Table 2.
Maximal severity of toxicities per phase I patient and type regardless of attribution to study drugs occurring in ≥ 20% patients.
| Exisulind Dose Level | Total (n=14) |
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125 mg BID (n=3) |
125 mg qAM 250 mg qPM (n=11) |
|||||||||||
| Grade | Grade | Grade | ||||||||||
| Event* | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 |
| Anemia | 1 | 2 | 9 | 2 | 1 | 10 | 4 | 1 | ||||
| Fatigue | 2 | 4 | 4 | 2 | 4 | 6 | 2 | |||||
| Constipation | 2 | 1 | 4 | 2 | 1 | 6 | 3 | 1 | ||||
| Neutropenia | 1 | 1 | 1 | 4 | 2 | 2 | 4 | 3 | ||||
| Dyspnea | 2 | 1 | 3 | 2 | 1 | 5 | 2 | |||||
| Pain | 2 | 4 | 1 | 1 | 6 | 1 | 1 | |||||
| Anorexia | 2 | 2 | 3 | 4 | 3 | |||||||
| Leukopenia | 1 | 1 | 1 | 3 | 1 | 4 | 1 | 2 | ||||
| Asparate aminotransferase | 1 | 4 | 5 | |||||||||
| Alkaline phosphatase | 1 | 2 | 1 | 1 | 2 | 1 | ||||||
| Diarrhea | 3 | 1 | 3 | 1 | ||||||||
| Nausea | 4 | 4 | ||||||||||
| Cough | 1 | 2 | 3 | |||||||||
| Hyperglycemia | 1 | 1 | 1 | 2 | 1 | |||||||
| Infection | 1 | 1 | 1 | 1 | 1 | 1 | ||||||
| Rash | 2 | 1 | 2 | 1 | ||||||||
| Vomiting | 3 | 3 | ||||||||||
*
National Cancer Institute Common Toxicity Criteria version 2.0
Abbreviations: BID, twice daily; n, number; q, every; AM, morning; PM, evening.