Table 3.
Summary of adverse events by severity
Adverse events | Any grade | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Treatment-related grade ≥ 3 |
---|---|---|---|---|---|---|
Non-hematological toxicity | ||||||
Increased AST level | 30 | 23 | 4 | 3 | 0 | 2 |
Increased ALT level | 27 | 23 | 3 | 1 | 0 | 1 |
Abnormal ECG | 22 | 22 | 0 | 0 | 0 | 0 |
Vomiting | 22 | 1 | 19 | 1 | 0 | 1 |
Nausea | 18 | 15 | 3 | 0 | 0 | 0 |
Fatigue | 18 | 16 | 2 | 0 | 0 | 0 |
Numbness | 17 | 16 | 1 | 0 | 0 | 0 |
Gingivitis | 15 | 10 | 5 | 0 | 0 | 0 |
Hyponatremia | 15 | 14 | 0 | 1 | 0 | 0 |
Hypoproteinemia | 15 | 10 | 5 | 0 | 0 | 0 |
Increased total bilirubin | 13 | 5 | 5 | 3 | 0 | 0 |
Rash | 11 | 3 | 6 | 2 | 0 | 2 |
Insomnia | 11 | 5 | 6 | 0 | - | 0 |
Poor appetite | 11 | 6 | 5 | 0 | 0 | 0 |
Abnormal pain | 10 | 3 | 7 | 0 | 0 | 0 |
Hypopotassemia | 10 | 8 | 0 | 2 | 0 | 0 |
Fever | 9 | 2 | 7 | 0 | 0 | 0 |
Hoarse voice | 9 | 9 | 0 | 0 | 0 | 0 |
Constipation | 9 | 1 | 8 | 0 | 0 | 0 |
Epistaxis | 9 | 9 | 0 | 0 | 0 | 0 |
Increases creatinine level | 9 | 7 | 2 | 0 | 0 | 0 |
Hypothyroidism | 8 | 4 | 4 | 0 | 0 | 0 |
Hypertension | 8 | 0 | 8 | 0 | 0 | 0 |
Leg soreness | 7 | 7 | 0 | 0 | 0 | 0 |
Weight loss | 7 | 6 | 1 | 0 | 0 | 0 |
Headache | 6 | 6 | 0 | 0 | 0 | 0 |
Hand-foot syndrome | 6 | 4 | 2 | 0 | 0 | 0 |
Hyperthyroidism | 5 | 2 | 3 | 0 | 0 | 0 |
Diarrhea | 5 | 0 | 5 | 0 | 0 | 0 |
Cough | 5 | 4 | 1 | 0 | 0 | 0 |
Tinnitus | 4 | 4 | 0 | 0 | 0 | 0 |
Proteinuria | 4 | 1 | 1 | 2 | - | 2 |
Adrenocortical insufficiency | 2 | 1 | 0 | 1 | 0 | 1 |
Myocarditis | 1 | 0 | 1 | 0 | 0 | 0 |
Interstitial pneumonia | 1 | 0 | 0 | 1 | 0 | 1 |
Cholecystitis | 1 | 0 | 1 | 0 | 0 | 0 |
Upper gastrointestinal hemorrhage | 1 | 0 | 0 | 1 | 0 | 1 |
Sepsis | 1 | 0 | 0 | 1 | 0 | 0 |
Gastrointestinal fistula | 1 | 0 | 0 | 1 | 0 | 0 |
Hematological toxicity | ||||||
Thrombocytopenia | 24 | 16 | 7 | 1 | 0 | 1 |
Anemic | 24 | 16 | 6 | 2 | 0 | 1 |
Neutropenia | 23 | 7 | 4 | 9 | 3 | 12 |
Leukocytopenia | 22 | 3 | 12 | 7 | 0 | 7 |
Data are reported as no. Only AEs occurring during treatment or within 30 days of the last study medication are reported. A patient with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment. A patient with multiple AEs is counted only once in the total row
AEs adverse events