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Table 5 Deaths, serious adverse events, and adverse events leading to permanent discontinuation of study drug (safety population)

From: EFFECTS: an expanded access program of everolimus for patients with subependymal giant cell astrocytoma associated with tuberous sclerosis complex

AEs, n (%) Everolimus
N  =  120
Patients with any AE(s) 89 (74.2)
 Death 0 (0.0)
 SAE(s) 32 (26.7)
 Discontinuation due to AE(s) a 8 (6.7)
 AE(s) causing dose adjustment or study drug interruption 36 (30.0)
 CTC Grade 3 or 4 28 (23.3)
 Leading to hospitalization/prolonged hospitalization 29 (24.2)
 Suspected to be drug related 62 (51.7)
  1. AE adverse event, CTC common terminology criteria, SAE serious adverse event
  2. aIncludes abnormal laboratory values