Duration and severity of DS events by steroid and hydroxyurea use
| . | 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 |
| Steroid use, n (%) | |||||||||
| No | 2 (50.0) | 2 (6.3) | 2 (10.5) | 4 (19.0) | 1 (6.7) | 6 (13.0) | 1 (7.7) | 2 (100.0) | 10 (13.2) |
| Yes | 2 (50.0) | 30 (93.8) | 17 (89.5) | 17 (81.0) | 14 (93.3) | 40 (87.0) | 12 (92.3) | 0 | 66 (86.8) |
| Time to initiation of steroid use, n (%) | |||||||||
| 0-1 d | 2 (50.0) | 24 (75.0) | 13 (68.4) | 10 (47.6) | 9 (60.0) | 30 (65.2) | 10 (76.9) | 0 | 49 (64.5) |
| 2-3 d | 0 | 2 (6.3) | 1 (5.3) | 3 (14.3) | 3 (20.0) | 2 (4.3) | 1 (7.7) | 0 | 6 (7.9) |
| ≥4 d | 0 | 4 (12.5) | 3 (15.8) | 4 (19.0) | 2 (13.3) | 8 (17.4) | 1 (7.7) | 0 | 11 (14.5) |
| Duration of steroid use, n (%) | |||||||||
| <5 d | 0 | 5 (15.6) | 4 (21.1) | 0 | 1 (6.7) | 7 (15.2) | 1 (7.7) | 0 | 9 (11.8) |
| 5-10 d | 0 | 12 (37.5) | 3 (15.8) | 1 (4.8) | 3 (20.0) | 8 (17.4) | 5 (38.5) | 0 | 16 (21.1) |
| 11-20 d | 0 | 9 (28.1) | 5 (26.3) | 5 (23.8) | 5 (33.3) | 11 (23.9) | 3 (23.1) | 0 | 19 (25.0) |
| >20 d | 2 (50.0) | 4 (12.5) | 5 (26.3) | 11 (52.4) | 5 (33.3) | 14 (30.4) | 3 (23.1) | 0 | 22 (28.9) |
| Time from end of steroid use for prior DS to recurrence of DS, n/N (%) | |||||||||
| N/A∗ | 0 | 1/5 (20.0) | 1/4 (25.0) | 0 | - | - | - | - | 2/9 (22.2) |
| <5 d | 0 | 0 | 0 | 0 | - | - | - | - | 0 |
| 5-10 d | 0 | 1/5 (20.0) | 0 | 0 | - | - | - | - | 1/9 (11.1) |
| 11-20 d | 0 | 1/5 (20.0) | 2/4 (50.0) | 0 | - | - | - | - | 3/9 (33.3) |
| >20 d | 0 | 2/5 (40.0) | 1/4 (25.0) | 0 | - | - | - | - | 3/9 (33.3) |
| Hydroxyurea use, n (%) | |||||||||
| No | 4 (100.0) | 22 (68.8) | 16 (84.2) | 16 (76.2) | 9 (60.0) | 36 (78.3) | 11 (84.6) | 2 (100.0) | 58 (76.3) |
| Yes | 0 | 10 (31.3) | 3 (15.8) | 5 (23.8) | 6 (40.0) | 10 (21.7) | 2 (15.4) | 0 | 18 (23.7) |
| Time to initiation of hydroxyurea, n (%) | |||||||||
| 0-1 d | 0 | 10 (31.3) | 0 | 2 (9.5) | 3 (20.0) | 7 (15.2) | 2 (15.4) | 0 | 12 (15.8) |
| 2-3 d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| ≥4 d | 0 | 0 | 3 (15.8) | 3 (14.3) | 3 (20.0) | 3 (6.5) | 0 | 0 | 6 (7.9) |
| Duration of hydroxyurea use, n (%) | |||||||||
| <5 d | 0 | 3 (9.4) | 0 | 0 | 0 | 2 (4.3) | 1 (7.7) | 0 | 3 (3.9) |
| 5-10 d | 0 | 5 (15.6) | 2 (10.5) | 0 | 1 (6.7) | 5 (10.9) | 1 (7.7) | 0 | 7 (9.2) |
| 11-20 d | 0 | 2 (6.3) | 1 (5.3) | 2 (9.5) | 3 (20.0) | 2 (4.3) | 0 | 0 | 5 (6.6) |
| >20 d | 0 | 0 | 0 | 3 (14.3) | 2 (13.3) | 1 (2.2) | 0 | 0 | 3 (3.9) |
| . | 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 |
