Table 4.
Treatment-related TEAEs in >5% of patients in either CR or non-CR group
| TEAEs, n (%) | CR (any UP/C ≤ 0.3 g/g) (n = 46) |
Non-CR (no UP/C ≤ 0.3 g/g) (n = 62) |
|---|---|---|
| Any treatment-related TEAE | 30 (65) | 41 (66) |
| Treatment-related TEAEs in >5% of patients | ||
| Hyperkalemia | 12 (26) | 7 (11) |
| Hypotension | 10 (22) | 9 (15) |
| Blood creatinine increased | 5 (11) | 3 (5) |
| Dizziness | 4 (9) | 9 (15) |
| Headache | 4 (9) | 7 (11) |
| Nausea | 4 (9) | 6 (10) |
| Blood creatine phosphokinase increased | 4 (9) | 2 (3) |
| Anemia | 3 (7) | 4 (6) |
| Edema peripheral | 2 (4) | 5 (8) |
| Glomerular filtration rate decreased | 1 (2) | 7 (11) |
| Vomiting | 0 | 7 (11) |
| Acute kidney injury | 0 | 5 (8) |
CR, complete remission; TEAE, treatment-emergent adverse event.
TEAEs indicating acute kidney injury include the preferred terms blood creatinine increases, acute kidney injury, and glomerular filtration rate decreased. TEAEs indicating fluid retention include the preferred terms edema peripheral, edema fluid overload, joint effusion, joint swelling, and pleural effusion.