Table 4 ECG after treatment administration: QTcB and QTcF (continuous parameter in ms)—Safety, QTcF/QTcB and strict QTcF/QTcB population
Safety population | QTcF/QTcB population | Strict QTcF/QTcB population | ||||
|---|---|---|---|---|---|---|
N = 294 | N = 143 | N = 60 | ||||
QTcF | QTcB | QTcF | QTcB | QTcF | QTcB | |
Baseline | ||||||
N | 234 | 237 | 143 | 143 | 60 | 60 |
Missing | 60 | 57 | 0 | 0 | 0 | 0 |
Mean (SD) | 387.8 (29.6) | 410.8 (32.3) | 385.3 (28.6) | 408.5 (29.8 | 386.8 (32.8) | 407.7 (33.4) |
Range | 290; 478 | 290; 557 | 299; 470 | 309; 486 | 299; 470 | 309; 480 |
Final treatment day | ||||||
N | 186 | 186 | 143 | 143 | ||
Missing | 108 | 108 | 0 | 0 | ||
Mean (SD) | 405.9 (28.8) | 413.9 (31.8) | 404.2 (29.1) | 411.8 (32.3) | ||
Range | 299; 494 | 289; 500 | 299; 494 | 289; 500 | ||
Strict final treatment day | ||||||
N | 71 | 71 | 60 | 60 | 60 | 60 |
Missing | 223 | 223 | 83 | 83 | 0 | 0 |
Mean (SD) | 406.7 (36.2) | 411.7 (38.8) | 404.3 (35.3) | 410.2 (38.4) | 404.3 (35.3) | 410.2 (38.4) |
Range | 299; 494 | 289; 500 | 299; 494 | 289; 500 | 299; 494 | 289; 500 |
Absolute change from baseline to final treatment day | ||||||
N | 143 | 146 | 143 | 143 | ||
Missing | 151 | 148 | 0 | 0 | ||
Mean (SD) | 18.9 (24.7) | 4.0 (26.7) | 18.9 (24.7) | 3.3 (25.0) | ||
Range | − 47; 81 | − 68; 116 | − 47; 81 | − 68; 80 | ||
Absolute change from baseline to strict final treatment day | ||||||
N | 60 | 62 | 60 | 60 | 60 | 60 |
Missing | 234 | 232 | 83 | 83 | 0 | 0 |
Mean (SD) | 17.5 (18.9) | 4.7 (26.7) | 17.5 (18.9) | 2.6 (22.8) | 17.5 (18.9) | 2.6 (22.8) |
Range | − 23; 69 | − 46; 116 | − 23; 69 | − 46; 80 | − 23; 69 | − 46; 80 |
Change in QTcF/QTcB in classes from baseline to final treatment day | ||||||
Missing | 151 | 148 | 0 | 0 | ||
Strict decrease or no change | 28 (19.6%) | 65 (44.5%) | 28 (19.6%) | 64 (44.8%) | ||
Increase < 30 ms | 70 (49.0%) | 59 (40.4%) | 70 (49.0%) | 58 (40.6%) | ||
Increase between 30 and 60 ms | 36 (25.2%) | 20 (13.7%) | 36 (25.2%) | 20 (14.0%) | ||
Increase > 60 ms | 9 (6.3%) | 2 (1.4%) | 9 (6.3%) | 1 (0.7%) | ||
Change in QTcF/QTcB in classes from baseline to strict final treatment day | ||||||
Missing | 234 | 232 | 83 | 83 | 0 | 0 |
Strict decrease or no change | 10 (16.7%) | 30 (48.4%) | 10 (16.7%) | 30 (50.0%) | 10 (16.7%) | 30 (50.0%) |
Increase < 30 ms | 36 (60.0%) | 24 (38.7%) | 36 (60.0%) | 23 (38.3%) | 36 (60.0%) | 23 (38.3%) |
Increase between 30 and 60 ms | 12 (20.0%) | 6 (9.7%) | 12 (20.0%) | 6 (10.0%) | 12 (20.0%) | 6 (10.0%) |
Increase > 60 ms | 2 (3.3%) | 2 (3.2%) | 2 (3.3%) | 1 (1.7%) | 2 (3.3%) | 1 (1.7%) |