| Steroid use, n (%) | |||||||||
| No | 2 (50.0) | 2 (6.3) | 2 (10.5) | 4 (19.0) | 1 (6.7) | 6 (13.0) | 1 (7.7) | 2 (100.0) | 10 (13.2) |
| Yes | 2 (50.0) | 30 (93.8) | 17 (89.5) | 17 (81.0) | 14 (93.3) | 40 (87.0) | 12 (92.3) | 0 | 66 (86.8) |
| Time to initiation of steroid use, n (%) | |||||||||
| 0-1 d | 2 (50.0) | 24 (75.0) | 13 (68.4) | 10 (47.6) | 9 (60.0) | 30 (65.2) | 10 (76.9) | 0 | 49 (64.5) |
| 2-3 d | 0 | 2 (6.3) | 1 (5.3) | 3 (14.3) | 3 (20.0) | 2 (4.3) | 1 (7.7) | 0 | 6 (7.9) |
| ≥4 d | 0 | 4 (12.5) | 3 (15.8) | 4 (19.0) | 2 (13.3) | 8 (17.4) | 1 (7.7) | 0 | 11 (14.5) |
| Duration of steroid use, n (%) | |||||||||
| <5 d | 0 | 5 (15.6) | 4 (21.1) | 0 | 1 (6.7) | 7 (15.2) | 1 (7.7) | 0 | 9 (11.8) |
| 5-10 d | 0 | 12 (37.5) | 3 (15.8) | 1 (4.8) | 3 (20.0) | 8 (17.4) | 5 (38.5) | 0 | 16 (21.1) |
| 11-20 d | 0 | 9 (28.1) | 5 (26.3) | 5 (23.8) | 5 (33.3) | 11 (23.9) | 3 (23.1) | 0 | 19 (25.0) |
| >20 d | 2 (50.0) | 4 (12.5) | 5 (26.3) | 11 (52.4) | 5 (33.3) | 14 (30.4) | 3 (23.1) | 0 | 22 (28.9) |
| Time from end of steroid use for prior DS to recurrence of DS, n/N (%) | |||||||||
| N/A∗ | 0 | 1/5 (20.0) | 1/4 (25.0) | 0 | - | - | - | - | 2/9 (22.2) |
| <5 d | 0 | 0 | 0 | 0 | - | - | - | - | 0 |
| 5-10 d | 0 | 1/5 (20.0) | 0 | 0 | - | - | - | - | 1/9 (11.1) |
| 11-20 d | 0 | 1/5 (20.0) | 2/4 (50.0) | 0 | - | - | - | - | 3/9 (33.3) |
| >20 d | 0 | 2/5 (40.0) | 1/4 (25.0) | 0 | - | - | - | - | 3/9 (33.3) |
| Hydroxyurea use, n (%) | |||||||||
| No | 4 (100.0) | 22 (68.8) | 16 (84.2) | 16 (76.2) | 9 (60.0) | 36 (78.3) | 11 (84.6) | 2 (100.0) | 58 (76.3) |
| Yes | 0 | 10 (31.3) | 3 (15.8) | 5 (23.8) | 6 (40.0) | 10 (21.7) | 2 (15.4) | 0 | 18 (23.7) |
| Time to initiation of hydroxyurea, n (%) | |||||||||
| 0-1 d | 0 | 10 (31.3) | 0 | 2 (9.5) | 3 (20.0) | 7 (15.2) | 2 (15.4) | 0 | 12 (15.8) |
| 2-3 d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| ≥4 d | 0 | 0 | 3 (15.8) | 3 (14.3) | 3 (20.0) | 3 (6.5) | 0 | 0 | 6 (7.9) |
| Duration of hydroxyurea use, n (%) | |||||||||
| <5 d | 0 | 3 (9.4) | 0 | 0 | 0 | 2 (4.3) | 1 (7.7) | 0 | 3 (3.9) |
| 5-10 d | 0 | 5 (15.6) | 2 (10.5) | 0 | 1 (6.7) | 5 (10.9) | 1 (7.7) | 0 | 7 (9.2) |
| 11-20 d | 0 | 2 (6.3) | 1 (5.3) | 2 (9.5) | 3 (20.0) | 2 (4.3) | 0 | 0 | 5 (6.6) |
| >20 d | 0 | 0 | 0 | 3 (14.3) | 2 (13.3) | 1 (2.2) | 0 | 0 | 3 (3.9) |
Data from the pooled AML safety population.
AML, acute myeloid leukemia; d, day(s); DS, differentiation syndrome; N/A, not applicable.
No steroid use for prior event.