Table 2.
Key Grade 3–5 Adverse Event Incidence, Any Attribution
A (n=42) | B (n=44) | C (n=48) | |||||||
---|---|---|---|---|---|---|---|---|---|
Grade | Grade | Grade | |||||||
3 | 4 | 5 | 3 | 4 | 5 | 3 | 4 | 5 | |
Adverse Event Type | (n) | (n) | (n) | (n) | (n) | (n) | (n) | (n) | (n) |
Anemia | 7 | 0 | 0 | 3 | 1 | 0 | 5 | 1 | 0 |
Febrile neutropenia | 3 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 0 |
Fatigue | 6 | 0 | 0 | 9 | 0 | 0 | 5 | 0 | 0 |
Rash acneiform | 2 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 |
Diarrhea | 0 | 0 | 0 | 1 | 0 | 0 | 4 | 0 | 0 |
Nausea | 5 | 0 | 0 | 3 | 0 | 0 | 4 | 0 | 0 |
Vomiting | 3 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 |
Lung Infection | 3 | 0 | 1 | 2 | 0 | 0 | 3 | 0 | 0 |
Neutrophil count decreased | 3 | 9 | 0 | 5 | 8 | 0 | 6 | 14 | 0 |
Platelet count decreased | 1 | 2 | 0 | 1 | 5 | 0 | 2 | 4 | 0 |
Anorexia | 3 | 0 | 0 | 4 | 0 | 0 | 2 | 0 | 0 |
Dehydration | 1 | 0 | 0 | 2 | 0 | 0 | 3 | 0 | 0 |
Hyperglycemia | 1 | 0 | 0 | 6 | 0 | 0 | 5 | 3 | 0 |
Hyponatremia | 1 | 0 | 0 | 2 | 0 | 0 | 8 | 0 | 0 |
Arthralgia | 3 | 0 | 0 | 4 | 0 | 0 | 3 | 0 | 0 |
Myalgia | 1 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 |
Dyspnea | 10 | 1 | 0 | 6 | 0 | 0 | 4 | 2 | 0 |
Thromboembolic event | 0 | 1 | 0 | 2 | 2 | 0 | 0 | 0 | 0 |