TABLE 2.
Most common (>10% of patients) adverse events (AEs)
Preferred term | All patients N = 26 n (%) | Maximum severity grade | ||
---|---|---|---|---|
Mild (grade 1) n (%) | Moderate (grade 2) n (%) | Severe (grade 3) n (%) | ||
Patients with at least 1 AE | 26 (100%) | 2 (8%) | 12 (46%) | 12 (46%) |
Diarrhea | 11 (42%) | 10 (38%) | 1 (4%) | 0 |
Fatigue | 11 (42%) | 6 (23%) | 4 (15%) | 1 (4%) |
Hypertension | 7 (27%) | 3 (12%) | 4 (15%) | 0 |
Dizziness | 7 (27%) | 6 (23%) | 1 (4%) | 0 |
Insomnia | 6 (23%) | 6 (23%) | 0 | 0 |
Nausea | 5 (19%) | 5 (19%) | 0 | 0 |
Upper respiratory tract infection | 6 (23%) | 6 (23%) | 0 | 0 |
Anemia | 4 (15%) | 0 | 2 (8%) | 2 (8%) |
Jaundice | 4 (15%) | 2 (8%) | 1 (4%) | 1 (4%) |
Neutrophil count decreased | 4 (15%) | 2 (8%) | 1 (4%) | 1 (4%) |
Pyrexia | 4 (15%) | 3 (12%) | 0 | 1 (4%) |
Cough | 4 (15%) | 4 (15%) | 0 | 0 |
Headache | 4 (15%) | 3 (12%) | 1 (4%) | 0 |
Pain in extremity | 4 (15%) | 4 (15%) | 0 | 0 |
Abdominal pain | 3 (12%) | 2 (8%) | 1 (4%) | 0 |
Alanine aminotransferase increased | 3 (12%) | 1 (4%) | 2 (8%) | 0 |
Alopecia | 3 (12%) | 2 (8%) | 1 (4%) | 0 |
Aspartate aminotransferase increased | 3 (12%) | 2 (8%) | 1 (4%) | 0 |
Atrial fibrillation | 3 (12%) | 1 (4%) | 2 (8%) | 0 |
Blood bilirubin increased | 3 (12%) | 0 | 3 (12%) | 0 |
Constipation | 3 (12%) | 2 (8%) | 1 (4%) | 0 |
Dyspnea | 3 (12%) | 2 (8%) | 1 (4%) | 0 |
Arthralgia | 3 (12%) | 0 | 2 (8%) | 1 (4%) |
Hypokalemia | 3 (12%) | 1 (4%) | 1 (4%) | 1 (4%) |
Muscle spasms | 3 (12%) | 2 (8%) | 1 (4%) | 0 |
Oropharyngeal pain | 3 (12%) | 3 (12%) | 0 | 0 |
Rash | 3 (12%) | 2 (8%) | 1 (4%) | 0 |
Urinary tract infection | 3 (12%) | 1 (4%) | 2 (8%) | 0 |
Weight increased | 3 (12%) | 3 (12%) | 0 | 0 |
Note: Patients are counted for the most severe event in a given row. Less common events (those occurring in <10% of patients) were not listed but contributed to the total number (top row).
Abbreviation: AE, adverse event.