Table 4. Incidence of adverse events ^a per treatment group.

n (%)	CVC 100 mg (n = 58)	CVC 200 mg (n = 57)	EFV 600 mg (n = 28)	P value b
Treatment-emergent grade ≥3 adverse events	2 (3)	3 (5)	4 (14)	0.142
Grade 3	2 (3)	3 (5)	3 (11)
Grade 4	0 (0)	0 (0)	1 (4)
Treatment-emergent grade ≥2 adverse events c	5 (9) d	5 (9) d	10 (36)	0.001
Psychiatric disorders	1 (2)	2 (4)	6 (21)
Abnormal dreams	1 (2)	0 (0)	3 (11)
Insomnia	0 (0)	0 (0)	3 (11)
Gastrointestinal disorders	2 (3)	2 (4)	2 (7)
Nausea	0 (0)	2 (4)	2 (7)
Nervous system disorders	1 (2)	1 (2)	3 (11)
Skin and subcutaneous tissue disorders	2 (3)	0 (0)	3 (11)
Rash events	1 (2)	0 (0)	2 (7)
Adverse events leading to discontinuation	0 (0) e	1 (2) e	6 (21)	<0.001
Serious adverse events	1 (2)	1 (2)	1 (4)	0.833
Deaths	0 (0)	0 (0)	0 (0)

CVC, cenicriviroc; EFV, efavirenz; ITT, intention-to-treat.

^aIn study participants who had received at least one dose of study drug. One study participant was randomized to receive CVC 100 mg, but took CVC 200 mg (incorrect treatment kit); the study participant was included in the 100 mg arm in the ITT population, but in the 200 mg arm in the safety population.

^bThe P values were assessed using a Cochran–Mantel–Haenszel test for differences between treatment groups in number of study participants with the adverse event type.

^cAt least possibly related (as determined by study investigator) in at least 5% of study participants.

^dPairwise comparisons with the EFV arm, using a Cochran–Mantel–Haenszel test, showed statistical significance (P = 0.002 for each CVC dose versus EFV).

^ePairwise comparisons with the EFV arm, using a Cochran–Mantel–Haenszel test, showed statistical significance (P < 0.001 CVC100 versus EFV; P = 0.002 for CVC200 versus EFV).