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【資料No.1】2.5_臨床に関する概括資料 (138 ページ)
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| 公開元URL | https://www.mhlw.go.jp/stf/newpage_29325.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
S-217622
125 mg
N = 603
2.4, 493.3 +
S-217622
250 mg
N = 595
9.4, 493.1 +
N = 600
0.0, 492.4 +
254.4 [240.1, 268.6]
-5.6 [-25.9, 14.6]
245.1 [231.0, 259.2]
-14.9 [-35.0, 5.2]
260.0 [245.6, 274.4]
---
Stratified log-rank test vs. placebo [b]
- One-sided p-value
- Two-sided p-value
0.3184
0.6368
0.0676
0.1351
-----
Key secondary analysis for the primary endpoint
Stratified Peto-Prentice's generalized Wilcoxon test
vs. placebo [b]
- One-sided p-value
- Two-sided p-value
0.2176
0.4352
0.0636
0.1273
-----
Min, Max [a]
Up to 21 days
Restricted Mean Survival Time (RMST) [95% CI]
Difference in RMST vs. placebo [95% CI]
Placebo
Stratified Cox proportional hazard model [b]
- Hazard ratio [95% CI]
1.03 [0.90, 1.18]
1.11 [0.97, 1.27]
--- Two-sided p-value
0.6467
0.1324
--CI = Confidence Interval; Min = Minimum; Max = Maximum
5 symptoms (stuffy or runny nose, sore throat, cough, feeling hot or feverish, and low energy or tiredness)
[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])
図 2.5.4.2-5
COVID-19 の 5 症状が快復するまでの時間の Kaplan-Meier 曲線：Phase 3 Part
(ITT 集団)
- 138 -
2.5 臨床に関する概括評価
S-217622
125 mg
N = 603
2.4, 493.3 +
S-217622
250 mg
N = 595
9.4, 493.1 +
N = 600
0.0, 492.4 +
254.4 [240.1, 268.6]
-5.6 [-25.9, 14.6]
245.1 [231.0, 259.2]
-14.9 [-35.0, 5.2]
260.0 [245.6, 274.4]
---
Stratified log-rank test vs. placebo [b]
- One-sided p-value
- Two-sided p-value
0.3184
0.6368
0.0676
0.1351
-----
Key secondary analysis for the primary endpoint
Stratified Peto-Prentice's generalized Wilcoxon test
vs. placebo [b]
- One-sided p-value
- Two-sided p-value
0.2176
0.4352
0.0636
0.1273
-----
Min, Max [a]
Up to 21 days
Restricted Mean Survival Time (RMST) [95% CI]
Difference in RMST vs. placebo [95% CI]
Placebo
Stratified Cox proportional hazard model [b]
- Hazard ratio [95% CI]
1.03 [0.90, 1.18]
1.11 [0.97, 1.27]
--- Two-sided p-value
0.6467
0.1324
--CI = Confidence Interval; Min = Minimum; Max = Maximum
5 symptoms (stuffy or runny nose, sore throat, cough, feeling hot or feverish, and low energy or tiredness)
[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])
図 2.5.4.2-5
COVID-19 の 5 症状が快復するまでの時間の Kaplan-Meier 曲線：Phase 3 Part
(ITT 集団)
- 138 -