よむ、つかう、まなぶ。
【資料No.1】2.5_臨床に関する概括資料 (61 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
Weight (kg)
BMI
Race
Drinking habits
Smoking habits
Condition of subject
Time from onset to
randomization (Category
1)
Time from onset to
randomization (Category
2)
Vaccination of SARSCoV-2
2.5 臨床に関する概括評価
S-217622
125 mg
N = 114
n (%)
166.14 (8.96)
147.6
167.10
185.4
114
63.50 (15.77)
35.0
60.50
115.0
114
22.80 (4.25)
14.2
21.80
37.3
114 (100.0)
0
S-217622
250 mg
N = 116
n (%)
166.51 (8.41)
147.0
166.85
189.5
116
63.57 (12.67)
42.0
62.00
108.0
116
22.85 (3.79)
16.0
22.75
37.0
115 (99.1)
0
N = 111
n (%)
167.82 (8.77)
144.5
169.00
188.1
111
67.95 (14.49)
40.6
66.50
115.6
111
23.97 (4.05)
17.5
23.10
38.4
110 (99.1)
0
0
0
0
0
0
0
0
0
54 (47.4)
60 (52.6)
27 (23.7)
87 (76.3)
29 (25.4)
49 (43.0)
2 (1.8)
34 (29.8)
0
1 (0.9)
49 (42.2)
67 (57.8)
20 (17.2)
96 (82.8)
44 (37.9)
40 (34.5)
1 (0.9)
31 (26.7)
0
1 (0.9)
62 (55.9)
49 (44.1)
30 (27.0)
81 (73.0)
33 (29.7)
48 (43.2)
0
30 (27.0)
0
55 (48.2)
0
53 (45.7)
0
54 (48.6)
≥ 72 hours
< 24 hours
59 (51.8)
11 (9.6)
63 (54.3)
2 (1.7)
57 (51.4)
5 (4.5)
Between ≥ 24 and < 48 hours
Between ≥ 48 and < 72 hours
Between ≥ 72 and < 96 hours
Between ≥ 96 and ≤ 120 hours
> 120 hours
Yes
21 (18.4)
23 (20.2)
37 (32.5)
22 (19.3)
0
97 (85.1)
21 (18.1)
30 (25.9)
38 (32.8)
23 (19.8)
2 (1.7)
97 (83.6)
24 (21.6)
25 (22.5)
33 (29.7)
24 (21.6)
0
97 (87.4)
17 (14.9)
2 (1.8)
112 (98.2)
53 (46.5)
61 (53.5)
87 (76.3)
27 (23.7)
82 (71.9)
32 (28.1)
0
19 (16.4)
8 (6.9)
108 (93.1)
49 (42.2)
67 (57.8)
86 (74.1)
30 (25.9)
86 (74.1)
30 (25.9)
0
14 (12.6)
7 (6.3)
104 (93.7)
60 (54.1)
51 (45.9)
82 (73.9)
29 (26.1)
80 (72.1)
31 (27.9)
0
Mean (SD)
Min
Median
Max
N
Mean (SD)
Min
Median
Max
N
Mean (SD)
Min
Median
Max
Asian
American Indian or Alaska
Native
Black or African American
Native Hawaiian or Other
Pacific Islander
White
Other
Yes
No
Yes
No
Hospitalization
Outpatient
Recuperation at home
Recuperation at accommodation
(hotel)
Other
< 72 hours
No
Yes
No
Current medical conditions Yes
No
Prior drugs
Yes
No
Concomitant drugs
Yes
No
Prior therapies
Yes
Past medical conditions
- 61 -
Placebo
Weight (kg)
BMI
Race
Drinking habits
Smoking habits
Condition of subject
Time from onset to
randomization (Category
1)
Time from onset to
randomization (Category
2)
Vaccination of SARSCoV-2
2.5 臨床に関する概括評価
S-217622
125 mg
N = 114
n (%)
166.14 (8.96)
147.6
167.10
185.4
114
63.50 (15.77)
35.0
60.50
115.0
114
22.80 (4.25)
14.2
21.80
37.3
114 (100.0)
0
S-217622
250 mg
N = 116
n (%)
166.51 (8.41)
147.0
166.85
189.5
116
63.57 (12.67)
42.0
62.00
108.0
116
22.85 (3.79)
16.0
22.75
37.0
115 (99.1)
0
N = 111
n (%)
167.82 (8.77)
144.5
169.00
188.1
111
67.95 (14.49)
40.6
66.50
115.6
111
23.97 (4.05)
17.5
23.10
38.4
110 (99.1)
0
0
0
0
0
0
0
0
0
54 (47.4)
60 (52.6)
27 (23.7)
87 (76.3)
29 (25.4)
49 (43.0)
2 (1.8)
34 (29.8)
0
1 (0.9)
49 (42.2)
67 (57.8)
20 (17.2)
96 (82.8)
44 (37.9)
40 (34.5)
1 (0.9)
31 (26.7)
0
1 (0.9)
62 (55.9)
49 (44.1)
30 (27.0)
81 (73.0)
33 (29.7)
48 (43.2)
0
30 (27.0)
0
55 (48.2)
0
53 (45.7)
0
54 (48.6)
≥ 72 hours
< 24 hours
59 (51.8)
11 (9.6)
63 (54.3)
2 (1.7)
57 (51.4)
5 (4.5)
Between ≥ 24 and < 48 hours
Between ≥ 48 and < 72 hours
Between ≥ 72 and < 96 hours
Between ≥ 96 and ≤ 120 hours
> 120 hours
Yes
21 (18.4)
23 (20.2)
37 (32.5)
22 (19.3)
0
97 (85.1)
21 (18.1)
30 (25.9)
38 (32.8)
23 (19.8)
2 (1.7)
97 (83.6)
24 (21.6)
25 (22.5)
33 (29.7)
24 (21.6)
0
97 (87.4)
17 (14.9)
2 (1.8)
112 (98.2)
53 (46.5)
61 (53.5)
87 (76.3)
27 (23.7)
82 (71.9)
32 (28.1)
0
19 (16.4)
8 (6.9)
108 (93.1)
49 (42.2)
67 (57.8)
86 (74.1)
30 (25.9)
86 (74.1)
30 (25.9)
0
14 (12.6)
7 (6.3)
104 (93.7)
60 (54.1)
51 (45.9)
82 (73.9)
29 (26.1)
80 (72.1)
31 (27.9)
0
Mean (SD)
Min
Median
Max
N
Mean (SD)
Min
Median
Max
N
Mean (SD)
Min
Median
Max
Asian
American Indian or Alaska
Native
Black or African American
Native Hawaiian or Other
Pacific Islander
White
Other
Yes
No
Yes
No
Hospitalization
Outpatient
Recuperation at home
Recuperation at accommodation
(hotel)
Other
< 72 hours
No
Yes
No
Current medical conditions Yes
No
Prior drugs
Yes
No
Concomitant drugs
Yes
No
Prior therapies
Yes
Past medical conditions
- 61 -
Placebo