Enasidenib interruption/discontinuation for DS
| . | Duration of DS . | DS severity . | All DS events . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| <5 d . | 5-10 d . | 11-20 d . | >20 d . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . | ||
| Number of DS events, n | 4 | 32 | 19 | 21 | 15 | 46 | 13 | 2 | 76 |
| Enasidenib interruption or discontinuation, n (%) | |||||||||
| No | 3 (75.0) | 16 (50.0) | 8 (42.1) | 11 (52.4) | 8 (53.3) | 23 (50.0) | 5 (38.5) | 2 (100.0) | 38 (50.0) |
| Yes | |||||||||
| Interruption | 1 (25.0) | 15 (46.9) | 9 (47.4) | 10 (47.6) | 7 (46.7) | 21 (45.7) | 7 (53.8) | 0 | 35 (46.1) |
| Discontinuation | 0 | 1 (3.1) | 2 (10.5) | 1 (4.8) | 0 | 3 (6.5) | 1 (7.7) | 0 | 4 (5.3) |
| Duration of interruption, n (%) | |||||||||
| <5 d | 1 (25.0) | 4 (12.5) | 1 (5.3) | 0 | 0 | 3 (6.5) | 3 (23.1) | 0 | 6 (7.9) |
| 5-10 d | 0 | 9 (28.1) | 2 (10.5) | 0 | 1 (6.7) | 8 (17.4) | 2 (15.4) | 0 | 11 (14.5) |
| 11-20 d | 0 | 2 (6.3) | 4 (21.1) | 3 (14.3) | 4 (26.7) | 4 (8.7) | 1 (7.7) | 0 | 9 (11.8) |
| >20 d | 0 | 0 | 2 (10.5) | 6 (28.6) | 2 (13.3) | 5 (10.9) | 1 (7.7) | 0 | 8 (10.5) |
| Missing | 0 | 0 | 0 | 1 (4.8) | 0 | 1 (2.2) | 0 | 0 | 1 (1.3) |
| Time from DS start date to dose interruption/discontinuation, n (%) | |||||||||
| Dose stopped before DS event | 0 | 2 (6.3) | 1 (5.3) | 1 (4.8) | 2 (13.3) | 1 (2.2) | 1 (7.7) | 0 | 4 (5.3) |
| 0-1 d | 1 (25.0) | 10 (31.3) | 5 (26.3) | 4 (19.0) | 2 (13.3) | 14 (30.4) | 4 (30.8) | 0 | 20 (26.3) |
| 2-3 d | 0 | 4 (12.5) | 2 (10.5) | 2 (9.5) | 2 (13.3) | 3 (6.5) | 3 (23.1) | 0 | 8 (10.5) |
| ≥4 d | 0 | 0 | 3 (15.8) | 3 (14.3) | 1 (6.7) | 5 (10.9) | 0 | 0 | 6 (7.9) |
| Time from end of prior DS to recurrence of DS, n/N (%) | |||||||||
| No enasidenib interruption∗ | 0 | 0 | 1/3 (33.3) | 3/5 (60.0) | - | - | - | - | 4/9 (44.4) |
| Enasidenib interruption∗ | 0 | 1/1 (100.0) | 2/3 (66.7) | 2/5 (40.0) | - | - | - | - | 5/9 (55.6) |
| . | Duration of DS . | DS severity . | All DS events . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| <5 d . | 5-10 d . | 11-20 d . | >20 d . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . | ||
| Number of DS events, n | 4 | 32 | 19 | 21 | 15 | 46 | 13 | 2 | 76 |
| Enasidenib interruption or discontinuation, n (%) | |||||||||
| No | 3 (75.0) | 16 (50.0) | 8 (42.1) | 11 (52.4) | 8 (53.3) | 23 (50.0) | 5 (38.5) | 2 (100.0) | 38 (50.0) |
| Yes | |||||||||
| Interruption | 1 (25.0) | 15 (46.9) | 9 (47.4) | 10 (47.6) | 7 (46.7) | 21 (45.7) | 7 (53.8) | 0 | 35 (46.1) |
| Discontinuation | 0 | 1 (3.1) | 2 (10.5) | 1 (4.8) | 0 | 3 (6.5) | 1 (7.7) | 0 | 4 (5.3) |
| Duration of interruption, n (%) | |||||||||
| <5 d | 1 (25.0) | 4 (12.5) | 1 (5.3) | 0 | 0 | 3 (6.5) | 3 (23.1) | 0 | 6 (7.9) |
| 5-10 d | 0 | 9 (28.1) | 2 (10.5) | 0 | 1 (6.7) | 8 (17.4) | 2 (15.4) | 0 | 11 (14.5) |
| 11-20 d | 0 | 2 (6.3) | 4 (21.1) | 3 (14.3) | 4 (26.7) | 4 (8.7) | 1 (7.7) | 0 | 9 (11.8) |
| >20 d | 0 | 0 | 2 (10.5) | 6 (28.6) | 2 (13.3) | 5 (10.9) | 1 (7.7) | 0 | 8 (10.5) |
| Missing | 0 | 0 | 0 | 1 (4.8) | 0 | 1 (2.2) | 0 | 0 | 1 (1.3) |
| Time from DS start date to dose interruption/discontinuation, n (%) | |||||||||
| Dose stopped before DS event | 0 | 2 (6.3) | 1 (5.3) | 1 (4.8) | 2 (13.3) | 1 (2.2) | 1 (7.7) | 0 | 4 (5.3) |
| 0-1 d | 1 (25.0) | 10 (31.3) | 5 (26.3) | 4 (19.0) | 2 (13.3) | 14 (30.4) | 4 (30.8) | 0 | 20 (26.3) |
| 2-3 d | 0 | 4 (12.5) | 2 (10.5) | 2 (9.5) | 2 (13.3) | 3 (6.5) | 3 (23.1) | 0 | 8 (10.5) |
| ≥4 d | 0 | 0 | 3 (15.8) | 3 (14.3) | 1 (6.7) | 5 (10.9) | 0 | 0 | 6 (7.9) |
| Time from end of prior DS to recurrence of DS, n/N (%) | |||||||||
| No enasidenib interruption∗ | 0 | 0 | 1/3 (33.3) | 3/5 (60.0) | - | - | - | - | 4/9 (44.4) |
| Enasidenib interruption∗ | 0 | 1/1 (100.0) | 2/3 (66.7) | 2/5 (40.0) | - | - | - | - | 5/9 (55.6) |
Data from the pooled AML safety population.
AML, acute myeloid leukemia; d, day(s); DS, differentiation syndrome.
Enasidenib interruption for prior event.