Table 2.
Summary of TEAEs.
| Variable, n (%) | ALIS 590 mg Once Daily N=148 |
TIS 300 mg Twice Daily N=146 |
Total N=294 |
|---|---|---|---|
| Patients with TEAEs | 125 (84.5) | 115 (78.8) | 240 (81.6) |
| Patients with TEAEs by relationship to study druga | |||
| Related | 57 (38.5) | 21 (14.4) | 78 (26.5) |
| Not related | 68 (45.9) | 94 (64.4) | 162 (55.1) |
| Patients with TEAEs by maximum severity | |||
| Mild | 52 (35.1) | 50 (34.2) | 102 (34.7) |
| Moderate | 62 (41.9) | 59 (40.4) | 121 (41.2) |
| Severe | 11 (7.4) | 5 (3.4) | 16 (5.4) |
| Life-threatening or disabling | 0 | 1 (0.7) | 1 (0.3) |
| Patients with treatment-emergent SAEs | 26 (17.6) | 29 (19.9) | 55 (18.7) |
| Patients with treatment-emergent SAEs by strongest relationship to study drug | |||
| Related | 1 (0.7) | 1 (0.7) | 2 (0.7) |
| Not related | 25 (16.9) | 28 (19.2) | 53 (18.0) |
| Patients with AEs leading to study drug discontinuation | 15 (10.1) | 7 (4.8) | 22 (7.5) |
a
Assessed by the investigator. Related events are defined as events with relationships to study procedure of probably, possibly, or unknown. Events not related are defined as events with relationships to study procedures of unlikely or not related.
AE, adverse event; ALIS, amikacin liposome inhalation suspension; SAE, serious adverse event; TEAEs, treatment-emergent adverse events; TIS, tobramycin inhaled solution.