Table 4.
Proportion of patients (95% confidence interval) with clinically significant Grade 3 and 4 toxicities attributed to ch14.18 on COG study ANBL0931 (courses 1, 3, and 5 contained GM-CSF and Courses 2 and 4 contained IL-2).
Pain | Allergic reactions | Capillary leak syndrome | Hypotension | Fever | |
---|---|---|---|---|---|
Course 1 (n = 104) | 41% (32.4, 51.0%) | 3% (0.9, 8.1%) | 1% (0.2, 5.2%) | 10% (5.3, 16.8%) | 21% (14.4, 30.0%) |
Course 2 (n = 100) | 28% (20.1, 37.5%) | 10% (5.5, 17.4%) | 4% (1.6, 9.8%) | 17% (10.9, 25.6%) | 59% (49.2, 68.1%) |
Course 3 (n = 98) | 22% (15.3, 31.7%) | 5% (2.2, 11.4%) | 0% (0.0, 3.8%) | 4% (1.6, 10.0%) | 6% (2.8, 12.7%) |
Course 4 (n = 90) | 31% (22.5, 41.3%) | 7% (3.1, 13.8%) | 2% (0.6, 7.7%) | 14% (8.6, 23.2%) | 32% (23.5, 42.4%) |
Course 5 (n = 88) | 24% (16.2, 33.7%) | 2% (0.6, 7.9%) | 0% (0.0, 4.2%) | 8% (3.9, 15.5%) | 5% (1.8, 11.1%) |