Table III.
Summary of secondary efficacy endpoints (PPS)
| Secondary efficacy endpoint | Number of patients (%) | Number of events/days (annualized rate) |
|---|---|---|
| Total number of patients or exposure days (diary daysa) | 21 | 1,840 (1,990) |
| SBIs | 0 | 0 |
| Infection episodes | 11 (52.4) | 15 (2.98) |
| Days with antibiotics for infection prophylaxis | 5 (23.8) | 422 (83.71) |
| Days with antibiotics for infection treatment | 13 (61.9) | 458 (90.85) |
| Days hospitalized due to infectionsa | 1 (4.8) | 3 (0.55) |
| Days missed from work/school or unable to perform normal activities due to infectionsa | 7 (33.3) | 19 (3.48) |
aAs per “diary days” based on analysis of patients’ diaries. SBI serious bacterial infection; PPS per-protocol data set