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【資料No.1】2.5_臨床に関する概括資料 (108 ページ)
出典
| 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
Time Point
Risk diff [95% CI] [a]
24 hours post-dose
Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]
36 hours post-dose
Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]
48 hours post-dose
Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]
72 hours post-dose
Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]
96 hours post-dose
Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]
120 hours post-dose Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]
S-217622
125 mg
N = 114
0.02 [-0.12, 0.16]
S-217622
250 mg
N = 116
0.00 [-0.14, 0.14]
Placebo
N = 111
---
48.0% (47/98)
59.8% (61/102)
57.4% (58/101)
0.1759
0.7336
---
0.83 [0.64, 1.09]
-0.10 [-0.24, 0.04]
1.04 [0.83, 1.31]
0.02 [-0.11, 0.16]
-----
65.9% (60/91)
73.3% (66/90)
70.7% (65/92)
0.4566
0.7176
---
0.93 [0.76, 1.13]
-0.05 [-0.19, 0.08]
1.03 [0.86, 1.24]
0.02 [-0.11, 0.15]
-----
71.6% (73/102)
77.8% (77/99)
79.4% (77/97)
0.2002
0.7750
---
0.90 [0.77, 1.06]
-0.08 [-0.20, 0.04]
0.98 [0.85, 1.13]
-0.02 [-0.13, 0.10]
-----
84.2% (85/101)
83.2% (79/95)
83.8% (83/99)
0.9956
0.8893
---
1.00 [0.89, 1.13]
0.00 [-0.10, 0.10]
0.99 [0.88, 1.12]
-0.01 [-0.11, 0.10]
-----
90.8% (89/98)
88.3% (83/94)
86.6% (84/97)
0.4295
0.7028
---
1.04 [0.94, 1.15]
0.04 [-0.05, 0.12]
1.02 [0.92, 1.13]
0.02 [-0.07, 0.11]
-----
93.3% (84/90)
92.3% (84/91)
95.6% (87/91)
0.4999
0.3461
---
0.98 [0.91, 1.05]
-0.02 [-0.09, 0.04]
0.97 [0.90, 1.04]
-0.03 [-0.10, 0.04]
-----
CI = Confidence Interval
[a] Adjusted by the following strata (time from onset to randomization [<72 hours or ≥72 hours], SARS-CoV-2 vaccination
history [Yes or No])
出典：5.3.5.1-01_T1221 CSR (Phase 2b Part)_Table 14.2.28.1.1
- 108 -
2.5 臨床に関する概括評価
Time Point
Risk diff [95% CI] [a]
24 hours post-dose
Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]
36 hours post-dose
Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]
48 hours post-dose
Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]
72 hours post-dose
Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]
96 hours post-dose
Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]
120 hours post-dose Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]
S-217622
125 mg
N = 114
0.02 [-0.12, 0.16]
S-217622
250 mg
N = 116
0.00 [-0.14, 0.14]
Placebo
N = 111
---
48.0% (47/98)
59.8% (61/102)
57.4% (58/101)
0.1759
0.7336
---
0.83 [0.64, 1.09]
-0.10 [-0.24, 0.04]
1.04 [0.83, 1.31]
0.02 [-0.11, 0.16]
-----
65.9% (60/91)
73.3% (66/90)
70.7% (65/92)
0.4566
0.7176
---
0.93 [0.76, 1.13]
-0.05 [-0.19, 0.08]
1.03 [0.86, 1.24]
0.02 [-0.11, 0.15]
-----
71.6% (73/102)
77.8% (77/99)
79.4% (77/97)
0.2002
0.7750
---
0.90 [0.77, 1.06]
-0.08 [-0.20, 0.04]
0.98 [0.85, 1.13]
-0.02 [-0.13, 0.10]
-----
84.2% (85/101)
83.2% (79/95)
83.8% (83/99)
0.9956
0.8893
---
1.00 [0.89, 1.13]
0.00 [-0.10, 0.10]
0.99 [0.88, 1.12]
-0.01 [-0.11, 0.10]
-----
90.8% (89/98)
88.3% (83/94)
86.6% (84/97)
0.4295
0.7028
---
1.04 [0.94, 1.15]
0.04 [-0.05, 0.12]
1.02 [0.92, 1.13]
0.02 [-0.07, 0.11]
-----
93.3% (84/90)
92.3% (84/91)
95.6% (87/91)
0.4999
0.3461
---
0.98 [0.91, 1.05]
-0.02 [-0.09, 0.04]
0.97 [0.90, 1.04]
-0.03 [-0.10, 0.04]
-----
CI = Confidence Interval
[a] Adjusted by the following strata (time from onset to randomization [<72 hours or ≥72 hours], SARS-CoV-2 vaccination
history [Yes or No])
出典：5.3.5.1-01_T1221 CSR (Phase 2b Part)_Table 14.2.28.1.1
- 108 -