AEs by treatment group
| AE . | IST group (n = 49), patients with AE . | ELTR + IST group (n = 49), patients with AE . | ||||
|---|---|---|---|---|---|---|
| NCI CTCAE grade | 1-2 | 3-4 | 5 | 1-2 | 3-4 | 5 |
| Febrile neutropenia | 17 | 2 | 0 | 12 | 6 | 0 |
| Infection | 5 | 15 | 0 | 2 | 16 | 1 |
| Nausea | 0 | 1 | 0 | 3 | 0 | 0 |
| Vomiting | 0 | 1 | 0 | 2 | 0 | 0 |
| Diarrhea | 2 | 1 | 0 | 3 | 0 | 0 |
| ALT increase | 7 | 6 | 0 | 12 | 10 | 0 |
| AST increase | 5 | 6 | 0 | 7 | 8 | 0 |
| Bilirubin increase | 5 | 4 | 0 | 10 | 12 | 0 |
| Rash | 2 | 3 | 0 | 1 | 5 | 0 |
| Myalgia | 1 | 2 | 0 | 0 | 6 | 0 |
| Joint pain | 0 | 6 | 0 | 1 | 7 | 0 |
| Renal failure | 2 | 2 | 0 | 2 | 3 | 0 |
| Hypertension | 6 | 1 | 0 | 6 | 2 | 0 |
| Skin hyperpigmentation | 0 | 0 | 0 | 6 | 0 | 0 |
| Prolonged QTc interval | 4 | 0 | 0 | 7 | 1 | 0 |
| Nephritis | 2 | 0 | 0 | 0 | 0 | 0 |
| Tremor | 1 | 0 | 0 | 1 | 0 | 0 |
| Psychosis | 0 | 0 | 0 | 0 | 1 | 0 |
| Blurred vision | 0 | 0 | 0 | 0 | 1 | 0 |
| Ileus | 0 | 1 | 0 | 0 | 1 | 0 |
| Neoplasm benign∗ | 0 | 0 | 0 | 0 | 1 | 0 |
| AE . | IST group (n = 49), patients with AE . | ELTR + IST group (n = 49), patients with AE . | ||||
|---|---|---|---|---|---|---|
| NCI CTCAE grade | 1-2 | 3-4 | 5 | 1-2 | 3-4 | 5 |
| Febrile neutropenia | 17 | 2 | 0 | 12 | 6 | 0 |
| Infection | 5 | 15 | 0 | 2 | 16 | 1 |
| Nausea | 0 | 1 | 0 | 3 | 0 | 0 |
| Vomiting | 0 | 1 | 0 | 2 | 0 | 0 |
| Diarrhea | 2 | 1 | 0 | 3 | 0 | 0 |
| ALT increase | 7 | 6 | 0 | 12 | 10 | 0 |
| AST increase | 5 | 6 | 0 | 7 | 8 | 0 |
| Bilirubin increase | 5 | 4 | 0 | 10 | 12 | 0 |
| Rash | 2 | 3 | 0 | 1 | 5 | 0 |
| Myalgia | 1 | 2 | 0 | 0 | 6 | 0 |
| Joint pain | 0 | 6 | 0 | 1 | 7 | 0 |
| Renal failure | 2 | 2 | 0 | 2 | 3 | 0 |
| Hypertension | 6 | 1 | 0 | 6 | 2 | 0 |
| Skin hyperpigmentation | 0 | 0 | 0 | 6 | 0 | 0 |
| Prolonged QTc interval | 4 | 0 | 0 | 7 | 1 | 0 |
| Nephritis | 2 | 0 | 0 | 0 | 0 | 0 |
| Tremor | 1 | 0 | 0 | 1 | 0 | 0 |
| Psychosis | 0 | 0 | 0 | 0 | 1 | 0 |
| Blurred vision | 0 | 0 | 0 | 0 | 1 | 0 |
| Ileus | 0 | 1 | 0 | 0 | 1 | 0 |
| Neoplasm benign∗ | 0 | 0 | 0 | 0 | 1 | 0 |
n, number of patients with the AE; ALT, alanine aminotransferase; AST, aspartate aminotransferase; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events.
A patient with multiple occurrences of AEs of the same grade was counted once.
Inflammatory myofibroblastic tumor considered unrelated to study treatment.