Table 3.
Summary of incidence of AEs, serious AEs, discontinuations due to AEs, and most common AEs occurring up to last visit (safety population bacteremia subset)
| n (%) | cIAI | cUTI/pyelonephritis | NP/VAP | All indications combined | ||||
|---|---|---|---|---|---|---|---|---|
| Ceftazidime-avibactam (n = 27) | Comparator (n = 24) | Ceftazidime-avibactam (n = 48) | Comparator (n = 42) | Ceftazidime-avibactam (n = 24) | Meropenem (n = 18) | Ceftazidime-avibactam (n = 99) | Comparator (n = 84) | |
| AE category | ||||||||
| Any AE | 15 (55.6) | 15 (62.5) | 35 (72.9) | 22 (52.4) | 19 (79.2) | 14 (77.8) | 69 (69.7) | 51 (60.7) |
| Any AE with outcome of death | 0 (0.0) | 0 (0.0) | 1 (2.1) | 0 (0.0) | 1 (4.2) | 1 (5.6) | 2 (2.0) | 1 (1.2) |
| Any SAE | 2 (7.4) | 6 (25.0) | 6 (12.5) | 0 (0.0) | 4 (16.7) | 2 (11.1) | 12 (12.1) | 8 (9.5) |
| Any AE leading to discontinuation of study drug | 2 (7.4) | 1 (4.2) | 3 (6.3) | 0 (0.0) | 1 (4.2) | 2 (11.1) | 6 (6.1) | 3 (3.6) |
| Any AE of severe intensity | 1 (3.7) | 4 (16.7) | 2 (4.2) | 0 (0.0) | 3 (12.5) | 2 (11.1) | 6 (6.1) | 6 (7.1) |
| AEsa (MedDRA v19.0 preferred term) | ||||||||
| Diarrhea | 0 (0.0) | 2 (8.3) | 3 (6.3) | 1 (2.4) | 9 (37.5) | 1 (5.6) | 12 (12.1) | 4 (4.8) |
| Nausea | 0 (0.0) | 1 (4.2) | 5 (10.4) | 2 (4.8) | 4 (16.7) | 2 (11.1) | 9 (9.1) | 5 (6.0) |
| Constipation | 1 (3.7) | 1 (4.2) | 5 (10.4) | 3 (7.1) | 1 (4.2) | 1 (5.6) | 7 (7.1) | 5 (6.0) |
| Vomiting | 2 (7.4) | 1 (4.2) | 3 (6.3) | 0 (0.0) | 2 (8.3) | 1 (5.6) | 7 (7.1) | 2 (2.4) |
| Headache | 0 (0.0) | 1 (4.2) | 4 (8.3) | 4 (9.5) | 1 (4.2) | 2 (11.1) | 5 (5.1) | 7 (8.3) |
| Hypertension | 2 (7.4) | 0 (0.0) | 3 (6.3) | 2 (4.8) | 0 (0.0) | 0 (0.0) | 5 (5.1) | 2 (2.4) |
| Pyrexia | 0 (0.0) | 4 (16.7) | 5 (10.4) | 0 (0.0) | 0 (0.0) | 1 (5.6) | 5 (5.1) | 5 (6.0) |
| Urinary tract infection | 1 (3.7) | 2 (8.3) | 2 (4.2) | 0 (0.0) | 2 (8.3) | 2 (11.1) | 5 (5.1) | 4 (4.8) |
| Pneumonia | 2 (7.4) | 1 (4.2) | 0 (0.0) | 1 (2.4) | 0 (0.0) | 3 (16.7) | 2 (2.0) | 5 (6.0) |
| Anemia | 0 (0.0) | 2 (8.3) | 0 (0.0) | 2 (4.8) | 1 (4.2) | 1 (5.6) | 1 (1.0) | 5 (6.0) |
AE adverse event, cIAI complicated intra-abdominal infection, cUTI complicated urinary tract infection, MedDRA Medical Dictionary for Regulatory Activities, NP nosocomial pneumonia, SAE serious adverse event
aAEs occurring in ≥ 5% patients (all indications)