Table 2.
Summary of Annualized rates for infections, antibiotics use, days lost for work/school/daycare, unscheduled visits, and hospitalizations
| Total | 3-Week cycle | 4-Week cycle | |
|---|---|---|---|
| Number of mITT Subjects | 59 | 19 | 40 |
| Total number subject-years | 55.9 | 17.3 | 38.6 |
| Infections | |||
| Number of Serious acute bacterial infections (SBIs) | 0 | 0 | 0 |
| Rate of SBIs per person per years (one-sided 99 % upper bound) | 0.000 (<1.0) | 0.000 (<1.0) | 0.000 (<1.0) |
| Total infections of any kind/seriousness | 192 | 62 | 130 |
| Infections per subject per year (one-sided 95 % upper bound) | 3.436 (3.869) | 3.584 (4.417) | 3.370 (3.893) |
| Antibiotic use for therapy | |||
| Number of subjects, n (%) | 37 (62.7) | 12 (63.2) | 25 (62.5) |
| Days per subject per year | 32.9 | 41.2 | 29.2 |
| Days off school/work/day care due to infection | |||
| Number of Subjects, n (%) | 23 (39.0) | 7 (36.8) | 16 (40.0) |
| Total days | 93 | 27 | 66 |
| Days per subject per year (one-sided 95 % upper bound) | 1.66 (1.97) | 1.56 (2.14) | 1.71 (2.09) |
| Unscheduled visits to the ER and physician due to infection | |||
| Number of subjects, n (%) | 24 (40.7) | 9 (47.4) | 15 (37.5) |
| Total days | 54 | 18 | 36 |
| Days per subject per year (one-sided 95 % upper bound) | 0.97 (1.21) | 1.04 (1.53) | 0.93 (1.23) |
| Hospitalization due to infection | |||
| Number of subjects, n (%) | 1 (1.7) | 0 | 1 (2.5) |
| Number of days | 5 | 0 | 5 |
| Hospitalizations per subject per year | 0.018 | 0 | 0.026 |