Table 3.
Summary of selected AEs recorded in the safety profiles for ASPIRE and ENDEAVOR trial.
| Adverse Events | ASPIRE trial (93) | ENDEAVOR trial (88, 94) | ||||||
|---|---|---|---|---|---|---|---|---|
| KRd group (N = 392) % | Rd group (N = 389) % | Kd group (N = 463) % | Vd group (N = 456) % | |||||
| All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | |
| Acute renal failure1 | 8.4 | 3.3 | 7.2 | 3.1 | 10.4 | 5.6 | 6.1 | 3.3 |
| Anaemia | 42.6 | 17.9 | 39.8 | 17.2 | 42.5 | 16.4 | 28.3 | 10.1 |
| Cardiac failure2 | 6.4 | 3.8 | 4.1 | 1.8 | 10.8 | 5.8 | 3.3 | 2.0 |
| Constipation | 20.2 | 0.3 | 17.2 | 0.5 | 16.2 | 0.4 | 27.6 | 1.8 |
| Cough | 28.8 | 0.3 | 17.2 | 0 | 27.6 | 0 | 15.8 | 0.2 |
| Diarrhea | 42.3 | 3.8 | 33.7 | 4.1 | 36.3 | 3.9 | 40.6 | 8.6 |
| Dyspnea | 19.4 | 2.8 | 14.9 | 1.8 | 32.2 | 6.3 | 13.6 | 2.2 |
| Fatigue | 32.9 | 7.7 | 30.6 | 6.4 | 32.2 | 6.7 | 30.7 | 7.7 |
| Headache | not given | not given | not given | not given | 20.5 | 0.9 | 10.7 | 0.7 |
| Hypertension | 14.3 | 4.3 | 6.9 | 1.8 | 32.2 | 14.5 | 9.9 | 3.3 |
| Hypokalemia | 27.6 | 9.4 | 13.4 | 4.9 | 13.0 | 2.4 | 11.1 | 3.7 |
| Lymphopenia | not given | not given | not given | not given | 6.7 | 4.8 | 5.5 | 3.1 |
| Muscle spasms | 26.5 | 1.0 | 21.1 | 0.8 | 19.9 | 0.2 | 6.1 | 0.7 |
| Nausea | not given | not given | not given | not given | 23.5 | 1.9 | 20.0 | 0.7 |
| Neutropenia | 37.8 | 29.6 | 33.7 | 26.5 | 6.0 | 2.4 | 5.7 | 2.2 |
| Peripheral Neuropathy | 17.1 | 2.6 | 17.0 | 3.1 | 10.9 | 1.3 | 28.5 | 6.1 |
| Pneumonia | not given | not given | not given | not given | 11.4 | 9.1 | 11.6 | 8.6 |
| Pyrexia | 28.6 | 1.8 | 20.8 | 0.5 | 32.4 | 3.0 | 15.1 | 0.7 |
| Thrombocytopenia | 29.1 | 16.6 | 22.6 | 12.3 | 21.6 | 8.9 | 18.4 | 9.4 |
| Upper respiratory tract infection | 28.6 | 1.8 | 19.3 | 1.0 | 25.7 | 1.7 | 18.2 | 0.9 |
KRd, carfilzomib +Rd; Rd, lenalidomide + dexamethasone; Kd, carfilzomib + dexamethasone; Vd, bortezomib + dexamethasone.
1Acute renal failure group includes acute renal failure, renal failure, renal impairment, azotemia, oliguria, anuria, toxic nephropathy, acute pre-renal failure and pre-renal failure.
2Cardiac failure group includes cardiac failure, congestive cardiac failure, pulmonary edema, hepatic congestion, cardiopulmonary failure, acute pulmonary edema, acute cardiac failure and right ventricular failure for ASPIRE trial and cardiac failure, ejection fraction decreased, pulmonary edema, acute cardiac failure, congestive cardiac failure, acute pulmonary edema, acute left ventricular failure, chronic cardiac failure, cardiopulmonary failure, hepatojugular reflex, right ventricular failure, and left ventricular failure for ENDEAVOR trial.