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【資料No.1】2.5_臨床に関する概括資料 (92 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 2.5.4.3-19
2.5 臨床に関する概括評価
SARS-CoV-2 のウイルス力価陰性が最初に確認されるまでの時間：Phase 2b
Part (ITT1 集団)
S-217622
125 mg
N = 114
111
111 (100.0)
0 (0.0)
S-217622
250 mg
N = 116
113
112 (99.1)
1 (0.9)
N = 111
108
108 (100.0)
0 (0.0)
Kaplan-Meier estimator (hours)
Median [95% CI]
Difference in median vs. placebo [95% CI]
25th percentile, 75th percentile
Min, Max [a]
51.3 [44.1, 61.8]
-40.6 [-58.5, -26.5]
41.5, 69.8
14.8, 144.4
62.1 [43.7, 66.5]
-29.8 [-52.0, -23.6]
36.5, 70.9
12.7, 138.0
91.9 [84.0, 109.9]
--62.0, 117.9
12.0, 307.8
Up to 21 days
Restricted Mean Survival Time (RMST) [95% CI]
Difference in RMST vs. placebo [95% CI]
55.8 [51.1, 60.5]
-41.2 [-52.9, -29.6]
56.5 [51.2, 61.8]
-40.6 [-52.5, -28.7]
97.0 [86.4, 107.7]
---
Stratified log-rank test vs. placebo [b]
- p-value
<.0001
<.0001
---
Stratified Peto-Prentice's generalized Wilcoxon test
vs. placebo [b]
- p-value
<.0001
<.0001
---
N
Number of events
Number of censored
Placebo
Stratified Cox proportional hazard model [b]
- Hazard ratio [95% CI]
3.4 [2.5, 4.6]
3.2 [2.4, 4.4]
--- p-value
<.0001
<.0001
--CI = Confidence Interval; Min = Minimum; Max = Maximum
[a] +: Max includes censored data.
[b] 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 14.2.5.1.1.1
- 92 -
表 2.5.4.3-19
2.5 臨床に関する概括評価
SARS-CoV-2 のウイルス力価陰性が最初に確認されるまでの時間：Phase 2b
Part (ITT1 集団)
S-217622
125 mg
N = 114
111
111 (100.0)
0 (0.0)
S-217622
250 mg
N = 116
113
112 (99.1)
1 (0.9)
N = 111
108
108 (100.0)
0 (0.0)
Kaplan-Meier estimator (hours)
Median [95% CI]
Difference in median vs. placebo [95% CI]
25th percentile, 75th percentile
Min, Max [a]
51.3 [44.1, 61.8]
-40.6 [-58.5, -26.5]
41.5, 69.8
14.8, 144.4
62.1 [43.7, 66.5]
-29.8 [-52.0, -23.6]
36.5, 70.9
12.7, 138.0
91.9 [84.0, 109.9]
--62.0, 117.9
12.0, 307.8
Up to 21 days
Restricted Mean Survival Time (RMST) [95% CI]
Difference in RMST vs. placebo [95% CI]
55.8 [51.1, 60.5]
-41.2 [-52.9, -29.6]
56.5 [51.2, 61.8]
-40.6 [-52.5, -28.7]
97.0 [86.4, 107.7]
---
Stratified log-rank test vs. placebo [b]
- p-value
<.0001
<.0001
---
Stratified Peto-Prentice's generalized Wilcoxon test
vs. placebo [b]
- p-value
<.0001
<.0001
---
N
Number of events
Number of censored
Placebo
Stratified Cox proportional hazard model [b]
- Hazard ratio [95% CI]
3.4 [2.5, 4.6]
3.2 [2.4, 4.4]
--- p-value
<.0001
<.0001
--CI = Confidence Interval; Min = Minimum; Max = Maximum
[a] +: Max includes censored data.
[b] 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 14.2.5.1.1.1
- 92 -