Table 1 Adverse events (AEs) that occurred in >5% of elderly subjects in any treatment group during the 1-year study.

Ordered by total frequency. Under one treatment, a participant with multiple occurrences of an AE is counted only once in the AE category.

RAD001 (0.1 mg)
N = 52 (%)
RAD001 (0.5 mg)
N = 54 (%)
BEZ235 (10 mg)
N = 53 (%)
RAD001 (0.1 mg) +
BEZ235 (10 mg)
N = 53 (%)
Placebo, pooled
N = 52 (%)
Total N = 264 (%)
Total AEs3204063463194011792
Patients with AEs50 (96.2)52 (96.3)52 (98.1)51 (96.2)51 (98.1)256 (97.0)
Upper respiratory
tract infection
11 (21.2)12 (22.2)11 (20.8)14 (26.4)16 (30.8)64 (24.2)
Headache7 (13.5)16 (29.6)13 (24.5)11 (20.8)9 (17.3)56 (21.2)
Nasopharyngitis14 (26.9)13 (24.1)6 (11.3)7 (13.2)10 (19.2)50 (18.9)
Diarrhea10 (19.2)12 (22.2)10 (18.9)9 (17.0)4 (7.7)45 (17.0)
Cough7 (13.5)7 (13.0)6 (11.3)5 (9.4)10 (19.2)35 (13.3)
Fatigue6 (11.5)4 (7.4)8 (15.1)4 (7.5)6 (11.5)28 (10.6)
Oropharyngeal pain8 (15.4)2 (3.7)8 (15.1)1 (1.9)7 (13.5)26 (9.8)
Arthralgia4 (7.7)7 (13.0)6 (11.3)3 (5.7)5 (9.6)25 (9.5)
Fall4 (7.7)3 (5.6)6 (11.3)7 (13.2)5 (9.6)25 (9.5)
Nausea4 (7.7)6 (11.1)4 (7.5)7 (13.2)4 (7.7)25 (9.5)
Rhinitis3 (5.8)4 (7.4)3 (5.7)9 (17.0)6 (11.5)25 (9.5)
Dizziness5 (9.6)5 (9.3)6 (11.3)3 (5.7)4 (7.7)23 (8.7)
Back pain5 (9.6)08 (15.1)2 (3.8)5 (9.6)20 (7.6)
Contusion5 (9.6)2 (3.7)2 (3.8)7 (13.2)4 (7.7)20 (7.6)
Oral herpes5 (9.6)2 (3.7)7 (13.2)3 (5.7)3 (5.8)20 (7.6)
Urinary tract
infection
5 (9.6)5 (9.3)2 (3.8)07 (13.5)19 (7.2)
Lower respiratory
tract infection
3 (5.8)3 (5.6)1 (1.9)5 (9.4)6 (11.5)18 (6.8)
Gastroenteritis3 (5.8)4 (7.4)3 (5.7)5 (9.4)2 (3.8)17 (6.4)
Mouth ulceration5 (9.6)2 (3.7)2 (3.8)6 (11.3)2 (3.8)17 (6.4)
Muscle strain3 (5.8)4 (7.4)2 (3.8)3 (5.7)5 (9.6)17 (6.4)
Constipation3 (5.8)6 (11.1)4 (7.5)1 (1.9)2 (3.8)16 (6.1)
Bronchitis3 (5.8)3 (5.6)2 (3.8)3 (5.7)3 (5.8)14 (5.3)
Laceration4 (7.7)2 (3.7)2 (3.8)3 (5.7)3 (5.8)14 (5.3)
Musculoskeletal pain1 (1.9)8 (14.8)1 (1.9)4 (7.5)014 (5.3)
Pain in extremity1 (1.9)3 (5.6)3 (5.7)2 (3.8)5 (9.6)14 (5.3)