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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