Table 2.
Median injection interval | Number of subjects in interval groupa n (%) | Number of subjects with ≥1 AEb n (%) |
---|---|---|
6 to ≤10 weeks | 22 (23.7) | 18/22 (81.8)c |
>10 to ≤12 weeks | 30 (32.3) | 24/30 (80.0)c |
>12 to ≤14 weeks | 23 (24.7) | 22/23 (95.7)c |
>14 to 20 weeks | 18 (19.4) | 12/18 (66.7)c |
All intervals | 93 (100) | 76/93 (81.7)c |
Subjects were actively asked at each visit if they experienced drooping of the eyelid, problems with vision, dry eyes, dry mouth, swallowing difficulties, speech problems, shortness of breath, respiratory infection, local weakness, facial weakness, general body weakness, or stomach or bowel disturbances
AE treatment-emergent adverse event, OLEX open-label extension period
aNinety-three subjects received ≥2 injections and ≤5 injections in the OLEX and were included in this analysis
bSeventy-six of these 93 subjects experienced ≥1 AE during the OLEX
cA Chi square test did not show significant differences in the overall occurrence of AEs between the different injection interval groups (p = 0.1229)