Table 2.
Primary Outcome of Time to Illness Alleviation Related to Enrollment Subgroup Characteristics
| Variable | US316 | US317 | ||
|---|---|---|---|---|
| Placebo | Favipiravir | Placebo | Favipiravir | |
| Age, y | ||||
| 18–49 | 100.0 (95.5–113.7) (n = 213) |
88.8 (77.1–95.8) (n = 207) |
78.5 (72.3–91.5) (n = 128) |
77.8 (72.1–83.3) (n = 374) |
| ≥50 | 95.7 (77.1–118.2) (n = 93) |
83.7 (68.3–98.8) (n = 81) |
106.1 (70.7–152.7) (n = 35) |
77.8 (70.8–95.6) (n = 131) |
| Sex | ||||
| Female | 103.8 (95.6–119.8) (n = 179) |
92.8 (74.2–96.6) (n = 169) |
83.3 (71.6–96.3) (n = 85) |
79.7 (75.3–92.3) (n = 289) |
| Male | 94.0 (72.6–100.8) (n = 127) |
82.2 (71.8–96.0) (n = 119) |
84.1 (75.6–101.7) (n = 78) |
72.2 (71.1–80.1) (n = 216) |
| Influenza vaccine | ||||
| No | 95.9 (93.9–105.7) (n = 235) |
90.3 (77.8–95.8) (n = 224) |
83.3 (72.3–95.7) (n = 131) |
77.9 (72.2–83.3) (n = 443) |
| Yes | 102.3 (82.0–126.1) (n = 66) |
75.4 (68.7–101.9) (n = 61) |
102.7 (68.0–145.1) (n = 20) |
73.9 (58.4–97.6) (n = 42) |
| Weight, kg | ||||
| <80 | 100.0 (93.9–115.2) (n = 161) |
84.0 (72.9–95.6) (n = 144) |
84.1 (70.9–101.0) (n = 85) |
76.6 (71.8–83.0) (n = 259) |
| ≥80 | 96.3 (84.4–113.7) (n = 145) |
95.5 (71.8–97.4) (n = 144) |
78.8 (72.3–95.5) (n = 77) |
78.8 (72.0–92.8) (n = 245) |
| Time from onset to first dose, h | ||||
| <24 | 101.4 (95.3–135.3) (n = 91) |
95.7 (77.6–106.9) (n = 87) |
71.7 (59.5–89.1) (n = 40) |
79.0 (71.8–94.4) (n = 155) |
| ≥24 | 96.1 (89.8–107.1) (n = 212) |
79.0 (72.2–95.6) (n = 200) |
84.2 (77.7–101.3) (n = 122) |
76.0 (71.8–82.0) (n = 345) |
| Total symptom score | ||||
| <15 | 95.8 (93.8–102.3) (n = 239) |
78.2 (72.4–95.5) (n = 218) |
78.8 (71.7–92.3) (n = 115) |
75.3 (71.8–80.8) (n = 367) |
| ≥15 | 115.8 (94.2–141.0) (n = 60) |
96.0 (74.7–123.9) (n = 67) |
96.3 (72.3–119.0) (n = 41) |
92.3 (75.6–100.6) (n = 132) |
Results are presented as median (95% confidence interval) hours to illness alleviation. The study was not powered to assess the effect of treatment in subgroups, and no adjustments were made to account for multiplicity. In addition, the number of subjects in some subgroups was small.