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Table 1 Patient disposition

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

n (%)

Everolimus

FAS (N = 120)

Everolimus pediatric subpopulation

(N = 90)

Patients

 Completed study

100 (83.3)

79 (87.8)

 Discontinued

20 (16.7)

11 (12.2)

Primary reason for premature discontinuation

 Adverse event(s)

8 (6.7) a

4 (4.4)

 Otherb

5 (4.2)

3 (3.3)

 Subject withdrew consent

5 (4.2)

2 (2.2)

 Administrative problems

1 (0.8)

1 (1.1)

 SEGA progression

1 (0.8)

1 (1.1)

  1. FAS full analysis set, SEGA subependymal giant cell astrocytoma
  2. aIncludes abnormal laboratory values
  3. bIncludes investigator’s decision and mother’s decision