よむ、つかう、まなぶ。
【資料No.1】2.5_臨床に関する概括資料 (134 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_29325.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5回 11／22）、医薬品第二部会（令和4年度第13回 11／22）（合同開催）《厚生労働省》 |
ページ画像
ダウンロードした画像を利用する際は「出典情報」を明記してください。
低解像度画像をダウンロード
プレーンテキスト
資料テキストはコンピュータによる自動処理で生成されており、完全に資料と一致しない場合があります。
テキストをコピーしてご利用いただく際は資料と付け合わせてご確認ください。
S-217622
2.5 臨床に関する概括評価
S-217622
125 mg
250 mg
N = 347
N = 340
n (%)
n (%)
0
0
322 (92.8)
313 (92.1)
25 (7.2)
27 (7.9)
41 (11.8)
35 (10.3)
306 (88.2)
305 (89.7)
8 (2.3)
11 (3.2)
339 (97.7)
329 (96.8)
126 (36.3)
113 (33.2)
221 (63.7)
227 (66.8)
171 (49.3)
153 (45.0)
176 (50.7)
187 (55.0)
176 (50.7)
176 (51.8)
171 (49.3)
164 (48.2)
0
2 (0.6)
347 (100.0)
338 (99.4)
1 (0.3)
3 (0.9)
346 (99.7)
337 (99.1)
> 120 hours
Vaccination of SARS-CoV-2 Yes
No
Pollen allergic conditions [b] Yes
No
Past medical conditions
Yes
No
Current medical conditions
Yes
No
Prior drugs
Yes
No
Concomitant drugs
Yes
No
Prior therapies
Yes
No
Concomitant therapies
Yes
No
Min = Minimum; Max = Maximum; SD = Standard Deviation
BMI = Body Mass Index; SARS-CoV-2 = Severe Acute Respiratory Syndrome Coronavirus 2
[a] Only Participants with Mild/Moderate SARS-CoV-2 Infection
[b] Pollen allergic conditions were determined using medical histories for each participant.
表 2.5.4.2-2
Sex
Age (Years) (informed
consent obtained)
Height (cm)
Weight (kg)
BMI
Race
Placebo
N = 343
n (%)
0
315 (91.8)
28 (8.2)
41 (12.0)
302 (88.0)
13 (3.8)
330 (96.2)
124 (36.2)
219 (63.8)
160 (46.6)
183 (53.4)
168 (49.0)
175 (51.0)
0
343 (100.0)
0
343 (100.0)
被験者の人口統計学的特性：Phase 3 Part (ITT 集団)
S-217622
125 mg
250 mg
N = 603
N = 595
n (%)
n (%)
318 (52.7)
323 (54.3)
285 (47.3)
272 (45.7)
603
595
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
- 134 -
Placebo
N = 600
n (%)
311 (51.8)
289 (48.2)
600
35.9 (12.7)
14
34.0
69
603
165.40 (9.97)
140.0
165.00
264.0
603
63.69 (14.46)
36.4
61.90
156.0
603
23.15 (4.03)
7.0
22.70
49.8
601 (99.7)
0
35.9 (12.7)
13
34.0
68
595
164.83 (9.57)
117.0
164.30
189.7
595
63.06 (13.87)
38.0
61.60
125.8
595
23.06 (3.87)
13.8
22.50
48.1
593 (99.7)
0
35.3 (12.6)
12
33.0
69
600
164.82 (9.17)
145.0
164.00
188.9
600
62.81 (13.80)
36.7
61.35
140.0
600
22.95 (3.70)
14.7
22.40
40.6
598 (99.7)
0
0
1 (0.2)
0
2.5 臨床に関する概括評価
S-217622
125 mg
250 mg
N = 347
N = 340
n (%)
n (%)
0
0
322 (92.8)
313 (92.1)
25 (7.2)
27 (7.9)
41 (11.8)
35 (10.3)
306 (88.2)
305 (89.7)
8 (2.3)
11 (3.2)
339 (97.7)
329 (96.8)
126 (36.3)
113 (33.2)
221 (63.7)
227 (66.8)
171 (49.3)
153 (45.0)
176 (50.7)
187 (55.0)
176 (50.7)
176 (51.8)
171 (49.3)
164 (48.2)
0
2 (0.6)
347 (100.0)
338 (99.4)
1 (0.3)
3 (0.9)
346 (99.7)
337 (99.1)
> 120 hours
Vaccination of SARS-CoV-2 Yes
No
Pollen allergic conditions [b] Yes
No
Past medical conditions
Yes
No
Current medical conditions
Yes
No
Prior drugs
Yes
No
Concomitant drugs
Yes
No
Prior therapies
Yes
No
Concomitant therapies
Yes
No
Min = Minimum; Max = Maximum; SD = Standard Deviation
BMI = Body Mass Index; SARS-CoV-2 = Severe Acute Respiratory Syndrome Coronavirus 2
[a] Only Participants with Mild/Moderate SARS-CoV-2 Infection
[b] Pollen allergic conditions were determined using medical histories for each participant.
表 2.5.4.2-2
Sex
Age (Years) (informed
consent obtained)
Height (cm)
Weight (kg)
BMI
Race
Placebo
N = 343
n (%)
0
315 (91.8)
28 (8.2)
41 (12.0)
302 (88.0)
13 (3.8)
330 (96.2)
124 (36.2)
219 (63.8)
160 (46.6)
183 (53.4)
168 (49.0)
175 (51.0)
0
343 (100.0)
0
343 (100.0)
被験者の人口統計学的特性：Phase 3 Part (ITT 集団)
S-217622
125 mg
250 mg
N = 603
N = 595
n (%)
n (%)
318 (52.7)
323 (54.3)
285 (47.3)
272 (45.7)
603
595
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
- 134 -
Placebo
N = 600
n (%)
311 (51.8)
289 (48.2)
600
35.9 (12.7)
14
34.0
69
603
165.40 (9.97)
140.0
165.00
264.0
603
63.69 (14.46)
36.4
61.90
156.0
603
23.15 (4.03)
7.0
22.70
49.8
601 (99.7)
0
35.9 (12.7)
13
34.0
68
595
164.83 (9.57)
117.0
164.30
189.7
595
63.06 (13.87)
38.0
61.60
125.8
595
23.06 (3.87)
13.8
22.50
48.1
593 (99.7)
0
35.3 (12.6)
12
33.0
69
600
164.82 (9.17)
145.0
164.00
188.9
600
62.81 (13.80)
36.7
61.35
140.0
600
22.95 (3.70)
14.7
22.40
40.6
598 (99.7)
0
0
1 (0.2)
0