Table 3

Summary of treatment-emergent adverse events (TEAEs) by preferred terms reported in > 1% of patients in the FAS

TEAE, n (%)FAS (n = 294)
Urinary tract infection21 (7.1)
Anemia19 (6.5)
Pneumonia8 (2.7)
Hypoproteinemia8 (2.7)
Diarrhea6 (2.0)
Hypokalemia6 (2.0)
Hematuria6 (2.0)
Hepatic function abnormal6 (2.0)
Hot flush6 (2.0)
Constipation5 (1.7)
Insomnia5 (1.7)
Upper respiratory tract infection5 (1.7)
Liver injury5 (1.7)
Chronic gastritis4 (1.4)
Hyperlipidemia4 (1.4)
Blood lactate dehydrogenase increased4 (1.4)

FAS, full analysis set.