TABLE 5

Summary of efficacy, influenza A virus-infected subjects confirmed by RT-PCR (intent-to-treat population)a

CohortMedian (range)
Median time to resolution of any symptoms, h (95% CI)aMedian duration and severity of symptoms, total score (score-h)bMedian 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)
  • a Confidence intervals (CI) were calculated based on the medians obtained from Kaplan-Meier analysis.

  • b 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.

  • c The median time to return of ability to perform usual activities is summarized by Kaplan-Meier curves. Subjects with missing values are censored.

  • d OS, oseltamivir.

  • e NA, not applicable. The median time could not be calculated because there were not enough subjects who returned to ability to perform usual activities.