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【資料No.1】2.5_臨床に関する概括資料 (123 ページ)
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S-217622
表 2.5.5.1-1
2.5 臨床に関する概括評価
安全性評価対象：Phase 2b Part (無作為割付された集団)
S-217622
125 mg
N = 142
n (%)
Participants included in Safety Analysis Population
140 (98.6)
Participants excluded from Safety Analysis Population
2 (1.4)
Reason for exclusion [a]
Informed Consent
1 (0.7)
Study Drug
2 (1.4)
[a] Participant may have had more than one reason for exclusion from the analysis population.
出典：5.3.5.1-01_T1221 CSR (Phase 2b Part)_Table 14.1.1.4.1.1
表 2.5.5.1-2
S-217622
250 mg
N = 143
n (%)
140 (97.9)
3 (2.1)
0
3 (2.1)
Placebo
N = 143
n (%)
141 (98.6)
2 (1.4)
1 (0.7)
1 (0.7)
被験者の人口統計学的特性：Phase 2b Part (安全性解析対象集団)
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
- 123 -
S-217622
125 mg
N = 140
n (%)
76 (54.3)
64 (45.7)
140
S-217622
250 mg
N = 140
n (%)
77 (55.0)
63 (45.0)
140
Placebo
N = 141
n (%)
93 (66.0)
48 (34.0)
141
35.5 (13.4)
13
32.0
68
140
166.18 (9.15)
147.6
166.40
185.4
140
63.92 (15.59)
35.0
62.10
115.0
140
22.97 (4.36)
14.2
21.80
37.3
140 (100.0)
0
34.6 (13.0)
12
33.0
69
140
166.26 (8.73)
147.0
166.35
189.5
140
62.98 (12.72)
38.5
61.35
108.0
140
22.68 (3.64)
16.0
22.30
37.0
139 (99.3)
0
36.4 (12.9)
16
34.0
68
141
168.01 (8.38)
144.5
170.00
188.1
141
68.55 (15.23)
40.6
66.00
116.8
141
24.13 (4.28)
17.5
23.10
38.4
139 (98.6)
0
0
0
0
0
0
0
0
0
70 (50.0)
70 (50.0)
34 (24.3)
106 (75.7)
36 (25.7)
61 (43.6)
3 (2.1)
0
1 (0.7)
57 (40.7)
83 (59.3)
25 (17.9)
115 (82.1)
49 (35.0)
53 (37.9)
2 (1.4)
0
2 (1.4)
80 (56.7)
61 (43.3)
40 (28.4)
101 (71.6)
44 (31.2)
57 (40.4)
0
表 2.5.5.1-1
2.5 臨床に関する概括評価
安全性評価対象：Phase 2b Part (無作為割付された集団)
S-217622
125 mg
N = 142
n (%)
Participants included in Safety Analysis Population
140 (98.6)
Participants excluded from Safety Analysis Population
2 (1.4)
Reason for exclusion [a]
Informed Consent
1 (0.7)
Study Drug
2 (1.4)
[a] Participant may have had more than one reason for exclusion from the analysis population.
出典：5.3.5.1-01_T1221 CSR (Phase 2b Part)_Table 14.1.1.4.1.1
表 2.5.5.1-2
S-217622
250 mg
N = 143
n (%)
140 (97.9)
3 (2.1)
0
3 (2.1)
Placebo
N = 143
n (%)
141 (98.6)
2 (1.4)
1 (0.7)
1 (0.7)
被験者の人口統計学的特性：Phase 2b Part (安全性解析対象集団)
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
- 123 -
S-217622
125 mg
N = 140
n (%)
76 (54.3)
64 (45.7)
140
S-217622
250 mg
N = 140
n (%)
77 (55.0)
63 (45.0)
140
Placebo
N = 141
n (%)
93 (66.0)
48 (34.0)
141
35.5 (13.4)
13
32.0
68
140
166.18 (9.15)
147.6
166.40
185.4
140
63.92 (15.59)
35.0
62.10
115.0
140
22.97 (4.36)
14.2
21.80
37.3
140 (100.0)
0
34.6 (13.0)
12
33.0
69
140
166.26 (8.73)
147.0
166.35
189.5
140
62.98 (12.72)
38.5
61.35
108.0
140
22.68 (3.64)
16.0
22.30
37.0
139 (99.3)
0
36.4 (12.9)
16
34.0
68
141
168.01 (8.38)
144.5
170.00
188.1
141
68.55 (15.23)
40.6
66.00
116.8
141
24.13 (4.28)
17.5
23.10
38.4
139 (98.6)
0
0
0
0
0
0
0
0
0
70 (50.0)
70 (50.0)
34 (24.3)
106 (75.7)
36 (25.7)
61 (43.6)
3 (2.1)
0
1 (0.7)
57 (40.7)
83 (59.3)
25 (17.9)
115 (82.1)
49 (35.0)
53 (37.9)
2 (1.4)
0
2 (1.4)
80 (56.7)
61 (43.3)
40 (28.4)
101 (71.6)
44 (31.2)
57 (40.4)
0