Table 3.
Integrated analysis of adverse events from four Phase II studies of single-agent carfilzomib in patients with relapsing and remitting multiple myeloma (n=526)
| All grades n (%) |
All grades relateda n (%) |
Grades 3/4 n (%) |
SAEb n (%) |
|
|---|---|---|---|---|
| Hematologic | ||||
| Anemia | 246 (46.8) | 141 (26.8) | 118 (22.4) | 7 (1.3) |
| Thrombocytopenia | 191 (36.3) | 149 (28.3) | 123 (23.4) | 6 (1.1) |
| Lymphopenia | 126 (24.0) | 93 (17.7) | 95 (18.1) | 0 |
| Neutropenia | 109 (20.7) | 84 (16.0) | 54 (10.3) | 2 (0.4) |
| Leukopenia | 71 (13.5) | 56 (10.6) | 28 (5.3) | 0 |
| Nonhematologic | ||||
| Fatigue | 292 (55.5) | 218 (41.4) | 40 (7.6) | 0 |
| Nausea | 236 (44.9) | 185 (35.2) | 7 (1.3) | 0 |
| Dyspnea | 182 (34.6) | 107 (20.3) | 26 (4.9) | 11 (2.1) |
| Diarrhea | 172 (32.7) | 118 (22.4) | 5 (1.0) | 3 (0.6) |
| Pyrexia | 160 (30.4) | 79 (15.0) | 9 (1.7) | 18 (3.4) |
| Upper respiratory tract infection | 149 (28.3) | 38 (7.2) | 17 (3.2) | 5 (1.0) |
| Headache | 145 (27.6) | 83 (15.8) | 7 (1.3) | 0 |
| Cough | 137 (26.0) | 39 (7.4) | 1 (0.2) | 1 (0.2) |
| Increased serum creatinine | 127 (24.1) | 93 (17.7) | 14 (2.7) | 7 (1.3) |
| Peripheral edema | 126 (24.0) | 56 (10.6) | 3 (0.6) | 0 |
| Vomiting | 117 (22.2) | 85 (16.2) | 5 (1.0) | 2 (0.4) |
| Constipation | 110 (20.9) | 57 (10.8) | 1 (0.2) | 0 |
| Back pain | 106 (20.2) | 12 (2.3) | 15 (2.9) | 1 (0.2) |
| Pneumoniac | 67 (12.7) | 24 (4.6) | 55 (10.5) | 52 (9.9) |
Notes:
a
Possibly or probably related to carfilzomib treatment
b
hospitalization or prolongation of existing hospitalization, life-threatening, or led to death
c
one grade 5 event in study 003-A1. Adverse events graded according to the National Cancer Institute Common Terminology Criteria.21 Obtained from Haematologica/the Hematology Journal website http://www.haematologica.org.12
Abbreviation: SAE, serious AEs.