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. 2020 Jun 29;43(8):751–766. doi: 10.1007/s40264-020-00934-3

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