TABLE 4.
TEAEs in at least 1 percent of the open-label subjects
| TEAE MEASUREMENT | STUDY 04 | STUDY 05 |
|---|---|---|
| Subjects with one or more TEAEs, n (%) | 65 (22.9) | 120 (32.2) |
| Noncutaneous AEs, n (%) | ||
| Nasopharyngitis | 10 (3.5) | 23 (6.2) |
| Influenza | 6 (2.1) | 5 (1.3) |
| CK increase | 5 (1.8) | 10 (2.7) |
| Cough | 4 (1.4) | NA |
| Headache | 4 (1.4) | 17 (4.6) |
| URTI | 4 (1.4) | NA |
| Back pain | 3 (1.1) | NA |
| Pharyngitis streptococcal | 3 (1.1) | NA |
| Pyrexia | 3 (1.1) | NA |
| UTI | 3 (1.1) | NA |
| Sinusitis | NA | 8 (2.1) |
| ALT increase | NA | 5 (1.3) |
| Abdominal pain | NA | 4 (1.1) |
| AST increase | NA | 4 (1.1) |
| Gastroenteritis | NA | 4 (1.1) |
| Cutaneous AEs, n (%) | ||
| Application-site acne | 3 (1.1) | NA |
ALT: alanine aminotransferase; AST: aspartate aminotransferase; CK: creatine phosphokinase; NA: not applicable; TEAE: treatment-emergent adverse event; URTI: upper respiratory tract infection; UTI: urinary tract infection