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【資料No.1】2.5_臨床に関する概括資料 (109 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
表 2.5.4.3-29
2.5 臨床に関する概括評価
各時点における味覚異常又は嗅覚異常を有する被験者の割合：Phase 2b Part
(ITT1 集団)
Time Point
12 hours post-dose
Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
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
19.0% (19/100)
S-217622
250 mg
N = 116
13.3% (13/98)
Placebo
N = 111
17.0% (16/94)
0.8405
0.4393
---
1.06 [0.59, 1.92]
0.01 [-0.09, 0.12]
0.77 [0.40, 1.49]
-0.04 [-0.14, 0.06]
-----
22.9% (24/105)
19.1% (21/110)
21.7% (23/106)
0.8343
0.6328
---
1.06 [0.64, 1.75]
0.01 [-0.10, 0.12]
0.88 [0.52, 1.48]
-0.03 [-0.13, 0.08]
-----
21.9% (21/96)
16.3% (16/98)
18.4% (18/98)
0.5650
0.7151
---
1.18 [0.67, 2.06]
0.03 [-0.08, 0.14]
0.89 [0.48, 1.66]
-0.02 [-0.12, 0.09]
-----
20.4% (22/108)
18.7% (20/107)
22.3% (23/103)
0.7243
0.5056
---
0.91 [0.54, 1.53]
-0.02 [-0.13, 0.09]
0.84 [0.49, 1.41]
-0.04 [-0.14, 0.07]
-----
18.5% (20/108)
18.6% (19/102)
23.8% (25/105)
0.3158
0.3317
---
0.77 [0.46, 1.29]
-0.06 [-0.16, 0.05]
0.77 [0.45, 1.31]
-0.06 [-0.17, 0.05]
-----
16.2% (17/105)
15.8% (16/101)
25.5% (26/102)
0.0780
0.0923
---
0.62 [0.36, 1.06]
-0.10 [-0.21, 0.01]
0.63 [0.36, 1.09]
-0.10 [-0.21, 0.01]
-----
17.7% (17/96)
10.2% (10/98)
25.0% (24/96)
0.2249
0.0076
---
0.71 [0.41, 1.23]
-0.07 [-0.19, 0.04]
0.41 [0.21, 0.81]
-0.15 [-0.25, -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 14.2.29.1.1
- 109 -
表 2.5.4.3-29
2.5 臨床に関する概括評価
各時点における味覚異常又は嗅覚異常を有する被験者の割合：Phase 2b Part
(ITT1 集団)
Time Point
12 hours post-dose
Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
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
19.0% (19/100)
S-217622
250 mg
N = 116
13.3% (13/98)
Placebo
N = 111
17.0% (16/94)
0.8405
0.4393
---
1.06 [0.59, 1.92]
0.01 [-0.09, 0.12]
0.77 [0.40, 1.49]
-0.04 [-0.14, 0.06]
-----
22.9% (24/105)
19.1% (21/110)
21.7% (23/106)
0.8343
0.6328
---
1.06 [0.64, 1.75]
0.01 [-0.10, 0.12]
0.88 [0.52, 1.48]
-0.03 [-0.13, 0.08]
-----
21.9% (21/96)
16.3% (16/98)
18.4% (18/98)
0.5650
0.7151
---
1.18 [0.67, 2.06]
0.03 [-0.08, 0.14]
0.89 [0.48, 1.66]
-0.02 [-0.12, 0.09]
-----
20.4% (22/108)
18.7% (20/107)
22.3% (23/103)
0.7243
0.5056
---
0.91 [0.54, 1.53]
-0.02 [-0.13, 0.09]
0.84 [0.49, 1.41]
-0.04 [-0.14, 0.07]
-----
18.5% (20/108)
18.6% (19/102)
23.8% (25/105)
0.3158
0.3317
---
0.77 [0.46, 1.29]
-0.06 [-0.16, 0.05]
0.77 [0.45, 1.31]
-0.06 [-0.17, 0.05]
-----
16.2% (17/105)
15.8% (16/101)
25.5% (26/102)
0.0780
0.0923
---
0.62 [0.36, 1.06]
-0.10 [-0.21, 0.01]
0.63 [0.36, 1.09]
-0.10 [-0.21, 0.01]
-----
17.7% (17/96)
10.2% (10/98)
25.0% (24/96)
0.2249
0.0076
---
0.71 [0.41, 1.23]
-0.07 [-0.19, 0.04]
0.41 [0.21, 0.81]
-0.15 [-0.25, -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 14.2.29.1.1
- 109 -