よむ、つかう、まなぶ。
【資料No.1】2.5_臨床に関する概括資料 (126 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_26901.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3回 7／20)、医薬品第二部会(令和4年度第6回 7／20)（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
Placebo
125 mg
N = 21
n (%)
10 (47.6)
250 mg
N = 23
n (%)
13 (56.5)
N = 24
n (%)
17 (70.8)
0
17 (81.0)
2 (9.5)
0
15 (65.2)
2 (8.7)
0
16 (66.7)
2 (8.3)
2 (9.5)
6 (26.1)
6 (25.0)
0
19 (90.5)
2 (9.5)
7 (33.3)
0
20 (87.0)
3 (13.0)
8 (34.8)
0
20 (83.3)
4 (16.7)
8 (33.3)
≥ 72 hours
12 (57.1)
12 (52.2)
Time from onset to
< 24 hours
0
0
randomization [a] (Category 2)
Between ≥ 24 and < 48 hours
2 (9.5)
0
Between ≥ 48 and < 72 hours
5 (23.8)
8 (34.8)
Between ≥ 72 and < 96 hours
7 (33.3)
8 (34.8)
Between ≥ 96 and ≤ 120 hours
5 (23.8)
4 (17.4)
> 120 hours
0
0
Days from day of close contact 0 day
0
0
with SARS-CoV-2 patients to
randomization [b]
1 day
0
0
2 days
0
0
3 days
0
0
4 days
0
0
5 days
0
2 (8.7)
6 days
1 (4.8)
0
7 days
0
0
> 7 days
0
0
Unknown
1 (4.8)
1 (4.3)
Vaccination of SARS-CoV-2
Yes
16 (76.2)
17 (73.9)
No
5 (23.8)
6 (26.1)
Past medical conditions
Yes
0
1 (4.3)
No
21 (100.0)
22 (95.7)
Current medical conditions
Yes
13 (61.9)
11 (47.8)
No
8 (38.1)
12 (52.2)
Prior drugs
Yes
15 (71.4)
15 (65.2)
No
6 (28.6)
8 (34.8)
Concomitant drugs
Yes
17 (81.0)
15 (65.2)
No
4 (19.0)
8 (34.8)
Prior therapies
Yes
0
0
No
21 (100.0)
23 (100.0)
Concomitant therapies
Yes
0
0
No
21 (100.0)
23 (100.0)
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] Only Participants with Asymptomatic SARS-CoV-2 Infection
出典：5.3.5.1-01_T1221 CSR (Phase 2a Part)_Table 14.1.2.1.2.3
12 (50.0)
0
Pathogen Test Method
COVID-19 Symptom
Time from onset to
randomization [a] (Category 1)
Recuperation at
accommodation (hotel)
Other
Nucleic acid detection test
Antigen test (quantitative
analysis)
Antigen test (qualitative
analysis)
Other
Mild/Moderate
Asymptomatic
< 72 hours
- 126 -
2 (8.3)
6 (25.0)
5 (20.8)
7 (29.2)
0
0
0
0
0
0
1 (4.2)
0
0
2 (8.3)
1 (4.2)
17 (70.8)
7 (29.2)
0
24 (100.0)
12 (50.0)
12 (50.0)
12 (50.0)
12 (50.0)
12 (50.0)
12 (50.0)
1 (4.2)
23 (95.8)
1 (4.2)
23 (95.8)
2.5 臨床に関する概括評価
S-217622
Placebo
125 mg
N = 21
n (%)
10 (47.6)
250 mg
N = 23
n (%)
13 (56.5)
N = 24
n (%)
17 (70.8)
0
17 (81.0)
2 (9.5)
0
15 (65.2)
2 (8.7)
0
16 (66.7)
2 (8.3)
2 (9.5)
6 (26.1)
6 (25.0)
0
19 (90.5)
2 (9.5)
7 (33.3)
0
20 (87.0)
3 (13.0)
8 (34.8)
0
20 (83.3)
4 (16.7)
8 (33.3)
≥ 72 hours
12 (57.1)
12 (52.2)
Time from onset to
< 24 hours
0
0
randomization [a] (Category 2)
Between ≥ 24 and < 48 hours
2 (9.5)
0
Between ≥ 48 and < 72 hours
5 (23.8)
8 (34.8)
Between ≥ 72 and < 96 hours
7 (33.3)
8 (34.8)
Between ≥ 96 and ≤ 120 hours
5 (23.8)
4 (17.4)
> 120 hours
0
0
Days from day of close contact 0 day
0
0
with SARS-CoV-2 patients to
randomization [b]
1 day
0
0
2 days
0
0
3 days
0
0
4 days
0
0
5 days
0
2 (8.7)
6 days
1 (4.8)
0
7 days
0
0
> 7 days
0
0
Unknown
1 (4.8)
1 (4.3)
Vaccination of SARS-CoV-2
Yes
16 (76.2)
17 (73.9)
No
5 (23.8)
6 (26.1)
Past medical conditions
Yes
0
1 (4.3)
No
21 (100.0)
22 (95.7)
Current medical conditions
Yes
13 (61.9)
11 (47.8)
No
8 (38.1)
12 (52.2)
Prior drugs
Yes
15 (71.4)
15 (65.2)
No
6 (28.6)
8 (34.8)
Concomitant drugs
Yes
17 (81.0)
15 (65.2)
No
4 (19.0)
8 (34.8)
Prior therapies
Yes
0
0
No
21 (100.0)
23 (100.0)
Concomitant therapies
Yes
0
0
No
21 (100.0)
23 (100.0)
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] Only Participants with Asymptomatic SARS-CoV-2 Infection
出典：5.3.5.1-01_T1221 CSR (Phase 2a Part)_Table 14.1.2.1.2.3
12 (50.0)
0
Pathogen Test Method
COVID-19 Symptom
Time from onset to
randomization [a] (Category 1)
Recuperation at
accommodation (hotel)
Other
Nucleic acid detection test
Antigen test (quantitative
analysis)
Antigen test (qualitative
analysis)
Other
Mild/Moderate
Asymptomatic
< 72 hours
- 126 -
2 (8.3)
6 (25.0)
5 (20.8)
7 (29.2)
0
0
0
0
0
0
1 (4.2)
0
0
2 (8.3)
1 (4.2)
17 (70.8)
7 (29.2)
0
24 (100.0)
12 (50.0)
12 (50.0)
12 (50.0)
12 (50.0)
12 (50.0)
12 (50.0)
1 (4.2)
23 (95.8)
1 (4.2)
23 (95.8)