よむ、つかう、まなぶ。
【資料No.1】2.5_臨床に関する概括資料 (83 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_26901.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3回 7／20)、医薬品第二部会(令和4年度第6回 7／20)（合同開催）《厚生労働省》 |
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S-217622
Time Point
Day 6
2.5 臨床に関する概括評価
Response Type Statistics
Observed
Value
Change from
Baseline
Max
p-value [a]
n
Mean (SD)
Min
Median
Max
p-value [a]
n
Mean (SD)
Day 9
Observed
Value
Change from
Baseline
Min
Median
Max
p-value [a]
n
Mean (SD)
Min
Median
Max
p-value [a]
n
Mean (SD)
Min
Median
Max
p-value [a]
S-217622
125 mg
N = 14
-0.96
0.0148
13
Mild/Moderate
S-217622
250 mg
N = 12
-0.37
0.0267
12
Placebo
N = 14
1.72
--13
S-217622
125 mg
N=2
-1.88
--2
Asymptomatic
S-217622
250 mg
N=2
-2.42
--2
Placebo
N=3
-0.83
--3
S-217622
125 mg
N = 16
-0.96
0.0029
15
All
S-217622
250 mg
N = 14
-0.37
0.0039
14
Placebo
N = 17
1.72
--16
3.914 (0.808) 3.685 (0.361) 4.400 (1.170) 3.398 (0.000) 3.398 (0.000) 3.970 (0.991) 3.845 (0.770) 3.644 (0.348) 4.319 (1.121)
3.40
3.40
3.40
3.40
3.40
3.40
3.40
3.40
3.40
3.398
3.452
3.863
3.398
3.398
3.398
3.398
3.398
3.697
6.00
4.26
6.48
3.40
3.40
5.11
6.00
4.26
6.48
0.5774
0.2327
--------0.2443
0.1853
--13
12
13
2
2
3
15
14
16
-3.125
(0.999)
-4.60
-3.441
-1.38
0.0870
12
-3.088
(1.236)
-4.84
-2.952
-0.37
0.0330
11
-1.999
(1.195)
-4.28
-2.125
0.00
--12
-3.042
(1.643)
-4.20
-3.042
-1.88
--2
-3.329
(1.283)
-4.24
-3.329
-2.42
--2
-1.599
(0.736)
-2.30
-1.664
-0.83
--3
-3.114
(1.025)
-4.60
-3.441
-1.38
0.0108
14
-3.122
(1.194)
-4.84
-2.952
-0.37
0.0041
13
-1.924
(1.114)
-4.28
-1.903
0.00
--15
3.525 (0.254) 3.552 (0.349) 3.891 (0.767) 3.581 (0.258) 3.398 (0.000) 3.398 (0.000) 3.533 (0.245) 3.529 (0.323) 3.793 (0.710)
3.40
3.40
3.40
3.40
3.40
3.40
3.40
3.40
3.40
3.398
3.398
3.423
3.581
3.398
3.398
3.398
3.398
3.398
4.11
4.38
5.77
3.76
3.40
3.40
4.11
4.38
5.77
0.2387
0.2871
--------0.3538
0.1478
--12
11
12
2
2
3
14
13
15
-3.633
(0.831)
-4.83
-3.638
-2.38
0.1130
-3.078
(1.250)
-4.56
-2.964
-0.37
0.5271
-2.757
(0.974)
-4.23
-2.918
-1.38
---
-2.860
(1.384)
-3.84
-2.860
-1.88
---
UNIT: log10 (copies/mL)
SD = Standard Deviation; Min = Minimum; Max = Maximum
All : Combination of Mild/Moderate and Asymptomatic
Day 9 was optional visit in Korea. (Participants in Korea were not entered into Phase 2a Part)
Lower limit of detection for viral RNA is 3.3979400087 log10 (copies/mL).
