Patient disposition
. | Cohort 1 No RUX NTD (n = 22) . | Cohort 3A RUX NTD (n = 14) . | Cohort 2 No RUX TD (n = 21) . | Cohort 3B RUX TD (n = 38) . | Total (N = 95) . |
---|---|---|---|---|---|
Patients who discontinued treatment | 22 (100) | 14 (100) | 21 (100) | 38 (100) | 95 (100) |
Primary reason for treatment discontinuation | |||||
Completed primary phase∗ | 8 (36.4) | 2 (14.3) | 10 (47.6) | 8 (21.1) | 28 (29.5) |
Death | 1 (4.5) | 0 | 2 (9.5) | 5 (13.2) | 8 (8.4) |
AE | 1 (4.5) | 0 | 2 (9.5) | 5 (13.2) | 8 (8.4) |
Progressive disease | 1 (4.5) | 1 (7.1) | 0 | 1 (2.6) | 3 (3.2) |
Withdrawal by patient | 2 (9.1) | 5 (35.7) | 1 (4.8) | 4 (10.5) | 12 (12.6) |
Lack of efficacy | 2 (9.1) | 2 (14.3) | 2 (9.5) | 6 (15.8) | 12 (12.6) |
Physician decision | 0 | 0 | 1 (4.8) | 0 | 1 (1.1) |
Other: loss of response | 4 (18.2) | 3 (21.4) | 2 (9.5) | 4 (10.5) | 13 (13.7) |
Other: rollover to LTFU | 1 (4.5) | 0 | 1 (4.8) | 5 (13.2) | 7 (7.4) |
Other: blasts of >10% | 1 (4.5) | 1 (7.1) | 0 | 0 | 2 (2.1) |
Other: received BMT | 1 (4.5) | 0 | 0 | 0 | 1 (1.1) |
Patients continued to follow-up | 18 (81.8) | 11 (78.6) | 14 (66.7) | 20 (52.6) | 63 (66.3) |
. | Cohort 1 No RUX NTD (n = 22) . | Cohort 3A RUX NTD (n = 14) . | Cohort 2 No RUX TD (n = 21) . | Cohort 3B RUX TD (n = 38) . | Total (N = 95) . |
---|---|---|---|---|---|
Patients who discontinued treatment | 22 (100) | 14 (100) | 21 (100) | 38 (100) | 95 (100) |
Primary reason for treatment discontinuation | |||||
Completed primary phase∗ | 8 (36.4) | 2 (14.3) | 10 (47.6) | 8 (21.1) | 28 (29.5) |
Death | 1 (4.5) | 0 | 2 (9.5) | 5 (13.2) | 8 (8.4) |
AE | 1 (4.5) | 0 | 2 (9.5) | 5 (13.2) | 8 (8.4) |
Progressive disease | 1 (4.5) | 1 (7.1) | 0 | 1 (2.6) | 3 (3.2) |
Withdrawal by patient | 2 (9.1) | 5 (35.7) | 1 (4.8) | 4 (10.5) | 12 (12.6) |
Lack of efficacy | 2 (9.1) | 2 (14.3) | 2 (9.5) | 6 (15.8) | 12 (12.6) |
Physician decision | 0 | 0 | 1 (4.8) | 0 | 1 (1.1) |
Other: loss of response | 4 (18.2) | 3 (21.4) | 2 (9.5) | 4 (10.5) | 13 (13.7) |
Other: rollover to LTFU | 1 (4.5) | 0 | 1 (4.8) | 5 (13.2) | 7 (7.4) |
Other: blasts of >10% | 1 (4.5) | 1 (7.1) | 0 | 0 | 2 (2.1) |
Other: received BMT | 1 (4.5) | 0 | 0 | 0 | 1 (1.1) |
Patients continued to follow-up | 18 (81.8) | 11 (78.6) | 14 (66.7) | 20 (52.6) | 63 (66.3) |
Data are n (%).
BMT, bone marrow transplant; LTFU, long term follow-up; RUX, ruxolitinib.
Completed primary treatment phase without clinical benefit.