Table 2.

Number of adverse events (AEs) (safety set)

Category	Twice-daily treatment period (N = 18)	Once-daily treatment period (N = 18)	Any treatment period (N = 18)
Patients who had an AE	13 (72.2%)	11 (61.1%)	15 (83.3%)
Number of AEs	18	18	36
Patient who had a mild AE	12 (66.7%)	11 (61.1%)	14 (77.8%)
Number of mild AEs	15	16	31
Patients who had a moderate AE	2 (11.1%)	2 (11.1%)	4 (22.2%)
Number of moderate AEs	3	2	5
Patients who had a severe AE	0	0	0
Patients who had a treatment-related AE a	0	0	0
Patients who had an SAE	1 (5.6%)	0	1 (5.6%)
Number of SAEs	1	0	1
Patients who had an AE resulting in death	0	0	0

Note: Only AEs after first dose of study drug included. Percentages based on the number of patients in each treatment period

AE adverse event, SAE serious adverse event

^aRelationship judged by the investigator