Table 5.
Potentially clinically significant laboratory measurements up to the last study visit (pooled safety population)
| Clinical laboratory variable | Potentially clinically significant criteria | n/m with both baseline and post-baseline values (%) | |
|---|---|---|---|
| Ceftazidime–avibactam ± metronidazole (N = 2024) | Comparator (N = 2026) | ||
| Haematology | |||
| Basophils, particle concentration (109/L) | > 4 × ULN and > 300% increase from baseline | 1/1729 (0.1) | 2/1732 (0.1) |
| Coombs test, direct | Negative at baseline and positive at post-baseline | 128/986 (13.0) | 37/978 (3.8) |
| Eosinophils, particle concentration (109/L) | > 4 × ULN and > 300% increase from baseline | 2/1736 (0.1) | 3/1742 (0.2) |
| Erythrocyte, volume fraction (ratio) | < 0.8 × LLN and > 20% decrease from baseline | 87/1578 (5.5) | 94/1573 (6.0) |
| > 1.3 × ULN and > 30% increase from baseline | 0/1578 (0.0) | 0/1573 (0.0) | |
| Erythrocytes, particle concentration (1012/L) | < 0.8 × LLN and > 20% decrease from baseline | 95/1759 (5.4) | 92/1772 (5.2) |
| > 1.3 × ULN and > 30% increase from baseline | 1/1759 (0.1) | 0/1772 (0.0) | |
| Haemoglobin (g/L) | < 0.8 × LLN and > 20% decrease from baseline | 101/1760 (5.7) | 100/1772 (5.6) |
| > 1.3 × ULN and > 30% increase from baseline | 0/1760 (0.0) | 0/1772 (0.0) | |
| Leukocytes, particle concentration (109/L) | < 0.65 × LLN and > 60% decrease from baseline | 13/1759 (0.7) | 13/1772 (0.7) |
| > 1.6 × ULN and > 100% increase from baseline | 32/1759 (1.8) | 37/1772 (2.1) | |
| Lymphocytes, particle concentration (109/L) | < 0.25 × LLN and > 75% decrease from baseline | 3/1747 (0.2) | 6/1754 (0.3) |
| > 1.5 × ULN and > 100% increase from baseline | 6/1747 (0.3) | 11/1754 (0.6) | |
| Monocytes, particle concentration (109/L) | > 4 × ULN and > 300% increase from baseline | 1/1743 (0.1) | 1/1746 (0.1) |
| Neutrophils, particle concentration (109/L) | < 0.65 × LLN and > 75% decrease from baseline | 16/1743 (0.9) | 17/1747 (1.0) |
| > 1.6 × ULN and > 100% increase from baseline | 70/1743 (4.0) | 59/1747 (3.4) | |
| Platelets, particle concentration (109/L) | < 0.65 × LLN and > 50% decrease from baseline | 17/1663 (1.0) | 20/1673 (1.2) |
| > 1.5 × ULN and > 100% increase from baseline | 59/1663 (3.5) | 63/1673 (3.8) | |
| Clinical chemistry | |||
| ALT (μkat/L) | > 3 × ULN and > 200% increase from baseline | 66/1818 (3.6) | 71/1821 (3.9) |
| Albumin (g/L) | < 0.5 × LLN and > 50% decrease from baseline | 2/1837 (0.1) | 3/1829 (0.2) |
| > 1.5 × ULN and > 50% increase from baseline | 0/1837 (0.0) | 0/1829 (0.0) | |
| ALP (μkat/L) | < 0.5 × LLN and > 80% decrease from baseline | 0/1919 (0.0) | 0/1923 (0.0) |
| > 2 × ULN and > 100% increase from baseline | 51/1919 (2.7) | 44/1923 (2.3) | |
| AST (μkat/L) | > 3 × ULN and > 200% increase from baseline | 63/1761 (3.6) | 53/1757 (3.0) |
| Bilirubin, direct (conjugated) (μmol/L) | > 2.5 × ULN and > 150% increase from baseline | 4/1403 (0.3) | 17/1381 (1.2) |
| Total bilirubin (μmol/L) | > 2 × ULN and > 150% increase from baseline | 4/1841 (0.2) | 13/1836 (0.7) |
| Creatinine (μmol/L) | > 2 × ULN and > 100% increase from baseline | 8/1929 (0.4) | 12/1928 (0.6) |
| Gamma-glutamyltransferase (μkat/L) | > 3 × ULN and > 200% increase from baseline | 78/1763 (4.4) | 84/1759 (4.8) |
| Urea nitrogen (mmol/L) | < 0.2 × LLN and > 100% decrease from baseline | 0/1930 (0.0) | 0/1927 (0.0) |
| > 3 × ULN and > 200% increase from baseline | 3/1930 (0.2) | 3/1927 (0.2) | |
| Potassium (mmol/L) | < 0.8 × LLN and > 20% decrease from baseline | 43/1893 (2.3) | 39/1882 (2.1) |
| > 1.2 × ULN and > 20% increase from baseline | 15/1893 (0.8) | 13/1882 (0.7) | |
| Coagulation | |||
| Activated partial thromboplastin time (s) | < 0.5 × LLN and > 50% decrease from baseline | 0/1617 (0.0) | 0/1642 (0.0) |
| > 2 × ULN and > 100% increase from baseline | 8/1617 (0.5) | 18/1642 (1.1) | |
| International normalised ratio | < 0.5 × LLN and > 50% decrease from baseline | 0/1638 (0.0) | 0/1663 (0.0) |
| > 2 × ULN and > 100% increase from baseline | 24/1638 (1.5) | 13/1663 (0.8) | |
| Prothrombin time (s) | < 0.5 × LLN and > 50% decrease from baseline | 0/1627 (0.0) | 0/1652 (0.0) |
| > 2 × ULN and > 100% increase from baseline | 24/1627 (1.5) | 14/1652 (0.8) | |
ALP alkaline phosphatase, ALT alanine aminotransferase, AST aspartate aminotransferase, LLN lower limit of normal value, m number of patients with both baseline and post-baseline values, n number of patients with potentially clinically significant criteria, N number of patients in treatment group, ULN upper limit of normal