Table 3.

Treatment-Emergent Adverse Events Leading to Dose Modification/Discontinuation of Treatment

Treatment-Emergent Adverse Events	Favipiravir
	N=1083
	n (%) (E)
Number of patients with at least one TEAE	4 (0.37) (6)
Gastrointestinal disorders	2 (0.18) (2)
Gastritis	2 (0.18) (2)
Investigations	2 (0.18) (4)
Alanine aminotransferase increased	2 (0.18) (2)
Aspartate aminotransferase increased	2 (0.18) (2)

Notes: A patient with multiple AEs was counted only once in the “at least one event” row. At each level of summarization, a patient with multiple AEs within SOC/PT was counted only once. SOCs were presented alphabetically; PTs were sorted within the primary SOC by descending frequency. Percentages were based on the number of patients in the safety analysis set. AEs with a start date on or after the date of the first study treatment administration were counted.

Abbreviations: AE, adverse event; E, the total number of events in the safety analysis set; PT, preferred term; SOC, system organ class; TEAE, treatment-emergent adverse event.