Treatment exposure, dose intensity, dose adjustment, and study drug discontinuation
| Dosing and exposure . | Momelotinib overall (N = 725) . | Momelotinib-randomized treatment phase (n = 448) . | Momelotinib open-label phase (n = 604) . |
|---|---|---|---|
| Median duration of exposure (range), mo | 11.3 (0.1-90.4) | 5.5 (0.1-6.1) | 11.0 (0.0-85.0) |
| Duration of exposure, n (%) | |||
| ≥4 wk | 684 (94.3) | 425 (94.9) | 565 (93.5) |
| ≥8 wk | 637 (87.9) | 402 (89.7) | 515 (85.3) |
| ≥12 wk | 602 (83.0) | 385 (85.9) | 486 (80.5) |
| ≥24 wk | 513 (70.8) | 207 (46.2) | 406 (67.2) |
| ≥48 wk | 367 (50.6) | — | 302 (50.0) |
| ≥96 wk | 213 (29.4) | — | 193 (32.0) |
| ≥36 mo | 134 (18.5) | — | 122 (20.2) |
| ≥48 mo | 103 (14.2) | — | 98 (16.2) |
| ≥60 mo | 88 (12.1) | — | 84 (13.9) |
| Average daily dose, median (range), mg | 194.6 (0-494) | 200.0 (0-229) | 194.3 (0-775) |
| Relative dose intensity, median (range), % | 97.3 (0-247) | 100 (0-114) | 97.2 (0-387) |
| Dosing and exposure . | Momelotinib overall (N = 725) . | Momelotinib-randomized treatment phase (n = 448) . | Momelotinib open-label phase (n = 604) . |
|---|---|---|---|
| Median duration of exposure (range), mo | 11.3 (0.1-90.4) | 5.5 (0.1-6.1) | 11.0 (0.0-85.0) |
| Duration of exposure, n (%) | |||
| ≥4 wk | 684 (94.3) | 425 (94.9) | 565 (93.5) |
| ≥8 wk | 637 (87.9) | 402 (89.7) | 515 (85.3) |
| ≥12 wk | 602 (83.0) | 385 (85.9) | 486 (80.5) |
| ≥24 wk | 513 (70.8) | 207 (46.2) | 406 (67.2) |
| ≥48 wk | 367 (50.6) | — | 302 (50.0) |
| ≥96 wk | 213 (29.4) | — | 193 (32.0) |
| ≥36 mo | 134 (18.5) | — | 122 (20.2) |
| ≥48 mo | 103 (14.2) | — | 98 (16.2) |
| ≥60 mo | 88 (12.1) | — | 84 (13.9) |
| Average daily dose, median (range), mg | 194.6 (0-494) | 200.0 (0-229) | 194.3 (0-775) |
| Relative dose intensity, median (range), % | 97.3 (0-247) | 100 (0-114) | 97.2 (0-387) |
| Discontinuations . | Momelotinib overall (N = 725) . | ||
|---|---|---|---|
| Momelotinib discontinuation, n (%) | 537 (74.1) | ||
| Primary reason for momelotinib discontinuation | |||
| AE | 183 (25.2) | ||
| Disease progression | 100 (13.8) | ||
| Insufficient treatment efficacy | 63 (8.7) | ||
| Patient decision | 61 (8.4) | ||
| Death | 55 (7.6) | ||
| Investigator discretion | 47 (6.5) | ||
| Study terminated by sponsor | 18 (2.5) | ||
| Discontinuations . | Momelotinib overall (N = 725) . | ||
|---|---|---|---|
| Momelotinib discontinuation, n (%) | 537 (74.1) | ||
| Primary reason for momelotinib discontinuation | |||
| AE | 183 (25.2) | ||
| Disease progression | 100 (13.8) | ||
| Insufficient treatment efficacy | 63 (8.7) | ||
| Patient decision | 61 (8.4) | ||
| Death | 55 (7.6) | ||
| Investigator discretion | 47 (6.5) | ||
| Study terminated by sponsor | 18 (2.5) | ||
Data cutoff: 3 December 2021.