TABLE 4.
Summary Targeted Toxicities Grade 2–5 During Each Reporting Phase*
| Reporting Period | S-PEG | I-PEG |
|---|---|---|
| Consolidation | N=54 | N=30 |
| Anaphylaxis | 9 (17%) | 5 (17%)** |
| Allergy | 4 (7%) | 2 (6%)** |
| Pancreatitis | 1 (2%) | 1 (3%) |
| Thrombosis | 2 (4%) | 1 (3%) |
| Bleeding | 0 (0%) | 1 (3%) |
| CNS | 1 (2%) | 2 (7%) |
| Sepsis | 0 (0%) | 0 (0%) |
| Interim Maintenance | N=54 | N=18 |
| Anaphylaxis | 0 (0%) | 0 (0%) |
| Allergy | 2 (4%) | 0 (0%) |
| Pancreatitis | 0 (0%) | 0 (0%) |
| Thrombosis | 0 (0%) | 0 (0%) |
| Bleeding | 0 (0%) | 0 (0%) |
| CNS | 1 (2%) | 1 (6%) |
| Sepsis | 0 (0%) | 0 (0%) |
| Delayed Intensification | N=54 | N=18 |
| Anaphylaxis | 1 (2%) | 0 (0%) |
| Allergy | 1 (2%) | 1 (3%)** |
| Pancreatitis | 2 (4%) | 1 (6%) |
| Thrombosis | 0 (0%) | 0 (0%) |
| Bleeding | 0 (0%) | 0 (0%) |
| CNS | 1 (2%) | 1 (6%) |
| Sepsis | 0 (0%) | 1 (6%) |
*
No comparisons were statistically significant P>0.05
**
Four of five patients with anaphylaxis in Consolidation were removed from study. One was not removed as it was felt to be unrelated to treatment. One grade 3 allergic adverse event during Consolidation was also removed from study. One grade 2 allergy adverse event during DI, patient was removed from study.