Table 5.

AEs occurring in ≥10% of patients in either treatment schedule (safety set)

AEs, n (%)Everolimus 70 mg/wk (n = 99)Everolimus 10 mg/d (n = 100)
All gradesGrade 3/4All gradesGrade 3/4
Fatigue50 (50.5)7 (7.1)37 (37.0)5 (5.0)
Nausea41 (41.4)3 (3.0)22 (22.0)0
Rash34 (34.3)029 (29.0)0
Decreased appetite31 (31.3)1 (1.0)25 (25.0)1 (1.0)
Diarrhea29 (29.3)2 (2.0)26 (26.0)2 (2.0)
Vomiting29 (29.3)4 (4.0)14 (14.0)2 (2.0)
Anemia26 (26.3)5 (5.1)19 (19.0)3 (3.0)
Constipation24 (24.2)2 (2.0)13 (13.0)0
Dyspnea21 (21.2)3 (3.0)21 (21.0)4 (4.0)
Abdominal pain20 (20.2)3 (3.0)15 (15.0)3 (3.0)
Stomatitis18 (18.2)2 (2.0)22 (22.0)4 (4.0)
Mucosal inflammation17 (17.2)011 (11.0)0
Edema peripheral16 (16.2)014 (14.0)0
Thrombocytopenia16 (16.2)2 (2.0)18 (18.0)3 (3.0)
Asthenia15 (15.2)3 (3.0)23 (23.0)5 (5.0)
Pyrexia14 (14.1)016 (16.0)0
Weight decreased14 (14.1)014 (14.0)0
Cough13 (13.1)1 (1.0)16 (16.0)0
Dehydration13 (13.1)3 (3.0)11 (11.0)3 (3.0)
Hypercholesterolemia13 (13.1)3 (3.0)10 (10.0)2 (2.0)
Hyperglycemia13 (13.1)4 (4.0)9 (9.0)4 (4.0)
Back pain10 (10.1)08 (8.0)2 (2.0)
Headache10 (10.1)07 (7.0)0
Gamma-glutamyltransferase increased9 (9.1)6 (6.1)13 (13.0)7 (7.0)
Epistaxis5 (5.1)1 (1.0)10 (10.0)0