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Table 3 Adverse events of any cause experienced by ≥10 % patients over the study (N = 19)

From: Everolimus safety and efficacy for renal angiomyolipomas associated with tuberous sclerosis complex: a Spanish expanded access trial

Adverse event, n (%)

All grades

Grade 1

Grade 2

Grade 3

Aphthous stomatitis

11 (57.9)

11 (57.9)

0 (0.0)

0 (0.0)

Hypercholesterolaemia

11 (57.9)

5 (26.3)

6 (31.6)

0 (0.0)

Hypertriglyceridaemia

8 (42.1)

3 (15.8)

3 (15.8)

2 (10.5)

Urinary tract infection

8 (42.1)

2 (10.5)

6 (31.6)

0 (0.0)

Mucosal inflammation

7 (36.8)

5 (26.3)

1 (5.3)

1 (5.3)

Hypertension

6 (31.6)

3 (15.8)

2 (10.5)

1 (5.3)

Dermatitis acneiform

5 (26.3)

5 (26.3)

0 (0.0)

0 (0.0)

Insomnia

5 (26.3)

5 (26.3)

0 (0.0)

0 (0.0)

Catarrh

4 (21.1)

4 (21.1)

0 (0.0)

0 (0.0)

Diarrhoea

4 (21.1)

3 (15.8)

1 (5.3)

0 (0.0)

Amenorrhoea

3 (15.8)

3 (15.8)

0 (0.0)

0 (0.0)

Asthenia

3 (15.8)

3 (15.8)

0 (0.0)

0 (0.0)

Headache

3 (15.8)

3 (15.8)

0 (0.0)

0 (0.0)

Dysgeusia

3 (15.8)

3 (15.8)

0 (0.0)

0 (0.0)

Pharyngitis

3 (15.8)

3 (15.8)

0 (0.0)

0 (0.0)

Nasopharyngitis

3 (15.8)

2 (10.5)

1 (5.3)

0 (0.0)

Cough

3 (15.8)

3 (15.8)

0 (0.0)

0 (0.0)

Menstrual disorder

3 (15.8)

3 (15.8)

0 (0.0)

0 (0.0)

Conjunctivitis

2 (10.5)

2 (10.5)

0 (0.0)

0 (0.0)

Dermatitis

2 (10.5)

2 (10.5)

0 (0.0)

0 (0.0)

Back pain

2 (10.5)

2 (10.5)

0 (0.0)

0 (0.0)

Abdominal pain upper

2 (10.5)

2 (10.5)

0 (0.0)

0 (0.0)

Epistaxis

2 (10.5)

2 (10.5)

0 (0.0)

0 (0.0)

Erythema

2 (10.5)

1 (5.3)

1 (5.3)

0 (0.0)

Rash

2 (10.5)

2 (10.5)

0 (0.0)

0 (0.0)

Oral herpes

2 (10.5)

2 (10.5)

0 (0.0)

0 (0.0)

Dizziness

2 (10.5)

2 (10.5)

0 (0.0)

0 (0.0)

Menorrhagia

2 (10.5)

2 (10.5)

0 (0.0)

0 (0.0)

Myalgia

2 (10.5)

2 (10.5)

0 (0.0)

0 (0.0)

Pyrexia

2 (10.5)

2 (10.5)

0 (0.0)

0 (0.0)

Vomiting

2 (10.5)

2 (10.5)

0 (0.0)

0 (0.0)

Gamma-glutamyltransferase increased

2 (10.5)

0 (0.0)

2 (10.5)

0 (0.0)

Transaminases increased

2 (10.5)

0 (0.0)

1 (5.3)

1 (5.3)

  1. All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA) preferred term and graded as per the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (version 4.03)