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【資料No.1】2.5_臨床に関する概括資料 (112 ページ)

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》
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S-217622

表 2.5.4.1-29

2.5 臨床に関する概括評価

各時点における味覚異常又は嗅覚異常を有する被験者の割合:Phase 2b Part
(ITT1 集団)

Time Point
12 hours post-dose

Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]

24 hours post-dose

Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]

36 hours post-dose

Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]

48 hours post-dose

Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]

72 hours post-dose

Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]

96 hours post-dose

Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]

120 hours post-dose

Proportion of participants
Mantel-Haenszel test vs. placebo [a]
- p-value
Risk ratio [95% CI] [a]
Risk diff [95% CI] [a]

S-217622
125 mg
N = 114
19.0% (19/100)

S-217622
250 mg
N = 116
13.3% (13/98)

Placebo
N = 111
17.0% (16/94)

0.8405

0.4393

---

1.06 [0.59, 1.92]
0.01 [-0.09, 0.12]

0.77 [0.40, 1.49]
-0.04 [-0.14, 0.06]

-----

22.9% (24/105)

19.1% (21/110)

21.7% (23/106)

0.8343

0.6328

---

1.06 [0.64, 1.75]
0.01 [-0.10, 0.12]

0.88 [0.52, 1.48]
-0.03 [-0.13, 0.08]

-----

21.9% (21/96)

16.3% (16/98)

18.4% (18/98)

0.5650

0.7151

---

1.18 [0.67, 2.06]
0.03 [-0.08, 0.14]

0.89 [0.48, 1.66]
-0.02 [-0.12, 0.09]

-----

20.4% (22/108)

18.7% (20/107)

22.3% (23/103)

0.7243

0.5056

---

0.91 [0.54, 1.53]
-0.02 [-0.13, 0.09]

0.84 [0.49, 1.41]
-0.04 [-0.14, 0.07]

-----

18.5% (20/108)

18.6% (19/102)

23.8% (25/105)

0.3158

0.3317

---

0.77 [0.46, 1.29]
-0.06 [-0.16, 0.05]

0.77 [0.45, 1.31]
-0.06 [-0.17, 0.05]

-----

16.2% (17/105)

15.8% (16/101)

25.5% (26/102)

0.0780

0.0923

---

0.62 [0.36, 1.06]
-0.10 [-0.21, 0.01]

0.63 [0.36, 1.09]
-0.10 [-0.21, 0.01]

-----

17.7% (17/96)

10.2% (10/98)

25.0% (24/96)

0.2249

0.0076

---

0.71 [0.41, 1.23]
-0.07 [-0.19, 0.04]

0.41 [0.21, 0.81]
-0.15 [-0.25, -0.04]

-----

CI = Confidence Interval
[a] Adjusted by the following strata (time from onset to randomization [<72 hours or ≥72 hours], SARS-CoV-2 vaccination
history [Yes or No])
出典:5.3.5.1-01_T1221 CSR (Phase 2b Part)_Table 14.2.29.1.1

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