よむ、つかう、まなぶ。
【資料No.1】2.5_臨床に関する概括資料 (104 ページ)
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| 公開元URL | https://www.mhlw.go.jp/stf/newpage_26901.html |
| 出典情報 | 薬事・食品衛生審議会 薬事分科会(令和4年度第3回 7／20)、医薬品第二部会(令和4年度第6回 7／20)（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
S-217622
S-217622
Placebo
125 mg
250 mg
N = 114
N = 116
N = 111
Max
6
4
5
LS mean (SE) by ANCOVA [a]
-3.98 (0.34)
-3.51 (0.33)
-3.68 (0.34)
Difference in LS means vs. Placebo (SE)
-0.29 (0.42)
0.17 (0.41)
--95% CI for difference
-1.12, 0.53
-0.64, 0.98
--p-value
0.4887
0.6801
--36 hours post-dose n
93
96
97
Mean
-5.4
-4.7
-4.5
SD
4.7
3.9
3.5
Min
-23
-20
-14
Median
-5.0
-5.0
-4.0
Max
6
4
3
LS mean (SE) by ANCOVA [a]
-4.83 (0.36)
-4.50 (0.34)
-4.55 (0.35)
Difference in LS means vs. Placebo (SE)
-0.28 (0.44)
0.04 (0.43)
--95% CI for difference
-1.15, 0.58
-0.81, 0.90
--p-value
0.5214
0.9208
--48 hours post-dose n
106
105
102
Mean
-6.0
-5.7
-4.7
SD
4.8
4.3
3.6
Min
-27
-20
-17
Median
-5.0
-5.0
-4.0
Max
5
6
3
LS mean (SE) by ANCOVA [a]
-5.45 (0.32)
-5.39 (0.31)
-5.07 (0.33)
Difference in LS means vs. Placebo (SE)
-0.38 (0.40)
-0.32 (0.40)
--95% CI for difference
-1.16, 0.40
-1.10, 0.46
--p-value
0.3394
0.4208
--72 hours post-dose n
105
100
104
Mean
-6.7
-6.8
-5.9
SD
4.3
4.2
3.8
Min
-21
-23
-17
Median
-6.0
-6.0
-5.0
Max
3
5
4
LS mean (SE) by ANCOVA [a]
-5.94 (0.28)
-6.16 (0.28)
-5.93 (0.28)
Difference in LS means vs. Placebo (SE)
-0.01 (0.35)
-0.24 (0.35)
--95% CI for difference
-0.70, 0.67
-0.93, 0.45
--p-value
0.9673
0.4987
--96 hours post-dose n
102
99
101
Mean
-7.4
-7.5
-6.5
SD
4.4
4.2
3.9
Min
-25
-21
-17
Median
-7.0
-7.0
-6.0
Max
4
1
2
LS mean (SE) by ANCOVA [a]
-6.76 (0.26)
-7.08 (0.27)
-6.64 (0.27)
Difference in LS means vs. Placebo (SE)
-0.12 (0.32)
-0.44 (0.33)
--95% CI for difference
-0.75, 0.52
-1.08, 0.21
--p-value
0.7222
0.1829
--120 hours post-dose n
93
96
95
Mean
-8.3
-7.9
-7.2
SD
4.7
4.1
3.9
Min
-27
-20
-18
Median
-7.0
-7.0
-7.0
Max
0
0
1
LS mean (SE) by ANCOVA [a]
-7.78 (0.24)
-7.62 (0.24)
-7.43 (0.24)
Difference in LS means vs. Placebo (SE)
-0.35 (0.30)
-0.18 (0.30)
--95% CI for difference
-0.94, 0.24
-0.77, 0.40
--p-value
0.2445
0.5380
--[a] Covariate: Baseline values of each parameter, time from onset to randomization [<72 hours or ≥72 hours], SARS-CoV-2
vaccination history [Yes or No]
Time Point
Statistics
- 104 -
2.5 臨床に関する概括評価
S-217622
S-217622
Placebo
125 mg
250 mg
N = 114
N = 116
N = 111
Max
6
4
5
LS mean (SE) by ANCOVA [a]
-3.98 (0.34)
-3.51 (0.33)
-3.68 (0.34)
Difference in LS means vs. Placebo (SE)
-0.29 (0.42)
0.17 (0.41)
--95% CI for difference
-1.12, 0.53
-0.64, 0.98
--p-value
0.4887
0.6801
--36 hours post-dose n
93
96
97
Mean
-5.4
-4.7
-4.5
SD
4.7
3.9
3.5
Min
-23
-20
-14
Median
-5.0
-5.0
-4.0
Max
6
4
3
LS mean (SE) by ANCOVA [a]
-4.83 (0.36)
-4.50 (0.34)
-4.55 (0.35)
Difference in LS means vs. Placebo (SE)
-0.28 (0.44)
0.04 (0.43)
--95% CI for difference
-1.15, 0.58
-0.81, 0.90
--p-value
0.5214
0.9208
--48 hours post-dose n
106
105
102
Mean
-6.0
-5.7
-4.7
SD
4.8
4.3
3.6
Min
-27
-20
-17
Median
-5.0
-5.0
-4.0
Max
5
6
3
LS mean (SE) by ANCOVA [a]
-5.45 (0.32)
-5.39 (0.31)
-5.07 (0.33)
Difference in LS means vs. Placebo (SE)
-0.38 (0.40)
-0.32 (0.40)
--95% CI for difference
-1.16, 0.40
-1.10, 0.46
--p-value
0.3394
0.4208
--72 hours post-dose n
105
100
104
Mean
-6.7
-6.8
-5.9
SD
4.3
4.2
3.8
Min
-21
-23
-17
Median
-6.0
-6.0
-5.0
Max
3
5
4
LS mean (SE) by ANCOVA [a]
-5.94 (0.28)
-6.16 (0.28)
-5.93 (0.28)
Difference in LS means vs. Placebo (SE)
-0.01 (0.35)
-0.24 (0.35)
--95% CI for difference
-0.70, 0.67
-0.93, 0.45
--p-value
0.9673
0.4987
--96 hours post-dose n
102
99
101
Mean
-7.4
-7.5
-6.5
SD
4.4
4.2
3.9
Min
-25
-21
-17
Median
-7.0
-7.0
-6.0
Max
4
1
2
LS mean (SE) by ANCOVA [a]
-6.76 (0.26)
-7.08 (0.27)
-6.64 (0.27)
Difference in LS means vs. Placebo (SE)
-0.12 (0.32)
-0.44 (0.33)
--95% CI for difference
-0.75, 0.52
-1.08, 0.21
--p-value
0.7222
0.1829
--120 hours post-dose n
93
96
95
Mean
-8.3
-7.9
-7.2
SD
4.7
4.1
3.9
Min
-27
-20
-18
Median
-7.0
-7.0
-7.0
Max
0
0
1
LS mean (SE) by ANCOVA [a]
-7.78 (0.24)
-7.62 (0.24)
-7.43 (0.24)
Difference in LS means vs. Placebo (SE)
-0.35 (0.30)
-0.18 (0.30)
--95% CI for difference
-0.94, 0.24
-0.77, 0.40
--p-value
0.2445
0.5380
--[a] Covariate: Baseline values of each parameter, time from onset to randomization [<72 hours or ≥72 hours], SARS-CoV-2
vaccination history [Yes or No]
Time Point
Statistics
- 104 -