Table 1.
Characteristic | LO-2 (N = 487) | LO-3 (N = 486) | Placebo (N = 478) | Characteristic | LO-2 (N = 487) | LO-3 (N = 486) | Placebo (N = 478) |
---|---|---|---|---|---|---|---|
Participants | Index patientsa | ||||||
Age | Age | ||||||
Mean ± SD (years) | 34.5 ± 9.7 | 33.8 ± 10.2 | 34.0 ± 9.2 | Mean ± SD (years) | 7.5 ± 3.5 | 7.5 ± 4.3 | 7.7 ± 5.3 |
Group (years) [no. (%)] | Group (years) [no. (%)] | ||||||
10–14 | 43 (8.8) | 58 (11.9) | 43 (9.0) | 0–4 | 98 (20.1) | 96 (19.8) | 89 (18.6) |
15–19 | 18 (3.7) | 9 (1.9) | 11 (2.3) | 5–9 | 264 (54.2) | 281 (57.8) | 275 (57.5) |
20–29 | 36 (7.4) | 37 (7.6) | 42 (8.8) | 10–14 | 116 (23.8) | 97 (20.0) | 99 (20.7) |
30–39 | 241 (49.5) | 235 (48.4) | 264 (55.2) | 15–19 | 6 (1.2) | 5 (1.0) | 7 (1.5) |
40–49 | 144 (29.6) | 141 (29.0) | 113 (23.6) | 20–29 | 3 (0.6) | 4 (0.8) | 3 (0.6) |
50–59 | 4 (0.8) | 5 (1.0) | 4 (0.8) | 30–39 | 0 (0.0) | 2 (0.4) | 2 (0.4) |
60– | 1 (0.2) | 1 (0.2) | 1 (0.2) | 40–49 | 0 (0.0) | 0 (0.0) | 2 (0.4) |
Sex [no. (%)] | 50–59 | 0 (0.0) | 1 (0.2) | 0 (0.0) | |||
Female | 427 (87.7) | 423 (87.0) | 422 (88.3) | 60– | 0 (0.0) | 0 (0.0) | 1 (0.2) |
Male | 60 (12.3) | 63 (13.0) | 56 (11.7) | Sex [no. (%)] | |||
Time to first dose after onset in index patients | Female | 238 (48.9) | 236 (48.6) | 219 (45.8) | |||
Mean ± SD (h) | 21.6 ± 11.3 | 23.0 ± 12.5 | 22.5 ± 12.6 | Male | 249 (51.1) | 250 (51.4) | 259 (54.2) |
Group (h) [no. (%)] | Rapid diagnostic test [no. (%)] | ||||||
0–12 | 101 (20.7) | 101 (20.8) | 99 (20.7) | Positive | 487 (100.0) | 486 (100.0) | 478 (100.0) |
12–24 | 207 (42.5) | 181 (37.2) | 189 (39.5) | Laboratory-confirmed influenza infection | |||
24–36 | 122 (25.1) | 123 (25.3) | 117 (24.5) | Virus Type and Subtype [no. (%)] | |||
36–48 | 54 (11.1) | 80 (16.5) | 70 (14.6) | 2009H1N1 | 0 (0.0) | 0 (0.0) | 0 (0.0) |
48– | 3 (0.6) | 1 (0.2) | 3 (0.6) | H1N1 | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Relationship to index patient [no. (%)] | H3N2 | 443 (91.0) | 440 (90.5) | 434 (90.8) | |||
Parent | 423 (86.9) | 413 (85.0) | 415 (86.8) | B | 43 (8.8) | 44 (9.1) | 43 (9.0) |
Sibling | 62 (12.7) | 69 (14.2) | 54 (11.3) | Mixed | 1 (0.2) | 2 (0.4) | 1 (0.2) |
Child | 0 (0.0) | 1 (0.2) | 1 (0.2) | Treatment of influenza [no. (%)] | |||
Spouse | 1 (0.2) | 0 (0.0) | 3 (0.6) | Oseltamivir | 373 (76.6) | 389 (80.0) | 372 (77.8) |
Other | 1 (0.2) | 3 (0.6) | 5 (1.0) | Zanamivir | 113 (23.2) | 94 (19.3) | 101 (21.1) |
High-riskb [no. (%)] | 14 (2.9) | 10 (2.1) | 20 (4.2) | Other | 1 (0.2) | 3 (0.6) | 5 (1.0) |
LO-2 20 mg of laninamivir octanoate administered once daily for 2 days, LO-3 20 mg of laninamivir octanoate administered once daily for 3 days, SD standard deviation, 2009H1N1 influenza A(H1N1)pdm09, H1N1 seasonal influenza A(H1N1), H3N2 influenza A(H3N2), B influenza B
aMore than one participant could be enrolled for each index patient. In this case, the index patient was counted once for each household contact who was enrolled. Actually, 1278 index patients (FASIINAB) were enrolled. In this table, the “N” is identical for household contacts and index patients in each treatment group. This is due to “reduplicative” counting
bAge ≥65 years or with concomitant illness (immunodeficiency, metabolic disorder, chronic respiratory illness, chronic renal impairment, or chronic heart disease)