TABLE 3.
Overview of Secondary Efficacy and Virologic End Points in the ITTi Population*
| Baloxavir Marboxil (n = 61) | Oseltamivir (n = 33) | |
|---|---|---|
| Efficacy | ||
| Evaluable children, n | 56 | 27 |
| Median TTAS, h (95% CI) | 138.4 (116.7–163.4) | 126.1 (95.9–165.7) |
| Evaluable children, n | 34 | 20 |
| In patients with H3N2 infection (95% CI) | 128.7 (92.3–163.2) | 111.6 (71.3–158.1) |
| Evaluable children, n | 10 | 4 |
| In patients with H1N1pdm09 infection (95% CI) | 140.3 (77.3–192.3) | 165.7 (63.4–NE) |
| Evaluable children, n | 60 | 31 |
| Median duration of fever, h (95% CI) | 66.4 (41.7–76.4) | 56.0 (41.2–78.5) |
| Virology | ||
| Patients with a postbaseline virology assessment, n | 48 | 29 |
| Evaluable children, n | 48 | 28 |
| TCVS, h (95% CI) | 24.1 (23.3–24.6) | 75.8 (69.3–95.6) |
*
The ITTi population comprised children 5–11 years old who received treatment and had a laboratory RT-PCR confirmation of influenza infection from any swab sample collected at baseline or during the study.
ITTi indicates intent-to-treat influenza-infected; NE, not evaluable; RT-PCR, reverse transcriptase–polymerase chain reaction; TCVS, time to cessation of viral shedding; TTAS, time to alleviation of symptoms.