD 7.39 8.10 5.87 6.76 11.58 6.23 5.72 3.61 3.24 4.53 4.01
95%CI 11.17-17.56 5.26-12.26 4.15-9.35 4.43-10.43 2.43-12.98 2.54-8.55 1.84-7.53 2.43-6.02 1.89-5.22 1.85-6.51 1.48-5.60
Test* 0.001 <0.001 <0.001 0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
Duration of apneic event (seconds) No. 23 23 22 22 21 19 18 18 17 17 17
Mean 347.2 190.9 179.9 198.3 156.0 154.6 120.7 112.3 84.5 110.2 80.2
SD 198.9 184.6 184.0 221.2 195.3 199.5 171.1 109.3 87.7 140.7 111.7
95%CI 261.2-433.2 111.0-270.7 98.3-261.5 100.2-296.4 67.1-244.9 58.4-250.7 35.7-205.8 58.0-166.7 39.4-129.6 37.9-182.5 22.7-137.6
test* 0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
Minimum SpO2 during apneic event (%) No. 23 21 20 19 19 16 13 16 15 14 15
Mean 72.7 75.0 76.7 75.6 78.6 78.8 81.4 80.5 78.7 81.4 79.3
SD 10.3 10.7 10.0 13.1 13.8 11.7 8.2 10.3 10.9 6.8 7.8
95%CI 68.3-77.2 70.1-79.9 72.0-81.3 69.3-81.9 72.0-85.3 72.5-85.0 76.4-86.3 75.0-86.0 72.7-84.7 77.5-85.3 75.0-83.7
test* 0.650 0.144 0.547 0.111 0.019 0.005 0.006 0.097 <0.001 0.014
Proportion of events having SpO2 less than 85% (%) No. 23 21 20 19 19 16 13 16 15 14 15
Mean 35.00 44.74 42.35 44.90 41.94 40.87 33.25 43.96 37.17 32.76 38.07
SD 27.86 33.08 36.72 32.61 34.96 33.74 31.58 35.45 42.94 36.85 29.50
95%CI 22.95-47.05 29.68-59.79 25.16-59.53 29.18-60.62 25.09-58.79 22.89-58.85 14.16-52.33 25.07-62.85 13.39-60.94 11.48-54.03 21.74-54.41
test* 0.099 0.404 0.229 0.548 0.732 0.943 0.715 0.801 0.455 0.413
*Wilcoxon’s signed rank sum test;95%CI=95% confidence interval
Table 2: Change in secondary outcome measures of efficacy.