よむ、つかう、まなぶ。
【資料No.1】2.5_臨床に関する概括資料 (144 ページ)
出典
| 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》 |
ページ画像
ダウンロードした画像を利用する際は「出典情報」を明記してください。
低解像度画像をダウンロード
プレーンテキスト
資料テキストはコンピュータによる自動処理で生成されており、完全に資料と一致しない場合があります。
テキストをコピーしてご利用いただく際は資料と付け合わせてご確認ください。
S-217622
表 2.5.4.2-9
2.5 臨床に関する概括評価
COVID-19 の 14 症状が快復するまでの時間：Phase 3 Part (ITT 集団のうち，
COVID-19 発症から無作為割付までの時間が 72 時間未満の集団)
S-217622
125 mg
N = 347
336
241 (71.7)
95 (28.3)
S-217622
250 mg
N = 340
330
255 (77.3)
75 (22.7)
N = 343
321
224 (69.8)
97 (30.2)
Kaplan-Meier estimator (hours)
Median [95% CI]
Difference in median vs. placebo [95% CI]
25th percentile, 75th percentile
Min, Max [a]
187.8 [156.4, 217.0]
-44.1 [-95.3, 4.5]
105.6, --2.4, 489.1 +
190.3 [171.4, 244.0]
-41.5 [-81.2, 27.3]
117.1, 431.6
9.4, 490.1 +
231.8 [192.1, 265.8]
--129.7, --13.9, 492.4 +
Up to 21 days
Restricted Mean Survival Time (RMST) [95% CI]
Difference in RMST vs. placebo [95% CI]
257.9 [239.0, 276.8]
-20.1 [-46.5, 6.3]
256.0 [238.1, 273.8]
-22.0 [-47.7, 3.7]
278.0 [259.5, 296.4]
---
Stratified log-rank test vs. placebo [b]
- One-sided p-value
- Two-sided p-value
0.0892
0.1784
0.0206
0.0412
-----
Stratified Peto-Prentice's generalized Wilcoxon test
vs. placebo [b]
- Two-sided p-value
0.0304
0.0525
---
n
Number of events
Number of censored
Placebo
Stratified Cox proportional hazard model [b]
- Hazard ratio [95% CI]
1.13 [0.94, 1.36]
1.20 [1.00, 1.44]
--- Two-sided p-value
0.1867
0.0455
--CI = Confidence Interval; Min = Minimum; Max = Maximum
COVID-19 symptoms were 14 symptoms (low energy or tiredness, muscle or body aches, headache, chills or shivering,
feeling hot or feverish, stuffy or runny nose, sore throat, cough, shortness of breath [difficulty breathing], nausea, vomiting,
diarrhea, taste disorder and smell disorder)
[a] +: Max includes censored data.
[b] Adjusted by the following stratum (SARS-CoV-2 vaccination history [Yes or No])
- 144 -
表 2.5.4.2-9
2.5 臨床に関する概括評価
COVID-19 の 14 症状が快復するまでの時間：Phase 3 Part (ITT 集団のうち，
COVID-19 発症から無作為割付までの時間が 72 時間未満の集団)
S-217622
125 mg
N = 347
336
241 (71.7)
95 (28.3)
S-217622
250 mg
N = 340
330
255 (77.3)
75 (22.7)
N = 343
321
224 (69.8)
97 (30.2)
Kaplan-Meier estimator (hours)
Median [95% CI]
Difference in median vs. placebo [95% CI]
25th percentile, 75th percentile
Min, Max [a]
187.8 [156.4, 217.0]
-44.1 [-95.3, 4.5]
105.6, --2.4, 489.1 +
190.3 [171.4, 244.0]
-41.5 [-81.2, 27.3]
117.1, 431.6
9.4, 490.1 +
231.8 [192.1, 265.8]
--129.7, --13.9, 492.4 +
Up to 21 days
Restricted Mean Survival Time (RMST) [95% CI]
Difference in RMST vs. placebo [95% CI]
257.9 [239.0, 276.8]
-20.1 [-46.5, 6.3]
256.0 [238.1, 273.8]
-22.0 [-47.7, 3.7]
278.0 [259.5, 296.4]
---
Stratified log-rank test vs. placebo [b]
- One-sided p-value
- Two-sided p-value
0.0892
0.1784
0.0206
0.0412
-----
Stratified Peto-Prentice's generalized Wilcoxon test
vs. placebo [b]
- Two-sided p-value
0.0304
0.0525
---
n
Number of events
Number of censored
Placebo
Stratified Cox proportional hazard model [b]
- Hazard ratio [95% CI]
1.13 [0.94, 1.36]
1.20 [1.00, 1.44]
--- Two-sided p-value
0.1867
0.0455
--CI = Confidence Interval; Min = Minimum; Max = Maximum
COVID-19 symptoms were 14 symptoms (low energy or tiredness, muscle or body aches, headache, chills or shivering,
feeling hot or feverish, stuffy or runny nose, sore throat, cough, shortness of breath [difficulty breathing], nausea, vomiting,
diarrhea, taste disorder and smell disorder)
[a] +: Max includes censored data.
[b] Adjusted by the following stratum (SARS-CoV-2 vaccination history [Yes or No])
- 144 -