30 CHAPTER 1 baseline was significantly lower than the first baseline. The third drooling quotient baseline was not significantly different compared to baseline 1. An overall clinically meaningful change was observed in 74.0%, 41.6%, and 45.8% after the first, second, and third injection respectively. A paired t-test showed no significant time difference in duration of assessment between the injections. The mean duration between the first injection and the subsequent baseline was 50.3 weeks (SD 40.8). The mean duration between the second injection and third baseline was 61.6 weeks (SD 52.4). A repeated ANOVA with a Greenhouse–Geisser correction showed no significant difference of the duration between the day of injection to the actually performed 8-week follow-up per each injection (first injection 9.1wks, SD 2.0 wks, second injection 9.0wks, SD 1.5wks, third injection 9.5wks, SD 3.8wk). Potential complications and adverse events Adverse events after each onabotulinum neurotoxin A injection are reported in Table 2. No serious adverse events were reported. χ2 tests show no significant differences between injections in the overall frequency of adverse events. Table 2: Adverse events and complications after onabotulinum neurotoxin A injections reported by parents Injection #1 #2 #3 Adverse events, n (%) 12 (15.6) 10 (13.0) 4 (16.7) Xerostomiaa 5 3 1 Diminished feeding or discomfort during feeding 4 1 2 Diminished drinking 0 1 1 Saliva swallowing problemsb 6 7 2 Pneumonia (possibly due to aspiration) 0 1 0 Teeth grinding 0 0 1 Bruises injection location 1 0 0 aXerostomia included dry mouth and dry lips. bProblems with saliva swallowing included changes in viscosity, increased choking/gagging, and discomfort during swallowing.29
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