よむ、つかう、まなぶ。
【資料No.1】2.5_臨床に関する概括資料 (88 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 = 14
-2.43 (0.30)
Mild/Moderate
S-217622
Placebo
250 mg
N = 12
N = 14
-2.65 (0.30) -1.52 (0.26)
S-217622
125 mg
N=2
-2.05 (0.51)
Asymptomatic
S-217622
Placebo
250 mg
N=2
N=3
-2.10 (0.54) -1.30 (0.30)
S-217622
125 mg
N = 16
-2.69 (0.26)
All
S-217622
250 mg
N = 14
-2.91 (0.26)
Placebo
N = 17
LS mean (SE) by
-1.71 (0.25)
ANCOVA [a]
Difference in LS means vs. -0.91 (0.37) -1.13 (0.37)
---0.75 (0.57) -0.80 (0.60)
---0.98 (0.31) -1.20 (0.32)
--Placebo (SE)
95% CI for difference
-1.65, -0.16 -1.88, -0.38
---3.20, 1.69
-3.39, 1.79
---1.62, -0.35 -1.84, -0.56
--p-value
0.0191
0.0043
--0.3167
0.3136
--0.0033
0.0005
--Day 6
n
13
12
13
2
2
3
15
14
16
Mean
-3.125
-3.088
-1.999
-3.042
-3.329
-1.599
-3.114
-3.122
-1.924
SD
0.999
1.236
1.195
1.643
1.283
0.736
1.025
1.194
1.114
Min
-4.60
-4.84
-4.28
-4.20
-4.24
-2.30
-4.60
-4.84
-4.28
Median
-3.441
-2.952
-2.125
-3.042
-3.329
-1.664
-3.441
-2.952
-1.903
Max
-1.38
-0.37
0.00
-1.88
-2.42
-0.83
-1.38
-0.37
0.00
LS mean (SE) by
-2.76 (0.26) -2.95 (0.26) -2.16 (0.24) -1.89 (0.00) -1.89 (0.00) -1.89 (0.00) -2.99 (0.23) -3.13 (0.23) -2.29 (0.22)
ANCOVA [a]
Difference in LS means vs. -0.60 (0.32) -0.80 (0.32)
--0.00 (---)
0.00 (---)
---0.69 (0.28) -0.84 (0.28)
--Placebo (SE)
95% CI for difference
-1.26, 0.05
-1.44, -0.15
---------1.26, -0.12 -1.41, -0.26
--p-value
0.0677
0.0177
--------0.0187
0.0053
--Day 9
n
12
11
12
2
2
3
14
13
15
Mean
-3.633
-3.078
-2.757
-2.860
-3.329
-2.171
-3.522
-3.116
-2.640
SD
0.831
1.250
0.974
1.384
1.283
1.279
0.900
1.203
1.019
Min
-4.83
-4.56
-4.23
-3.84
-4.24
-3.38
-4.83
-4.56
-4.23
Median
-3.638
-2.964
-2.918
-2.860
-3.329
-2.301
-3.638
-2.964
-2.891
Max
-2.38
-0.37
-1.38
-1.88
-2.42
-0.83
-1.88
-0.37
-0.83
LS mean (SE) by
-3.24 (0.16) -3.13 (0.16) -2.83 (0.15) -2.66 (0.14) -2.87 (0.15) -2.73 (0.08) -3.27 (0.14) -3.23 (0.15) -2.93 (0.14)
ANCOVA [a]
Difference in LS means vs. -0.41 (0.20) -0.30 (0.20)
--0.07 (0.15) -0.14 (0.16)
---0.34 (0.18) -0.30 (0.18)
--Placebo (SE)
95% CI for difference
-0.83, 0.00
-0.72, 0.11
---0.59, 0.73
-0.84, 0.56
---0.71, 0.03
-0.66, 0.07
--p-value
0.0515
0.1423
--0.7040
0.4851
--0.0693
0.1088
--UNIT: log10 (copies/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 viral RNA is 3.3979400087 log10 (copies/mL). If viral RNA is less than the lower limit of detection, the viral RNA will be imputed 3.3979400087 log 10
(copies/mL).
