Table 4.
AEs (all grades, all causes; >20% in any cohort)
| AEs | R/I to imatinib or dasatinib (n = 33)* | Newly diagnosed (n = 25)† | All patients (N = 58) | |||
|---|---|---|---|---|---|---|
| All grades | Grade 3 to 4 | All grades | Grade 3 to 4 | All grades | Grade 3 to 4 | |
| AEs related to bilirubin increases‡ | 17 (51.5) | 3 (9.1) | 15 (60.0) | 4 (16.0) | 32 (55.2) | 7 (12.1) |
| Headache | 13 (39.4) | 1 (3.0) | 14 (56.0) | 0 | 27 (46.6) | 1 (1.7) |
| Pyrexia | 13 (39.4) | 0 | 8 (32.0) | 1 (4.0) | 21 (36.2) | 1 (1.7) |
| Increased ALT | 10 (30.3) | 4 (12.1) | 10 (40.0) | 3 (12.0) | 20 (34.5) | 7 (12.1) |
| Rash | 6 (18.2) | 2 (6.1) | 11 (44.0) | 1 (4.0) | 17 (29.3) | 3 (5.2) |
| Upper respiratory tract infection | 11 (33.3) | 1 (3.0) | 7 (28.0) | 0 | 18 (31.0) | 1 (1.7) |
| Increased AST | 8 (24.2) | 1 (3.0) | 8 (32.0) | 1 (4.0) | 16 (27.6) | 2 (3.4) |
| Nausea | 8 (24.2) | 0 | 7 (28.0) | 0 | 15 (25.9) | 0 |
| Vomiting | 5 (15.2) | 0 | 7 (28.0) | 1 (4.0) | 12 (20.7) | 1 (1.7) |
| Abdominal pain§ | 3 (9.1) | 0 | 8 (32.0) | 0 | 11 (19.0) | 0 |
| Nasopharyngitis | 5 (15.2) | 0 | 6 (24.0) | 0 | 11 (19.0) | 0 |
| Fatigue | 0 | 0 | 6 (24.0) | 0 | 6 (10.3) | 0 |
Data are presented as number (%).
ALT, alanine aminotransferase; AST, aspartate aminotransferase.
The most frequently reported drug-related AEs (>20%) in the R/I cohort included AEs related to bilirubin increases (n = 17 [51.5%] [including increased blood bilirubin: n = 12 (36.4%); hyperbilirubinemia: n = 4 (12.1%); increased conjugated bilirubin: n = 2 (6.1%); and increased unconjugated blood bilirubin: n = 1 (3.0%)]), increased ALT (n = 10 [30.3%]), headache (n = 8 [24.2%]), and increased AST (n = 8 [24.2%]).
The most frequently reported drug-related AEs (>20%) in the newly diagnosed cohort included AEs related to bilirubin increases (n = 15 [60.0%] [including increased blood bilirubin: n = 8 (32.0%); hyperbilirubinemia: n = 8 (32.0%); increased conjugated bilirubin: n = 2 (8.0%); and increased unconjugated blood bilirubin: n = 2 (8.0%)]), increased ALT (n = 10 [40.0%]), increased AST (n = 8 [32.0%]), headache (n = 8 [32.0%]), and rash (n = 6 [24.0%]).
Pooled frequency of events reported under the following terms: increased blood bilirubin, hyperbilirubinemia, increased conjugated bilirubin, and increased unconjugated blood bilirubin. Rates of AEs reported under each of these terms are detailed in supplemental Table 1.
Two patients with abdominal pain (1 in each cohort) also had amylase and lipase increases, which resolved after interruption of study drug. No events of pancreatitis were reported.