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【資料No.1】2.5_臨床に関する概括資料 (71 ページ)
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| 出典情報 | 薬事・食品衛生審議会 薬事分科会（令和4年度第5回 11／22）、医薬品第二部会（令和4年度第13回 11／22）（合同開催）《厚生労働省》 |
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S-217622
2.5 臨床に関する概括評価
The participants whose total score of COVID-19 symptoms at baseline is 0 were excluded from this analysis.
出典：5.3.5.1-01_T1221 CSR (Phase 2b Part)_Table 14.2.1.1.1
表 2.5.4.1-6
COVID-19 症状の各サブ合計スコアの Day 1 から Day 6 までの単位時間あたり
の変化量：Phase 2b Part (ITT1 集団)
Parameter
Statistics
Acute Symptoms
N
Mean
SD
Min
Median
Max
LS mean (SE) by ANCOVA [a]
Difference in LS means vs. Placebo (SE)
95% CI for difference
p-value
Main Clinical Symptoms N
Mean
SD
Min
Median
Max
LS mean (SE) by ANCOVA [a]
Difference in LS means vs. Placebo (SE)
95% CI for difference
p-value
Respiratory Symptoms
N
Mean
SD
Min
Median
Max
LS mean (SE) by ANCOVA [a]
Difference in LS means vs. Placebo (SE)
95% CI for difference
p-value
Systemic Symptoms
N
Mean
SD
Min
Median
Max
LS mean (SE) by ANCOVA [a]
Difference in LS means vs. Placebo (SE)
95% CI for difference
p-value
Digestive Symptoms
N
Mean
SD
Min
Median
Max
LS mean (SE) by ANCOVA [a]
Difference in LS means vs. Placebo (SE)
95% CI for difference
- 71 -
S-217622
125 mg
N = 114
107
-2.52
1.34
-6.19
-2.55
0.45
-2.36 (0.10)
-0.20 (0.12)
-0.44, 0.04
0.1080
109
-3.56
2.01
-9.76
-3.33
0.55
-3.34 (0.14)
-0.34 (0.17)
-0.68, 0.00
0.0504
106
-2.28
1.54
-6.44
-1.99
1.30
-2.09 (0.12)
-0.37 (0.15)
-0.67, -0.07
0.0153
100
-3.71
2.86
-14.30
-3.18
1.80
-3.31 (0.14)
0.15 (0.18)
-0.20, 0.49
0.4052
35
-1.39
1.18
-5.80
-0.99
-0.16
-1.27 (0.14)
0.06 (0.18)
-0.30, 0.42
S-217622
250 mg
N = 116
108
-2.63
1.34
-6.93
-2.71
0.52
-2.50 (0.10)
-0.33 (0.12)
-0.58, -0.09
0.0070
111
-3.54
2.00
-10.11
-3.42
0.39
-3.42 (0.14)
-0.42 (0.17)
-0.76, -0.08
0.0149
111
-2.33
1.58
-6.34
-2.30
2.29
-2.16 (0.12)
-0.44 (0.15)
-0.74, -0.15
0.0033
104
-3.19
2.54
-9.66
-2.81
2.71
-3.16 (0.14)
0.30 (0.17)
-0.04, 0.64
0.0843
35
-1.13
1.37
-5.78
-0.79
0.50
-1.08 (0.14)
0.25 (0.18)
-0.11, 0.61
Placebo
N = 111
109
-2.09
1.31
-4.92
-1.99
1.18
-2.16 (0.10)
------110
-2.94
1.94
-7.81
-2.91
1.81
-2.99 (0.14)
------109
-1.67
1.44
-5.56
-1.53
1.81
-1.72 (0.13)
------98
-3.35
2.28
-11.26
-2.55
0.60
-3.46 (0.14)
------32
-1.27
0.86
-3.58
-0.95
0.19
-1.32 (0.14)
-----
2.5 臨床に関する概括評価
The participants whose total score of COVID-19 symptoms at baseline is 0 were excluded from this analysis.
出典：5.3.5.1-01_T1221 CSR (Phase 2b Part)_Table 14.2.1.1.1
表 2.5.4.1-6
COVID-19 症状の各サブ合計スコアの Day 1 から Day 6 までの単位時間あたり
の変化量：Phase 2b Part (ITT1 集団)
Parameter
Statistics
Acute Symptoms
N
Mean
SD
Min
Median
Max
LS mean (SE) by ANCOVA [a]
Difference in LS means vs. Placebo (SE)
95% CI for difference
p-value
Main Clinical Symptoms N
Mean
SD
Min
Median
Max
LS mean (SE) by ANCOVA [a]
Difference in LS means vs. Placebo (SE)
95% CI for difference
p-value
Respiratory Symptoms
N
Mean
SD
Min
Median
Max
LS mean (SE) by ANCOVA [a]
Difference in LS means vs. Placebo (SE)
95% CI for difference
p-value
Systemic Symptoms
N
Mean
SD
Min
Median
Max
LS mean (SE) by ANCOVA [a]
Difference in LS means vs. Placebo (SE)
95% CI for difference
p-value
Digestive Symptoms
N
Mean
SD
Min
Median
Max
LS mean (SE) by ANCOVA [a]
Difference in LS means vs. Placebo (SE)
95% CI for difference
- 71 -
S-217622
125 mg
N = 114
107
-2.52
1.34
-6.19
-2.55
0.45
-2.36 (0.10)
-0.20 (0.12)
-0.44, 0.04
0.1080
109
-3.56
2.01
-9.76
-3.33
0.55
-3.34 (0.14)
-0.34 (0.17)
-0.68, 0.00
0.0504
106
-2.28
1.54
-6.44
-1.99
1.30
-2.09 (0.12)
-0.37 (0.15)
-0.67, -0.07
0.0153
100
-3.71
2.86
-14.30
-3.18
1.80
-3.31 (0.14)
0.15 (0.18)
-0.20, 0.49
0.4052
35
-1.39
1.18
-5.80
-0.99
-0.16
-1.27 (0.14)
0.06 (0.18)
-0.30, 0.42
S-217622
250 mg
N = 116
108
-2.63
1.34
-6.93
-2.71
0.52
-2.50 (0.10)
-0.33 (0.12)
-0.58, -0.09
0.0070
111
-3.54
2.00
-10.11
-3.42
0.39
-3.42 (0.14)
-0.42 (0.17)
-0.76, -0.08
0.0149
111
-2.33
1.58
-6.34
-2.30
2.29
-2.16 (0.12)
-0.44 (0.15)
-0.74, -0.15
0.0033
104
-3.19
2.54
-9.66
-2.81
2.71
-3.16 (0.14)
0.30 (0.17)
-0.04, 0.64
0.0843
35
-1.13
1.37
-5.78
-0.79
0.50
-1.08 (0.14)
0.25 (0.18)
-0.11, 0.61
Placebo
N = 111
109
-2.09
1.31
-4.92
-1.99
1.18
-2.16 (0.10)
------110
-2.94
1.94
-7.81
-2.91
1.81
-2.99 (0.14)
------109
-1.67
1.44
-5.56
-1.53
1.81
-1.72 (0.13)
------98
-3.35
2.28
-11.26
-2.55
0.60
-3.46 (0.14)
------32
-1.27
0.86
-3.58
-0.95
0.19
-1.32 (0.14)
-----