Safety summary
| AE, n (%) . | R/I cohort n = 33 . | ND cohort n = 25 . | All patients N = 58 . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | |
| Any AE | 33 (100) | 20 (60.6) | 25 (100) | 18 (72.0) | 58 (100) | 38 (65.5) |
| AEs suspected to be treatment related | 29 (87.9) | 16 (48.5) | 24 (96.0) | 17 (68.0) | 53 (91.4) | 33 (56.9) |
| AEs leading to discontinuation | 6 (18.2) | 2 (6.1) | 8 (32.0) | 4 (16.0) | 14 (24.1) | 6 (10.3) |
| AEs leading to dose adjustment or interruption∗ | 22 (66.7) | 15 (45.5) | 18 (72.0) | 16 (64.0) | 40 (69.0) | 31 (53.4) |
| SAEs | 11 (33.3) | 7 (21.2) | 4 (16.0) | 3 (12.0) | 15 (25.9) | 10 (17.2) |
| SAEs suspected to be treatment related | 1 (3.0)† | 0 | 2 (8.0)‡ | 1 (4.0) | 3 (5.2) | 1 (1.7) |
| All deaths§ | 1 (3.0)‖ | — | 3 (12.0)¶ | — | 4 (6.9) | — |
| AE, n (%) . | R/I cohort n = 33 . | ND cohort n = 25 . | All patients N = 58 . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | |
| Any AE | 33 (100) | 20 (60.6) | 25 (100) | 18 (72.0) | 58 (100) | 38 (65.5) |
| AEs suspected to be treatment related | 29 (87.9) | 16 (48.5) | 24 (96.0) | 17 (68.0) | 53 (91.4) | 33 (56.9) |
| AEs leading to discontinuation | 6 (18.2) | 2 (6.1) | 8 (32.0) | 4 (16.0) | 14 (24.1) | 6 (10.3) |
| AEs leading to dose adjustment or interruption∗ | 22 (66.7) | 15 (45.5) | 18 (72.0) | 16 (64.0) | 40 (69.0) | 31 (53.4) |
| SAEs | 11 (33.3) | 7 (21.2) | 4 (16.0) | 3 (12.0) | 15 (25.9) | 10 (17.2) |
| SAEs suspected to be treatment related | 1 (3.0)† | 0 | 2 (8.0)‡ | 1 (4.0) | 3 (5.2) | 1 (1.7) |
| All deaths§ | 1 (3.0)‖ | — | 3 (12.0)¶ | — | 4 (6.9) | — |
A patient with multiple reasons for dose reduction or interruption is only counted once.
One patient had a SAE of grade 1 growth hormone deficiency.
One patient had diarrhea, abdominal pain, and rash (all grade 1), and 1 patient had grade 1 QT prolongation and grade 3 hyperbilirubinemia.
Includes deaths that occurred during the treatment and survival follow-up periods; no deaths occurred during nilotinib treatment.
Reason for death was CML, which occurred during the follow-up period.
Reasons for death were CML, respiratory failure, and after transplantation of lymphoproliferative disorder (1 patient each), all of which occurred during the follow-up period.