Table 3.
Common adverse events (≥ 2% in either treatment group) up to the last study visit ordered by incidence in the overall ceftazidime–avibactam ± metronidazole treatment group (pooled safety population)
MedDRA v19.0 preferred term, n (%) | cIAI | cUTI | NP including VAP | Total | ||||
---|---|---|---|---|---|---|---|---|
Ceftazidime–avibactam + metronidazole (N = 857) | Comparator (N = 863) | Ceftazidime–avibactam (N = 731) | Comparator (N = 729) | Ceftazidime–avibactam (N = 436) | Meropenem (N = 434) | Ceftazidime–avibactam ± metronidazole (N = 2024) | Comparator (N = 2026) | |
Most common AEs (≥ 2%) | ||||||||
Diarrhoea | 60 (7.0) | 38 (4.4) | 23 (3.1) | 21 (2.9) | 67 (15.4) | 67 (15.4) | 150 (7.4) | 126 (6.2) |
Nausea | 67 (7.8) | 35 (4.1) | 21 (2.9) | 22 (3.0) | 14 (3.2) | 7 (1.6) | 102 (5.0) | 64 (3.2) |
Headache | 23 (2.7) | 18 (2.1) | 53 (7.3) | 72 (9.9) | 7 (1.6) | 7 (1.6) | 83 (4.1) | 97 (4.8) |
Vomiting | 45 (5.3) | 20 (2.3) | 8 (1.1) | 6 (0.8) | 25 (5.7) | 24 (5.5) | 78 (3.9) | 50 (2.5) |
Pyrexia | 42 (4.9) | 48 (5.6) | 9 (1.2) | 7 (1.0) | 14 (3.2) | 16 (3.7) | 65 (3.2) | 71 (3.5) |
Constipation | 17 (2.0) | 25 (2.9) | 20 (2.7) | 9 (1.2) | 25 (5.7) | 32 (7.4) | 62 (3.1) | 66 (3.3) |
Hypokalaemia | 8 (0.9) | 4 (0.5) | 2 (0.3) | 4 (0.5) | 47 (10.8) | 37 (8.5) | 57 (2.8) | 45 (2.2) |
Hypertension | 21 (2.5) | 28 (3.2) | 12 (1.6) | 11 (1.5) | 14 (3.2) | 17 (3.9) | 47 (2.3) | 56 (2.8) |
Anaemia | 17 (2.0) | 14 (1.6) | 4 (0.5) | 5 (0.7) | 25 (5.7) | 19 (4.4) | 46 (2.3) | 38 (1.9) |
Aspartate aminotransferase increased | 16 (1.9) | 19 (2.2) | 4 (0.5) | 5 (0.7) | 17 (3.9) | 17 (3.9) | 37 (1.8) | 41 (2.0) |
Alanine aminotransferase increased | 15 (1.8) | 18 (2.1) | 3 (0.4) | 6 (0.8) | 17 (3.9) | 19 (4.4) | 35 (1.7) | 43 (2.1) |
Patients with multiple AEs in the same category were counted once in that category; those with AEs in more than one category were counted in each category
AE adverse event, cIAI complicated intra-abdominal infection, cUTI complicated urinary tract infection, n number of patients, N number of patients in treatment group, NP nosocomial pneumonia, SAE serious adverse event, VAP ventilator-associated pneumonia