Table 2.
AEs related to study treatment
| AE | Grade 1-2 | Grade ≥3 | Any | |||
|---|---|---|---|---|---|---|
| n | % | n | % | n | % | |
| Diarrhea | 22 | 59 | 0 | 0 | 22 | 59 |
| Fatigue | 20 | 54 | 0 | 0 | 20 | 54 |
| Myalgia | 20 | 54 | 0 | 0 | 20 | 54 |
| Nausea | 19 | 51 | 0 | 0 | 19 | 51 |
| Upper respiratory infection | 15 | 41 | 2 | 5 | 17 | 46 |
| Anemia | 14 | 38 | 2 | 5 | 16 | 43 |
| Bruising | 16 | 43 | 0 | 0 | 16 | 43 |
| Hypertension | 12 | 32 | 4 | 11 | 16 | 43 |
| Headache | 15 | 41 | 0 | 0 | 15 | 41 |
| Decreased platelet count | 7 | 19 | 8 | 22 | 15 | 41 |
| Arthralgia | 14 | 38 | 0 | 0 | 14 | 38 |
| Cough | 13 | 35 | 1 | 3 | 14 | 38 |
| Edema in the limbs | 14 | 38 | 0 | 0 | 14 | 38 |
| Maculo-papular rash | 12 | 32 | 2 | 5 | 14 | 38 |
| Dizziness | 13 | 35 | 0 | 0 | 13 | 35 |
| Decreased lymphocyte count | 6 | 16 | 7 | 19 | 13 | 35 |
| Decreased neutrophil count | 5 | 14 | 8 | 22 | 13 | 35 |
| Decreased white blood cell count | 5 | 14 | 8 | 22 | 13 | 35 |
| Back pain | 11 | 30 | 0 | 0 | 11 | 30 |
| Hyperuricemia | 11 | 30 | 0 | 0 | 11 | 30 |
| Paresthesia | 11 | 30 | 0 | 0 | 11 | 30 |
| Increased creatinine | 10 | 27 | 0 | 0 | 10 | 27 |
| Hyperglycemia | 10 | 27 | 0 | 0 | 10 | 27 |
| Nasal congestion | 10 | 27 | 0 | 0 | 10 | 27 |
| Increased alkaline phosphatase | 9 | 24 | 0 | 0 | 9 | 24 |
| Constipation | 9 | 24 | 0 | 0 | 9 | 24 |
| Mucositis oral | 9 | 24 | 0 | 0 | 9 | 24 |
| Increased aspartate aminotransferase | 8 | 22 | 0 | 0 | 8 | 22 |
| Increased blood bilirubin | 7 | 19 | 1 | 3 | 8 | 22 |
| Gastroesophageal reflux disease | 8 | 22 | 0 | 0 | 8 | 22 |
| Pain in extremity | 8 | 22 | 0 | 0 | 8 | 22 |
| Abdominal pain | 7 | 19 | 0 | 0 | 7 | 19 |
| Allergic rhinitis | 7 | 19 | 0 | 0 | 7 | 19 |
| Fall | 7 | 19 | 0 | 0 | 7 | 19 |
| Hypoalbuminemia | 7 | 19 | 0 | 0 | 7 | 19 |
| Hypocalcemia | 7 | 19 | 0 | 0 | 7 | 19 |
| Insomnia | 7 | 19 | 0 | 0 | 7 | 19 |
| Lung infection | 1 | 3 | 6 | 16 | 7 | 19 |
| Pain | 6 | 16 | 1 | 3 | 7 | 19 |
| Productive cough | 7 | 19 | 0 | 0 | 7 | 19 |
| Sore throat | 7 | 19 | 0 | 0 | 7 | 19 |
| Vomiting | 6 | 16 | 1 | 3 | 7 | 19 |
| Increased alanine aminotransferase | 6 | 16 | 0 | 0 | 6 | 16 |
| Atrial fibrillation | 6 | 16 | 0 | 0 | 6 | 16 |
| Dry mouth | 6 | 16 | 0 | 0 | 6 | 16 |
| Dry skin | 6 | 16 | 0 | 0 | 6 | 16 |
| Dyspnea | 5 | 14 | 1 | 3 | 6 | 16 |
| Palpitations | 6 | 16 | 0 | 0 | 6 | 16 |
| Sinus bradycardia | 6 | 16 | 0 | 0 | 6 | 16 |
| Urinary tract infection | 5 | 14 | 1 | 3 | 6 | 16 |
| Hypophosphatemia | 2 | 5 | 3 | 8 | 5 | 14 |
| Increased lymphocyte count | 3 | 8 | 2 | 5 | 5 | 14 |
| Nail infection | 4 | 11 | 1 | 3 | 5 | 14 |
| Skin infection | 4 | 11 | 1 | 3 | 5 | 14 |
| Febrile neutropenia | 0 | 0 | 4 | 11 | 4 | 11 |
| Generalized muscle weakness | 3 | 8 | 1 | 3 | 4 | 11 |
| Atrial flutter | 1 | 3 | 1 | 3 | 2 | 5 |
| Cholecystitis | 1 | 3 | 1 | 3 | 2 | 5 |
| Heart failure | 0 | 0 | 2 | 5 | 2 | 5 |
| Paronychia | 1 | 3 | 1 | 3 | 2 | 5 |
| Sleep apnea | 1 | 3 | 1 | 3 | 2 | 5 |
| Aortic valve disease | 0 | 0 | 1 | 3 | 1 | 3 |
| Colitis | 0 | 0 | 1 | 3 | 1 | 3 |
| Decreased ejection fraction* | 0 | 0 | 1 | 3 | 1 | 3 |
| Enterocolitis | 0 | 0 | 1 | 3 | 1 | 3 |
| Other infections and infestations; throat infection | 0 | 0 | 1 | 3 | 1 | 3 |
| Leukocytosis | 0 | 0 | 1 | 3 | 1 | 3 |
| Other nervous system disorders; spinal cord compression | 0 | 0 | 1 | 3 | 1 | 3 |
| Pneumonitis | 0 | 0 | 1 | 3 | 1 | 3 |
| Prostatic obstruction | 0 | 0 | 1 | 3 | 1 | 3 |
| Sepsis | 0 | 0 | 1 | 3 | 1 | 3 |
| Vasovagal reaction | 0 | 0 | 1 | 3 | 1 | 3 |
Includes all AEs occurring in ≥15% of patients or grade ≥3.
*
Also reported as left ventricular systolic dysfunction.