よむ、つかう、まなぶ。
【資料No.1】2.5_臨床に関する概括資料 (80 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》 |
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S-217622
Time Point
2.5 臨床に関する概括評価
Statistics
S-217622
125 mg
N = 13
-3.00
0.0
-2.28 (0.21)
Mild/Moderate
S-217622
Placebo
250 mg
N = 12
N = 12
-2.90
-1.70
-0.7
0.0
-2.45 (0.22) -1.61 (0.20)
S-217622
125 mg
N=2
-2.35
-1.0
-2.37 (0.00)
Asymptomatic
S-217622
Placebo
250 mg
N=2
N=2
-2.70
-1.05
-2.0
-0.7
-2.37 (0.00) -1.37 (0.00)
S-217622
125 mg
N = 15
-3.00
0.0
-2.47 (0.20)
All
S-217622
250 mg
N = 14
-2.90
-0.7
-2.63 (0.20)
Placebo
N = 14
Median
-1.55
Max
0.0
LS mean (SE) by
-1.65 (0.20)
ANCOVA [a]
Difference in LS means vs. -0.66 (0.27) -0.83 (0.28)
---1.00 (0.00) -1.00 (0.00)
---0.82 (0.24) -0.98 (0.25)
--Placebo (SE)
95% CI for difference
-1.21, -0.11 -1.40, -0.27
---------1.31, -0.33 -1.48, -0.47
--p-value
0.0198
0.0052
--<.0001
<.0001
--0.0018
0.0004
--Day 6
n
13
12
11
2
2
2
15
14
13
Mean
-2.59
-2.78
-2.12
-2.35
-2.70
-1.85
-2.56
-2.76
-2.08
SD
1.35
1.26
0.99
1.91
0.99
0.21
1.35
1.19
0.91
Min
-4.4
-4.7
-3.7
-3.7
-3.4
-2.0
-4.4
-4.7
-3.7
Median
-3.00
-2.85
-2.00
-2.35
-2.70
-1.85
-3.00
-2.85
-2.00
Max
0.0
-0.7
0.0
-1.0
-2.0
-1.7
0.0
-0.7
0.0
LS mean (SE) by
-2.50 (0.11) -2.40 (0.12) -2.28 (0.11) -2.17 (0.00) -2.17 (0.00) -2.17 (0.00) -2.60 (0.11) -2.52 (0.11) -2.34 (0.11)
ANCOVA [a]
Difference in LS means vs. -0.22 (0.15) -0.12 (0.15)
--0.00 (---)
0.00 (---)
---0.26 (0.13) -0.17 (0.14)
--Placebo (SE)
95% CI for difference
-0.52, 0.08
-0.43, 0.19
---------0.52, 0.01
-0.45, 0.10
--p-value
0.1477
0.4268
--------0.0620
0.2093
--Day 9
n
12
11
11
2
2
2
14
13
13
Mean
-2.75
-2.79
-2.24
-2.35
-2.70
-2.05
-2.69
-2.78
-2.21
SD
1.25
1.25
1.20
1.91
0.99
0.49
1.27
1.18
1.11
Min
-4.4
-4.7
-3.7
-3.7
-3.4
-2.4
-4.4
-4.7
-3.7
Median
-3.00
-2.40
-2.00
-2.35
-2.70
-2.05
-3.00
-2.40
-2.00
Max
-0.7
-0.7
0.0
-1.0
-2.0
-1.7
-0.7
-0.7
0.0
LS mean (SE) by
-2.59 (0.07) -2.65 (0.07) -2.54 (0.07) -2.37 (0.00) -2.37 (0.00) -2.37 (0.00) -2.59 (0.06) -2.63 (0.06) -2.54 (0.06)
ANCOVA [a]
Difference in LS means vs. -0.05 (0.09) -0.11 (0.09)
--0.00 (---)
0.00 (---)
---0.05 (0.07) -0.09 (0.07)
--Placebo (SE)
95% CI for difference
-0.23, 0.13
-0.29, 0.07
---------0.19, 0.10
-0.25, 0.06
--p-value
0.5668
0.2359
--------0.5324
0.2137
--UNIT: log10 (TCID50/mL)
ANCOVA = Analysis of Covariance, SD = Standard Deviation; SE = Standard Error; Min = Minimum; Max = Maximum, LS = Least Squares, CI = Confidence Interval
All: Combination of Mild/Moderate and Asymptomatic
Lower limit of detection for virus titer is 0.8 log10 (TCID50/mL). If virus titer is less than the lower limit of detection, the virus titer was imputed 0.8 log10 (TCID50/mL).
