AEs
| . | All patients (n = 106) . | |
|---|---|---|
| Number of patients . | Incidence (%) . | |
| All TEAEs | 101 | 95.3 |
| AEs reported in ≥10% of patients | ||
| Thrombocytopenia | 36 | 34.0 |
| Upper respiratory tract infection | 29 | 27.4 |
| Neutropenia | 26 | 24.5 |
| Anemia | 21 | 19.8 |
| Leukopenia | 21 | 19.8 |
| Pneumonitis | 19 | 17.9 |
| Hypertension | 18 | 17.0 |
| Hypokalemia | 18 | 17.0 |
| Rash | 18 | 17.0 |
| Cough | 17 | 16.0 |
| Hyperglycemia | 13 | 12.3 |
| Pyrexia | 13 | 12.3 |
| Weight increase | 12 | 11.3 |
| Prolonged QT interval | 12 | 11.3 |
| Diarrhea | 12 | 11.3 |
| Pneumonia | 12 | 11.3 |
| Alanine aminotransferase increase | 11 | 10.4 |
| Hematuria | 11 | 10.4 |
| Hypoalbuminemia | 11 | 10.4 |
| All grade ≥3 TEAEs | 55 | 51.9 |
| Grade ≥3 AEs reported in >2 patients | ||
| Thrombocytopenia | 14 | 13.2 |
| Neutropenia | 9 | 8.5 |
| Anemia | 8 | 7.5 |
| Hypertension | 6 | 5.7 |
| Pneumonia | 6 | 5.7 |
| Disease progression | 5 | 4.7 |
| Leukocytosis | 4 | 3.8 |
| Lymphocytosis | 4 | 3.8 |
| Pneumonitis | 4 | 3.8 |
| Hypokalemia | 3 | 2.8 |
| Soft tissue infection | 3 | 2.8 |
| . | All patients (n = 106) . | |
|---|---|---|
| Number of patients . | Incidence (%) . | |
| All TEAEs | 101 | 95.3 |
| AEs reported in ≥10% of patients | ||
| Thrombocytopenia | 36 | 34.0 |
| Upper respiratory tract infection | 29 | 27.4 |
| Neutropenia | 26 | 24.5 |
| Anemia | 21 | 19.8 |
| Leukopenia | 21 | 19.8 |
| Pneumonitis | 19 | 17.9 |
| Hypertension | 18 | 17.0 |
| Hypokalemia | 18 | 17.0 |
| Rash | 18 | 17.0 |
| Cough | 17 | 16.0 |
| Hyperglycemia | 13 | 12.3 |
| Pyrexia | 13 | 12.3 |
| Weight increase | 12 | 11.3 |
| Prolonged QT interval | 12 | 11.3 |
| Diarrhea | 12 | 11.3 |
| Pneumonia | 12 | 11.3 |
| Alanine aminotransferase increase | 11 | 10.4 |
| Hematuria | 11 | 10.4 |
| Hypoalbuminemia | 11 | 10.4 |
| All grade ≥3 TEAEs | 55 | 51.9 |
| Grade ≥3 AEs reported in >2 patients | ||
| Thrombocytopenia | 14 | 13.2 |
| Neutropenia | 9 | 8.5 |
| Anemia | 8 | 7.5 |
| Hypertension | 6 | 5.7 |
| Pneumonia | 6 | 5.7 |
| Disease progression | 5 | 4.7 |
| Leukocytosis | 4 | 3.8 |
| Lymphocytosis | 4 | 3.8 |
| Pneumonitis | 4 | 3.8 |
| Hypokalemia | 3 | 2.8 |
| Soft tissue infection | 3 | 2.8 |
Incidence is calculated as the number of patients with the AEs divided by the total number of patients.
All patients include 86 patients in the 150 mg once daily cohort and 20 patients in 100 mg twice daily cohort.
The data cut-off date is 31 December 2020.
AEs were coded using MedDRA version 22.1.
TEAEs, Treatment-emergent AEs.