Summary of patient-reported convenience status (intention-to-treat population)
| . | Twice-weekly KRd27 (N = 226) . | Once-weekly KRd56 (N = 228) . | Treatment difference . |
|---|---|---|---|
| Patient-reported convenience status at cycle 2 | |||
| All randomized patients∗ | 226 | 228 | |
| Convenient, n (%) (95% CI) | 151 (66.8) (60.3-72.9) | 179 (78.5) (72.6-83.7) | |
| Inconvenient | 44 (19.5) | 10 (4.4) | |
| Missing | 31 (13.7) | 39 (17.1) | |
| All expected patients† | 222 | 217 | |
| Convenient | 151 (68.0) | 179 (82.5) | |
| Inconvenient | 44 (19.8) | 10 (4.6) | |
| Missing | 27 (12.2) | 28 (12.9) | |
| Patient-reported convenience status at cycle 5 | |||
| All randomized patients∗ | 226 | 228 | |
| Convenient, n (%) (95% CI) | 160 (70.8) (64.4-76.6) | 172 (75.4) (69.3-80.9) | |
| Inconvenient | 31 (13.7) | 10 (4.4) | |
| Missing | 35 (15.5) | 46 (20.2) | |
| All expected patients† | 205 | 199 | |
| Convenient | 160 (78.0) | 172 (86.4) | |
| Inconvenient | 31 (15.1) | 10 (5.0) | |
| Missing | 14 (6.8) | 17 (8.5) | |
| Patient-reported convenience status at cycle 12 | |||
| All randomized patients∗ | 226 | 228 | |
| Convenient, n (%) (95% CI) | 125 (55.3) (48.6-61.9) | 125 (54.8) (48.1-61.4) | |
| Inconvenient | 18 (8.0) | 8 (3.5) | |
| Missing | 83 (36.7) | 95 (41.7) | |
| All expected patients† | 161 | 157 | |
| Convenient | 125 (77.6) | 125 (79.6) | |
| Inconvenient | 18 (11.2) | 8 (5.1) | |
| Missing | 18 (11.2) | 24 (15.3) | |
| Patient-reported convenience status at safety follow-up‡ | |||
| All randomized patients∗ | 226 | 228 | |
| Convenient, n (%) (95% CI) | 129 (57.1) (50.3-63.6) | 142 (62.3) (55.6-68.6) | |
| Inconvenient | 24 (10.6) | 9 (3.9) | |
| Missing | 73 (32.3) | 77 (33.8) | |
| All expected patients† | 224 | 225 | |
| Convenient | 129 (57.6) | 142 (63.1) | |
| Inconvenient | 24 (10.7) | 9 (4.0) | |
| Missing | 71 (31.7) | 74 (32.9) | |
| Patient-reported convenience status after cycle 4 | |||
| All randomized patients∗ | 226 | 228 | |
| Convenient, n (%) (95% CI) | 182 (80.5) (74.8-85.5) | 186 (81.6) (75.9-86.4) | |
| Very convenient, n (%) | 24 (10.6) | 39 (17.1) | |
| Inconvenient | 21 (9.3) | 7 (3.1) | |
| Missing | 23 (10.2) | 35 (15.4) | |
| Odds ratio (once-weekly KRd56 vs twice-weekly KRd27) (95% CI) | 1.049 (0.653-1.683) | ||
| . | Twice-weekly KRd27 (N = 226) . | Once-weekly KRd56 (N = 228) . | Treatment difference . |
|---|---|---|---|
| Patient-reported convenience status at cycle 2 | |||
| All randomized patients∗ | 226 | 228 | |
| Convenient, n (%) (95% CI) | 151 (66.8) (60.3-72.9) | 179 (78.5) (72.6-83.7) | |
| Inconvenient | 44 (19.5) | 10 (4.4) | |
| Missing | 31 (13.7) | 39 (17.1) | |
| All expected patients† | 222 | 217 | |
| Convenient | 151 (68.0) | 179 (82.5) | |
| Inconvenient | 44 (19.8) | 10 (4.6) | |
| Missing | 27 (12.2) | 28 (12.9) | |
| Patient-reported convenience status at cycle 5 | |||
| All randomized patients∗ | 226 | 228 | |
| Convenient, n (%) (95% CI) | 160 (70.8) (64.4-76.6) | 172 (75.4) (69.3-80.9) | |
| Inconvenient | 31 (13.7) | 10 (4.4) | |
| Missing | 35 (15.5) | 46 (20.2) | |
| All expected patients† | 205 | 199 | |
| Convenient | 160 (78.0) | 172 (86.4) | |
| Inconvenient | 31 (15.1) | 10 (5.0) | |
| Missing | 14 (6.8) | 17 (8.5) | |
| Patient-reported convenience status at cycle 12 | |||
| All randomized patients∗ | 226 | 228 | |
| Convenient, n (%) (95% CI) | 125 (55.3) (48.6-61.9) | 125 (54.8) (48.1-61.4) | |
| Inconvenient | 18 (8.0) | 8 (3.5) | |
| Missing | 83 (36.7) | 95 (41.7) | |
| All expected patients† | 161 | 157 | |
| Convenient | 125 (77.6) | 125 (79.6) | |
| Inconvenient | 18 (11.2) | 8 (5.1) | |
| Missing | 18 (11.2) | 24 (15.3) | |
| Patient-reported convenience status at safety follow-up‡ | |||
| All randomized patients∗ | 226 | 228 | |
| Convenient, n (%) (95% CI) | 129 (57.1) (50.3-63.6) | 142 (62.3) (55.6-68.6) | |
| Inconvenient | 24 (10.6) | 9 (3.9) | |
| Missing | 73 (32.3) | 77 (33.8) | |
| All expected patients† | 224 | 225 | |
| Convenient | 129 (57.6) | 142 (63.1) | |
| Inconvenient | 24 (10.7) | 9 (4.0) | |
| Missing | 71 (31.7) | 74 (32.9) | |
| Patient-reported convenience status after cycle 4 | |||
| All randomized patients∗ | 226 | 228 | |
| Convenient, n (%) (95% CI) | 182 (80.5) (74.8-85.5) | 186 (81.6) (75.9-86.4) | |
| Very convenient, n (%) | 24 (10.6) | 39 (17.1) | |
| Inconvenient | 21 (9.3) | 7 (3.1) | |
| Missing | 23 (10.2) | 35 (15.4) | |
| Odds ratio (once-weekly KRd56 vs twice-weekly KRd27) (95% CI) | 1.049 (0.653-1.683) | ||
The number of all randomized patients was calculated as the number of randomized patients in each treatment group in the intention-to-treat population.
The number of all expected patients was calculated as the number of patients expected to have an assessment, that is, randomized patients who were still alive and remaining on carfilzomib treatment at the scheduled visit.
The number of patients at the safety follow-up visit was calculated as the number of randomized patients who had ended all study treatments or were remaining on treatment at the safety follow-up visit. Patients who had ended all study treatments included patients who discontinued treatment early or completed the 12-cycle treatment.