Table 2. Adverse Events With at Least 2 Cases.
| System Organ Class/Preferred Termsa | No. (%) | |||||
|---|---|---|---|---|---|---|
| Sirolimus | Placebo | |||||
| Total (n = 30) |
Pediatric (n = 13) |
Adult (n = 17) |
Total (n = 32) |
Pediatric (n = 14) |
Adult (n = 18) |
|
| Any adverse event | 27 (90) | 10 (77) | 17 (100) | 22 (69) | 10 (71) | 12 (67) |
| Influenza | 3 (10) | 3 (23) | 0 | 0 | 0 | 0 |
| Nasopharyngitis | 1 (3) | 1 (8) | 0 | 3 (9) | 3 (21) | 0 |
| Eye irritation | 1 (3) | 1 (8) | 0 | 2 (6) | 1 (7) | 1 (6) |
| Upper respiratory tract inflammation | 0 | 0 | 0 | 2 (6) | 1 (7) | 1 (6) |
| Stomatitis | 1 (3) | 0 | 1 (6) | 2 (6) | 0 | 2 (11) |
| Acne | 2 (7) | 0 | 2 (12) | 0 | 0 | 0 |
| Dry skin | 11 (37) | 4 (31) | 7 (41) | 4 (13) | 2 (14) | 2 (11) |
| Pruritus | 7 (23) | 1 (8) | 6 (35) | 4 (13) | 2 (14) | 2 (11) |
| Application site irritation | 11 (37) | 4 (31) | 7 (41) | 9 (28) | 3 (21) | 6 (33) |
| Skin abrasion | 0 | 0 | 0 | 2 (6) | 1 (7) | 1 (6) |
a
MedDRA (Medical Dictionary for Regulatory Activities), version 19.0.