TABLE 4.
Summary of the number of participants with AEs by renal function group (safety population)a
| AE category, n (%) | Normal renal function (CLCR, ≥80 ml/min) |
Mild RI (CLCR, >50 to <80 ml/min) |
Moderate RI (CLCR, ≥30 to ≤50 ml/min) |
Severe RI (CLCR, ≥15 to <30 ml/min) |
||||
|---|---|---|---|---|---|---|---|---|
| C/T (n = 227) | MEM (n = 235) | C/T (n = 82) | MEM (n = 77) | C/T (n = 35) | MEM (n = 26) | C/T (n = 17) | MEM (n = 21) | |
| Any AEs | 189 (83.3) | 193 (82.1) | 72 (87.8) | 62 (80.5) | 33 (94.3) | 24 (92.3) | 16 (94.1) | 20 (95.2) |
| AEs by severity | ||||||||
| Mild | 48 (21.1) | 44 (18.7) | 15 (18.3) | 10 (13.0) | 3 (8.6) | 3 (11.5) | 3 (17.6) | 1 (4.8) |
| Moderate | 65 (28.6) | 74 (31.5) | 19 (23.2) | 22 (28.6) | 11 (31.4) | 6 (23.1) | 3 (17.6) | 3 (14.3) |
| Severe | 76 (33.5) | 75 (31.9) | 38 (46.3) | 30 (39.0) | 19 (54.3) | 15 (57.7) | 10 (58.8) | 16 (76.2) |
| Any treatment-related AEsb | 23 (10.1) | 19 (8.1) | 11 (13.4) | 1 (1.3) | 2 (5.7) | 4 (15.4) | 2 (11.8) | 3 (14.3) |
| Any serious AEs | 79 (34.8) | 71 (30.2) | 42 (51.2) | 30 (39.0) | 21 (60.0) | 13 (50.0) | 10 (58.8) | 15 (71.4) |
| Any treatment-related serious AEsb | 7 (3.1) | 2 (0.9) | 1 (1.2) | 0 | 0 | 0 | 0 | 0 |
| Any AEs that led to discontinuation of study drug | 16 (7.0) | 23 (9.8) | 10 (12.2) | 10 (13.0) | 7 (20.0) | 3 (11.5) | 4 (23.5) | 6 (28.6) |
| Any treatment-related AEs that led to discontinuation of study drugb | 3 (1.3) | 3 (1.3) | 0 | 1 (1.3) | 0 | 1 (3.8) | 1 (5.9) | 0 |
| Any AEs that resulted in death | 51 (22.5) | 50 (21.3) | 33 (40.2) | 27 (35.1) | 13 (37.1) | 11 (42.3) | 8 (47.1) | 13 (61.9) |
| Any treatment-related AEs that resulted in deathb | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
a
AE, adverse event; CLCR, creatinine clearance; C/T, ceftolozane/tazobactam; MEM, meropenem; RI, renal impairment.
b
In participants with multiple events for which at least one was treatment related, the AE was counted as related to study drug.