Table 2 Overview of adverse events (AEs) and serious adverse events (SAEs)
From: Safety and efficacy of low-dose sirolimus in the PIK3CA-related overgrowth spectrum
Intention-to-treat population (n=39) | |
|---|---|
Total number of AEs recorded | 103 AEs in 31/39 (79%) participants 54/103 AEs (52%) unrelated to sirolimus |
At least one sirolimus-related AE (all grades) | 28/39 (72%) |
At least one event of ≥ grade 3 severity | 13/39 (33%) |
Death (grade 5) | 0 (0%) |
At least one SAE | 11/39 (28%) |
At least one SAE and ≥ grade 3 severity | 10/39 (26%) |
At least one event leading to permanent discontinuation of sirolimus | 7/39 (18%) |
