よむ、つかう、まなぶ。
【資料No.1】2.5_臨床に関する概括資料 (135 ページ)
出典
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| 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》 |
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S-217622
2.5 臨床に関する概括評価
S-217622
Placebo
125 mg
N = 603
n (%)
0
250 mg
N = 595
n (%)
1 (0.2)
N = 600
n (%)
0
0
2 (0.3)
214 (35.5)
389 (64.5)
94 (15.6)
509 (84.4)
65 (10.8)
138 (22.9)
212 (35.2)
188 (31.2)
0
0
224 (37.6)
371 (62.4)
98 (16.5)
497 (83.5)
87 (14.6)
122 (20.5)
226 (38.0)
160 (26.9)
0
2 (0.3)
206 (34.3)
394 (65.7)
87 (14.5)
513 (85.5)
75 (12.5)
131 (21.8)
219 (36.5)
175 (29.2)
0
268 (44.4)
49 (8.1)
0
245 (41.2)
38 (6.4)
0
260 (43.3)
40 (6.7)
285 (47.3)
312 (52.4)
300 (50.0)
1 (0.2)
347 (57.5)
0
340 (57.1)
0
343 (57.2)
≥ 72 hours
256 (42.5)
255 (42.9)
Time from onset to
< 24 hours
52 (8.6)
57 (9.6)
randomization [a] (Category 2)
Between ≥ 24 and < 48 hours
126 (20.9)
113 (19.0)
Between ≥ 48 and < 72 hours
169 (28.0)
170 (28.6)
Between ≥ 72 and < 96 hours
159 (26.4)
164 (27.6)
Between ≥ 96 and ≤ 120 hours
97 (16.1)
91 (15.3)
> 120 hours
0
0
Vaccination of SARS-CoV-2 Yes
562 (93.2)
551 (92.6)
No
41 (6.8)
44 (7.4)
Pollen allergic conditions [b] Yes
79 (13.1)
67 (11.3)
No
524 (86.9)
528 (88.7)
Past medical conditions
Yes
18 (3.0)
19 (3.2)
No
585 (97.0)
576 (96.8)
Current medical conditions
Yes
227 (37.6)
217 (36.5)
No
376 (62.4)
378 (63.5)
Prior drugs
Yes
341 (56.6)
311 (52.3)
No
262 (43.4)
284 (47.7)
Concomitant drugs
Yes
312 (51.7)
319 (53.6)
No
291 (48.3)
276 (46.4)
Prior therapies
Yes
0
3 (0.5)
No
603 (100.0)
592 (99.5)
Concomitant therapies
Yes
1 (0.2)
4 (0.7)
No
602 (99.8)
591 (99.3)
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.
257 (42.8)
49 (8.2)
Drinking habits
Smoking habits
Condition of subject
Pathogen Test Method
Time from onset to
randomization [a] (Category 1)
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
< 72 hours
- 135 -
132 (22.0)
162 (27.0)
167 (27.8)
90 (15.0)
0
553 (92.2)
47 (7.8)
85 (14.2)
515 (85.8)
25 (4.2)
575 (95.8)
221 (36.8)
379 (63.2)
329 (54.8)
271 (45.2)
299 (49.8)
301 (50.2)
1 (0.2)
599 (99.8)
1 (0.2)
599 (99.8)
2.5 臨床に関する概括評価
S-217622
Placebo
125 mg
N = 603
n (%)
0
250 mg
N = 595
n (%)
1 (0.2)
N = 600
n (%)
0
0
2 (0.3)
214 (35.5)
389 (64.5)
94 (15.6)
509 (84.4)
65 (10.8)
138 (22.9)
212 (35.2)
188 (31.2)
0
0
224 (37.6)
371 (62.4)
98 (16.5)
497 (83.5)
87 (14.6)
122 (20.5)
226 (38.0)
160 (26.9)
0
2 (0.3)
206 (34.3)
394 (65.7)
87 (14.5)
513 (85.5)
75 (12.5)
131 (21.8)
219 (36.5)
175 (29.2)
0
268 (44.4)
49 (8.1)
0
245 (41.2)
38 (6.4)
0
260 (43.3)
40 (6.7)
285 (47.3)
312 (52.4)
300 (50.0)
1 (0.2)
347 (57.5)
0
340 (57.1)
0
343 (57.2)
≥ 72 hours
256 (42.5)
255 (42.9)
Time from onset to
< 24 hours
52 (8.6)
57 (9.6)
randomization [a] (Category 2)
Between ≥ 24 and < 48 hours
126 (20.9)
113 (19.0)
Between ≥ 48 and < 72 hours
169 (28.0)
170 (28.6)
Between ≥ 72 and < 96 hours
159 (26.4)
164 (27.6)
Between ≥ 96 and ≤ 120 hours
97 (16.1)
91 (15.3)
> 120 hours
0
0
Vaccination of SARS-CoV-2 Yes
562 (93.2)
551 (92.6)
No
41 (6.8)
44 (7.4)
Pollen allergic conditions [b] Yes
79 (13.1)
67 (11.3)
No
524 (86.9)
528 (88.7)
Past medical conditions
Yes
18 (3.0)
19 (3.2)
No
585 (97.0)
576 (96.8)
Current medical conditions
Yes
227 (37.6)
217 (36.5)
No
376 (62.4)
378 (63.5)
Prior drugs
Yes
341 (56.6)
311 (52.3)
No
262 (43.4)
284 (47.7)
Concomitant drugs
Yes
312 (51.7)
319 (53.6)
No
291 (48.3)
276 (46.4)
Prior therapies
Yes
0
3 (0.5)
No
603 (100.0)
592 (99.5)
Concomitant therapies
Yes
1 (0.2)
4 (0.7)
No
602 (99.8)
591 (99.3)
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.
257 (42.8)
49 (8.2)
Drinking habits
Smoking habits
Condition of subject
Pathogen Test Method
Time from onset to
randomization [a] (Category 1)
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
< 72 hours
- 135 -
132 (22.0)
162 (27.0)
167 (27.8)
90 (15.0)
0
553 (92.2)
47 (7.8)
85 (14.2)
515 (85.8)
25 (4.2)
575 (95.8)
221 (36.8)
379 (63.2)
329 (54.8)
271 (45.2)
299 (49.8)
301 (50.2)
1 (0.2)
599 (99.8)
1 (0.2)
599 (99.8)