Table 1.
Most common (> 30%)a any grade TEAEs by age (< 65 years and ≥ 65 years).
| < 65 years | ≥ 65 years | |||
|---|---|---|---|---|
| Most common TEAEs, n (%) | D-RVd (n = 72) | RVd (n = 75) | D-RVd (n = 27) | RVd (n = 27) |
| Hematologic | ||||
| Neutropenia | 47 (65.3) | 29 (38.7) | 16 (59.3) | 12 (44.4) |
| Thrombocytopenia | 30 (41.7) | 24 (32.0) | 14 (51.9) | 12 (44.4) |
| Leukopenia | 29 (40.3) | 21 (28.0) | 10 (37.0) | 9 (33.3) |
| Anemia | 25 (34.7) | 25 (33.3) | 12 (44.4) | 8 (29.6) |
| Lymphopenia | 23 (31.9) | 23 (30.7) | 8 (29.6) | 6 (22.2) |
| Nonhematologic | ||||
| Upper respiratory tract infection | 51 (70.8) | 37 (49.3) | 16 (59.3) | 14 (51.9) |
| Diarrhea | 48 (66.7) | 39 (52.0) | 18 (66.7) | 17 (63.0) |
| Fatigue | 48 (66.7) | 45 (60.0) | 23 (85.2) | 18 (66.7) |
| Peripheral neuropathyb | 41 (56.9) | 56 (74.7) | 21 (77.8) | 22 (81.5) |
| Nausea | 38 (52.8) | 37 (49.3) | 14 (51.9) | 14 (51.9) |
| Constipation | 37 (51.4) | 29 (38.7) | 14 (51.9) | 13 (48.1) |
| Insomnia | 36 (50.0) | 25 (33.3) | 9 (33.3) | 6 (22.2) |
| Cough | 35 (48.6) | 26 (34.7) | 18 (66.7) | 5 (18.5) |
| Pyrexia | 34 (47.2) | 27 (36.0) | 14 (51.9) | 6 (22.2) |
| Back pain | 30 (41.7) | 29 (38.7) | 11 (40.7) | 7 (25.9) |
| Arthralgia | 27 (37.5) | 26 (34.7) | 12 (44.4) | 12 (44.4) |
| Headache | 27 (37.5) | 18 (24.0) | 6 (22.2) | 6 (22.2) |
| Muscle spasms | 26 (36.1) | 11 (14.7) | 4 (14.8) | 9 (33.3) |
| Vomiting | 25 (34.7) | 21 (28.0) | 7 (25.9) | 8 (29.6) |
| Peripheral edema | 24 (33.3) | 25 (33.3) | 12 (44.4) | 12 (44.4) |
| Hypokalemia | 19 (26.4) | 20 (26.7) | 9 (33.3) | 7 (25.9) |
| Pain in extremity | 19 (26.4) | 13 (17.3) | 3 (11.1) | 9 (33.3) |
| Dyspnea | 14 (19.4) | 24 (32.0) | 10 (37.0) | 7 (25.9) |
| Dizziness | 15 (20.8) | 16 (21.3) | 8 (29.6) | 9 (33.3) |
| Pneumonia | 14 (19.4) | 16 (21.3) | 10 (37.0) | 2 (7.4) |
| Dysgeusia | 14 (19.4) | 14 (18.7) | 9 (33.3) | 5 (18.5) |
TEAE treatment-emergent adverse event, D-RVd daratumumab plus lenalidomide/bortezomib/dexamethasone, RVd lenalidomide/bortezomib/dexamethasone.
aIncludes TEAEs occurring in ≥ 30% of patients aged < 65 years or ≥ 65 years in either treatment group from the safety analysis population (all randomized patients who received ≥ 1 dose of study treatment).
bIncludes preferred terms neuropathy peripheral and peripheral sensory neuropathy.