Table 2.
Incidence of AEs and SAEs in the SS Study Population
| Letibotulinum Toxin A (n = 376) | Onabotulinum Toxin A (n = 122) | P | |||
|---|---|---|---|---|---|
| Participants, n (Prevalence, %) | Events, n | Participants, n (Prevalence, %) | Events, n | ||
| All AEs | 142 (37.8) | 221 | 53 (43.4) | 80 | 0.264 |
| Severity of AEs | |||||
| Light | 117 (31.1) | 194 | 43 (35.2) | 66 | 0.537 |
| Intermediate | 25 (6.6) | 27 | 9 (7.4) | 13 | |
| Serious | 0 | 0 | 1 (0.8) | 1 | |
| Relevance to study drug | |||||
| Unrelated* | 126 (33.5) | 203 | 49 (40.2) | 76 | 0.748 |
| Related† | 16 (4.3) | 18 | 4 (3.3) | 4 | |
| AEs leading to study discontinuation | 0 | 0 | 0 | 0 | NA |
| SAEs | 6 (1.6) | 6 | 3 (2.5) | 4 | 0.463 |
| sADRs‡ | 1 (0.3) | 1 | 0 | 0 | >0.999 |
*
AEs unrelated to study drug include AEs classified as “not related” and “may not be related.”
†
AEs related to study drug include AEs classified as “maybe related,” “highly probably related,” and “definitely related.”
‡
The sADR in the letibotulinum toxin A group was classified as MedDRA primary SOC (PT): eye disorders (eyelid ptosis).