Table 6 Adverse events reported during the study
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%) |