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【資料No.1】2.5_臨床に関する概括資料 (148 ページ)
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| 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
ANCOVA = Analysis of Covariance; SD = Standard Deviation; SE = Standard Error; Min = Minimum; Max = Maximum;
LS = Least Squares; CI = Confidence Interval
Day 3 and Day 5 were optional visit in all countries. Day 9 was optional visit in countries other than Japan.
Lower limit of quantification of viral RNA is 2.08 log10 copies/mL.
If viral RNA is negative and less than the lower limit of quantification, the viral RNA was imputed 2.27 and 2.08 log 10
copies/mL, respectively.
[a] Covariate: SARS-CoV-2 viral RNA at baseline, SARS-CoV-2 vaccination history [Yes or No]
[b] van Elteren test vs. placebo adjusted by the following stratum (SARS-CoV-2 vaccination history [Yes or No])
表 2.5.4.2-12
各時点における SARS-CoV-2 のウイルス RNA 量のベースラインからの変化
量：Phase 3 Part (ITT 集団)
Time Point
Response Type
Baseline
Observed Value
Day 2
Change from Baseline
Day 4
Change from Baseline
Day 6
Change from Baseline
Day 9
Change from Baseline
Statistics
Mild/Moderate
S-217622
S-217622
Placebo
125 mg
250 mg
N = 603
N = 595
N = 600
n
600
589
597
Mean (SD)
6.825 (1.048) 6.727 (1.079) 6.770 (1.074)
Min
2.21
2.08
2.08
Median
7.105
7.020
7.030
Max
8.63
8.35
8.82
n
598
588
589
Mean (SD)
-0.772 (0.859) -0.722 (0.877) -0.304 (0.971)
Min
-5.31
-4.20
-5.21
Median
-0.755
-0.725
-0.340
Max
3.39
2.22
4.40
LS mean (SE) by ANCOVA [a]
-0.64 (0.05) -0.61 (0.05) -0.19 (0.05)
Difference in LS mean vs Placebo (SE)
-0.45 (0.05) -0.43 (0.05)
--95% CI for difference
-0.55, -0.36 -0.53, -0.33
--Two-sided p-value
<.0001
<.0001
--Two-sided p-value by van Elteren test [b]
<.0001
<.0001
--n
592
579
589
Mean (SD)
-2.646 (1.097) -2.594 (1.010) -1.419 (1.423)
Min
-5.71
-5.27
-5.39
Median
-2.695
-2.710
-1.620
Max
4.34
1.01
5.10
LS mean (SE) by ANCOVA [a]
-2.46 (0.06) -2.46 (0.06) -1.26 (0.06)
Difference in LS mean vs Placebo (SE)
-1.20 (0.06) -1.20 (0.06)
--95% CI for difference
-1.32, -1.08 -1.32, -1.08
--Two-sided p-value
<.0001
<.0001
--Two-sided p-value by van Elteren test [b]
<.0001
<.0001
--n
588
577
579
Mean (SD)
-3.594 (1.166) -3.577 (1.057) -2.572 (1.438)
Min
-5.96
-5.66
-5.73
Median
-3.750
-3.710
-2.770
Max
2.79
0.19
4.65
LS mean (SE) by ANCOVA [a]
-3.43 (0.06) -3.47 (0.06) -2.44 (0.06)
Difference in LS mean vs Placebo (SE)
-0.99 (0.06) -1.04 (0.06)
--95% CI for difference
-1.10, -0.88 -1.15, -0.93
--Two-sided p-value
<.0001
<.0001
--Two-sided p-value by van Elteren test [b]
<.0001
<.0001
--n
555
516
541
Mean (SD)
-4.086 (1.168) -4.011 (1.121) -3.642 (1.263)
Min
-6.36
-6.16
-6.55
Median
-4.320
-4.180
-3.780
Max
2.10
0.55
2.82
LS mean (SE) by ANCOVA [a]
-3.91 (0.05) -3.93 (0.05) -3.52 (0.05)
Difference in LS mean vs Placebo (SE)
-0.39 (0.05) -0.41 (0.05)
--95% CI for difference
-0.49, -0.30 -0.51, -0.32
---
- 148 -
2.5 臨床に関する概括評価
ANCOVA = Analysis of Covariance; SD = Standard Deviation; SE = Standard Error; Min = Minimum; Max = Maximum;
LS = Least Squares; CI = Confidence Interval
Day 3 and Day 5 were optional visit in all countries. Day 9 was optional visit in countries other than Japan.
