Table 4.

Treatment-emergent AEs occurring in ≥20% of patients in either treatment arm

Adverse event, n (%)	Telaglenastat + Everolimus (n=46)			Placebo + Everolimus (n=23)
	Any Grade	Grade 3	Grade 4	Any Grade	Grade 3	Grade 4
Any event	46 (100)	27 (59)	7 (15)	23 (100)	11 (48)	3 (13)
Fatigue	22 (48)	2 (4)	0	12 (52.2)	2 (9)	0
Anemia	19 (41)	9 (20)	0	8 (35)	4 (17)	0
Cough	16 (35)	0	0	10 (44)	0	0
Dyspnea	16 (35)	1 (2)	0	9 (39)	1 (4)	0
Blood creatinine increased	16 (35)	0	0	8 (35)	0	1 (4)
Decreased appetite	15 (33)	0	0	4 (17)	0	0
Nausea	15 (33)	1 (2)	0	4 (17)	0	0
Thrombocytopenia	15 (33)	3 (7)	0	1 (4)	0	0
Peripheral edema	12 (26)	1 (2)	0	5 (22)	0	0
Pruritus	11 (24)	1 (2)	0	7 (30)	1 (4)	0
Abdominal pain	11 (24)	4 (9)	0	3 (13)	0	0
Constipation	10 (22)	1 (2)	0	2 (9)	0	0
Diarrhea	10 (22)	1 (2)	0	11 (48)	0	0
Photophobia	10 (22)	0	0	3 (13)	0	0
Stomatitis	10 (22)	1 (2)	0	7 (30)	1 (4)	0
Hyperglycemia	7 (15)	3 (7)	0	6 (26)	1 (4)	0
Rash maculo-papular	5 (11)	1 (2)	0	6 (26)	1 (4)	0
Epistaxis	4 (9)	0	0	6 (26)	0	0

NOTE: Adverse events occurring during or after the first dose of study drug and up to 28 d after the last dose are shown, irrespective of whether the event was considered by the investigator to be related to the study treatment.