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% |
82 events missing in the age-stratified analysis due to missing age.