TABLE 5.
Summary of efficacy, influenza A virus-infected subjects confirmed by RT-PCR (intent-to-treat population)a
| Cohort | Median (range) |
||
|---|---|---|---|
| Median time to resolution of any symptoms, h (95% CI)a | Median duration and severity of symptoms, total score (score-h)b | Median time to return of ability to perform usual activities (h)c | |
| Cohort 1: 750 mg MEDI8852 + OSd (n = 27) | 106.75 (60.12–155.17) | 903.30 (157.50–2493.70) | NAe (45–288) |
| Cohort 2: 3,000 mg MEDI8852 + OS (n = 23) | 138.10 (95.87–189.55) | 1,204.90 (674.20–3288.00) | 238.4 (108–286) |
| Cohort 3: placebo + OS (n = 31) | 94.83 (71.17–161.75) | 1,007.10 (379.40–2,790.10) | 254.3 (47–288) |
| Cohort 4: 3,000 mg MEDI8852 (n = 25) | 128.00 (64.05–156.82) | 876.50 (406.40–2992.10) | 237.3 (115–241) |
| Cohorts 1, 2, and 4 combined: total MEDI8852 (n = 75) | 119.25 (94.40–148.50) | 1189.80 (157.50–3288.00) | 238.4 (45–288) |
Confidence intervals (CI) were calculated based on the medians obtained from Kaplan-Meier analysis.
Score-hours were assessed by area-under-the-curve analysis derived on a by-subject basis, using the linear trapezoidal rule with all available data from baseline to the last time point with influenza symptoms measurement up to day 13.
The median time to return of ability to perform usual activities is summarized by Kaplan-Meier curves. Subjects with missing values are censored.
OS, oseltamivir.
NA, not applicable. The median time could not be calculated because there were not enough subjects who returned to ability to perform usual activities.