- 88 -
Time Point
2.5 臨床に関する概括評価
Statistics
S-217622
125 mg
N = 14
-2.43 (0.30)
Mild/Moderate
S-217622
Placebo
250 mg
N = 12
N = 14
-2.65 (0.30) -1.52 (0.26)
S-217622
125 mg
N=2
-2.05 (0.51)
Asymptomatic
S-217622
Placebo
250 mg
N=2
N=3
-2.10 (0.54) -1.30 (0.30)
S-217622
125 mg
N = 16
-2.69 (0.26)
All
S-217622
250 mg
N = 14
-2.91 (0.26)
Placebo
N = 17
LS mean (SE) by
-1.71 (0.25)
ANCOVA [a]
Difference in LS means vs. -0.91 (0.37) -1.13 (0.37)
---0.75 (0.57) -0.80 (0.60)
---0.98 (0.31) -1.20 (0.32)
--Placebo (SE)
95% CI for difference
-1.65, -0.16 -1.88, -0.38
---3.20, 1.69
-3.39, 1.79
---1.62, -0.35 -1.84, -0.56
--p-value
0.0191
0.0043
--0.3167
0.3136
--0.0033
0.0005
--Day 6
n
13
12
13
2
2
3
15
14
16
Mean
-3.125
-3.088
-1.999
-3.042
-3.329
-1.599
-3.114
-3.122
-1.924
SD
0.999
1.236
1.195
1.643
1.283
0.736
1.025
1.194
1.114
Min
-4.60
-4.84
-4.28
-4.20
-4.24
-2.30
-4.60
-4.84
-4.28
Median
-3.441
-2.952
-2.125
-3.042
-3.329
-1.664
-3.441
-2.952
-1.903
Max
-1.38
-0.37
0.00
-1.88
-2.42
-0.83
-1.38
-0.37
0.00
LS mean (SE) by
-2.76 (0.26) -2.95 (0.26) -2.16 (0.24) -1.89 (0.00) -1.89 (0.00) -1.89 (0.00) -2.99 (0.23) -3.13 (0.23) -2.29 (0.22)
ANCOVA [a]
Difference in LS means vs. -0.60 (0.32) -0.80 (0.32)
--0.00 (---)
0.00 (---)
---0.69 (0.28) -0.84 (0.28)
--Placebo (SE)
95% CI for difference
-1.26, 0.05
-1.44, -0.15
---------1.26, -0.12 -1.41, -0.26
--p-value
0.0677
0.0177
--------0.0187
0.0053
--Day 9
n
12
11
12
2
2
3
14
13
15
Mean
-3.633
-3.078
-2.757
-2.860
-3.329
-2.171
-3.522
-3.116
-2.640
SD
0.831
1.250
0.974
1.384
1.283
1.279
0.900
1.203
1.019
Min
-4.83
-4.56
-4.23
-3.84
-4.24
-3.38
-4.83
-4.56
-4.23
Median
-3.638
-2.964
-2.918
-2.860
-3.329
-2.301
-3.638
-2.964
-2.891
Max
-2.38
-0.37
-1.38
-1.88
-2.42
-0.83
-1.88
-0.37
-0.83
LS mean (SE) by
-3.24 (0.16) -3.13 (0.16) -2.83 (0.15) -2.66 (0.14) -2.87 (0.15) -2.73 (0.08) -3.27 (0.14) -3.23 (0.15) -2.93 (0.14)
ANCOVA [a]
Difference in LS means vs. -0.41 (0.20) -0.30 (0.20)
--0.07 (0.15) -0.14 (0.16)
---0.34 (0.18) -0.30 (0.18)
--Placebo (SE)
95% CI for difference
-0.83, 0.00
-0.72, 0.11
---0.59, 0.73
-0.84, 0.56
---0.71, 0.03
-0.66, 0.07
--p-value
0.0515
0.1423
--0.7040
0.4851
--0.0693
0.1088
--UNIT: log10 (copies/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 viral RNA is 3.3979400087 log10 (copies/mL). If viral RNA is less than the lower limit of detection, the viral RNA will be imputed 3.3979400087 log 10
(copies/mL).
- 88 -