N | Number of doses | Mean number of TEAEsa | Mean differenceb | 95% confidence interval | Paired t-test | Wilcoxson signed rank test | |
---|---|---|---|---|---|---|---|
TEAEs | |||||||
Total doses ≥ 10 | 289 | 1st to 5th dose | 2.86 | ||||
6th to 10th dose | 2.10 | 0.758 | 0.371, 1.145 | p ≤ 0.0001 | p < 0.0001 | ||
Total doses ≥ 20 | 181 | 1st to 5th dose | 2.84 | ||||
6th to 10th dose | 2.07 | 0.768 | 0.226, 1.310 | p = 0.0057 | p = 0.0002 | ||
11th to 15th dose | 1.70 | 1.138 | 0.535, 1.741 | p = 0.0003 | p < 0.0001 | ||
16th to 20th dose | 1.61 | 1.227 | 0.613, 1.840 | p = 0.0001 | p < 0.0001 | ||
Visits with TEAEs | Mean number of visits with TEAEs | Mean differencea | 95% confidence interval | Paired t-test | Wilcoxson signed rank test | ||
Total doses ≥ 10 | 289 | 1st to 5th dose | 1.61 | ||||
6th to 10th dose | 1.25 | 0.360 | 0.204, 0.516 | p < 0.0001 | p < 0.0001 | ||
Total doses ≥ 20 | 181 | 1st to 5th dose | 1.59 | ||||
6th to 10th dose | 1.29 | 0.304 | 0.097, 0.511 | p = 0.0042 | p = 0.0018 | ||
11th to 15th dose | 1.12 | 0.475 | 0.241, 0.709 | p < 0.0001 | p < 0.0001 | ||
16th to 20th dose | 1.04 | 0.547 | 0.315, 0.779 | p < 0.0001 | p < 0.0001 |