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【資料No.1】2.5_臨床に関する概括資料 (133 ページ)
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S-217622
表 2.5.4.2-1
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 3 Part (ITT 集団のうち，COVID-19 発症か
ら無作為割付までの時間が 72 時間未満の集団)
Sex
Age (Years) (informed
consent obtained)
Height (cm)
Weight (kg)
BMI
Race
Drinking habits
Smoking habits
Condition of subject
Pathogen Test Method
Time from onset to
randomization [a]
S-217622
125 mg
250 mg
N = 347
N = 340
n (%)
n (%)
193 (55.6)
185 (54.4)
154 (44.4)
155 (45.6)
347
340
Male
Female
n
Mean (SD)
Min
Median
Max
n
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
Nucleic acid detection test
Antigen test (quantitative
analysis)
Antigen test (qualitative
analysis)
Other
< 24 hours
Between ≥ 24 and < 48 hours
Between ≥ 48 and < 72 hours
Between ≥ 72 and < 96 hours
Between ≥ 96 and ≤ 120 hours
- 133 -
Placebo
N = 343
n (%)
174 (50.7)
169 (49.3)
343
35.7 (12.5)
14
34.0
67
347
165.94 (10.55)
140.0
166.80
264.0
347
64.55 (15.36)
36.4
62.20
156.0
347
23.31 (4.31)
7.0
22.90
49.8
345 (99.4)
0
35.3 (12.2)
13
33.0
67
340
164.49 (8.93)
145.0
164.00
189.7
340
62.48 (13.55)
40.0
61.00
125.8
340
22.94 (3.69)
15.1
22.60
39.7
338 (99.4)
0
34.7 (12.2)
12
32.0
68
343
164.33 (9.36)
145.0
163.50
188.9
343
62.00 (12.71)
38.0
60.40
117.0
343
22.82 (3.48)
16.0
22.30
40.5
341 (99.4)
0
0
0
1 (0.3)
1 (0.3)
0
0
0
2 (0.6)
106 (30.5)
241 (69.5)
55 (15.9)
292 (84.1)
31 (8.9)
98 (28.2)
142 (40.9)
76 (21.9)
0
0
116 (34.1)
224 (65.9)
56 (16.5)
284 (83.5)
43 (12.6)
68 (20.0)
159 (46.8)
70 (20.6)
0
2 (0.6)
103 (30.0)
240 (70.0)
48 (14.0)
295 (86.0)
38 (11.1)
80 (23.3)
151 (44.0)
74 (21.6)
0
128 (36.9)
36 (10.4)
0
114 (33.5)
21 (6.2)
0
114 (33.2)
24 (7.0)
182 (52.4)
205 (60.3)
205 (59.8)
1 (0.3)
52 (15.0)
0
57 (16.8)
0
49 (14.3)
126 (36.3)
169 (48.7)
0
0
113 (33.2)
170 (50.0)
0
0
132 (38.5)
162 (47.2)
0
0
表 2.5.4.2-1
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 3 Part (ITT 集団のうち，COVID-19 発症か
ら無作為割付までの時間が 72 時間未満の集団)
Sex
Age (Years) (informed
consent obtained)
Height (cm)
Weight (kg)
BMI
Race
Drinking habits
Smoking habits
Condition of subject
Pathogen Test Method
Time from onset to
randomization [a]
S-217622
125 mg
250 mg
N = 347
N = 340
n (%)
n (%)
193 (55.6)
185 (54.4)
154 (44.4)
155 (45.6)
347
340
Male
Female
n
Mean (SD)
Min
Median
Max
n
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
Nucleic acid detection test
Antigen test (quantitative
analysis)
Antigen test (qualitative
analysis)
Other
< 24 hours
Between ≥ 24 and < 48 hours
Between ≥ 48 and < 72 hours
Between ≥ 72 and < 96 hours
Between ≥ 96 and ≤ 120 hours
- 133 -
Placebo
N = 343
n (%)
174 (50.7)
169 (49.3)
343
35.7 (12.5)
14
34.0
67
347
165.94 (10.55)
140.0
166.80
264.0
347
64.55 (15.36)
36.4
62.20
156.0
347
23.31 (4.31)
7.0
22.90
49.8
345 (99.4)
0
35.3 (12.2)
13
33.0
67
340
164.49 (8.93)
145.0
164.00
189.7
340
62.48 (13.55)
40.0
61.00
125.8
340
22.94 (3.69)
15.1
22.60
39.7
338 (99.4)
0
34.7 (12.2)
12
32.0
68
343
164.33 (9.36)
145.0
163.50
188.9
343
62.00 (12.71)
38.0
60.40
117.0
343
22.82 (3.48)
16.0
22.30
40.5
341 (99.4)
0
0
0
1 (0.3)
1 (0.3)
0
0
0
2 (0.6)
106 (30.5)
241 (69.5)
55 (15.9)
292 (84.1)
31 (8.9)
98 (28.2)
142 (40.9)
76 (21.9)
0
0
116 (34.1)
224 (65.9)
56 (16.5)
284 (83.5)
43 (12.6)
68 (20.0)
159 (46.8)
70 (20.6)
0
2 (0.6)
103 (30.0)
240 (70.0)
48 (14.0)
295 (86.0)
38 (11.1)
80 (23.3)
151 (44.0)
74 (21.6)
0
128 (36.9)
36 (10.4)
0
114 (33.5)
21 (6.2)
0
114 (33.2)
24 (7.0)
182 (52.4)
205 (60.3)
205 (59.8)
1 (0.3)
52 (15.0)
0
57 (16.8)
0
49 (14.3)
126 (36.3)
169 (48.7)
0
0
113 (33.2)
170 (50.0)
0
0
132 (38.5)
162 (47.2)
0
0