TABLE 3.
Summary of TEAEs in the safety population and rates of discontinuation
| PARAMETERS | STUDY 04 (n=284) |
STUDY 05 (n=373) |
|---|---|---|
| Subjects with any TEAE, n (%) | 65 (22.9) | 120 (32.2) |
| Number of TEAEs | 132 | 207 |
| Subjects with any serious TEAE, n (%) | 1 (0.4) | 1 (0.3) |
| Number of serious TEAEs | 1a | 2b |
| Subjects with treatment-related TEAEs, n (%) | 5 (1.8) | 8 (2.1) |
| Number of treatment-related TEAEs | 7c | 11d |
| Subjects discontinued due to TEAE, n (%) | 2 (0.7) | 5 (1.3) |
| Number of TEAEs leading to discontinuation | 25 | 55 |
TEAE: treatment-emergent adverse event
a
Pneumonia
b
Fatigue, head injury from fainting
c
Increased alanine aminotransferase, increased aspartate aminotransferase, increased gamma-glutamyltransferase, application-site acne, headache
d
Headache, migraine, sunburn, application-site dermatitis, application-site discoloration, application-site edema, pharyngeal erythema, seborrheic dermatitis, lymphadenopathy
e
Application-site acne
f
Application-site edema, upper abdominal pain, flank pain, application-site dermatitis