TABLE V.
Dosing symptoms by treatment group
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Dosing symptoms by dose
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| Treatment group | No. of doses |
Any reaction
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Patch-site reactions
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Reaction extended past patch site
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Non–patch-site reaction
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Non–patch-site symptoms
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Symptoms >8 h
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Treated
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Any patch-site reaction
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Grade 2 patch-site reaction
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Grade 3 patch-site reaction
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Grade 4 patch-site reaction
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Mild symptoms
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Moderate symptoms
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Severe symptoms
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| No. | Percent | No. | Percent | No. | Percent | No. | Percent | No. | Percent | No. | Percent | No. | Percent | No. | Percent | No. | Percent | No. | Percent | No. | Percent | No. | Percent | ||
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo | 8418 | 1216 | 14.4 | 1200 | 14.3 | 128 | 1.5 | 0 | 0.00 | 0 | 0.0 | 133 | 1.58 | 17 | 0.2 | 17 | 0.2 | 0 | 0.00 | 0 | 0.00 | 982 | 11.7 | 106 | 1.3 |
| VP100 | 8121 | 6482 | 79.8 | 6479 | 79.8 | 1513 | 18.6 | 6 | 0.01 | 1 | 0.0 | 720 | 8.87 | 20 | 0.2 | 18 | 0.2 | 1 | 0.01 | 0 | 0.00 | 4989 | 61.4 | 2218 | 27.3 |
| VP250 | 9033 | 7205 | 79.8 | 7203 | 79.7 | 2110 | 23.4 | 7 | 0.00 | 0 | 0.0 | 1466 | 16.23 | 6 | 0.1 | 6 | 0.1 | 0 | 0.00 | 0 | 0.00 | 6397 | 70.8 | 2142 | 23.7 |
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| Dosing symptoms by subject | |||||||||||||||||||||||||
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| No. of subjects | No. | Percent | No. | Percent | No. | Percent | No. | Percent | No. | Percent | No. | Percent | No. | Percent | No. | Percent | No. | Percent | No. | Percent | No. | Percent | No. | Percent | |
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| Placebo | 25 | 22 | 88.0 | 22 | 88.0 | 6 | 24.0 | 0 | 0.0 | 0 | 0.0 | 8 | 32.00 | 3 | 12.0 | 3 | 12.0 | 0 | 0.00 | 0 | 0.00 | 15 | 60.0 | 9 | 36.0 |
| VP100 | 24 | 24 | 100.0 | 24 | 100.0 | 22 | 91.7 | 4 | 16.7 | 1 | 4.2 | 22 | 91.67 | 8 | 33.3 | 7 | 29.2 | 1 | 4.17 | 0 | 0.00 | 22 | 91.7 | 23 | 95.8 |
| VP250 | 25 | 25 | 100.0 | 25 | 100.0 | 25 | 100.0 | 5 | 20.0 | 0 | 0.0 | 25 | 100.00 | 3 | 12.0 | 3 | 12.0 | 0 | 0.00 | 0 | 0.00 | 25 | 100.0 | 25 | 100.0 |
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| Dosing symptoms by percentage of doses per subject | |||||||||||||||||||||||||
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| No. of doses, median (IQR) | Median (IQR) | Median (IQR) | Median (IQR) | Median (IQR) | Median (IQR) | Median (IQR) | Median (IQR) | Median (IQR) | Median (IQR) | Median (IQR) | Median (IQR) | Median (IQR) | |||||||||||||
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| Placebo | 357 (350–364) | 1.6 (0.5–11.9) | 1.6 (0.5–7.9) | 0 (0–0) | 0 (0–0) | 0 (0–0) | 0 (0–0.3) | 0 (0–0) | 0 (0–0) | 0 (0–0) | 0 (0–0) | 0.5 (0–2.8) | 0 (0–0.3) | ||||||||||||
| VP100 | 357 (345–367) | 93.9 (73.9–98.3) | 92.8 (73.9–98.3) | 6.8 (1.6–28.4) | 0 (0–0) | 0 (0–0) | 2.8 (1.2–6.9) | 0 (0–0.3) | 0 (0–0.3) | 0 (0–0) | 0 (0–0) | 76.7 (22.5–94.5) | 8.9 (0.7–53) | ||||||||||||
| VP250 | 361 (352–370) | 96.1 (75.5–98.3) | 96.1 (75.5–98.3) | 7.4 (1.6–36.8) | 0 (0–0) | 0 (0–0) | 7.6 (1.7–22.6) | 0 (0–0) | 0 (0–0) | 0 (0–0) | 0 (0–0) | 93.6 (27–96.1) | 16.2 (4.9–37.7) | ||||||||||||