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. Author manuscript; available in PMC: 2014 Jul 15.
Published in final edited form as: Clin Cancer Res. 2013 Jun 6;19(14):3987–3995. doi: 10.1158/1078-0432.CCR-13-0027

Table 5.

Adverse Events Occurring in ≥ 10% of Patients in Either Treatment Schedule (Safety Set)

Adverse events, N (%) Everolimus 70 mg/week (N = 99) Everolimus 10 mg/day (N = 100)

All grades Grade 3/4 All grades Grade 3/4
Fatigue 50 (50.5) 7 (7.1) 37 (37.0) 5 (5.0)
Nausea 41 (41.4) 3 (3.0) 22 (22.0) 0
Rash 34 (34.3) 0 29 (29.0) 0
Decreased appetite 31 (31.3) 1 (1.0) 25 (25.0) 1 (1.0)
Diarrhea 29 (29.3) 2 (2.0) 26 (26.0) 2 (2.0)
Vomiting 29 (29.3) 4 (4.0) 14 (14.0) 2 (2.0)
Anemia 26 (26.3) 5 (5.1) 19 (19.0) 3 (3.0)
Constipation 24 (24.2) 2 (2.0) 13 (13.0) 0
Dyspnea 21 (21.2) 3 (3.0) 21 (21.0) 4 (4.0)
Abdominal pain 20 (20.2) 3 (3.0) 15 (15.0) 3 (3.0)
Stomatitis 18 (18.2) 2 (2.0) 22 (22.0) 4 (4.0)
Mucosal inflammation 17 (17.2) 0 11 (11.0) 0
Edema peripheral 16 (16.2) 0 14 (14.0) 0
Thrombocytopenia 16 (16.2) 2 (2.0) 18 (18.0) 3 (3.0)
Asthenia 15 (15.2) 3 (3.0) 23 (23.0) 5 (5.0)
Pyrexia 14 (14.1) 0 16 (16.0) 0
Weight decreased 14 (14.1) 0 14 (14.0) 0
Cough 13 (13.1) 1 (1.0) 16 (16.0) 0
Dehydration 13 (13.1) 3 (3.0) 11 (11.0) 3 (3.0)
Hypercholesterolemia 13 (13.1) 3 (3.0) 10 (10.0) 2 (2.0)
Hyperglycemia 13 (13.1) 4 (4.0) 9 (9.0) 4 (4.0)
Back pain 10 (10.1) 0 8 (8.0) 2 (2.0)
Headache 10 (10.1) 0 7 (7.0) 0
Gamma-glutamyltransferase increased 9 (9.1) 6 (6.1) 13 (13.0) 7 (7.0)
Epistaxis 5 (5.1) 1 (1.0) 10 (10.0) 0