Table 2.

Incidence of events after random assignment and stratified by ODC1 genotype (dominant model)

Adverse events	Placebo (n = 111)		Eflornithine/sulindac (n = 117)		P*
	GG, No. (%)	GA or AA, No. (%)	GG, No. (%)	GA or AA, No. (%)
Any adenoma recurrence	22 (50)	18 (34)	7 (11)	9 (21)	<.001
Any adverse event
Cardiovascular events†	8 (15)	8 (14)	13 (18)	9 (20)	.30
Gastrointestinal events‡	4 (7)	8 (14)	9 (13)	7 (15)	.54
Hearing loss of at least 15dB at ≥ 2 frequencies	10 (23)	9 (17)	14 (22)	11 (27	.26

^*P value for the likelihood ratio test for treatment effect (eflornithine and sulindac vs placebo) on adenoma recurrence in the full model, which includes age (years, as a continuous variable), sex, race or ethnicity, aspirin use, treatment, genotype, and treatment and genotype interaction as covariates. A statistically significant interaction was detected in the full model for adenoma recurrence (P = .038); no interaction was detected for cardiovascular toxicity, gastrointestinal toxicity, or ototoxicity. All statistical tests were two-sided.

^†Cardiovascular events included coronary artery disease, myocardial infarction, cerebrovascular accident, congestive heart failure, and chest pain.

^‡Gastrointestinal events included gastrointestinal bleeding (from any region), such as rectal bleeding, upper gastrointestinal bleeding, hematochezia, or occult blood in the stool.