Lower limit of quantification of viral RNA is 2.08 log10 copies/mL.
If viral RNA is negative and less than the lower limit of quantification, the viral RNA was imputed 2.27 and 2.08 log 10
copies/mL, respectively.
[a] Covariate: SARS-CoV-2 viral RNA at baseline, SARS-CoV-2 vaccination history [Yes or No]
[b] van Elteren test vs. placebo adjusted by the following stratum (SARS-CoV-2 vaccination history [Yes or No])
表 2.5.4.2-12
各時点における SARS-CoV-2 のウイルス RNA 量のベースラインからの変化
量：Phase 3 Part (ITT 集団)
Time Point
Response Type
Baseline
Observed Value
Day 2
Change from Baseline
Day 4
Change from Baseline
Day 6
Change from Baseline
Day 9
Change from Baseline
Statistics
Mild/Moderate
S-217622
S-217622
Placebo
125 mg
250 mg
N = 603
N = 595
N = 600
n
600
589
597
Mean (SD)
6.825 (1.048) 6.727 (1.079) 6.770 (1.074)
Min
2.21
2.08
2.08
Median
7.105
7.020
7.030
Max
8.63
8.35
8.82
n
598
588
589
Mean (SD)
-0.772 (0.859) -0.722 (0.877) -0.304 (0.971)
Min
-5.31
-4.20
-5.21
Median
-0.755
-0.725
-0.340
Max
3.39
2.22
4.40
LS mean (SE) by ANCOVA [a]
-0.64 (0.05) -0.61 (0.05) -0.19 (0.05)
Difference in LS mean vs Placebo (SE)
-0.45 (0.05) -0.43 (0.05)
--95% CI for difference
-0.55, -0.36 -0.53, -0.33
--Two-sided p-value
<.0001
<.0001
--Two-sided p-value by van Elteren test [b]
<.0001
<.0001
--n
592
579
589
Mean (SD)
-2.646 (1.097) -2.594 (1.010) -1.419 (1.423)
Min
-5.71
-5.27
-5.39
Median
-2.695
-2.710
-1.620
Max
4.34
1.01
5.10
LS mean (SE) by ANCOVA [a]
-2.46 (0.06) -2.46 (0.06) -1.26 (0.06)
Difference in LS mean vs Placebo (SE)
-1.20 (0.06) -1.20 (0.06)
--95% CI for difference
-1.32, -1.08 -1.32, -1.08
--Two-sided p-value
<.0001
<.0001
--Two-sided p-value by van Elteren test [b]
<.0001
<.0001
--n
588
577
579
Mean (SD)
-3.594 (1.166) -3.577 (1.057) -2.572 (1.438)
Min
-5.96
-5.66
-5.73
Median
-3.750
-3.710
-2.770
Max
2.79
0.19
4.65
LS mean (SE) by ANCOVA [a]
-3.43 (0.06) -3.47 (0.06) -2.44 (0.06)
Difference in LS mean vs Placebo (SE)
-0.99 (0.06) -1.04 (0.06)
--95% CI for difference
-1.10, -0.88 -1.15, -0.93
--Two-sided p-value
<.0001
<.0001
--Two-sided p-value by van Elteren test [b]
<.0001
<.0001
--n
555
516
541
Mean (SD)
-4.086 (1.168) -4.011 (1.121) -3.642 (1.263)
Min
-6.36
-6.16
-6.55
Median
-4.320
-4.180
-3.780
Max
2.10
0.55
2.82
LS mean (SE) by ANCOVA [a]
-3.91 (0.05) -3.93 (0.05) -3.52 (0.05)
Difference in LS mean vs Placebo (SE)
-0.39 (0.05) -0.41 (0.05)
--95% CI for difference
-0.49, -0.30 -0.51, -0.32
---
- 148 -