Table 4.
Adverse event summary in ASPECT-NP participants with ventilated hospital-acquired bacterial pneumonia by treatment arm
| Adverse event category, n (%) | C/T (N = 99) |
Meropenem (N = 105) |
Total (N = 204) |
|---|---|---|---|
| Number of patients with ≥ 1 TEAE | 88 (88.9) | 92 (87.6) | 180 (88.2) |
| Number of patients with ≥ 1 TEAE by maximum severity* | |||
| Mild | 15 (15.2) | 14 (13.3) | 29 (14.2) |
| Moderate | 30 (30.3) | 28 (26.7) | 58 (28.4) |
| Severe | 43 (43.4) | 50 (47.6) | 93 (45.6) |
| Number of patients with ≥ 1 DRAE‡ | 13 (13.1) | 11 (10.5) | 24 (11.8) |
| Number of patients with ≥ 1 serious TEAE | 49 (49.5) | 48 (45.7) | 97 (47.5) |
| Number of patients with ≥ 1 serious DRAE‡ | 3 (3.0) | 1 (1.0) | 4 (2.0) |
| Number of patients with ≥ 1 TEAE leading to study drug discontinuation | 8 (8.1) | 18 (17.1) | 26 (12.7) |
| Number of patients with ≥ 1 DRAE leading to study drug discontinuation‡ | 2 (2.0) | 1 (1.0) | 3 (1.5) |
| Number of patients with ≥ 1 TEAE resulting in death | 31 (31.3) | 41 (39.0) | 72 (35.3) |
| Number of patients with ≥ 1 DRAE resulting in death‡ | 0 | 0 | 0 |
Adverse events were coded using MedDRA version 17.0. For each category, patients counted only once, even if they experienced multiple events in the category
AE, adverse event. C/T, ceftolozane/tazobactam. DRAE, drug-related adverse event. n, number of patients in specific category. N, number of patients in safety population. TEAE, treatment-emergent adverse event (defined as any AE starting on/after the first study drug administration)
*If patients have multiple events, they are counted only once with the maximum (highest) severity rating. The orders of severity from worst case to best case are severe, moderate, and mild
‡If a patient had multiple events and ≥ 1 was deemed related to study drug, then that patient was included into the count