Table 2.
All-cause adverse events.
| ERd (n = 318) | Rd (n = 317) | |||||
|---|---|---|---|---|---|---|
| Any grade | Grade 3–4 | Events/100 PYa | Any grade | Grade 3–4 | Events/100 PYb | |
| Event | 316 (99) | 244 (77) | NR | 314 (99) | 217 (68) | NR |
| AEs in ≥30% of patients | ||||||
| Diarrhea | 160 (50) | 24 (8) | NR | 125 (39) | 17 (5) | NR |
| Fatigue | 155 (49) | 32 (10) | NR | 131 (41) | 27 (9) | NR |
| Anemia | 139 (44) | 57 (18) | NR | 120 (38) | 53 (17) | NR |
| Pyrexia | 129 (41) | 11 (3) | NR | 81 (26) | 11 (3) | NR |
| Constipation | 115 (36) | 4 (1) | NR | 89 (28) | 1 (<1) | NR |
| Neutropenia | 114 (36) | 86 (27) | NR | 137 (43) | 109 (34) | NR |
| Cough | 109 (34) | 1 (<1) | NR | 62 (20) | 0 | NR |
| Back pain | 108 (34) | 19 (6) | NR | 98 (31) | 17 (5) | NR |
| Muscle spasm | 100 (31) | 2 (1) | NR | 85 (27) | 3 (1) | NR |
| Peripheral edema | 95 (30) | 4 (1) | NR | 78 (25) | 1 (<1) | NR |
| AEs/AE categories of special interest | ||||||
| Infections | 267 (84) | 112 (35) | 199 | 239 (75) | 85 (27) | 185 |
| Pneumonia | 69 (22) | 48 (15) | 13 | 51 (16) | 33 (10) | 12 |
| Herpes zoster | 23 (7) | 6 (2) | 3 | 7 (2) | 2 (1) | 1 |
| Sepsisc | 13 (4) | 11 (3) | NR | 13 (4) | 6 (2) | NR |
| Renal and urinary disorders | 87 (27) | 17 (5) | 17 | 60 (19) | 15 (5) | 17 |
| Cardiac disorders | 75 (24) | 18 (6) | 17 | 59 (19) | 24 (8) | 18 |
| Lymphopenia | 41 (13) | 27 (8) | 12 | 23 (7) | 12 (4) | 11 |
| SPMs | 39 (12) | NR | 5d | 28 (9) | NR | 4e |
| Basal cell carcinoma | 11 (3) | NR | 1d | 6 (2) | NR | 1e |
| Squamous cell carcinoma of the skin | 10 (3) | NR | 1d | 6 (2) | NR | 1e |
| Total serious AEs | 238 (75) | 169 (53) | NR | 194 (61) | 127 (40) | NR |
Data are n (%).
AE adverse event, ERd elotuzumab plus lenalidomide and dexamethasone, NR not reported, PY patient-years, Rd lenalidomide and dexamethasone, SPM second primary malignancy.
a746.70 PY.
b543.77 PY.
cIncludes urosepsis, bacterial, biliary, neutropenic, pneumococcal, pseudomonal, pulmonary, device-related, and staphylococcal sepsis.
dAdjusted based on 1166.98 PY of follow-up.
eAdjusted based on 1050.78 PY of follow-up.