Table 5 Events occurring pre-treatment and on or post-treatment (AE = adverse events; TESS = treatment-emergent signs & symptoms)
Pre-treatment | On or Post-treatment | ||
|---|---|---|---|
AE | TESS | ||
N patient with at least 1 event | 1213 | 441 | 347 |
(%) | 33% | 12% | 9% |
N patient with at least 1 event by age | |||
< 6 yr | 141 (4%) | 35 (8%) | 28 (8%) |
6-16 yr | 529 (44%) | 167 (38%) | 126 (36%) |
> 16 yr | 521 (43%) | 228 (52%) | 175 (50%) |
p-value | < .0001 | < .0001 | < .0001 |
N of events | 3897 | 1144 | 688 |
N mild/ moderate | 2828 | 806 | 516 |
(%) | 73% | 70% | 75% |
N severe/ very severe | 1071 | 338 | 172 |
(%) | 27% | 30% | 25% |