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【資料No.1】2.5_臨床に関する概括資料 (111 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

2.5 臨床に関する概括評価

Time Point
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
0.02 [-0.12, 0.16]

S-217622
250 mg
N = 116
0.00 [-0.14, 0.14]

Placebo
N = 111
---

48.0% (47/98)

59.8% (61/102)

57.4% (58/101)

0.1759

0.7336

---

0.83 [0.64, 1.09]
-0.10 [-0.24, 0.04]

1.04 [0.83, 1.31]
0.02 [-0.11, 0.16]

-----

65.9% (60/91)

73.3% (66/90)

70.7% (65/92)

0.4566

0.7176

---

0.93 [0.76, 1.13]
-0.05 [-0.19, 0.08]

1.03 [0.86, 1.24]
0.02 [-0.11, 0.15]

-----

71.6% (73/102)

77.8% (77/99)

79.4% (77/97)

0.2002

0.7750

---

0.90 [0.77, 1.06]
-0.08 [-0.20, 0.04]

0.98 [0.85, 1.13]
-0.02 [-0.13, 0.10]

-----

84.2% (85/101)

83.2% (79/95)

83.8% (83/99)

0.9956

0.8893

---

1.00 [0.89, 1.13]
0.00 [-0.10, 0.10]

0.99 [0.88, 1.12]
-0.01 [-0.11, 0.10]

-----

90.8% (89/98)

88.3% (83/94)

86.6% (84/97)

0.4295

0.7028

---

1.04 [0.94, 1.15]
0.04 [-0.05, 0.12]

1.02 [0.92, 1.13]
0.02 [-0.07, 0.11]

-----

93.3% (84/90)

92.3% (84/91)

95.6% (87/91)

0.4999

0.3461

---

0.98 [0.91, 1.05]
-0.02 [-0.09, 0.04]

0.97 [0.90, 1.04]
-0.03 [-0.10, 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 14.2.28.1.1

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