Table 2.

Summary of AEs (safety analysis set)

	Maximum reported CTCAE gradeb	Number (%) of patientsa
		Imaradenant 50-mg QD (n = 3)	Imaradenant 75-mg QD (n = 7)	Total (N = 10)
Any AE	Any grade	2 (67)	7 (100)	9 (90)
	Grade 1–2	2 (67)	7 (100)	9 (90)
	Grade ≥ 3	0	0	0
Any AE leading to dose interruption of treatment	Any grade	0	2 (29)	2 (20)
Any AE causally related to treatmentc	Any grade	1 (33)	4 (57)	5 (50)
	Grade 1	1 (33)	1 (14)	2 (20)
	Grade 2	0	3 (43)	3 (30)
Treatment-related AEs, System organ class, Preferred termd
Metabolism and nutrition disorders	Grade 1	0	1 (14)	1 (10)
Decreased appetite	Grade 1	0	1 (14)	1 (10)
Psychiatric disorders	Grade 1	0	1 (14)	1 (10)
Insomnia	Grade 1	0	1 (14)	1 (10)
Vascular disorders	Grade 1	0	1 (14)	1 (10)
Orthostatic hypotension	Grade 1	0	1 (14)	1 (10)
Gastrointestinal disorders	Grade 1	1 (33)	0	1 (10)
	Grade 2	0	3 (43)	3 (30)
Diarrhea	Grade 2	0	1 (14)	1 (10)
Gastritis	Grade 1	1 (33)	0	1 (10)
Nausea	Grade 1	1 (33)	1 (14)	2 (20)
	Grade 2	0	2 (29)	2 (20)
Vomiting	Grade 1	1 (33)	1 (14)	2 (20)
General disorders and administration site conditions	Grade 1	1 (33)	1 (14)	2 (20)
	Grade 2	0	1 (14)	1 (10)
Malaise	Grade 1	0	1 (14)	1 (10)
	Grade 2	0	1 (14)	1 (10)
Pyrexia	Grade 1	1 (33)	0	1 (10)

AE adverse event, CTCAE Common Terminology Criteria for Adverse Events version 4.03, QD once daily

^aPatients with multiple events in the same category were counted only once in that category. Patients with events in more than one category were counted once in each of those categories. Includes AEs with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of study medication

^bThe maximum CTCAE grade was reported for each event occurring per patient

^cAs assessed by the investigator and programmatically derived from causality assessments

^dClassified using the Medical Dictionary for Regulatory Activities version 23.1