AESIs
| AE group, n (%) . | R/I patients* (n = 33) . | ND patients (n = 25) . | All patients (n = 58) . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | |
| Elevated blood cholesterol† | 3 (9.1) | 0 | 2 (8) | 1 (4) | 5 (8.6) | 1 (1.7) |
| Elevated blood glucose‡ | 2 (6.1) | 0 | 0 | 0 | 2 (3.4) | 0 |
| Fluid retention | 2 (6.1) | 0 | 4 (16) | 1 (4) | 6 (10.3) | 1 (1.7) |
| Edema and other fluid retentions | 2 (6.1) | 0 | 4 (16) | 1 (4) | 6 (10.3) | 1 (1.7) |
| Growth retardation | 2 (6.1) | 0 | 1 (4) | 0 | 3 (5.2) | 0 |
| Hepatotoxicity | 19 (57.6) | 9 (27.3) | 17 (68) | 7 (28) | 36 (62.1) | 15 (25.9) |
| Drug-induced liver injury | 1 (3) | 1 (3) | 0 | 0 | 1 (1.7) | 1 (1.7) |
| Hepatic transaminase/bilirubin elevations | 19 (57.6) | 8 (24.2) | 17 (68) | 7 (28) | 36 (62.1) | 15 (25.9) |
| Thrombocytopenia | 1 (3) | 0 | 8 (32) | 3 (12) | 9 (15.5) | 3 (5.2) |
| QT prolongation§ | 5 (15.2) | 0 | 3 (12) | 0 | 8 (13.8) | 0 |
| Rash | 16 (48.5) | 5 (15.2) | 15 (60) | 3 (12) | 31 (53.4) | 8 (13.8) |
| AE group, n (%) . | R/I patients* (n = 33) . | ND patients (n = 25) . | All patients (n = 58) . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | |
| Elevated blood cholesterol† | 3 (9.1) | 0 | 2 (8) | 1 (4) | 5 (8.6) | 1 (1.7) |
| Elevated blood glucose‡ | 2 (6.1) | 0 | 0 | 0 | 2 (3.4) | 0 |
| Fluid retention | 2 (6.1) | 0 | 4 (16) | 1 (4) | 6 (10.3) | 1 (1.7) |
| Edema and other fluid retentions | 2 (6.1) | 0 | 4 (16) | 1 (4) | 6 (10.3) | 1 (1.7) |
| Growth retardation | 2 (6.1) | 0 | 1 (4) | 0 | 3 (5.2) | 0 |
| Hepatotoxicity | 19 (57.6) | 9 (27.3) | 17 (68) | 7 (28) | 36 (62.1) | 15 (25.9) |
| Drug-induced liver injury | 1 (3) | 1 (3) | 0 | 0 | 1 (1.7) | 1 (1.7) |
| Hepatic transaminase/bilirubin elevations | 19 (57.6) | 8 (24.2) | 17 (68) | 7 (28) | 36 (62.1) | 15 (25.9) |
| Thrombocytopenia | 1 (3) | 0 | 8 (32) | 3 (12) | 9 (15.5) | 3 (5.2) |
| QT prolongation§ | 5 (15.2) | 0 | 3 (12) | 0 | 8 (13.8) | 0 |
| Rash | 16 (48.5) | 5 (15.2) | 15 (60) | 3 (12) | 31 (53.4) | 8 (13.8) |
The MedDRA PTs reported in ≥1 patient within each AESI group term listed in this table are shown in supplemental Table 1. A patient with multiple severity grades for an AE was counted only under the maximum grade. No events were reported for the following AESI group terms: “cardiovascular event” (including ischemic cerebrovascular events, ischemic heart disease, peripheral arterial occlusive disease, and other cardiovascular events); “cardiac failure”; “pancreatitis, lipase, and amylase elevations”; “renal events”; or “significant bleeding” (including central nervous system or gastrointestinal hemorrhage).
Patients were R/I to 1 prior TKI, either imatinib or dasatinib.
Specific group term is “increased blood cholesterol.”
Specific group term is “increased blood glucose.”
MedDRA PT included syncope for 1 patient and QT prolonged for 7 patients (reported in Hijiya et al7).