Table 3:
Summary of efficacy results
| Children (≥2 to <17 years) | Adults (≥17 years) | Total | ||||
|---|---|---|---|---|---|---|
| Main study (n = 38) |
Extension (n = 10) |
Main study (n = 37) |
Extension (n = 17) |
Main study (N = 75) |
Extension (N = 27) |
|
| Total number of patient years | 35 | 20.7 | 35.5 | 33.4 | 70.5 | 54.1 |
| Infections | ||||||
| Any infection [n events] | 109 | 42 | 122 | 77 | 231 | 119 |
| Mild infection | 91 | 30 | 79 | 43 | 170 | 73 |
| Moderate infection | 17 | 12 | 43 | 32 | 60 | 44 |
| Severe infection | 1 | 0 | 0 | 2 | 1 | 2 |
| Annual rate [number of other infections per patient-year (two-sided 95% CI)] | 3.1 (2.0, 4.8) | 2.0 (0.9, 4.8) | 3.4 (2.2, 5.4) | 2.3 (1.0, 4.9) | 3.3 (2.4, 4.5) | 2.2 (1.2, 3.9) |
| SBIs [n events] | 0 | 0 | 0 | 1 | 0 | 1 |
| Annual rate [number of SBIs* per patient-year (upper one-sided 99% CI)] | 0 (0.13)† | 0 (0.22)† | 0 (0.13)† | 0.03 (0.31) | 0 (0.06)† | 0.02 (0.19) |
| Absences from work/school, days [rate per person-year] | 180 (5.2) | 75 (3.6) | 72 (2.0) | 55 (1.7) | 252 (3.6) | 130 (2.4) |
| Hospitalizations due to infection, days [rate per person-year] | 29 (0.8) | 0 | 0 | 10 (0.3) | 29 (0.4) | 10 (0.2) |
| Systemic antibiotic use, [n (%)] | 24 (63.2) | 6 (60.0) | 25 (67.6) | 13 (76.5) | 49 (65.3) | 19 (70.4) |
| Annual rate [days on treatment per patient-year (two-sided 95%CI)] | 32.1 (17.2, 60.1) | 70.6 (22.7, 220.0) | 62.6 (31.0, 126.4) | 30.9 (12.2, 78.4) | 47.2 (28.4, 78.6) | 46.0 (21.3, 99.4) |
*Defined as bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.
†Calculation for the upper limit of two-sided 95% or one-sided 99% CI was based on the standard Poisson model for zero counts.
Abbreviations: CI, confidence interval; SBI, serious bacterial infection.