TABLE 2.
Frequent TRAEs (>3%, overall) in the overall population, by sex, and across age groups.
| Category | Overall | By sex | By age at consent, years | ||||
|---|---|---|---|---|---|---|---|
| N = 179 | Female N = 106 | Male N = 73 | ≤2 N = 7 | >2 to ≤9 N = 27 | >9 to <18 N = 27 | ≥18 N = 118 | |
| Patients with any frequent AEs suspected to be everolimus-related, n (%) | 49 (27.4) | 30 (28.3) | 19 (26.0) | 5 (71.4) | 12 (44.4) | 11 (40.7) | 21 (17.8) |
| Stomatitis | 14 (7.8) | 7 (6.6) | 7 (9.6) | 2 (28.6) | 4 (14.8) | 5 (18.5) | 3 (2.5) |
| Aphthous ulcer | 12 (6.7) | 7 (6.6) | 5 (6.8) | 1 (14.3) | 3 (11.1) | 1 (3.7) | 7 (5.9) |
| Hypercholesterolemia | 11 (6.1) | 8 (7.5) | 3 (4.1) | 1 (14.3) | 4 (14.8) | 3 (11.1) | 3 (2.5) |
| Pneumonia | 8 (4.5) | 3 (2.8) | 5 (6.8) | 2 (28.6) | 3 (11.1) | 0 | 3 (2.5) |
| Headache | 7 (3.9) | 5 (4.7) | 2 (2.7) | 0 | 0 | 2 (7.4) | 5 (4.2) |
| Hypertriglyceridemia | 6 (3.4) | 5 (4.7) | 1 (1.4) | 0 | 0 | 4 (14.8) | 2 (1.7) |
| Mouth ulceration | 6 (3.4) | 5 (4.7) | 1 (1.4) | 1 (14.3) | 2 (7.4) | 2 (7.4) | 1 (0.8) |
| Patients with frequent AEs suspected to be everolimus-related with CTC grade a , n (%) | 49 (27.4) | 30 (28.3) | 19 (26.0) | 5 (71.4) | 12 (44.4) | 11 (40.7) | 21 (17.8) |
| Grade 1 | 27 (15.1) | 17 (16.0) | 10 (13.7) | 2 (28.6) | 8 (29.6) | 7 (25.9) | 10 (8.5) |
| Grade 2 | 15 (8.4) | 9 (8.5) | 6 (8.2) | 2 (28.6) | 1 (3.7) | 2 (7.4) | 10 (8.5) |
| Grade 3 | 7 (3.9) | 4 (3.8) | 3 (4.1) | 1 (14.3) | 3 (11.1) | 2 (7.4) | 1 (0.8) |
AEs, adverse events; CTC, Common Terminology Criteria; CTCAE, Common Terminology Criteria for Adverse Events; MedDRA, Medical Dictionary for Regulatory Activities; TRAEs, treatment-related adverse events.
MedDRA version 22.1 and CTCAE version 4.03 were used.
a
If a patient reported multiple frequent AEs, the frequent AE with the worst severity was used.