Table 3:
Grade 3–5 Adverse Events Observed by Infusion Schedule: one grade 5 event of sudden death seen in 2-day schedule; 23% of patients in 2-day schedule had no Grade 3–5 events
| Organ systems, Toxicity Type | Dosing Schedule1 | ||||
|---|---|---|---|---|---|
| 2-day schedule (N=30) | 4-day schedule (N=9) | ||||
| n | Percent | n | Percent | ||
| None | 7 | (23) | |||
| Gastrointestinal disorders | Abdominal pain | 3 | (10) | 5 | (56) |
| Diarrhea | 3 | (10) | 1 | (11) | |
| Nausea | 1 | (3.3) | |||
| Vomiting | 2 | (6.7) | |||
| Vascular disorders | Hypotension | 8 | (27) | 2 | (22) |
| Respiratory, thoracic and mediastinal disorders | Hypoxia | 7 | (23) | 4 | (44) |
| General disorders and administration site conditions | Pain | 5 | (17) | 2 | (22) |
| Sudden death NOS | 1 | (3.3) | |||
1
None of the comparisons between the two schedules of the rates of specific toxicity were significant at the 0.05 level after the Bonferroni correction was applied.