よむ、つかう、まなぶ。
【資料No.1】2.5_臨床に関する概括資料 (64 ページ)
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S-217622
表 2.5.4.3-3
2.5 臨床に関する概括評価
被験者の人口統計学的特性：Phase 2a Part (軽症/中等症の SARS-CoV-2 感染
者，ITT 集団)
S-217622
Sex
Male
Female
Age (Years) (informed consent N
obtained)
Mean (SD)
Min
Median
Max
Height (cm)
N
Mean (SD)
Min
Median
Max
Weight (kg)
N
Mean (SD)
Min
Median
Max
BMI
N
Mean (SD)
Min
Median
Max
Race
Asian
American Indian or Alaska
Native
Black or African American
Native Hawaiian or Other
Pacific Islander
White
Other
Drinking habits
Yes
No
Smoking habits
Yes
No
Condition of subject
Hospitalization
Outpatient
Recuperation at home
Recuperation at
accommodation (hotel)
Other
Time from onset to
< 72 hours
randomization [a] (Category 1)
≥ 72 hours
Time from onset to
< 24 hours
randomization [a] (Category 2)
Between ≥ 24 and < 48 hours
Between ≥ 48 and < 72 hours
Between ≥ 72 and < 96 hours
Between ≥ 96 and ≤ 120 hours
> 120 hours
Vaccination of SARS-CoV-2
Yes
No
- 64 -
Placebo
125 mg
N = 14
n (%)
6 (42.9)
8 (57.1)
14
250 mg
N = 12
n (%)
6 (50.0)
6 (50.0)
12
N = 14
n (%)
11 (78.6)
3 (21.4)
14
38.0 (13.2)
22
34.5
59
14
165.20 (8.04)
155.0
164.55
182.5
14
60.96 (17.18)
45.7
53.80
107.6
14
22.08 (4.69)
18.6
20.20
35.7
14 (100.0)
0
40.7 (11.6)
23
37.5
63
12
164.76 (8.77)
151.3
165.00
179.0
12
66.69 (20.56)
45.5
60.55
105.8
12
24.27 (6.07)
18.6
21.70
36.7
12 (100.0)
0
36.6 (15.1)
16
35.0
61
14
170.20 (5.74)
158.6
168.75
180.0
14
66.11 (10.16)
49.2
67.00
81.1
14
22.76 (2.87)
17.7
22.40
27.7
14 (100.0)
0
0
0
0
0
0
0
0
0
10 (71.4)
4 (28.6)
4 (28.6)
10 (71.4)
5 (35.7)
1 (7.1)
0
8 (57.1)
0
0
10 (83.3)
2 (16.7)
1 (8.3)
11 (91.7)
5 (41.7)
0
0
7 (58.3)
0
0
3 (21.4)
11 (78.6)
6 (42.9)
8 (57.1)
5 (35.7)
0
0
9 (64.3)
0
5 (35.7)
0
5 (41.7)
0
5 (35.7)
9 (64.3)
0
7 (58.3)
0
9 (64.3)
0
1 (7.1)
4 (28.6)
4 (28.6)
5 (35.7)
0
12 (85.7)
2 (14.3)
0
5 (41.7)
4 (33.3)
3 (25.0)
0
10 (83.3)
2 (16.7)
2 (14.3)
3 (21.4)
3 (21.4)
6 (42.9)
0
10 (71.4)
4 (28.6)
表 2.5.4.3-3
2.5 臨床に関する概括評価
被験者の人口統計学的特性：Phase 2a Part (軽症/中等症の SARS-CoV-2 感染
者，ITT 集団)
S-217622
Sex
Male
Female
Age (Years) (informed consent N
obtained)
Mean (SD)
Min
Median
Max
Height (cm)
N
Mean (SD)
Min
Median
Max
Weight (kg)
N
Mean (SD)
Min
Median
Max
BMI
N
Mean (SD)
Min
Median
Max
Race
Asian
American Indian or Alaska
Native
Black or African American
Native Hawaiian or Other
Pacific Islander
White
Other
Drinking habits
Yes
No
Smoking habits
Yes
No
Condition of subject
Hospitalization
Outpatient
Recuperation at home
Recuperation at
accommodation (hotel)
Other
Time from onset to
< 72 hours
randomization [a] (Category 1)
≥ 72 hours
Time from onset to
< 24 hours
randomization [a] (Category 2)
Between ≥ 24 and < 48 hours
Between ≥ 48 and < 72 hours
Between ≥ 72 and < 96 hours
Between ≥ 96 and ≤ 120 hours
> 120 hours
Vaccination of SARS-CoV-2
Yes
No
- 64 -
Placebo
125 mg
N = 14
n (%)
6 (42.9)
8 (57.1)
14
250 mg
N = 12
n (%)
6 (50.0)
6 (50.0)
12
N = 14
n (%)
11 (78.6)
3 (21.4)
14
38.0 (13.2)
22
34.5
59
14
165.20 (8.04)
155.0
164.55
182.5
14
60.96 (17.18)
45.7
53.80
107.6
14
22.08 (4.69)
18.6
20.20
35.7
14 (100.0)
0
40.7 (11.6)
23
37.5
63
12
164.76 (8.77)
151.3
165.00
179.0
12
66.69 (20.56)
45.5
60.55
105.8
12
24.27 (6.07)
18.6
21.70
36.7
12 (100.0)
0
36.6 (15.1)
16
35.0
61
14
170.20 (5.74)
158.6
168.75
180.0
14
66.11 (10.16)
49.2
67.00
81.1
14
22.76 (2.87)
17.7
22.40
27.7
14 (100.0)
0
0
0
0
0
0
0
0
0
10 (71.4)
4 (28.6)
4 (28.6)
10 (71.4)
5 (35.7)
1 (7.1)
0
8 (57.1)
0
0
10 (83.3)
2 (16.7)
1 (8.3)
11 (91.7)
5 (41.7)
0
0
7 (58.3)
0
0
3 (21.4)
11 (78.6)
6 (42.9)
8 (57.1)
5 (35.7)
0
0
9 (64.3)
0
5 (35.7)
0
5 (41.7)
0
5 (35.7)
9 (64.3)
0
7 (58.3)
0
9 (64.3)
0
1 (7.1)
4 (28.6)
4 (28.6)
5 (35.7)
0
12 (85.7)
2 (14.3)
0
5 (41.7)
4 (33.3)
3 (25.0)
0
10 (83.3)
2 (16.7)
2 (14.3)
3 (21.4)
3 (21.4)
6 (42.9)
0
10 (71.4)
4 (28.6)