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Table 1 The most common adverse events (>10%) in SEGA patients aged 0–65 years in EXIST-1 and adult AML patients in EXIST-2 [20, 21]

From: Management of everolimus-associated adverse events in patients with tuberous sclerosis complex: a practical guide

Adverse event (all grades) EXIST-1 EXIST-2
  Everolimus
4.5 mg/m2 per day
Placebo Everolimus 10 mg/day Placebo
Mouth ulceration 32 5 16 5
Stomatitis 31 21 48 8
Convulsion 23 26 - -
Pyrexia 22 15 - -
Nasopharyngitis 18 23 24 31
Vomiting 17 13 15 5
Upper respiratory tract infection 15 18 10 5
Fatigue 14 3 18 18
Cough 13 10 20 13
Diarrhoea 13 5 13 5
Rash 12 5 - -
Bronchitis 10 10 - -
Otitis media 10 5 - -
Pharyngitis 10 3 - -
Acne-like skin lesions - - 22 5
Headache - - 22 18
Hypercholesterolaemia - - 20 3
Aphthous stomatitis - - 19 10
Nausea - - 16 13
Urinary tract infection - - 15 15
Anaemia - - 13 3
Arthralgia - - 13 5
Abdominal pain - - 11 8
Blood lactate dehydrogenase increased - - 11 5
Hypophosphataemia - - 11 0
Eczema - - 10 8
Leucopenia - - 10 8
Oropharyngeal pain - - 10 10