Table 6.
Number of patients presenting adverse events (n, %) | Children [N = 203] |
Adults [N = 280] |
Total [N = 483] |
---|---|---|---|
Any adverse event Number of adverse events |
47 (23.2%) 91 |
75 (26.8%) 164 |
122 (25.3%) 255 |
Adverse events related to 5GPE-SLIT Number of adverse events |
36 (17.7%) 67 |
62 (22.1%) 140 |
98 (20.3%) 207 |
Unexpected adverse events related to 5GPE-SLIT Number of adverse events |
3 (1.5%) | 5 (1.8%) | 8 (1.7%) |
Serious adverse events related to 5GPE-SLIT Number of adverse events |
2 (1.0%) | 2 (0.7%) | 4 (0.8%) 11 |
Serious and unexpected adverse events related to 5GPE-SLIT Number of adverse events |
None | 1 (0.4%) | 1 (0.2%) |
Italic represents the number of adverse events (one patient could have several dares event, and could be removed for the 3 last items (unexpected adverse events, serious adverse events, unexpected and serious adverse events)