- 80 -
Time Point
2.5 臨床に関する概括評価
Statistics
S-217622
125 mg
N = 13
-3.00
0.0
-2.28 (0.21)
Mild/Moderate
S-217622
Placebo
250 mg
N = 12
N = 12
-2.90
-1.70
-0.7
0.0
-2.45 (0.22) -1.61 (0.20)
S-217622
125 mg
N=2
-2.35
-1.0
-2.37 (0.00)
Asymptomatic
S-217622
Placebo
250 mg
N=2
N=2
-2.70
-1.05
-2.0
-0.7
-2.37 (0.00) -1.37 (0.00)
S-217622
125 mg
N = 15
-3.00
0.0
-2.47 (0.20)
All
S-217622
250 mg
N = 14
-2.90
-0.7
-2.63 (0.20)
Placebo
N = 14
Median
-1.55
Max
0.0
LS mean (SE) by
-1.65 (0.20)
ANCOVA [a]
Difference in LS means vs. -0.66 (0.27) -0.83 (0.28)
---1.00 (0.00) -1.00 (0.00)
---0.82 (0.24) -0.98 (0.25)
--Placebo (SE)
95% CI for difference
-1.21, -0.11 -1.40, -0.27
---------1.31, -0.33 -1.48, -0.47
--p-value
0.0198
0.0052
--<.0001
<.0001
--0.0018
0.0004
--Day 6
n
13
12
11
2
2
2
15
14
13
Mean
-2.59
-2.78
-2.12
-2.35
-2.70
-1.85
-2.56
-2.76
-2.08
SD
1.35
1.26
0.99
1.91
0.99
0.21
1.35
1.19
0.91
Min
-4.4
-4.7
-3.7
-3.7
-3.4
-2.0
-4.4
-4.7
-3.7
Median
-3.00
-2.85
-2.00
-2.35
-2.70
-1.85
-3.00
-2.85
-2.00
Max
0.0
-0.7
0.0
-1.0
-2.0
-1.7
0.0
-0.7
0.0
LS mean (SE) by
-2.50 (0.11) -2.40 (0.12) -2.28 (0.11) -2.17 (0.00) -2.17 (0.00) -2.17 (0.00) -2.60 (0.11) -2.52 (0.11) -2.34 (0.11)
ANCOVA [a]
Difference in LS means vs. -0.22 (0.15) -0.12 (0.15)
--0.00 (---)
0.00 (---)
---0.26 (0.13) -0.17 (0.14)
--Placebo (SE)
95% CI for difference
-0.52, 0.08
-0.43, 0.19
---------0.52, 0.01
-0.45, 0.10
--p-value
0.1477
0.4268
--------0.0620
0.2093
--Day 9
n
12
11
11
2
2
2
14
13
13
Mean
-2.75
-2.79
-2.24
-2.35
-2.70
-2.05
-2.69
-2.78
-2.21
SD
1.25
1.25
1.20
1.91
0.99
0.49
1.27
1.18
1.11
Min
-4.4
-4.7
-3.7
-3.7
-3.4
-2.4
-4.4
-4.7
-3.7
Median
-3.00
-2.40
-2.00
-2.35
-2.70
-2.05
-3.00
-2.40
-2.00
Max
-0.7
-0.7
0.0
-1.0
-2.0
-1.7
-0.7
-0.7
0.0
LS mean (SE) by
-2.59 (0.07) -2.65 (0.07) -2.54 (0.07) -2.37 (0.00) -2.37 (0.00) -2.37 (0.00) -2.59 (0.06) -2.63 (0.06) -2.54 (0.06)
ANCOVA [a]
Difference in LS means vs. -0.05 (0.09) -0.11 (0.09)
--0.00 (---)
0.00 (---)
---0.05 (0.07) -0.09 (0.07)
--Placebo (SE)
95% CI for difference
-0.23, 0.13
-0.29, 0.07
---------0.19, 0.10
-0.25, 0.06
--p-value
0.5668
0.2359
--------0.5324
0.2137
--UNIT: log10 (TCID50/mL)
ANCOVA = Analysis of Covariance, SD = Standard Deviation; SE = Standard Error; Min = Minimum; Max = Maximum, LS = Least Squares, CI = Confidence Interval
All: Combination of Mild/Moderate and Asymptomatic
Lower limit of detection for virus titer is 0.8 log10 (TCID50/mL). If virus titer is less than the lower limit of detection, the virus titer was imputed 0.8 log10 (TCID50/mL).
- 80 -