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Table 4 Adverse events in >  3 % of patients

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

AEs, n (%) Safety population
(N  =  120)
Pediatric subpopulation
(N  =  90)
All Grades Grade 3 or 4 All Grades Grade 3 or 4
Patients with any AE(s) 89 (74.2) 28 (23.3) 67 (74.4) 23 (25.5)
Preferred term
 Aphthous stomatitis 18 (15.0) 2 (1.7) 13 (14.4) 1 (1.1)
 Pyrexia 18 (15.0) 1 (0.8) 16 (17.8) 1 (1.1)
 Bronchitis 11 (9.2) 1 (0.8) 11 (12.2) 1 (1.1)
 Stomatitis 10 (8.3) 4 (3.3) 7 (7.8) 4 (4.4)
 Cough 6 (5.0) - 5 (5.6) -
 Diarrhea 6 (5.0) 1 (0.8) 5 (5.6) 1 (1.1)
 Headache 6 (5.0) 1 (0.8) 3 (3.3) 1 (1.1)
 Mouth ulceration 6 (5.0) - 5 (5.6) -
 Sinusitis 6 (5.0) 1 (0.8) 6 (6.7) 1 (1.1)
 Abdominal pain 5 (4.2) - 3 (3.3) -
 Blood creatine phosphokinase increased 5 (4.2) 1 (0.8) 3 (3.3) 1 (1.1)
 Gastroenteritis 5 (4.2) 1 (0.8) 4 (4.4) 1 (1.1)
 Hypercholesterolemia 5 (4.2) - - -
 Pharyngitis 5 (4.2) - 5 (5.6) -
 Pneumonia 5 (4.2) - 5 (5.6) -
 Pneumonitis 5 (4.2) - 5 (5.6) -
 Upper respiratory tract infection 5 (4.2) - 4 (4.4) -
 Menstruation irregular 4 (3.3) a - 3 (3.3) -
 Nasopharyngitis 4 (3.3) - 4 (4.4) -
 Otitis media 4 (3.3) - 4 (4.4) -
 Urinary tract infection 4 (3.3) - - -
  1. AE adverse event
  2. aThis percentage includes all patients as the denominator. If we consider the females with child bearing potential (n = 24), 16.6 % of patients reported menstrual irregular events