Table 2.
For each of the adverse events of grade 3+ for which results are presented, the number of patients who experienced that adverse event, the total number of experiences, and the total duration for which that adverse event was experienced
| Adverse eventa | Patients, n (%) | No. of events | Total duration, days | Incidence rate, events per 1,000 patient‐days |
|---|---|---|---|---|
| Any adverse event | 264 (61) | 537 | 5108 | 11.5 |
| Any hematologic | 131 (30) | 268 | 2547 | 5.8 |
| Neutropenia | 81 (19) | 155 | 1403 | 3.3 |
| Thrombocytopenia | 29 (7) | 45 | 354 | 1 |
| Anemia | 30 (7) | 44 | 459 | 0.9 |
| Neutropenia | 16 (4) | 30 | 270 | 0.6 |
| Leukopenia | 13 (3) | 21 | 198 | 0.5 |
| Any gastrointestinal | 39 (9) | 48 | 279 | 1 |
| Abdominal pain | 20 (5) | 26 | 131 | 0.6 |
| Any constitutional | 28 (7) | 33 | 354 | 0.7 |
| Fatigue | 19 (4) | 23 | 271 | 0.5 |
| Any hepatologic | 18 (4) | 21 | 251 | 0.5 |
| AST elevated | 12 (3) | 14 | 160 | 0.3 |
A longer version of this table that includes the many adverse events for which insufficient data were available to stably estimate the effect of antibacterial exposure is included in supplemental online Table 1.
a
Adverse events were defined based on patient report and physician recording, rather than by lab values.
Abbreviation: AST, aspartate aminotransferase.