Table 3.

Incidence of adverse events reported by more than 3 patients in the PLA-DON10 group over time (SAS)

	PLA-DON10 group a
	AE				Treatment-related AE b
AE	Week 16–28	Week 28-40	Week >40	36 weeks	36 weeks
	( n =37)	( n =36)	( n =34)	( n =37)	( n =37)
				n (%)	n (%)
Total number of incidents	26	7	0	33 (89.2)	22 (59.5)
Constipation	3	0	0	3 (8.1)	1 (2.7)
Diarrhea	3	0	0	3 (8.1)	2 (5.4)
Nasopharyngitis	6	3	4	13 (35.1)	0
Dizziness	3	0	0	3 (8.1)	2 (5.4)
Parkinsonism	2	1	0	3 (8.1)	3 (8.1)

SAS, safety analysis set; AE, adverse event.

^aTreatment with 3 mg started at Week 16, and the dose was increased to 5 mg at Week 18 and to 10 mg at Week 24.

^bAEs for which a causal relation with the study drug was considered possible or probable.