Table 4.
Integrated analysis of AE by grouped-term organ system from four Phase II studies of single-agent carfilzomib in patients with relapsing and remitting multiple myeloma (n=526)
| Any AE n (%) |
≥grade 3 n (%) |
SAE n (%) |
|
|---|---|---|---|
| Any cardiac | 116 (22.1) | 50 (9.5) | 41 (7.8) |
| Cardiac arrhythmia | 70 (13.3) | 12 (2.3) | 11 (2.1) |
| Cardiac failure | 38 (7.2) | 30 (5.7) | 26 (4.9) |
| Ischemic heart disease | 18 (3.4) | 7 (1.3) | 5 (1.0) |
| Cardiomyopathy | 9 (1.7) | 3 (0.6) | 2 (0.4) |
| Any respiratory | 363 (69.0) | 54 (10.3) | 34 (6.5) |
| Dyspnea | 222 (42.2) | 26 (4.9) | 11 (2.1) |
| Cough | 137 (26.0) | 1 (0.2) | 1 (0.2) |
| Pneumonia | 67 (12.7) | 55 (10.5) | 52 (9.9) |
| Any grouped renal impairment | 174 (33.1) | 38 (7.2) | 32 (6.1) |
| Increased serum creatinine | 127 (24.1) | 14 (2.7) | 7 (1.3) |
| Acute renal failure | 28 (5.3) | 23 (4.4) | 22 (4.2) |
| Renal failure | 20 (3.8) | 6 (1.1) | 7 (1.3) |
Notes: Obtained from Haematologica/the Hematology Journal website http://www.haematologica.org.12
Abbreviations: AE, adverse event; SAE, serious adverse event.