Table 2.
Patient disposition (ITT population)a.
| Non-frailb | Frail | |||||||
|---|---|---|---|---|---|---|---|---|
| Fit (19.8%c; n = 146/737) | Intermediate (33.9%c; n = 250/737) | Total–non-frailb (53.7%c; n = 396/737) | Frail (46.3%c; n = 341/737) | |||||
| D-Rd (18.5%d; n = 68/368) | Rd (21.1%e; n = 78/369) | D-Rd (34.8%d; n = 128/368) | Rd (33.1%e; n = 122/369) | D-Rd (53.3%d; n = 196/368) | Rd (54.2%e; n = 200/369) | D-Rd (46.7%d; n = 172/368) | Rd (45.8%e; n = 169/369) | |
| Patients who discontinued treatment, n (%) | 20 (29.4) | 45 (57.7) | 45 (35.2) | 74 (60.7) | 65 (33.2) | 119 (59.5) | 78 (45.3) | 114 (67.5) |
| Reason for discontinuation, n (%) | ||||||||
| PD | 14 (20.6) | 21 (26.9) | 25 (19.5) | 35 (28.7) | 39 (19.9) | 56 (28.0) | 32 (18.6) | 43 (25.4) |
| AE | 5 (7.4) | 12 (15.4) | 9 (7.0) | 21 (17.2) | 14 (7.1) | 33 (16.5) | 17 (9.9) | 32 (18.9) |
| Non-compliance with study drugf | 1 (1.5) | 4 (5.1) | 5 (3.9) | 7 (5.7) | 6 (3.1) | 11 (5.5) | 8 (4.7) | 12 (7.1) |
| Death | 0 | 2 (2.6) | 5 (3.9) | 3 (2.5) | 5 (2.6) | 5 (2.5) | 18 (10.5) | 15 (8.9) |
| Physician decision | 0 | 5 (6.4) | 0 | 7 (5.7) | 0 | 12 (6.0) | 2 (1.2) | 6 (3.6) |
| Patient withdrawal | 0 | 1 (1.3) | 0 | 1 (0.8) | 0 | 2 (1.0) | 0 | 4 (2.4) |
| Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (1.2) |
| Other | 0 | 0 | 1 (0.8) | 0 | 1 (0.5) | 0 | 1 (0.6) | 0 |
| Patients who discontinued treatment during the first 12 months, n (%) | 5 (7.4) | 19 (24.4) | 16 (12.5) | 42 (34.4) | 21 (10.7) | 61 (30.5) | 38 (22.1) | 56 (33.1) |
| Reason for discontinuation during the first 12 months, n (%) | ||||||||
| PD | 3 (4.4) | 6 (7.7) | 8 (6.3) | 16 (13.1) | 11 (5.6) | 22 (11.0) | 12 (7.0) | 12 (7.1) |
| AE | 1 (1.5) | 6 (7.7) | 5 (3.9) | 15 (12.3) | 6 (3.1) | 21 (10.5) | 10 (5.8) | 20 (11.8) |
| Non-compliance with study drugf | 1 (1.5) | 3 (3.8) | 2 (1.6) | 3 (2.5) | 3 (1.5) | 6 (3.0) | 4 (2.3) | 8 (4.7) |
| Death | 0 | 1 (1.3) | 1 (0.8) | 3 (2.5) | 1 (0.5) | 4 (2.0) | 10 (5.8) | 9 (5.3) |
| Physician decision | 0 | 3 (3.8) | 0 | 4 (3.3) | 0 | 7 (3.5) | 2 (1.2) | 3 (1.8) |
| Patient withdrawal | 0 | 0 | 0 | 1 (0.8) | 0 | 1 (0.5) | 0 | 3 (1.8) |
| Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.6) |
ITT intent-to-treat, D-Rd daratumumab plus lenalidomide/dexamethasone, Rd lenalidomide/dexamethasone, PD progressive disease, AE adverse event.
aPercentages in the table were calculated using the number of patients in each treatment cohort per frailty subgroup of the ITT population (fit: D-Rd, n = 68; Rd, n = 78; intermediate: D-Rd, n = 128; Rd, n = 122; total–non-frail: D-Rd, n = 196; Rd, n = 200; frail: D-Rd, n = 172; Rd, n = 169) as the denominator, unless otherwise indicated.
bNon-frail subgroup consists of fit and intermediate patients.
cPercentage was calculated using the number of patients in the ITT population as the denominator.
dPercentage was calculated using the number of patients in the D-Rd cohort of the ITT population as the denominator.
ePercentage was calculated using the number of patients in the Rd cohort of the ITT population as the denominator.
fBased on reason “Patient refused further study treatment.”