| 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 |
