Table 4. Adverse events of any grade by lines of therapy (safety population).
|
1 previous line of therapy |
⩾ 2 previous lines of therapy |
|||
|---|---|---|---|---|
| KRd n=182 | Rd n=154 | KRd n=210 | Rd n=235 | |
| AEs occurring in ⩾10% of patients in any subgroup (preferred terms), n (%) | ||||
| Diarrhea | 83 (45.6) | 59 (38.3) | 83 (39.5) | 72 (30.6) |
| Anemia | 82 (45.1) | 66 (42.9) | 85 (40.5) | 89 (37.9) |
| Fatigue | 65 (35.7) | 45 (29.2) | 64 (30.5) | 74 (31.5) |
| Neutropenia | 59 (32.4) | 45 (29.2) | 89 (42.4) | 86 (36.6) |
| Muscle spasms | 55 (30.2) | 28 (18.2) | 49 (23.3) | 54 (23.0) |
| URTI | 54 (29.7) | 29 (18.8) | 58 (27.6) | 46 (19.6) |
| Cough | 50 (27.5) | 29 (18.8) | 63 (30.0) | 38 (16.2) |
| Pyrexia | 49 (26.9) | 33 (21.4) | 63 (30.0) | 48 (20.4) |
| Thrombocytopenia | 49 (26.9) | 32 (20.8) | 65 (31.0) | 56 (23.8) |
| Nasopharyngitis | 48 (26.4) | 28 (18.2) | 36 (17.1) | 35 (14.9) |
| Hypokalemia | 45 (24.7) | 25 (16.2) | 63 (30.0) | 27 (11.5) |
| Edema peripheral | 45 (24.7) | 28 (18.2) | 40 (19.0) | 47 (20.0) |
| Constipation | 43 (23.6) | 27 (17.5) | 36 (17.1) | 40 (17.0) |
| Dyspnea | 42 (23.1) | 22 (14.3) | 34 (16.2) | 36 (15.3) |
| Insomnia | 38 (20.9) | 23 (14.9) | 37 (17.6) | 40 (17.0) |
| Asthenia | 35 (19.2) | 29 (18.8) | 35 (16.7) | 27 (11.5) |
| Nausea | 34 (18.7) | 26 (16.9) | 44 (21.0) | 29 (12.3) |
| Hypocalcemia | 33 (18.1) | 16 (10.4) | 30 (14.3) | 29 (12.3) |
| Pneumonia | 31 (17.0) | 19 (12.3) | 37 (17.6) | 37 (15.7) |
| Bronchitis | 29 (15.9) | 21 (13.6) | 45 (21.4) | 33 (14.0) |
| Back pain | 27 (14.8) | 35 (22.7) | 40 (19.0) | 43 (18.3) |
| Hypophosphatemia | 27 (14.8) | 13 (8.4) | 25 (11.9) | 16 (6.8) |
| Hyperglycemia | 26 (14.3) | 17 (11.0) | 23 (11.0) | 21 (8.9) |
| Rash | 25 (13.7) | 23 (14.9) | 27 (12.9) | 37 (15.7) |
| Arthralgia | 22 (12.1) | 27 (17.5) | 27 (12.9) | 24 (10.2) |
| Dizziness | 22 (12.1) | 19 (12.3) | 26 (12.4) | 25 (10.6) |
| Pain in extremity | 22 (12.1) | 19 (12.3) | 24 (11.4) | 22 (9.4) |
| Headache | 21 (11.5) | 9 (5.8) | 32 (15.2) | 22 (9.4) |
| Hypertension | 21 (11.5) | 7 (4.5) | 35 (16.7) | 20 (8.5) |
| RTI | 20 (11.0) | 17 (11.0) | 23 (11.0) | 22 (9.4) |
| Vomiting | 20 (11.0) | 16 (10.4) | 27 (12.9) | 16 (6.8) |
| Decreased appetite | 19 (10.4) | 17 (11.0) | 25 (11.9) | 18 (7.7) |
| Bone pain | 15 (8.2) | 18 (11.7) | 24 (11.4) | 18 (7.7) |
| AEs of interest (grouped terms), n (%) | ||||
| Cardiac failurea | 10 (5.5) | 8 (5.2) | 15 (7.1) | 8 (3.4) |
| Ischemic heart diseaseb | 12 (6.6) | 7 (4.5) | 11 (5.2) | 11 (4.7) |
| Acute renal failurec | 20 (11.0) | 10 (6.5) | 13 (6.2) | 18 (7.7) |
Abbreviations: AE, adverse event; CAD, coronary artery disease; KRd, carfilzomib, lenalidomide and dexamethasone; MI, myocardial infarction; Rd, lenalidomide and dexamethasone; RTI, respiratory tract infection; URTI, upper respiratory tract infection.
Included: cardiac failure, congestive cardiac failure, pulmonary edema, hepatic congestion, cardiopulmonary failure, acute pulmonary edema, acute cardiac failure and right ventricular failure.
Included: angina pectoris, MI, acute MI, increased blood creatinine phosphokinase, CAD, myocardial ischemia, coronary artery occlusion, increased troponin, increased troponin T, acute coronary syndrome, abnormal cardiac stress test, cardiomyopathy stress, unstable angina, coronary artery stenosis, abnormal electrocardiogram ST-T segment and abnormal electrocardiogram T wave.
Included: acute renal failure, renal failure, renal impairment, azotemia, oliguria, anuria, toxic nephropathy and prerenal failure.