Table 3.
Safety summary.a,b
| Intense (n = 41) | Intermediate (n = 41) | Short (n = 40)c | |
|---|---|---|---|
| Median (range) duration of treatment, months | 25.8 (1.0–33.1) | 25.8 (1.9–33.1) | 1.6 (0.1–1.9) |
| Most common (>25%) any grade TEAE, n (%) | |||
| Fatigue | 17 (41.5) | 25 (61.0) | 9 (22.5) |
| Upper respiratory tract infection | 15 (36.6) | 14 (34.1) | 4 (10.0) |
| Cough | 15 (36.6) | 13 (31.7) | 11 (27.5) |
| Insomnia | 13 (31.7) | 13 (31.7) | 5 (12.5) |
| Headache | 11 (26.8) | 10 (24.4) | 13 (32.5) |
| Diarrhea | 11 (26.8) | 10 (24.4) | 4 (10.0) |
| Arthralgia | 11 (26.8) | 9 (22.0) | 0 |
| Nausea | 8 (19.5) | 11 (26.8) | 3 (7.5) |
| Grade 3/4 TEAEs, n (%) | 18 (43.9) | 11 (26.8) | 6 (15.0) |
| Serious AEs, n (%) | 13 (31.7) | 6 (14.6) | 4 (10.0) |
| Within the first 8 weeks | 5 (12.2) | 0 | 4 (10.0) |
| Related to daratumumab | 0 | 1 (2.4) | 1 (2.5) |
| Discontinued treatment due to TEAE, n (%) | 3 (7.3) | 1 (2.4) | 2 (5.0) |
| Related to daratumumab | 1 (2.4)d | 0 | 1 (2.5)e |
| Any grade IRR rate, n (%) | 23 (56.1) | 18 (43.9) | 22 (55.0) |
TEAE treatment-emergent adverse event, AE adverse event, IRR infusion-related reaction.
aBased on the clinical cutoff date of June 29, 2018.
bThe safety analysis population included patients who were randomized, received at least one dose of study drug, and contributed any safety data after the start of study treatment.
cOne patient in the short arm was randomized but did not receive study treatment.
dThrombocytopenia.
eUnstable angina.