Table 3 Serious adverse events during months 0–12 and months13–24 by kidney function group
CTCAE category | Time period | Control (n = 93) | Dose escalation (n = 90) | ||||
|---|---|---|---|---|---|---|---|
CrCL <30 ml/min (n = 14) | CrCL ≥30 to <60 ml/min (n = 31) | CrCL ≥60 ml/min (n = 48) | CrCL <30 ml/min (n = 10) | CrCL ≥30 to <60 ml/min (n = 40) | CrCL ≥60 ml/min (n = 40) | ||
Cardiac disorders | Month 0–12 | 6 (3) | 7 (4) | 1 (1) | 1 (1) | 9 (7) | 4 (3) |
Month 13–24 | 3 (2) | 8 (5) | 0 | 0 | 6 (5) | 2 (2) | |
Gastrointestinal disorders | Month 0–12 | 1 (1) | 3 (3) | 2 (2) | 0 | 3 (3) | 0 |
Month 13–24 | 0 | 5 (4) | 1 (1) | 0 | 3 (3) | 0 | |
General disorders | Month 0–12 | 1 (1) | 0 | 0 | 0 | 0 | 1 (1) |
Month 13–24 | 1 (1) | 0 | 1 (1) | 0 | 0 | 1 (1) | |
Hepatobiliary disorders | Month 0–12 | 0 | 0 | 0 | 0 | 1 (1) | 0 |
Month 13–24 | 0 | 0 | 0 | 0 | 0 | 0 | |
Infections and infestations | Month 0–12 | 2 (2) | 3 (3) | 3 (3) | 1 (1) | 2 (1) | 1 (1) |
Month 13–24 | 0 | 6 (4) | 2 (2) | 3 (3) | 5 (3) | 1 (1) | |
Injury, poisoning and procedural complications | Month 0–12 | 1 (1) | 0 | 1 (1) | 0 | 1 (1) | 0 |
Month 13–24 | 1 (1) | 3 (2) | 1 (1) | 0 | 1 (1) | 0 | |
Investigations | Month 0–12 | 0 | 0 | 0 | 0 | 1 (1) | 0 |
Month 13–24 | 0 | 0 | 0 | 0 | 0 | 0 | |
Metabolism and nutrition | Month 0–12 | 0 | 0 | 0 | 1 (1) | 1 (1) | 0 |
Month 13–24 | 0 | 0 | 0 | 0 | 0 | 0 | |
Musculoskeletal | Month 0–12 | 0 | 0 | 1 (1) | 1 (1) | 0 | 0 |
Month 13–24 | 0 | 0 | 2 (1) | 0 | 1 (1) | 0 | |
Nervous system disorders | Month 0–12 | 1 (1) | 1 (1) | 1 (1) | 0 | 0 | 1 (1) |
Month 13–24 | 3 (2) | 0 | 0 | 1 (1) | 3 (3) | 0 | |
Renal and urinary disorders | Month 0–12 | 3 (3) | 2 (2) | 0 | 1 (1) | 1 (1) | 0 |
Month 13–24 | 0 | 0 | 0 | 2 (2) | 1 (1) | 0 | |
Respiratory, thoracic and mediastinal disorders | Month 0–12 | 0 | 1 (1) | 1 (1) | 1 (1) | 1 (1) | 0 |
Month 13–24 | 0 | 0 | 0 | 0 | 0 | 0 | |
Skin and subcutaneous tissue disorders | Month 0–12 | 1 (1) | 0 | 0 | 0 | 0 | 2 (1) |
Month 13–24 | 0 | 0 | 0 | 0 | 0 | 0 | |
Psychiatric disorders | Month 0–12 | 0 | 0 | 0 | 0 | 0 | 0 |
Month 13–24 | 1 (1) | 0 | 0 | 0 | 0 | 1 (1) | |
Vascular disorders | Month 0–12 | 0 | 0 | 0 | 0 | 0 | 0 |
Month 13–24 | 0 | 0 | 0 | 0 | 1 (1) | 0 | |