Table 2.
Protective Effect of Laninamivir Against Influenza Infection
| LO-40SD |
LO-20TD |
Placebo | |||||
|---|---|---|---|---|---|---|---|
| Outcome | No./Total (%) | P Valuea | RRRb (95% CI) | No./Total (%) | P Valuea | RRRb (95% CI) | No./Total (%) |
| Primary endpoint (FAS) | |||||||
| Clinical influenza | 12/267 (4.5) | .001 | 62.8 (29.3 to 80.4) | 12/269 (4.5) | .001 | 63.1 (29.8 to 80.5) | 32/265 (12.1) |
| Secondary endpoints (FAS) | |||||||
| Symptomatic influenza | 23/267 (8.6) | <.001 | 54.3 (27.4 to 71.3) | 25/269 (9.3) | .001 | 50.7 (22.8 to 68.6) | 50/265 (18.9) |
| Asymptomatic influenza | 25/267 (9.4) | .32 | 22.5 (–27.2 to 52.7) | 29/269 (10.8) | .68 | 10.7 (−43.3 to 44.4) | 32/265 (12.1) |
| Laboratory-confirmed influenza infectionc | 29/248 (11.7) | <.001 | 53.8 (30.8 to 69.2) | 32/247 (13.0) | <.001 | 48.8 (24.5 to 65.3) | 62/245 (25.3) |
| Other endpoints | |||||||
| Clinical influenza in FASII | 12/267 (4.5) | .001 | 63.3 (30.4 to 80.7) | 12/262 (4.6) | .001 | 62.6 (29.1 to 80.3) | 32/261 (12.3) |
| Clinical influenza in FASIINAB | 8/248 (3.2) | .001 | 68.9 (32.4 to 85.7) | 8/243 (3.3) | .002 | 68.3 (31.0 to 85.4) | 25/241 (10.4) |
Abbreviations: CI, confidence interval; FAS, the full analysis set; FASII, the full analysis set, index-infected; FASIINAB, the full analysis set, index-infected virus-negative at baseline; LO-20TD, 20 mg of laninamivir octanoate administered once daily for 2 days; LO-40SD, 40 mg of laninamivir octanoate, single administration; RRR, relative risk reduction.
a Analyzed using Fisher exact test.
b 100 × (1 − laninamivir/placebo).
c Participants confirmed to be infected with the influenza virus at baseline were excluded.