Table 3.
Treatment-related adverse events in the training and validation sets.
| Adverse Event | All patients (n = 133) | Training set (n = 93) | Validation set (n = 40) | |||
|---|---|---|---|---|---|---|
| All Grades, n (%) | Grades 3/4, n (%) | All Grades, n (%) | Grades 3/4, n (%) | All Grades, n (%) | Grades 3/4, n (%) | |
| Hepatitis* | 42 (31.6) | 4 (3.0) | 33 (35.5) | 2 (2.2) | 9 (22.5) | 2 (5.0) |
| Abdominal pain | 36 (27.1) | 3 (2.3) | 29 (31.2) | 3 (3.2) | 7 (17.5) | 0 |
| Thrombocytopenia | 36 (27.1) | 1 (0.8) | 25 (26.9) | 0 | 11 (27.5) | 1 (2.5) |
| Diarrhea | 32 (24.1) | 4 (3.0) | 23 (24.7) | 3 (3.2) | 9 (22.5) | 1 (2.5) |
| Hypothyroidism | 31 (23.3) | 4 (3.0) | 25 (26.9) | 2 (2.2) | 6 (15.0) | 2 (5.0) |
| Hypertension | 30 (22.6) | 3 (2.3) | 22 (23.7) | 0 | 8 (20.0) | 3 (7.5) |
| Headache | 29 (21.8) | 2 (1.5) | 19 (20.4) | 2 (2.2) | 10 (25.0) | 0 |
| Fatigue | 25 (18.8) | 0 | 18 (19.4) | 0 | 7 (17.5) | 0 |
| Proteinuria | 24 (18.0) | 3 (2.3) | 18 (19.4) | 1 (1.1) | 6 (15.0) | 2 (5.0) |
| Rash | 22 (16.5) | 4 (3.0) | 19 (20.4) | 3 (3.2) | 3 (7.5) | 1 (2.5) |
| Leukopenia | 14 (10.5) | 0 | 11 (11.8) | 0 | 3 (7.5) | 0 |
| Vomiting | 11 (8.3) | 1 (0.8) | 9 (9.7) | 1 (1.1) | 2 (5.0) | 0 |
| Hoarseness | 6 (4.5) | 0 | 4 (4.3) | 0 | 2 (5.0) | 0 |
| Dental ulcer | 3 (2.3) | 0 | 3 (3.2) | 0 | 0 | 0 |
There was no grade 5 adverse event (death) in any patient.
* Hepatitis was detected by Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) increase.