よむ、つかう、まなぶ。
【資料No.1】2.5_臨床に関する概括資料 (66 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
表 2.5.4.1-2
2.5 臨床に関する概括評価
有効性解析対象集団：Phase 2a Part (無作為割付された集団)
S-217622
125 mg
N = 20
n (%)
14 (70.0)
6 (30.0)
6 (30.0)
Mild/Moderate
S-217622
250 mg
N = 20
n (%)
12 (60.0)
8 (40.0)
8 (40.0)
Participants included in mITT
Participants excluded from
mITT
Reason for exclusion [a]
RT-PCR result
Viral titer result
13 (65.0)
7 (35.0)
Participants included in PPS
Participants excluded from
PPS
Reason for exclusion [a]
Participants included in ITT
Participants excluded from ITT
Reason for exclusion [a]
RT-PCR result
N = 20
n (%)
14 (70.0)
6 (30.0)
6 (30.0)
S-217622
125 mg
N=2
n (%)
2 (100.0)
0
0
Asymptomatic
S-217622
250 mg
N=3
n (%)
2 (66.7)
1 (33.3)
1 (33.3)
12 (60.0)
8 (40.0)
12 (60.0)
8 (40.0)
2 (100.0)
0
6 (30.0)
5 (25.0)
8 (40.0)
5 (25.0)
6 (30.0)
6 (30.0)
13 (65.0)
7 (35.0)
9 (45.0)
11 (55.0)
11 (55.0)
9 (45.0)
Placebo
Excluded from ITT
6 (30.0)
8 (40.0)
6 (30.0)
Exclusion Criteria
0
1 (5.0)
1 (5.0)
Inclusion Criteria
0
0
1 (5.0)
Overdose/Misuse
1 (5.0)
1 (5.0)
0
Prohibited Co4 (20.0)
3 (15.0)
3 (15.0)
Medication
ITT = Intention-to-Treat; mITT = modified Intention-to-Treat; PPS = Per Protocol Set
[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 2a Part)_Table 14.1.1.3.1
- 66 -
N=4
n (%)
3 (75.0)
1 (25.0)
1 (25.0)
S-217622
125 mg
N = 22
n (%)
16 (72.7)
6 (27.3)
6 (27.3)
All
S-217622
250 mg
N = 23
n (%)
14 (60.9)
9 (39.1)
9 (39.1)
N = 24
n (%)
17 (70.8)
7 (29.2)
7 (29.2)
2 (66.7)
1 (33.3)
2 (50.0)
2 (50.0)
15 (68.2)
7 (31.8)
14 (60.9)
9 (39.1)
14 (58.3)
10 (41.7)
0
0
1 (33.3)
1 (33.3)
1 (25.0)
2 (50.0)
6 (27.3)
5 (22.7)
9 (39.1)
6 (26.1)
7 (29.2)
8 (33.3)
2 (100.0)
0
2 (66.7)
1 (33.3)
3 (75.0)
1 (25.0)
15 (68.2)
7 (31.8)
11 (47.8)
12 (52.2)
14 (58.3)
10 (41.7)
0
0
0
0
0
1 (33.3)
0
0
0
0
1 (25.0)
0
0
0
0
6 (27.3)
0
0
1 (4.5)
4 (18.2)
9 (39.1)
1 (4.3)
0
1 (4.3)
3 (13.0)
7 (29.2)
1 (4.2)
1 (4.2)
0
3 (12.5)
Placebo
Placebo
表 2.5.4.1-2
2.5 臨床に関する概括評価
有効性解析対象集団：Phase 2a Part (無作為割付された集団)
S-217622
125 mg
N = 20
n (%)
14 (70.0)
6 (30.0)
6 (30.0)
Mild/Moderate
S-217622
250 mg
N = 20
n (%)
12 (60.0)
8 (40.0)
8 (40.0)
Participants included in mITT
Participants excluded from
mITT
Reason for exclusion [a]
RT-PCR result
Viral titer result
13 (65.0)
7 (35.0)
Participants included in PPS
Participants excluded from
PPS
Reason for exclusion [a]
Participants included in ITT
Participants excluded from ITT
Reason for exclusion [a]
RT-PCR result
N = 20
n (%)
14 (70.0)
6 (30.0)
6 (30.0)
S-217622
125 mg
N=2
n (%)
2 (100.0)
0
0
Asymptomatic
S-217622
250 mg
N=3
n (%)
2 (66.7)
1 (33.3)
1 (33.3)
12 (60.0)
8 (40.0)
12 (60.0)
8 (40.0)
2 (100.0)
0
6 (30.0)
5 (25.0)
8 (40.0)
5 (25.0)
6 (30.0)
6 (30.0)
13 (65.0)
7 (35.0)
9 (45.0)
11 (55.0)
11 (55.0)
9 (45.0)
Placebo
Excluded from ITT
6 (30.0)
8 (40.0)
6 (30.0)
Exclusion Criteria
0
1 (5.0)
1 (5.0)
Inclusion Criteria
0
0
1 (5.0)
Overdose/Misuse
1 (5.0)
1 (5.0)
0
Prohibited Co4 (20.0)
3 (15.0)
3 (15.0)
Medication
ITT = Intention-to-Treat; mITT = modified Intention-to-Treat; PPS = Per Protocol Set
[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 2a Part)_Table 14.1.1.3.1
- 66 -
N=4
n (%)
3 (75.0)
1 (25.0)
1 (25.0)
S-217622
125 mg
N = 22
n (%)
16 (72.7)
6 (27.3)
6 (27.3)
All
S-217622
250 mg
N = 23
n (%)
14 (60.9)
9 (39.1)
9 (39.1)
N = 24
n (%)
17 (70.8)
7 (29.2)
7 (29.2)
2 (66.7)
1 (33.3)
2 (50.0)
2 (50.0)
15 (68.2)
7 (31.8)
14 (60.9)
9 (39.1)
14 (58.3)
10 (41.7)
0
0
1 (33.3)
1 (33.3)
1 (25.0)
2 (50.0)
6 (27.3)
5 (22.7)
9 (39.1)
6 (26.1)
7 (29.2)
8 (33.3)
2 (100.0)
0
2 (66.7)
1 (33.3)
3 (75.0)
1 (25.0)
15 (68.2)
7 (31.8)
11 (47.8)
12 (52.2)
14 (58.3)
10 (41.7)
0
0
0
0
0
1 (33.3)
0
0
0
0
1 (25.0)
0
0
0
0
6 (27.3)
0
0
1 (4.5)
4 (18.2)
9 (39.1)
1 (4.3)
0
1 (4.3)
3 (13.0)
7 (29.2)
1 (4.2)
1 (4.2)
0
3 (12.5)
Placebo
Placebo