- 83 -
-3.329
(1.283)
-4.24
-3.329
-2.42
---
-2.171
(1.279)
-3.38
-2.301
-0.83
---
-3.522
(0.900)
-4.83
-3.638
-1.88
0.0323
-3.116
(1.203)
-4.56
-2.964
-0.37
0.2574
-2.640
(1.019)
-4.23
-2.891
-0.83
---
Time Point
Day 6
2.5 臨床に関する概括評価
Response Type Statistics
Observed
Value
Change from
Baseline
Max
p-value [a]
n
Mean (SD)
Min
Median
Max
p-value [a]
n
Mean (SD)
Day 9
Observed
Value
Change from
Baseline
Min
Median
Max
p-value [a]
n
Mean (SD)
Min
Median
Max
p-value [a]
n
Mean (SD)
Min
Median
Max
p-value [a]
S-217622
125 mg
N = 14
-0.96
0.0148
13
Mild/Moderate
S-217622
250 mg
N = 12
-0.37
0.0267
12
Placebo
N = 14
1.72
--13
S-217622
125 mg
N=2
-1.88
--2
Asymptomatic
S-217622
250 mg
N=2
-2.42
--2
Placebo
N=3
-0.83
--3
S-217622
125 mg
N = 16
-0.96
0.0029
15
All
S-217622
250 mg
N = 14
-0.37
0.0039
14
Placebo
N = 17
1.72
--16
3.914 (0.808) 3.685 (0.361) 4.400 (1.170) 3.398 (0.000) 3.398 (0.000) 3.970 (0.991) 3.845 (0.770) 3.644 (0.348) 4.319 (1.121)
3.40
3.40
3.40
3.40
3.40
3.40
3.40
3.40
3.40
3.398
3.452
3.863
3.398
3.398
3.398
3.398
3.398
3.697
6.00
4.26
6.48
3.40
3.40
5.11
6.00
4.26
6.48
0.5774
0.2327
--------0.2443
0.1853
--13
12
13
2
2
3
15
14
16
-3.125
(0.999)
-4.60
-3.441
-1.38
0.0870
12
-3.088
(1.236)
-4.84
-2.952
-0.37
0.0330
11
-1.999
(1.195)
-4.28
-2.125
0.00
--12
-3.042
(1.643)
-4.20
-3.042
-1.88
--2
-3.329
(1.283)
-4.24
-3.329
-2.42
--2
-1.599
(0.736)
-2.30
-1.664
-0.83
--3
-3.114
(1.025)
-4.60
-3.441
-1.38
0.0108
14
-3.122
(1.194)
-4.84
-2.952
-0.37
0.0041
13
-1.924
(1.114)
-4.28
-1.903
0.00
--15
3.525 (0.254) 3.552 (0.349) 3.891 (0.767) 3.581 (0.258) 3.398 (0.000) 3.398 (0.000) 3.533 (0.245) 3.529 (0.323) 3.793 (0.710)
3.40
3.40
3.40
3.40
3.40
3.40
3.40
3.40
3.40
3.398
3.398
3.423
3.581
3.398
3.398
3.398
3.398
3.398
4.11
4.38
5.77
3.76
3.40
3.40
4.11
4.38
5.77
0.2387
0.2871
--------0.3538
0.1478
--12
11
12
2
2
3
14
13
15
-3.633
(0.831)
-4.83
-3.638
-2.38
0.1130
-3.078
(1.250)
-4.56
-2.964
-0.37
0.5271
-2.757
(0.974)
-4.23
-2.918
-1.38
---
-2.860
(1.384)
-3.84
-2.860
-1.88
---
UNIT: log10 (copies/mL)
SD = Standard Deviation; Min = Minimum; Max = Maximum
All : Combination of Mild/Moderate and Asymptomatic
Day 9 was optional visit in Korea. (Participants in Korea were not entered into Phase 2a Part)
Lower limit of detection for viral RNA is 3.3979400087 log10 (copies/mL).
- 83 -
-3.329
(1.283)
-4.24
-3.329
-2.42
---
-2.171
(1.279)
-3.38
-2.301
-0.83
---
-3.522
(0.900)
-4.83
-3.638
-1.88
0.0323
-3.116
(1.203)
-4.56
-2.964
-0.37
0.2574
-2.640
(1.019)
-4.23
-2.891
-0.83
---