TABLE 2.

Overview of Adverse Events Experienced by >2% of Children in at Least One Treatment Group (Safety Population)^*

Adverse Event (MedDRA Preferred Term), n (%)	Baloxavir Marboxil (n = 79)	Oseltamivir (n = 39)	All (N = 118)
Vomiting	4 (5)	7 (18)	11 (9)
Medication error	4 (5)	1 (3)	5 (4)
Diarrhea	4 (5)	0	4 (3)
Rhinorrhea	3 (4)	1 (3)	4 (3)
Headache	2 (3)	1 (3)	3 (3)
Pharyngitis streptococcal	2 (3)	1 (3)	3 (3)
Upper respiratory tract infection	2 (3)	1 (3)	3 (3)
Accidental overdose	2 (3)	1 (3)	3 (3)
Rash	2 (3)	0	2 (2)
Ear pain	1 (1)	1 (3)	2 (2)
Abdominal pain	1 (1)	1 (3)	2 (2)
Otitis media	0	2 (5)	2 (2)
Asthma	1 (1)	1 (3)	2 (2)
Rhinitis allergic	2 (3)	0	2 (2)
Gastroenteritis viral	0	1 (3)	1 (1)
Otitis media acute	0	1 (3)	1 (1)

^*The safety population comprised children 5–11 years of age who received any portion of a single dose of treatment.

MedDRA indicates Medical Dictionary for Regulatory Activities.