Table 2.
Adverse Events
| Early Robust Responder Intent to Treat Population | Non–early Robust Responder Intent to Treat Population | |||||
|---|---|---|---|---|---|---|
| Randomized i.v. duration | 10 d | 14 d | Total | 14 d | 21 d | Total |
| N | 140 | 137 | 277 | 353 | 352 | 705 |
| Total number AEs | 21 | 16 | 37 | 40 | 73 | 113 |
| Maximum severity of AE | ||||||
| Mild | 4 | 4 | 8 | 6 | 19 | 25 |
| Moderate | 14 | 10 | 24 | 15 | 27 | 42 |
| Severe | 3 | 2 | 5 | 16 | 24 | 40 |
| Life-threatening | 0 | 0 | 0 | 3 | 3 | 6 |
| Participants with any AE, n (%) | 18 (12.9) | 12 (8.8) | 30 (10.8) | 33 (9.3) | 47 (13.4) | 80 (11.3) |
| Person-weeks follow-up | 347.71 | 427.71 | 775.42 | 1105.71 | 1412.00 | 2517.71 |
| AE rate (AEs/person-week) | 0.060 | 0.037 | 0.039 | 0.036 | 0.052 | 0.045 |
| Participants with any SAE, n (%) | 4 (2.9) | 1 (0.7) | 5 (1.8) | 19 (5.4) | 19 (5.4) | 38 (5.4) |
| Total number of SAEs | 4 | 1 | 5 | 21 | 26 | 47 |
| Relatedness of SAE | ||||||
| Unrelated | 4 | 1 | 5 | 15 | 24 | 39 |
| Possibly | 0 | 0 | 0 | 4 | 1 | 5 |
| Probably | 0 | 0 | 0 | 2 | 0 | 2 |
| Definitely | 0 | 0 | 0 | 0 | 1 | 1 |
| AE occurring in 5% of participants | ||||||
| Infective pulmonary exacerbation, n (%) | 9 (6.4) | 5 (3.6) | 14 (5.1) | 13 (3.7) | 13 (3.7) | 26 (3.7) |
Definition of abbreviations: AE = adverse event; SAE = serious adverse event.