Table 2.
Toxicities in phase 1 (n = 15)
Level 1 (n = 3) | Level 2 (n = 6) | Level 3 (n = 6) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Grade | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 |
Anemia | 2 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 1 | 1 | 0 | 0 |
Blood bilirubin increased | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Creatinine increased | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Hyperglycemia | 1 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
Neutrophil count decreased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Platelet count decreased | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
White blood cell count decreased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
Anorexia | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 1 | 1 | 0 |
Diarrhea | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 5 | 1 | 0 | 0 |
Dry mouth | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Dry skin | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
Fatigue | 1 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Oral mucositis | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 4 | 1 | 0 | 0 |
Nausea | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 3 | 0 | 1 | 0 |
Papulopustular rash | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Pruritus | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 4 | 0 | 0 | 0 |
Acneiform rash | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Maculopapular rash | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
Nasal mucositis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Vomiting | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |